CMS-10431 Supporting Statement Part A

Supporting Statement – Part A
New Procedural Requirements beginning with FY2015 PPS-Exempt Cancer Hospital
Quality Reporting Program (PCHQR Program) and Modification to OMB Approved
Forms
A. Background
Pursuant to section 1886(d)(1)(B)(v) of the Act as amended by section 3005 of the Affordable
Care Act , starting in FY2014, and for subsequent fiscal years, PPS-exempt cancer hospitals
(PCHs) shall submit pre-defined quality measures to CMS. We are expanding the PPS-exempt
Cancer Hospital Quality Reporting Program (PCHQR) as part of our sustained efforts to
improving the quality of care for inpatient cancer patients. It is our aim to facilitate high quality
of care in a manner that is effective and meaningful, while remaining mindful of the reporting
burden this poses on the PCHs. Therefore, CMS intends to reduce duplicative reporting efforts
whenever possible by leveraging existing infrastructure.
For the FY2014 program year, we adopted five (5) NQF-endorsed quality measures developed
by the Center for Disease Control (CDC) and American College of Surgeons’/Commission on
Cancer (ACoS/CoC).
Measure Steward

ACoS/CoC

CDC

Quality Measures
Adjuvant chemotherapy for Stage III colon
cancer (NQF #0223)
Combination chemotherapy for AJCC T1c or
Stage II or III hormone receptor-negative
breast cancer (NQF #0559)
Hormone therapy for AJCC T1c or Stage II or
III hormone receptor-positive breast cancer
(NQF #0220)
National Healthcare Safety Network (NHSN)
Central Line-Associated Bloodstream Infection
(CLABSI) Outcome Measure (NQF #0139)
National Healthcare Safety Network (NHSN)
Catheter-Associated Urinary Tract Infection
(CAUTI) Outcome Measure (NQF #0138)

Although prior to the inception of this program, PCHs have not reported on quality measures to
CMS, they have some familiarity with and experience in reporting of quality data. More
specifically, out of the 11 existing PCHs, 10 are currently reporting the proposed measures to the
ACoS/CoC. The fact that the majority of the PCHs have demonstrated the ability to report the
measures indicates the proposed regulation does not significantly impact PCHs.
CMS is proposing to implement some procedural requirements to meet the statutory mandate by
aligning with current quality reporting programs. These procedural requirements would involve
submission of forms to comply with the PCHQR Program requirement and align with current
CMS reporting requirements for other quality programs (i.e., Hospital Inpatient Quality
Reporting, Hospital Outpatient Quality Reporting, and Hospital Value-Based Purchasing).
Last year, OMB approved the NOP, DACA, Withdrawal, Decline to Participate, and HAI
Exception forms (OMB Control Number: 0938-1175). This year, we would like to modify three
forms (NOP, DACA, and HAI Exception).

1) We have added information about the submitter and information on where to submit the
forms to the NOP and DACA forms.
2) Additionally, we have revised the HAI exception form by deleting CLABSI and CAUTI
exceptions and added other measures (e.g., NQF 0753 SSI measure).
In our effort to streamline records and leverage the Electronic Health Records (EHR) program,
we have developed three online applications (NOP, DACA, and Extraordinary Circumstances
Waiver). We have experienced in the past with other quality reporting program that under some
unforeseen circumstances (natural disaster), hospital providers have been unable to gain access
to the internet. In the event that this happens, we have developed some paper-based forms (NOP,
DACA, and Extraordinary Circumstances Waiver) for the hospital providers to submit their
information as required by the PCHQR Program.
Additionally, we would like to request clearance for the following additional forms: the Waiver
(extraordinary circumstances) and SCIP and Oncology Care measures data collection. We have
included both screenshots of the web-based tool and paper forms for these measures. The paper
submission forms acts as a contingency plan if access to the internet is unavailable and hospital
providers will not be unduly penalize for late submission.
For the FY 2015/FY 2016 PCHQR Program, we will continue to collect the current five measures
that were used in reporting FY 2014 data (listed in the table above). We also intend to collect 14
additional NQF-endorsed measures. We have listed the proposed measures applicable beginning
with FY2015 and FY2016 in the tables below. More information will be available following
publication of the final rule.
Measure Domain
Patient Safety

Measure Domain

Surgical Care
Improvement
Project (SCIP)

Proposed Measures Beginning with FY 2015
NQF Endorsement Number
Measure Name
Harmonized Procedure Specific Surgical
0753
Site Infection (SSI) Outcome Measure
Proposed Measures Beginning with FY 2016
NQF Endorsement Number
Measure Name
Surgery Patients who Received
Appropriate VTE Prophylaxis within 24
0218
Hrs Prior to Surgery to 24 Hrs After
Surgery End Time
Surgery Patients on Beta Blocker Therapy
0284
Prior to Admission who received a Beta
Blocker during the Perioperative Period
Urinary Catheter Removed on PostOperative Day 1 or Post-Operative Day 2
0453
with Day Surgery Being Day Zero
Prophylactic Antibiotic Received Within 1
0527
Hr Prior to Surgical Incision
Prophylactic Antibiotic Selection for
0528
Surgical Patients

0529
0380
0382
Clinical
Process/Oncology
Care

0383
0384
0390
0389

Patient
Engagement/Patient
Experience of Care

0166

Prophylactic Antibiotic Discontinued
Within 24 Hrs After Surgery End Time
Multiple Myeloma-Treatment with
Bisphosphonates
Oncology-Radiation Dose Limits to
Normal Tissues
Oncology: Plan of Care for Pain
Oncology: Pain Intensity Quantified
Prostate Cancer-Adjuvant Hormonal
Therapy for High-Risk Patients
Prostate Cancer-Avoidance of Overuse
Measure-Bone Scan for Staging Low-Risk
Patients
HCAHPS Patient Experience of Care
Survey

In selecting the proposed quality measures, we strive to achieve several objectives. First, the
measures should relate to the National Quality Strategy aims of better care, healthy populations
and communities, and affordable care. Second, the measures should be tailored to the needs of
improved quality in the inpatient cancer setting; thus, the measures selected are most relevant to
PCHs. Finally, the measures should be minimally burdensome to the PCHs
B. Justification
1. Need and Legal Basis
Section 1886(d)(1)(B)(v) in accordance with paragraph (2) of the Act requires that, for FY2014
and each subsequent fiscal year, each PPS-exempt cancer hospital shall submit to the Secretary
data on quality measures as specified by the Secretary. Such data shall be submitted in a form
and manner, and at a time, specified by the Secretary.
In implementing the PPS-exempt Cancer Hospital Quality Reporting (PCHQR) Program, we
believe that the development of a quality reporting program that is successful in promoting the
delivery of high quality health care services in the PCH setting is of paramount importance.
Therefore, in our effort to provide services to the PCHs, we are proposing some procedural
requirements to ascertain that the PCHs that wish to participate in the Program accept the
conditions put forth to comply with our agency’s reporting (procedural) requirements.
As the statute provides in section 1886(d)(1)(B)(v) in accordance with paragraph (4), in
establishing the PCHQR Program, the Secretary is required to establish procedures for making
public the data/measure rates submitted by PPS-exempt cancer hospitals (PCHs) under the
PCHQR Program. In order for CMS to publish the measure rates, PCHs would need to pledge to
participate in the PCHQR program, meaning PCHs would need to submit the Notice of
Participation (NOP) form. By submitting the NOP, PCHs are pledging to participate in the
PCHQR Program and shall submit the required data pertaining to the PCHQR quality measures
and additionally, consent to publicly report their measure rates on the Hospital Compare Web
site. We are mindful and respectful that PCHs may choose not to participate or withdraw from

the Program. In our effort to maintain good stewardship, we are providing some means to
provide PCHs the opportunities to decline or withdraw from the Program.
As part of our procedural requirements, we are also requiring the PCHs to acknowledge and
attest to the data submitted. We seek to efficiently collect information on valid, reliable, and
relevant measures of quality and to share this information with the public, as provided under
section 1886(d)(1)(B)(v) as amended by section 3005 of the Affordable Care Act. PCHs will
have to submit the Data Accuracy and Completeness Acknowledgement (DACA) form. In
submitting this form, PCHs acknowledge that the data submitted are true, accurate, and
complete. Besides submitting the DACA, PCHs are given the opportunity to submit the
exception/waiver form for inadequate number of cases as defined by the measure steward (e.g.,
CDC or CMS). PCHs experiencing low case threshold to meet the inclusion criteria, as set forth
by the CDC on two (2) Health Acquired Infection (HAI) measures and one (1) Surgical Site
Infection (SSI) measure, may request for a waiver to be excluded from data submission.
2. Information Users
• PCHs: The main points of focus for PCHs are to examine their individual PCHspecific care domains and types of patients so they can compare present performance to
past performance and to national performance norms; to evaluate the effectiveness of
care provided to specific types of patients and, in the context of investigating processes
of care, to individual patients; to continuously monitor quality improvement outcomes
over time, and to objectively assess their own strengths and weaknesses in the clinical
services they provide; and to inform the respective PCH of the care-related areas,
activities, and/or behaviors that result in effective patient care, and alert them to needed
improvements. Such information is essential to PCHs in initiating quality improvement
strategies. They can also be used to improve PCHs’ financial planning and marketing
strategies.
• State Agencies/CMS: Agency profiles are used in the process to compare a PCH’s
results with its peer performance. The availability of peer performance enables state
agencies and CMS to identify opportunities for improvement in the PCH, and to
evaluate more effectively the PCH’s own quality assessment and performance
improvement program.
• Accrediting Bodies: National accrediting organizations such as the Joint Commission
(TJC) or state accreditation agencies may wish to use the information to target
potential or identified problems during the organization’s accreditation review of that
facility.
• Beneficiaries/Consumers: Since November 2003, the Hospital Inpatient Quality
Reporting (IQR) Program has been publicly reporting quality measures on the Hospital
Compare Web site available to consumers on www.Medicare.gov. The website
provides information for consumers and their families about the quality of care
provided by an individual hospital, allowing them to see how well patients of one
facility fare compared to other facilities and to the state and national average. The
website presents the quality measures in consumer-friendly language and provides a
tool to assist consumers in the selection of a hospital. Modeling after the Hospital IQR
Program, the PCHQR Program uses quality measures to assist consumers in making
informed decisions when choosing a cancer hospital; to monitor the care the cancer
hospital is providing; and to stimulate the cancer hospital to further improve quality to
identify the optimal practice.

3. Use of Information Technology
PCHs will be able to utilize electronic means to submit/transmit their forms and data via a CMS
provided secure web-based tool which will be available on the QualityNet website. PCH users
will be required to open an account to set up secure logins and then will be able to complete all
the necessary forms/applications as may be applicable to their circumstance (i.e. the NOP,
DACA, and Waivers). We have included copies of these forms with this package.
A Web-based Measure online tool will be used for data entry through the QualityNet website.
Data will be stored to support retrieving reports for hospitals to view their measure
rates/results. Hospitals will be sent a preview report via QualityNet Exchange prior to the data
release on the CMS website for public viewing.
4. Duplication of Efforts
The PCHQR Program does not impose duplicate data collection. It uses elements that are
currently collected by the CDC and the American College of Surgeons (ACoS) and integrating it
into our current CMS’s system. Currently, under the Hospital IQR program, hospitals (including
some PCHs) are already submitting the CLABSI, CAUTI, and SSI measures to CDC.
Additionally, some PCHs are already submitting cancer-specific measures and HCAHPS
measure to ACoS and CMS. In an effort to reduce burden and minimize duplicative efforts, CMS
is leveraging existing infrastructure through the CDC, ACoS’s, and our own CMS
infrastructures.
5. Small Business
Information collection requirements were designed to allow maximum flexibility specifically to
small PCH providers participating in the PCHQR program. This effort will assist small PCH
providers in gathering information for their own quality improvement efforts. For example, we
will be providing a help-desk hotline for troubleshooting purposes and 24/7 free information
available on the QualityNet Web site through a Questions and Answers (Q&A) function.
6. Less Frequent Collection
Unlike other existing quality reporting programs, this program is not linked to any payment
penalties if quality measures are not submitted. Therefore, we propose to collect data on
quarterly basis.
7. Special Circumstances
PCHs will have to abide with the reporting procedures set forth by the CDC and the CMS
contractor to collect ACoS quality measures.
8. Federal Register Notice/Outside Consultation
We are proposing to solicit comments on the procedural requirements through the proposed rule.
Additionally, we have been working closely with the reporting entities (CDC and CMS
contractor to collect ACoS) and the individual PCHs on details pertaining to the Program.

A 60-day Federal Register Notice will be included as part of the proposed regulation that is
expected to be displayed in April 2013.
9. Payment/Gift to Respondent
No other payments or gifts will be given to respondents for participation.
10. Confidentiality
We pledge confidentiality of patient-specific data as provided by the Privacy Act of 1974 (5
U.S.C. 552a).
11. Sensitive Questions
There are no sensitive questions.
12. Burden Estimate (Total Hours & Wages)
Until FY2014, PCHs have not reported quality data to CMS for the PCHQR Program. However,
they have reported quality measures to other entities such as state surveys and other certification
organizations or to CMS through other quality reporting programs (such as Hospital IQR).
Therefore, PCHs have some familiarity with and experience reporting quality data. In our
burden calculation, we have included the time used for chart abstraction and for training
personnel on collection of chart-abstracted data and for submitting the data through QualityNet.
Because PCHs have been submitting seven of the 19 measures to CMS, the amount of training
required to submit data should be reduced to training on the collection of data and submission
only for the proposed (14) new measures.
The burden estimates for data collection related to the proposed measures for the PCHQR
Program are calculated for the PCHs based on the following data:
• There are approximately 11 PCH facilities nationwide
• There is an average of approximately 63,468 1 cancer cases across all PCHs per
year
• The average PCH facility handles 5,770 cases per year
• The average time spent per each measure per patient chart abstraction is
approximately one half of an hour (based on 2007 GAO measure abstraction work
effort survey – GAO-07-320)
• The time spent for abstracting each measure is 30 minutes per case (including 25
minutes of clinical time and five minutes of administrative time submitting the
data)
• For 19 measures for time for abstracted is 9.5 hours per case
• This yields a total of 54,815 hours of abstraction and submission for each of the
11 facilities. The total burden hours for all 11 facilities are 602,965.
The PRA costs related to wages is based on the salary.com wage estimates for healthcare
workers that are known to engage in chart abstraction (e.g., $33 hour). This calculated for the
54,815 hours for chart abstraction and data is $1,808,895 annual cost for each facility. The
estimated burden for training personnel for data collection and submission for newly adopted
1

FY2011 CMS MedPAR

measures is 7 hours per facility. The cost for this training based on an hourly rate of $33 is $231
training costs for each PCH and $2,541 training costs for all PCHs annually. The highest total
burden estimates for all measure data collection and submission costs for all facilities is
$19,897,845 annually, the actual expense will be incrementally increased based on the program
year each measure is adopted. The total annual cost for all the facilities for training is $2,541 and
the all-inclusive total is $19,900,386 (See Table A).
Table A
Tasks
Chart Abstracted
Measure Data
Collection and
Submission
Training
Total

Hours per
PCH
54,815

Wage rate

Cost per PCH

$33

$1,808,895

7

$33

$231

Total cost for all
PCHs
$19,897,845

$2,541
$19,900,386

The NoP and the DACA forms are required to be filled out only once for each data submission
period. All others forms are optional. It is estimated that these forms should take less than five
minutes to complete thus the burden related to this activity is negligible.
13. Capital Costs (Maintenance of Capital Costs)
There are no capital costs being placed on PCHs.
14. Cost to Federal Government
The aggregated data for the PCHQR Program measures will be reported directly to QualityNet
Exchange website utilizing existing system functionality and support. There will be minimal
additional costs to modify existing infrastructure.
The labor cost for government employees to support this program is estimated below:.
•
•

current year 1.0 FTE (2080 hours) at GS-12 salary = $83,200
for subsequent years .254FTE (520 hours)at GS-12 salary = $20,800

15. Program or Burden Changes
The number of PCH cases is constantly changing. For the first program year data indicated
approximately 2,479 cases per hospital per year. For this estimate that number has increased to
5,770. The change in burden hours from the first program year went from 68,182 to 602,965
for this year due to the increase in the number of measures included in its data collection
requirements. Also, these calculations include measures for both FY2015 and FY2016.
The CMS program reduces the reporting burden for quality of care information collected by
allowing hospitals to abstract data directly into electronic systems in lieu of submitting paper
charts, or to utilize electronic data that they already report to other entities. The long-term vision
for the PCHQR program is to allow hospitals to submit data directly from their electronic health
records, which we anticipate will reduce burden substantially. The 2012 Electronic Reporting
Pilot (76 FR 74490) is an important step in the transition from paper to electronic reporting.

16. Publication/Tabulation Dates
CMS will not be employing any sampling techniques or statistical methods. CMS is not the
measure steward and does not have ownership of the measure specifications. However, PCHs
will have to comply with the measure specifications (including sampling and validation
techniques) set forth by measure stewards.
PCHs will submit their measures through a web-based measures tool on the QualityNet website.
After PCHs have previewed their data and agree to publicly report their measure rates, CMS will
publicly display the measure rates on the CMS Web site. The following is a tentative example of
a schedule of activities to reach these objectives, more information will be known following
adoption of public comments on program dates considered in the proposed rule.
04/13/2013
08/02/2013
10/01/2013
01/01/2014
01/01/2014
12/31/2014
7/1/2014
8/15/2014
8/15/2014
Not required for
FY2014
30 days
FY 2014

Proposed Rule Published
Final Rule Published
Measures Publicly Announced
Start of Reporting Period
Notice of Participation Begins
End of Reporting Period
Begin Data Submission
End Submission Deadline
Deadline to Submit Notice of Participation
Deadline to Complete Data Accuracy Completion Agreement (DACA)
Preview Period for Public Reporting
Public Posting on CMS.gov

17. Expiration Date
We request an exemption from displaying the expiration date because these tools will be used on
a continuous basis by hospitals reporting quality data.