1366 Federal Register / Vol. 76, No. 6 / Monday, January 10, 2011 / Rules and Regulations 

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 § 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 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 76, No. 6 / Monday, January 10, 2011 / Rules and Regulations 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 

■ 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 

§ 410.15 [Amended] 

■ 2. Section 410.15 is amended as 

follows: 

■ 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). 

■ 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). 

■ 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 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 580 

[Docket No. NHTSA–2010–0046; Notice 2] 

Petition for Approval of Alternate 

Odometer Disclosure Requirements 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), DOT. 

ACTION: Final Determination. 

SUMMARY: The State of Wisconsin has 

petitioned for approval of alternate 

requirements to certain requirements 

under Federal odometer law. NHTSA is 

issuing this final determination granting 

Wisconsin’s petition as it pertains to 

vehicle transfers. This determination 

does not include vehicles covered by a 

lease agreement. 

DATES: Effective Date: February 9, 2011. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or the street 

address listed above. Follow the online 

instructions for accessing the dockets. 

Anyone is able to search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review DOT’s 

complete Privacy Act Statement in the 

Federal Register published on April 11, 

2000 (65 FR 19477–78) or you may visit 

http://DocketInfo.dot.gov. 

FOR FURTHER INFORMATION CONTACT: 

David Case, Office of the Chief Counsel, 

National Highway Traffic Safety 

Administration, 1200 New Jersey 

Avenue, SE., Washington, DC 20590 

(Telephone: 202–366–2239) (Fax: 202– 

366–3820). 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Federal odometer law, which is 

largely based on the Motor Vehicle 


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