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OMB Control No: 0938-0941	ICR Reference No: 200809-0938-015
Status: Historical Active	Previous ICR Reference No: 200511-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool ("PAT")
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/08/2009
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/26/2008
Terms of Clearance: This ICR is approved consistent with CMS memos of 11/10/08 and 12/30/08 and revised supporting statement. Accordingly, CMS 1) agrees to acknowledge all study limitations when discussing study results; 2) recognizes that the results of these demonstrations will not be generalizable to the general population or the Medicare provider/beneficiary population and that further study is needed before pay-for-performance programs are implemented on a wider scale and will therefore not generalize the results beyond the study sites as such; and 3) acknowledges that these demonstrations were not designed to evaluate changes in quality as a function of varying incentive amounts. Further, CMS acknowledges that pay-for-performance programs can lead to unintended consequences (e.g. cream-skimming, exacerbation of health disparities, coding creep, cost-shifting, impeded knowledge transfer among providers, etc.), particularly in the absence of rigorous risk-adjustment methodologies. While CMS intends to evaluate the degree to which these pay-for-performance demonstration programs may have resulted in any unintended consequences, CMS acknowledges that the design of these demonstration programs may not allow for a robust evaluation of these unintended consequences. For all these reasons, caution should be exercised--and further studies conducted--before rolling these programs out on a wider scale. Future rounds should address these limitations to the maximum extent possible. Finally, CMS shall discontinue 0938-0942 as those burdens are being rolled into this ICR. Previous terms of clearance remain in effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2012	36 Months From Approved	01/31/2009
Responses	1,060	0	800
Time Burden (Hours)	25,990	0	19,200
Cost Burden (Dollars)	0	0	0

Abstract: The Performance Assessment Tool ("PAT) is being used in 3 CMS pay for performance demonstrations to collect clinical quality measure information. It is not an electronic health record but rather a tool for collecting 'numerator' and 'denominator' information that is used to calculate performance measures on specific clinical quality measures. The tool is currently approved for use in the Physician Group Practice (PGP) Demonstration and the Medicare Care Management Performance Demonstration (MCMP). These are both Congressionally mandated demonstrations and will continue data collection past the current expiration date and through FY 2011. In 2008, CMS will implement the Electronic Health Records (EHR) demonstration, a high Secretarial and Administration priority, to encourage the adoption of electronic health records in small to medium sized primary care practices. This demonstration does not involve the development by CMS of an electronic health record, but will require physician offices to implement them over a specific period of time. This demonstration will include the collection of the same clinical quality measures using the same PAT data collection tool and methodology as the MCMP demonstration. The first year clinical data collection for this demonstration will begin in the fall of 2011, and, therefore, should be covered under this PRA approval.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,060	800	400	-140
Annual Time Burden (Hours)	25,990	19,200	9,600	-2,810
Annual Cost Burden (Dollars)	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We are combining two previously approved forms (for the PGP and MCMP Demonstration) into one submission as the data collection tools used for both are substantially the same. A revised estimate of the burden is provided. The difference in the total burden of effort is due to a combination of factors. On a per submission basis, the burden for the PGP demonstration is greater than the MCMP Demonstration due to the larger size of practices and the greater number of patients for whom data is collected per respondent. However, the number of respondents for the MCMP Demonstration has been reduced from a projected 800 (prior to recruitment of practices) to an actual of 650, thus contributing to a reduction in the burden estimate. Also, starting in 2011, we are adding a third demonstration, the EHR Demonstration. This demonstration, which is being conducted under CMS's statutory demonstration authority, has been approved by OMB and is a Administration and Secretarial priority. The goal of this demonstration is to encourage the adoption of electronic health records as a tool to improve the quality and efficiency of care provided to Medicare beneficiaries. As part of this effort, demonstration practices who volunteer to participate will use this data collection tool to submit the same clinical quality measures as the MCMP Demonstration. Finally, we have increased the hourly average cost (salary + fringe) to submit the data due to the general increase in salaries over time. More detail on the estimate of burden is provided in the Supporting Statement.

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