30584 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

ascertain whether there have been any 

adverse events or medication errors 

associated with the doxycycline hyclate 

tablet emergency kit. If any such adverse 

events or medication errors have not 

previously been reported to FDA as outlined 

in paragraph H, they must be reported within 

15 days to FDA. FDA has authorized ASPR’s 

Form entitled ‘‘Questions to Determine 

Status of Your Household Antibiotic Kit 

(HAK)’’ (Kit Status form). Any revision of the 

Kit Status form is subject to FDA’s prior 

approval. USPS, in conjunction with 

appropriate local public health authorities, 

will be responsible for ensuring that 

completed Kit Status forms are maintained 

until notified by FDA. A report summarizing 

the information collected on Kit Status forms 

under this paragraph will be submitted to 

FDA within 30 days of gathering such 

information. Associated records will be made 

available to FDA for inspection upon request. 

L. USPS will be responsible for collecting 

any expired doxycycline hyclate tablet 

emergency kits and turning them over to the 

participating public health authority(ies). 

The participating public health authority(ies) 

will be responsible for disposing of expired 

doxycycline hyclate tablet emergency kits as 

instructed by ASPR at that time. The 

participating public health authority(ies) will 

ensure that drug accountability records are 

maintained and reconciled. Such records 

shall be made available to FDA for inspection 

upon request. 

M. USPS and the participating public 

health authority(ies) will be responsible for 

ensuring that completed Health Assessment 

Forms, Healthcare Provider Quality 

Checklists, and any other records associated 

with this EUA are maintained until notified 

by FDA. Such records will be made available 

to FDA for inspection upon request. 

N. As a condition of this EUA, all 

advertising and promotional descriptive 

printed matter relating to the use of 

doxycycline hyclate tablet emergency kits 

authorized under this EUA shall be 

consistent with the Fact Sheets, home 

preparation instructions, and placard 

information, as well as the terms set forth in 

this EUA and other requirements set forth in 

the Act and FDA regulations. 

O. Upon termination of the declaration of 

emergency under section 564(b)(2) of the Act 

or upon revocation of this EUA under section 

564(g) of the Act, USPS will be responsible 

for collecting all doxycycline hyclate tablet 

emergency kits and turning them over to the 

participating public health authority(ies). 

The participating public health authority(ies) 

will dispose of doxycycline hyclate 

emergency kits as instructed by ASPR at that 

time. The participating public health 

authority(ies) will ensure that drug 

accountability records are maintained and 

reconciled. Such records will be made 

available to FDA for inspection upon request. 

P. HHS will notify FDA of its decision to 

add a CRI location and its decision to initiate 

distribution of doxycycline hyclate tablet 

emergency kits under this EUA to particular 

CRI locations. 

The emergency use of doxycycline hyclate 

tablet emergency kits as described in this 

letter of authorization must comply with the 

conditions above and all other terms of this 

authorization. 

V. Duration of Authorization 

This EUA will be effective until the 

declaration of emergency is terminated under 

section 564(b)(2) of the Act or the EUA is 

revoked under section 564(g) of the Act. 

Randall W. Lutter, Ph.D. 

Deputy Commissioner for Policy 

Dated: June 17, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–15044 Filed 6–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2896–FN2] 

Medicare and Medicaid Programs; 

Approval of the Joint Commission’s 

Continued Deeming Authority for 

Critical Access Hospitals 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final Notice of Removal of 

Conditional Probationary Status. 

SUMMARY: Based on our review and 

observations, we have determined that 

the Joint Commission’s accreditation 

standards for critical access hospitals 

(CAHs) meet or exceed our 

requirements. Therefore, this final 

notice announces our decision to 

approve without condition the Joint 

Commission’s request for continued 

recognition as a national accreditation 

program for CAHs seeking to participate 

in the Medicare or Medicaid programs. 

DATES: Effective Date: This final notice 

of approval is effective November 21, 

2008 through November 21, 2011. 

FOR FURTHER INFORMATION CONTACT: 

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 a Critical Access Hospital 

(CAH) provided certain requirements 

are met. Sections 1820(c)(2)(B) and 

1861(mm) of the Social Security Act 

(the Act) establish distinct criteria for 

facilities seeking designation as a CAH. 

Under this authority, the minimum 

requirements that a CAH must meet to 

participate in Medicare are set forth in 

regulations at 42 CFR part 485, subpart 

F (Conditions of Participation: Critical 

Access Hospitals (CAHs)) which 

determine the basis and scope of CAH 

covered services. Conditions for 

Medicare payment for CAHs are set 

forth at § 413.70. Applicable regulations 

concerning provider agreements are 

located in 42 CFR part 489 (Provider 

Agreements and Supplier Approval) and 

those pertaining to facility survey and 

certification are located in 42 CFR part 

488, subparts A and B. 

In general, we approve a CAH for 

participation in the Medicare program if 

it is participating as a hospital at the 

time it applies for CAH designation, and 

it is in compliance with part 482 

(Conditions of Participation for 

Hospitals) and part 485, subpart F 

(Conditions of Participation: Critical 

Access Hospital (CAHs)). 

For a CAH to enter into a provider 

agreement, a State survey agency must 

certify that the CAH is in compliance 

with the conditions or standards set 

forth in section 1820 of the Act and part 

485 of our regulations. Thereafter, the 

CAH is subject to ongoing review by a 

State survey agency to determine 

whether it continues to meet the 

Medicare requirements. There is, 

however, an alternative to State 

compliance surveys. Accreditation by a 

nationally-recognized accreditation 

program can substitute for ongoing State 

review. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization (AO) 

that all applicable Medicare conditions 

are met or exceeded, we may ‘‘deem’’ 

that provider entity as having met the 

requirements. Accreditation by an AO is 

voluntary and is not required for 

Medicare participation. 

A national AO applying for approval 

of deeming authority under part 488, 

subpart A must provide us with 

reasonable assurance that the AO 

requires the accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare conditions of 

participation. Our regulations 

concerning re-approval of AOs are set 

forth at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require AOs 

to reapply for continued approval of 

deeming authority every 6 years, or 

sooner as we determine. The regulations 

at § 488.8(f)(3)(i) provide CMS the 

authority to grant conditional approval 

of an AO’s deeming authority, with a 

180-day probationary period, if the AO 

has not adopted comparable standards 

during the reapplication process. 

We received a complete application 

from the Joint Commission for 

continued recognition as a national 

accrediting organization for CAHs on 

March 28, 2008. In accordance with the 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30585 

requirements at § 488.4 and 

§ 488.8(d)(3), we published a proposed 

notice on May 23, 2008 (73 FR 30107) 

and a final notice announcing our 

decision approving deeming authority 

subject to probationary conditions on 

October 24, 2008 (73 FR 63480). This 

final notice is in response to the 

conditional approval with a 180-day 

probationary period granted to the Joint 

Commission on October 24, 2008. The 

Joint Commission did not adopt 

comparable standards to meet the 

requirements for distinct part units 

(DPU) in CAHs during its reapplication 

for renewal of deeming authority. This 

final notice is required to be published 

no later than July 19, 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 to conduct our survey 

activities and application review 

process. Within 60 days of receiving a 

complete application, we must publish 

a notice in the Federal Register that 

identifies the national accreditation 

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 

an approval or denial of the application. 

In accordance with § 488.8(f)(2), if CMS 

determines, following the deeming 

authority review that the organization 

has failed to adopt requirements 

comparable to CMS requirements, the 

AO may be given a conditional approval 

of its deeming authority for a 

probationary period of up to 180 days to 

adopt comparable requirements. Within 

60 days after the end of this period, we 

must make a final determination as to 

whether or not the Joint Commission’s 

CAH DPU accreditation requirements 

are comparable to CMS requirements 

and issue an appropriate notice that 

includes the reasons for our 

determination. 

III. Provisions of the October 23, 2008 

Final Notice 

We revised the CAH requirements on 

August 11, 2004 (69 FR 49272) to 

include a new condition at § 485.647. 

This condition of participation (CoP) 

outlines the eligibility requirements for 

CAHs that wish to have a psychiatric or 

rehabilitation DPU. Under this 

condition, a CAH can provide inpatient 

psychiatric or rehabilitation services in 

a DPU so long as the services furnished 

in the DPU comply with the general 

hospital requirements specified at part 

482, the requirements for excluded 

hospital units at § 412.25, and the 

additional requirements at § 412.27 for 

excluded psychiatric units; and § 412.29 

and § 412.30 for excluded rehabilitation 

units as applicable. As a result, the Joint 

Commission had to address all of the 

DPU requirements set out at § 485.647, 

including a crosswalk addressing the 

Medicare hospital CoPs at part 482, as 

part of its application for renewal of 

CAH deeming authority. Review of the 

Joint Commission’s accreditation 

standards during the reapplication 

submitted for renewal of deeming 

authority revealed significant gaps 

between the Joint Commission’s 

standards and the Medicare CoPs. On 

October 24, 2008, we conditionally 

approved the Joint Commission’s 

accreditation program for CAHs that 

request participation in the Medicare 

program with a 180 day probationary 

period. Under section 1865(a)(2) of the 

Act and our regulations at § 488.4 and 

§ 488.8, we conducted a comparability 

review of the Joint Commission’s CAH 

DPU standards to CMS hospital 

standards in part 482 and appropriate 

provisions of part 412 in order to 

determine compliance with the CAH 

DPU requirements at § 485.647. 

IV. Provisions of the Final Notice 

A. Differences Between the Joint 

Commission’s CAH DPU Standards and 

Requirements for Accreditation and 

Medicare’s Conditions and Survey 

Requirements 

During the 180-day probationary 

period, we conducted a comparison of 

the Joint Commission’s CAH DPU 

accreditation standards to our current 

Medicare CAH CoPs as outlined in the 

State Operations Manual. We also 

conducted a survey observation to 

validate proper application of the 

standards. Our review and evaluation of 

the Joint Commission’s CAH DPU 

standards yielded the following: 

• To meet the requirements at 

§ 482.12(b), the Joint Commission added 

an element of performance (EP) to affirm 

that only one individual or designee 

may be the chief executive officer. 

• To meet the requirements at 

§ 482.12(e)(2), the Joint Commission 

added a new EP to require hospitals to 

maintain a list of all contracted services. 

• To meet the requirements at 

§ 482.12(f)(2), the Joint Commission 

added a new EP to require that the 

medical staff have written policies and 

procedures for on-campus and offcampus locations appraising 

emergencies, providing initial 

treatment, and for referring and 

transferring patients. 

• To meet the requirements at 

§ 482.13(e)(1)(i),the Joint Commission 

revised its EPs to include a definition of 

restraints. 

• To meet the requirements at 

§ 482.13(e)(1)(ii), the Joint Commission 

revised its EPs to include a definition of 

seclusion. 

• To meet the requirements at 

§ 482.13(e)(5), § 482.13(e)(8)(ii), 

§ 482.23(c), and § 482.23(c)(2), the Joint 

Commission revised its EPs to include 

the reference ‘‘as specified under 

§ 482.12(c),’’ which addresses the care 

of the patient. 

• To meet the requirements at 

§ 482.13(e)(10), the Joint Commission 

revised its EP to address the staff 

training requirements of individuals 

that monitor patients in restraints and 

seclusion. 

• To meet the requirements at 

§ 482.11(e)(11), the Joint Commission 

revised its EPs to require physicians and 

other licensed independent 

practitioners authorized to order 

restraints and seclusion have a working 

knowledge of hospital policy regarding 

the use of restraint and seclusion. 

• To meet the requirements at 

§ 482.13(f)(2), the Joint Commission 

revised its EPs to address the 

components of training, education, and 

demonstrated knowledge on restraint 

and seclusion. 

• To meet the requirements at 

§ 482.22(c)(5)(i), the Joint Commission 

revised its EP to include ‘‘as defined in 

section 1861(r) of the Social Security 

Act,’’ which contains the definition of a 

physician. 

• To meet the requirements at 

§ 482.23(b), the Joint Commission 

revised its EP to address the nurse 

staffing requirements, supervisory 

personnel, and immediate availability of 

a registered nurse for bedside care. 

• To meet the requirements at 

§ 482.23(c)(2), the Joint Commission 

revised its EP to address the 

requirements related to orders for drugs 

and biologicals. 

• To meet the requirements at 

§ 482.23(c)(2)(ii), the Joint Commission 

revised its EPs to address the 

requirement that hospitals have policies 

and procedures on who is authorized to 

accept verbal orders. 

• To meet the requirements at 

§ 482.23(c)(3), the Joint Commission 

added a new EP to require special 

training for staff members administering 

blood transfusions. 

• To meet the requirements at 

§ 482.24, the Joint Commission revised 

its EPs to include medical records as an 

essential service. 

30586 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

• To meet the requirements at 

§ 482.24(a), the Joint Commission added 

a new EP that states the hospital must 

be able to ensure prompt completion, 

filing, and retrieval of records. 

• To meet the requirements at 

482.24(c)(1), the Joint Commission 

added a new EP that requires all patient 

medical records entries be timed. 

• To meet the requirements at 

482.24(c)(1)(i), the Joint Commission 

revised its EP to address ‘‘all orders.’’ 

• To meet the requirements at 

§ 482.24(c)(1)(iii), the Joint Commission 

added a new EP to address the 

timeframe requirement for verbal order 

authentication. 

• To meet the requirements at 

§ 482.25, the Joint Commission revised 

its EP to include a requirement that the 

pharmacy must be directed by a 

registered pharmacist. 

• To meet the requirements at 

§ 482.25(b)(1), the Joint Commission 

revised its EP to require a pharmacist 

supervise all compounding, packing, 

and dispensing of drugs and biologicals. 

• To meet the requirements at 

§ 482.25(b)(2)(ii), the Joint Commission 

revised its EP to require all controlled 

substances included in Schedules II, III, 

IV, and V of the Comprehensive Drug 

Abuse and Prevention and Control Act 

be locked and secure. 

• To meet the requirements at 

§ 482.25(b)(6), the Joint Commission 

revised its EP to address the 

requirement, if necessary, to report drug 

administration errors, adverse drug 

reactions and incompatibilities to the 

hospital-wide quality assurance 

program. 

• To meet the requirements at 

§ 482.26(c)(1), the Joint Commission 

revised its EPs to state that a radiologist 

is a doctor of medicine or osteopathy. 

• To meet the requirements at 

§ 482.27(a), the Joint Commission 

revised its EP to include a statement 

that hospitals must provide laboratory 

services with a certified laboratory that 

meet the requirements of part 493 of 

title 42 of the Code of Federal 

Regulations. 

• To meet the requirements at 

§ 482.27(a)(1), the Joint Commission 

added a new EP requiring laboratory 

services be available 24 hours a day. 

• To meet the requirements at 

§ 482.27(a)(4), the Joint Commission 

added a new EP to require the medical 

staff and pathologist establish which 

tissue specimens require macroscopic 

and microscopic examinations. 

• To meet the requirements at 

§ 482.27(b), the Joint Commission added 

new EPs associated with potentially 

infectious blood and blood components. 

• To meet the requirements at 

§ 482.27(b)(5)(ii), the Joint Commission 

revised its EP to include the 

requirement that the plan to transfer 

medical records must be ‘‘fully funded.’’ 

• To meet the requirements at 

§ 482.27(b)(6)(ii), the Joint Commission 

revised its EPs to include the statement 

that if the hospital administered 

potentially HIV or HCV infectious blood 

or blood components and the physician 

is unavailable or declines to make the 

notification, the hospital must make 

reasonable attempts to give this 

notification to the patient, legal 

guardian, or relative. 

• To meet the requirements at 

§ 482.28(a)(1)(iii), the Joint Commission 

revised its EP to include that the full 

time director of food and dietetic 

services be qualified by experience or 

training. 

• To meet the requirements at 

§ 482.43, the Joint Commission added a 

new EP to require hospitals have a 

discharge planning process that applies 

to all patients. 

• To meet the requirements at 

§ 482.43(b)(2), the Joint Commission 

added a new EP to require RNs, social 

workers or other appropriately qualified 

personnel develop, or supervise the 

development of the evaluation. 

• To meet the requirements at 

§ 482.43(b)(6), the Joint Commission 

added a new EP to require the inclusion 

of a discharge planning evaluation in 

the medical record for use in 

establishing an appropriate discharge 

plan. The Joint Commission also 

requires the hospital to discuss the 

results of the discharge plan with the 

patient or individual acting on behalf of 

the patient. 

• To meet the requirements at 

§ 482.43(c), the Joint Commission added 

new EPs to address the discharge 

planning requirements. 

• To meet the requirements at 

§ 482.51(b)(1)(ii), the Joint Commission 

revised its EPs to include a requirement 

for an update within 24 hours after 

admission or registration when the 

medical history and physical 

examination are completed within 30 

days before admission or registration. 

• To meet the requirements at 

§ 482.52(a)(5), the Joint Commission 

revised its EPs to include ‘‘as defined in 

§ 410.69(c),’’ which provides the 

definition of an anesthesiologist 

assistant. 

• To meet the requirements at 

§ 482.52(b)(3), the Joint Commission 

added a new EP to address the 

requirements of the postanesthesia 

evaluation. 

• To meet the requirements at 

§ 482.53(a)(1), the Joint Commission 

added a new EP to identify the nuclear 

medicine services that must be 

supervised and administered by a 

doctor of medicine or osteopathy 

qualified in nuclear medicine. 

• To meet the requirements at 

§ 482.53(b)(1), the Joint Commission 

added a new EP to state that the ‘‘inhouse preparation’’ of 

radiopharmaceuticals must be under the 

supervision of an ‘‘appropriately trained 

registered pharmacist or a doctor of 

medicine or osteopathy.’’ 

• To meet the requirements at 

§ 482.55(a)(1), the Joint Commission 

added a new EP that requires a qualified 

member of the medical staff direct 

emergency services. 

• To meet the requirements at 

§ 482.55(a)(3), the Joint Commission 

added an EP to clarify that the policies 

and procedures governing medical care 

provided in the emergency department 

are established by and are a continuing 

responsibility of the medical staff. 

• To meet the requirements at 

§ 482.55(b)(1), the Joint Commission 

added a new EP to require a qualified 

member of the medical staff supervise 

emergency services. 

• To meet the requirements at 

§ 482.57(a)(1), the Joint Commission 

added a new EP to address the 

requirement that there must be a 

director of respiratory services who is a 

doctor of medicine or osteopathy. 

• To meet the requirements at 

§ 482.57(b)(3), the Joint Commission 

added new EPs to state respiratory 

services are provided only on and in 

accordance with, the orders of a doctor 

of medicine or osteopathy. 

B. Term of Approval 

Based on the review and observations, 

we have determined that the Joint 

Commission’s accreditation standards 

for CAHs meet or exceed our 

requirements. Therefore, we approve the 

Joint Commission as a national 

accreditation organization for CAHs that 

request participation in the Medicare 

program, effective November 21, 2008 

through November 21, 2011. Under 

§ 488.8(f)(4), notice was given to the 

Joint Commission on October 24, 2008 

(73 FR 63480) and this notice, although 

not required by our regulations is being 

published as a public service for 

informational purposes. 

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 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30587 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

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—Supplemental Medical Insurance 

Program) 

Dated: May 7, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–14778 Filed 6–25–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2476–PN] 

Medicare and Medicaid Programs; 

Application by the American 

Association for Accreditation of 

Ambulatory Surgery Facilities for 

Continued Deeming Authority for 

Ambulatory Surgical Centers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the American 

Association for Accreditation of 

Ambulatory Surgery Facilities 

(AAAASF) for continued recognition as 

a national accrediting organization for 

ambulatory surgical centers (ASCs) that 

wish to participate in the Medicare or 

Medicaid programs. The statute requires 

that we publish, within 60 days of 

receipt of an organization’s complete 

application, a notice identifying the 

national accrediting body making the 

request, describing the nature of the 

request, and providing at least a 30-day 

public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 27, 2009. 

ADDRESSES: In commenting, please refer 

to file code CMS–2476–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–2476–PN, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

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–2476–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of 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.) 

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, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 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 from an ambulatory surgical 

center (ASC) provided certain 

requirements are met. Section 

1832(a)(2)(F)(i) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as an 

ASC. 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 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. 

Generally, in order to enter into a 

provider agreement with the Medicare 

program, an ASC must first be certified 

by a State survey agency as complying 

with the conditions or requirements set 

forth in part 416 of our regulations. 

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. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any