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
01/31/2012
36 Months From Approved
01/31/2009
1,060
0
800
25,990
0
19,200
0
0
0
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.
US Code:
42
USC 1395b-1 Name of Law: EHR Demonstration
PL:
Pub.L. 108 - 173 649 Name of Law: MCMP Demonstration - Medicare
Prescription Drug Improvement and Modernization Act of 2003
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.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.