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pdfEvaluation of the
National DMEPOS
Competitive Bidding
Program
Revised Supporting
Statement for
Paperwork
Reduction Act
Submission
November 20, 2006
Prepared for
Ann Meadow, Sc.D.
Centers for Medicare & Medicaid
7500 Security Blvd.
Baltimore, MD 21244-1850
Prepared by
Abt Associates Inc.
Contents
Part A:
Background ....................................................................................................................... 1
Part B:
Justification ....................................................................................................................... 1
B.1 Explanation of Circumstances That Make Collection of Data Necessary .............................. 1
B.2 How the Information Will Be Collected, by Whom, and For What Purpose ......................... 1
B.3 Use of Improved Information Technology to Reduce Burden............................................... 4
B.4 Efforts to Identify and Avoid Duplication ............................................................................ 4
B.5 Efforts to Minimize Burden on Small Business or Other Entities ......................................... 5
B.6 Consequences of Less-Frequent Data Collection.................................................................. 5
B.7 Special Circumstances Requiring Collection of Information in a Manner Inconsistent with
Section 1320.5(d)(2) of the Code of Federal Regulations ............................................................... 6
B.8 Federal Register Comments and Persons Consulted Outside the Agency............................. 6
B.9 Payments to Respondents ................................................................................................... 7
B.10 Assurance of Confidentiality.............................................................................................. 7
B.11 Questions of a Sensitive Nature .......................................................................................... 8
B.12 Estimates of Respondent Burden ........................................................................................ 8
B.13 Estimates of the Cost Burden to Respondents ................................................................... 10
B.14 Estimates of Annualized Government Costs ..................................................................... 10
B.15 Changes in Hour Burden .................................................................................................. 10
B.16 Time Schedule, Publication, and Analysis Plan................................................................. 10
B.17 Display of Expiration Date for OMB Approval................................................................. 16
B.18 Exceptions to Certification Statement ............................................................................... 16
Part C:
C.1
C.2
C.3
C.4
C.5
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Collection of Information Employing Statistical Methods............................................. 16
Respondent Universe and Sampling Methods .................................................................... 16
Information Collection Procedures .................................................................................... 18
Methods to Maximize Response Rate ................................................................................ 21
Tests of Procedures ........................................................................................................... 24
Individuals Consulted on Statistical Aspects of Design ...................................................... 24
Medicare Prescription Drug, Improvement and Modernization Act of 2003
Statistical Data Collection Instruments
Nonstatistical Data Collection Instruments
Nonstatistical Informed Consent Forms and Scripts
Federal Register Notice
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Part A: Background
Section 302(b) of The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public
Law 108-173) (MMA) requires the Centers for Medicare and Medicaid Services (CMS) to begin a
program of competitive bidding for Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS) in 10 Competitive Acquisition Areas (CAAs) in 2007. MMA Section 303(d) requires a
Report to Congress on the program. This project’s purpose is to provide information for this Report to
Congress.
To collect this information for CMS, we will use the following three (3) data collection methods:
beneficiary and supplier surveys, focus groups with suppliers and referral agents, and key informant
discussions with beneficiary groups or advocates, CMS officials or CMS’ bidding contract managers,
referral agents and suppliers.
Part B: Justification
B.1
Explanation of Circumstances That Make Collection of Data
Necessary
Section 302(b) of the MMA requires CMS to begin a program of competitive bidding for DME, supplies,
certain orthotics, and enteral nutrients and related equipment and supplies. The bidding program is to be
established in 10 CAAs in 2007, an additional 80 CAAs in 2009 and additional CAAs thereafter. The
initial CAAs will be based in 10 of the largest Metropolitan Statistical Areas (MSAs).
MMA Section 303(d) requires a Report to Congress on the program, covering program savings,
reductions in cost sharing, impacts on access to and quality of affected goods and services, and
beneficiary satisfaction. This project’s purpose is to provide information for this Report to Congress.
Also, interim site visit information and other data collected during this project may be helpful to CMS as
it makes plans to implement the second phase (adding 80 large CAAs).
This evaluation’s objectives are both summative (is the program having identifiable impacts on costs,
access, and quality?) and formative (what early implementation lesson learned can improve the bid and
award process as the program expands from 10 competitive acquisition areas (CAAs) in 2007 to 80 or
more by 2009?).
Copies of Section 302(b) and 303(d) can be found in Appendix A.
B.2
How the Information Will Be Collected, by Whom, and For What
Purpose
The following data will be collected to support a pre-post evaluation design:
Beneficiary and supplier surveys in three (3) study CAAs and two (2) comparison areas;
Focus groups with suppliers and referral agents in (3) study CAAs;
Key informant discussions with beneficiary groups or advocates, CMS officials or CMS’
bidding contract managers, referral agents and suppliers in the three (3) CAAs; and
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Key informant discussions over the telephone with beneficiary groups or advocates,
referral agents and suppliers in the two (2) comparison areas.
We are requesting Office of Management and Budget (OMB) approval for the beneficiary and supplier
surveys, focus groups and key informant discussions in this submission. Please see Exhibit 1 for the
research questions each data source will address.
Medicare
expenditures &
Savings
Beneficiary
cost-Sharing
Access
Quality of goods
and services
Consumer
satisfaction
Administrative
operations &
stakeholder
impacts
Health
Outcomes
(Oxygen Users)
Utilization
Program
Data
Supplier
Surveys
Research Questions
Unit prices
Focus
Groups &
Discussions
Domain
Beneficiary
Surveys
Medicare
Claims
Exhibit 1 Overview of Research Questions and Major Data Sources
X
X
Program Costs
Estimated savings in beneficiary out
of pocket costs
X
X
X
Number and geographic
accessibility of suppliers
X
X
X
Finding a supplier
Transition issues
Diversity of products available
X
X
X
X
X
X
X
Access to specific products
Quality of service
Product quality
Consumer satisfaction
X
X
X
X
X
X
X
X
X
Program dissemination and
outreach
Bidding process
Transition issues
Quality Standards
Health outcomes
X
X
X
X
X
X
X
X
CMS has planned two kinds of data collections among beneficiaries for purposes of administering the
new national DMEPOS competitive bidding program. One data collection mailed by the competitive
bidding program intermediary addresses beneficiary satisfaction along several dimensions with a short,
one page, survey. This survey will be mailed routinely to new product users. The format of the questions
are a rating scale rather than specific response categories and there are no customized questions. While
the sample size eventually will be larger, the information gathered will be more general than the program
evaluation survey. This is in line with the purpose of the survey, which is quite different from that of the
evaluation survey: to monitor regularly the beneficiary experience under the program after it gets
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underway, to identify suppliers who may have difficulties serving beneficiaries adequately, and,
potentially, to identify overall program issues that may arise from time to time.
In contrast, the evaluation survey uses a pre-post survey design with comparison groups and its purpose is
to detect possible changes in beneficiary cost sharing, access, quality of goods and services and customer
satisfaction as a result of the new program. Questions are structured with specific sets of response
categories that address specific issues in beneficiary cost sharing, access, beneficiary choice of
equipment, service quality, training, and customer support.
STATISTICAL DATA COLLECTION
The beneficiary and supplier surveys will focus on oxygen users and users of four other types of
DMEPOS. While CMS has not made any final decisions regarding products to select for competitive
bidding (pending issuance of the final regulation expected later this year), CMS is required under the
Paperwork Reduction Act (PRA) to seek clearance of the data collection forms for the evaluation project
at least six (6) months before beginning data collection. An oxygen user survey was designed to allow for
the contingency that oxygen would be selected, because oxygen is the highest-volume and highestexpenditure category of durable medical equipment, and because the government’s evaluation of the
demonstration concluded that oxygen should be monitored if included under future competitive bidding
initiatives. A survey of power wheelchair users was also designed and will serve as a prototype for the
four “Other DMEPOS” products. After CMS determines the products that will be competitively bid, we
will select four products and modify the wheelchair survey to address these products. The majority of the
survey will remain intact, however a subset of 14 questions will be modified to accommodate the specific
product (beyond substituting the product name throughout the survey). Of the 14 questions, only 6
require changes to the question itself whereas the other 8 only require changes to the answer choices. In
the event that oxygen is not part of the competitive bidding program, the customized “Other DMEPOS”
users questionnaires will be used.
CMS administrative data sources (including Medicare DMEPOS claims data and other administrative
data), National Supplier Clearinghouse (NSC) file data, CMNs for selected beneficiary groups, and
supplier bids will be analyzed to address the research questions. A Technical Expert Panel (TEP)
convened to provide guidance on some aspects of the evaluation, specifically on how to assess the impact
of competitive bidding on beneficiaries who are oxygen users.
NONSTATISTICAL DATA COLLECTION
The referral agent and DMEPOS supplier focus group participants will be asked to assess how the
competitive bidding program affected them as well as their perceptions on the impact of competitive
bidding on Medicare beneficiaries. The referral agent focus group participants may include discharge
planners, case managers, social workers, home health care workers, physical therapists and nurses, among
others. The aim is to select referral agents from a diverse array of health care organizations. The supplier
focus group participants will include suppliers with a significant part of their business providing at least
one of the DMEPOS items chosen for competitive bidding. The different types of referral agents and
suppliers selected for the focus groups will provide a greater breadth and diversity of perspectives.
The key informant discussions will be conducted with beneficiary groups/advocates, CMS officials or
bidding program managers, referral agents, and suppliers to understand the impact of the program on each
of the groups and on Medicare beneficiaries access to and quality of DMEPOS products and services. The
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information gathered through the key informant discussions will provide a deeper understanding of
program impacts from individuals who are highly engaged with the DMEPOS market and process and
have extensive experience in their role.
Trained researchers experienced in moderating focus groups and conducting key informant discussions
will collect the nonstatistical data.
B.3
Use of Improved Information Technology to Reduce Burden
Information technology will reduce respondent burden and avoid data duplication for both the beneficiary
and supplier surveys in two ways.
First, the self-administered pencil-and-paper beneficiary surveys may alternatively be administered by
telephone upon respondent request. Telephone data collection is also used to follow up withnonrespondents. The telephone data collection is supported by a full-featured computer-assisted telephone
interviewing (CATI) system with automated case delivery and built-in quality control. We expect 30
percent of beneficiaries will use the CATI system to respond to the survey.
Second, the supplier survey has been developed as a self-administered web-based survey. Respondents
are asked to provide information on eight (8) beneficiary claims that were submitted for payment in the
previous year (2006). The computer-based format of this survey enables the seamless import of casespecific claims data into the survey to facilitate its administration. Suppliers also have the option of
completing this survey via telephone.
B.4
Efforts to Identify and Avoid Duplication
To avoid duplication of beneficiary and supplier data, data collection instruments were developed to ask
respondents only about information that cannot be found in extant databases. We have identified the
following as sources of extant data that will be used in this evaluation:
CMS databases, including DMEPOS claims data and other administrative data;
National Supplier Clearinghouse (NSC) File data; and
Selected beneficiary group CMNs.
The key informant discussion and focus group recruits (referral agents and suppliers) will be selected to
meet different data collection aims. Referral agents included in the key informant discussions will be
selected based on extensive experience and their active involvement referring Medicare beneficiaries to
DMEPOS suppliers. In contrast, referral agent focus group participants will be selected from different
health system types (e.g. urban, rural, public, private) and roles (e.g. discharge planner, physical therapist)
to provide a diversity of perspectives from the focus groups. The suppliers for the key informant
discussions will be selected for their involvement and familiarity with the local DMEPOS market and
years of experience, whereas the focus group suppliers will be selected from a list of suppliers available in
the area.
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B.5
Efforts to Minimize Burden on Small Business or Other Entities
Small business or other small entities may constitute a large portion of the respondents in the supplier
surveys (and qualitative data collection). Therefore, it is critical that burden be minimized for these
respondents. As described in Section A.3, the supplier survey is a self-administered web survey
requesting the supplier to provide information about eight (8) beneficiary claims pre-selected randomly
by the evaluation team from Medicare claims. The TEP and CMS have suggested that eight (8) claims is
a number that could be reasonably asked of the supplier to document.
Before initiating baseline data collection, we will conduct cognitive testing with nine (9) DMEPOS
suppliers on the survey. The list of potential respondents will be obtained from a convenience sample
from the Bethesda metropolitan area and/or drawn from suggestions from the suppliers on the TEP. The
cognitive testing will include monitoring ease of navigating efficiently through the instrument, entering
responses in the prescribed manner, the appropriateness of claims information requested, the
completeness of the drop down menus for product manufacturers and product names/models, burden of
completing the survey, and potential wording or administration that increases perceived integrity and
diminishes respondents’ concerns.
The resulting supplier survey will be provided in a web-based format that enables the seamless import of
the supplier’s specific and applicable details about the pre-selected claims into the survey. The claims
questions will employ drop-down menus for the respondent to select first from the list of manufacturers
for the subject claim’s coded procedure, and then from that manufacturer choice the applicable products
will populate the next question’s drop-down menu for the specific product name/model that was supplied
to the Medicare beneficiary. The second section of the survey, which asks a few questions about products
carried, also uses drop-down menus. Respondents will have the option to complete the survey via
telephone. Finally, the supplier survey will provide the option of being completed by a designee whom
the identified contact deemed to have enough knowledge about the company’s Medicare transactions to
be able to accurately respond to the survey.
Small business or other small entities may constitute a portion of the respondents in the supplier focus
groups and key informant discussions too. Therefore, it is critical that burden be minimized for these
respondents. The supplier focus groups will take up to 90 minutes and the key informant discussions will
take up to 60 minutes, and at the supplier’s place of business to minimize burden.
B.6
Consequences of Less-Frequent Data Collection
Neither the statistical data (the beneficiary and supplier surveys) nor nonstatistical data (the focus groups
and key informant discussions) collected during this evaluation can be collected less frequently. First, the
beneficiary and supplier surveys must be administered at two (2) points in time, to allow a measurement
of the competitive bidding program’s effects in a pre-post analysis. The nonstatistical data collection will
be conducted at three (3) time points, the first prior to program implementation, the second three to six (36) months after implementation, and the third 12-15 months after program implementation. Nonstatistical
data must be collected this frequently to allow sufficient understanding of competitive bidding program
impacts from the perspective of the key stakeholders at these important implementation times.
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B.7
Special Circumstances Requiring Collection of Information in a
Manner Inconsistent with Section 1320.5(d)(2) of the Code of
Federal Regulations
There are no special circumstances associated with this data collection.
B.8
Federal Register Comments and Persons Consulted Outside
the Agency
In accordance with the Paperwork Reduction Act of 1995, CMS submitted a notice to the Federal
Register announcing the agency’s intention to request an OMB review of data collection activities. The
notice was published on June 16, 2006, in Volume 71, Number 116, Page 34928 and provided a 60-day
period for public comments. A copy of the Federal Register notice for this information is included in
Appendix E. Comments were received from Abbott and a response was provided. Modifications to the
instruments and evaluation design were incorporated into this re-submission. This resubmission is
provided for a 30-day public comment period.
This study’s design phase involved convening and consulting with a TEP that provided and continues to
provide essential information related to the design of the data collection instruments. The TEP consists of
six (6) experts, including:
A DMERC medical director;
An individual with expertise in research design;
A pulmonologist;
Two (2) oxygen equipment industry representatives; and
An expert on mobility products.
The first TEP teleconference was held on November 29, 2005, to discuss issues relevant to oxygen
therapy, competitive bidding, and the structure of the beneficiary and supplier surveys. The follow up
meeting was held on 12/9/05 to review the first draft of the beneficiary survey for oxygen users.
Evaluation staff also called several TEP members individually to consult on different components of the
data collection and study design. The last teleconference with the TEP was held on January 5, 2006 to
review the final versions of the survey and qualitative instruments.
Exhibit 2 contains a complete listing of the TEP members and their affiliations.
Exhibit 2
Technical Expert Panel Members
Dr. Kent Christopher, PhD, 9086 East Colorado Circle, Denver, CO
Dr. Doran Edwards, PhD, Palmetto GBA, SADMERC, Columbia, SC
Laraine Forry, Air Products Healthcare, Lewisberry, PA
Professor Bruce Friedman, PhD, Dept of Community and Preventative Medicine, University of
Rochester, Rochester, NY
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Joseph Lewarski, Inogen, Eastlake, OH
Jean Minkel, Minkel Consulting, New Windsor, NY
B.9
Payments to Respondents
Honoraria will be provided to the following respondents:
Pilot cognitive testing of surveys: prior to the start of data collection, nine (9)
beneficiaries and nine (9) suppliers will be recruited to pilot test the survey instruments
and to provide feedback on the language, ease of administration, and use of the web site
(for the supplier survey). Beneficiaries will be offered $35 honorarium and suppliers will
be offered a $75 honorarium for their participation.
Focus groups: at each of three waves of data collection, focus groups will be conducted
with referral agents (e.g. discharge planners, rehabilitation therapists, home care staff)
and with suppliers and/or supplier group representatives. The focus groups will be held
in the evening and participants will be offered dinner and a $75 honorarium.
Suppliers will be offered a $75 honorarium for their participation in the supplier survey.
No honoraria will be offered to participants in the in-depth interviews.
B.10 Assurance of Confidentiality
Abt Associates has conducted numerous projects involving sensitive information; consequently, facilities
and procedures have been developed to maintain this confidentiality. To begin, all staff assigned to Abt
projects sign confidentiality agreements. In addition, access to the data processing areas is controlled,
with only authorized personnel allowed in the computer rooms and the computer tape libraries. All
databases are password protected, with only the data administrators having write authority over files.
Finally, electronic data transferred via diskette or CD-ROM to clients are aggregated, encrypted, and
password-protected before shipping via a bonded courier.
Abt will also work with their subcontractor, Pulse Train, for the web survey to ensure secure transmission
of the supplier data across the web as it is entered and stored. Abt’s Survey Area has been using Bellview
by Pulse Train for data collection since 1992. Pulse Train markets and supports the Bellview system and
currently hosts and maintains Abt’s Survey Department web-based surveys. Pulse Train uses a NetScreen
5GT firewall that integrates several security functions—stateful and Deep Inspection firewall, IPSec VPN
(utilizing 168 bit 3DES encryption), Denial of Service protection and Antivirus—with an Asymmetric
Digital Subscriber Line (ADSL) interface. Web surveys with sensitive information that require more
stringent needs are hosted on a server using Secure Socket Layering (SSL).
The focus groups and key informant discussions will not be audiotaped or videotaped. The written notes
collected from the focus groups and discussions will be labeled with a study code and will not include the
name of the participant or his/her organization. The materials will be stored in secured locations and
electronic materials will be stored in a password–protected computer. Any information presented to
outside parties will be presented in summary form. The informed consent forms for the key informant
discussions conducted in-person and the informed consent scripts for the key informant discussions
conducted over the telephone are provided in Appendix D.
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B.11 Questions of a Sensitive Nature
The beneficiary and supplier surveys do not contain any questions concerning sexual behavior and
attitudes, or religious beliefs. The beneficiary survey, however, does include key demographic items such
as income, race and ethnicity, and health status. Collecting these key demographic data will allow us to
determine whether samples in the program and comparison areas are comparable. The supplier survey
asks its respondents to provider specific claims data some suppliers may consider to be proprietary
business information such as the manufacturers or models of certain HCPCs routinely stocked, estimates
of percentage of product share within their business. This information is collected to analyze changes in
elements such as product diversity after competitive bidding is implemented.
Respondents to the beneficiary and supplier surveys are explicitly informed that their participation is
voluntary, and that they may choose to withdraw from the study or to omit specific items without penalty.
No written consent is obtained from the beneficiaries or suppliers; their consent is implied by the
completion of their surveys.
Participants in the focus groups and key informant discussions are explicitly informed that their
participation is voluntary, and that they may choose to withdraw from the study without penalty. Written
consent will be obtained from participants in the in-person discussions and focus groups and verbal
consent will be obtained from participants in the telephone discussions (see Appendix D).
B.12 Estimates of Respondent Burden
Exhibit 3 presents estimates of the annual reporting burden for each wave of the data collection process.
Time estimates are based on experience with similar instruments used with comparable respondents.
Exhibit 3
Estimates of Annual Burden Hours and Cost
Data Collection
Sources
Number of Minutes Per
Response
Estimated Cost Costs per Total Burden
Respondents Respondent Burden in Hours
Per Hour a
Respondent
(Costs)
STATISTICAL DATA **
Beneficiary
Surveys in Program
and Comparison
Areas at each wave
Oxygen
6,000
30
3,000
0
0
0
Other DMEPOS
6,000
30
3,000
0
0
0
Supplier Surveys in
Program and
Comparison Areas
at each wave
575
45
431
$46.88
$35.16
$20,217.00
NONSTATISTICAL DATA ***
Focus Groups at
each wave
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Referral Agent
Suppliers
30
30
90
90
45
45
$19.23
$46.88
$28.85
$70.32
$865.50
$2,109.60
6
60
6
$16.83
$16.83
$100.98
6
60
6
$0.00
$0
$0
6
6
60
60
6
6
$19.23
$46.88
$19.23
$46.88
$115.38
$281.28
4
60
4
$16.83
$16.83
$67.32
4
60
4
$19.23
$19.23
$76.92
4
60
4
$46.88
$46.88
$187.52
Key Informant
Discussion at each
wave
Beneficiary
Group/ Advocates
CMS Officials
Referral Agent
Suppliers
Comparison Area
Key Informant
Discussion at each
wave
Beneficiary
Group/ Advocates
Referral Agent
Suppliers
a
Costs for beneficiaries assumed that virtually all would be retired, and thus would incur no loss of wages. Suppliers’ hourly wage was estimated
based on the targeted population of supply administrators (management level) and supervisors of claims-processing and sales staff. These annual
salaries can range from $75,000-$120,00 or an hourly range of $36.06-57.69. Table estimate uses the mean of these two hourly wages.
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B.13 Estimates of the Cost Burden to Respondents
Other than their time to participate in the study, which is estimated in Exhibit 3, there are no direct
monetary costs to respondents.
B.14 Estimates of Annualized Government Costs
Below are the annual costs for the evaluation of the national DMEPOS competitive bidding program.
These costs include labor, other direct costs (printing, postage, travel, telecommunications, etc.) and
indirect costs.
Exhibit 4
Annual Costs for the Evaluation of the National DMEPOS Competitive Bidding Program
Year One
Year Two
Year Three
Year Four
Total
Task 1: Technical Expert
Panel
$18,981
$306
$0
$0
$19,287
Task 2: Prepare for Survey
$29,730
$113
$0
$0
$29,843
Task 3: Qualitative Data
Collection
$60,002
$154,820
$27,570
$0
$242,392
Task 4: Conduct Surveys
$732,018
$366,175
$0
$0
$1,098,193
Task 5: Assemble and
Analyze Secondary Data
$51,571
$168,681
$74,741
$41,534
$336,527
Task 6: Reports
$89,937
$8,002
$21,326
$84,446
$203,711
Tack 7: Project Management
$40,071
$36,126
$34,249
$48,026
$158,472
Task 8: Data Tapes and
Documentation
$0
$0
$55
$10,707
$10,762
Task 9: Analysis
--
--
--
$0
$0
$1,022,309
$734,223
$157,942
$184,713
$2,099,187
All Tasks
B.15 Changes in Hour Burden
No change in burden is requested. This submission to OMB is for an initial request for approval.
B.16 Time Schedule, Publication, and Analysis Plan
Described below are the analysis plans and timelines for both the statistical and nonstatistical data
collection efforts.
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STATISTICAL DATA COLLECTION
Analysis Plan: Beneficiary Surveys
The basic framework for the analysis of the beneficiary survey data will be “differences-in-differences,”
in which we compare changes in key outcome variables in three (3) study CAAs with changes in the same
variables in selected comparison areas.
The report will contain five (5) sets of analyses:
Analyses of response rates.
Descriptive tables presenting the survey data.
Univariate analyses of key independent variables (such as beneficiary demographic
characteristics) by program area to determine whether samples in selected program and
comparison areas are comparable.
Univariate analyses of outcome variables and univariate tests of demonstration effects.
Multivariate analyses of outcome variables and multivariate test of outcome effects.
These analyses include the independent variables as control variables and may therefore
offer more precise estimates of program effects.
Note that these two (2) types of areas (program and comparison) should be comparable in terms of
independent variables because they were selected in a similar way; if they are not comparable in terms of
measured variables, then it becomes more important to use multivariate methods to adjust for the
underlying differences among samples. In addition, the analysis of survey data will incorporate other
variables from the DMEPOS claims, Medicare’s enrollment database, and the certificates of medical
necessity that will be linked to the survey data. These variables will also be used to establish
comparability and will also serve as control variables.
Analysis Plan: Supplier Survey
The following measures, constructed using data from the supplier survey, will be used to estimate
program impacts:
The number of products available within the HCPC and/or the number of products
exceeding some threshold level of market share within the HCPC.
The Herfindahl index (sum of squared market shares of the products or manufacturers
within the HCPC), a summary measure of market concentration.
Concentration ratios (share of market going to the top N products or top N
manufacturers).
Other measures of diversity, for example there may be meaningful ways to group
products and re-estimate the Herfindahl index or the concentration ratios based on these
groupings.
Measures of quality, if applicable; these might either be measures based on wholesale
acquisition cost or measures based on grouping products according to features associated
with product quality.
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These measures will be calculated for study CAAs and comparison areas before and after the start of
the new payment system. The program effect will be estimated using the difference-in-difference
estimator. Comparisons will be conducted between the three (3) study CAAs and the two (2)
comparison areas. If necessary, estimates will incorporate appropriate weights to account for varying
response rates among different substrata of the sample (such as large and small suppliers).
The report will also contain the following sets of analyses:
Descriptive statistics on the sample frame, i.e. number and characteristics of suppliers by
study HCPC, geographic area, and time period
Analyses of response rates
Descriptive tables presenting the survey data
Timelines
Exhibits 5-7 illustrate the timelines for the beneficiary and supplier surveys, as well as for the Data
Analysis.
Exhibit 5
Data Collection Overview by Week – Supplier Survey
Date for
20062007
Date for
2008
12/15/06
– 1/15/07
1/31/07
2/15/07
N/A
7/3/08
7/3/08
3/1/07
3/13/07
3/13/07
9/1/08
9/20/08
9/20/08
1
1
1
3/20/07
3/27/07
4/3/07
7/10/07
4/24/07
5/3/07
5/10/075/25/07
6/5/07
6/20/07
9/27/08
10/6/08
10/13/08
10/20/08
11/3/08
11/10/08
11/17/0812/4/08
12/11/08
1/17/08
2
3
4
5
7
8
9-12
Finalize web survey for programming
Testing web survey against programming
specifications
Train Research Assistants on study
Launch Web survey
Survey Advance Letter with Link & Password /
Inbound calls (800-line) begin
Letter with password & Link Reminder I
Postcard Reminder I
E-mail Reminder I (link / password provided)
Postcard Reminder II
Letter with password & Link Reminder II
E-mail Reminder II (link / password provided)
Outbound calls to eligible non-responders
13
14
Send incentive checks to all completed cases
Deliver final data set
Abt Associates Inc.
Week of
Field Period
Task
Conduct Cognitive Testing of Instrument
Paperwork Reduction Act Submission
Est. Qty. Supplier
Survey
9
N/A
N/A
N/A
1,000
1,000
1,000
850
850
750
750
700
700
N/A
N/A
12
Exhibit 6
Data Collection Overview by Week – Beneficiary Survey
Date 20062007
Date 2008
Week of Field
Period
11/30/06
N/A
Finalize test surveys for cognitive testing
11/15/061/15/07
N/A
Conduct Cognitive testing
1/25/07
N/A
Finalize Instrument
1/25/072/8/07
12/17/07
3/20/07
12/31/07
3/22/07
9/5/08
1
Survey Packet I / Inbound calls (800-line)
begin
18,462
3/29/07
9/12/08
2
Post card Reminder I
18,462
Task
Program and Test CATI system
Train Interviewers
Est. Qty.
Beneficiary
Survey
N/A
9
N/A
N/A
4/6/07
9/19/08
3
Survey Packet II
12,920
4/13/07
9/26/08
4
Postcard Reminder II
12,920
4/20/07
10/03/08
5
Survey Packet III
10,193
4/28/07
10/10/08
6
Postcard Reminder III
8,470
5/06/07
10/17/08
7
Survey Packet IV
8,470
5/13/07
10/24/08
8
Postcard Reminder IV
8,000
5/20/07
11/1/08
9
Postcard Reminder V – “Please Call Us”
8,000
5/20/076/19/07
11/1/0812/1/08
9-12
Outbound calls to eligible non-responders
8,000
6/25/07
12/20/08
14
Abt Associates Inc.
Deliver final data file
Paperwork Reduction Act Submission
13
Exhibit 7:
Timeline for Secondary Data Analysis
PROGRAM MILESTONES
NPRM
Final rule, containing HCPCs and communities
Payment under new program begins
Date
April 2006
Nov 2006
Oct 2007
ANALYSIS
Analysis to refine project design
Jan-Dec 2006
Selection of comparison areas
Identify likely CAAs and likely HCPCs
Identify likely comparison areas (ARF)
Develop variables and approach for final selection
Final selection
Jan-March 2006
Jan-March 2006
March-Sept 2006
Nov 2006
Sampling frame for beneficiary survey (Wave 1)
Jan-March 2007
Sampling frame for supplier survey (Wave 1)
Select suppliers
Select claims within supplier
Jan-March 2007
Jan-March 2007
Sampling frame for beneficiary survey (Wave 2)
July-Aug 2008
Sampling frame for supplier survey (Wave 2)
July-Aug 2008
DATA ACQUISITION AND DATABASE CONSTRUCTION
DUA
Nov 2005
Design Files
Data acquisition
Database construction
May-July 2006
July-Sept 2006
Sample Files Wave 1
Data acquisition
Database construction
Jan-March 2007
Jan-March 2007
Sample Files Wave 2
Data acquisition
Database construction
July-Aug 2008
July-Aug 2008
Program Impact files
Data acquisition CY 2007
Initial database construction
Data acquisition CY 2008
Final database construction
Q1 2008
Q2-Q3 2008
Q1 2009
Q2-Q3 2009
ANALYSIS OF PROGRAM IMPACTS
DELIVERABLES
Bene survey Wave 1/ Supplier survey Wave 1
Bene survey Wave 2 / Supplier survey Wave 2
Interim Report
Final Report
Abt Associates Inc.
Paperwork Reduction Act Submission
Q1-Q3, 2009
Q2 2007
Q1 2009
Q1 2009
Q3 2009
14
NONSTATISTICAL DATA COLLECTION
Analysis Plan: Nonstatistical Data
The purpose of the nonstatistical data collection is to understand the impact of the competitive bidding
program from the perspective of the key stakeholders: beneficiary groups/advocates, CMS officials and
bidding program managers, referral agents, and suppliers. The nonstatistical data collected will contribute
to the formative and summative evaluation of the competitive bidding program outreach, information
dissemination, implementation and impact.
Summaries of key themes or issues that arise in each of the focus groups and key informant discussions
will be drafted. From Wave 1 the data will provide a baseline understanding of the DMEPOS
environment in that study CAA and will be used as a point of reference from which to compare findings
obtained in Waves 2 and 3. The findings from Wave 2 will contribute to a formative evaluation of the
program and provide CMS recommendations for improving rollout of competitive bidding in the next
CAAs. Additionally, Wave 2 should provide a preliminary understanding of the transition issues and
initial impact of the program. Wave 3 should provide an in-depth understanding, from different key
stakeholders, of the impact of the competitive bidding program.
The summaries as well as the primary data will be analyzed by the project team with the aim of
identifying common themes across the groups and for each of the research domains and questions. A
content analysis will be performed for every research question and responses coded. The coded responses
will be classified and analyzed for patterns and trends.
The selected comparison area findings will provide a baseline understanding of the environment for
DMEPOS, quality and access for Medicare beneficiaries, and the new quality standards. The findings
from the comparison areas may also be used to identify any market or DMEPOS changes during and
across the three (3) waves that could account for a change identified in the study CAAs. For example, the
introduction of a new DMEPOS item that changed the quality of a specific durable medical equipment
product may account for the identified change in the CAA.
The analysis plan for the nonstatistical data draws its rigor from 1) the experience of the project team with
nonstatistical data collection and analysis and 2) data triangulation. The data is acquired from diverse
data sources (four different informant types and documents) and data collection methods (focus groups
and key informant discussions). Nonstatistical data triangulation provides a test for consistency (Patton,
2002). This does not necessarily imply demonstrating similar findings across the different data sources,
rather it allows for the recognition of inconsistencies or differences that arise from the different data
sources. These inconsistencies can be illuminative, particularly when evaluating a new program from the
perspective of different stakeholders. This is the strongest design available for use with the observational
data that can be generated for the evaluation of the competitive bidding program.
Timeline
Exhibit 8 illustrates the timeline for the nonstatistical data collection and analysis.
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Exhibit 8
Nonstatistical Data Collection and Analysis Timeline
SUBTASK
DATE (Wave 1, 2, 3)
Preparation for focus groups and key informant discussions
Collect and create recruitment lists
December 06, 07, 08
Contact and schedule CAA focus groups and key informant discussions
Jan – Mar 07, 08, 09
Make travel arrangements for CAA site visits
Jan – Mar 07, 08, 09
Contact and schedule comparison area key informant discussions
Jan – Mar 07, 08, 09
Conduct focus groups and key informant discussions
Study CAAs 1-3, comparison areas 1&2
Feb – April 07, 08, 09
Write summaries of focus group and key informant discussions
Feb - April 07, 08, 09
Analysis of Data
Identify common themes from data collected in that wave
May 07, 08, 09
Conduct content analysis for research domains and questions in that wave
May 07, 08, 09
Code data in that wave
May 07, 08, 09
Synthesize data across the three waves, code data, and conduct analyses
June – July 09
B.17 Display of Expiration Date for OMB Approval
The CMS will display the expiration date for OMB approval on all of the data collection instruments.
B.18 Exceptions to Certification Statement
This submission requires no exceptions to the Certificate for Paperwork Reduction Act (5 CFR 1320.9).
Part C: Collection of Information Employing
Statistical Methods
C.1
Respondent Universe and Sampling Methods
Beneficiary Survey
CMS requires a survey of a sample of Medicare beneficiaries in three (3) CAAs and two (2) comparison
areas. The three (3) CAAs will be selected based on size, presence of adequate comparison area, and
geographic diversity. Furthermore, because payment rates during the baseline period varied by state and
because certain other regulations governing suppliers also vary by state, the CAAs selected for primary
data collection must not cross state lines. The two (2) comparison areas selected will be similar to the
study CAAs with respect to the proportion of the population over 65, number of hospital beds per 1000,
user rates, rates of new users and number of suppliers. The survey is to be conducted in two (2) waves,
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the first wave in 2006 prior to program launch and the second in 2008 about 15-18 months after program
launch.
The target population for the survey is all Medicare beneficiaries in each of the five (5) areas (three (3)
study CAAs and two (2) comparison areas) who are users of one of five (5) product categories. These
users will be further divided into new and existing users of these products. The product categories will be
further defined upon CMS’ selection of product lines to include in the bidding process. Essentially, we
will be creating 50 strata formed by the cross classification of five (5) geographic areas, five (5) product
categories and two (2) types of users (new and existing).
A total sample of 12,000 completed interviews is required per wave. Exhibit 9 shows the number of
beneficiaries required in the sample in each stratum.
Exhibit 9
Number of Beneficiaries in Sample by Strata, per Wave
Subgroup
Oxygen
Other DMEPOS
Total
CAA new user
2,800
1,600
4,400
CAA existing user
2,000
800
2,800
Comparison area,
new user
1,867
1,067
2,934
Comparison area
existing user
1,333
533
1,866
Total
8,000
4,000
12,000
The sample size in each stratum is in terms of number of completed interviews. We assume a 65%
response rate overall to the beneficiary survey at each wave—50 % will complete and return a written
questionnaire and 15% will complete the questionnaire via telephone. Of the 50% of non-respondents to
the written questionnaire, we assume that we will be able to locate telephone numbers for 60% and 50%
of those will respond via telephone. Thus, we need to select 18,462 beneficiaries per wave to complete
12,000 surveys per wave.
Supplier Survey
The supplier survey will be conducted in the same five (5) geographic areas as the beneficiary survey
(three (3) CAAs and two (2) comparison areas). The target population for this survey is all suppliers who
are active with Medicare and have a substantial presence in the selected product categories in the five (5)
geographic areas designated for the survey.
In 2007, a sample of approximately 958 suppliers will be selected from the available population in each of
the strata shown below. Based on an estimated response rate of 60%, the ultimate sample sizes by strata
are also shown. It is possible that in some communities the number of active suppliers will be sufficiently
low that the supplier survey will be sent to almost all active suppliers. As in the case of beneficiaries,
the survey will be conducted in two (2) waves with an independent sample of suppliers in each wave.
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Our sampling plan calls for sampling a large number of suppliers, for this is the only means of achieving
statistical significance. It is possible that some areas and product categories may not offer these numbers
of suppliers. Other options for achieving statistical significance (namely, expanding the number of study
areas) is costly and outside of the resources for this project.
Exhibit 10
Sampling Plan for Supplier Survey: Suppliers (Anticipated Completed Surveys)
Oxygen
HCPC1 and
Other
Other
HCPC 1
HCPC 2
Area
HCPC2
Total
CAA
195
(65/site)
75
(25/site)
75
(25/site)
345
Comparison Area
130
(65/site)
50
(25/site)
50
(25/site)
230
325
125
125
575
Total
Each sampled supplier will be asked to provide data on eight (8) claims.
C.2
Information Collection Procedures
Beneficiary Surveys
Oxygen users will be defined based on the presence of a claim within a pre-defined set of oxygen HCPCs.
Other DMEPOS users will be defined based on the use of other DMEPOS within product lines selected
for competitive bidding. Once those product lines have been chosen, we will sample within product line,
i.e., if the products chosen are “wheelchairs” and “hospital beds,” we will sample from within the two
sub-strata of “wheel chair users,” and “hospital bed users.” The same number of beneficiaries will be
sampled for each of the product categories, regardless of that product categories’ market share.
New users of oxygen and “other DMEPOS” will be defined based on the presence of a claim for the
product line under study within the last quarter but the lack of a claim in the three quarters before that. .
We will construct sampling frames for the selection of beneficiaries in each stratum using the Medicare
claims. All the information required for selecting the beneficiaries will be included in the sampling
frame. A systematic sample will be selected in each stratum after sorting the list of beneficiaries by
gender and age.
Oxygen users will receive the oxygen survey. Other DMEPOS users will receive one of the other
DMEPOS surveys. This survey will ask them to discuss a particular DMEPOS product. For example,
those who were sampled as “wheelchair users” will be asked to think about their wheelchair supplier
when they complete the survey. Most of the questions asked on each of the different products (oxygen
and other DMEPOS) surveys will be the same, i.e., those who were sampled as “wheelchair users” will be
asked many of the same questions about their wheelchair supplier as those who were sampled as “hospital
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bed users” will be asked about their hospital bed supplier. Since not all questions or answer choices are
appropriate for all products, a subset of 14 questions will only address a specific product line.
Supplier Survey
To have adequate statistical power to detect any diversity effects that may exist, we propose to limit the
supplier survey to two oxygen HCPCs and two non-oxygen DMEPOS HCPCs that are included in the
competitive bidding program. Our criteria for selecting these HCPCs will be the following:
The number of HCPC suppliers in each of the study CAAs and comparison areas is
large enough to detect statistical significance. Some areas and product categories may
have only a small number of suppliers for certain HCPCs. We will choose the HCPCs
for analysis based on which HCPCs have enough suppliers to achieve statistical
significance in our analysis.
Significance of product diversity from the beneficiary’s point of view. It should be
important to beneficiaries’ health and quality of life that a range of products exists within
the HCPC. These may well be items that must be matched to beneficiary’s individual
health conditions or lifestyle.
Expected sensitivity to competitive bidding. Items that are sensitive to competitive
bidding are those whose Medicare payment is likely to be significantly reduced or those
where suppliers might make changes in product lines they carry as a result of lower
pricing under competitive bidding.
Appropriate number of products within HCPC. To keep the survey simple and to
facilitate the analysis of survey results, we will seek to choose a HCPC in which between
two and fifteen different products (or meaningful product groupings) exist.
Ease of reporting. To increase response rates and reduce the effort required for
suppliers to respond, we will seek to choose a HCPC in which suppliers are likely to have
accessible records that show the make and model of the item supplied. Based on our
initial conversations with suppliers, these are likely to be higher-value items, which are
typically tracked using serial numbers.
A typical as opposed to a one-of-a-kind item. This survey will pertain to a small
number of DMEPOS HCPCs, and it will not be possible to generalize to the wider
universe of competitively bid items. Nevertheless, other things equal, we would prefer to
choose an item that appears likely to reflect trends among durable medical equipment as a
whole, rather than one that is clearly unique or atypical.
Until the specific items are identified in the Final Rule, we will not be able to definitively identify the
HCPCs to be used in the survey.
The project team will construct the sampling frame for the supplier survey using DMEPOS claims. This
sampling frame will contain a sampling weight that reflects the respondent’s share of the total market for
the selected HCPC or pair of HCPCs in the geographic area; the sample will be selected so that each
supplier’s probability of being included will be proportional to its market share.
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Each sampled supplier will be asked to provide data on eight (8) claims. The unit of analysis will be the
individual claims (not the supplier). The number of claims asked of the suppliers was selected to balance
the project’s need for statistical precision with the need to manage the response burden. Specifically, this
number was chosen to maintain the sizes of the sample of suppliers; to allow us to examine two (2)
HCPCs within each supplier category (two (2) oxygen HCPC and two (2) other DMEPOS HCPCs) given
finite resources; and to allow us to detect a ten percent change in a binary variable (e.g., whether a given
product held the largest share of the HCPC as a whole) with mean of 0.25. Based on our current
understanding of suppliers’ record keeping, the majority of suppliers could access the data needed to
respond to this survey in about 45 minutes, although those with ‘paper’ systems may take longer. This
plan will be discussed with CMS once the CAAs and products are determined, prior to making final
decisions.
In this sampling plan, we also assume that it is reasonable to expect oxygen suppliers to offer all of
Medicare’s units of payment for oxygen, comprising about a dozen HCPCS codes. Under this
assumption, we can ask one supplier to provide data regarding four (4) claims in one study oxygen HCPC
and four (4) claims in the other study oxygen HCPC in order to maximize statistical power in the presence
of design effects. Each of the eight (8) claims will be for a different beneficiary. We assume however
that it is not reasonable to expect suppliers of non-oxygen DMEPOS to offer the entire range of nonoxygen DMEPOS products. We thus plan to have two (2) separate samples of suppliers for the two nonoxygen HCPCs and to ask each of those suppliers about eight claims within a single HCPC. We will
examine the validity of this assumption using claims data prior to fielding the survey and adjust our plans
if necessary.
Based on these sample sizes and the differences-in-differences framework, ranges for detectable
differences for each HCPC are shown below in Exhibit 11. These differences are based on a one-sided
hypothesis test at a 5 percent level of significance and a binary variable (such as whether the claim
reflected the top product) with a mean value of 0.25. For determining the detectable difference we have
taken into account the design effect because the sample of claims is not a simple random sample but is
sampled from a sample of suppliers. The design effect depends on the size of the variation in the outcome
variables between suppliers and within suppliers. For the upper bound on the design effect, we have
assumed that ten percent of the variation in the outcome variables stems from between-supplier as
opposed to within-supplier effects. With four (4) claims per supplier, we get a design effect of 1.3 for the
two oxygen HCPCs whereas with eight (8) claims we get a design effect of 1.7 for the other DMEPOS
HCPCs. These design effects produce a smaller effective sample size than the actual sample size. For the
lower bound, we have assumed no design effect.
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Exhibit 11
Sampling Plan for Supplier Survey: Claims
Claims per supplier
Oxygen
HCPC 1
Oxygen
HCPC 2
Other
HCPC 1 (e.g.
Glucose
Monitor)
Other
HCPC 2
(e.g. Manual
wheelchair)
4
4
8
8
195
75
75
CAA: suppliers (1)
195
CAA: claims
780
780
600
600
Comparison area:
suppliers (1)
130
130
50
50
Comparison area: claims
Total claims
Detectable difference in
a binary variable
Total
2,760
520
520
400
400
1,840
1,300
1,300
1,000
1,000
4,600
9.9-12.9
9.9-12.9
8.7-9.9
8.7-9.9
(percentage points) (2)
Notes: (1) The samples of claims in both oxygen HCPCs are drawn from the same sample of suppliers. The samples of
claims in the two non-oxygen HCPCs are drawn from two different samples of suppliers.
(2) Detectable difference calculations are based on pooling the three CAAs together and the two comparison areas
together. More information about the detectable difference calculation is provided in the text.
C.3
Methods to Maximize Response Rate
Beneficiary Surveys
The beneficiary surveys (written in English and Spanish) are mailed surveys (one for oxygen-users and
four for other DMEPOS users) with phone-follow-up, with the goal of a 65% response rate. We
anticipate approximately 50% of the cases will be completed by mail, and 15% by telephone.
In our experience with surveying elderly respondents, we have found a high degree of willingness to
participate. However, this population is much more likely than the general population to have physical
and cognitive limitations that affect their ability to complete the survey, making it difficult to achieve
high response rates. While our goal response rate (65%) is below the target of 80% specified by the
Office of Management and Budget (OMB) guidelines, we will seek to minimize the impact of nonresponse bias by the techniques described below and through statistical measures such as adding weights
to our final data.
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Instrument Design
We address the challenge of addressing the Medicare population by tailoring the instruments to the needs
of this population. The surveys are clearly written, use simple vocabulary, and are printed in large font
for respondents who might have visual problems.
The items in each instrument were designed to meet not only the analytical objectives necessary to answer
the research questions, but also to be unambiguous, non-threatening, unbiased, non-repetitive and
properly sequenced. Response categories are written to be mutually exclusive and collectively
exhaustive, where applicable. Each survey will have both a self-administered mail questionnaire and an
interviewer-administered telephone survey script in order to offer respondents an option to complete the
survey by telephone.
Mail Survey Procedures
Once the sample for the beneficiary survey is drawn, we will send the names and addresses through the
National Change of Address (NCOA) system to ensure the address file completeness and accuracy. We
will use phone follow-up and other efforts to locate individuals who lack a valid mailing address.
The outer encasement of the mailing materials will convey the importance of the contents. We will use a
well-designed, high quality outer envelope with graphics and colored print to convey a clear message
about credibility of the source and the importance of a reply. We will mail the beneficiary survey packets
using first-class mail and the outer envelope will use the CMS logo and will be designed by a professional
graphic artist.
The survey packets mailed to beneficiaries will include a cover letter, study fact sheet, the survey
instrument, and a postage-paid reply envelope. The cover letter explains: the purpose of the study and
the risks and benefits of participation. In addition, it provides a toll-free number to call with questions,
request a Spanish survey, or to complete the interview over the telephone. The materials will be
personalized, will clearly identify CMS as the study sponsor, and will depict endorsing professional
organizations, in an effort to increase perceived legitimacy.
We will ship a postcard reminder one week after each survey packet to each presumed eligible nonrespondent. The follow-up postcard will stress the importance of participation in the study and offer the
toll-free number with a request that the recipients call us to complete the interview by phone or let us
know why they did not to respond to the mailings.1 This presents an opportunity for the interviewing staff
to conduct refusal conversion efforts, as needed.
Telephone Follow Up
We will minimize non-response by using highly effective sample management techniques by the
adherence to strict quality control standards with respect to interviewer monitoring, on-going feedback
and training. Highly trained and skilled Abt interviewing staff, including Spanish-speaking interviewers,
will conduct phone surveys upon respondent request or as follow up to beneficiaries who have not
responded to the mailed surveys.
1
Staff will also fulfill re-mail requests, as needed, during the outbound phone follow-up efforts.
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Phone follow-up to presumed eligible non-respondents will begin at week nine of the field period and will
last through week twelve. First, we will send the list of presumed eligible non-respondents for telematching. Dialing for the beneficiary survey will be from 9:00 a.m. to 9:00 p.m., respondent time. Our
telephone data collection is supported by a full-featured CATI system with automated case delivery and
built-in quality control. The sample management system developed by Abt Associates is extraordinarily
sophisticated, providing efficient and effective sample distribution.
Supplier Survey
The strategies for minimizing non-response to the supplier survey draw from standard methods used to
attain higher response rates as well as customized approaches aimed at allaying suppliers’ concerns and
increasing the perceived integrity of the survey. Based on our experience and discussions with our TEP,
we anticipate challenges to achieving the targeted response rate because of potential barriers to
participation. The potential barriers include suspicion of an ulterior motive for the survey, the similarities
of the survey to an audit (using claims), confidentiality and HIPAA concerns, the (unfounded) concern
that an already paid claim is being disputed, and other perceptions of past negative experiences with
CMS. Therefore recruitment strategies will include the following:
An advance letter explaining the purpose of the survey;
Careful attention to the language used in the survey letters;
Full compliance with all HIPAA regulations and assurances to suppliers that this is the
case;
Assurances that all data will be held in confidence and that the transmission over the
Internet will be secure;
An offer of two modes of survey completion – via the web or on the telephone, both of
which will be easily accessible to participants in a corporate setting;
Endorsement from the relevant professional organizations and associations. These may
include the American Association of Homecare (AAHomecare) and other applicable
associations/organizations, depending on the products that are chosen for competitive
bidding and the supplier survey. Members of the TEP have offered to help us to secure
these endorsements;
Reminder postcards;
Automated e-mail reminders;
Telephone follow-ups; and
A $75 thank you gift upon completing the survey.
Once the DMEPOS products are chosen for competitive bidding there will be a need for a more focused
consideration of the concerns unique to those product categories. Besides these strategies, there will be
continued discussion on the project team and with the suppliers from the TEP to identify additional ways
to encourage participation and dispel concerns.
As part of our ongoing sample management, we will carefully monitor not only the overall completion
rates for the surveys but also the completion rates within each of the subgroups (new and existing users of
oxygen and other DMEPOS) to ensure that we meet analytical requirements. We will be able to monitor
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progress on the Web survey in real time. Specifically, we will be able to track whether a given supplier
has logged in and begun the survey, how far he / she has progressed, and whether or not the survey is
completed. As a result, we will be targeting and tailoring our phone follow-up to the suppliers who have
not yet completed their surveys accordingly, to maximize the results from our efforts and minimize
respondent burden.
C.4
Tests of Procedures
Beneficiary Survey Testing
Before we field the beneficiary surveys, we will cognitively test the surveys over the telephone and in
person with nine (9) beneficiaries. Through cognitive testing, we hope to determine whether respondents
find it easy or hard to complete the survey, identify specific issues or problems with the beneficiary’s
survey structure and organization, and determine if the wording of specific survey questions could be
improved or simplified. Cognitive interviewing is based on the production of verbal reports about each
phase of the response process, typically modeled as: comprehension, recall, response formation, and
reporting. Cognitive interview protocols will be designed to combine concurrent or retrospective “Think
Aloud” techniques with other procedures. Cognitive interviewing can provide possible reasons that a
particular question is not performing as intended. Such information will be used for revising instruments.
After completing the cognitive testing interviews, we will conduct a respondent debriefing to determine
whether there were any other points of confusion or lack of clarity.
Supplier Survey Testing
The supplier survey has been designed in light of the project’s objectives and the desire to maximize
response rates and minimize respondent burden. Several members of the TEP, convened for the
beneficiary survey, have also advised us on this design.
Prior to the initiation of Wave 1, we will conduct cognitive testing with nine (9) DMEPOS suppliers on
the survey. The cognitive testing will include monitoring ease of navigating efficiently through the
instrument, entering responses in the prescribed manner, the appropriateness of claims information
requested, the completeness of the drop down menus for product manufacturers and product
names/models, burden of completing the survey, and potential wording or administration that increases
perceived integrity and diminishes perceived barriers to completing the survey.
After completion of the survey, we will conduct a debriefing session with the participants to discuss
aforementioned properties of the survey. When possible, we will conduct these testing and debriefing
sessions in-person. The cognitive testing participants will receive a $75 honorarium. Additionally, the
results of the cognitive testing and subsequent debriefings may be discussed with suppliers of the TEP to
explore ideas for further refinement of the instrument before implementation.
C.5
Individuals Consulted on Statistical Aspects of Design
Exhibit 12 contains the names, affiliations, and contact information for the individuals who consulted on
statistical aspects of the design. These individuals also assisted in developing the project design and data
collection protocols. Abt Associates Inc., Cambridge, Massachusetts is the contractor who will conduct
the data collection and analysis for CMS.
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Exhibit 12
Statistical Design Consultants
Dr. Kent Christopher, PhD, Denver, CO, 303-337-8080
Dr. Doran Edwards, PhD, Palmetto GBA, SADMERC, Columbia, SC, 803-763-4519
Laraine Forry, Air Products Healthcare, Lewisberry, PA, 717-579-2638
Professor Bruce Friedman, PhD, University of Rochester, Rochester, NY, 585-273-2618
Joseph Lewarski, Inogen, Eastlake, OH, 440-269-8046
Jean Minkel, Minkel Consulting, New Windsor, NY, 845-496-5022
Jon Christianson, PhD, University of Minnesota, 612-624-3849
Roger Feldman, PhD, University of Minnesota, 612-624-5669
Marian Wrobel, PhD, Abt Associates, Cambridge, MA, 617-349-2454
K.P. Srinath, PhD, Abt Associates, Bethesda, MD, 301-634-1836
Susan Jureidini, Abt associates, Cambridge, MA, 617-492-7100
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APPENDIX A
Medicare Prescription Drug, Improvement and
Modernization Act of 2003
Medicare Prescription Drug, Improvement and
Modernization Act of 2003
MMA Section 302(b)
H. R. 159-171
One Hundred Eighth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the seventh day of January, two thousand and three
An Act
To amend title XVIII of the Social Security Act to provide for a voluntary program
for prescription drug coverage under the Medi care Program, to modernize the
Medicare Program, to amend the Internal Revenue Code of 1986 to allow a
deduction to individuals for amounts contributed to health savings security accounts
and health savings accounts, to provide for the disposition of unused
health benefits in cafeteria plans and flexible spending arrangements, and for
other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
TITLE III—COMBATTING WASTE, FRAUD, AND ABUSE
Sec. 301. Medicare secondary payor (MSP) provisions.
Sec. 302. Payment for durable medical equipment; competitive acquisition of certain
items and services.
Sec. 303. Payment reform for covered outpatient drugs and biologicals.
Sec. 304. Extension of application of payment reform for covered outpatient drugs
and biologicals to other physician specialties.
Sec. 305. Payment for inhalation drugs.
Sec. 306. Demonstration project for use of recovery audit contractors.
Sec. 307. Pilot program for national and St ate background checks on direct patient
access employees of long-term care facilities or providers.
er medicare.
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SEC. 302. PAYMENT FOR DURABLE MEDICAL EQUIPMENT; COMPETITIVE
ACQUISITION OF CERTAIN ITEMS AND SERVICES.
(b) COMPETITIVE A CQUISITION.—
(1) I N GENERAL.—Section 1847 (42 U.S.C. 1395w– 3) is
amended to read as follows:
‘‘COMPETITIVE ACQUISITION OF CERTAIN ITEMS AND SERVICES
‘‘SEC. 1847. (a) ESTABLISHMENT OF COMPETITIVE A CQUISITION
PROGRAMS.—
‘‘(1) IMPLEMENTATION OF PROGRAMS.—
‘‘(A) IN GENERAL.—The Secretary shall establish and
implement programs under which competitive acquisition
areas are established throughout the United States for
contract award purposes for the furnishing under this part
of competitively priced items and services (described in
paragraph (2)) for which payment is made under this part.
Such areas may differ for different items and services.
‘‘(B) P HASED- IN IMPLEMENTATION.—The programs —
‘‘(i) shall be phased in among competitive acquisition
areas in a manner so that the competition under
the programs occurs in—
‘‘(I) 10 of the largest metropolitan statistical
areas in 2007;
‘‘(II) 80 of the largest metropolitan statistical
areas in 2009; and
‘‘(III) additional areas after 2009; and
‘‘(ii) may be phased in first among the highest
cost and highest volume items and services or those
items and services that the Secretary determines have
the largest savings potential.
‘‘(C) W AIVER OF CERTAIN PROVISIONS .—In carrying out
the programs, the Secretary may waive such provisions
of the Federal Acquisition Regulation as are necessary
for the efficient implementation of this section, other than
provisions relating to confidentiality of information and
such other provisions as the Secretary determines appropriate.
‘‘(2) ITEMS AND SERVICES DESCRIBED.—The items and services
referred to in paragraph (1) are the following:
‘‘(A) D URABLE MEDICAL EQUIPMENT AND MEDICAL SUPPLIES .
—Covered items (as defined in section 1834(a)(13))
for which payment would otherwise be made under section
1834(a), including items used in infusion and drugs (other
than inhalation drugs) and supplies used in conjunction
with durable medical equipment, but excluding class III
devices under the Federal Food, Drug, and Cosmetic Act.
‘‘(B) OTHER EQUIPMENT AND SUPPLIES .—Items and services
described in section 1842(s)(2)(D), other than parenteral
nutrients, equipment, and supplies.
‘‘(C) OFF -THE-SHELF ORTHOTICS .—Orthotics described
in section 1861(s)(9) for which payment would otherwise
be made under section 1834(h) which require minima l selfadjustment
for appropriate use and do not require expertise
in trimming, bending, molding, assembling, or customizing
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to fit to the individual.
‘‘(3) EXCEPTION AUTHORITY.—In carrying out the programs
under this section, the Secretary may exempt—
‘‘(A) rural areas and areas with low population density
within urban areas that are not competitive, unless there
is a significant national market through mail order for
a particular item or service; and
‘‘(B) items and services for which the application of
competitive acquisition is not likely to result in significant
savings.
‘‘(4) SPECIAL RULE FOR CERTAIN RENTED ITEMS OF DURABLE
MEDICAL EQUIPMENT AND OXYGEN.—In the case of a covered
item for which payment is made on a rental basis under section
1834(a) and in the case of payment for oxygen under section
1834(a)(5), the Secretary shall establish a process by which
rental agreements for the covered items and supply arrangements
with oxygen suppliers entered into before the application
of the competitive acquisition program under this section for
the item may be continued notwithstanding this section. In
the case of any such continuation, the supplier involved shall
provide for appropriate servicing and replacement, as required
under section 1834(a).
‘‘(5) PHYSICIAN AUTHORIZATION.—
‘‘(A) IN GENERAL.—With respect to items or services
included within a particular HCPCS code, the Secretary
may establish a process for certain items and services
under which a physician may prescribe a particular brand
or mode of delivery of an item or service within such
code if the physician determines that use of the particular
item or service would avoid an adverse medical outcome
on the individual, as determined by the Secretary.
‘‘(B) NO EFFECT ON PAYMENT AMOUNT .—A prescription
under subparagraph (A) shall not affect the amount of
payment otherwise applicable for the item or service under
the code involved.
‘‘(6) A PPLICATION.—For each competitive acquisition area
in which the program is implemented under this subsection
with respect to items and services, the payment basis determined
under the competition conducted under subsection (b)
shall be substituted for the payment basis otherwise applied
under section 1834(a), section 1834(h), or section 1842(s), as
appropriate.
‘‘(b) PROGRAM REQUIREMENTS.—
‘‘(1) IN GENERAL.—The Secretary shall conduct a competition
among entities supplying items and services described
in subsection (a)(2) for each competitive acquisition area in
which the program is implemented under subsection (a) with
respect to such items and services.
‘‘(2) CONDITIONS FOR AWARDING CONTRACT .—
‘‘(A) IN GENERAL.—The Secretary may not award a
contract to any entity under the competition conducted
in an competitive acquisition area pursuant to paragraph
(1) to furnish such items or services unless the Secretary
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finds all of the following:
‘‘(i) The entity meets applicable quality standards
specified by the Secretary under section 1834(a)(20).
‘‘(ii) The entity meets applicable financial standards
specified by the Secretary, taking into account
the needs of small providers.
‘‘(iii) The total amounts to be paid to contractors
in a competitive acquisition area are expected to be
less than the total amounts that would otherwise be
paid.
‘‘(iv) Access of individuals to a choice of multiple
suppliers in the area is maintained.
‘‘(B) TIMELY IMPLEMENTATION OF PROGRAM.—Any delay
in the implementation of quality standards under section
1834(a)(20) or delay in the receipt of advice from the program
oversight committee established under subsection (c)
shall not delay the implementation of the competitive
acquisition program under this section.
‘‘(3) CONTENTS OF CONTRACT .—
‘‘(A) IN GENERAL.—A contract entered into with an
entity under the competition conducted pursuant to paragraph
(1) is subject to terms and conditions that the Secretary
may specify.
‘‘(B) T ERM OF CONTRACTS .—The Secretary shall recompete
contracts under this section not less often than once
every 3 years.
‘‘(4) LIMIT ON NUMBER OF CONTRACTORS.—
‘‘(A) IN GENERAL.—The Secretary may limit the number
of contractors in a competitive acquisition area to the
number needed to meet projected demand for items and
services covered under the contracts. In awarding contracts,
the Secretary shall take into account the ability of bidding
entities to furnish items or services in sufficient quantities
to meet the anticipated needs of individuals for such items
or services in the geographic area covered under the contract
on a timely basis.
‘‘(B) M ULTIPLE WINNERS.—The Secretary shall award
contracts to multiple entities submitting bids in each area
for an item or service.
‘‘(5) PAYMENT .—
‘‘(A) IN GENERAL.—Payment under this part for
competitively priced items and services described in subsection
(a)(2) shall be based on bids submitted and accepted
under this section for such items and services. Based on
such bids the Secretary shall determine a single payment
amount for each item or service in each competitive acquisition
area.
‘‘(B) REDUCED BENEFICIARY COST-SHARING.—
‘‘(i) A PPLICATION OF COINSURANCE.—Payment
under this section for items and services shall be in
an amount equal to 80 percent of the payment basis
described in subparagraph (A).
‘‘(ii) A PPLICATION OF DEDUCTIBLE.—Before applying
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clause (i), the individual shall be required to meet
the deductible described in section 1833(b).
‘‘(C) P AYMENT ON ASSIGNMENT -RELATED BASIS .—Payment
for any item or service furnished by the entity may
only be made under this section on an assignment-related
basis.
‘‘(D) CONSTRUCTION.—Nothing in this section shall be
construed as precluding the use of an advanced beneficiary
notice with respect to a competitively priced item and
service.
‘‘(6) PARTICIPATING CONTRACTORS .—
‘‘(A) IN GENERAL.—Except as provided in subsection
(a)(4), payment shall not be made for items and services
described in subsection (a)(2) furnished by a contractor
and for which competition is conducted under this section
unless—
‘‘(i) the contractor has submitted a bid for such
items and services under this section; and
‘‘(ii) the Secretary has awarded a contract to the
contractor for such items and services under this section.
‘‘(B) BID DEFINED.—In this section, the term ‘bid’ means
an offer to furnish an item or service for a particular
price and time period that includes, where appropriate,
any services that are attendant to the furnishing of the
item or service.
‘‘(C) RULES FOR MERGERS AND ACQUISITIONS .—In
applying subparagraph (A) to a contractor, the contractor
shall include a successor entity in the case of a merger
or acquisition, if the successor entity assumes such contract
along with any liabilities that may have occurred thereunder.
‘‘(D) PROTECTION OF SMALL SUPPLIERS.—In developing
procedures relating to bids and the awarding of contracts
under this section, the Secretary shall take appropriate
steps to ensure that small suppliers of items and services
have an opportunity to be considered for participation in
the program under this section.
‘‘(7) CONSIDERATION IN DETERMINING CATEGORIES FOR
BIDS .—The Secretary may consider the clinical efficiency and
value of specific items within codes, including whether some
items have a greater therapeutic advantage to individuals.
‘‘(8) A UTHORITY TO CONTRACT FOR EDUCATION, MONITORING,
OUTREACH, AND COMPLAINT SERVICES .—The Secretary may
enter into contracts with appropriate entities to address complaints
from individuals who receive items and services from
an entity with a contract under this section and to conduct
appropriate education of and outreach to such individuals and
monitoring quality of services with respect to the program.
‘‘(9) A UTHORITY TO CONTRACT FOR IMPLEMENTATION.—The
Secretary may contract with appropriate entities to implement
the competitive bidding program under this section.
‘‘(10) NO ADMINISTRATIVE OR JUDICIAL REVIEW .—There shall
be no administrative or judicial review under section 1869,
section 1878, or otherwise, of—
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‘‘(A) the establishment of payment amounts under
paragraph (5);
‘‘(B) the awarding of contracts under this section;
‘‘(C) the designation of competitive acquisition areas
under subsection (a)(1)(A);
‘‘(D) the phased-in implementation under subsection
(a)(1)(B);
‘‘(E) the selection of items and services for competitive
acquisition under subsection (a)(2); or
‘‘(F) the bidding structure and number of contractors
selected under this section.
‘‘(c) PROGRAM A DVISORY AND OVERSIGHT COMMITTEE.—
‘‘(1) ESTABLISHMENT .—The Secretary shall establish a Program
Advisory and Oversight Committee (hereinafter in this
section referred to as the ‘Committee’).
‘‘(2) M EMBERSHIP ; TERMS .—The Committee shall consist of
such members as the Secretary may appoint who shall serve
for such term as the Secretary may specify.
‘‘(3) D UTIES .—
‘‘(A) A DVICE.—The Committee shall provide advice to
the Secretary with respect to the following functions:
‘‘(i) The implementation of the program under this
section.
‘‘(ii) The establishment of financial standards for
purposes of subsection (b)(2)(A)(ii).
‘‘(iii) The establishment of requirements for collection
of data for the efficient management of the program.
‘‘(iv) The development of proposals for efficient
interaction among manufacturers, providers of services,
suppliers (as defined in section 1861(d)), and individuals.
‘‘(v) The establishment of quality standards under
section 1834(a)(20).
‘‘(B) A DDITIONAL DUTIES .—The Committee shall perform
such additional functions to assist the Secretary in
carrying out this section as the Secretary may specify.
‘‘(4) INAPPLICABILITY OF FACA.—The provisions of the Federal
Advisory Committee Act (5 U.S.C. App.) shall not apply.
‘‘(5) TERMINATION .—The Committee shall terminate on
December 31, 2009.
‘‘(d) REPORT .—Not later than July 1, 2009, the Secretary shall
submit to Congress a report on the programs under this section.
The report shall include information on savings, reductions in costsharing,
access to and quality of items and services, and satisfaction
of individuals.
‘‘(e) DEMONSTRATION PROJECT FOR CLINICAL LABORATORY SERVICES .
—
‘‘(1) IN GENERAL.—The Secretary shall conduct a demonstration
project on the application of competitive acquisition
under this section to clinical diagnostic laboratory tests —
‘‘(A) for which payment would otherwise be made under
section 1833(h) (other than for pap smear laboratory tests
under paragraph (7) of such section) or section 1834(d)(1)
(relating to colorectal cancer screening tests); and
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‘‘(B) which are furnished by entities that did not have
a face-to-face encounter with the individual.
‘‘(2) TERMS AND CONDITIONS .—
‘‘(A) IN GENERAL.—Except as provided in subparagraph
(B), such project shall be under the same conditions as
are applicable to items and services described in subsection
(a)(2), excluding subsection (b)(5)(B) and other conditions
as the Secretary determines to be appropriate.
‘‘(B) A PPLICATION OF CLIA QUALITY STANDARDS .—The
quality standards established by the Secretary under section
353 of the Public Health Service Act for clinical diagnostic
laboratory tests shall apply to such tests under the
demonstration project under this section in lieu of quality
standards described in subsection (b)(2)(A)(i).
‘‘(3) REPORT .—The Secretary shall submit to Congress—
‘‘(A) an initial report on the project not later than
December 31, 2005; and
‘‘(B) such progress and final reports on the project
after such date as the Secretary determines appropriate.’’.
(2) CONFORMING AMENDMENTS.—Section 1833(a)(1) (42
U.S.C. 1395l(a)(1)) is amended—
(A) by striking ‘‘and (U)’’ and inserting ‘‘(U)’’;
(B) by inserting before the semicolon at the end the
following: ‘‘, and (V) notwithstanding subparagraphs (I)
(relating to durable medical equipment), (M) (relating to
prosthetic devices and orthotics and prosthetics), and (Q)
(relating to 1842(s) items), with respect to competitively
priced items and services (described in section 1847(a)(2))
that are furnished in a competitive area, the amounts
paid shall be the amounts described in section 1847(b)(5)’’;
and
(C) in clause (D)—
(i) by striking ‘‘or (ii)’’ and inserting ‘‘(ii)’’; and
(ii) by adding at the end the following: ‘‘or (iii)
on the basis of a rate established under a demonstration
project under section 1847(e), the amount paid
shall be equal to 100 percent of such rate,’’.
(3) GAO REPORT ON IMPACT OF COMPETITIVE ACQUISITION
ON SUPPLIERS.—
(A) STUDY.—The Comptroller General of the United
States shall conduct a study on the impact of competitive
acquisition of durable medical equipment under section
1847 of the Social Security Act, as amended by paragraph
(1), on suppliers and manufacturers of such equipment
and on patients. Such study shall specifically examine the
impact of such competitive acquisition on access to, and
quality of, such equipment and service related to such
equipment.
(B) REPORT .—Not later than January 1, 2009, the
Comptroller General shall submit to Congress a report
on the study conducted under subparagraph (A) and shall
include in the report such recommendations as the Comptroller
General determines appropriate.
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(c) TRANSITIONAL FREEZE.—
(1) DME.—
(A) I N GENERAL.—Section 1834(a)(14) (42 U.S.C.
1395m(a)(14)) is amended—
(i) in subparagraph (E), by striking ‘‘and’’ at the
end;
(ii) in subparagraph (F)—
(I) by striking ‘‘a subsequent year’’ and
inserting ‘‘2003’’; and
(II) by striking ‘‘the previous year.’’ and
inserting ‘‘2002;’’; and
(iii) by adding at the end the following new subparagraphs:
‘‘(G) for 2004 through 2006—
‘‘(i) subject to clause (ii), in the case of class III
medical devices described in section 513(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(c)(1)(C)), the percentage increase described in
subparagraph (B) for the year involved; and
‘‘(ii) in the case of covered items not described
in clause (i), 0 percentage points;
‘‘(H) for 2007—
‘‘(i) subject to clause (ii), in the case of class III
medical devices described in section 513(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(c)(1)(C)), the percentage change determined by the
Secretary to be appropriate taking into account recommendations
contained in the report of the Comptroller
General of the United States under section
302(c)(1)(B) o f the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003; and
‘‘(ii) in the case of covered items not described
in clause (i), 0 percentage points; and
‘‘(I) for 2008—
‘‘(i) subject to clause (ii), in the case of class III
medical devices described in section 513(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(c)(1)(C)), the percentage increase described in
subparagraph (B) (as applied to the payment amount
for 2007 determined after the application of the
percentage change under subparagraph (H)(i)); and
‘‘(ii) in the case of covered items not described
in clause (i), 0 percentage points; and
‘‘(J) for a subsequent year, the percentage increase
in the consumer price index for all urban consumers (U.S.
urban average) for the 12-month period ending with June
of the previous year.’’.
(B) GAO REPORT ON CLASS III MEDICAL DEVICES .—Not
later than March 1, 2006, the Comptroller General of the
United States shall submit to Congress, and transmit to
the Secretary, a report containing recommendations on the
appropriate update percentage under section 1834(a)(14)
of the Social Security Act (42 U.S.C. 1395m(a)(14)) for
class III medical devices described in section 513(a)(1)(C)
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of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(a)(1)(C)) furnished to medicare beneficiaries during
2007 and 2008.
(2) P AYMENT RULE FOR SPECIFIED ITEMS .—Section 1834(a)
(42 U.S.C. 1395m(a)), as amended by subsection (a), is further
amended by adding at the end the following new paragraph:
‘‘(21) SPECIAL PAYMENT RULE FOR SPECIFIED ITEMS AND
SUPPLIES .—
‘‘(A) IN GENERAL.—Notwithstanding the preceding
provisions of this subsection, for specified items and supplies
(described in subparagraph (B)) furnished during
2005, the payment amount otherwise determined under
this subsection for such specified items and supplies shall
be reduced by the percentage difference between—
‘‘(i) the amount of payment otherwise determined
for the specified item or supply under this subsection
for 2002, and
‘‘(ii) the amount of payment for the specified item
or supply under chapter 89 of title 5, United States
Code, as identified in the column entitled ‘Median
FEHP Price’ in the table entitled ‘SUMMARY OF
MEDICARE PRICES COMPARED TO VA, MEDICAID,
RETAIL, AND FEHP PRICES FOR 16 ITEMS’
included in the Testimony of the Inspector General
before the Senate Committee on Appropriations, June
12, 2002, or any subsequent report by the Inspector
General.
‘‘(B) SPECIFIED ITEM OR SUPPLY DESCRIBED.—For purposes
of subparagraph (A), a specified item or supply means
oxygen and oxygen equipment, standard wheelchairs
(including standard power wheelchairs), nebulizers,
diabetic supplies consisting of lancets and testing strips,
hospital beds, and air mattresses, but only if the HCPCS
code for the item or supply is identified in a table referred
to in subparagraph (A)(ii).
‘‘(C) A PPLICATION OF UPDATE TO SPECIAL PAYMENT
AMOUNT .—The covered item update under paragraph (14)
for specified items and supplies for 2006 and each subsequent
year shall be applied to the payment amount under
subparagraph (A) unless payment is made for such items
and supplies under section 1847.’’.
(3) PROSTHETIC DEVICES AND ORTHOTICS AND PROSTHETICS.
—Section 1834(h)(4)(A) (42 U.S.C. 1395m(h)(4)(A)) is
amended—
(A) in clause (vii), by striking ‘‘and’’ at the end;
(B) in clause (viii), by striking ‘‘a subsequent year’’
and inserting ‘‘2003’’; and
(C) by adding at the end the following new clauses:
‘‘(ix) for 2004, 2005, and 2006, 0 percent; and
‘‘(x) for a subsequent year, the percentage increase
in the consumer price index for all urban consumers
(United States city average) for the 12-month period
ending with June of the previous year;’’.
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(d) CONFORMING A MENDMENTS.—
(1) DURABLE MEDICAL EQUIPMENT ; LIMITATION OF INHERENT
REASONABLENESS AUTHORITY.—Section 1834(a) (42 U.S.C.
1395m(a)) is amended—
(A) in paragraph (1)(B), by striking ‘‘The payment
basis’’ and inserting ‘‘Subject to subparagraph (F)(i), the
payment basis’’;
(B) in paragraph (1)(C), by striking ‘‘This subsection’’
and inserting ‘‘Subject to subparagraph (F)(ii), this subsection’’;
(C) by adding at the end of paragraph (1) the following
new subparagraph:
‘‘(F) A PPLICATION OF COMPETITIVE ACQUISITION; LIMITATION
OF INHERENT REASONABLENESS AUTHORITY.—In the
case of covered items furnished on or after January 1,
2009, that are included in a competitive acquisition program
in a competitive acquisition area under section
1847(a)—
‘‘(i) the payment basis under this subsection for
such items and services furnished in such area shall
be the payment basis determined under such competitive
acquisition program; and
‘‘(ii) the Secretary may use information on the
payment determined under such competitive acquisition
programs to adjust the payment amount otherwise
recognized under subparagraph (B)(ii) for an area that
is not a competitive acquisition area under section
1847 and in the case of such adjustment, paragraph
(10)(B) shall not be applied.’’; and
(D) in paragraph (10)(B), by inserting ‘‘in an area and
with respect to covered items and services for which the
Secretary does not make a payment amount adjustment
under paragraph (1)(F)’’ after ‘‘under this subsection’’.
(2) OFF -THE-SHELF ORTHOTICS ; LIMITATION OF INHERENT
REASONABLENESS AUTHORITY.—Section 1834(h) (42 U.S.C.
1395m(h)) is amended—
(A) in paragraph (1)(B), by striking ‘‘and (E)’’ and
inserting ‘‘, (E), and (H)(i)’’;
(B) in paragraph (1)(D), by striking ‘‘This subsection’’
and inserting ‘‘Subject to subparagraph (H)(ii), this subsection’’;
and
(C) by adding at the end of paragraph (1) the following
new subparagraph:
‘‘(H) A PPLICATION OF COMPETITIVE ACQUISITION TO
ORTHOTICS ; LIMITATION OF INHERENT REASONABLENESS
AUTHORITY.—In the case of orthotics described in paragraph
(2)(C) of section 1847(a) furnished on or after January
1, 2009, that are included in a competitive acquisition
program in a competitive acquisition area under such
section—
‘‘(i) the payment basis under this subsection for
such orthotics furnished in such area shall be the
payment basis determined under such competitive
acquisition program; and
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‘‘(ii) the Secretary may use information on the
payment determined under such competitive acquisition
programs to adjust the payment amount otherwise
recognized under subparagraph (B)(ii) for an area that
is not a comp etitive acquisition area under section
1847, and in the case of such adjustment, paragraphs
(8) and (9) of section 1842(b) shall not be applied.’’.
(3) OTHER ITEMS AND SERVICES ; LIMITATION OF INHERENT
REASONABLENESS AUTHORITY.—Section 1842(s) (42 U.S.C.
1395u(s)) is amended—
(A) in the first sentence of paragraph (1), by striking
‘‘The Secretary’’ and inserting ‘‘Subject to paragraph (3),
the Secretary’’; and
(B) by adding at the end the following new paragraph:
‘‘(3) In the case of items and services described in paragraph
(2)(D) that are included in a competitive acquisition program in
a competitive acquisition area under section 1847(a)—
‘‘(A) the payment basis under this subsection for such items
and services furnished in such area shall be the payment basis
determined under such competitive acquisition program; and
‘‘(B) the Secretary may use information on the payment
determined under such competitive acquisition programs to
adjust the payment amount otherwise applicable under paragraph
(1) for an area that is not a competitive acquisition
area under section 1847, and in the case of such adjustment,
paragraphs (8) and (9) of section 1842(b) shall not be applied.’’.
(e) REPORT ON ACTIVITIES OF SUPPLIERS.—The Inspector General
of the Department of Health and Human Services shall conduct
a study to determine the extent to which (if any) suppliers of
covered items of durable medical equipment that are subject to
the competitive acquisition program under section 1847 of the Social
Security Act, as amended by subsection (a), are soliciting physicians
to prescribe certain brands or modes of delivery of covered items
based on profitability. Not later than July 1, 2009, the Inspector
General shall submit to Congress a report on such study.
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MMA Section 303(d)
H. R. 178-179
SEC. 303. PAYMENT REFORM FOR COVERED OUTPATIENT DRUGS AND
BIOLOGICALS.
‘‘(d) M ONITORING OF M ARKET PRICES .—
‘‘(1) IN GENERAL.—The Inspector General of the Department
of Health and Human Services shall conduct studies, which
may include surveys, to determine the widely available market
prices of drugs and biologicals to which this section applies,
as the Inspector General, in consultation with the Secretary,
determines to be appropriate.
‘‘(2) COMPARISON OF PRICES .—Based upon such studies and
other data for drugs and biologicals, the Inspector General
shall compare the average sales price under this section for
drugs and biologicals with—
‘‘(A) the widely available market price for such drugs
and biologicals (if any); and
‘‘(B) the average manufacturer price (as determined
under section 1927(k)(1)) for such drugs and biologicals.
‘‘(3) LIMITATION ON AVERAGE SALES PRICE.—
‘‘(A) IN GENERAL.—The Secretary may disregard the
average sales price for a drug or biological that exceeds
the widely available market price or the average manufacturer
price for such drug or biological by the applicable
threshold percentage (as defined in subparagraph (B)).
‘‘(B) A PPLICABLE THRESHOLD PERCENTAGE DEFINED.—
In this paragraph, the term ‘applicable threshold percentage’
means—
‘‘(i) in 2005, in the case of an average sales price
for a drug or biological that exceeds widely available
market price or the average manufacturer price, 5
percent; and
‘‘(ii) in 2006 and subsequent years, the percentage
applied under this subparagraph subject to such
adjustment as the Secretary may specify for the widely
available market price or the average manufacturer
price, or both.
‘‘(C) A UTHORITY TO ADJUST AVERAGE SALES PRICE.—
If the Inspector General finds that the average sales price
for a drug or biological exceeds such widely available
market price or average manufacturer price for such drug
or biological by the applicable threshold percentage, the
Inspector General shall inform the Secretary (at such times
as the Secretary may specify to carry out this subparagraph)
and the Secretary shall, effective as of the next
quarter, substitute for the amount of payment otherwise
determined under this section for such drug or biological
the lesser of—
‘‘(i) the widely available market price for the drug
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MMA Sections 302(b) and 303(d)
12
or biological (if any); or
‘‘(ii) 103 percent of the average manufacturer price
(as determined under section 1927(k)(1)) for the drug
or biological.
‘‘(4) CIVIL MONEY PENALTY.—
‘‘(A) IN GENERAL.—If the Secretary determines that
a manufacturer has made a misrepresentation in the
reporting of the manufacturer’s average sales price for a
drug or biological, the Secretary may apply a civil money
penalty in an amount of up to $10,000 for each such price
misrepresentation and for each day in which such price
misrepresentation was applied.
‘‘(B) PROCEDURES .—The provisions of section 1128A
(other than subsections (a) and (b)) shall apply to civil
money penalties under subparagraph (B) in the same
manner as they apply to a penalty or proceeding under
section 1128A(a).
‘‘(5) W IDELY AVAILABLE MARKET PRICE.—
‘‘(A) IN GENERAL.—In this subsection, the term ‘widely
available market price’ means the price that a prudent
physician or supplier would pay for the drug or biological.
In determining such price, the Inspector General shall
take into account the discounts, rebates, and other price
concessions routinely made available to such prudent physicians
or suppliers for such drugs or biologicals.
‘‘(B) CONSIDERATIONS .—In determining the price under
subparagraph (A), the Inspector General shall consider
information from one or more of the following sources:
‘‘(i) Manufacturers.
‘‘(ii) Wholesalers.
‘‘(iii) Distributors.
‘‘(iv) Physician supply houses.
‘‘(v) Specialty pharmacies.
‘‘(vi) Group purchasing arrangements.
‘‘(v ii) Surveys of physicians.
‘‘(viii) Surveys of suppliers.
‘‘(ix) Information on such market prices from
insurers.
‘‘(x) Information on such market prices from private
health plans.
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APPENDIX B
Statistical Data Collection Instruments
OMB# 0938-NEW
ABT ID #
CMS Survey of
Oxygen Equipment
Beneficiaries
If the person this survey was mailed to cannot complete the survey and there is no one else who can
do so for him or her, please check the appropriate box below and return the blank survey in the
enclosed postage-paid envelope. The person this survey was mailed to is:
1
In a nursing home or other institution and cannot complete the survey
2
Deceased
3
Not able to complete the survey and has no one else who can help
95 Other reason (Specify:) __________________________
Please return by ______.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless it displays a valid OMB control number. The valid OMB control number for this
information collection is 0938-NEW. The time required to complete this information collection is estimated to
average 30 minutes per response, including the time to review instructions, search existing data resources,
gather the data needed, and complete and review the information collection. If you have comments concerning
the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500
Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 212441850.
Abt Associates, Inc.
CMS 10197-BOS
Beneficiary Oxygen Survey
1
Instructions
The questions in this survey ask about your experiences as a person who uses oxygen
equipment.
To complete the survey, please answer the questions by checking the box to the left of your answer (as
shown below). You are sometimes told to skip over some questions in this survey. When this happens you will
see an arrow beside your response with a note that tells you which question to answer next, like this:
Yes
No → Skip to A5
I don’t know
If there is no arrow next to your response, please proceed to the next question.
Some people might ask someone else (maybe a spouse, child, or friend) to help them complete this
survey. If someone is helping you fill out the survey, remember that the questions always refer to you
and your experience with oxygen treatment and equipment.
Confidentiality
All information that would let someone identify you or your family will be kept private. You may choose to
answer this survey or not. If you choose not to, this will not affect the Medicare benefits you get. You
may notice a number on the cover of this survey. This number is ONLY used to let us know if you
returned your survey so we won’t send you reminders.
If you have any questions about the survey, please call 1-xxx-xxx-xxxx.
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A. INTRODUCTION – ALL USERS
A1. Do you use any type of oxygen system now? This includes using oxygen all of the
time, with exercise or walking only, at night only, or using it with another
medical device such as a CPAP machine or ventilator.
1 Yes (→ Skip to A2 )
2 No
3 I have never used Oxygen (→ Skip to SECTION H)
A1a. Why did you stop using oxygen? (Please check all that apply and then
go to SECTION H)
1 I believed that my breathing got better so I didn’t need it anymore
2 My doctor said I didn’t need it
3 Oxygen therapy cost too much
4 I just didn’t like using it
5 Equipment was too heavy or cumbersome
6 Equipment kept breaking down
7 I had a problem getting the supplies from my oxygen supplier
8 Other (Please specify:)
98 I don’t know
A2. Do you have anyone who regularly helps you use your oxygen equipment (e.g. a
relative or a friend)?
1 Yes
2 No
98 I don’t know
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A3. Did your doctor or health care provider (e.g. respiratory therapist) ever explain
to you why you needed oxygen?
1 Yes
2 No
98 I don’t know
A4. Did your doctor or health care provider (e.g. respiratory therapist) ever explain
to you how much oxygen you needed?
1 Yes
2 No
98 I don’t know
A5. Did your doctor or health care provider (e.g. respiratory therapist) ever explain
to you when you’re supposed to use it?
1 Yes
2 No
98 I don’t know
A6. Did your doctor or health care provider (e.g. respiratory therapist) ever explain
to you the equipment options that you have?
1 Yes
2 No
98 I don’t know
A7. Did your doctor or health care provider (e.g. respiratory therapist) ever suggest
that you contact your supplier about your equipment options?
1 Yes
2 No
98 I don’t know
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A8.
1
2
3
4
98
When you were first prescribed oxygen, how long did you expect to use it?
Less than 1 month
2 to 6 months
More than 6 months
Forever
I don’t know
A9. When was the last time you saw a doctor or other health care provider (e.g.
respiratory therapist) to discuss your need for oxygen?
1 Within the last 6 months
2 Between 6 months and 1 year ago
3 Between 1 and 3 years ago
4 More than 3 years ago
98 I don’t know
A10.Do you believe that you have the oxygen equipment that is right for you?
1 Yes
2 No
98 I don’t know
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A11. Are you able to do what you want with your oxygen equipment?
1 Yes (→ Skip to A12)
2 No
98 I don’t know (→ Skip to A12)
A11a. What do you want to do that your oxygen equipment does not allow you
to do? (Please check all that apply)
1 Can’t move freely around my home
2 Can’t go outside of my home to get the mail or for a short walk
3 Can’t go to the doctor when I need to
4 Can’t go to church, visit friends, shop, or leave the house for more than a short time
5 Something else (Specify):
____________________________
98 I don’t know
A12. Is using the oxygen equipment difficult or uncomfortable?
1 Yes
2 No (→ Skip to A13)
98I don’t know (→ Skip to A13)
A12a. What is it about your oxygen equipment that makes it difficult or
uncomfortable for you to use it? (Please check all that apply)
1 It is not difficult or uncomfortable to use
2 Equipment is too heavy or cumbersome (hard to lift, doesn’t fit easily into the car)
3 Equipment doesn’t supply enough air for the necessary amount of time/ I’m afraid I’ll run out
of air
4
5
6
7
98
Equipment breaks down a lot
I don’t know how to use the equipment well enough to be away from home
I am embarrassed to use it
Other (please tell us what else): ___________________________________
I don’t know
A14. Does using the equipment make you feel better?
1 Yes
2 No
98 I don’t know
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A15.Are you still using the same oxygen equipment as when you first started oxygen
therapy?
1 Yes
2 No (→ Skip to SECTION B)
98 I don’t know (→ Skip to SECTION B)
A15a.Why did you make these changes? (Please check all that apply)
1 Equipment needed to be replaced because it didn’t work
2 My condition/breathing changed
3 I found new equipment that was better for me
4 Equipment no longer available through supplier
5 Supplier told me Medicare no longer covered equipment
6 Doctor prescribed a different type of equipment
7 Other (Please specify:)
B. STATIONARY OXYGEN – ALL USERS
Stationary oxygen systems are heavy pieces of equipment that you cannot move
easily.
These include non-portable oxygen concentrators, liquid oxygen vessels, and large
compressed gas oxygen cylinders.
B1. Do you use any type of stationary oxygen system now?
1 Yes
2 No (→ Skip to SECTION C)
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B2. What type of stationary oxygen system(s) do you usually use at home? (Please
check all that apply)
[Pictures to be provided]
1
2
3
4
5
8
98
Oxygen concentrator machine (unit that plugs into the wall and produces oxygen)
Liquid oxygen vessel (large tank that resembles a large thermos)
Large compressed oxygen cylinder (resembles a welding tank)
Oxygen concentrator system that allows me to fill small cylinders
Small portable concentrator that also serves as a stationary source
Don’t use a stationary oxygen system
I don’t know
[pictures]
B3. What type of oxygen delivery device do you breathe from to get your oxygen?
(Please check all that apply)
[Pictures to be provided]
1
2
3
4
5
6
98
Nasal cannula (nasal prongs/tubes)
Transtracheal catheter (very thin tube that goes directly in my throat)
Reservoir cannula (nasal or pendant)
Oxygen mask
Connection to my tracheostomy tube
Connection to my CPAP machine, bi-level device, or ventilator
I don’t know
[photos]
B4. In general, how often do you use your stationary oxygen system?
1 Every day
2 A few days a week
3 One day per week
4 One day or two per month
98 I don’t know
B5. On the days that you do use stationary oxygen, about how many hours per day do
you use it?
______ hours per day
98 I don’t know
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B6. Are you using less oxygen from your stationary system than was prescribed by
your doctor?
1 Yes
2 No (→ Skip to B7)
98 I don’t know (→ Skip to B7)
B6a. Please tell us why you are using less oxygen from your stationary system
than was prescribed. (Please check all that apply)
1 I’m using oxygen as prescribed
2 I believe that my breathing got better so I don’t need it anymore
3 Oxygen therapy costs too much
4 I just don’t like using it
5 Equipment is too heavy or cumbersome
6 Equipment keeps breaking down
7 I have a problem getting the supplies from my oxygen supplier
8 Other (Please specify:)
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Sometimes people have serious problems with their stationary systems that force
them to go without oxygen or to use another source of oxygen, such as a portable
tank or emergency back-up tank.
B7.During the past 6 months, did you have any serious problems like these?
1
2
Yes
No (→ Skip to SECTION C)
98 I don’t know (→ Skip to SECTION C)
B7a. Can you describe the kind of problem(s) that you had? (Please check all
that apply)
1 Power outage in my home
2 Equipment failed or did not work
3 Unit ran out of oxygen (liquid or cylinder)
4 Other (Please specify:) _______
___________________________
98 I don’t know
B7b. How many times did you have these kinds of problems?
1 One time
2 2 or 3 times
3 4 or more times
4 Don’t recall the exact number of times
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C. PORTABLE OXYGEN – ALL USERS
Portable oxygen systems are made to let you keep using oxygen when you are away
from the stationary system. They may be light enough to carry on a strap over your
shoulder, or to pull on a wheeled cart.
Your portable oxygen system may be a small gaseous oxygen tank, a small liquid
oxygen cylinder, or a small portable oxygen concentrator.
C1. Do you use any type of portable oxygen system now?
1 Yes
2 No (→ Skip to SECTION D)
C2. What type of portable oxygen system(s) do you use? (Please check all that apply)
[Pictures to be provided]
1
2
3
4
5
6
7
Mid-sized compressed oxygen tank (E-cylinder, resembles a diving tank)
Very small and light compressed oxygen tank (can carry on my shoulder)
Mid-sized or standard portable liquid oxygen unit
Very small liquid portable unit (i.e., can carry on my shoulder or belt and delivers pulses of oxygen)
Small portable oxygen concentrator
Combination of liquid and portable cylinder.
Don’t use a portable oxygen system
[photos]
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C3.
1
2
3
4
98
In general, how often do you use your portable oxygen system?
Every day
A few days a week
One day per week
One day or two per month
I don’t know
C4. On the days that you do use portable oxygen, about how many hours per day do
you use it?
______ hours per day
98 I don’t know
C5. Are you using less oxygen from your portable system than was prescribed by
your doctor?
1 Yes
2 No (→ Skip to C6)
98 I don’t know (→ Skip to C6)
C5a. Please tell us why you are using less oxygen from your portable
system than was prescribed. (Please check all that apply)
1 I use my portable oxygen very often
2 I think that my breathing is better so I don’t need oxygen very much
3 I don’t want other people to stare at me or know about my condition
4 I just don’t like using it
5 I don’t know how to use it very well
6 My doctor said not to use it very often
7 Equipment is too heavy or cumbersome
8 Equipment is too complicated
9 Equipment keeps breaking down
10 I have a problem getting the supplies from the supplier
11 Other (Please specify:)
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C6. In general, how often do you get deliveries/refills from your oxygen supplier for
your portable oxygen systems? This may include oxygen tank deliveries, liquid
oxygen refills, etc.
1
2
3
4
5
6
98
4 times a month
2-3 times a month
Once a month
Once every year
Less than once per year
Don’t get refills of any type (→ Skip to C7)
I don’t know
C6a.If you get tank refills for your portable oxygen system, how many tank
refills do you normally get at one time (that is, number of tanks per
delivery)?
____ Number of tanks at one time
95 Don’t get refills
An intermittent flow device gives you oxygen only when you breathe in. Examples of
these oxygen-conserving devices are pulse-dosing oxygen regulators, small liquid
portable units, or portable concentrators.
C7. Do you use any type of intermittent flow devices with your portable system now?
1 Yes
2 No (→ Skip to SECTION D)
98 I don’t know (→ Skip to SECTION D)
C7a. When you were first provided with your intermittent flow device, who
adjusted the device and tested you while you were using it? (Please check
all that apply)
1 Home oxygen supplier
2 Doctor
3 Other medical personnel
4 No one
5 Not sure who the person was
6
Don’t remember if anyone did
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D. MEDICAL EXPENSES – ALL USERS
D1. In 2006, did you buy any oxygen equipment or supplies with your own money
because they were not covered by your insurance? Do not include your
Medicare co-pay.
1 Yes
2 No (→ Skip to SECTION E )
3 Don’t know (→ Skip to SECTION E)
D2.
1
2
3
4
5
6
98
What did you buy with your own money in 2006? (Please check all that apply)
Extra portable oxygen system
Extra stationary oxygen system
Oxygen conserving/intermittent device
Special nasal cannula
Transtracheal supplies
Other (specify) ________________
I don’t know
D3. Think about what you’ve paid for with your own money for the oxygen
equipment and supplies that were not covered by insurance. How much did you
spend in 2006? Do not include your Medicare co-pay.
1 Less than $100
2 $100-$500
3 $500 or more
98 I don’t know
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E. OXYGEN SUPPLIER – ALL USERS
E1. Do you have more than one supplier for your oxygen equipment, supplies,
maintenance and repairs?
1 Yes
2
No
E2. Overall, how would you rate the supplier that you use most?
1
Poor
2
3
4
5
98
Fair
Good
Very good
Excellent
I don’t know
E3. Would you recommend this oxygen supplier to a friend who needed similar
services?
1 Yes
2 No
98 I don’t know
E4.
1
2
3
4
How do you get your oxygen refills and supplies? (Please check all that apply)
Delivered to my home by my supplier
Mailed to my home by my supplier
I pick them up from my oxygen supplier
Some other way (Please tell us how): ______________________________
E5. In general, how much time and energy does it take to get your oxygen
equipment, supplies, maintenance and repairs from your supplier?
1
2
3
4
No time and energy
A little time and energy
Some time and energy
A lot of time and energy
98 I don’t know
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F. YOUR SUPPLIER – NEW USERS ONLY
F1. Have you used oxygen for less than 6 months?
1 Yes
2 No (→ Skip to SECTION G)
98 I don’t know (→ Skip to SECTION G)
F2. When you were first prescribed oxygen therapy, were there any problems
finding a home oxygen supplier?
1 Yes
2 No (→ Skip to F3)
98 I don’t know (→ Skip to F3)
F2a.What kinds of problems were there? (Please check all that apply)
1 Hard to find a supplier who covered my area
2 Supplier didn’t carry what I needed
3 Supplier could not deliver equipment when I needed it
4 Supplier did not accept Medicare
5 Other (describe:) _______________
_____________________________
98 I don’t know
F3.
1
2
3
98
When you were first prescribed oxygen therapy, was there a choice of suppliers?
Yes, many
Yes, a few
No, only one supplier available
I don’t know
F4. How long after it was ordered did your oxygen supplier deliver your first
equipment?
1 Same day
2 Next day
3 Within a week
4 More than 1 week later
98 I don’t know
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F5. When you were first prescribed oxygen therapy, what kind of training or help
did the supplier give you or the person who takes care of you? (Please check all
that apply)
Did he/she…
1 Give you written instructions on how to use the equipment or supplies
2 Show you how to use the equipment or supplies
3 Choose a safe and convenient place to store the equipment or supplies
4 Show you how to clean and maintain the equipment or supplies
5 Show you how to use oxygen safely
6 Let you practice how to use and maintain your equipment and supplies while they watched
7 Gave me the manufacturer’s customer assistance toll-free telephone number
8 I didn’t get any training or help from my oxygen supplier (→ Skip to F6)
98 I don’t know (→ Skip to F6)
F5a.As a result of that training, how comfortable do you feel using and
maintaining your oxygen equipment?
1 Very comfortable
2 Comfortable
3 Uncomfortable
4 Very uncomfortable
5 My comfort level has nothing to do with the training that my supplier gave me
F6. When you were first prescribed oxygen therapy and asked your supplier
questions about your first equipment, did you get answers that you could
understand?
1 Yes, completely
2 Yes, somewhat
3 No
4 I didn’t ask any questions
98 I don’t know
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F7. When you were first prescribed oxygen therapy, did your supplier tell you as
much as you wanted to know about the options for your first equipment?
1 Yes, completely
2 Yes, somewhat
3 No
98 I don’t know
F8. When you were first prescribed oxygen therapy, did your supplier spend as
much time with you as you wanted?
1 Yes
2 No
98 I don’t know
G. RECENT EXPERIENCES – ALL USERS
A respiratory therapist is a specially trained professional who helps you improve
your breathing.
G1.During the past 3 months, about how often did your oxygen supplier send a
respiratory therapist to your home to check on your breathing?
1 Never in the 3 months
2 Once in the past 3 months
3 More than once in the past 3 months
98 I don’t know
G2. During the past 3 months, how often did your supplier send someone to your
home to make sure that your oxygen equipment was working right? (Don’t
include times when they came because you called them).
1 Never in the 3 months
2 1-2 times in the 3 months
3 More than 2 times in the 3 months
98 I don’t know
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G3. During the past 3 months, how reliable was your oxygen supplier in making
deliveries?
1 Very reliable
2 Somewhat reliable
3 Not reliable at all
98 I don’t know
G4. During the past 3 months, did you contact your oxygen supplier with a complaint
or a problem?
1 Yes
2 No (→ Skip to G5)
3 Don’t remember (Go to question G5)
4 Don’t know how to contact my oxygen supplier (→ Skip to G5)
G4a.Was your complaint or problem settled to your satisfaction?
1 Yes
2 No
3 I am waiting for it to be settled
98 I don’t know
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G5. During the past 3 months, did you contact your oxygen supplier to get
emergency service or advice ?
1 Yes
2 No (→ Skip to G6)
98 I don’t know (→ Skip to G6)
G5a. In general, how fast did they respond to your needs, either by phone or in
person? Would you say…
1 Within 1 day
2 Within 2 days
3 Within 1 week
4 Longer than 1 week
5 Don’t remember
6 Don’t know how to contact my oxygen supplier (→ Skip to G6)
G5b.Were you able to get the emergency service or advice you needed?
1 Yes
2 No
98 I don’t know
G6. During the past 3 months, did you need to contact your supplier after regular
business hours?
1 Yes
2 No (→ Skip to G7)
98 I don’t know (→ Skip to G7)
G6a.During the past 3 months when you contacted your supplier after business
hours in general, were you able to get the service or advice you needed?
1
Yes
2
No
98
I don’t know
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G7. During the past 3 months, how reliable has your oxygen equipment been? Would
you say…
1 Very reliable
2 Somewhat reliable
3 Somewhat unreliable
4 Very unreliable
98 I don’t know
G8.
1
2
98
During the past 3 months, have you changed your oxygen supplier?
Yes
No (→ Skip to SECTION H)
I don’t know (→ Skip to SECTION H)
G8a.Why did you change your oxygen supplier? (Please check all that
apply)
1 I moved
2 Supplier no longer accepted Medicare for oxygen equipment and supplies
3 Supplier went out of business
4 Not happy with the quality of service
5 Not happy with equipment
6 Not happy with the choices of oxygen equipment I could get
7 Changed to an HMO and had to use a different supplier
8 Other (Please describe:)
________________________________
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H. ABOUT YOU – ALL
Section H is about you, the person whose name is on the mailing label of
this survey.
H1.
1
2
3
4
5
In general, how would you rate your overall health?
Excellent
Very good
Good
Fair
Poor
H2. Compared to 1 year ago, how would you rate your health now? Would you
say…
1 Much better now
2 Somewhat better now
3 About the same
4 Somewhat worse now
5 Much worse now
98 I don’t know
H3.
1
2
3
4
5
6
7
Which best describes your living situation now? (Please check all that apply)
H4.
1
2
3
4
5
6
What is the highest grade or level of school that you have completed?
I live alone
Spouse/partner
Parent/step-parent
Child/children
Other relative(s)
Friend
Other person(s) not related to me
8th grade or less
Some high school but did not graduate
High school graduate or GED
Some college or technical school
College graduate
More than a 4-year college degree
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H5.
1
2
3
4
5
98
What was your household’s annual income during 2006 before taxes?
Less than $5,000 ($416 per month)
Between $5,001 and $10,000 ($417–$833 per month)
Between $10,001 and $20,000 ($834–$1,666 per month)
Between $20,001 and $30,000 ($1,667–2,500 per month)
Over $30,001 (More than $2,500 per month)
I don’t know
H6. Are you of Hispanic or Latino heritage?
1 Yes
2 No
H7.
1
2
3
4
5
6
How would you describe your race? (Please check all that apply)
American Indian or Alaskan Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White or Caucasian
Other (Please tell us:)
____________
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I. Other Information
I1. Please check the correct statement:
1 I am the person to whom this survey was addressed (→ Skip to END)
2 I filled this survey out or helped fill it out for someone else
I2.
1
2
3
Which of these comes closest to how you helped the person with this survey?
I wrote the answers that the person told me
I answered the questions myself based on my knowledge of the person’s condition
Both of the above
END
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Thank you for completing the survey. Please return the completed survey in the
postage-paid envelope addressed to:
Todd Robbins
CMS Survey of Beneficiaries Using Oxygen
55 Wheeler Street,
Cambridge, MA 02138
If you have any questions about the survey, please call toll-free 1-xxx-xxx-xxxx.
If you have any questions about Medicare, please visit the website of the Center for
Medicare Services at: http://www.medicare.gov/, or call 1-800-MEDICARE.
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OMB# 0938-NEW
ABT ID #
CMS Survey of
Beneficiaries Using Power
Wheelchairs
If the person this survey was mailed to cannot complete the survey and there is no one else who can
do so for him or her, please check the appropriate box below and return the blank survey in the
enclosed postage-paid envelope. The person this survey was mailed to is:
1
In a nursing home or other institution and cannot complete the survey
2
Deceased
3
Not able to complete the survey and has no one else who can help
95 Other reason (Specify:) __________________________
Please return by ______.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless it displays a valid OMB control number. The valid OMB control number for this information
collection is 0938-NEW. The time required to complete this information collection is estimated to average 30
minutes per response, including the time to review instructions, search existing data resources, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of
the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn:
PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.
Abt Associates Inc.
Beneficiary DMEPOS Survey
1
Instructions
The questions in this survey ask about your experiences as a person who uses a power
wheelchair.
To complete the survey, please answer the questions by checking the box to the left of your answer (as
shown below). You are sometimes told to skip over some questions in this survey. When this happens you will
see an arrow beside your response with a note that tells you which question to answer next, like this:
Yes
No → Skip to A5
I don’t know
If there is no arrow next to your response, please proceed to the next question.
Some people might ask someone else (maybe a spouse, child, or friend) to help them complete this
survey. If someone is helping you fill out the survey, remember that the questions always refer to you
and your experience with your power wheelchair.
Confidentiality
All information that would let someone identify you or your family will be kept private. You may choose
to answer this survey or not. If you choose not to, this will not affect the Medicare benefits you get.
You may notice a number on the cover of this survey. This number is ONLY used to let us know if you
returned your survey so we won’t send you reminders.
If you have any questions about the survey, please call 1-xxx-xxx-xxxx
Abt Associates Inc.
Beneficiary DMEPOS Survey
2
A. INTRODUCTION – ALL USERS
A1. Do you use your power wheelchair now? This includes using a power
wheelchair all of the time or just occasionally.
1 Yes (→ Skip to A2)
2 No
3 I have never used a power wheelchair (→ Skip to SECTION F)
A1a.Why did you stop using your power wheelchair? (Please check all that
apply and then skip to SECTION F)
1 My condition got better so I didn’t need it anymore
2 My condition got worse so I couldn’t use it anymore
3 I was embarrassed to use it
4 I was not comfortable sitting in it
5 I did not feel safe driving it
6 I just didn’t like using it
7 It was too difficult to use
8 It kept breaking down
9 I had no place to charge it and/or store it
10 It did not have the features I needed
11 Other (Please specify:)
98 I don’t know
A2. Do you have anyone who regularly helps you use your power wheelchair (e.g. a
relative or a friend)?
1 Yes
2 No
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
3
A3. Did your doctor or health care provider (e.g. physical therapist) ever explain to
you why you needed to use a power wheelchair?
1 Yes
2 No
98 I don’t know
A4. Did your doctor or health care provider (e.g. physical therapist) ever explain to
you the different types of power wheelchairs, controls options and accessories
that exist?
1 Yes
2 No
98 I don’t know
A5. Did your doctor or health care provider (e.g. physical therapist) ever suggest
that you contact your supplier about your options?
1 Yes
2 No
98 I don’t know
A6. When you were first prescribed your power wheelchair, how long did you
expect to use it?
1 Less than 1 month
2 2 to 6 months
3 More than 6 months
4 Forever
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
4
A7. When was the last time you saw a doctor or health care provider (e.g. physical
therapist) to discuss your mobility needs or issues related to your wheelchair?
1 Within the last 6 months
2 Between 6 months and 1 year ago
3 Between 1 and 3 years ago
4 More than 3 years ago
98 I don’t know
A8. Do you believe that you have the power wheelchair that is right for you?
1 Yes
2 No
98 I don’t know
A9. Are you able to do what you want with your power wheelchair?
1 Yes (→ Skip to A10)
2 No
98 I don’t know (→ Skip to A10)
A9a.What do you want to do that your current power wheelchair does not
allow you to do? (Please check all that apply)
1 Nothing
2 Maneuver the chair more easily inside my home
3 Maneuver the chair more easily outside of my home
4 Put the chair in a car/taxi to go places
5 Sit comfortably in it for a longer time
6 Be able to transfer in and out of the wheelchair easily
6 Other (please tell us what else):
____________________________
____________________________
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
5
A10. Is using the power wheelchair difficult or uncomfortable?
1 Yes
2 No (→Skip to A11)
98 I don’t know (→Skip to A11)
A10a.What is it about your power wheelchair that makes it difficult or
uncomfortable for you to use it? (Please check all that apply)
1 It is not difficult or uncomfortable
2 I cannot sit comfortably in it
3 I cannot maneuver it well
4 I can’t transfer in and out of it easily
5 I can’t put it in the car or taxi
6 It goes too slow or too fast
7 It is too heavy and cumbersome to use
8 I have trouble charging it
98 I don’t know
A11.In general, how often do you use your power wheelchair?
1 Less than once a day
2 Every day
3 A few days a week
4 One day per week
5 One day or two per month
98 I don’t know
A12.On the days that you do use your power wheelchair how much do you us it?
______ hours per day
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
6
A13.During the past 6 months, did you have any problems with your power
wheelchair that made you go without it or made you use an unsuitable
wheelchair instead?
1 Yes
2 No (→ Skip to A13)
98 I don’t know (→ Skip to A13)
A13a.
1
2
3
4
How many times did you have these kinds of problems?
One time
2 or 3 times
4 or more times
Don’t recall the exact number of times
A13b. Can you describe the kind of problem(s) that you had? (Please check
all that apply)
1 Wheelchair failed/did not work
2 Other (Please specify:) _______
98 I don’t know
A14.Are you still using the same wheelchair and accessories (e.g. controls, cushion)
as when it (they) was originally prescribed?
1 Yes (→ Skip to B1)
2 No, I have a different wheelchair
3 No, I have different accessories
98 I don’t know (→ Skip to B1)
A14a. Why did you make this (these) change(s)? (Please check all that apply)
1 Wheelchair needed to be replaced because the original one didn’t work
2 My medical condition changed, so I needed something different
3 Found a new wheelchair that was better for me
4 Found new features/accessories that were better for me
5 Doctor/ health care provider prescribed a different type of wheelchair
6 Supplier changed
7 Other (Please specify:)
___________________________________
Abt Associates Inc.
Beneficiary DMEPOS Survey
7
B. MEDICAL EXPENSES – ALL USERS
B1. In 2006, did you buy any accessories or parts for your power wheelchair or
have maintenance or repairs done with your own money because they were not
covered by your insurance? Do not include your Medicare co-pay.
1 Yes
2 No (→ Skip to SECTION C)
98 I don’t know (→ Skip to SECTION C)
B2. What did you buy with your own money in 2006? (Please check all that apply)
1 Seat or back cushions
2 Tires
3 Crutch holder
4 Lap tray
5 Repairs
6 Routine maintenance
7 Other (specify) ______________
B3. Think about what you’ve paid for with your own money for your accessories,
parts, maintenance or repairs not covered by insurance. How much did you
spend in 2006? Do not include your Medicare co-pay.
1 Less than $100
2 $100-$500
3 $500 or more
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
8
C. YOUR SUPPLIER – ALL USERS
C1. Do you have more than one supplier for your power wheelchair, accessories,
parts, maintenance and repairs?
1 Yes
2 No
C2. Overall, how would you rate the supplier that you use most?
1 Poor
2 Fair
3 Good
4 Very good
5 Excellent
98 I don’t know
C3. Would you recommend this power wheelchair supplier to a friend who needed
similar equipment and services?
1 Yes
2 No
98 I don’t know
C4. How did you get your power wheelchair?
1 Delivered to my home by my supplier
2 Mailed to my home by my supplier
3 I picked it up from my supplier
4 I picked it up at a seating clinic or rehabilitation center
5 Some other way (Specify): ______________________________
C5.In general, how much time and energy did it take to get the power wheelchair,
accessories, parts, maintenance and repairs from your supplier?
1
2
3
4
No time and energy
A little time and energy
Some time and energy
A lot of time and energy
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
9
D. YOUR SUPPLIER – NEW USERS ONLY
D1. Have you used your power wheelchair for less than 6 months?
1 Yes
2 No (→ Skip to SECTION E)
98 I don’t know (→ Skip to SECTION E)
D2. When you were first prescribed your power wheelchair, were there any
problems finding a supplier?
1 Yes
2 No (→ Skip to D3)
98 I don’t know (→ Skip to D3)
D2a. What kinds of problems were there? (Please check all that apply)
1 Hard to find a supplier who covered my area
2 Supplier did not carry what I needed
3 Supplier could not deliver equipment when I needed it
4 Supplier did not accept Medicare
5 Other (describe:) ______________________________________
98 I don’t know
D3. When you were first prescribed your power wheelchair, was there a choice of
suppliers?
1 Yes, many
2 Yes, a few
3 No, only one supplier available
98 I don’t know
D4. How long after it was ordered did you receive your first power wheelchair?
1 Same day
2 Next day
3 Within a week
4 More than 1 week later
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
10
D5. When you were first prescribed your power wheelchair, what kind of training or
help did the supplier give you or the person who takes care of you? Did
he/she… (Please check all that apply)
1 Give you written instructions on how to use the power wheelchair
2 Show you how to use the power wheelchair
3 Choose a safe and convenient place to store and charge the power wheelchair
4 Show you how to clean and maintain the power wheelchair
5 Show you how to use the power wheelchair safely
6 Let you practice how to use and maintain your power wheelchair while they watched
7 Gave me the manufacturer’s customer assistance toll-free telephone number
8 I didn’t get any training or help from my supplier (→ Skip to D5)
98 I don’t know (→ Skip to D5)
D5a.As a result of that training, how comfortable do you feel using and
maintaining your power wheelchair?
1 Very comfortable
2 Comfortable
3 Uncomfortable
4 Very uncomfortable
5 My comfort level has nothing to do with the training that my supplier gave me
D6. When you first got your power wheelchair and asked your supplier questions,
did you get answers that you could understand?
1 Yes, completely
2 Yes, somewhat
3 No
4 I didn’t ask any questions
98 I don’t know
D7. When you first got your power wheelchair, did your supplier tell you as much
as you wanted to know about the options for your power wheelchair?
1 Yes, completely
2 Yes, somewhat
3 No
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
11
D8. When you first got your power wheelchair, did your supplier spend as much
time with you as you wanted?
1 Yes
3 No
98 I don’t know
E. RECENT EXPERIENCES – ALL USERS
E1. During the past 3 months, how often did your supplier send someone to your
home to make sure that your power wheelchair was working right? (Don’t
include times when they came because you called them).
1 Never
2 Once in the 3 months
3 More than once in the 3 months
98 I don’t know
E2. During the past 3 months, how reliable was your supplier in making deliveries
or repairs?
1 Very reliable
2 Somewhat reliable
3 Not reliable at all
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
12
E3. During the past 3 months, did you contact your supplier with a complaint or a
problem?
1 Yes
2 No (→ Skip to E4)
98 I don’t know (→ Skip to E4)
4 Don’t know how to contact my supplier (→ Skip to E4)
E3a.When you contacted your supplier, was your complaint or problem settled
to your satisfaction?
1 Yes
2 No
3 I am waiting for it to be settled
98 I don’t know
E4. During the past 3 months, did you contact your supplier to get emergency
service or advice?
1 Yes
2 No ( → Skip to E5)
98 I don’t know (→ Skip to E5)
E4a. In general, how fast did they respond to your needs, either by phone or
in person? Would you say…
1 Within 1 day
2 Within 2 days
3 Within 1 week
4 Longer than 1 week
98 I don’t know
E4b. Were you able to get the emergency service or advice you needed?
1 Yes
2 No
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
13
E5. During the past 3 months, did you need to contact your supplier after regular
business hours?
1 Yes
2 No (→ Skip to E6)
98 I don’t know (→ Skip to E6)
E5a.During the past 3 months when you contacted your supplier after
business hours in general, were you able to get the service or advice you
needed?
1
Yes
2
No
98
I don’t know
E6. During the past 3 months, how reliable has your power wheelchair been?
Would you say…
1 Very reliable
2 Somewhat reliable
3 Somewhat unreliable
4 Very unreliable
98 I don’t know
Abt Associates Inc.
Beneficiary DMEPOS Survey
14
E7. During the past 3 months, have you changed your power wheelchair supplier?
1 Yes
2 No (→ Skip to SECTION F)
98 I don’t know (→ Skip to SECTION F)
E7a.Why did you change your power wheelchair supplier? (Please check all
that apply)
1 I moved
2 Supplier no longer accepted Medicare for the equipment
3 Supplier went out of business
4 Not happy with the quality of service
5 Not happy with equipment
6 Not happy with the choices of equipment/service I could get
7 Supplier did not provide power wheelchair, accessories or repair service I needed
8 Changed to an HMO and had to use a different supplier
9 Other (Please describe):_____________________
F. ABOUT YOU - ALL
Section F is about you, the person whose name is on the mailing label of
this survey.
F1. In general, how would you rate your overall health?
1 Excellent
2 Very good
3 Good
4 Fair
5 Poor
Abt Associates Inc.
Beneficiary DMEPOS Survey
15
F2. Compared to 1 year ago, how would you rate your health now? Would you
say…
1 Much better now
2 Somewhat better now
3 About the same
4 Somewhat worse now
5 Much worse now
98 I don’t know
F3. Which best describes your living situation now? (Please check all that apply)
I live….
1 Alone
2 With spouse/partner
3 With parent/step-parent
4 With child/children
5 With other relative(s)
6 With friend
7 With other person(s) not related to me
F4. What is the highest grade or level of school that you have completed?
1
2
3
4
5
6
8th grade or less
Some high school but did not graduate
High school graduate or GED
Some college or technical school
College graduate
More than a 4-year college degree
Abt Associates Inc.
Beneficiary DMEPOS Survey
16
F5. What was your household’s annual income during 2006 before taxes?
1 Less than $5,000 ($416 per month)
2 Between $5,001 and $10,000 ($417–$833 per month)
3 Between $10,001 and $20,000 ($834–$1,666 per month)
4 Between $20,001 and $30,000 ($1,667–2,500 per month)
5 Over $30,001 (More than $2,500 per month)
98 I don’t know
F6. Are you of Hispanic or Latino decent?
1 Yes
2 No
F7. How would you describe your race? (Please check all that apply)
1 American Indian or Alaskan Native
2 Asian
3 Black or African American
4 Native Hawaiian or other Pacific Islander
5 White or Caucasian
6 Other (Please tell us:) ______________________________
G. Other Information
G1. Please check the correct statement:
1 I am the person to whom this survey was addressed (→ Skip to END)
2 I filled this survey out or helped fill it out for someone else
G2. Which of these comes closest to describing how you helped the person with this
survey?
1 I wrote the answers that the person told me
2 I answered the questions myself based on my knowledge of the person’s condition
3 Both of the above
END
Abt Associates Inc.
Beneficiary DMEPOS Survey
17
Thank you for completing the survey. Please return the completed survey in the
postage-paid envelope addressed to:
Todd Robbins
CMS Survey of Beneficiaries Using [Medical Equipment and Supplies]
55 Wheeler Street,
Cambridge, MA 02138
If you have any questions about the survey, please call toll-free 1-xxx-xxx-xxxx.
If you have any questions about Medicare, please visit the website of the Center for
Medicare Services at: http://www.medicare.gov/, or call 1-800-MEDICARE.
Abt Associates Inc.
Beneficiary DMEPOS Survey
18
CMS letterhead
COVER LETTER FOR SURVEY PACKET I
[Date]
«AbtID»
«FName» «MI» «LName»
«Addr1», «Addr2»
«City», «State» «Zip»
Dear «FName» «MI» «LName»:
I am writing to ask your help with a voluntary research survey that the Centers for Medicare and
Medicaid Services (CMS) is conducting about your experiences as a person who uses medical equipment and
supplies. CMS is the federal agency that runs Medicare.
Your name was selected at random from a list of people who have recently obtained medical
equipment and supplies that were paid for by Medicare. The enclosed questionnaire contains questions
about your experiences with your equipment and your equipment supplier. Please take a few minutes to
complete the questionnaire and return it in the postage-paid envelope to Abt Associates, the research
company helping CMS with the survey. If you would prefer to complete the survey by telephone, please call
NUMBER, toll-free- Monday-Friday between TIME and TIME Eastern Time.
Your answers to the questions will be grouped together with everyone else who completes the survey.
We do not foresee any possible risks to you from participating in this survey, other than the minimal risk that
your confidentiality might not be preserved. All the information you provide will be held in strict
confidence by CMS and Abt Associates and will be protected by the Federal Privacy Act and the full extent
provided by law. You may choose to answer this survey or not. Your participation is voluntary and will not
affect any benefits you receive, now or in the future. However, the answers you provide will help CMS help
Medicare make sure that beneficiaries have access to the medical equipment and services they need. This
study has been endorsed by (INSERT NAME OF AGENCIES). They encourage your participation. Enclosed
is a fact sheet that provides more information about the study.
Your participation is critical to the success of the study.
We hope to receive your completed survey by [FILL DATE].
If you have questions about the survey or to complete the survey by telephone or to request a
questionnaire in Spanish, please call NUMBER.
Thank you in advance for your participation.
Sincerely,
________Privacy Officer
The Centers for Medicare & Medicaid Services
Abt Associates, Inc.
Cover Letter for Beneficiary Survey
1
CMS letterhead
COVER LETTER FOR SURVEY PACKET 2
[Date]
«AbtID»
«FName» «MI» «LName»
«Addr1», «Addr2»
«City», «State» «Zip»
Dear «FName» «MI» «LName»:
I am writing to ask your help with a voluntary research survey that the Centers for Medicare and
Medicaid Services (CMS) is conducting about your experiences as a person who uses medical equipment and
supplies. CMS is the federal agency that runs Medicare. Enclosed is a fact sheet that provides more information
about the study.
Your name was selected at random from a list of people who have recently obtained medical equipment
and supplies that were paid for by Medicare. A few weeks ago, we sent you a letter and a questionnaire in the
mail. If you have already completed it, we thank you for your participation. Since we have not yet received
your survey, we have enclosed another copy for your convenience and extended our submission deadline to
[DATE].
The survey contains questions about your experiences with your equipment and your equipment
supplier. Please take a few minutes to complete and return the questionnaire in the postage-paid envelope to Abt
Associates, the research company helping CMS with the survey. If you would prefer to complete the survey by
telephone, please call NUMBER, toll-free Monday-Friday between TIME and TIME Eastern Time.
Your answers to the questions will be grouped together with everyone else who completes the survey.
We do not foresee any possible risks to you from participating in this survey, other than the minimal risk that
your confidentiality might not be preserved. All the information you provide will be held in strict confidence
by CMS and Abt Associates and will be protected by the Federal Privacy Act and the full extent provided by
law. You may choose to answer this survey or not. Your participation is voluntary and will not affect any
benefits you receive, now or in the future. However, the answers you provide will help CMS help Medicare
make sure that beneficiaries have access to the medical equipment and services they need. Your participation is
critical to the success of the study! This study has been endorsed by (INSERT NAME OF AGENCIES). They
encourage your participation.
If you have questions about the survey or to complete the survey by telephone or to request a
questionnaire in Spanish, please call NUMBER.
Thank you in advance for your participation.
Sincerely,
________Privacy Officer, The Centers for Medicare & Medicaid Services
Abt Associates, Inc.
Cover Letter 2 for Beneficiary Survey
1
Study Fact Sheet:
Centers for Medicare and Medicaid Services (CMS)
Survey of Oxygen Users
Purpose of the Study
The purpose of the study is to learn more about your satisfaction with the equipment, supplies,
and service you receive from your oxygen (or other durable medical equipment) supplier. We
also hope to better understand your experiences in obtaining and using this equipment.
Study Sponsor
The study is funded by the Centers for Medicaid and Medicare Services (CMS), the federal
agency that runs the Medicare program. CMS has arranged for Abt Associates, a research
company, to conduct the study.
Who Else is Participating?
We have sent this survey to approximately thousands of other Medicare Beneficiaries like you,
who use Oxygen or other durable Medical Equipment. Each person selected at random for the
study will represent others like him or herself across the United States, so CMS can better
understand your experiences in obtaining and using this equipment.
Will My Information Be Kept Confidential?
All of your study information will be stored securely by staff at Abt Associates Inc., who are
trained to protect your privacy and confidentiality. Your answers to the questions will be
grouped together with everyone else who completes the survey and presented in summary
format. Your name or contact information will not be linked to your answers provided to CMS.
Your name will not be used in any study publication or presentation.
Options for Completing the Survey
You may complete this survey by filling out the enclosed questionnaire and returning it in the
postage-paid envelope provided. Or, if you prefer, you may call our toll-free number and
complete the survey over the telephone. If you feel you are unable to answer these questions,
you may also choose someone to answer these questions on your behalf. This person should
be knowledgeable about your health and your experiences with this equipment. However,
please do not ask personnel from your oxygen supplier to help you complete this survey.
Contact Information for Questions
If you have any questions about the study procedures, you may call Todd Robbins, Survey
Director at Abt Associates Inc., toll-free at 1-800-xxx-xxxx. If you have any questions about
your rights as a study participant, you may call Marianne Beauregard, the person in charge of
the committee at Abt Associates that is responsible for making sure that study subjects are
treated fairly and properly. She may be reached at 617-349-2852.
Abt Associates Inc.
Beneficiary Oxygen Fact Sheet
1
Study Fact Sheet:
Centers for Medicare and Medicaid Services (CMS)
Survey of Durable Medical Equipment Users
Purpose of the Study
The purpose of the study is to learn more about your satisfaction with the equipment, supplies,
and service you receive from your oxygen (or other durable medical equipment) supplier. We
also hope to better understand your experiences in obtaining and using this equipment.
Study Sponsor
The study is funded by the Centers for Medicaid and Medicare Services (CMS), the federal
agency that runs the Medicare program. CMS has arranged for Abt Associates, a research
company, to conduct the study.
Who Else is Participating?
We have sent this survey to approximately thousands of other Medicare Beneficiaries like you,
who use Oxygen or other durable Medical Equipment. Each person selected at random for the
study will represent others like him or herself across the United States, so CMS can better
understand your experiences in obtaining and using this equipment.
Will My Information Be Kept Confidential?
All of your study information will be stored securely by staff at Abt Associates Inc., who are
trained to protect your privacy and confidentiality. Your answers to the questions will be
grouped together with everyone else who completes the survey and presented in summary
format. Your name or contact information will not be linked to your answers provided to CMS.
Your name will not be used in any study publication or presentation.
Options for Completing the Survey
You may complete this survey by filling out the enclosed questionnaire and returning it in the
postage-paid envelope provided. Or, if you prefer, you may call our toll-free number and
complete the survey over the telephone. If you feel you are unable to answer these questions,
you may also choose someone to answer these questions on your behalf. This person should
be knowledgeable about your health and your experiences with this equipment. However,
please do not ask personnel from your oxygen supplier to help you complete this survey.
Contact Information for Questions
If you have any questions about the study procedures, you may call Todd Robbins, Survey
Director at Abt Associates Inc., toll-free at 1-800-xxx-xxxx. If you have any questions about
your rights as a study participant, you may call Marianne Beauregard, the person in charge of
the committee at Abt Associates that is responsible for making sure that study subjects are
treated fairly and properly. She may be reached at 617-349-2852.
Abt Associates Inc.
Beneficiary DMEPOS Fact Sheet
1
BENEFICIARY SURVEY POSTCARD REMINDER
Dear Sir or Madam:
We recently sent you a survey. The purpose of the survey is to learn about your experiences
with obtaining medical equipment and supplies. Your participation is voluntary, but it is important
that we hear from you because only you can tell us about your unique experience.
If you have already completed the survey, we thank you for your participation. If you have any
questions, or if you prefer to complete the survey over the telephone, please call us, toll-free at
xxxxxx. Thank you for taking part in this important study.
Sincerely,
Todd Robbins, Senior Survey Director
Abt Associates Inc.
Abt Associates Inc.
Beneficiary Postcard Reminder
1
Durable Medical Equipment and
Prosthetics, Orthotics and
Supplies (DMEPOS)
Supplier Survey
(OMB# 0938-NEW)
A Study of Medical Equipment
Suppliers
Sponsored by:
The Centers for Medicare & Medicaid Services (CMS)
Abt Associates Inc.
Supplier Survey
1
NOTES FOR WEB PROGRAMMER:
THROUGHOUT THE SURVEY – WEB PROGRAMMING SPECS WILL BE IN ALL CAPS WITH
THE INTRO OF “CATI: XXXX”.
DATA FOR THE SURVEY WILL BE SUPPLIED (FOR THE FILLS) BY THE SAMPLE
INFORMATION. FOR EACH CASE, WE WILL LOAD CLAIMS DATA FOR 8 CLAIMS,
CORRESPONDING TO THE CASE BY THE ABT ID PROVIDED.
IN THE LOGIN SCREEN:
WE WOULD LIKE TO CONFIRM THE CONTACT INFORMATION FOR THE USER,
WITH THE SAMPLE INFORMATION PROVIDED (COMPANY AFFILIATION).
LINK TO A PDF OF THE STUDY FACT SHEET.
DISPLAY THE ABT AND CMS LOGOS AT THE BOTTOM OF EACH SCREEN IN THE
SURVEY (LOGOS WILL BE PROVIDED ELECTRONICALLY).
LOAD ONLY 1-2 SURVEY ITEMS PER PAGE. IF AN ITEM IS LEFT BLANK, DO NOT
REQUEST CONFIRMATION THAT THE ITEM WAS INTENDED TO BE BLANK (UNLESS
SPECIFIED IN PROGRAMMING SPECIFICATIONS).
USE RADIO BUTTONS FOR THE ANSWER OPTIONS, UNLESS THEY ARE ENTERING
TEXT. PLACE THE BUTTONS TO THE LEFT OF THE ANSWER CHOICES, AS SHOWN IN
ATTACHED SPECIFICATIONS.
USE ARIAL FONT, SIZE 12 FOR TEXT ON THE SCREENS. USE COLOR OR SHADING
WHEN SPECIFIED. BACKGROUND OF SCREEN SHOULD BE LIGHT BLUE, TEXT SHOULD
BE BLACK.
Abt Associates Inc.
Supplier Survey
2
SUPPLIER SURVEY
SCREEN LAYOUT AND QUESTIONS
ENTRY SCREEN A
(CMS LOGO)
(ABT ASSOCIATES INC. LOGO)
The Centers for Medicare & Medicaid Services (CMS)
Survey of Suppliers of Durable Medical Equipment
PASSWORD:
XXXXX
CATI: IF POSSIBLE, PASSWORDS ARE NOT TO EXCEED A 5 DIGIT / LETTERS
COMBINATION.
ENTRY SCREEN B
The Centers for Medicare & Medicaid Services (CMS)
Survey of Suppliers of Durable Medical Equipment
Thank you for your participation in this important study. Please confirm you are
completing this survey on behalf of [INSERT SUPPLIER NAME].
1
Yes, that is correct SKIP TO SCREEN 1
2
No, that is not the company I represent SKIP TO TERMINATE
CATI: NEW SCREEN: : It appears the password you provided does
not match the company you represent. Please call us, toll-free, at 1-800-xxx-xxxx to
receive the correct password for your company.
Abt Associates Inc.
Supplier Survey
3
INTRO SCREEN 1
The purpose of this study is to help CMS better understand the types of products
beneficiaries receive under the broad HCPCs categories provided in the claims. In
addition, we are examining if and how these products change over time, particularly in
the environment of competitive bidding. Your participation is critical to the success of
this study.
The questions in this survey will take approximately 45 minutes to answer. We will be
asking you to provide detailed information on eight DMEPOS claims submitted to CMS
on behalf of Medicare beneficiaries who recently obtained products from your company.
Therefore, you may need to access records in your computer system or from your
patient files. Additionally, the survey will end with a few general, non-claim questions
about the types of products you provide to Medicare beneficiaries. We do not request
any identifying patient information.
Supplying these data will not violate any HIPAA regulations. All the information you
provide will remain confidential. The findings from this survey will be presented in
summary format, – with everyone’s answers grouped together. This survey is not an
audit. Your responses to this survey will not affect any claims that have been paid by
CMS.
The American Association for Respiratory Care and [INSERT NAME OF
ORGANIZATION] have endorsed and strongly encourage your participation in this
survey.
CATI: Insert logos of endorsing organization
We have attached the Study Fact Sheet in the link below to provide you with additional
information about the study.
1
Continue to begin survey
[AFFIX LINK TO STUDY FACT SHEET (.pdf) ON THIS SCREEN]
INTRO SCREEN 2 (Oxygen supplier Sample only)
On the screens that follow are 8 different claims you have submitted for [INSERT
PRODUCT CATEGORY]. Of these 8 claims, 4 will pertain to HCPC [INSERT HCPC]
and 4 claims will pertain to HCPC [INSERT HCPC].
Abt Associates Inc.
Supplier Survey
4
Each question will provide the claim number, HCPC, and date of service to facilitate the
retrieval of the claim in order to provide the specific information about the product that
was provided to the Medicare beneficiary.
INTRO SCREEN 3 (Wheelchair or hospital bed Sample only)
On the screens that follow are 8 different claims you have submitted for [INSERT
PRODUCT CATEGORY].
Each question will provide the claim number, HCPC, and date of service to facilitate the
retrieval of the claim in order to provide the specific information about the product that
was provided to the Medicare beneficiary.
CATI: Only one manufacturer or drop down item can be selected for each claim.
CLAIM 1 NEW SCREEN
1.
The first claim we would like you to provide information about is:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
Please retrieve your records for this claim and tell us what specific product was
provided.
1A.
Select the product manufacturer [INSERT DROP DOWN MENU]
1B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 2 NEW SCREEN
2.
For the second claim, please retrieve your records for:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
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5
For this claim, what specific/exact product was provided?
2A.
Select the product manufacturer [INSERT DROP DOWN MENU]
2B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 3 NEW SCREEN
3.
Please retrieve your records for the following claim:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
For this claim, what specific/exact product was provided?
3A.
Select the product manufacturer [INSERT DROP DOWN MENU]
3B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 4 NEW SCREEN
4. Please retrieve your records for the following claim:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
For this claim, what specific/exact product was provided?
4A.
Select the product manufacturer [INSERT DROP DOWN MENU]
4B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 5 SCREEN
Abt Associates Inc.
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6
5. Please retrieve your records for the following claim:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
For this claim, what specific/exact product was provided?
5A.
Select the product manufacturer [INSERT DROP DOWN MENU]
5B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 6 NEW SCREEN
6. Please retrieve your records for the following claim:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
For this claim, what specific/exact product was provided?
6A.
Select the product manufacturer [INSERT DROP DOWN MENU]
6B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 7 NEW SCREEN
7. Please retrieve your records for the following claim:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
For this claim, what specific/exact product was provided?
7A.
Abt Associates Inc.
Select the product manufacturer [INSERT DROP DOWN MENU]
Supplier Survey
7
7B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
CLAIM 8 NEW SCREEN
8. Please retrieve your records for the following claim:
Beneficiary Name (INSERT BENE NAME)
Beneficiary HIC#
Claim number [INSERT CLAIM NUMBER]
HCPCS code [INSERT HCPC]
Date of Service [INSERT DATE OF SERVICE]
For this claim, what specific/exact product was provided?
8A.
Select the product manufacturer [INSERT DROP DOWN MENU]
8B.
Select the product name and/or model [INSERT DROP DOWN
MENU, UPDATED FROM MANUFACTURER SELECTED]
GENERAL QUESTIONS NEW SCREEN
In this last set of questions, we would like to know the types of products you most
commonly provide to Medicare beneficiaries. Please provide us your best estimates for
the following questions.
9. From the menus of products listed below, please select the different types (models)
of [INSERT DMEPOS PRODUCT], that you regularly offer Medicare beneficiaries.
[INSERT DROP DOWN MENU OF ALL MODELS FROM ALL MANUFACTURERS
ALPHABETICALLY]
9a. Of the ones you selected above, which are the two models that you tend to provide
Medicare beneficiaries most often? [INSERT DROP DOWN MENU OF ALL MODELS
SELECTED IN QUESTION #9)
10. Approximately what percentage of your total [INSERT DMEPOS PRODUCT]
business for Medicare beneficiaries does each of these makeup? (Please refer to #
number of items sold and not % of dollar volume)
___ %
Manufacturer/Model 1 [POPULATE FIELD FROM QUESTION 9A]
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8
___ %
Manufacturer/Model 2 [POPULATE FIELD FROM QUESTION 9A]
(PROGRAMMER’S NOTE: ASK 12, 12a, AND 13 ONLY IF OXYGEN SUPPLER
SAMPLE )—IF WHEELCHAIR OR HOSPITAL BED SAMPLE SKIP TO FINAL NEW
SCREEN)
12. From the menus of products listed below, please select the different types (models)
of [INSERT DMEPOS PRODUCT], that you regularly offer Medicare beneficiaries.
[INSERT DROP DOWN MENU OF ALL MODELS FROM ALL MANUFACTURERS
ALPHABETICALLY]
12a. Of the ones you selected above, which are the two models that you tend to provide
Medicare beneficiaries most often? [INSERT DROP DOWN MENU OF ALL MODELS
SELECTED IN QUESTION #12)
13. Of these two, approximately what percentage of your total [INSERT DMEPOS
PRODUCT] business for Medicare beneficiaries does each of these make up? Please
refer to # number of items sold and not dollar volume.
___ %
___ %
Manufacturer/Model 1 [POPULATE FIELD FROM QUESTION 12A]
Manufacturer/Model 2 [POPULATE FIELD FROM QUESTION 12A]
FINAL NEW SCREEN
Thank you for your participation in the Centers for Medicare & Medicaid Services (CMS)
Survey of Suppliers of Durable Medical Equipment and Supplies. Your participation has
been critical to the success of the study.
We would like to thank you by offering you a check for $75.00. Please tell us how you
would like us to make out the check:
__ Please make the check payable to the company--(INSERT NAME OF COMPANY)
__ Please make the check payable to me __________________ (Please insert your
name)
__ No, thank you. I do not wish to receive a check.
Abt Associates Inc.
Supplier Survey
9
If you have any questions about the study, or need more information, please call Todd
Robbins, Survey Director at Abt Associates, toll-free at 1-800-xxx-xxxx.
Abt Associates Inc.
Supplier Survey
10
Supplier Survey Illustrative Example
Abt Associates Inc.
Supplier Survey
11
Supplier Survey Illustrative Example
EXAMPLE DMEPOS ITEM: Manual Wheelchair, Standard; HCPC Code: K0001
1.
Please retrieve your records for the following claim:
Claim number: 123456
HCPCS code: K0001
Date of Service: 11-11-1111
For this claim, what specific/exact product was provided?
1A.
Select the product manufacturer
Manufacturer Drop Down Menu
Access Point Medical, Inc.
Alum Creek Wheelchair, Inc.
American Bantex Corporation
Dalton Medical Corporation
Damaco
Dr. K Healthcare Products
Drive Medical Design & Manufacturing
Everest & Jennings
Evermed
Freedom Designs, Inc.
Gendron
Graham-Field
Guardian
HME Providers
Hoveround Corporation
Invacare
Kareco
Karman Healthcare Inc.
Labac
Levo USA, Inc.
Lumex
Major Mobility Products, Inc.
Maple Leaf Wheelchairs
Medline Industries, Inc.
Merits
New Solutions, LLC
Nova Ortho-Med, Inc.
PMI Incorporated
Summit Durable Medical Equipment
Theradyne
Tuffcare
Other
Abt Associates Inc.
Supplier Survey
12
1B.
Select the product name and/or model
Models
9000 Recliner
CareGuard
Futuro 4800
Futuro 4130
Invacare MG
IVC 900 (Formerly Rolss 900)
IVC Tracer EX2 Fixed Frame Builder Wheelchair (Model TREXFF)
Rolls 400
Rolls 900 (Name Changed to IVC 900)
Tracer
Tracer EX
Tracer LX - Standard Adult Frame
Tracer Plus
Other
9. From the menus of products listed below, please select the different types (models)
of [INSERT DMEPOS PRODUCT], that you regularly offer Medicare beneficiaries.
[INSERT DROP DOWN MENU OF ALL MODELS FROM ALL MANUFACTURERS
ALPHABETICALLY]
Manufacturer Drop Down Menu
Access Point Medical, Inc.
Alum Creek Wheelchair, Inc.
American Bantex Corporation
Dalton Medical Corporation
Damaco
Dr. K Healthcare Products
Drive Medical Design & Manufacturing
Everest & Jennings
Evermed
Freedom Designs, Inc.
Gendron
Graham-Field
Guardian
HME Providers
Hoveround Corporation
Invacare
Kareco
Karman Healthcare Inc.
Labac
Levo USA, Inc.
Lumex
Abt Associates Inc.
Supplier Survey
13
Major Mobility Products, Inc.
Maple Leaf Wheelchairs
Medline Industries, Inc.
Merits
New Solutions, LLC
Nova Ortho-Med, Inc.
PMI Incorporated
Summit Durable Medical Equipment
Theradyne
Tuffcare
Other
FOR EACH MANUFACTURER SELECTED THE RANGE OF MODELS OFFERED BY
THE MANUFACTURER WILL APPEAR FOR THE SUPPLIER TO SELECT. FOR
EXAMPLE:
Invacare Models
9000 Recliner
CareGuard
Futuro 4800
Futuro 4130
Invacare MG
IVC 900 (Formerly Rolss 900)
IVC Tracer EX2 Fixed Frame Builder Wheelchair (Model TREXFF)
Rolls 400
Rolls 900 (Name Changed to IVC 900)
Tracer
Tracer EX
Tracer LX - Standard Adult Frame
Tracer Plus
Other
10. Of the ones you selected above, which are the two models that you tend to provide
Medicare beneficiaries most often? [insert drop down menu of al models selected in
question #9)
Selected Manufacturers: Drop Down Menu
Access Point Medical, Inc.
Damaco
Everest & Jennings
Invacare
Medline Industries, Inc.
Tuffcare
11. Of these two, approximately what percentage of your total [insert DMEPOS product]
business for Medicare beneficiaries does each of these makeup? Please refer to #
number of items sold and not dollar volume.
Abt Associates Inc.
Supplier Survey
14
25 %
30 %
Abt Associates Inc.
Everest & Jennings
Invacare
Supplier Survey
15
SUPPLIER SURVEY -- COVER LETTER FOR SURVEY PACKET I
[Date]
«AbtID»
«FName» «MI» «LName»
«Addr1», «Addr2»
«City», «State» «Zip»
Dear «FName» «MI» «LName»:
As a supplier of [INSERT PRODUCT NAME CHOSEN], you play an important role in providing
Medicare beneficiaries with equipment and services they need to maintain their health and wellbeing. At the Centers for Medicare & Medicaid Services (CMS), we are interested in information
about how the national competitive bidding program might impact the types of products
available to Medicare beneficiaries. To provide data for a formal study of the new program, we
have hired a research firm, Abt Associates, which is conducting a survey of DMEPOS suppliers.
Your company was selected at random from suppliers working with Medicare. To participate in
this study, simply log on to the web link provided and enter your unique password. It should
take about 45 minutes to complete. Your participation is voluntary, but critical to the success of
this study. As a token of appreciation for your time and effort in assisting us with this survey, we
will send you a thank-you gift of $75; details are available at the bottom of the computerized
survey form.
The website for the survey is: www.xxxxxxxx.com
Your unique password is: xxxxxx
We hope to receive your completed survey by [INSERT DATE]
Your answers to the questions will be grouped together with everyone else who completes the
survey. We do not foresee any possible risks to you from participating in this survey, other than
the minimal risk that your confidentiality might not be preserved. All the information you
provide will be held in strict confidence by CMS and Abt Associates and will be protected by the
Federal Privacy Act and the full extent provided by law. This survey is not an audit. Your
responses to this survey will not affect any claims that have been paid by CMS.
The American Association for Respiratory Care and [INSERT NAME HERE] have endorsed and
strongly encourage your participation in this survey.
We have also enclosed a study fact sheet for your review. If you have any questions about the
study, or if you prefer to complete the survey over the telephone, please call Todd Robbins,
Survey Director at Abt Associates Inc., toll-free at: 1-800-xxx-xxxx. Thank you for taking part in
this important study.
Sincerely,
__________________, Title
The Centers for Medicare & Medicaid Services
Abt Associates Inc.
Cover Letter 1 Supplier Survey
1
SUPPLIER SURVEY -- COVER LETTER FOR SURVEY PACKET II
[Date]
«AbtID»
«FName» «MI» «LName»
<>«Addr1», «Addr2»
«City», «State» «Zip»
Dear «FName» «LName»:
A few weeks ago, we sent you a letter inviting you to participate in an important study conducted
by the Centers for Medicare & Medicaid Services (CMS). As a supplier of oxygen or other
durable medical equipment, you play an important role in providing Medicare beneficiaries with
products and services they need to maintain their health and well-being.
At CMS, we are responsible for understanding how the competitive bidding program might
impact you and the types of products available to Medicare beneficiaries. So we have hired a
research firm, Abt Associates, to conduct a survey of suppliers from across the country. Your
company was selected at random from suppliers working with Medicare. If you are willing to be
part of this study, simply log in to the web link provided and enter your unique password. It
should take you about 45 minutes to complete. Your participation is voluntary, but critical to the
success of this study. You will receive a thank you gift of $75 upon completion of the survey.
This survey is not an audit. Your responses to this survey will not affect any claims that have
been paid by CMS.
The American Association for Respiratory Care and [INSERT NAME HERE] have endorsed and
strongly encourage your participation in this survey.
Because your participation is so important to the success of the study – we have extended our
submission deadline. We hope to receive your completed survey by [INSERT DATE]
The website for the survey is: www.xxxxxxxx.com
Your unique password is: xxxxxx
Your answers to the questions will be grouped together with everyone else who completes the
survey. We do not foresee any possible risks to you from participating in this survey, other than
the minimal risk that your confidentiality might not be preserved. All the information you provide
will be held in strict confidence by CMS and Abt Associates and will be protected by the Federal
Privacy Act and the full extent provided by law.
We have also enclosed a study fact sheet for your review. If you have any questions about the
study, or if you prefer to complete the survey over the telephone, please call Todd Robbins,
Survey Director at Abt Associates Inc., toll-free at: 1-800-xxx-xxxx. Thank you for taking part in
this important study.
Sincerely,
__________________, Title
The Centers for Medicare & Medicaid Services
Abt Associates Inc.
Cover Letter 2 for Supplier Survey
1
Study Fact Sheet: Centers for Medicare & Medicaid Services (CMS)
Survey of Durable Medical Equipment Suppliers
Purpose of the Study
The purpose of this study is to better understand the impacts of the national competitive bidding
program being launched by Medicare this year. The survey of suppliers is one part of a multifaceted research project to provide information to the Congress, the Executive Branch, and the
public about the new program. Your participation in the supplier survey will provide information
about the new program’s impact on the types of products available to Medicare beneficiaries.
This survey is not an audit or any other type of payment investigation. Your responses to this
survey will not affect any claims that have been paid by Medicare. The survey’s sole purpose is
to collect information in a scientific manner to enable researchers to understand whether and
how product offerings might change under competitive bidding.
Study Sponsor
The study is funded by the Centers for Medicaid and Medicare Services (CMS), the government
agency that runs the Medicare program. CMS has asked Abt Associates, a research company,
to conduct the study.
Study Endorsements
The study has been endorsed by American Association for Respiratory Care and the [INSERT
NAME HERE]. These organizations encourage your participation and recognize that this study
is an important research effort.
Who Else is Participating?
This survey is being sent to hundreds of suppliers, like yourself, who provide oxygen or other
durable medical equipment to Medicare beneficiaries. Each supplier was scientifically selected
at random to represent other companies like yours. Each payment record about which we ask
in this survey was also selected at random.
Will My Information Be Kept Confidential?
Yes. All the information you provide will be kept confidential. Your answers will be grouped
together with those of the other participants and presented in summary format. All of your study
information will be stored securely at Abt Associates Inc. Staff at Abt Associates is trained to
protect your privacy and confidentiality. Your name or contact information will not be linked to
your answers provided to CMS. Your answers to the questions will not be linked to your
company’s contact information in any report or publication.
HIPAA Regulations on Providing Information about Beneficiaries
The questions in the survey pertain to information on beneficiary claims. We do not ask you to
provide any names or contact information for the beneficiaries associated with these claims.
Providing these data will not be in violation of any HIPAA regulations.
Options for Completing the Survey
The survey can be completed on-line at www.xxxxxxx.xxxx. Your password is provided in the
enclosed cover letter. Alternatively, you can reach us, toll-free, at 1-800-xxx-xxxx to complete
the survey via telephone. Use this toll free number to confirm your password, or with any
questions you may have about the study. You will receive a thank you gift of $75 after
completing the survey.
Abt Associates Inc.
Supplier Survey Fact Sheet
1
Contact Information for Questions
If you have any questions about the study procedures, you may call Todd Robbins, Survey
Director at Abt Associates Inc., toll-free at 1-800-xxx-xxxx. If you have any questions about
your rights as a study participant, you may call Marianne Beauregard, the person in charge of
the committee at Abt Associates that is responsible for making sure that study subjects are
treated fairly and properly. She may be reached at 617-349-2852.
Abt Associates Inc.
Supplier Survey Fact Sheet
2
SUPPLIER POSTCARD/EMAIL REMINDER
Dear Supplier:
We recently sent you a survey.
The purpose of the survey is to learn about how the
competitive bidding program might affect the types of products available to Medicare
beneficiaries. Your participation is voluntary but vital to decision-makers who oversee the
program. The survey is not an audit and it will not affect your relationship with CMS.
The American Association of Respiratory Care and [INSERT NAME HERE] have endorsed and
strongly support participation in this survey.
If you have already completed the survey on-line, we thank you for your participation. If you
need the link and password provided again, if you have any questions, or if you prefer to
complete the survey over the telephone, please call us, toll-free at 1-800-xxx-xxxx. As a token
of our appreciation, we will send you a gift of $75 after you complete the survey. Thank you for
taking part in this important study.
Sincerely,
__________________, Title
The Centers for Medicare & Medicaid Services
Abt Associates Inc.
Supplier Survey Postcard Reminder
1
APPENDIX C
Nonstatistical Data Collection Instruments
OMB# 0938-NEW
Focus Group Guide
Referral Agents (Wave 1)
Introduction (5 minutes)
Welcome. Thank you for joining us today. I am ___________ [Insert your
name] from Abt Associates Inc. We do research on health care. I will be
moderating our discussion and _______ [Insert co-moderator] will be
assisting and taking notes.
The topic we’ll be discussing today is the changes in Medicare with regard
to durable medical equipment and the fee schedule they use to pay suppliers
of these products. This “competitive bidding program” has recently been
implemented in your area. Each of you has been asked to participate
because you are a referral agent that works with Medicare beneficiaries. We
are particularly interested in your perspective on the current durable medical
equipment market and suppliers available to Medicare beneficiaries. Over
the next year and a half, two more focus groups will be held in your area as a
part of this study. Focus groups are also being held in other areas and these
will help the Centers for Medicare & Medicaid Services (CMS) understand
the impact of the program.
Informed Consent (5 minutes)
Before we begin, I need to read aloud some of the key points of the consent
form you just signed. Did everyone sign the form?
• Today we will ask you to discuss your experiences with Medicare
beneficiaries and durable medical equipment
• Your participation is voluntary
• The focus groups will last approximately 1.5 hours
• The discussion will be confidential
• You can refuse to take part in this focus group if you wish without
affecting your professional relationship with CMS
• You do not have to answer any questions you do not wish to
answer
• You can quit the study at any time
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 1)
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• We do not foresee any possible risks from participating in this
focus group, other than the minimal risk that confidentiality might
not be preserved
• There are no costs to you for participating in the focus group
• You will receive $75 today for participating and dinner is provided
• This discussion will not be video or audiotaped, rather ________
[Insert co-moderator] will be taking notes. The notes from tonight
will be labeled with a study code, not your names, and they will be
kept in a locked file and/or a password-protected computer at Abt
Associates Inc. in Cambridge, Massachusetts. A summary of the
notes will be shared with CMS
• Your comments, and those of others in the focus group, will be
used in reports to the government, in summary form and your
name will not be included in the report
• Does anyone have any questions?
How the focus group will work (3 minutes)
• Want to keep the discussion informal and relaxed
• Eat and use the restrooms as you like
• During the discussion, please feel free to ask me or each other if
something is unclear
• There are no right or wrong answers
• If you disagree with what someone else says, or have a different
experience, please say so or I’ll think that you all agree
• Some of you may have strong opinions, so please be respectful of
other’s
• Be careful not to talk all at once; I don’t want to miss anything that
is said
• My job is to make sure we hear from everyone. Some people talk
more than others, and I’ll be encouraging everyone to speak up.
Participant Introductions (7 minutes)
Let’s go around the room and quickly introduce ourselves. [Write on the flip
chart the following items]
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 1)
-2-
•
•
•
•
•
First name
Title (for example social worker, discharge planner, etc)
Organization you represent
Clients you serve
Role with durable medical equipment
BASELINE ENVIRONMENT
1. Could you describe the referral process as it happens in your
role? Let’s go around the room.
From beginning to end
What do you do for your patients? (e.g. file the certificate of
medical necessity – CMN)
How is it different as a discharge planner, Physical
Therapist, social worker, home health worker, etc?
2. How do you determine which supplier you refer your clients to?
a. Do you have a list of suppliers? Where does it come from?
b. Do you have a preferred supplier?
c. Are you satisfied with your interactions with suppliers? Why or
why not?
d. Do you find any significant problems related to accessing
suppliers at present?
3. How is the DMEPOS market in this area?
a. Are there enough suppliers?
b. Is there a dominant supplier?
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 1)
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i. For oxygen?
ii. Product X, Y, Z?
c. How do suppliers compete for referrals?
d. Do suppliers market their services?
i. How do they market? (pamphlets, visits, etc.)
ii. To whom do they market? (you, patients, etc.)
4. What do you think of the current level of access and quality of
DMEPOS products and services that suppliers provide your
clients?
COMPETITIVE BIDDING PROGRAM
5. How many of you have heard about Medicare’s change in the
durable medical equipment fee schedule for suppliers, also known
as “competitive bidding”?
COUNT NUMBER OF RAISED HANDS
_______
PROGRAM DESCRIPTION: The competitive bidding program for
durable medical equipment, prosthetic, orthotic supplies (DMEPOS) is a
program administered by the Center for Medicare and Medicaid Services
(CMS), part of the Department of Health and Human Services (DHS), to
control the costs of DMEPOS by requiring suppliers to bid for a contract
to provide DMEPOS products and services to Medicare beneficiaries.
This will result in a new fee schedule for specific DMEPOS items, which
could reduce the number of suppliers available to beneficiaries and
potentially change the suppliers with whom you work. Currently the
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 1)
-4-
suppliers are submitting their bids and CMS is beginning to provide
information to referral agents and beneficiaries.
6. How did you hear about the program?
7. What are your initial thoughts about it?
8. How do you think the program will affect your role?
The referral process? (e.g. if suppliers you previously used are
not winning bidders)
9. How do you think the program will affect suppliers in your area?
Reduce the numbers?
More marketing?
Change in level of service provided?
10. How do you think the program will affect Medicare beneficiaries?
QUALITY STANDARDS
11. How many of you have heard about the “quality standards”
required of DMEPOS suppliers for items & services provided
Medicare beneficiaries?
COUNT NUMBER OF RAISED HANDS
Abt Associates Inc.
_______
Focus Group Guide: Referral Agent (WAVE 1)
-5-
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare
Modernization Act 2003, the Center for Medicare and Medicaid Services
(CMS) requires Durable Medical Equipment, Prosthetic, Orthotic Supplies
(DMEPOS) Suppliers to comply with newly established quality standards in
order to receive payment for items or services provided to Medicare
beneficiaries.
12. What do you think of the quality standards?
a. Are they needed?
b. Is there a problem with them?
c. Will they change your role?
d. How will they affect beneficiaries?
ENDING QUESTION
13. Do you have any final thoughts about the current state of
DMEPOS in this area or the competitive bidding program?
Those are all the questions that I have today. I want to thank you for participating in this
discussion.
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 1)
-6-
OMB# 0938-NEW
Focus Group Guide
Referral Agents (Wave 2)
Introduction (5 minutes)
Welcome. Thank you for joining us today. I am ___________ [Insert your
name] from Abt Associates Inc. We do research on health care. I will be
moderating our discussion and _______ [Insert co-moderator] will be
assisting and taking notes.
The topic we’ll be discussing today is the changes in Medicare with regard
to durable medical equipment and the fee schedule they use to pay suppliers
of these products. This “competitive bidding program” has recently been
implemented in your area. Each of you has been asked to participate
because you are a referral agent that works with Medicare beneficiaries. We
are particularly interested in your perspective on the current durable medical
equipment market and suppliers available to Medicare beneficiaries. Over
the next year and a half, two more focus groups will be held as a part of this
study. Focus groups are also being held in other areas and these will help
the Centers for Medicare & Medicaid Services (CMS) understand the impact
of the program.
Informed Consent (5 minutes)
Before we begin, I need to read aloud some of the key points of the consent
form you just signed. Did everyone sign the form?
• Today we will ask you to discuss your experiences with Medicare
beneficiaries and durable medical equipment
• Your participation is voluntary
• The focus groups will last approximately 1.5 hours
• The discussion will be confidential
• You can refuse to take part in this focus group if you wish without
affecting your professional relationship with CMS
• You do not have to answer any questions you do not wish to
answer
• You can quit the study at any time
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 2)
-1-
• We do not foresee any possible risks from participating in this
focus group, other than the minimal risk that confidentiality might
not be preserved
• There are no costs to you for participating in the focus group
• You will receive $75 today for participating and dinner is provided
• This discussion will not be video or audiotaped, rather ________
[Insert co-moderator] will be taking notes. The notes from tonight
will be labeled with a study code, not your names, and they will be
kept in a locked file and/or a password-protected computer at Abt
Associates Inc. in Cambridge, Massachusetts. A summary of the
notes will be shared with CMS
• Your comments, and those of others in the focus group, will be
used in reports to the government, in summary form and your
name will not be included in the report
• Does anyone have any questions?
How the focus group will work (3 minutes)
• Want to keep the discussion informal and relaxed
• Eat and use the restrooms as you like
• During the discussion, please feel free to ask me or each other if
something is unclear
• There are no right or wrong answers
• If you disagree with what someone else says, or have a different
experience, please say so or I’ll think that you all agree
• Some of you may have strong opinions, so please be respectful of
other’s
• Be careful not to talk all at once; I don’t want to miss anything that
is said
• My job is to make sure we hear from everyone. Some people talk
more than others, and I’ll be encouraging everyone to speak up.
Participant Introductions (7 minutes)
Let’s go around the room and quickly introduce ourselves. [Write on the flip
chart the following items]
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 2)
-2-
•
•
•
•
•
First name
Title (for example social worker, discharge planner, etc)
Organization you represent
Clients you serve
Role with durable medical equipment
COMPETITIVE BIDDING PROGRAM
1. The DMEPOS competitive bidding program began a few months
ago, how was the information you were provided regarding the
program?
a. General information about the program
i. What information did you receive? In what form? From
whom did you receive this information?
ii. Information regarding what (which supplies) is covered?
iii. Did you find it helpful? Why or why not?
iv. CMS’ availability or contractors?
v. From who else did you receive information?
vi. What other information would you have wanted?
b. List (directory) of “winning” suppliers?
i. Received in a timely manner?
ii. From whom?
iii. In what form? (email, paper, etc.)
2. How has the transition to the competitive bidding program been?
a. For example transition to new suppliers?
b. What other transitions have you had to make?
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 2)
-3-
PROGRAM IMPACT
3. What changes have you noticed in your role/work? Be specific.
a. Changes in the referral process
b. New relationships with suppliers
c. Difficulties
4. What changes have you noticed in the quality and access of
DMEPOS products provided Medicare beneficiaries?
a. Quantity of suppliers?
i. Are there an adequate number of suppliers in the area?
For oxygen? Products X, Y, Z?
b. Quality of products?
i. Changes in products provided?
5. What changes have you noticed in the DMEPOS market?
a. Are there enough suppliers?
b. Is there a new dominant supplier?
i. For oxygen?
ii. Product X, Y, Z?
c. How do suppliers compete for referrals?
d. Do suppliers market their services?
i. How do they market? (pamphlets, visits, etc.)
ii. To whom do they market? (you, patients, etc.)
6. Are beneficiaries aware of the program? What do they know
about it?
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 2)
-4-
a. Have they noticed changes? What?
b. Have they been able to get information when they have had
problems or questions?
c. What questions have your clients/patients been asking with
regard to this program?
d. What could be done to better inform beneficiaries?
7. What do you see as the successes and failures of the program?
QUALITY STANDARDS
8. This program included a requirement that suppliers meet certain
quality standards, have you noticed any changes?
IF PARTICIPANTS AREN’T FAMILIAR WITH THE STANDARDS,
READ DESCRIPTION BELOW
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare
Modernization Act 2003, the Center for Medicare and Medicaid Services
(CMS) requires Durable Medical Equipment, Prosthetic, Orthotic Supplies
(DMEPOS) Suppliers to comply with newly established quality standards in
order to receive payment for items or services provided to Medicare
beneficiaries.
9. What do you think of the quality standards?
a. Are they needed?
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 2)
-5-
b. Is there a problem with them?
c. Will they change your role?
d. How will they affect beneficiaries?
ENDING QUESTIONS
10. What questions or concerns about the program do you have as it
continues forward?
11. Do you have any final thoughts about the Medicare DMEPOS
competitive bidding program?
Those are all the questions that I have today. I want to thank you for
participating in this discussion.
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 2)
-6-
OMB# 0938-NEW
Focus Group Guide
Referral Agents (Wave 3)
Introduction (5 minutes)
Welcome. Thank you for joining us today. I am ___________ [Insert your
name] from Abt Associates Inc. We do research on health care. I will be
moderating our discussion and _______ [Insert co-moderator] will be
assisting and taking notes.
The topic we’ll be discussing today is the changes in Medicare with regard
to durable medical equipment and the fee schedule they use to pay suppliers
of these products. This “competitive bidding program” has recently been
implemented in your area. Each of you has been asked to participate
because you are a referral agent that works with Medicare beneficiaries. We
are particularly interested in your perspective on the current durable medical
equipment market and suppliers available to Medicare beneficiaries. Over
the next year and a half, two more focus groups will be held in your area as a
part of this study. Focus groups are also being held in other areas and these
will help the Centers for Medicare & Medicaid Services (CMS) understand
the impact of the program.
Informed Consent (5 minutes)
Before we begin, I need to read aloud some of the key points of the consent
form you just signed. Did everyone sign the form?
• Today we will ask you to discuss your experiences with Medicare
beneficiaries and durable medical equipment
• Your participation is voluntary
• The focus groups will last approximately 1.5 hours
• The discussion will be confidential
• You can refuse to take part in this focus group if you wish without
affecting your professional relationship with CMS
• You do not have to answer any questions you do not wish to
answer
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 3)
-1-
• You can quit the study at any time
• We do not foresee any possible risks from participating in this
focus group, other than the minimal risk that confidentiality might
not be preserved
• There are no costs to you for participating in the focus group
• You will receive $75 today for participating and dinner is provided
• This discussion will not be video or audiotaped, rather ________
[Insert co-moderator] will be taking notes. The notes from tonight
will be labeled with a study code, not your names, and they will be
kept in a locked file and/or a password-protected computer at Abt
Associates Inc. in Cambridge, Massachusetts. A summary of the
notes will be shared with CMS
• Your comments, and those of others in the focus group, will be
used in reports to the government, in summary form and your
name will not be included in the report
• Does anyone have any questions?
How the focus group will work (3 minutes)
• Want to keep the discussion informal and relaxed
• Eat and use the restrooms as you like
• During the discussion, please feel free to ask me or each other if
something is unclear
• There are no right or wrong answers
• If you disagree with what someone else says, or have a different
experience, please say so or I’ll think that you all agree
• Some of you may have strong opinions, so please be respectful of
other’s
• Be careful not to talk all at once; I don’t want to miss anything that
is said
• My job is to make sure we hear from everyone. Some people talk
more than others, and I’ll be encouraging everyone to speak up.
Participant Introductions (7 minutes)
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 3)
-2-
Let’s go around the room and quickly introduce ourselves. [Write on the flip
chart the following items]
• First name
• Title (for example social worker, discharge planner, etc)
• Organization you represent
• Clients you serve
• Role with durable medical equipment
QUESTIONS
1. We spoke with some of you a few months after the program
began, in the midst of transition. Now a year later does it seem
that the transition is complete (for you, suppliers, beneficiaries)?
Transitioning to new suppliers?
Other aspects?
2. What changes have you noticed since the program began a year
ago?
a. Changes in the referral process
b. Suppliers
i. Quantity of suppliers?
ii. Quality of suppliers?
iii. How and to whom they market?
iv. Product changes?
3. How has the program affected your work and role?
Changes in the referral process
New relationships with suppliers
Extra or different responsibilities
Difficulties/Challenges
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 3)
-3-
4. How has the competitive bidding program affected beneficiary
care?
a. In terms of access
i. Are there adequate numbers of suppliers in the area?
For oxygen
For products X, Y, Z
ii. Convenience?
b. In terms of facility
i. Changes in products provided?
ii. Diverse array of products?
iii. Quality of services provided?
c. Have patients been able to get information when they have
problems or questions?
5. What changes have you noticed in the DMEPOS market?
a. Are there enough suppliers?
b. Is there a new dominant supplier?
i. For oxygen?
ii. Product X, Y, Z?
c. How do suppliers compete for referrals?
d. Do suppliers market their services?
i. How do they market? (pamphlets, visits, etc.)
ii. To whom do they market? (you, patients, etc.)
6. This program included a requirement that suppliers meet certain
quality standards, have you noticed any changes?
IF PARTICIPANTS AREN’T FAMILIAR WITH THE STANDARDS,
READ DESCRIPTION BELOW
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 3)
-4-
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare
Modernization Act 2003, the Center for Medicare and Medicaid Services
(CMS) requires Durable Medical Equipment, Prosthetic, Orthotic Supplies
(DMEPOS) Suppliers to comply with newly established quality standards in
order to receive payment for items or services provided to Medicare
beneficiaries.
7. What do you think of the quality standards?
a. Are they needed?
b. Is there a problem with them?
c. Will they change your role?
d. How will they affect beneficiaries?
8. What do you see as the successes and failures of the program?
Poorer suppliers have left the market
9. What questions or concerns about the program do you have as it
continues forward?
10. Do you have any final thoughts about the Medicare competitive
bidding program?
Those are all the questions that I have today. I want to thank you for
participating in this interview.
Abt Associates Inc.
Focus Group Guide: Referral Agent (WAVE 3)
-5-
OMB# 0938-NEW
Focus Group Guide
Suppliers (Wave 1)
Introduction (5 minutes)
Welcome. Thank you for joining us today. I am ___________ [Insert your
name] from Abt Associates Inc. We do research on health care. I will be
moderating our discussion and _______ [Insert co-moderator] will be
assisting and taking notes.
The topic we’ll be discussing today is the changes in Medicare durable
medical equipment, prosthetic, orthotic, supplies (DMEPOS) fee schedule
for suppliers. Your area has been chosen as a site for implementation. Each
of you has been asked to participate because you are a supplier or supplier
group representative that provides DMEPOS products and services to
Medicare beneficiaries. We are particularly interested in your experiences
and perspectives on this new program. Over the next year and a half, two
more focus groups will be held in your area as a part of this study. Focus
groups are also being held in other areas and these will help the Centers for
Medicare & Medicaid Services (CMS) understand the impact of the
program.
Informed Consent (5 minutes)
Before we begin, I need to read aloud some of the key points of the consent
form you just signed. Did everyone sign the form?
• Today we will ask you to discuss your experiences with preparing
for this new fee schedule and providing DMEPOS to Medicare
beneficiaries
• Your participation is voluntary
• The focus groups will last approximately 1.5 hours
• The discussion will be confidential
• You can refuse to take part in this focus group if you wish without
affecting your professional relationship with CMS
• You do not have to answer any questions you do not wish to
answer
• You can quit the study at any time
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 1)
-1-
• We do not foresee any possible risks from participating in this
focus group, other than the minimal risk that confidentiality might
not be preserved
• There are no costs to you for participating in the focus group
• You will receive $75 today for participating and dinner is provided
• This discussion will not be video or audiotaped, rather ________
[Insert co-moderator] will be taking notes. The notes from tonight
will be labeled with a study code, not your names, and they will be
kept in a locked file and/or a password-protected computer at Abt
Associates Inc. in Cambridge, Massachusetts. A summary of the
notes will be shared with CMS
• Your comments, and those of others in the focus group, will be
used in reports to the government, in summary form and your
name will not be included in the report
• Does anyone have any questions?
How the focus group will work (3 minutes)
• Want to keep the discussion informal and relaxed
• Eat and use the restrooms as you like
• During the discussion, please feel free to ask me or each other if
something is unclear
• There are no right or wrong answers
• If you disagree with what someone else says, or have a different
experience, please say so or I’ll think that you all agree
• Some of you may have strong opinions, so please be respectful of
other’s
• Be careful not to talk all at once; I don’t want to miss anything that
is said
• My job is to make sure we hear from everyone. Some people talk
more than others, and I’ll be encouraging everyone to speak up.
Participant Introductions (7 minutes)
Let’s go around the room and quickly introduce ourselves. [Write on
the flip chart the following items]
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 1)
-2-
•
•
•
First name
Supplier or organization you represent
Types of DMEPOS you provide
BASELINE ENVIRONMENT
1. How do Medicare beneficiaries get to each of you as a supplier?
a. Discharged from hospital? Referred from clinics? Walk-ins?
b. Who refers them to you?
c. Are you satisfied with your referral patterns?
2. Do you think that there are an adequate number of suppliers in
this area? Why or why not?
COUNT # OF RAISED HANDS
3. How many of you think beneficiaries are generally satisfied with
their choices of DMEPOS suppliers in this area? Why?
COUNT # OF RAISED HANDS
BIDDING PROGRAM
4. How many of you are aware of the Medicare DMEPOS
competitive bidding program?
COUNT # OF RAISED HANDS
a. When did you first hear about it?
b. How did you hear about the program?
Informational meeting by CMS?
Trade organization?
5. When you first heard about the competitive bidding program,
what did you think?
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 1)
-3-
6. Do you think your area (MSA) is a good market for competitive
bidding? Why or why not?
7. One goal of competitive bidding is to reduce the prices that
Medicare pays for DMEPOS. Medicare has included products
Z,Y,Z in the competitive bidding program: X, Y, and Z.
a. Which of these product groups has the greatest potential of
obtaining lower prices from competitive bidding?
X
Y
Z
b. Which has the least potential?
c. Are there any excluded product groups that should be in the
program?
8. What did you hear from CMS about the program and Requests
for Bids (RFBs)?
a. Were you officially notified?
b. What materials did you receive?
c. What did you think of the materials?
Were they clear?
Straightforward?
Complete?
d. Do you feel that you were adequately informed?
e. Was a Medicare representative available for questions? Who
was it? Were they helpful?
f.
9. How many of you submitted the bid?
COUNT # OF RAISED HANDS
a. Why did you decide to bid?
b. How did you decide which products to bid on? Why?
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 1)
-4-
10. What do you think of the bidding process?
Does it seem appropriate?
Is it too much?
Confusing?
How is it compared to private bids you have made?
Did it take long time to complete the bidding process?
How long?
CMS (or bidding program manager) available?
11. Do you have a good sense of how they are going to evaluate the
bids and pick the winners?
PROGRAM IMPACT
12. How do you anticipate the program will affect you as a supplier?
a. If you lose a bid(s), how will it affect you? Why?
b. If you win a bid(s), how will it affect you? Why?
13. How do you think the program will impact Medicare
beneficiaries?
14. How might the program affect the quality of DMEPOS supplies
and services you are able to provide? Can you give me an
example?
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 1)
-5-
15. What do you think of the DMEPOS quality standards?
16. What challenges/issues do you anticipate arising with this
program?
ENDING QUESTION
17. Do you have any final thoughts about the Medicare competitive
bidding program as it gets underway?
Those are all the questions that I have today. I want to thank you for
participating in this interview.
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 1)
-6-
OMB# 0938-NEW
Focus Group Guide
Suppliers (Wave 2)
Introduction (5 minutes)
Welcome. Thank you for joining us today. I am ___________ [Insert your
name] from Abt Associates Inc. We do research on health care. I will be
moderating our discussion and _______ [Insert co-moderator] will be
assisting and taking notes.
The topic we’ll be discussing today is the changes in Medicare durable
medical equipment, prosthetic, orthotic, supplies (DMEPOS) fee schedule
for suppliers. Your area has been chosen as a site for implementation. Each
of you has been asked to participate because you are a supplier or supplier
group representative that provides DMEPOS products and services to
Medicare beneficiaries. We are particularly interested in your experiences
and perspectives on this new program. Over the next year and a half, two
more focus groups will be held in your area as a part of this study. Focus
groups are also being held in other areas and these will help the Centers for
Medicare & Medicaid Services (CMS) understand the impact of the
program.
Informed Consent (5 minutes)
Before we begin, I need to read aloud some of the key points of the consent
form you just signed. Did everyone sign the form?
• Today we will ask you to discuss your experiences with preparing
for this new fee schedule and providing DMEPOS to Medicare
beneficiaries
• Your participation is voluntary
• The focus groups will last approximately 1.5 hours
• The discussion will be confidential
• You can refuse to take part in this focus group if you wish without
affecting your professional relationship with CMS
• You do not have to answer any questions you do not wish to
answer
• You can quit the study at any time
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 2)
-1-
• We do not foresee any possible risks from participating in this
focus group, other than the minimal risk that confidentiality might
not be preserved
• There are no costs to you for participating in the focus group
• You will receive $75 today for participating and dinner is provided
• This discussion will not be video or audiotaped, rather ________
[Insert co-moderator] will be taking notes. The notes from tonight
will be labeled with a study code, not your names and they will be
kept in a locked file and/or a password-protected computer at Abt
Associates Inc. in Cambridge, Massachusetts. A summary of the
notes will be shared only with CMS
• Your comments, and those of others in the focus group, will be
used in reports to the government, in summary form and your
name will not be included in the report
• Does anyone have any questions?
How the focus group will work (3 minutes)
• Want to keep the discussion informal and relaxed
• Eat and use the restrooms as you like
• During the discussion, please feel free to ask me or each other if
something is unclear
• There are no right or wrong answers
• If you disagree with what someone else says, or have a different
experience, please say so or I’ll think that you all agree
• Some of you may have strong opinions, so please be respectful of
other’s
• Be careful not to talk all at once; I don’t want to miss anything that
is said
• My job is to make sure we hear from everyone. Some people talk
more than others, and I’ll be encouraging everyone to speak up.
Participant Introductions (7 minutes)
Let’s go around the room and quickly introduce ourselves. [Write on
the flip chart the following items]
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 2)
-2-
•
First name
Supplier or organization you represent
Types of DMEPOS you provide
•
•
THE BIDDING PROCESS
1. All of you completed the bidding process for the DMEPOS
competitive bid program, what did you think?
Length of time to complete RFBs?
CMS availability?
Any problems?
Any concerns? (e.g. did the process raise any concerns about
the bid Medicare would receive in terms of quality?)
WINNING BIDS
2. Were you informed in a timely manner that you won the bid(s)?
3. Do you feel that the bid decisions were fair? Why or why not?
4. What effect do you think winning will have on your business?
Relationships with referral agents?
Personnel or staffing?
Finances?
Billing system?
Clients?
Products and services provided?
PROGRAM IMPACT
5. The Medicare competitive bidding program has begun – we
would like to hear your thoughts about it.
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 2)
-3-
How has the transition gone?
Have there been any problems or issues from the transition to
competitive bidding?
Does it seem that there are enough winners?
6. What effect, if any, has the provision in place for beneficiaries to
transition to different suppliers had?
On you as a supplier?
On beneficiaries?
7. How has the program affected you as a supplier?
How has the competitive bidding program affected the products
you provide?
Do you anticipate that the program will narrow or limit the
services you are able to provide?
For example would you conduct follow-up visits less
frequently?
Instruction / Training?
8. How has the program affected beneficiaries?
9. What do you think of the DMEPOS quality standards that are
also a requirement of the program?
Appropriate?
Ending Question
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 2)
-4-
10. Do you have any final thoughts about the Medicare competitive
bidding program?
Those are all the questions that I have today. I want to thank you for
participating in this discussion.
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 2)
-5-
OMB# 0938-NEW
Focus Group Guide
Suppliers (Wave 3)
Introduction (5 minutes)
Welcome. Thank you for joining us today. I am ___________ [Insert your
name] from Abt Associates Inc. We do research on health care. I will be
moderating our discussion and _______ [Insert co-moderator] will be
assisting and taking notes.
The topic we’ll be discussing today is the changes in Medicare durable
medical equipment, prosthetic, orthotic, supplies (DMEPOS) fee schedule
for suppliers. Your area has been chosen as a site for implementation. Each
of you has been asked to participate because you are a supplier or supplier
group representative that provides DMEPOS products and services to
Medicare beneficiaries. We are particularly interested in your experiences
and perspectives on this new program. Over the next year and a half, two
more focus groups will be held in your area as a part of this study. Focus
groups are also being held in other areas and these will help the Centers for
Medicare & Medicaid Services (CMS) understand the impact of the
program.
Informed Consent (5 minutes)
Before we begin, I need to read aloud some of the key points of the consent
form you just signed. Did everyone sign the form?
• Today we will ask you to discuss your experiences with preparing
for this new fee schedule and providing DMEPOS to Medicare
beneficiaries
• Your participation is voluntary
• The focus groups will last approximately 1.5 hours
• The discussion will be confidential
• You can refuse to take part in this focus group if you wish without
affecting your professional relationship with CMS
• You do not have to answer any questions you do not wish to
answer
• You can quit the study at any time
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 3)
-1-
• We do not foresee any possible risks from participating in this
focus group, other than the minimal risk that confidentiality might
not be preserved
• There are no costs to you for participating in the focus group
• You will receive $75 today for participating and dinner is provided
• This discussion will not be video or audiotaped, rather ________
[Insert co-moderator] will be taking notes. The notes from tonight
will be labeled with a study code, not your names, and they will be
kept in a locked file and/or a password-protected computer at Abt
Associates Inc. in Cambridge, Massachusetts. A summary of the
notes will be shared with CMS
• Your comments, and those of others in the focus group, will be
used in reports to the government, in summary form and your
name will not be included in the report
• Does anyone have any questions?
How the focus group will work (3 minutes)
• Want to keep the discussion informal and relaxed
• Eat and use the restrooms as you like
• During the discussion, please feel free to ask me or each other if
something is unclear
• There are no right or wrong answers
• If you disagree with what someone else says, or have a different
experience, please say so or I’ll think that you all agree
• Some of you may have strong opinions, so please be respectful of
other’s
• Be careful not to talk all at once; I don’t want to miss anything that
is said
• My job is to make sure we hear from everyone. Some people talk
more than others, and I’ll be encouraging everyone to speak up.
Participant Introductions (7 minutes)
Let’s go around the room and quickly introduce ourselves. [Write on
the flip chart the following items]
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 3)
-2-
•
•
•
First name
Supplier or organization you represent
Types of DMEPOS you provide
PROGRAM IMPACT
1. It has been a year since the Medicare competitive bidding
program began.
a. What has been successful about the program?
b. What has been unsuccessful?
2. How has the program affected you as a supplier?
3. Can you provide examples of “tough” choices you have had to
make as a result of the program?
Have you had to cut back on staff/employees?
Have you decreased the frequency of f/u visits?
4. How has the competitive bidding program affected the products
and services you are able to provide?
5. How has the program affected beneficiaries?
6. Do you have any final comments about the Medicare competitive
bidding program?
7. Has your relationship with CMS or the DMEPOS changed in
anyway because of the competitive bidding? How?
Those are all the questions that I have today. I want to thank you for
participating in this interview.
Abt Associates Inc.
Focus Group Guide: Suppliers (WAVE 3)
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Key Informant Discussion Guide
Beneficiary Groups/Advocates (WAVE 1)
Questions:
1. What is the name of your organization?
2. What type of organization are you? What role do you serve?
a. Are you a local/national organization?
b. Does your local organization use resources, activities, etc. designed or
distributed by a parent organization?
c. Is your organization part of a community level coalition? Working with
other organizations? Please describe.
d. Who are your clients/constituents?
e. Are any of your clients Medicare beneficiaries? What percent?
3. Do you work with Medicare beneficiaries? With DMEPOS?
a. What do you do for Medicare beneficiaries regarding DMEPOS? Please
provide examples?
i. Educational services?
ii. Outreach?
iii. Advocacy?
iv. Lobbying?
v. Referral?
vi. Financial Assistance?
4. How is the DMEPOS supplier market in this area currently structured?
a. Are the available suppliers spread out or are they concentrated in a
particular geographic area?
Abt Associates Inc.
Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 1)
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b. Is there a dominant supplier?
c. Are there both large and small suppliers?
d. Do you perceive that there are an adequate number of suppliers in this
area? IF NOT, for what products is supply inadequate?
e. Do suppliers have to compete? Based on what?
Quality?
Price?
Service?
Referral agents?
f. How do suppliers market their products and services?
g. Do the suppliers compete with mail-order suppliers?
5. Do you refer beneficiaries to suppliers?
a. Which ones?
b. How do you decide which suppliers to refer people to? Do you have a list?
c. How did you develop the referral list?
6. What do you think of the current level of DMEPOS products and services
provided Medicare beneficiaries? Please provide examples.
a. Access?
b. Quality?
c. Diversity of products? Choice?
d. Ancillary services – education, maintenance, etc.
Abt Associates Inc.
Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 1)
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7. Have you heard of the Medicare plan to use Competitive Bidding to modify
the DMEPOS fee schedule for reimbursing suppliers?
INTERVIEWER: If they have not heard of the program, read the
description below.
PROGRAM DESCRIPTION: The competitive bidding program for durable
medical equipment, prosthetic, orthotic supplies (DMEPOS) is a program
administered by the Center for Medicare and Medicaid Services (CMS), part of the
Department of Health and Human Services (DHS), to control the costs of DMEPOS
by requiring suppliers to bid for a contract to provide DMEPOS products and services
to Medicare beneficiaries. This will result in a new fee schedule for specific
DMEPOS items and could reduce the number of suppliers available to beneficiaries.
Currently the suppliers are submitting their bids and CMS is beginning to provide
information to referral agents and beneficiaries.
a. What do you think about it?
b. How do you think it might affect (positively and negatively) your clients?
8. Does your organization have a policy or position statement on Medicare’s
competitive bidding program?
9. Do you have any final comments about the current environment of DMEPOS
for Medicare beneficiaries in your area (and the competitive bidding
program)?
Abt Associates Inc.
Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 1)
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Key Informant Discussion Guide
Beneficiary Groups/Advocates (WAVE 2)
Questions:
1. What information has your organization received regarding the DMEPOS
Competitive Bidding Program?
a. What did you receive?
b. When?
c. From whom?
d. Did you find the information helpful?
e. What questions are remaining for you?
f. What additional information would have been helpful?
2. What, if anything, has your organization been doing with regard to Medicare
beneficiaries, DMEPOS and this relatively new program?
Educational activities
Outreach
3. Have members/clients asked about the program?
a. What types of questions or comments are you getting?
b. What are the primary concerns or issues being raised?
4. Have any suppliers contacted you regarding the program?
a. What was the purpose of the contact?
b. What was your response?
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Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 2)
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5. Did CMS conduct any outreach efforts to educate beneficiaries about the
program through your organization? Describe.
6. How do you think DMEPOS suppliers have changed over the past few
months (under the competitive bidding program)?
a. Number of suppliers? Is it adequate?
b. Has there been a change in suppliers? (Those not part of the program)
c. Has there been a change in how suppliers compete? Based on what?
Quality?
Price?
Service?
Referral agents?
d. Suppliers marketing their products and services?
7. Have you noticed any impact of the program on beneficiaries?
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
d. Ancillary services – education, maintenance, etc.
8. Do you think the program will ultimately be successful? Why or why not?”
9. Do you have any final comments about the relatively new competitive
bidding program for Medicare beneficiaries and DMEPOS?
Abt Associates Inc.
Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 2)
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Key Informant Discussion Guide
Beneficiary Groups/Advocates (WAVE 3)
Questions:
1. It has been a year since the inception of the competitive bidding program.
What do think of the program at this point?
a. Successes of the program
b. Failures or limitations
c. Significant changes
2. What has your organization done with or for beneficiaries with regard to
DMEPOS over the past year related to the program? (e.g. education)
a. How does that differ from your activities prior to the program?
3. How has the program affected you as an organization in any way, or your
role?
4. How do you think the DMEPOS suppliers available to beneficiaries have
changed over the past year (under the competitive bidding program)?
a. Number of suppliers? Is it adequate?
b. Competition among suppliers?
Quality?
Price?
Service?
Abt Associates Inc.
Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 3)
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Referral agents’ preferences?
c. The way that suppliers market?
5. From what you have seen and heard, how has the program affected
beneficiaries?
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
d. Ancillary services – training, maintenance, etc.
e. Assistance with insurance?
6. Do you have any final comments about the competitive bidding program for
Medicare beneficiaries and their DMEPOS? Suggestions to make the
program better?
Abt Associates Inc.
Key Informant Discussion Guide Beneficiary Groups/Advocates (WAVE 3)
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Key Informant Discussion Guide
CMS Officials or CMS’ Bidding Program Managers (Wave 1)
Researcher Note: Some questions may be more appropriate for the CMS official than for
the bidding program manager and vice versa. Inform the participant at the beginning
that they can defer if he/she is not the appropriate individual to answer that question.
Questions:
1. Responsibility for Program Administration
a. What are the responsibilities of CMS officials versus the bidding program
managers?
b. How will the competitive bidding program be administered in this MSA?
c. Who is responsible for administration?
d. What responsibilities reside at the local level?
e. How is oversight of local program administration to be carried out?
f. When will (was) the program be initiated at this site?
2. Process for Selecting Suppliers (Ask questions only if it is unknown from available
materials)?
a. How were suppliers and the potential bidders informed about the program?
i. bidders conferences/meetings?
ii. written materials?
iii. other means of education
b. How was the RFB distributed?
c. What information was required of bidders in the RFB?
--quality (customer service, facilities, inventory, etc)
--service capacity
--finances
--geographic coverage
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 1)
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d. What support was provided to suppliers in constructing their bids?
e. How are suppliers being selected?
3. How do you anticipate this program will affect the referral process?
a. For referral agents?
b. Suppliers?
c. Beneficiaries?
d. Beneficiary advocates
4. Program Outreach and Dissemination
a. How and when will referral agents be notified that the program has begun?
b. How and when will beneficiaries be notified?
c. What vehicles of communication will be used for outreach?
d. When were (will) materials sent out? What was sent? (can we get copies)
5. Assessment of the Market
a. What process will be used to assess overall supplier capacity in the market?
b. How will the ability of suppliers to increase capacity be assessed?
c. How will geographic coverage in the market be assessed?
d. Are any changes projected in the physician authorization process expected as
part of the program? If so, what are they?
e. Is an exemption process for small suppliers anticipated? If so, what are the
key features of this process likely to be?
6. Plans for Program Monitoring
a. What type of complaint reporting system is envisioned for the program? How
will it differ from the system now in place?
b. What ombudsman services will be available for consumers?
c. What data will the ombudsman collect? Are the data available?
d. How will the program be monitored locally?
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 1)
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e. What rules are likely to be implemented or steps taken to create a level
playing field for small suppliers?
f. What
7. General Observations
a. What do you see as the biggest obstacles to program implementation in this
MSA? Why?
b. What are your biggest concerns about your ability to monitor supplier
performance?
c. How long do you think it will be before some form of steady state under the
program will be achieved?
d. Overall, in your opinion. What is the biggest threat to the success of the
program in this MSA?
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 1)
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Key Informant Discussion Guide
CMS Officials or CMS’ Bidding Program Managers (Wave 2)
Researcher Note: Some questions may be more appropriate for the CMS official than for
the bidding program manager and vice versa. Inform the participant at the beginning
that they can defer if he/she is not the appropriate individual to answer that question.
Questions:
1. Program Administration
a. How has the administration of the program gone?
b. What has been successful? Unsuccessful?
c. After the program was begun, what were the most important issues that
arose requiring decisions or policy refinement? How were they resolved?
2. Selecting Suppliers
a. How and when were the RFBs distributed?
b. What support was provided to suppliers in constructing their bids?
c. How did the selection process go? What problems arose?
d. How were winners selected?
e. How were winners informed about the program?
3. Supplier market
a. Are there enough suppliers?
b. Have the suppliers been able to maintain the capacity they proposed?
c. Are suppliers meeting the needs of beneficiaries?
4. How has the program affected the referral process?
a. For referral agents?
b. Suppliers?
c. Beneficiaries?
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 2)
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5. Program Outreach and Dissemination
a. Was the program outreach successful? Unsuccessful?
b. How and when were referral agents and beneficiaries notified about the
program?
c. What vehicles of communication were used for outreach?
d. When were materials sent out? What was sent?
6. Program Monitoring
a. How is the program monitored?
b. Is there a complaint reporting system?
i. What types of complaints have you received?
c. How is quality being monitored or assessed as the program rolls out?
7. What have been the reactions to the program from each of these
stakeholders?
a. Suppliers
b. Referral agents
c. Beneficiaries
d. Beneficiary advocacy organizations
e. Congress
8. General Observations
a. What do you think were the biggest obstacles? Why? Can they be
corrected?
b. What are your biggest concerns as the program moves forward?
c. What areas to you see as needing improvement and can they be addressed
within the coming ½ year?
d. What changes, if any, do you anticipate for the remainder of this initial
year of the program?
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 2)
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Key Informant Discussion Guide
CMS Officials or CMS’ Bidding Program Managers (Wave 3)
Researcher Note: Some questions may be more appropriate for the CMS official than for
the bidding program manager and vice versa. Inform the participant at the beginning
that they can defer if he/she is not the appropriate individual to answer that question.
Questions:
1. Program Administration
a. How has the administration of the program gone?
b. What has been successful? Unsuccessful?
c. After the program was begun, what were the most important issues that
arose requiring decisions or policy refinement? How were they resolved?
2. Supplier market
a. Are there enough suppliers?
b. Have the suppliers been able to maintain the capacity they proposed?
c. Are suppliers meeting the needs of beneficiaries? How is that being
determined?
3. How has the program affected the referral process?
a. For referral agents?
b. Suppliers?
c. Beneficiaries?
4. Program Outreach and Dissemination
a. Was the program outreach successful? Unsuccessful?
b. How and when were referral agents and beneficiaries notified?
c. What vehicles of communication were used for outreach?
i. Were they effective?
d. When were materials sent out? What was sent?
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 3)
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e. How has the ongoing communication gone compared to the initial
communication?
5. Program Monitoring
a. How is the program monitored?
b. Is there a complaint reporting system?
i. What types of complaints have you received?
ii. What are the most common complaints?
iii. What is the process for resolving – for example?
c. How is quality being monitored or assessed as the program is being
implemented?
6. What has been the impact of the program on each of these stakeholders?
a. Suppliers
b. Referral agents
c. Beneficiaries
d. Beneficiary advocacy organizations
7. General Observations
a. Did the problems or concerns with the program in the first months
improve over the subsequent 9 months?
b. What do you think were the biggest obstacles? Why? Can they be
corrected?
c. What have been the big problems with the program?
d. What areas do you see as needing improvement?
e. What changes do you think would better meet the goals of this competitive
bidding program?
Abt Associates Inc.
Key Informant Discussion Guide: CMS Officials (WAVE 3)
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Key Informant Discussion Guide
Referral Agents (Wave 1)
Questions:
Background Information
1. What is your title and training?
2. What organization are you affiliated with and what type of an organization is
it?
3. What is your role in working with clients generally and Medicare
beneficiaries specifically?
4. Which DMEPOS products do your clients most frequently use?
Referral Process
5. Could you describe your referral process from beginning to end?
a. How or when do you get involved with patients/clients?
Discharged from hospital?
Referral from doctor’s office?
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Key Informant Discussion Guide: Referral Agent (WAVE 1)
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b. What do you do for patients?
File the certificate of medical necessity (CMN)?
c. Do you feel satisfied with the outcomes you can achieve? Why or why
not?
6. How do you determine which supplier you refer your clients to?
a. Do you have a list of suppliers? Where does it come from?
b. Do you have a preferred supplier?
c. Are you satisfied with your interactions with suppliers? Why or why not?
d. Do you find any significant problems related to accessing suppliers at
present?
7. How is the DMEPOS market in this area?
a. Are there enough suppliers?
b. Is there a dominant supplier?
i. For oxygen?
ii. Product X, Y, Z?
c. How do suppliers compete for referrals?
d. Do suppliers market their services?
i. How do they market? (pamphlets, visits, etc.)
ii. To whom do they market? (you, patients, etc.)
8. What do you think of the current level of access and quality of DMEPOS
products and services that suppliers provide your clients?
BIDDING PROGRAM
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 1)
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9. Have you heard about Medicare’s change in the durable medical equipment
fee schedule for suppliers, also known as “competitive bidding”?
PROGRAM DESCRIPTION: The competitive bidding program for durable
medical equipment, prosthetic, orthotic supplies (DMEPOS) is a program
administered by the Center for Medicare and Medicaid Services (CMS), part of the
Department of Health and Human Services (DHS), to control the costs of DMEPOS
by requiring suppliers to bid for a contract to provide DMEPOS products and services
to Medicare beneficiaries. This will result in a new fee schedule for specific
DMEPOS items, which could reduce the number of suppliers available to
beneficiaries and potentially change the suppliers with whom you work. Currently the
suppliers are submitting their bids and CMS is beginning to provide information to
referral agents and beneficiaries.
10. How did you hear about it?
11. What are your initial thoughts about it?
12. How do you think competitive bidding will affect your role?
Referral process
To whom you refer patients
Suppliers you prefer or do not prefer
13. How do you think the program will affect suppliers in your area?
14. How do you think competitive bidding could affect Medicare beneficiaries?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 1)
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Access to products
Quality of services
QUALITY STANDARDS
15. Have you heard about the “quality standards” required of DMEPOS
suppliers for items & services provided Medicare beneficiaries?
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare Modernization Act
2003, the Center for Medicare and Medicaid Services (CMS) requires Durable Medical
Equipment, Prosthetic, Orthotic Supplies (DMEPOS) Suppliers to comply with newly
established quality standards in order to receive payment for items or services provided to
Medicare beneficiaries.
16. What do you think of the quality standards?
a. Are they needed?
b. Is there a problem with them?
c. Will they change your role?
d. How will they affect beneficiaries?
Closing Question
17. Do you have any final thoughts about the current state of DMEPOS and the
new Medicare competitive bidding program?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 1)
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Key Informant Discussion Guide
Referral Agents (Wave 2)
Questions:
Skip questions 1 to 4 if the referral agent was a participant in Wave 1.
Background Information
1. What is your title and training?
2. What organization are you affiliated with and what type of an organization is
it?
3. What is your role in working with clients generally and Medicare
beneficiaries specifically?
4. Which DMEPOS products do your clients most frequently use?
5. The DMEPOS competitive bidding program began a few months ago. How
was the information you were provided regarding the program?
a. General information about the program
i. From whom?
ii. What form?
b. List (directory) of “winning” suppliers?
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Key Informant Discussion Guide: Referral Agent (WAVE 2)
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iii. Received in a timely manner?
iv. From whom?
v. In what form? (email, paper, etc.)
b. Information regarding what (which supplies) is covered
c. Information received
i. Did you find it helpful? Why or why not?
ii. Has CMS or its representatives been available to respond to
concerns?”
iii. From whom else did you receive information?
iv. What other information would you like?
6. The Medicare competitive bidding program has been underway the past few
months. How has the transition been?
a. Have you had to transition to new suppliers? For what services?
b. Have there been any significant issues relating to suppliers that did not
exist prior to this program?
i. How did they arise?
ii. Why do you believe they are related to the new program?
7. What changes have you noticed in your role/work since the program began?
a. Referral process?
b. Your professional relationships? (e.g. with suppliers)
c. Difficulties?
8. What changes have you noticed in the quality and access of DMEPOS
products provided Medicare beneficiaries?
a. Are there an adequate number of suppliers?
i. For oxygen?
ii. For product X, Y, Z?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 2)
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b. Have the specific products provided changed? (e.g. brand of a product)
c. How has the quality of services provided changed? (e.g. instruction
provided, follow-up visits, timeliness, etc.)
9. What changes have you noticed in the DMEPOS supplier market, with
regard to the following?
a. Number of suppliers available?
b. Dominance of certain suppliers?
i. For oxygen?
ii. Product X, Y, Z?
c. How suppliers compete for referrals?
d. How suppliers market their services?
i. How they market? (pamphlets, visits, etc.)
ii. To whom they market? (you, patients, etc.)
10. What do beneficiaries know about this program?
Are they aware of the program?
Have they noticed changes? What?
What questions, if any, have your clients/patients been asking with regard
to this program?
Have they been able to get help when they have problems or questions?
What could be done to better inform beneficiaries?
11. The change in Medicare DMEPOS included a requirement that suppliers
meet certain quality standards. Are you familiar with these standards?
IF THE INFORMANT ISN’T FAMILIAR WITH THE STANDARDS, READ
DESCRIPTION BELOW, THEN ASK QUESTION 8.
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 2)
-3-
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare Modernization Act
2003, the Center for Medicare and Medicaid Services (CMS) requires Durable Medical
Equipment, Prosthetic, Orthotic Supplies (DMEPOS) Suppliers to comply with newly
established quality standards in order to receive payment for items or services provided to
Medicare beneficiaries.
12. What do you think of the quality standards?
a. Are they needed?
b. Is there a problem with them?
c. Have they changed your role at all?
d. Have they affected the products and services provided beneficiaries?
13. What questions or concerns about the program do you have as it continues
forward?
14. Do you have any final thoughts about the Medicare competitive bidding
program?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 2)
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Key Informant Discussion Guide
Referral Agents (Wave 3)
Questions:
Skip questions 1 to 4 if the referral agent was a participant in Wave 1.
Background Information
1. What is your title and training?
2. What organization are you affiliated with and what type of an organization is
it?
3. What is your role in working with clients generally and Medicare
beneficiaries specifically?
4. Which DMEPOS products do your clients most frequently use?
5. We spoke a few months after the program began, still in the midst of
transition. Now a year later, what changes have you noticed since the
program began?
6. Has your work or role changed since the program was implemented?
New challenges?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 3)
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Extra or different responsibilities?
Relationships
7. What changes have you noticed in the DMEPOS supplier market?
a. Changes in the referral process?
b. Suppliers
i. Adequate number of suppliers?
ii. Quality of suppliers available to beneficiaries?
iii. Product changes?
8. How has the competitive bidding program affected beneficiary care?
a. Access to DMEPOS products and services?
b. Diverse array of products?
c. Quality or level of products and services provided?
d. Have patients been able to get information when they have problems or
questions?
e. How and to whom suppliers market?
f. Timeliness of DMEPOS product provision and services?
g. Communication with suppliers?
9. What do you see as the successes and failures of the program?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 3)
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Poorer suppliers have left the market
Supplier response to service requests is not as quick
10. What questions or concerns about the program do you have as it continues
forward?
11. Do you have any suggestions for how it could be improved?
12. Do you have any final thoughts about the Medicare competitive bidding
program?
Abt Associates Inc.
Key Informant Discussion Guide: Referral Agent (WAVE 3)
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Key Informant Discussion Guide
Suppliers (Wave 1)
Questions:
1. What DMEPOS do you provide?
Oxygen
Wheelchairs
Hospital beds
Orthotics
Prosthetics
2. Are you accredited? By whom?
3. How would you describe yourself as a supplier?
a. How long have you been supplying DMEPOS?
Large vs. small
Niche vs. full service
Geographic limitations
4. How do Medicare beneficiaries get to you as a supplier?
a. Discharged from hospital? Referred from clinic? Walk-in? Most common?
Variation by service type?
b. Who refers them to you?
5. Are you satisfied with your referral network at present?
a. How do referral agents know about your services?
b. How do you market your products and services?
c. What types of referrals do you get?
d. How are your relationships with referral agents?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 1)
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6. What services are beneficiaries typically provided as a part of the DMEPOS?
(If you provide a lot of DMEPOS, describe the services provided with one of your
highest volume products?)
a. Delivery and set-up
i. Who does it? What is their background or training?
b. Equipment maintenance
c. Level of training or instruction provided
d. Type and frequency of follow-up
DMEPOS Market
7. How would you describe the DMEPOS supplier market in this area?
Are suppliers spread out or concentrated in a particular geographic here?
Is there a dominant company?
o How does this vary, if at all, by product type?
Do you perceive that there are an adequate number of suppliers?
o How does this vary by product type?
8. Where do you fit as a supplier in this market?
a. How do you compete with other suppliers?
Price
Service / Quality
Referral agents’ preferences
b. To what extent do you compete with mail-order suppliers?
Competitive Bidding
9. What have you heard from CMS (or CMS’ bidding program managers)
about the competitive bidding program and Request for Bids (RFBs)?
a. Were you officially notified?
b. What materials did you receive?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 1)
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c. What did you think of the materials?
Were they clear?
Straightforward?
Complete?
d. Do you feel that you were adequately informed?
e. Was a Medicare representative available for questions? Who was it? Were
they helpful?
10. Did you submit a bid(s)?
a. Why did you decide to bid?
b. How did you choose products you bid on?
11. What did you think of the bidding process?
a. Do you have a good understanding of how bids will be evaluated and
chosen?
b. Do you feel that adequate consideration has been given to ensuring that
small suppliers can participate in the program (are you a small/large
supplier)?
Program Impact
12. If you win, how will it affect your company?
a. What will you gain?
b. Will you supply fewer (more) brands of products?
c. How you market your products and services?
13. If you lose, how will it affect your company?
a. What will you gain/lose?
b. Will you supply fewer (more) brands of products?
c. How you market your products and services?
14. How do you anticipate the program will affect Medicare beneficiaries?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 1)
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a. Will beneficiaries be able to get the same products and services they had
before this program?
b. Will suppliers experience any pressure to shift to lower-quality products?
If so, how will that happen (e.g. lower profit margins)?
c. What other influences will affect the products and services used by
patients you work with?
15. What do you think will be the changes both positive and negative on quality?
Consulting with prescribers
Assessing appropriateness of the equipment
Develop service plan
Equipment management? Repairs? Adjustments?
Replacing equipment
Procedure for equipment delivery and set-up? Who sets up? Their
background?
Provide training or instruction? Who does this?
What information or training is provided? Operation? Safety? Repair?
Written or oral?
Follow-up
16. Any other thoughts about the program or its likely impact?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 1)
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Key Informant Discussion Guide
Suppliers (Wave 2)
Questions:
Skip questions 1 to 6 if supplier participated in wave 1.
1. What DMEPOS do you provide?
Oxygen
Wheelchairs
Hospital beds
Orthotics
Prosthetics
2. Are you accredited? By whom?
3. How would you describe yourself as a supplier?
a. How long have you been supplying DMEPOS?
Large vs. small
Niche vs. full service
Geographic limitations
4. How do Medicare beneficiaries get to you as a supplier?
a. Discharged from hospital? Referred from clinic? Walk-in? Most common?
Variation by service type?
b. Who refers them to you?
5. Are you satisfied with your referral network at present?
a. How do referral agents know about your services?
b. How do you market your products and services?
c. What types of referrals do you get?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 2)
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d. How are your relationships with referral agents?
6. What services are beneficiaries typically provided as a part of the DMEPOS?
If you provide a lot of DMEPOS, describe the services provided with one
of your highest volume products?
a. Delivery and set-up
i. Who does it? What is their background or training?
b. Equipment maintenance
c. Level of training or instruction provided
d. Type and frequency of follow-up
The Bidding Process
7. Overall, how was the bidding process?
Did you have the resources you needed to submit a bid?
Was the receipt of the information timely?
Was the process described in the information you received?
8. Did you have outside assistance formulating your bid(s)?
9. Have you had experience formulating bids for the private sector and was the
process similar? In what respect was it different?
10. How was the notification process?
Timeliness
Fairness
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 2)
-2-
11. Did you win any of the bid(s) you submitted? Lose any of the bid(s)?
INTERVIEWER:
If the supplier lost a bid asks questions 6-8,17,then stop.
If they won a bid skip to question 9.
If they won & lost a bid ask all questions.
Losing Bids
12. Were you informed in a timely manner that you lost the bid(s)?
13. Do you think the decision was fair, in light of what you know about other
suppliers’ bids?
What do you believe were the most important factors in losing the bid?
14. What effect will losing have on your business?
Relationships with referral agents?
Relationships with equipment distributors/suppliers?
Changes in personnel or staffing?
Effect on other aspects of your work?
Convert part of the store?
Merge? Sell?
Write your congressman?
Winning Bids
15. Were you informed in a timely manner that you won the bid(s)?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 2)
-3-
16. Do you feel that the bid decisions were fair? Why or why not?
17. What effect do you think winning is having and will continue to have on your
business?
Relationships with referral agents?
Personnel or staffing?
Finances
Billing system
Number of clients
Products and services provided
Transition
18. Do you think enough suppliers won contracts in this area to provide for the
Medicare beneficiaries? Why or why not?
19. How has the transition to this new contractual relationship with CMS gone?
20. Has CMS or its representatives been available to respond to concerns or
issues?”
21. What effect, if any, has the provision in place for beneficiaries to transition to
different suppliers had?
The Program Impact
22. With changes in reimbursement have you had to make tough choices about
the provision of DMEPOS product and services? If yes, what were they?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 2)
-4-
a. What factors were important in reaching these decisions?
23. How have beneficiaries been affected by this program?
Access to products
Level of services provided
24. What do you think of the quality standards required with the program?
Burdensome / Helpful?
Applicable / Appropriate?
Suggestion for how they could be improved?
25. What concerns do you anticipate will arise as the program roles out over the
next year?
26. Is there anything else that you would like to tell us about the program?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 2)
-5-
Key Informant Discussion Guide
Suppliers (Wave 3)
Questions:
Skip questions 1 to 6 if supplier participated in wave 1.
BACKGROUND INFORMATION:
1. What DMEPOS do you provide?
Oxygen
Wheelchairs
Hospital beds
Orthotics
Prosthetics
2. Are you accredited? By whom?
3. How would you describe yourself as a supplier?
a. How long have you been supplying DMEPOS?
Large vs. small
Niche vs. full service
Geographic limitations
4. How do Medicare beneficiaries get to you as a supplier?
a. Discharged from hospital? Referred from clinic? Walk-in? Most common?
Variation by service type?
b. Who refers them to you?
5. Are you satisfied with your referral network at present?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 3)
-1-
a. How do referral agents know about your services?
b. How do you market your products and services?
c. What types of referrals do you get?
d. How are your relationships with referral agents?
6. What services are beneficiaries typically provided as a part of the DMEPOS?
If you provide a lot of DMEPOS, describe the services provided with one
of your highest volume products?
a. Delivery and set-up
i. Who does it? What is their background or training?
b. Equipment maintenance
c. Level of training or instruction provided
d. Type and frequency of follow-up
PROGRAM IMPACT
7. How has the competitive bidding program changed your business?
a. Number of clients
b. Products and services provided
c. Personnel / staffing
d. Financially / Billing system
i. Prices for non-Medicare clients
ii. Private pay clients
e. Marketing
8. Since the institution of the competitive bidding program (~12 months ago)
what have you had to change (and why) in terms of the following:
a. Products provided
b. Delivery and set-up
i. Who does it? Their background or training?
c. Equipment maintenance
d. Level of training or instruction provided
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 3)
-2-
e. Frequency of follow-ups
9. Overall, what have been the consequent changes in your provision of
DMEPOS and the associated services under this program?
10. How do you think the competitive bidding program has changed the
DMEPOS supplier market in this area?
In terms of concentration in a given geographic area?
Is there a change in the dominant company?
o Does it vary, if at all, by product type?
Are there an adequate number of suppliers?
o Does this vary by product type?
11. Has the competitive bidding program changed your location in the supplier
market?
a. Where you fit in this market?
b. How you compete with other suppliers?
Price
Service / Quality
Referral agents’ preferences
c. Competition with mail-order suppliers?
12. How do you think the program has been successful? Why?
13. What do you think have been the failures or limitations of the program?
Why?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 3)
-3-
14. How has the competitive bidding affected the provision of DMEPOS for
Medicare beneficiaries? (From the referral process all the way to the arrival
of the product in the beneficiaries home)
15. Lastly, what feedback do you have for CMS to improve the program for your
area and the new areas that will begin competitive bidding?
Abt Associates Inc.
Key Informant Discussion Guide: Suppliers (WAVE 3)
-4-
Key Informant Discussion Guide
COMPARISON AREA: Beneficiary Groups/Advocates (WAVE 1)
Questions:
1. What is the name of your organization?
2. What type of organization are you? What role do you serve?
a. Are you a local/national organization?
b. Does your organization use resources, activities etc. from a parent
organization?
c. Is your organization part of a coalition? Working with other
organizations? Please describe.
d. Who are your clients/constituents?
3. Do you work with Medicare beneficiaries? With DMEPOS?
a. What do you do for Medicare beneficiaries with regard to DMEPOS?
Please provide examples?
i. Educational services?
ii. Outreach?
iii. Advocacy?
iv. Lobbying?
v. Referral?
vi. Financial Assistance?
4. How is the DMEPOS supplier market in this area currently?
a. Are suppliers spread out or are they concentrated in a geographic area?
b. Is there a dominant supplier?
c. Are there both large and small suppliers?
d. Do you perceive that there are an adequate number of suppliers in this
area?
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 1)
-1-
e. Do suppliers have to compete? Based on what?
Quality?
Price?
Service?
Referral agents’ preferences?
f. How do suppliers market their products and services?
g. Do the suppliers compete with mail-order suppliers?
5. Do you refer beneficiaries to suppliers?
a. Which ones?
b. How do you decide which suppliers to refer clients to? Do you have a list?
c. From where do you get your referral list? (or how do you create it)?
6. What do you think of the current level of DMEPOS products and services
provided Medicare beneficiaries? Please provide examples.
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
d. Ancillary services – education, maintenance, etc.
7. Do you have any additional comments or information that might be helpful if
I am trying to understand the DMEPOS market in this area?
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 1)
-2-
Key Informant Discussion Guide
COMPARISON AREA: Beneficiary Groups/Advocates (WAVE 2)
Questions:
1. Since we last spoke (X months ago) have there been any changes in the
DMEPOS products and services in this area? And why?
Number of suppliers?
Quality of products and services?
2. Since we last spoke have there been any changes in your role working
with Medicare beneficiaries and their DMEPOS ?
3. What, if anything, has your organization been doing differently (the past
few months) with regard to Medicare beneficiaries and DMEPOS ?
New education programs
4. Have your clients raised any new questions or concerns over the past
months? If so, what were they?
5. Have you heard of or are you familiar with the new Quality Standards
for DMEPOS put out by the Centers for Medicare and Medicaid Services
(CMS)?
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare Modernization Act
2003, the Center for Medicare and Medicaid Services (CMS) requires Durable Medical
Equipment, Prosthetic, Orthotic Supplies (DMEPOS) Suppliers to comply with newly
established quality standards in order to receive payment for items or services provided to
Medicare beneficiaries.
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 2)
-1-
a. What information have you received about them?
From whom?
When?
b. Have they changed your role?
c. Are beneficiaries aware of them?
d. How do you think the standards will affect beneficiaries?
e. What have you heard from suppliers about them?
f. What do you think about them?
i. Positives?
ii. Negatives?
6. Have there been any changes in the DMEPOS supplier market the past
few months?
a. Number of suppliers? Is it adequate?
b. Competition among suppliers? Based on what?
Quality? Price? Service? Referral agents?
c. Suppliers marketing their products and services?
7. Are you aware of any occurrences in health care or this area that have
impacted DMEPOS products, services, provision, etc.?
Product recall
New type of equipment
Health care crisis – (e.g. higher incidence of pneumonia)
New regulations or policies (e.g. Deficit Reduction Act cap on rentals)
8. Has the level of care beneficiaries are provided for DMEPOS changed
over the past few months?
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 2)
-2-
d. Ancillary services – education, maintenance, etc.
9. Do you have any additional comments about new occurrences in your
area with regard to Medicare beneficiaries, DMEPOS and suppliers?
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 2)
-3-
Key Informant Discussion Guide
COMPARISON AREA: Beneficiary Groups/Advocates (WAVE 3)
Questions:
1. Since we last spoke (X months ago) have there been any changes in the
DMEPOS products and services in this area? Why?
Number of suppliers?
Quality of products and services?
2. Since we last spoke have there been any changes in your role working with
Medicare beneficiaries and their DMEPOS?
3. What, if anything, has your organization been doing differently (the past
year) with regard to Medicare beneficiaries and DMEPOS? (e.g. education).
4. Have your clients raised any new questions or concerns over the past year? If
so, what were they?
5. What has changed with regard to the Quality Standards for DMEPOS?
a. Have they changed your role?
b. Are beneficiaries aware of them?
c. How do you think the standards are impacting beneficiaries’ care?
d. What have you heard from suppliers about the standards?
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 3)
-1-
e. What do you think about them, a year since they were required?
i. Positives?
ii. Negatives?
6. How do you think the DMEPOS supplier market has changed over the past
year?
a. Number of suppliers? Is it adequate?
b. Competition among suppliers? Based on what?
Quality? Price? Service? Referral agents?
c. Suppliers marketing their products and services?
7. Are you aware of any occurrences in health care or this area that have
impacted DMEPOS products, services, provision, etc.?
Product recall
New type of equipment
Health care crisis – (e.g. higher incidence of pneumonia)
New regulations or policies (e.g. Deficit Reduction Act cap on rentals)
8. Has the level of care beneficiaries are provided for DMEPOS changed over
the past year?
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
d. Ancillary services – education, maintenance, etc.
9. Do you have any additional comments about new occurrences in your area
with regard to Medicare beneficiaries, DMEPOS and suppliers?
Abt Associates Inc.
Comparison Area: Beneficiary Groups/Advocates (WAVE 3)
-2-
Key Informant Discussion Guide
COMPARISON AREA: Referral Agents (Wave 1)
Questions:
Role
1. What is your title and training?
2. What organization are you affiliated with and what type of an organization is
it?
3. What is your role in working with clients generally and Medicare
beneficiaries specifically?
4. What DMEPOS products do your clients use?
Referral Process
5. Could you describe the referral process from beginning to end?
a. How or when do you get involved with patients/clients?
Discharged from hospital?
Referral from doctor’s office?
b. What do you do for patients?
CMN – do you fill out?
6. Regarding the suppliers you refer beneficiaries to, how do you decide to
whom you refer your patients?
Do you have a list of suppliers?
Where did you get the list or how did you create that list?
7. How competitive is the DMEPOS market in this area?
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 1)
-1-
Enough suppliers? A lot of options?
A dominant supplier?
8. What do you think of the current level of care provided beneficiaries in this
area?
a. Quality of DMEPOS?
b. Access to DMEPOS?
c. Diversity of products?
d. Ancillary services?
Quality Standards
9. Have you heard of or received information about the new Quality Standards
for DMEPOS put out by the Centers for Medicare and Medicaid Services
(CMS)?
QUALITY STANDARDS DESCRIPTION: As a part of the Medicare Modernization Act
2003, the Center for Medicare and Medicaid Services (CMS) requires Durable Medical
Equipment, Prosthetic, Orthotic Supplies (DMEPOS) Suppliers to comply with newly
established quality standards in order to receive payment for items or services provided to
Medicare beneficiaries.
a. What information have you received about them?
i. From whom?
ii. When?
b. What has CMS done to inform you?
c. Has your professional organization informed you about it?
10. What do you think of the Quality Standards generally?
a. What is good about them?
a. What is a problem with them?
b. Are they appropriate/fair?
c. Will they change your business/role?
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 1)
-2-
d. How will they affect beneficiaries?
11. What do you think of the specific aspects of the Quality Standards, are they
appropriate, inappropriate, excessive, etc.?
a. Consulting with prescribers
b. Assessing appropriateness of the equipment
c. Develop service plan
d. Equipment management? Repairs? Adjustments?
e. Replacing equipment
f. Procedure for equipment delivery and set-up? Who sets up? Their
background?
g. Provide training or instruction? Who does this?
h. What information or training is provided? Operation? Safety? Repair?
Written or oral?
i. Follow-up
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 1)
-3-
Key Informant Discussion Guide
COMPARISON AREA: Referral Agents (Wave 2)
Questions:
1. Since we last spoke (X months ago), have there been any changes in the
referral process for you?
Which supplier you refer clients to?
Changes in paperwork needed/requested by suppliers?
2. How do you think the DMEPOS supplier market has changed over the past
few months?
a. Number of suppliers? Is it adequate?
b. Competition among suppliers? Based on what?
Quality? Price? Service? Referral agents?
c. Suppliers marketing their products and services?
3. Have there been any changes in the level of care provided beneficiaries?
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
d. Ancillary services – training, maintenance, etc.
4. Have your clients/patients raised any new questions or concerns over the past
months? If so, what were they?
5. Have there been any occurrences in health care or this area that have
impacted DMEPOS products, services, provision, etc.?
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 2)
-1-
Product recall
New type of equipment
Health care crisis – (e.g. higher incidence of pneumonia)
New regulations or policies (e.g. Deficit Reduction Act cap on rentals)
6. How have the DMEPOS Quality Standards affected you?
a. Have they changed your role?
b. Are beneficiaries aware of the standards?
c. How are the standards affecting beneficiaries?
d. What do you think about them now, a few months later?
i. Positives?
ii. Negatives?
7. Do you have any additional comments about new occurrences in your area
with regard to Medicare beneficiaries, DMEPOS and suppliers?
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 2)
-2-
Key Informant Discussion Guide
COMPARISON AREA: Referral Agents (Wave 3)
Questions:
1. Since we last spoke (X months ago), have there been any changes in the
referral process for you?
Which supplier you refer clients to?
Changes in paperwork needed/requested by suppliers?
2. How do you think the DMEPOS supplier market has changed over the past
year?
a. Number of suppliers? Is it adequate?
b. Competition among suppliers? Based on what?
Quality? Price? Service? Referral agents?
c. Suppliers marketing their products and services?
3. Have there been any changes in the level of care provided beneficiaries?
a. Access to DMEPOS?
b. Quality of DMEPOS?
c. Diversity of products? Choice?
d. Ancillary services – training, maintenance, etc.
4. Have your clients/patients raised any new questions or concerns over the past
months? If so, what were they?
5. Have there been any occurrences in health care or this area that have
impacted DMEPOS products, services, provision, etc.?
Product recall
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 3)
-1-
New type of equipment
Health care crisis – (e.g. higher incidence of pneumonia)
New regulations or policies (e.g. Deficit Reduction Act cap on rentals)
6. How have the DMEPOS Quality Standards affected you?
a. Have they changed your role?
b. Are beneficiaries aware of the standards?
c. How are the standards affecting beneficiaries?
d. What do you think about them now, a few months later?
i. Positives?
ii. Negatives?
7. Do you have any additional comments about new occurrences in your area
with regard to Medicare beneficiaries, DMEPOS and suppliers?
Abt Associates Inc.
Comparison Area: Referral Agent (Wave 3)
-2-
Key Informant Discussion Guide
COMPARISON AREA: Suppliers (Wave 1)
Questions:
Baseline Environment
1. What DMEPOS do you provide?
Oxygen
Wheelchairs
Hospital beds
Orthotics
Prosthetics
2. Are you accredited? By whom?
3. How would you describe yourself as a supplier?
a. How long have you been supplying DMEPOS?
Large vs. small
Niche vs. full service
Geographic limitations
4. How do beneficiaries get to you as a supplier?
a. Discharged from hospital? Referred from clinic? Walk-in?
b. Who refers them to you?
c. How do referral agents know about your services?
Do you market your products and services?
What is your relationship with referral agents?
5. Are you satisfied with your referral patterns?
b. How do referral agents know about your services?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 1)
-1-
c. How do you market your products and services?
d. What types of referrals do you get?
e. How are your relationships with referral agents?
6. What services are beneficiaries typically provided as a part of the DMEPOS?
a. Delivery and set-up
i. Who does it? Their background or training?
b. Equipment maintenance
i. Who does it? Their background or training?
c. Frequency of follow-ups
i. Who does it? Their background or training?
Market
7. How would you describe the DMEPOS supplier market in this area?
Are suppliers spread out or concentrated in a particular geographic area?
Is there a dominant company?
Do you perceive that there are an adequate number of suppliers?
8. How do you view yourself as a supplier?
a. Where do you fit in this market?
b. How do you compete with other suppliers?
Price
Service / Quality
Referral agents’ preferences
c. To what extent do you compete with mail-order suppliers?
Quality Standards
9. Have you heard of or received information about the new Quality Standards
for DMEPOS put out by the Centers for Medicare and Medicaid Services
(CMS)?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 1)
-2-
a. What information have you received about them?
i. From whom?
ii. When?
b. Has CMS or its representatives been available to respond to concerns?
c. Has your professional organization informed you about it?
10. What do you think of the Quality Standards generally?
a. What is good about them?
b. What is a problem with them?
c. Are they appropriate/fair?
d. Will they change your business/role?
e. How will the affect beneficiaries?
11. What do you think of the specific aspects of the Quality Standards, are they
appropriate, inappropriate, excessive, etc.?
a. Consulting with prescribers
b. Assessing appropriateness of the equipment
c. Develop service plan
d. Equipment management? Repairs? Adjustments?
e. Replacing equipment
f. Procedure for equipment delivery and set-up? Who sets up? Their
background?
g. Provide training or instruction? Who does this?
h. What information or training is provided? Operation? Safety? Repair?
Written or oral?
i. Follow-up
Abt Associates Inc.
Comparison Area: Suppliers (Wave 1)
-3-
Key Informant Discussion Guide
COMPARISON AREA: Suppliers (Wave 2)
Questions:
Skip questions 1 to 6 if supplier participated in wave 1.
1. What DMEPOS do you provide?
Oxygen
Wheelchairs
Hospital beds
Orthotics
Prosthetics
2. Are you accredited? By whom?
3. How would you describe yourself as a supplier?
a. How long have you been supplying DMEPOS?
Large vs. small
Niche vs. full service
Geographic limitations
4. How do beneficiaries get to you as a supplier?
a. Discharged from hospital? Referred from clinic? Walk-in?
b. Who refers them to you?
c. How do referral agents know about your services?
Do you market your products and services?
What is your relationship with referral agents?
5. Are you satisfied with your referral patterns?
a. How do referral agents know about your services?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 2)
-1-
b. How do you market your products and services?
c. What types of referrals do you get?
d. How are your relationships with referral agents?
6. What services are beneficiaries typically provided as a part of the DMEPOS?
a. Delivery and set-up
i. Who does it? Their background or training?
b. Equipment maintenance
c. Level of training or instruction provided
d. Frequency of follow-ups
7. Since we last spoke a few months ago, have there been any changes in the
referral process (how beneficiaries get to you as a supplier)?
a. Discharged from hospital? Referred from clinic? Walk-in?
b. Who refers them to you?
c. How do referral agents know about your services?
Do you market your products and services?
What is your relationship with referral agents?
8. Are you currently satisfied with your referral patterns?
9. Have you changed any of the DMEPOS products and services you provide
beneficiaries? For what reason?
Delivery and set-up
o Who does it? Their background or training?
Equipment maintenance
Level of education or instruction provided
Frequency of follow-ups
Product makes and models offered?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 2)
-2-
10. Have there been any significant changes in the DMEPOS supplier market in
this area over the past few months? What? Why?
Change in the suppliers in the area
11. Have there been any occurrences in health care or this area that have
impacted DMEPOS products, services, provision, etc.?
Product recall
New type of equipment
Health care crisis – (e.g. higher incidence of pneumonia)
New regulations or policies (e.g. Deficit Reduction Act cap on rentals)
12. How have the DMEPOS Quality Standards affected you?
a. Affected your business?
b. Have they changed your role?
c. Are beneficiaries aware of the standards?
d. How are the standards affecting beneficiaries?
e. What do you think about them now, a few months later?
i. Positives?
ii. Negatives?
13. Do you have any additional comments about new occurrences in your area
with regard to Medicare beneficiaries, DMEPOS and suppliers?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 2)
-3-
Key Informant Discussion Guide
COMPARISON GROUP: Suppliers (Wave 3)
Questions:
Skip questions 1 to 6 if supplier participated in wave 1.
1. What DMEPOS do you provide?
Oxygen
Wheelchairs
Hospital beds
Orthotics
Prosthetics
2. Are you accredited? By whom?
3. How would you describe yourself as a supplier?
a. How long have you been supplying DMEPOS?
Large vs. small
Niche vs. full service
Geographic limitations
4. How do beneficiaries get to you as a supplier?
a. Discharged from hospital? Referred from clinic? Walk-in?
b. Who refers them to you?
c. How do referral agents know about your services?
Do you market your products and services?
What is your relationship with referral agents?
5. Are you satisfied with your referral patterns?
a. How do referral agents know about your services?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 3)
-1-
b. How do you market your products and services?
c. What types of referrals do you get?
d. How are your relationships with referral agents?
6. What services are beneficiaries typically provided as a part of the DMEPOS?
a. Delivery and set-up
i. Who does it? Their background or training?
b. Equipment maintenance
c. Level of training or instruction provided
d. Frequency of follow-ups
7. Since we last spoke, have there been any changes in the referral process (how
beneficiaries get to you as a supplier)?
a. Discharged from hospital? Referred from clinic? Walk-in?
b. Who refers them to you?
c. How do referral agents know about your services?
Do you market your products and services?
What is your relationship with referral agents?
8. Are you currently satisfied with your referral patterns?
9. Have you changed any of the DMEPOS products and services you provide
beneficiaries? For what reason?
Delivery and set-up
o Who does it? Their background or training?
Equipment maintenance
Level of education or instruction provided
Frequency of follow-ups
Product makes and models offered?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 3)
-2-
10. Have there been any significant changes in the DMEPOS supplier market in
this area over the past few months? What? Why?
Change in the suppliers in the area
11. Have there been any occurrences in health care or this area that have
impacted DMEPOS products, services, provision, etc.?
Product recall
New type of equipment
Health care crisis – (e.g. higher incidence of pneumonia)
New regulations or policies (e.g. Deficit Reduction Act cap on rentals
12. Now that the DMEPOS quality standards have been in place a year what do
you think?
a. How have they affected your business?
b. Have they changed your role?
c. Are beneficiaries aware of the standards?
d. How are the standards affecting beneficiaries?
e. What do you think about them now, a few months later?
i. Positives?
ii. Negatives?
13. Do you have any additional comments about new occurrences in your area
with regard to Medicare beneficiaries, DMEPOS and suppliers?
Abt Associates Inc.
Comparison Area: Suppliers (Wave 3)
-3-
APPENDIX D
Nonstatistical Informed Consent Forms and
Scripts
INFORMED CONSENT FORM
Referral Agent Focus Group
Abt Associates Inc. has been hired by the Centers for Medicare & Medicaid Services (CMS) to
conduct an evaluation of the durable medical equipment, prosthetics, orthotics & suppliers
(DMEPOS) competitive bidding program. As part of that evaluation Abt Associates is
conducting focus groups to learn about the perceptions and experiences of referral agents with
durable medical equipment and the competitive bidding program in the area. These focus groups
will help CMS understand the affect of the program on referral agents, suppliers and Medicare
beneficiaries.
You are being asked to participate in a focus group because you are a referral agent for Medicare
beneficiaries and their durable medical equipment. A total of 6 focus groups with both suppliers
and referral agents are being held as part of the study and each focus group will have up to 10
participants and two moderators. Abt Associates will conduct the focus groups and other forms
of data collection, analysis, and reporting. Debra Frankel is the Principal Investigator at Abt
Associates.
You are being asked to sign a consent form to participate in the focus group.
PROCEDURES
You will be asked to join with other referral agents in a 1.5-hour discussion about the Medicare
competitive bidding program for DMEPOS. A researcher will facilitate the group in discussing
your experiences with the Medicare competitive bidding program. The focus group will not be
audio or video taped.
The discussion will be confidential. You can refuse to take part in this focus group if you wish
without losing any rights or benefits related to your professional relationship with CMS. You
can also refuse to answer a question during the focus group, without affecting your continued
participation in the group or your relationship with CMS.
RISKS OF TAKING PART IN THE STUDY
The researchers do not foresee any possible risks to you from participating in this focus group,
other than the minimal risk that your confidentiality might not be preserved. One of the risks to
confidentiality is that other focus group participants may repeat what they hear during the group.
The researchers will do everything allowable by law to assure that your privacy is protected and
will ask all participants at the beginning of the focus group not to repeat the focus group
discussion outside of the group.
Additionally, the focus group discussion notes will be labeled with a study code, not your or
another participant’s name. Notes and reports from the discussion will be stored in a secure
Abt Associates Inc.
Focus Groups: Referral Agen
1
location (i.e. locked office file cabinet) and electronic materials will be stored in a passwordprotected computer. Your comments, and those of others in the focus group, will be presented in
reports to the government in summary form. Your name will not be included in any reports.
COSTS AND FINANCIAL RISKS
There will be no costs charged to you for participating in the focus group.
POSSIBLE BENEFITS OF TAKING PART IN THE STUDY
There may not be any direct benefit to you from joining the focus group, although you may
benefit from the opportunity to hear about others’ experiences with the competitive bidding
program.
COMPENSATION
You will receive $75 for participating in the focus group today, after the discussion is held. You
will also receive dinner at the focus group facility.
VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT
It is up to you to decide whether to participate in the focus group. If you decide not to participate
in the focus group, you will not be penalized and your relationship with the Centers for Medicare
& Medicaid Services will not be affected. Even if you agree to participate, you are not required
to answer all the questions you are asked.
QUESTIONS
You understand that you may phone Debra Frankel of Abt Associates (617 349-2875) to have
my questions answered. You can also phone Ann Meadow at CMS (410 786-6022). You can
mail a letter to Ms. Frankel at:
Debra Frankel
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
You may also phone Marianne Beauregard, the chairperson of Abt Associates’ Institutional
Review Board (617 349-2852) if you have other questions about your rights as a focus group
participant. All of these numbers are toll calls.
Abt Associates Inc.
Focus Groups: Referral Agen
2
STATEMENT BY FOCUS GROUP MODERATOR IN THIS RESEARCH STUDY
I have explained the purpose of this research, the study procedures, identifying the potential risks
and benefits. I have answered any questions regarding the research study to the best of my
ability.
_____________________
Moderator’s Name
______________________
Moderator’s Signature
____________
Date
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS RESEARCH
STUDY
I have read and understand this information. I have had all my questions answered fully and I
freely and voluntarily choose to participate in the focus group. I have been given a copy of this
consent form.
_____________________
Volunteer’s Name
Abt Associates Inc.
______________________
Volunteer’s Signature
Focus Groups: Referral Agen
____________
Date
3
INFORMED CONSENT FORM
Supplier Focus Group
Abt Associates Inc. has been hired by the Centers for Medicare & Medicaid Services (CMS) to
conduct an evaluation of the durable medical equipment, prosthetics, orthotics & suppliers
(DMEPOS) competitive bidding program. As part of that evaluation Abt Associates is
conducting focus groups to learn about the perceptions and experiences of referral agents with
durable medical equipment and the competitive bidding program in the area. These focus groups
will help CMS understand the affect of the program on referral agents, suppliers and Medicare
beneficiaries.
You are being asked to participate in a focus group because you are a DMEPOS supplier who
provides these supplies to Medicare beneficiaries
A total of 6 focus groups with both suppliers and referral agents are being held as part of the
study and each focus group will have up to 10 participants and two moderators. Abt Associates
will conduct the focus groups and other forms of data collection, analysis, and reporting. Debra
Frankel is the Principal Investigator at Abt Associates.
You are being asked to sign a consent form to participate in the focus group.
PROCEDURES
You will be asked to join with other suppliers in a 1.5-hour discussion about the Medicare
competitive bidding program for DMEPOS. A researcher will facilitate the group in discussing
your experiences with the competitive bidding program. The focus group will not be audio or
video taped.
The discussion will be confidential. You can refuse to take part in this focus group if you wish
without losing any rights or benefits related to youtr professional relationship with CMS. You
can also refuse to answer a question during the focus group, without affecting your continued
participation in the group or your relationship with CMS.
RISKS OF TAKING PART IN THE STUDY
The researchers do not foresee any possible risks to you from participating in this focus group,
other than the minimal risk that your confidentiality might not be preserved. One of the risks to
confidentiality is that other focus group participants may repeat what they hear during the group.
The researchers will do everything allowable by law to assure that your privacy is protected and
will ask all participants at the beginning of the focus group not to repeat the focus group
discussion outside of the group.
Abt Associates Inc.
1
Additionally, the focus group discussion notes will be labeled with a study code, not your or
another participant’s name. Notes and reports from the discussion will be stored in a secure
location (i.e. locked office file cabinet) and electronic materials will be stored in a passwordprotected computer. Your comments, and those of others in the focus group, will be presented in
reports to the government in summary form. Your name will not be included in any reports.
COSTS AND FINANCIAL RISKS
There will be no costs charged to you for participating in the focus group.
POSSIBLE BENEFITS OF TAKING PART IN THE STUDY
There may not be any direct benefit to you from joining the focus group, although you may
benefit from the opportunity to hear about others’ experiences with the competitive bidding
program.
COMPENSATION
You will receive $75 for participating in the focus group today, after the discussion is held. You
will also receive dinner at the focus group facility.
VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT
It is up to you to decide whether to participate in the focus group. If you decide not to participate
in the focus group, you will not be penalized and your relationship with the Centers for Medicare
& Medicaid Services will not be affected. Even if you agree to participate, you are not required
to answer all the questions you are asked.
QUESTIONS
You understand that you may phone Debra Frankel of Abt Associates (617 349-2875) to have
my questions answered. You can also phone Ann Meadow at CMS (410 786-6022). You can
mail a letter to Ms. Frankel at:
Debra Frankel
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
You may also phone Marianne Beauregard, the chairperson of Abt Associates’ Institutional
Review Board (617 349-2852) if you have other questions about your rights as a focus group
participant. All of these numbers are toll calls.
Abt Associates Inc.
2
STATEMENT BY FOCUS GROUP MODERATOR IN THIS RESEARCH STUDY
I have explained the purpose of this research, the study procedures, identifying the potential risks
and benefits. I have answered any questions regarding the research study to the best of my
ability.
_____________________
Moderator’s Name
______________________
Moderator’s Signature
____________
Date
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS RESEARCH
STUDY
I have read and understand this information. I have had all my questions answered fully and I
freely and voluntarily choose to participate in the focus group. I have been given a copy of this
consent form.
_____________________
Volunteer’s Name
Abt Associates Inc.
______________________
Volunteer’s Signature
____________
Date
3
INFORMED CONSENT FORM
Key Informant Discussion: Beneficiary Group/Advocate
Abt Associates Inc. has been hired by the Centers for Medicare & Medicaid Services (CMS) to
conduct an evaluation of the durable medical equipment, prosthetics, orthotics & suppliers
(DMEPOS) competitive bidding program. As part of that evaluation Abt Associates is
conducting discussions to learn about the perceptions and experiences of beneficiary groups and
advocates. These discussions will help CMS understand the affect of the program on referral
agents, suppliers and Medicare beneficiaries.
You are being asked to participate in a discussion because you are with a beneficiary group or
are an advocate for Medicare beneficiaries and their durable medical equipment.
A total of 12 discussions with different groups are being held as part of the study. Abt Associates
will conduct the discussions and other forms of data collection, analysis, and reporting. Debra
Frankel is the Principal Investigator at Abt Associates.
PROCEDURES
You will be asked to discuss the durable medical equipment and the Medicare competitive
bidding program in this discussion that will last approximately 45 minutes.
The discussion will be confidential. You can refuse to take part if you wish without losing any
rights or benefits related to your professional relationship with CMS. You can also refuse to
answer any particular question during the discussion, without affecting your continued
participation in the discussion or your relationship with CMS.
RISKS OF TAKING PART IN THE STUDY
The researcher does not foresee any possible risks to you from participating in this discussion,
other than the minimal risk that your confidentiality might not be preserved.
The discussion notes will be labeled with a study code, not your name. Notes and reports from
the discussion will be stored in a secure location (i.e. locked office file cabinet) and electronic
materials will be stored in a password-protected computer. Your comments will be presented in
reports to the government in summary form. Your name will not be included in any reports.
COSTS AND FINANCIAL RISKS
There will be no costs charged to you for participating in the interview.
POSSIBLE BENEFITS OF TAKING PART IN THE STUDY
There may not be any direct benefit to you from being interviewed, although you may benefit
from the opportunity to share your experiences.
Abt Associates Inc.
-1-
COMPENSATION
You will not receive compensation.
VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT
It is up to you to decide whether to be interviewed. If you decide not to participate in the
discussion, you will not be penalized and your relationship with the Centers for Medicare &
Medicaid Services will not be affected. Even if you agree to participate, you are not required to
answer all the questions you are asked.
QUESTIONS
You understand that you may phone Debra Frankel of Abt Associates (617 349-2875) to have
my questions answered. You can also phone Ann Meadow at CMS (410 786-6022). You can
mail a letter to Ms. Frankel at:
Debra Frankel
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
You may also phone Marianne Beauregard, the chairperson of Abt Associates’ Institutional
Review Board (617 349-2852) if you have other questions about your rights as an interview
participant. All of these numbers are toll calls.
STATEMENT BY INTERVIEWER IN THIS RESEARCH STUDY
I have explained the purpose of this research, the study procedures, identifying the potential risks
and benefits. I have answered any questions regarding the research study to the best of my
ability.
__________________
Interviewer’s Name
______________________
Interviewer’s Signature
____________
Date
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS DISCUSSION
I have read and understand this information. I have had all my questions answered fully and I
freely and voluntarily choose to participate in the discussion. I have been given a copy of this
consent form.
__________________
Volunteer’s Name
Abt Associates Inc.
____________________
Volunteer’s Signature
____________
Date
-2-
INFORMED CONSENT FORM
Key Informant Discussion: CMS Officials/ Bidding Program Managers
Abt Associates Inc. has been hired by the Centers for Medicare & Medicaid Services (CMS) to
conduct an evaluation of the durable medical equipment, prosthetics, orthotics & suppliers
(DMEPOS) competitive bidding program. As part of that evaluation Abt Associates is
conducting discussions to learn about the perceptions and experiences of CMS officials and
bidding program managers. These discussions will help CMS understand the affect of the
program on referral agents, suppliers and Medicare beneficiaries.
You are being asked to participate in a discussion because you are a CMS official/bidding
program manager who works with Medicare beneficiaries to receive durable medical equipment.
A total of 12 discussions with different groups are being held as part of the study. Abt Associates
will conduct the focus groups and other forms of data collection, analysis, and reporting. Debra
Frankel is the Principal Investigator at Abt Associates.
PROCEDURES
You will be asked to discuss the Medicare competitive bidding program in this discussion that
will last approximately 45 minutes.
The discussion will be confidential. You can refuse to take part in this discussion if you wish
without losing any rights or benefits related to my professional relationship with CMS. You can
also refuse to answer any particular question during the discussion, without affecting your
continued participation in the discussion or your relationship with CMS.
RISKS OF TAKING PART IN THE STUDY
The researcher does not foresee any possible risks to you from participating in this discussion,
other than the minimal risk that your confidentiality might not be preserved.
The discussion notes will be labeled with a study code, not your name. Notes and reports from
the discussion will be stored in a secure location (i.e. locked office file cabinet) and electronic
materials will be stored in a password-protected computer. Your comments will be presented in
reports to the government in summary form. Your name will not be included in any reports.
COSTS AND FINANCIAL RISKS
There will be no costs charged to you for participating in the discussion.
POSSIBLE BENEFITS OF TAKING PART IN THE STUDY
There may not be any direct benefit to you from being interviewed, although you may benefit
from the opportunity to share your experiences.
Abt Associates Inc.
-1-
COMPENSATION
You will not receive compensation.
VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT
It is up to you to decide whether to be interviewed. If you decide not to participate in the
interview, you will not be penalized and your relationship with the Centers for Medicare &
Medicaid Services will not be affected. Even if you agree to participate, you are not required to
answer all the questions you are asked.
QUESTIONS
You understand that you may phone Debra Frankel of Abt Associates (617 349-2875) to have
my questions answered. You can also phone Ann Meadow at CMS (410 786-6022). You can
mail a letter to Ms. Frankel at:
Debra Frankel
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
You may also phone Marianne Beauregard, the chairperson of Abt Associates’ Institutional
Review Board (617 349-2852) if you have other questions about your rights as an interview
participant. All of these numbers are toll calls.
STATEMENT BY INTERVIEWER IN THIS RESEARCH STUDY
I have explained the purpose of this research, the study procedures, identifying the potential risks
and benefits. I have answered any questions regarding the research study to the best of my
ability.
_____________________
Interviewer’s Name
______________________
Interviewer’s Signature
____________
Date
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS DISCUSSION
I have read and understand this information. I have had all my questions answered fully and I
freely and voluntarily choose to participate in the discussion. I have been given a copy of this
consent form.
_____________________
Volunteer’s Name
Abt Associates Inc.
______________________
Volunteer’s Signature
____________
Date
-2-
INFORMED CONSENT FORM
Key Informant Discussion: Referral Agents
Abt Associates Inc. has been hired by the Centers for Medicare & Medicaid Services (CMS) to
conduct an evaluation of the durable medical equipment, prosthetics, orthotics & suppliers
(DMEPOS) competitive bidding program. As part of that evaluation Abt Associates is
conducting discussions to learn about the perceptions and experiences of referral agents. These
discussions will help CMS understand the affect of the program on referral agents, suppliers and
Medicare beneficiaries.
You are being asked to participate in a discussion because you are a referral agent who works
with Medicare beneficiaries to receive durable medical equipment.
A total of 12 discussions with different groups are being held as part of the study. Abt
Associates will conduct the discussions and other forms of data collection, analysis, and
reporting. Debra Frankel is the Principal Investigator at Abt Associates.
PROCEDURES
You will be asked to discuss the Medicare competitive bidding program in this discussion that
will last approximately 45 minutes.
The discussion will be confidential. You can refuse to take part in this discussion if you wish
without losing any rights or benefits related to your professional relationship with CMS. You
can also refuse to answer any particular question during the discussion, without affecting your
continued participation in the discussion or your relationship with CMS.
RISKS OF TAKING PART IN THE STUDY
The researcher does not foresee any possible risks to you from participating in this discussion,
other than the minimal risk that your confidentiality might not be preserved.
The discussion notes will be labeled with a study code, not your name. Notes and reports from
the discussion will be stored in a secure location (i.e. locked office file cabinet) and electronic
materials will be stored in a password-protected computer. Your comments will be presented in
reports to the government in summary form. Your name will not be included in any reports.
COSTS AND FINANCIAL RISKS
There will be no costs charged to you for participating in the discussion.
POSSIBLE BENEFITS OF TAKING PART IN THE STUDY
There may not be any direct benefit to you from being interviewed, although you may benefit
from the opportunity to share your experiences.
Abt Associates Inc.
-1-
COMPENSATION
You will not receive compensation.
VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT
It is up to you to decide whether to be interviewed. If you decide not to participate in the
discussion, you will not be penalized and your relationship with the Centers for Medicare &
Medicaid Services will not be affected. Even if you agree to participate, you are not required to
answer all the questions you are asked.
QUESTIONS
You understand that you may phone Debra Frankel of Abt Associates (617 349-2875) to have
my questions answered. You can also phone Ann Meadow at CMS (410 786-6022). You can
mail a letter to Ms. Frankel at:
Debra Frankel
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
You may also phone Marianne Beauregard, the chairperson of Abt Associates’ Institutional
Review Board (617 349-2852) if you have other questions about your rights as an interview
participant. All of these numbers are toll calls.
STATEMENT BY INTERVIEWER IN THIS RESEARCH STUDY
I have explained the purpose of this research, the study procedures, identifying the potential risks
and benefits. I have answered any questions regarding the research study to the best of my
ability.
_____________________
Interviewer’s Name
______________________
Interviewer’s Signature
____________
Date
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS DISCUSSION
I have read and understand this information. I have had all my questions answered fully and I
freely and voluntarily choose to participate in the discussion. I have been given a copy of this
consent form.
_____________________
Volunteer’s Name
Abt Associates Inc.
______________________
Volunteer’s Signature
____________
Date
-2-
INFORMED CONSENT FORM
Key Informant Discussion: Supplier
Abt Associates Inc. has been hired by the Centers for Medicare & Medicaid Services (CMS) to
conduct an evaluation of the durable medical equipment, prosthetics, orthotics & suppliers
(DMEPOS) competitive bidding program. As part of that evaluation Abt Associates is
conducting discussions to learn about the perceptions and experiences of suppliers of durable
medical equipment. These discussions will help CMS understand the affect of the program on
referral agents, suppliers and Medicare beneficiaries. You are being asked to participate in a
discussion because you are a DMEPOS supplier who provides durable medical equipment to
Medicare beneficiaries.
A total of 12 discussions with different groups are being held as part of the study. Abt
Associates will conduct the discussions and other forms of data collection, analysis, and
reporting. Debra Frankel is the Principal Investigator at Abt Associates.
PROCEDURES
You will be asked to discuss the Medicare competitive bidding program in this discussion that
will last approximately 45 minutes.
The discussion will be confidential. You can refuse to take part in this discussion if you wish
without losing any rights or benefits related to your professional relationship with CMS. You
can also refuse to answer any particular question during the discussion, without affecting your
continued participation in the discussion or your relationship with CMS.
RISKS OF TAKING PART IN THE STUDY
The researcher does not foresee any possible risks to you from participating in this discussion,
other than the minimal risk that your confidentiality might not be preserved.
COSTS AND FINANCIAL RISKS
There will be no costs charged to you for participating in the discussion.
POSSIBLE BENEFITS OF TAKING PART IN THE STUDY
There may not be any direct benefit to you from being interviewed, although you may benefit
from the opportunity to share your experiences.
Abt Associates Inc.
-1-
COMPENSATION
You will not receive compensation.
VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT
It is up to you to decide whether to be interviewed. If you decide not to participate in the
discussion, you will not be penalized and your relationship with the Centers for Medicare &
Medicaid Services will not be affected. Even if you agree to participate, you are not required to
answer all the questions you are asked.
QUESTIONS
You understand that you may phone Debra Frankel of Abt Associates (617 349-2875) to have
my questions answered. You can also phone Ann Meadow at CMS (410 786-6022). You can
mail a letter to Ms. Frankel at:
Debra Frankel
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
You may also phone Marianne Beauregard, the chairperson of Abt Associates’ Institutional
Review Board (617 349-2852) if you have other questions about your rights as an interview
participant. All of these numbers are toll calls.
STATEMENT BY INTERVIEWER IN THIS RESEARCH STUDY
I have explained the purpose of this research, the study procedures, identifying the potential risks
and benefits. I have answered any questions regarding the research study to the best of my
ability.
_____________________
Interviewer’s Name
______________________
Interviewer’s Signature
____________
Date
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS DISCUSSION
I have read and understand this information. I have had all my questions answered fully and I
freely and voluntarily choose to participate in the discussion. I have been given a copy of this
consent form.
_____________________
Volunteer’s Name
Abt Associates Inc.
______________________
Volunteer’s Signature
____________
Date
-2-
INFORMED CONSENT SCRIPT
Comparison Area Key Informant Discussion: Beneficiary Group
/Advocate
Hello/Good morning/Good afternoon…May I speak with…(if not available, leave a
message)
My name is [Interviewer name]. I am calling from Abt Associates Inc. You are scheduled
to conduct an interview on the evaluation of the Centers for Medicare and Medicaid
Services’ Durable Medical Equipment, Prosthetic, Orthotic Supplies’ competitive bidding
program. Is this still a good time to do the interview?
[If no] May I reschedule the interview at a time that is convenient for you?
[If yes] Before we begin, I need to review a few details about the study with you.
As you may or may not know, Medicare is implementing a new fee schedule for durable
medical equipment, prosthetic, and orthotic supplies (DMEPOS) in various areas of the
United States. The purpose of our study is to evaluate the affect of the competitive
bidding program on suppliers, beneficiaries and referral agents. The study is being
conducted by Abt Associates on behalf of the Centers for Medicare and Medicaid
Services (CMS).
You were chosen to participate as a member of a beneficiary group or an advocate to
provide an understanding of the current environment for Medicare beneficiaries and their
durable medical equipment in your area, as a comparison. [If relevant] You were also
recommended by [name referral].
Our interview today should last about 45 minutes. Please understand that your
participation in this study is voluntary and that if you choose not to participate you will
not be penalized in any way. You can refuse to answer any question I ask and may even
ask to stop the interview at any time. This interview will not be tape-recorded.
Instead I will take notes. These notes will be used to create summaries, which will not
include your personal information, and will be used to write a report to CMS on the
education and outreach program for the new Medicare drug benefit. Do you have any
questions?
If you have any questions that I may not be able to answer at this time, or at any time
after this interview, you may contact __________, at the Centers for Medicare and
Medicare Services (___) ___-____and she will be happy to assist you. Note, this is a toll
call.
Given the information that I have just reviewed with you, do you still wish to participate
in this study/interview?
If Yes, _______________ [Interviewer’s Initials}. Great. Let me begin with the first
question.
Abt Associates Inc.
Comparison Area Key Informant Discussion: Beneficiary Groups/Advocates
-1-
If No, ______________ [Interviewer’s Initials]. That is fine. We appreciate your time.
Thank you.
Abt Associates Inc.
Comparison Area Key Informant Discussion: Beneficiary Groups/Advocates
-2-
INFORMED CONSENT SCRIPT
Comparison Areas Key Informant Discussion: Referral Agents
Hello/Good morning/Good afternoon…May I speak with…(if not available, leave a
message)
My name is [Interviewer name]. I am calling from Abt Associates Inc. You are scheduled
to conduct an interview on the evaluation of the Centers for Medicare and Medicaid
Services’ Durable Medical Equipment, Prosthetic, Orthotic Supplies’ competitive bidding
program. Is this still a good time to do the interview?
[If no] May I reschedule the interview at a time that is convenient for you?
[If yes] Before we begin, I need to review a few details about the study with you.
As you may or may not know, Medicare is implementing a new fee schedule for durable
medical equipment, prosthetic, and orthotic supplies (DMEPOS) in various areas of the
United States. The purpose of our study is to evaluate the affect of the competitive
bidding program on suppliers, beneficiaries and referral agents. The study is being
conducted by Abt Associates on behalf of the Centers for Medicare and Medicaid
Services (CMS).
You were chosen to participate as a referral agent to provide an understanding of the
current environment for Medicare beneficiaries and their durable medical equipment in
your area, as a comparison. [If relevant] You were also recommended by [name referral].
Our interview today should last about 45 minutes. Please understand that your
participation in this study is voluntary and that if you choose not to participate you will
not be penalized in any way. You can refuse to answer any question I ask and may even
ask to stop the interview at any time. This interview will not be tape-recorded.
Instead I will take notes. These notes will be used to create summaries, which will not
include your personal information, and will be used to write a report to CMS on the
education and outreach program for the new Medicare drug benefit. Do you have any
questions?
If you have any questions that I may not be able to answer at this time, or at any time
after this interview, you may contact Ann Meadows, at the Centers for Medicare and
Medicare Services (___) ___-____and she will be happy to assist you. Note, this is a toll
call.
Given the information that I have just reviewed with you, do you still wish to participate
in this study/interview?
If Yes, _______________ [Interviewer’s Initials}. Great. Let me begin with the first
question.
If No, ______________ [Interviewer’s Initials]. That is fine. We appreciate your time.
Thank you.
Abt Associates Inc.
Comparison Area Key Informant Discussion: Referral Agent
-1-
INFORMED CONSENT SCRIPT
Comparison Areas Key Informant Discussion: Supplier
Hello/Good morning/Good afternoon…May I speak with…(if not available, leave a
message)
My name is [Interviewer name]. I am calling from Abt Associates Inc. You are scheduled
to conduct an interview on the evaluation of the Centers for Medicare and Medicaid
Services’ Durable Medical Equipment, Prosthetic, Orthotic Supplies’ competitive bidding
program. Is this still a good time to do the interview?
[If no] May I reschedule the interview at a time that is convenient for you?
[If yes] Before we begin, I need to review a few details about the study with you.
As you may or may not know, Medicare is implementing a new fee schedule for durable
medical equipment, prosthetic, and orthotic supplies (DMEPOS) in various areas of the
United States. The purpose of our study is to evaluate the affect of the competitive
bidding program on suppliers, beneficiaries and referral agents. The study is being
conducted by Abt Associates on behalf of the Centers for Medicare and Medicaid
Services (CMS).
You were chosen to participate as supplier to provide an understanding of the current
environment for Medicare beneficiaries and their durable medical equipment in your
area, as a comparison. [If relevant] You were also recommended by [name referral].
Our interview today should last about 45 minutes. Please understand that your
participation in this study is voluntary and that if you choose not to participate you will
not be penalized in any way. You can refuse to answer any question I ask and may even
ask to stop the interview at any time. This interview will not be tape-recorded.
Instead I will take notes. These notes will be used to create summaries, which will not
include your personal information, and will be used to write a report to CMS on the
education and outreach program for the new Medicare drug benefit. Do you have any
questions?
If you have any questions that I may not be able to answer at this time, or at any time
after this interview, you may contact Ann Meadows, at the Centers for Medicare and
Medicare Services (___) ___-____and she will be happy to assist you. Note, this is a toll
call.
Given the information that I have just reviewed with you, do you still wish to participate
in this study/interview?
If Yes, _______________ [Interviewer’s Initials}. Great. Let me begin with the first
question.
If No, ______________ [Interviewer’s Initials]. That is fine. We appreciate your time.
Thank you.
Abt Associates Inc.
Comparison Area Key Informant Discussion: Suppliers
-1-
APPENDIX E
Statistical Data Collection Instruments
Federal Register Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
Office of Research, Development and Information
Proposed Information Collection; Comment Request
AGENCY: Centers for Medicare and Medicaid Services
ACTION: Notice
SUMMARY: The Department of Commerce, as part of its continuing effort to reduce
paperwork and respondent burden, invites the general public and other Federal agencies to take
this opportunity to comment on proposed information collections, as required by the Paperwork
Reduction Act of 1995.
DATES: Written comments must be submitted on or before…...
ADDRESSES: Direct all written comments to …….
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection instrument and instructions should be directed to ……..
ABSTRACT: Section 302(b) of The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (Public Law 108-173) (MMA) requires CMS to begin a program of competitive bidding for
durable medical equipment, supplies, certain orthotics, and enteral nutrients and related equipment and
supplies (DMEPOS). The bidding program is to be established in 10 of the largest MSAs in 2007, an
additional 80 large MSAs in 2009, and additional MSAs thereafter. With certain exceptions, the
Secretary of Health and Human Services has discretion to select categories of supplies and equipment for
bidding to maximize savings.
MMA Section 303(d) requires a Report to Congress on the program, covering program savings,
reductions in cost sharing, impacts on access to and quality of affected goods and services, and
beneficiary satisfaction. The purpose of this project is to provide information for the Report to Congress
and to provide a technical report on the evaluation findings for attachment to the Report. Also, interim
information from site visits and other data collection may be helpful to CMS as it makes plans to
implement the second phase (adding 80 large MSAs).
The major evaluation areas for the proposed project include impacts in the following seven areas, which
all relate to traditional Medicare policy objectives on program costs, access, and quality:
•
Expenditures
Abt Associates Inc.
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•
•
•
•
•
•
Reductions in beneficia ry cost-sharing
Access to durable medical equipment and supplies and related services
Quality of goods and services
Consumer satisfaction
Medicare administrative operations
Savings in relation to program costs
The evaluation will draw on a range of data sources in order to explore these impacts and, when possible,
to get multiple perspectives on each. These data sources include: Medicare claims (notably DMEPOS
claims); data from a surveys of beneficiaries who use DMEPOS conducted before and after the initiation
of the new payment approach; surveys of suppliers conducted before and after the initiation of the new
payment approach that focus specifically on the diversity of products within a specific category supplied;
qualitative data collection including focus groups and interviews with referral agents, suppliers, CMS
officials and other stakeholders collected at three time points--before, immediately after, and 18 months
after the initiation of the new payment approach; and Medicare program data. Survey data and qualitative
data will be collected in three of the 10 selected Competitive Acquisition areas (CAAs) and 2 comparison
areas where the program will not be implemented until a later phase.
ESTIMATED BURDEN TABLE FOR SURVEY DATA COLLECTION ACROSS TWO
WAVES OF DATA COLLEC TION
Beneficiary
Survey
Supplier
Survey
Number of
Respondents
24,000
Total Annual
Response
1
Average Burden
in Hours
0.50
Total Burden
in Hours
12,000 hours
% WebBased
0
1,150
1
0.75
862 hours
90
REQUEST FOR COMMENTS: Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection of information on respondents.
Copies of the survey instruments may be obtained by contacting the office listed in the ADDRESSES
section of this notice.
Dated:
By:
BILLING CODE:
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| File Type | application/pdf |
| File Title | Microsoft Word - OMB_DMEBID_111306.doc |
| Author | JureidiniS |
| File Modified | 2006-11-20 |
| File Created | 2006-11-20 |