59138 Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Notices 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of CHAP’s 

request for continued deeming authority 

for HHAs. This notice also solicits 

public comment on whether CHAP’s 

requirements meet or exceed the 

Medicare conditions for participation 

for HHAs. 

III. Evaluation of Deeming Authority 

Request 

CHAP submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

reapproval as a deeming organization 

for HHAs. This application was 

determined to be complete on August 

26, 2011. Under section 1865(a)(2) of the 

Act and our regulations at § 488.8 

(Federal review of accrediting 

organizations), our review and 

evaluation of CHAP will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of CHAP’S 

standards for HHA’s as compared with 

CMS’ HHA conditions of participation. 

• CHAP’s survey process to 

determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of CHAP’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ CHAP’s processes and procedures 

for monitoring HHAs found out of 

compliance with CHAP’s program 

requirements. These monitoring 

procedures are used only when CHAP 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

++ CHAP’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ CHAP’s capacity to provide us 

with electronic data, and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of CHAP’s staff and 

other resources, and its financial 

viability. 

++ CHAP’s capacity to adequately 

fund required surveys. 

++ CHAP’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ CHAP’s agreement to provide us 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require (including corrective 

action plans). 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this notice, and, we will respond to the 

comments in a subsequent document. 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(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: August 31, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–24547 Filed 9–22–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4152–N] 

Medicare Program; Medicare Appeals; 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2012 

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, 2012. The 

calendar year 2012 AIC threshold 

amounts are $130 for ALJ hearings and 

$1,350 for judicial review. 

DATES: Effective Date: This notice is 

effective on January 1, 2012. 

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 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Notices 59139 

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. Section 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. 

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 2012 

The AIC threshold amount for ALJ 

hearing requests will remain at $130 

and the AIC threshold amount for 

judicial review will rise to $1,350 for CY 

2012. These updated amounts are based 

on the 34.51 percent increase in the 

medical care component of the CPI from 

July 2003 to July 2011. The CPI level 

was at 297.600 in July 2003 and rose to 

400.305 in July 2011. This change 

accounted for the 34.51 percent 

increase. The AIC threshold amount for 

ALJ hearing requests changes to $134.51 

based on the 34.51 percent increase. In 

accordance with section 940 of the 

MMA, this amount is rounded to the 

nearest multiple of $10. Therefore, the 

2012 AIC threshold amount for ALJ 

hearings is $130. The AIC threshold 

amount for judicial review changes to 

$1,345.11 based on the 34.51 percent 

increase. This amount was rounded to 

the nearest multiple of $10, resulting in 

the 2012 AIC threshold amount of 

$1,350 for judicial review. 

C. Summary Table of Adjustments in 

the AIC Threshold Amounts 

In the following table we list the CYs 

2005 through 2012 threshold amounts. 

CY 2005 CY 2006 CY 2007 CY 2008 CY 2009 CY 2010 CY 2011 CY 2012 

ALJ Hearing ..................... $100 $110 $110 $120 $120 $130 $130 $130 

Judicial Review ................ 1,050 1,090 1,130 1,180 1,220 1,260 1,300 1,350 

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 8, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–24539 Filed 9–22–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0481] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Animal Drugs 

for Investigational Uses 

AGENCY: Food and Drug Administration, 

HHS. 


sroberts on DSK5SPTVN1PROD with NOTICES