59618 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 25, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–23996 Filed 9–27–12; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4158–N] 

Medicare Program; Medicare Appeals; 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2013 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

annual adjustment in the amount in 

controversy (AIC) threshold amounts for 

Administrative Law Judge (ALJ) 

hearings and judicial review under the 

Medicare appeals process. The 

adjustment to the AIC threshold 

amounts will be effective for requests 

for ALJ hearings and judicial review 

filed on or after January 1, 2013. The 

calendar year 2013 AIC threshold 

amounts are $140 for ALJ hearings and 

$1,400 for judicial review. 

EFFECTIVE DATE: This notice is effective 

on January 1, 2013. 

FOR FURTHER INFORMATION CONTACT: Liz 

Hosna (Katherine.Hosna@cms.hhs.gov), 

(410) 786–4993. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1869(b)(1)(E) of the Social 

Security Act (the Act), as amended by 

section 521 of the Medicare, Medicaid, 

and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA), 

established the amount in controversy 

(AIC) threshold amounts for 

Administrative Law Judge (ALJ) hearing 

requests and judicial review at $100 and 

$1000, respectively, for Medicare Part A 

and Part B appeals. Section 940 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), amended section 

1869(b)(1)(E) of the Act to require the 

AIC threshold amounts for ALJ hearings 

and judicial review to be adjusted 

annually. The AIC threshold amounts 

are to be adjusted, as of January 2005, 

by the percentage increase in the 

medical care component of the 

consumer price index for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. Section 

940(b)(2) of the MMA provided 

conforming amendments to apply the 

AIC adjustment requirement to 

Medicare Part C/Medicare Advantage 

(MA) appeals and certain health 

maintenance organization and 

competitive health plan appeals. Health 

care prepayment plans are also subject 

to MA appeals rules, including the AIC 

adjustment requirement. Section 101 of 

the MMA provides for the application of 

the AIC adjustment requirement to 

Medicare Part D appeals. 

A. Medicare Part A and Part B Appeals 

The statutory formula for the annual 

adjustment to the AIC threshold 

amounts for ALJ hearings and judicial 

review of Medicare Part A and Part B 

appeals, set forth at section 

1869(b)(1)(E) of the Act, is included in 

the applicable implementing 

regulations, 42 CFR 405.1006(b) and (c). 

The regulations require the Secretary of 

the Department of Health and Human 

Services (the Secretary) to publish 

changes to the AIC threshold amounts 

in the Federal Register 

(§ 405.1006(b)(2)). In order to be entitled 

to a hearing before an ALJ, a party to a 

proceeding must meet the AIC 

requirements at § 405.1006(b). Similarly, 

a party must meet the AIC requirements 

at § 405.1006(c) at the time judicial 

review is requested for the court to have 

jurisdiction over the appeal 

(§ 405.1136(a)). 

B. Medicare Part C/Medicare Advantage 

Appeals 

Section 940(b)(2) of the MMA applies 

the AIC adjustment requirement to 

Medicare Part C (MA) appeals by 

amending section 1852(g)(5) of the Act. 

The implementing regulations for 

Medicare Part C (MA) appeals are found 

at 42 CFR part 422, subpart M. 

Specifically, § 422.600 and § 422.612 

discuss the AIC threshold amounts for 

ALJ hearings and judicial review. 

Section 422.600 grants any party to the 

reconsideration, except the MA 

organization, who is dissatisfied with 

the reconsideration determination, a 

right to an ALJ hearing as long as the 

amount remaining in controversy after 

reconsideration meets the threshold 

requirement established annually by the 

Secretary. Section 422.612 states, in 

part, that any party, including the MA 

organization, may request judicial 

review if the AIC meets the threshold 

requirement established annually by the 

Secretary. 

C. Health Maintenance Organizations, 

Competitive Medical Plans, and Health 

Care Prepayment Plans 

Section 1876(c)(5)(B) of the Act states 

that the annual adjustment to the AIC 

dollar amounts set forth in section 

1869(b)(1)(E) of the Act applies to 

certain beneficiary appeals within the 

context of health maintenance 

organizations and competitive medical 

plans. The applicable implementing 

regulations for Medicare Part C appeals 

are set forth in 42 CFR part 422, subpart 

M, and as discussed previously, apply 

to these appeals. The Medicare Part C 

appeals rules also apply to health care 

prepayment plan appeals. 

D. Medicare Part D (Prescription Drug 

Plan) Appeals 

The annually adjusted AIC threshold 

amounts for ALJ hearings and judicial 

review that apply to Medicare Parts A, 

B, and C appeals also apply to Medicare 

Part D appeals. Section 101 of the MMA 

added section 1860D–4(h)(1) of the Act 

regarding Part D appeals. This statutory 

provision requires a prescription drug 

plan sponsor to meet the requirements 

set forth in sections 1852(g)(4) and (g)(5) 

of the Act, in a similar manner as MA 

organizations. As noted previously, the 

annually adjusted AIC threshold 

requirement was added to section 

1852(g)(5) of the Act by section 

940(b)(2)(A) of the MMA. The 

implementing regulations for Medicare 

Part D appeals can be found at 42 CFR 

part 423, subparts M and U. The 

regulations at § 423.562(c) prescribe 

that, unless the Part D appeals rules 

provide otherwise, the Part C appeals 

rules (including the annually adjusted 

AIC threshold amount) apply to Part D 

appeals to the extent they are 

appropriate. More specifically, 

§ 423.1970 and § 423.1976 of the Part D 

appeals rules discuss the AIC threshold 

amounts for ALJ hearings and judicial 

review. Section 423.1970(a) grants a Part 

D enrollee, who is dissatisfied with the 

independent review entity (IRE) 

reconsideration determination, a right to 

an ALJ hearing if the amount remaining 

in controversy after the IRE 

reconsideration meets the threshold 

amount established annually by the 

Secretary. Sections 423.1976(a) and (b) 

allow a Part D enrollee to request 

judicial review of an ALJ or MAC 

decision if, in part, the AIC meets the 

threshold amount established annually 

by the Secretary. 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices 59619 

II. Annual AIC Adjustments 

A. AIC Adjustment Formula and AIC 

Adjustments 

As previously noted, section 940 of 

the MMA requires that the AIC 

threshold amounts be adjusted 

annually, beginning in January 2005, by 

the percentage increase in the medical 

care component of the consumer price 

index (CPI) for all urban consumers 

(U.S. city average) for July 2003 to July 

of the year preceding the year involved 

and rounded to the nearest multiple of 

$10. 

B. Calendar Year 2013 

The AIC threshold amount for ALJ 

hearing requests will increase to $140 

and the AIC threshold amount for 

judicial review will rise to $1,400 for CY 

2013. These updated amounts are based 

on the 40.04 percent increase in the 

medical care component of the CPI from 

July 2003 to July 2012. The CPI level 

was at 297.600 in July 2003 and rose to 

416.759 in July 2012. This change 

accounted for the 40.04 percent 

increase. The AIC threshold amount for 

ALJ hearing requests changes to $140.04 

based on the 40.04 percent increase. In 

accordance with section 940 of the 

MMA, this amount is rounded to the 

nearest multiple of $10. Therefore, the 

CY 2013 AIC threshold amount for ALJ 

hearings is $140. The AIC threshold 

amount for judicial review changes to 

$1,400.40 based on the 40.04 percent 

increase. This amount was rounded to 

the nearest multiple of $10, resulting in 

the CY 2013 AIC threshold amount of 

$1,400 for judicial review. 

C. Summary Table of Adjustments in 

the AIC Threshold Amounts 

In the following table we list the CYs 

2009 through 2013 threshold amounts. 

CY 2009 CY 2010 CY 2011 CY 2012 CY 2013 

ALJ Hearing ......................................................................... $120 $130 $130 $130 $140 

Judicial Review .................................................................... 1,220 1,260 1,300 1,350 1,400 

III. 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 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 12, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–23992 Filed 9–27–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0961] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Environmental 

Impact Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection entitled 

‘‘Environmental Impact 

Considerations.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 27, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, daniel.gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Environmental Impact 

Considerations—21 CFR Part 25 (OMB 

Control Number 0910–0322)— 

Extension) 

FDA is requesting OMB approval for 

the reporting requirements contained in 

the FDA collection of information 

‘‘Environmental Impact 

Considerations.’’ 

The National Environmental Policy 

Act (NEPA) (42 U.S.C. 4321–4347) states 

national environmental objectives and 

imposes upon each Federal Agency the 

duty to consider the environmental 

effects of its actions. Section 102(2)(c) of 


srobinson on DSK4SPTVN1PROD with NOTICES