[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Rules and Regulations]
[Pages 1366-1367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-164]



[[Page 1366]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 410

[CMS-1503-F2]
RIN 0938-AP79


Medicare Program; Amendment to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2011

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This amendment rescinds the addition and definition of 
voluntary advance care planning as a specified element of the annual 
wellness visit that was finalized in the ``Medicare Program; Payment 
Policies Under the Physician Fee Schedule and Other Revisions to Part B 
for CY 2011'' that appeared in the November 29, 2010 Federal Register.

DATES: Effective Date: This amendment is effective on January 10, 2011.

FOR FURTHER INFORMATION CONTACT: Dennis Wagoner, (410) 786-6841.

SUPPLEMENTARY INFORMATION:

I. Background

    The final rule with comment period entitled ``Medicare Program; 
Payment Policies Under the Physician Fee Schedule and Other Revisions 
to Part B for CY 2011'' appeared in the November 29, 2010 Federal 
Register (75 FR 73170). The November 29, 2010 final rule with comment 
period included the agency's responses to comments made by the public 
in response to its Notice of Proposed Rulemaking (NPRM) published on 
July 13, 2010. In that NPRM, CMS sought to define the new annual 
wellness visit providing personalized prevention plan services as 
provided by the Patient Protection and Affordable Care Act (the 
Affordable Care Act or the Act). CMS proposed that the specified 
elements of the ``first annual wellness visit'' and the ``subsequent 
annual wellness visit'' be only those identified in the Act. In 
response, a number of commenters urged CMS to include voluntary advance 
care planning as an additional specified element of the annual wellness 
visit in the final rule. As described more fully below, we are 
rescinding this part of the final rule.

II. Provisions of the Amendment

    In the July 13, 2010 Federal Register (75 FR 40039), we published 
the proposed rule entitled ``Medicare Program; Payment Policies Under 
the Physician Fee Schedule and Other Revisions to Part B for CY 2011.'' 
In response to this publication, we received comments from health care 
providers, and others urging us to add voluntary advance care planning 
as a specified element of the definitions of both the ``first annual 
wellness visit'' and the ``subsequent annual wellness visit.'' The 
commenters stated that their recommendations were based upon a number 
of recent research studies, and the inclusion by the Medicare initial 
preventive physical examination (IPPE) provisions of a similar element 
in the existing IPPE benefit.
    CMS agreed with the commenters that voluntary advance care planning 
should be added as a specified element in the definitions of both the 
``first annual wellness visit'' and the ``subsequent annual wellness 
visit'' based on the evidence provided and the inclusion of a similar 
element in the IPPE benefit (also referred to as the Welcome to 
Medicare exam) since January 1, 2009, and incorporated it into the 
final rule.
    It has since become apparent that we did not have an opportunity to 
consider prior to the issuance of the final rule the wide range of 
views on this subject held by a broad range of stakeholders (including 
members of Congress and those who were involved with this provision 
during the debate on the Affordable Care Act). Therefore, we are 
rescinding the provision of the final rule that includes voluntary 
advance care planning as a specified element of the annual wellness 
visits providing personalized prevention plan services, and returning 
to the policy that was proposed, which was limited to the elements 
specified in the Act. We are revising our regulation at Sec.  410.15(a) 
to remove voluntary advance care planning as a specified element from 
the definitions of ``first annual wellness visit providing personalized 
prevention plan services'' and ``subsequent annual wellness visit 
providing personalized prevention plan services'' and to remove the 
definition of ``voluntary advance care planning.''

III. Waiver of Proposed Rulemaking and Delay in Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule before 
the provisions of the rule take effect in accordance with section 
553(b) of the Administrative Procedure Act (5 U.S.C. 553(b)). The 
Physician Fee Schedule notice of proposed rulemaking includes a 
reference to the legal authority under which the rule is proposed, and 
the terms and substance of the proposed rule or a description of the 
subjects and issues involved. This notice and comment procedure can be 
waived, however, if an agency finds good cause that the procedure is 
impracticable, unnecessary, or contrary to the public interest, and 
incorporates a statement of the finding and its reasons for it in the 
rule. Section 553(d) of the APA ordinarily requires a 30-day delay in 
the effective date of final rules after the date of their publication. 
This 30-day delay in effective date can be waived, however, if an 
agency finds for good cause that the delay is impracticable, 
unnecessary, or contrary to the public interest, and the agency 
incorporates a statement of the findings and its reasons in the rule 
issued.
    As noted earlier, a number of commenters suggested in response to 
the NPRM that we should include voluntary advance care planning as an 
additional specified element of the new annual wellness visit. While we 
believe that we acted within our authority in including voluntary 
advance care planning as an additional specified element of the new 
annual wellness visit in the final rule, it has become apparent that we 
did not have an opportunity to consider prior to the issuance of the 
final rule the wide range of views on this subject held by a broad 
range of stakeholders (including members of Congress and those who were 
involved with this provision during the debate on the Affordable Care 
Act). Because we believe it is in the public interest to specify 
contemporaneous with the January 1, 2011 effective date the scope of 
the new ``annual wellness visit for personalized prevention plan 
services'' benefit, we believe it would be contrary to the public 
interest to provide for a 30-day delay in effective date. Therefore, we 
find good cause, based on the public interest, both to waive the notice 
of proposed rulemaking and the 30-day delay in effective date, and to 
issue this amendment effective January 1, 2011.

IV. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

V. Regulatory Impact Statement

    We have examined the impact of this amendment as required by 
Executive Order 12866 on Regulatory Planning

[[Page 1367]]

and Review (September 30, 1993), the Regulatory Flexibility Act (RFA) 
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social 
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism 
(August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This 
amendment does not reach the economic threshold and thus is not 
considered a major rule.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
$7.0 million to $34.5 million in any 1 year. Individuals and States are 
not included in the definition of a small entity. We are not preparing 
an analysis for the RFA because we have determined, and the Secretary 
certifies, that this amendment will not have a significant economic 
impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 for final rules 
of the RFA. For purposes of section 1102(b) of the Act, we define a 
small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area for Medicare payment regulations and has 
fewer than 100 beds. We are not preparing an analysis for section 
1102(b) of the Act because we have determined, and the Secretary 
certifies, that this amendment will not have a significant impact on 
the operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2010, that 
threshold is approximately $135 million. This amendment will have no 
consequential effect on State, local, or Tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Because this amendment does not impose any costs on State 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    In accordance with the provisions of Executive Order 12866, this 
amendment was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.
    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR part 410 as set forth below:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
1. The authority citation for part 410 continues to read as follows:

    Authority:  Secs. 1102, 1834, 1871, and 1893 of the Social 
Security Act (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd).

Subpart B--Medical and Other Health Services


Sec.  410.15  [Amended]

0
2. Section 410.15 is amended as follows:
0
A. In paragraph (a), in the definition of ``First annual wellness visit 
providing personalized prevention plan services'' removing paragraph 
(ix) and redesignating paragraph (x) as paragraph (ix).
0
B. In paragraph (a), in the definition of ``Subsequent annual wellness 
visit providing personalized prevention plan services'' removing 
paragraph (vii) and redesignating paragraph (viii) as paragraph (vii).
0
C. In paragraph (a), removing the definition of ``voluntary advance 
care planning''.

CMS-1503-F2.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: January 3, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: January 4, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-164 Filed 1-5-11; 4:15 pm]
BILLING CODE 4120-01-P