36518 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

Health Insurance Portability and 

Accountability Act (HIPAA) prohibits 

Medicare (a HIPAA covered entity) from 

disclosing an individual’s protected 

health information without a valid 

authorization. In order to be valid, an 

authorization must include specified 

core elements and statements. Medicare 

will make available to Medicare 

beneficiaries a standard, valid 

authorization to enable beneficiaries to 

request the disclosure of their protected 

health information. This standard 

authorization will simplify the process 

of requesting information disclosure for 

beneficiaries and minimize the response 

time for Medicare. Form CMS–10106, 

the Medicare Authorization to Disclose 

Personal Health Information, will be 

used by Medicare beneficiaries to 

authorize Medicare to disclose their 

protected health information to a third 

party. Form Number: CMS–10106 (OMB 

control number: 0938–0930); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 1,298,329; Total Annual 

Responses: 1,298,329; Total Annual 

Hours: 324,582. (For policy questions 

regarding this collection contact Sam 

Jenkins at 410–786–3261.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Data Use 

Agreement (DUA) for Data Acquired 

from the Centers for Medicare & 

Medicaid Services (CMS); Use: The 

Privacy Act of 1974 allows for 

discretionary releases of data 

maintained in Privacy Act protected 

systems of records under § 552a(b) 

(Conditions of Disclosure). The mandate 

to account for disclosures of data under 

the Privacy Act is found at 

§ 552a(c)(Accounting of Certain 

Disclosures). This section states that 

certain information must be maintained 

regarding disclosures made by each 

agency. This information is: Date, 

Nature, Purpose, and Name/Address of 

Recipient. Section 552a(e) sets the 

overall requirements that each agency 

must meet in order to maintain records 

under the Privacy Act. The Data Use 

Agreement (DUA) form is needed as part 

of the review of each CMS data request 

to ensure compliance with the 

requirements of the Privacy Act for 

disclosures that contain personally 

identifiable information (PII). The DUA 

form also provides data requestors and 

custodians with a formal means to agree 

to the data protection and destruction 

statutory and regulatory requirements of 

CMS’ PII data. The Health Insurance 

Portability and Accountability Act 

(HIPAA) of 1996, § 1173(d) (Security 

Standards for Health Information) 

requires us to protect PII. Additionally, 

the Federal Information Security 

Management Act (FISMA) of 2002, 

§ 3544 (b) (Federal Agency 

Responsibilities—Agency Program) also 

requires us to develop policies and 

procedures for the protection and 

destruction of sensitive data to include 

PII. We use the information collected by 

the DUA to track disclosures, conditions 

for disclosure, accounting of disclosures 

and agency requirements dictated by the 

Privacy Act, HIPAA and FISMA. 

Form Number: CMS–R–235 (OMB 

control number: 0938–0734); Frequency: 

Annually; Affected Public: Private 

sector—business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 9,220; Total Annual 

Responses: 9,220; Total Annual Hours: 

2,740. (For policy questions regarding 

this collection contact Sharon Kavanagh 

at 410–786–5441.) 

Dated: June 24, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–15075 Filed 6–26–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–370 and CMS– 

377, CMS 437, CMS–10510, CMS–216–94, 

CMS–10494, CMS–10224, CMS–10472 and 

CMS–10499] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the 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 functions; (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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by July 28, 2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 or, Email: 

OIRA_submission@omb.eop.gov. To 

obtain copies of a supporting statement 

and any related forms for the proposed 

collection(s) summarized in this notice, 

you may make your request using one 

of following: 

1. Access CMS’ Web site address at 

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

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 


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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 36519 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Titles of 

Information Collection: Health 

Insurance Benefits Agreement and 

Ambulatory Surgical Request for 

Certification or Update of Certification 

Information in the Medicare Program; 

Use: The CMS–370 is used to establish 

eligibility for payment. This agreement, 

upon submission by the ambulatory 

surgical center (ASC) and acceptance for 

filing by the Secretary of Health & 

Human Services, shall be binding on 

both the ASC and the Secretary. The 

agreement may be terminated by either 

party in accordance with regulations. In 

the event of termination, payment will 

not be available for ASC services 

furnished on or after the effective date 

of termination. The CMS–377 is used to 

collect facility-specific characteristics 

that facilitate CMS’ oversight of 

ambulatory surgical centers. The CMS– 

377 is submitted by ASCs when they 

request initial certification of 

compliance with the ASC conditions for 

coverage or to update an ASC’s existing 

certification information. It is also used 

by State agencies who conduct 

certification surveys on CMS’ behalf to 

maintain information on the facility’s 

characteristics that facilitate conducting 

surveys, e.g., determining the size and 

the composition of the survey team on 

the basis of the number of operating and 

procedure rooms and the types of 

surgical procedures performed in the 

ASC. 

Form Numbers: CMS–370 and CMS– 

377 (OMB control number: 0938–0266); 

Frequency: Occasionally; Affected 

Public: Private Sector—Business or 

other for-profit and Not-for-profit 

institutions; Number of Respondents: 

5,449; Total Annual Responses: 1,833; 

Total Annual Hours: 633. (For policy 

questions regarding this collection 

contact Erin McCoy at 410–786–2337.) 

2. Type of Information Collection 

Request: Reinstatement with Change of 

a currently approved collection; Title of 

Information Collection: Psychiatric Unit 

Criteria Work Sheet and Supporting 

Regulations; Use: Certain hospital units 

are excluded from the Medicare 

Prospective Payment System (PPS). The 

exclusion of units is not optional on the 

part of the provider but is required by 

section 1886(d)(1)(B) of the Social 

Security Act. That section excludes 

psychiatric hospitals, rehabilitation 

hospitals, hospitals whose inpatients are 

predominantly individuals under 18 

years of age (children’s hospitals), and 

psychiatric and rehabilitation units 

which are a distinct part of a hospital. 

We propose to continue the current 

process of performing initial 

verifications and annual re-verifications 

to determine that psychiatric units 

continue to comply with the regulatory 

criteria at 42 CFR 412.25 and 42 CFR 

412.27 of the PPS regulations. These 

regulations state the criteria that distinct 

part units must meet for exclusion. 

If, as a result of the regular survey 

process a hospital is certified as a 

psychiatric hospital by the State survey 

agency (SA), then it automatically 

satisfies the regulatory criteria for 

exclusion. Thus, no additional 

verification is required for psychiatric 

hospitals. Some verification is needed, 

however, to ensure that other types of 

hospitals and units meet the criteria for 

exclusion. Consequently, we instructed 

the Medicare Administrative 

Contractors (MACs) (formerly known as 

FIs) and SAs to perform certain 

verification activities, beginning in 

October 1983 when PPS was 

implemented. We originally developed 

the CMS–437 as an SA Worksheet for 

verifying exclusions from PPS for 

psychiatric units. 

Since April 9, 1994, PPS-excluded 

psychiatric units already excluded from 

the PPS have met our annual 

requirement for PPS-exclusion by selfattesting that they remain in compliance 

with the PPS exclusion criteria. Under 

the current procedure, all psychiatric 

units applying for first-time exclusion 

are surveyed by the SAs. The SAs also 

perform surveys to investigate 

complaint allegations and conduct 

annual sample re-verification surveys 

on 5 percent of all psychiatric units. The 

aforementioned exclusions continue to 

exist and thus we propose to continue 

to use the Criteria Worksheet, Forms 

CMS–437, for verifying first-time 

exclusions from the PPS, for complaint 

surveys, for its annual 5 percent 

validation sample, and for facility selfattestation. These forms are related to 

the survey and certification and 

Medicare approval of the PPS-excluded 

units. 

Form Number: CMS–437 (OMB 

control number: 0938–0358); Frequency: 

Annually; Affected Public: Private 

sector—Business or other for-profits; 

Number of Respondents: 1,614; Total 

Annual Responses: 1,614; Total Annual 

Hours: 404. (For policy questions 

regarding this collection contact Donald 

Howard at 410–786–6764.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Basic Health 

Program Report for Health Insurance 

Exchange Premium; Use: The Basic 

Health Program (BHP) is federally 

funded by determining the amount of 

payments that the federal government 

would have made through the premium 

tax credit (PTC) and cost sharing 

reductions (CSR) for people enrolled in 

BHP had they instead been enrolled in 

an Exchange. To calculate the amounts 

for each state, we need the reference 

premiums for the second lowest cost 

silver plans (SLCSP) in each geographic 

area in a state, as SLCSPs are a basic 

unit in the calculation of PTC and CSRs 

under the Exchanges. To estimate what 

PTC and CSRs would have been paid, 

the reference premiums for these 

SLCSPs are critical components in the 

BHP payment methodology. Similarly, 

we also need to collect reference 

premiums for the lowest cost bronze 

plans to appropriately account for CSR 

calculations for American Indians and 

Alaskan Natives. Reference premiums 

are foundational inputs into the BHP 

payment methodology. We have the 

necessary information to determine 

these reference premiums for states with 

Exchanges operated by the Federally 

Facilitated Exchange (FFE) or are 

operated in partnership with the FFE. 

Consequently, this collection only 

pertains to the 17 states that are 

operating State Based Exchanges. 

Form Number: CMS–10510 (OMB 

control number: 0938–1218); Frequency: 

Yearly; Affected Public: State, Local, or 

Tribal Governments; Number of 

Respondents: 17; Total Annual 

Responses: 17; Total Annual Hours: 68. 

(For policy questions regarding this 

collection contact Carey Appold at 410– 

786–2117). 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Organ 

Procurement Organization/

Histocompatibility Laboratory Cost 

Report; Use: We are requesting an 

extension of the Form CMS 216–94, 

Organ Procurement Organization (OPO)/ 

Histocompatibility Laboratory Cost 

Report. These cost reports are filed 

annually by freestanding OPO and 

Histocompatibility Lab providers 

participating in the Medicare program to 

determine the reasonable costs incurred 

to furnish treatment for renal transplant 

patients. Form Number: CMS–216–94 

(OMB control number: 0938–0102); 

Frequency: Annually; Affected Public: 

Private sector—Business or other forprofits; Number of Respondents: 107; 

Total Annual Responses: 107 Total 

Annual Hours: 4,815. (For policy 

questions regarding this collection 

contact Angela Havrilla at 410–786– 

4516.) 

5. Type of Information Collection 

Request: Revision of a previously 

approved information collection; Title 

of Information Collection: Consumer 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
36520 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

Assistance Tools and Programs of an 

Exchange and Certified Application 

Counselors; Exchange and Insurance 

Market Standards for 2015; Use: Section 

1321(a)(1) of the Affordable Care Act 

directs and authorizes the Secretary to 

issue regulations setting standards for 

meeting the requirements under title I of 

the Affordable Care Act, with respect to, 

among other things, the establishment 

and operation of Exchanges. Pursuant to 

this authority, regulations establishing 

the certified application counselor 

program are being finalized at 45 CFR 

155.225. Specifically, 45 CFR 155.225(a) 

requires an Exchange to establish a 

certified application counselor program 

that complies with the requirements of 

the rule. Section 155.225(b)(1) allows 

each Exchange to designate certain 

organizations, including organizations 

designated by state Medicaid or CHIP 

agencies, which will certify their staff 

and volunteers to act as certified 

application counselors. In accordance 

with 45 CFR 155.225(b)(2), Exchanges 

may choose to certify directly 

individuals who seek to act as certified 

application counselors, designate 

certain organizations which will certify 

staff or volunteers to perform 

application services, or do both. In 

accordance with 155.225(d)(7), certified 

application counselors in all Exchanges 

are required to be recertified on at least 

an annual basis and successfully 

complete Exchange-required 

recertification training. 

Form Number: CMS–10494 (OMB 

control number: 0938–1205); Frequency: 

On Occasion; Affected Public: State, 

Local, or Tribal Governments, Private 

Sector: not-for-profit institutions; 

individuals or households; Number of 

Respondents: 35,000; Number of 

Responses: 160,000; Total Annual 

Hours: 19,610. (For policy questions 

regarding this collection, contact Tricia 

Beckmann at 301–492–4328.) 

6. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Healthcare 

Common Procedure Coding System 

(HCPCS)—Level II Code Modification 

Request Process; Use: Each year in the 

United States healthcare insurers 

process over 5 billion claims for 

payment. For Medicare and other health 

insurance programs to ensure that these 

claims are processed in an orderly and 

consistent manner, standardized coding 

systems are essential. The Healthcare 

Common Procedure Coding System 

(HCPCS) Level II Code Set is one of the 

standard code sets used for this 

purpose. Level II of the HCPCS, also 

referred to as alpha-numeric codes, is a 

standardized coding system that is used 

primarily to identify products, supplies, 

and services not included in the CPT 

codes, such as ambulatory services and 

durable medical equipment, prosthetics, 

orthotics, and supplies (DMEPOS) when 

used in the home or outpatient setting. 

The HCPCS codeset has been 

maintained and distributed via 

modifications of codes, modifiers and 

descriptions, as a direct result of data 

received from applicants. The HCPCS 

codeset maintenance is an ongoing 

process, as changes are implemented 

and updated annually; therefore, the 

process requires continual collection of 

information from applicants on an 

annual basis. As new technology 

evolves and new devices, drugs and 

supplies are introduced to the market, 

applicants submit applications to us 

requesting modifications to the HCPCS 

Level II codeset. 

Form Number: CMS–10224 (OMB 

control number: 0938–1042); Frequency: 

Annually; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 300; Total Annual 

Responses: 300 Total Annual Hours: 

3,300. (For policy questions regarding 

this collection contact Kimberlee Combs 

Miller at 410–786–6707.) 

7. Type of Information Collection 

Request: Revision of a previously 

approved information collection; Title 

of Information Collection: Exchange 

Functions: Standards for Navigators and 

Non-Navigator Assistance Personnel; 

Use: Section 1321(a)(1) of the Affordable 

Care Act directs and authorizes the 

Secretary to issue regulations setting 

standards for meeting the requirements 

under title I of the Affordable Care Act, 

with respect to, among other things, the 

establishment and operation of 

Exchanges. Pursuant to this authority, 

regulations have been finalized at 45 

CFR 155.210(e)(6) and 45 CFR 

155.215(g) to require Navigators, as well 

as those non-Navigator personnel to 

whom 45 CFR 155.215 applies, to 

inform consumers of the functions and 

responsibilities of Navigators and nonNavigator assistance personnel (as 

applicable) and obtain authorization for 

the disclosure of consumer information 

to the Navigator or non-Navigator 

assistance personnel prior to obtaining 

the consumer’s personally identifiable 

information. Navigators and nonNavigator assistance personnel to whom 

45 CFR 155.215 applies are also 

required to maintain a record of the 

authorization provided in a form and 

manner as determined by the Exchange. 

Form Number: CMS–10472 (OMB 

control number. 0938–1220); Frequency: 

On Occasion; Affected Public: State, 

Local, or Tribal Governments, Private 

Sector (not-for-profit institutions); 

individuals or households; Number of 

Respondents: 5,610; Number of 

Responses: 5,610; Total Annual Hours: 

35,709. (For policy questions regarding 

this collection, contact Emily Ames at 

301–492–4246.) 

8. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Public Health 

Agency/Registry Readiness to Support 

Meaningful Use; Use: The Medicare and 

Medicaid Electronic Health Record 

(EHR) Incentive Programs provide 

incentives for the meaningful use of 

Certified Electronic Health Record 

Technology (CEHRT). We defined 

meaningful use as a set of objectives and 

measures in either Stage 1 or Stage 2 

depending on how long an eligible 

provider has participated in the 

program. Both Stage 1 (3 objectives) and 

Stage 2 (5 objectives) of meaningful use 

contain objectives and measures that 

require eligible providers to determine 

the readiness of public health agencies 

and registries to receive electronic data 

from CEHRT. Public comments on the 

notice of proposed rulemaking for Stage 

2 of meaningful use (77 FR 13697) 

asserted that the burden for each 

individual eligible provider to 

determine the readiness of multiple 

public health agencies and registries 

could be nearly eliminated if we were 

to maintain a database on the readiness 

of public health agencies and registries. 

In the final rule for Stage 2 of 

meaningful use (77 FR 53967), we 

agreed that the burden on eligible 

providers, public health agencies and 

registries would be greatly reduced and 

established that we would create such a 

database and it would serve as the 

definitive information source for 

determining public health agency and 

registry readiness to receive electronic 

data associated with the public health 

meaningful use objectives. The 

information will be made publicly 

available on the CMS Web site 

(www.cms.gov/EHRincentiveprograms) 

in order to provide a centralized 

repository of this information to eligible 

providers and eliminate there multiple 

individual inquiries to multiple public 

health agencies and registries. Form 

Number: CMS–10499 (OMB control 

number: 0938–New); Frequency: Yearly; 

Affected Public: Private sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 250; Total Annual 

Responses: 250; Total Annual Hours: 

83. (For policy questions regarding this 

collection contact Kathleen Connors de 

Laguna at 410–786–2256. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 36521 

Dated: June 24, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–15073 Filed 6–26–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3301–PN] 

Medicare and Medicaid Programs; 

Application From Det Norske Veritas 

Healthcare for Continued CMSApproval of Its Critical Access Hospital 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from Det Norske Veritas 

Healthcare (DNVHC) for continued 

recognition as a national accrediting 

organization for critical access hospitals 

(CAHs) that wish to participate in the 

Medicare or Medicaid programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 28, 2014. 

ADDRESSES: In commenting, please refer 

to file code CMS–3301–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways: 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.regulations.gov . Follow the 

‘‘submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3301– 

PN, P.O. Box 8016, Baltimore, MD 

21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3301–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments to the following 

addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Easterling, (410) 786–0482, 

Cindy Melanson, (410) 786–0310, 

Patricia Chmielewski, (410) 786–6899, 

or Lillian Williams, (410) 786–8636. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering issues and 

developing policies. Referencing the file 

code CMS–3301–PN and the specific 

‘‘issue identifier’’ that precedes the 

section on which you choose to 

comment will assist us in fully 

considering issues and developing 

policies. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a Critical Access Hospital 

(CAH) provided certain requirements 

are met by the CAH. Section 1820(e) and 

1861(mm) of the Social Security Act 

(the Act), establishes distinct criteria for 

facilities seeking designation as a CAH. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488. The regulations 

at 42 CFR part 485, subpart F specify the 

conditions that a CAH must meet to 

participate in the Medicare program, the 

scope of covered services, and the 

conditions for Medicare payment for 

CAHs. 

Generally, to enter into an agreement, 

a CAH must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

part 485, subpart F of our CMS 

regulations. Thereafter, the CAH 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. 

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 


wreier-aviles on DSK5TPTVN1PROD with NOTICES