CMS-10520 - Quality Standards Supporting Statement 2016

Supporting Statement – Quality Standards
A.

Background

The HHS’ goals for improving access to high-quality, affordable care, and supporting healthier
people and communities, as described in the National Strategy for Quality Improvement in
Health Care (National Quality Strategy) 1, continue to guide the establishment of quality
standards for Exchanges and for Qualified Health Plans (QHP). HHS is requesting approval, by
the Office of Management and Budget (OMB), for the revision associated with Part IV of this
supporting statement which details the information collection associated with finalized Patient
safety reporting standards for QHP issuers:
I.
II.
III.
IV.

Implementation and reporting for the Quality Rating System (QRS);
Implementation and reporting for the Enrollee Satisfaction Survey (ESS);
Monitoring and appeals process for survey vendors; and
Patient safety reporting standards for Qualified Health Plan (QHP) issuers.

B.

Justification

1. Need and Legal Basis
The Affordable Care Act establishes requirements to support the delivery of quality health care
coverage for health insurance issuers offering Qualified Health Plans (QHPs) in Exchanges.
Section 1311(c)(3) of the Affordable Care Act directs the Secretary to develop a system to rate
QHPs on the basis of quality and price and requires Exchanges to display this quality rating
information on their respective websites. Section 1311(c)(4) of the Affordable Care Act requires
the Secretary to develop an enrollee satisfaction survey (ESS) system to assess enrollee
experience with each QHP (with more than 500 enrollees in the previous year) offered through an
Exchange. Section 1311(h) requires QHPs to contract with certain hospitals that meet specific
patient safety and health care quality standards beginning January 1, 2015.
This Information Collection Request (ICR) was approved under OMB Control Number 09381249 so that HHS may collect required information in order to implement the proposed quality
standards outlined in §156.1105, §156.1110, §156.1120, §155.1125. The collection of
information is necessary to provide adequate and timely health care quality information for
consumers, regulators and Exchanges in the initial years of Exchange implementation. It is also
necessary to collect information to appropriately monitor and provide a process for a survey
vendor to appeal HHS’ decision to not approve the ESS vendor application. We revised this
information collection to account for the associated burden of the finalized QHP issuer patient
safety reporting standards from the HHS Notice of Benefit and Payment Parameters for 2017
(0938-AS57) published in the Federal Register on March 8, 2016.
2. Information Users
1 See Report to Congress: National Strategy for Quality Improvement in Health Care available at
http://www.healthcare.gov/law/resources/reports/quality03212011a.html.

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I.

Implementation and reporting for the Quality Rating System (QRS)

The QRS quality measure data will be collected from QHP issuers on an annual basis in order
for HHS to be able to calculate scores and quality ratings for QHPs, as required by section
1311(c)(3) of the Affordable Care Act. We intend to have a beta testing period in 2015 to
provide early feedback to Exchanges and QHP issuers and begin public reporting of quality
rating information in 2016. This quality rating information will be displayed on Exchange
websites for consumers to have QHP rating information including health care quality, health
outcomes, consumer experience, accessibility of care and affordability of care, which is
information that is essential to inform consumer choices and to perform certain required
functions of an Exchange. HHS will use the validated data that is submitted by QHP issuers to
calculate scores and ratings based on a standardized methodology which is currently being
developed and finalized.
II.

Implementation and reporting for the Enrollee Satisfaction Survey (ESS)

The information collection associated with implementation and reporting for the ESS, as
proposed in §156.1125, includes the collection, validation and submission of ESS data on an
annual basis. We intend to have a beta testing period in 2015 and begin public reporting of
enrollee satisfaction survey results in 2016. The ESS, also known as the QHP enrollee
experience survey, will provide member experience data which is a fundamental aspect of the
overall quality of the QHP. The burden estimates and costs regarding survey respondents are
already accounted for and described in the Federal Register Notice dated Nov. 1, 2013. 2 The
ESS information submitted to HHS will be used for HHS to calculate ESS scores and
benchmarks to send to Exchanges and to QHPs. In addition, a subset of the ESS scores will be
used as part of the quality ratings for QHPs. ESS results will be displayed on Exchange websites
to allow consumers to compare enrollee experience across QHPs.
III.

Monitoring and appeals process for survey vendors

We propose to establish a monitoring and appeals process for HHS-approved ESS vendors in the
Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015
and 2016. Specifically, in §156.1105(d), we establish a process in which HHS will monitor
approved vendors for ongoing compliance. HHS may require additional information from
approved vendors to be submitted as needed and in order to ensure continued compliance with
standards listed in §156.1105(b)(1) through (11). HHS will use this information to determine
whether the ESS vendor should remain on the approved list and/or whether the submitted survey
results may be ineligible to be included for ESS results. In §156.1105(e), we propose a process by
which a survey vendor that was not approved by HHS could appeal HHS’s determination. The
vendor would submit documentation to demonstrate how the vendor meets the necessary
standards to HHS for review. HHS will use this information to make a final approval
determination of whether or not to list the vendor as an HHS-approved ESS vendor.
2

Agency Information Collection Activities: Health Insurance Marketplace Consumer Experience Surveys: Enrollee
Satisfaction Survey and Marketplace Survey Data Collection; Notice, 78 FR 65658 (Nov. 1, 2013).

2

IV.

Patient safety reporting standards for QHP issuers.

We finalized amendments to QHP patient safety reporting standards in the Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 (81 FR 12203) ,
March, 2016. We finalized the documentation requirement in §156.1110(b) to require QHP
issuers to collect and maintain information such as a hospital attestation or a copy of the current
agreement to partner with a Patient Safety Organization (PSO), a Hospital Engagement Network,
or a Quality Improvement Organization. The documentation should reflect implementation of
PSO activities, such as PSOs and hospitals working together to collect, report and analyze patient
safety events, and implementation of a comprehensive person-centered hospital discharge
program to demonstrate compliance with the proposed requirements in §156.1110(a)(2)(i); or
implementation of a patient safety initiative to improve health care quality through the collection,
management and analysis of patient safety events that reduces all cause preventable harm,
prevents hospital readmission, or improves care coordination to demonstrate compliance with the
reasonable exception provision finalized in §156.1110(a)(2)(ii). An Exchange may request this
information and may use the information as demonstration of compliance by QHP issuers with
patient safety reporting standards outlined in §156.1110.
3. Use of Improved Information Technology and Burden Reduction
All information collected from QHP issuers for implementation and reporting of the QRS, ESS
and patient safety standards will be submitted electronically. HHS staff will analyze the data
electronically and communicate with issuers and State-based Exchanges, if necessary, by email
and telephone. Information collected from survey vendors regarding the monitoring and
appeals process will be electronic as well.
4. Efforts to Identify Duplication and Use of Similar Information
These are new quality reporting standards and programs created under the Affordable Care
Act and the information to be collected has never been collected by the federal government
for the use of providing quality ratings and ESS results for QHPs; for use in a monitoring and
appeals processes for ESS vendors; and for patient safety reporting by QHPs. We acknowledge
that similar information (i.e. quality measures and CCN data) is collected by CMS quality
reporting programs including Medicare Star Ratings, Medicaid Adult Core Measures, Initial
Children’s Core Set, Medicare Part C&D programs; however, we believe that this information
collection is not duplicative since it will provide necessary data for the new Exchange market
while also aligning with standards from established programs to minimize burden and costs for
stakeholders.
5. Impact on Small Businesses or Other Small Entities
No impact on small business.
6. Consequences of Collecting the Information Less Frequently
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If HHS does not collect the QRS and ESS information on an annual basis, HHS will be unable to
calculate scores and ratings for QHPs as required by section 1311(c)(3) and (c)(4) of the
Affordable Care Act. In addition, HHS will be unable to send the appropriate QHP quality
information to Exchanges for display on their websites as also required. If HHS does not collect
information to monitor ESS vendors then there may be increased risk of noncompliance by
vendors.
7. Special Circumstances
Not applicable.
8. Federal Register Notice/Outside Consultation
CMS provided an opportunity for the public to comment for 60-days through the Notice of
Proposed Rulemaking (80 FR 75488, December 2, 2015). No comments were received.
A 30-day comment solicitation published on March 8, 2016 at 81 FR 12204, giving the public 30days to comment.
9. Payment/Gift to Respondents
Not applicable
10. Confidentiality
No personal information will be collected. All information will be kept private to the extent
allowed by applicable laws/regulations.
11. Sensitive Questions
No sensitive information will be collected.

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12. Estimates of Annualized Burden Hours (Total Hours & Wages)
I.

Implementation and reporting for the Quality Rating System (QRS)

The burden estimate details the costs associated with QRS measure data collection, validation, and
submission to CMS for a QHP issuer (issuer) operating in the Health Insurance Marketplace. The
estimate assumes 575 issuers and covers the annual costs for an issuer over a three-year period
(2015-2017). The estimate relies on the assumption that each issuer will report the QRS measure set
only.
Though the QRS measure set consists of 43 measures, this burden estimate only considers the level
of effort associated with 31 measures that specify data collection using administrative data sources
and/or medical records. The burden estimate for survey respondents for the remaining 12 QRS
measure set survey measures was accounted for in a previous Federal Register notice related to the
ESS or QHP Enrollee Experience Survey3. See Exhibit 1 for the QRS measure set attributes
considered in estimating the burden of QRS measure data collection. The original burden estimates
were made based on the draft QRS measure set released in the FRN published November 3, 2013. 4
In response to the feedback received during the public comment period, CMS reviewed the
assumptions and data inputs used to create the QRS burden estimates. Since publication of the ICR,
the QRS measure set had been revised and was published soon after the Final Rule was issued. 5
Due to the changes in the QRS measure set, CMS revised the burden estimate to reflect the final
2015 QRS beta test measure set. Exhibit 1 shows the change in key measure set attributes between
the draft QRS measure set and the final 2015 beta test QRS measure set.

Exhibit 1. QRS Measure Set Attributes Related to Data Collection
Attribute Description

Draft
QRS
Measure
Set

Subset of QRS Measures Accounted for In Burden Estimate
Subset of QRS measure set that specify data collection using
administrative and/or medical record data sources
Administrative Measures

29

Final
2015 QRS
Beta Test
Measure
Set
31

20

18

3

Agency Information Collection Activities: Health Insurance Marketplace Consumer Experience Surveys: Enrollee
Satisfaction Survey and Marketplace Survey Data Collection; Notice, 78 FR 65658 (Nov. 1, 2013).
4
https://www.federalregister.gov/articles/2013/11/19/2013-27649/patient-protection-and-affordable-care-actexchanges-and-qualified-health-plans-quality-rating
5
Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond Final
Rule, 79 FR 30352 (May 27, 2014).

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Attribute Description

Draft
QRS
Measure
Set

Final
2015 QRS
Beta Test
Measure
Set

Measures that specify the use of claims or other administrative source
data
Hybrid Measures that Require a Unique Sample
9
10*
Measures that specify the use of medical record data to supplement
administrative data
Average # of Medical Records Reviewed for Each Hybrid Measure that 335
330
Requires a Unique Sample
The number of medical records, on average, that an issuer reviews to
determine measure compliance
*Though there are 13 hybrid measures in the final QRS measure set only 10 require a unique
sample.
CMS conducted interviews with issuers that had experience with performance measures data
collection and other technical experts to confirm the data collection process and the associated
burden. The following data collection process steps served as the basis for estimating labor hours:
•
•
•
•
•
•

Preparation of IT Systems for Data Collection
Data Collection – Administrative Method
Data Collection – Medical Record Method
Data Aggregation and Quality Assurance
Data Validation
Data Submission

The estimate assumes that issuers will report QRS measure data to CMS by product type ( HMO,
POS, PPO, and/or EPO). Thus, the estimate uses a weighting factor to represent the workload for
issuers with multiple product types 6.
Exhibit 2 includes the labor categories and wage rates used to derive the burden estimate. The
categories are based on those cited by the Department of Labor, Bureau of Labor Statistics (BLS). A
sample of issuers informed modifications to the function descriptions associated with each category
so that they aligned more with performance measures data collection. Wages, fringe benefits, and
overhead costs are based on BLS wage statistics as of May 2012. The 75th percentile is used for
hourly wages in order to generate a conservative burden estimate. This burden estimate represents
the average, annual cost for an issuer over the 2015-2017 QRS measure reporting period. Since
wage, fringe benefits, and overhead cost data were taken from 2012 BLS reports (the most recent
data available), the model includes a wage growth factor to account for the anticipated changes in
total compensation. The wage growth factor was determined by averaging annual growth rates of
6

The estimate uses a weight of 1.25 that equates to the average number of product types per issuer in aggregate. This is
based on CMS data received 11/01/13.

6

total compensation between 2004 Quarter 2 to 2013 Quarter 2 supplied by BLS.
Due to the increase in overall measures by 7%, including the addition of one hybrid measure that
requires a unique sample, CMS revised the burden estimate accordingly. Data collection for hybrid
measures requires a greater level of effort than administrative measures. Considering these changes,
CMS increased labor hours for QHP issuer staff by 11%, which resulted in an approximate 10%
increase (9.7%) in total cost per QHP issuer. The revised annual labor hours and associated costs
are reflected in Exhibit 2.
Exhibit 2. Labor Categories and Wage Rates
Total Hourly
Wage Rate for
Period 20152017 9

Function

Hourly Wage 7

Hourly Wage
Rate for Period
2015-2017 8

General and
Operations
Manager

Formulate policies,
manage daily operations,
and plan the use of
materials and human
resources.

$69.81

$76.41

$108.69

Computer
Programmer

Modify and test code.
Use statistical methods to
$45.26
organize, interpret, QA,
and summarize data.

$49.54

$70.46

Business
Operations
Specialist,
Other

Train reviewers. Review
and over-read charts for
quality assurance.

$41.81

$45.76

$65.09

Registered
Nurse

Review medical records
for measure data
collection.

$37.84

$41.42

$58.91

Medical
Records and

Compile, process,
review, and maintain

$21.33

$23.35

$33.21

Labor
Category

7

75th percentile is referenced. Data source: http://www.bls.gov/oes/current/oes_stru.htm
Hourly wage + wage growth factor of 2.28%. Wage growth factor data source: BLS 2004 Q2 to 2013 Q2 http://www.bls.gov/ncs/ect/data.htm
9
Hourly wage rate for period + overhead & fringe benefit rate of 42.24%. Overhead & fringe benefit data source: BLS
2012 Q2 - http://www.bls.gov/ncs/ect/data.htm
8

7

Labor
Category
Health
Information
Analyst

Hourly Wage 7

Function

Hourly Wage
Rate for Period
2015-2017 8

Total Hourly
Wage Rate for
Period 20152017 9

medical records and
patient information.

The estimated annual cost burden for issuers is based on an average of estimates provided by a
sample of issuers. The sample was comprised of issuers that have performance measures data
collection experience, which represents the majority of issuers that will report QRS measures data.
Each issuer estimated labor hours for each applicable labor category involved with the data
collection process. Estimates assumed that issuers will follow usual practices of contracting with a
third-party for data validation and using existing program data submission tools with which they are
familiar. Exhibit 3 displays the estimated annual cost burden for a single issuer and includes the
labor hours per labor category (for internal staff).
Exhibit 3. Annual Estimated Cost Burden for One Issuer
Third-Party
Validator

Internal Staff

General
and
Operations
Manager

Business
Computer
Operations
Programmer Specialist,
Other

Registered
Nurse

Medical
Records
and Health
Information
Analyst

Total
Hours by
Labor
Category

206

335

145

892

252

Total
Hourly
Wage
Rate

$108.69

$70.46

$65.09

$58.91

$33.21

Subtotal
Cost

$22,390

$23,604

$9,438

$52,548

$8,369

$12,500
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Third-Party
Validator

Internal Staff
Total Cost

$128,849

For one QHP issuer, the burden to collect and report data for the QRS is estimated to take
approximately 1830 hours and $128,849 each year. Therefore, the total annual hour and cost
burden for 575 issuers is 1,052,250 hours and $74,088,175.
II.

Implementation and reporting for the Enrollee Satisfaction Survey (ESS)

The estimated annual hour and cost burden for an issuer to collect, validate, and submit data for the
ESS includes contracting with an HHS-approved ESS vendor, contracting with an auditor,
generating the sampling frame data, reviewing survey materials, authorizing its contracted survey
vendor, and signing off on the data to be submitted to HHS.
The ESS is largely based on the Consumer Assessment of Healthcare Providers and Systems
(CAHPS®) 5.0 Health Plan Survey which the majority of issuers already have experience with.
Therefore, the burden estimates are similar to established CAHPS survey estimates for health plans
such as those approved under OMB Control Number 0938-0732 (Medicare CAHPS surveys). It is
estimated that an issuer takes an average of 54 hours a year for the ESS. For the estimated
575 QHP issuers, the total annual burden is 31,050 hours. It is estimated that it costs an
issuer $1349.60 each year for a total annual cost of $776,020 for 575 issuers.
Exhibit 6. Annual Estimated Hour and Cost Burden for QHP Issuers and ESS
Number Hours per
Total
of
response
Average Hourly
Issuer Activity
Burden
Responde
Wage Rate
Hours
nts

Total Cost
Burden

Contracting with HHSapproved ESS vendor

575

8

4600

$24.10

$110,860

Contracting with
auditor

575

8

4600

$24.10

$110,860

Generating sampling
frame

575

32

18,400

$24.10

$443,440

Reviewing survey
materials

575

4

3450

$24.10

$83,145

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Issuer Activity

Authorizing survey
vendor and signing off
on data to be submitted

Number
of
Responde
nts

Hours per
response

575

2

1150

54

31,050

Total

III.

Total
Burden
Hours

Average Hourly
Wage Rate

$24.10

Total Cost
Burden

$27,715

$776,020

Monitoring and appeals process for survey vendors

The estimated annual hour and cost burden for a survey vendor to provide information for HHS to
determine continued compliance with approval criteria and ESS vendor minimum business
requirements is approximately 40 hours and $964 for an estimated 40 vendors. It is estimated that
only five vendors may file an appeal each year if not approved by HHS to be an ESS vendor. The
annual hour and cost burden for those five vendors filing an appeal is estimated to be 5 hours and
$120.50. Therefore, the total annual estimated hour and cost burden for vendor monitoring
and appeals are 45 hours and $1084.50.

Exhibit 7. Annual Estimated Hour and Cost Burden for Vendor Monitoring and Appeals
Hours per
Total
Average
Number of
Total Cost
Vendor Activity
response
Burden
Hourly Wage
Respondents
Burden
Hours
Rate
Compliance with
monitoring

40

1

40

$24.10

$964.00

Filing an appeal

5

1

5

$24.10

$120.50

Total

45

45

$1084.5

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IV. Patient Safety Reporting Standards for QHP Issuers
In the HHS 2017 Payment Notice final rule 10, we describe the information collection,
recordkeeping, and disclosure requirements that a QHP issuer must meet to demonstrate compliance
with the patient safety standards outlined in §156.1110. The burden estimate associated with these
standards includes the time and effort required for QHP issuers to maintain and submit information
such as a hospital attestation or a copy of the current agreement to partner with a PSO, a Hospital
Engagement Network, or a Quality Improvement Organization, to the Exchange that demonstrates
that each of its contracted hospitals with greater than 50 beds meets the patient safety standards in
§156.1110(a)(2) for plan years beginning on or after January 1, 2017. We expect QHP issuers to
already be collecting network provider information which is accounted for in the Supporting
Statement associated with OMB Control Number 0938-1156. There is a wide range of numbers of
relevant hospitals with greater than 50 beds across states from only one in some states to more than
300 hospitals in other states. We estimate a total of 575 QHP issuers, offering 15 plans as potential
QHPs, would each take approximately an average of 3 hours to collect, maintain and submit
applicable hospital agreements or information as finalized in §156.1110 for their QHPs. At an
hourly billing rate of $91.31, we estimate the total annual cost for a QHP issuer to be $273.93.
Therefore, we estimate the total annual cost and annual burden to be $157,510and 1725 hours.
Exhibit 8. Annual Estimated Hour and Cost Burden for QHP Issuer Patient Safety Reporting
Hours per
Total
Average
Number of
Total Cost
Activity
response
Burden
Hourly Wage
Respondents
Burden
Hours
Rate
QHP issuers collect
and maintain
information such as
applicable hospital
agreements

575

2

575

$91.31

$105,007

QHP issuers
submit this data to
HHS and an
Exchange

575

1

575

$91.31

$52,503

3

1725

Total

$157,510

10

Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017; Final Rule, 81
FR 12203 (March 8, 2016).

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13. Estimates of other Total Annual Cost Burden to Respondents or Record Keepers
/Capital Costs
It is anticipated that capital costs would be incurred in the initial year(s) by issuers with limited
experience in quality measure collection and submission as they develop their data collection systems
and processes. These issuers will need to purchase and install software for QRS measure data
collection. The anticipated cost for this purchase and installation is an estimated cost of $80,000.
These issuers would also incur an additional $10,000 cost for third-party validation since validators
may initially set higher fees for these issuers, given the increased resources needed to validate new
systems and processes. Capital costs also include annual third-party validation costs which are
estimated to be $12,500 for issuers. Issuers would also have to contract with an ESS vendor which is
estimated to be approximately $16,000 annually. We estimate that these vendor contracting costs are
conservative since issuers already contract with survey vendors to administer other similar CAHPS
surveys and may not have to contract with additional new vendors for the ESS.
14. Annualized Cost to Federal Government
We estimate that the operations, maintenance and data collection costs associated with this
information collection to the Federal government include contract costs for the QRS measure
collection and reporting and the time and cost for one GS-level 13, one GS-level 14 and one GSlevel 15 for data processing, managerial review and oversight. The calculations for federal
employees’ hourly salary are obtained from the OPM website, with an additional 35% to account
for fringe benefits.
Task
Data Processing, Managerial Review, and Oversight
1 GS-13, Step 1: $46.98 X 20 hrs
1 GS-14, Step 1: $55.34 X 20 hrs
1 GS-15, Step 1: $65.31 X 5 hrs
QRS measure collection and reporting
ESS data collection

Total Costs to Government

Estimated Cost
$940
$1107
$327
$898,969
Already accounted for in OMB
Control #0938-1221
$901,343

15. Changes to Burden
This is an increase to the burden hour estimates approved in OMB Control Number 0938-1249. The
newly established QHP patient safety standards would result in an annual estimated increase of 600 hours
(1750-1150 hours) and $68,960 ($157,510-$88,550) for QHP issuers.
16. Publication/Tabulation Dates
Using the data collected for the QRS, HHS intends to calculate ratings associated with the QRS
according to a standard rating methodology. We intend to have a 2015 beta testing period and
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HHS proposes to direct Marketplaces to annually display the quality rating information on their
websites beginning for the 2016 open enrollment period.
The publication activities for the ESS are already addressed in the Supporting Statement
associated with OCN #0938-1221. We do not intend to publish any data associated with the
monitoring and appeals process for survey vendors and for QHP patient safety reporting
standards.
17. Expiration Date
Not applicable. We plan to include an OMB expiration date and the OMB control number on
data collection instruments.
17. Certification Statement
There are no exceptions to the certification.

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