Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices 44369 

and merely reflect accepted standards of 

management and care to which rural 

health clinics must adhere. Form 

Number: CMS–R–38 (OMB#: 0938– 

0334); Frequency: Recordkeeping and 

Reporting—Annually and upon initial 

application for Medicare approval; 

Affected Public: Business or other forprofits; Number of Respondents: 3,937; 

Total Annual Responses: 3,937; Total 

Annual Hours: 18,932. (For policy 

questions regarding this collection 

contact Mary Collins at 410–786–3189. 

For all other issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Durable Medical 

Equipment Medicare Administrative 

Contractors (MAC), Certificates of 

Medical Necessity; Use: The certificate 

of medical necessity (CMN) collects 

information required to help determine 

the medical necessity of certain items. 

CMS requires CMNs where there may be 

a vulnerability to the Medicare program. 

Each initial claim for these items must 

have an associated CMN for the 

beneficiary. Suppliers (those who bill 

for the items) complete the 

administrative information (e.g., 

patient’s name and address, items 

ordered, etc.) on each CMN. The 1994 

Amendments to the Social Security Act 

require that the supplier also provide a 

narrative description of the items 

ordered and all related accessories, their 

charge for each of these items, and the 

Medicare fee schedule allowance (where 

applicable). The supplier then sends the 

CMN to the treating physician or other 

clinicians (e.g., physician assistant, 

LPN, etc.) who completes questions 

pertaining to the beneficiary’s medical 

condition and signs the CMN. The 

physician or other clinician returns the 

CMN to the supplier who has the option 

to maintain a copy and then submits the 

CMN (paper or electronic) to CMS, 

along with a claim for reimbursement. 

Due to a technical oversight on the 

part of CMS, an important question on 

CMN Form 10269 was omitted from the 

last OMB submission that would allow 

claims with an apnea-hypopnea index 

(AHI) or respiratory disturbance index 

(RDI) greater than or equal to 5 without 

symptoms for Criterion 2 be paid for by 

the Medicare program. The omission of 

the following question ‘‘Does the patient 

have documented evidence of at least 

one of the following: Excessive daytime 

sleepiness, impaired cognition, mood 

disorders, insomnia, hypertension, 

ischemic heart disease or history of 

stroke’’ could cause improper payment 

of claims without regards as to whether 

the patient has signs or symptoms in 

support of meeting the applicable 

coverage criteria for PAP devices. We 

are resubmitting this information 

collection request to have the revised 

CMN Form 10269 approved. None of the 

other CMN forms have changed. Form 

Number: CMS–846–849, 854, 10125, 

10126, 10269 (OMB# 0938–0679); 

Frequency: Occasionally; Affected 

Public: Business or other for-profit and 

Not-for-profit institutions; Number of 

Respondents: 59,200; Total Annual 

Responses: 6,480,000; Total Annual 

Hours: 1,296,000. (For policy questions 

regarding this collection contact Doris 

Jackson at 410–786–4459. 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 September 28, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, e-mail: 

OIRA_submission@omb.eop.gov. 

Dated: August 21, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–20839 Filed 8–27–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Availability of Draft Policy 

Document for Comment 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: This Policy Information Notice 

(PIN) describes the documentation that 

will be considered by the Health 

Resources and Services Administration 

(HRSA) to establish whether an 

organization can qualify as a ‘‘public 

agency’’ (also referred to in previous 

PINs as ‘‘public entities’’ or ‘‘public 

applicants’’) for the purpose of 

determining eligibility for a Health 

Center Program grant under Section 330 

of the Public Health Service (PHS) Act 

(‘‘Section 330’’) and/or Federally 

Qualified Health Center (FQHC) LookAlike designation. This draft PIN is 

available on the Internet at http:// 

bphc.hrsa.gov/draftsforcomment/ 

publiccenter. 

DATES: Comments must be received by 

October 13, 2009. 

ADDRESSES: Comments should be 

submitted to OPPDGeneral@hrsa.gov by 

close of business October 13, 2009. 

SUMMARY: HRSA believes that 

community input is valuable to the 

development of policies and policy 

documents related to the 

implementation of HRSA programs, 

including the Health Center Program. 

Therefore, we are requesting comments 

on the PIN referenced above. Comments 

will be reviewed and analyzed, and a 

summary and general response will be 

published as soon as possible after the 

deadline for receipt of comments. 

Background: HRSA administers the 

Health Center Program, which supports 

more than 1,100 organizations operating 

more than 7,500 health care delivery 

sites, including community health 

centers, migrant health centers, health 

care for the homeless centers, and 

public housing primary care centers. 

Health centers serve medically 

underserved communities delivering 

preventive and primary care services to 

patients regardless of their ability to 

pay. The Health Center Program’s 

authorizing statute and implementing 

regulations (Section 330 of the PHS Act 

and 42 CFR Part 51c) state that any 

public or non-profit private entity is 

eligible to apply for a grant under the 

Health Center Program. The term 

‘‘public agency’’ is not explicitly 

defined in Section 330 or in the Health 

Center Program’s regulations; however, 

reference is made in Section 330 to 

these types of organizations within the 

definition of a public center as ‘‘a health 

center funded (or to be funded) through 

a grant under this section to a public 

agency’’ (Section 330(k)(3)(M) of the 

PHS Act). HRSA is issuing this PIN to 

describe the documentation that will be 

considered to establish whether an 

organization can qualify as a ‘‘public 

agency’’ (also referred to in previous 

PINs as ‘‘public entities’’ or ‘‘public 

applicants’’) for purposes of 

determining eligibility for a Health 

Center Program grant under Section 330 

of the PHS Act and/or FQHC Look-Alike 

designation. 

FOR FURTHER INFORMATION CONTACT: For 

questions regarding this notice, please 

contact the Office of Policy and Program 


hsrobinson on DSK69SOYB1PROD with NOTICES
44370 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices 

Development, Bureau of Primary Health 

Care, HRSA, at 301–594–4300. 

Dated: August 24, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–20818 Filed 8–27–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2299–FN] 

Medicare and Medicaid Programs; 

Application of the American 

Osteopathic Association for Continued 

Deeming Authority for Hospitals 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve the American 

Osteopathic Association (AOA) for 

continued recognition as a national 

accreditation program for hospitals 

seeking to participate in the Medicare or 

Medicaid programs. 

DATES: Effective Date: This final notice 

is effective September 25, 2009 through 

September 25, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a hospital provided 

certain requirements are met. The 

regulations specifying the Medicare 

conditions of participation (CoPs) for 

hospitals are located at 42 CFR part 482. 

These conditions implement section 

1861(e) of the Social Security Act (the 

Act), which specifies services covered 

as hospital care and the conditions that 

a hospital program must meet in order 

to participate in the Medicare program. 

Regulations concerning provider 

agreements are located at 42 CFR part 

489 and those pertaining to activities 

relating to the survey and certification 

of facilities are located at 42 CFR part 

488. 

Generally, in order to enter into a 

provider agreement, a hospital must first 

be certified by a State survey agency as 

complying with the conditions or 

requirements set forth in the statute and 

part 482 of the regulations. Then, the 

hospital is subject to routine State 

agency surveys to determine whether it 

continues to meet the Medicare 

requirements. There is an alternative, 

however, to State compliance surveys. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization that 

all applicable Medicare conditions are 

met or exceeded, we may ‘‘deem’’ those 

provider entities as having met the 

requirements. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, a 

provider entity accredited by the 

national accreditation organization 

approved program would be deemed to 

meet the Medicare conditions. 

Accreditation by an accreditation 

organization is voluntary and is not 

required for Medicare participation. 

A national accreditation organization 

applying for deeming authority under 

part 488, subpart A must provide us 

with reasonable assurance that the 

accreditation organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the 

reapproval of accreditation 

organizations are set forth at § 488.4 and 

§ 488.8(d)(3). The regulations at 

§ 488.8(d)(3) require accreditation 

organizations to reapply for continued 

deeming authority every 6 years or 

sooner as determined by CMS. 

AOA’s term of approval as a 

recognized accreditation program for 

hospitals expires September 25, 2009. 

II. Deeming Applications Approval 

Process 

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

provides a statutory timetable to ensure 

that our review of deeming applications 

is conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of a complete 

application, with any documentation 

necessary to make a determination, to 

complete our survey activities and 

application review. Within 60 days of 

receiving a complete application, we 

must publish a notice in the Federal 

Register that identifies the national 

accreditation organization making the 

request, describes the request, and 

provides no less that a 30-day public 

comment period. At the end of the 210- 

day period, we must publish an 

approval or denial of the application. 

III. Provisions of the Proposed Notice 

and Response to Comments 

On April 24, 2009, we published a 

proposed notice in the Federal Register 

(74 FR 18728) announcing AOA’s 

request for reapproval as a deeming 

organization for hospitals. In this notice, 

we detailed the evaluation criteria. 

Under section 1865(a)(2) of the Act and 

our regulations at § 488.4, we conducted 

a review of the AOA’s application in 

accordance with the criteria specified by 

our regulations, which include, but are 

not limited to the following factors: 

• An onsite administrative review of 

AOA’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 decisionmaking process for accreditation. 

• A comparison of AOA’s hospital 

accreditation standards to our current 

Medicare hospital CoPs. 

• A documentation review of AOA’s 

survey processes to: 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and AOA’s ability to provide continuing 

surveyor training. 

+ Compare AOA’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’s procedures for 

monitoring providers or suppliers found 

to be out of compliance with AOA 

program requirements. The monitoring 

procedures are used only when AOA 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

+ Assess AOA’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

+ Establish AOA’s ability to provide 

us with electronic data and reports 

necessary for effective validation and 

assessment of AOA’s survey process. 

+ Determine the adequacy of staff and 

other resources. 

+ Review AOA’s ability to provide 

adequate funding for performing 

required surveys. 

+ Confirm AOA’s policies with 

respect to whether surveys are 

announced or unannounced. 

+ Obtain AOA’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. 

In accordance with section 

1865(a)(3)(A) of the Act, the April 24, 

2009 proposed notice also solicited 

public comments regarding whether 


hsrobinson on DSK69SOYB1PROD with NOTICES