59616 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10161] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection. 

Title of Information Collection: New 

Freedom Initiative—Web-based 

Reporting System for Grantees. Use: 

CMS awards competitive grants to states 

and other eligible entities for the 

purpose of designing and implementing 

effective and enduring improvements in 

community-based long-term services 

and support systems. CMS requires that 

grantees report on a quarterly, semiannual, and/or annual basis depending 

upon the grant type. CMS requires the 

information obtained through webbased grantee reporting for two reasons: 

To effectively monitor the grants and to 

report to Congress and other interested 

stakeholders the progress and obstacles 

experienced by the grantees. The 

grantees are the respondents to the webbased reporting system. Form Number: 

CMS–10161 (OCN 0938–0979). 

Frequency: Annually, semi-annually, 

and quarterly. Affected Public: State, 

Local or Tribal Governments. Number of 

Respondents: 171. Total Annual 

Responses: 428. Total Annual Hours: 

3,764. (For policy questions regarding 

this collection contact Effie George at 

410–786–8639. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on October 29, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, 

Email: OIRA_submission@omb.eop.gov. 

Dated: September 25, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division-B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–23899 Filed 9–27–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3264–FN] 

Medicare and Medicaid Programs; 

Approval of the American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (AOA/HFAP) 

Application for Continuing CMSApproval of Its Ambulatory Surgical 

Center (ASC) Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the American 

Osteopathic Healthcare Facilities 

Accreditation Program (AOA/HFAP) for 

continued recognition as a national 

accrediting organization for ambulatory 

surgical centers (ASCs) that wish to 

participate in the Medicare and/or 

Medicaid programs. 

DATES: Effective Date: This final notice 

is effective October 23, 2013 through 

October 23, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Easterling (410) 786–0482. 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in an ASC provided certain 

health, safety, and other requirements 

are met. Section 1832(a)(2)(F)(i) of the 

Act permits the Secretary to establish 

distinct criteria for facilities seeking 

designation as an ASC. The regulations 

at 42 CFR part 416 specify the 

conditions that an ASC must meet in 

order to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for ASCs. Regulations 

pertaining to activities relating to the 

survey and certification of facilities are 

at 42 CFR part 488. 

Generally, in order to enter into an 

agreement, an ASC must first be 

certified by a State survey agency as 

complying with the conditions or 

requirements set forth in Part 416. 

Thereafter, the ASC is subject to regular 

surveys by a State survey agency to 

determine whether it continues to meet 

these requirements. There is an 

alternative, however, to surveys by State 

agencies. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. In accordance with the 

requirements at 416.26, an ASC may be 

deemed to meet conditions for coverage 

if it is accredited by a national 

accrediting body. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under Part 488 subpart A must provide 

us with reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of accrediting organizations are set forth 

at 488.4 and 488.8. The regulations at 

488.8(d)(3) require accrediting 

organizations to reapply for continued 

approval of its accreditation program 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices 59617 

every 6 years or sooner as determined 

by CMS. 

AOA/HFAP’s current term of 

approval for their ASC accreditation 

program expires October 23, 2012. 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On May 25, 2012, we published a 

proposed notice in the Federal Register 

(77 FR 31361) announcing AOA/HFAP’s 

request for continued approval of its 

ASC accreditation program. In the 

proposed notice, we detailed our 

evaluation criteria. Under section 

1865(a)(2) of the Act and in our 

regulations at 488.4 and 488.8, we 

conducted a review of AOA/HFAP’s 

application in accordance with the 

criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

AOA/HFAP’s—(1) corporate policies; 

(2) financial and human resources 

available to accomplish the proposed 

surveys; (3) procedures for training, 

monitoring, and evaluation of its 

surveyors; (4) ability to investigate and 

respond appropriately to complaints 

against accredited facilities; and (5) 

survey review and decision-making 

process for accreditation. 

• The comparison of AOA/HFAP’s 

accreditation to our current Medicare 

ASC conditions for coverage. 

• A documentation review of AOA/ 

HFAP’s survey process for the 

following: 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and AOA/HFAP’s ability to provide 

continuing surveyor training. 

+ Compare AOA/HFAP’s processes to 

those of State survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

+ Evaluate AOA/HFAP’s procedures 

for monitoring ASC’s found to be out of 

compliance with AOA/HFAP’s program 

requirements. The monitoring 

procedures are used only when AOA/ 

HFAP identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at 488.7(d). 

+ Assess AOA/HFAP’s ability to 

report deficiencies to the surveyed 

facilities and respond to the facility’s 

plan of correction in a timely manner. 

+ Establish AOA/HFAP’s ability to 

provide CMS with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

+ Determine the adequacy of staff and 

other resources. 

+ Confirm AOA/HFAP’s ability to 

provide adequate funding for 

performing required surveys. 

+ Confirm AOA/HFAP’s policies 

with respect to whether surveys are 

announced or unannounced. 

+ Obtain AOA/HFAP’s agreement to 

provide CMS 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. 

In accordance with Section 

1865(a)(3)(A) of the Act, the May 25, 

2012 proposed notice also solicited 

public comments regarding whether 

AOA/HFAP’s requirements met or 

exceeded the Medicare conditions for 

coverage for ASCs. We received one 

comment in response to our proposed 

notice. The commenter expressed 

support for AOA/HFAP’s ASC 

accreditation program. 

IV. Provisions of the Final Notice 

A. Differences Between AOA/HFAP’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared AOA/HFAP’s ASC 

requirements and survey process with 

the Medicare conditions for certification 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of AOA/HFAP’s 

ASC application, which were conducted 

as described in section III of this final 

notice, yielded the following: 

• To meet the requirements at 

416.44(b)(1), AOA/HFAP revised its 

standards to include thresholds for new 

and existing Life Safety Code (LSC) 

requirements. In addition, AOA/HFAP 

revised its standards to ensure all 

waivers for LSC deficiencies are 

reviewed and approved by the CMS 

Regional Office. 

• To meet the requirement at 

416.44(b)(4), AOA/HFAP revised its 

standards to ensure all ASCs are in 

compliance with the emergency lighting 

requirements. 

• To meet the requirement at 416.50, 

AOA/HFAP revised its crosswalk to 

include the patient rights condition for 

coverage requirements. 

• To meet the requirements at 488.4, 

AOA/HFAP revised its policies to 

ensure the survey process requirements 

for ASCs is accurate, clear and 

complete. 

• To meet the requirements at 488.8, 

AOA/HFAP modified its policies and 

procedures to ensure all complaints are 

appropriately triaged, and investigated. 

• To meet the requirements at section 

2728 of the SOM, AOA/HFAP modified 

its policies to ensure all accepted plans 

of correction include the citation cited, 

the procedure implementing the plan, 

and the monitoring procedure. 

• To meet the requirements of 2728B, 

AOA/HFAP revised its policies to 

ensure all plans of correction contain 

the procedure for implementing the 

plan and the monitoring procedure to 

ensure cited deficiencies remain 

corrected and in compliance with the 

regulatory requirements. 

• AOA/HFAP also made extensive 

organization-wide changes to their 

internal processes in response to an 18 

month accreditation program review 

that was concluded in July 2012. AOA/ 

HFAP demonstrated compliance with 

our requirements across their 

organization and accreditation 

programs. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that AOA/ 

HFAP’s requirements for ASCs meet or 

exceed our requirements. Therefore, we 

approve AOA/HFAP as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective October 23, 2013 

through October 23, 2017. 

V. 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—ASC 

Insurance Program; and No. 93.774, 


srobinson on DSK4SPTVN1PROD with NOTICES
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