AGENCY

Referral Prohibition 

Exceptions to the Physician SelfOwnership and Rural Provider 

Capacity Under the Hospital 

Prohibition on Expansion of Facility 

Request for an Exception to the 

Medicare Program; Announcement of 

[CMS–1774–PN] 

Services 

Centers for Medicare & Medicaid 

HUMAN SERVICES 

DEPARTMENT OF HEALTH AND 

BILLING CODE 4120–01–C 

[FR Doc. 2022–02677 Filed 2–8–22; 8:45 am] 

: Centers for Medicare & 

ACTION

Medicaid Services (CMS), HHS. 

: Notice with request for 

SUMMARY

comment. 

: The Social Security Act 

received a request from a physicianMedicare & Medicaid Services has 

hospital is located. The Centers for 

entities in the community where the 

on the request from individuals and 

that prohibition after considering input 

the hospital’s request for an exception to 

of Health and Human Services grants 

unless the Secretary of the Department 

from expanding its facility capacity 

prohibits a physician-owned hospital 

DATES

capacity. 

prohibition on expansion of facility 

qualifies for an exception to the 

whether the requesting hospital 

may inform our determination regarding 

hospital is located. Community input 

entities in the community in which the 

on the request from individuals and 

capacity. This notice solicits comments 

prohibition on expansion of facility 

owned hospital for an exception to the 

: To be assured consideration, 

ADDRESSES

11, 2022. 

the addresses provided below, by March 

comments must be received at one of 

: In commenting, refer to file 

code CMS–1774–PN. 

Comments, including mass comment 

choose only one of the ways listed): 

of the following three ways (please 

submissions, must be submitted in one 

1. Electronically. You may submit 

to 

electronic comments on this regulation 

http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

Baltimore, MD 21244–1850. 

CMS–1774–PN, P.O. Box 8010, 

Health and Human Services, Attention: 

Medicaid Services, Department of 

address ONLY: Centers for Medicare & 

written comments to the following 

Please allow sufficient time for mailed 

close of the comment period. 

comments to be received before the 

3. By express or overnight mail. You 

Boulevard, Baltimore, MD 21244–1850. 

Mail Stop C4–26–05, 7500 Security 

Services, Attention: CMS–1774–PN, 

Department of Health and Human 

Medicare & Medicaid Services, 

following address ONLY: Centers for 

may send written comments to the 

For information on viewing public 

SUPPLEMENTARY INFORMATION

comments, see the beginning of the 

section. 

FOR FURTHER INFORMATION CONTACT: 

POH-ExceptionRequests@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

have been received: 

website as soon as possible after they 

comment period on the following 

received before the close of the 

a comment. We post all comments 

business information that is included in 

personally identifiable or confidential 

viewing by the public, including any 

comment period are available for 

received before the close of the 

http://

www.regulations.gov. Follow the search 

Regulations.gov 

public comments. CMS will not post on 

instructions on that website to view 

public comments that 

comments from multiple unique 

comments. We will post acceptable 

individuals not to submit duplicative 

individual. CMS continues to encourage 

individual will take actions to harm the 

institutions or suggest that the 

make threats to individuals or 


EN09FE22.011</GPH>lotter on DSK11XQN23PROD with NOTICES1

Addendum XN: Medicare-Approved B

(October through Decem

Addendum XIV includes a listing of 

that meet minimum standards for facilities mo

society statements on competency. All faciliti

order to receive coverage for bariatric surgery 

2006, we issued our decision memorandum on 

We determined that bariatric surgical procedu

necessary for Medicare beneficiaries who hav

greater than or equal to 35, have at least one c

and have been previously unsuccessful with m

This decision also stipulated that covered bari

reasonable and necessary only when performe

certified by the American College of Surgeon

Surgery Center (program standards and requir

15, 2006); or (2) certified by the American So

(ASBS) as a Bariatric Surgery Center of Exce

standards and requirements in effect on Febru

There were no additions, deletions, o

Medicare-approved facilities that meet CMS' 

for bariatric surgery that have been certified b

3-month period. This information is available 

www.cms.gov/MedicareApprovedFacilitie/BS

questions or additional information, contact S

(410-786-2749). 

Addendum XV: FDG-PET for Dementi

Diseases Clinical Trials (October thr

There were no FDG-PET for Demen

Diseases Clinical Trials published in the 3-mo

This information is available on our w

www.cms.gov/MedicareApprovedFacilitie/PE

For questions or additional information, conta

786-3365). 
7472 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

Section 1877 of the Social Security 

Act (the Act), also known as the 

physician self-referral law: (1) Prohibits 

a physician from making referrals for 

certain designated health services 

payable by Medicare to an entity with 

which he or she (or an immediate family 

member) has a financial relationship 

unless the requirements of an applicable 

exception are satisfied; and (2) prohibits 

the entity from filing claims with 

Medicare (or billing another individual, 

entity, or third party payer) for any 

improperly referred designated health 

services. A financial relationship may 

be an ownership or investment interest 

in the entity or a compensation 

arrangement with the entity. The statute 

establishes a number of specific 

exceptions and grants the Secretary of 

the Department of Health and Human 

Services (the Secretary) the authority to 

create regulatory exceptions for 

financial relationships that do not pose 

a risk of program or patient abuse. 

Section 1877(d) of the Act sets forth 

exceptions related to ownership or 

investment interests held by a physician 

(or an immediate family member of a 

physician) in an entity that furnishes 

designated health services. Section 

1877(d)(2) of the Act provides an 

exception for ownership or investment 

interests in rural providers (the ‘‘rural 

provider exception’’). In order to qualify 

for the rural provider exception, the 

designated health services must be 

furnished in a rural area (as defined in 

section 1886(d)(2) of the Act) and 

substantially all the designated health 

services furnished by the entity must be 

furnished to individuals residing in a 

rural area, and, in the case where the 

entity is a hospital, the hospital must 

meet the requirements of section 

1877(i)(1) of the Act no later than 

September 23, 2011. Section 1877(d)(3) 

of the Act provides an exception for 

ownership or investment interests in a 

hospital located outside of Puerto Rico 

(the ‘‘whole hospital exception’’). In 

order to qualify for the whole hospital 

exception, the referring physician must 

be authorized to perform services at the 

hospital, the ownership or investment 

interest must be in the hospital itself 

(and not merely in a subdivision of the 

hospital), and the hospital must meet 

the requirements of section 1877(i)(1) of 

the Act no later than September 23, 

2011. 

II. Prohibition on Facility Expansion 

Section 6001(a)(3) of the Patient 

Protection and Affordable Care Act 

(Affordable Care Act) (Pub. L. 111–148) 

amended the rural provider and whole 

hospital exceptions to provide that a 

hospital may not increase the number of 

operating rooms, procedure rooms, and 

beds beyond that for which the hospital 

was licensed on March 23, 2010 (or, in 

the case of a hospital that did not have 

a provider agreement in effect as of this 

date, but did have a provider agreement 

in effect on December 31, 2010, the 

effective date of such provider 

agreement) (the hospital’s ‘‘baseline 

number of operating rooms, procedure 

rooms, and beds’’). Thus, since March 

23, 2010, a physician-owned hospital 

that seeks to avail itself of either 

exception is prohibited from expanding 

the number of operating rooms, 

procedure rooms, and beds (‘‘facility 

capacity’’) unless it qualifies as an 

‘‘applicable hospital’’ or ‘‘high Medicaid 

facility’’ (as defined in sections 

1877(i)(3)(E), (F) of the Act and 42 CFR 

411.362(c)(2), (3) of our regulations) and 

has been granted an exception to the 

prohibition by the Secretary. 

Section 6001(a)(3) of the Affordable 

Care Act added new section 

1877(i)(3)(A)(i) of the Act, which 

required the Secretary to establish and 

implement an exception process to the 

prohibition on expansion of facility 

capacity for hospitals that qualify as an 

‘‘applicable hospital.’’ Section 1106 of 

the Health Care and Education 

Reconciliation Act of 2010 (Pub. L. 111– 

152) amended section 1877(i)(3)(A)(i) of 

the Act to require the Secretary to 

establish and implement an exception 

process to the prohibition on expansion 

of facility capacity for hospitals that 

qualify as either an ‘‘applicable 

hospital’’ or a ‘‘high Medicaid facility.’’ 

These terms are defined at sections 

1877(i)(3)(E) and 1877(i)(3)(F) of the 

Act. The process for requesting an 

exception to the prohibition on 

expansion of facility capacity is 

discussed in section III of this notice. 

The requirements for qualifying as an 

applicable hospital are set forth at 

§ 411.362(c)(2), and the requirements for 

qualifying as a high Medicaid facility 

are set forth at § 411.362(c)(3). An 

applicable hospital means a hospital: (1) 

That is located in a county in which the 

percentage increase in the population 

during the most recent 5-year period (as 

of the date that the hospital submits its 

request for an exception to the 

prohibition on expansion of facility 

capacity) is at least 150 percent of the 

percentage increase in the population 

growth of the State in which the 

hospital is located during that period, as 

estimated by the Bureau of the Census; 

(2) whose annual percent of total 

inpatient admissions under Medicaid is 

equal to or greater than the average 

percent with respect to such admissions 

for all hospitals in the county in which 

the hospital is located during the most 

recent 12-month period for which data 

are available (as of the date that the 

hospital submits its request for an 

exception to the prohibition on 

expansion of facility capacity); (3) that 

does not discriminate against 

beneficiaries of Federal health care 

programs and does not permit 

physicians practicing at the hospital to 

discriminate against such beneficiaries; 

(4) that is located in a State in which the 

average bed capacity in the State is less 

than the national average bed capacity; 

and (5) that has an average bed 

occupancy rate that is greater than the 

average bed occupancy rate in the State 

in which the hospital is located. The 

regulations at § 411.362(c)(2)(ii), (iv), 

and (v) specify acceptable data sources 

for determining whether a hospital 

qualifies as an applicable hospital. A 

‘‘high Medicaid facility’’ means a 

hospital that: (1) Is not the sole hospital 

in a county; (2) with respect to each of 

the three most recent 12-month periods 

for which data are available, has an 

annual percent of total inpatient 

admissions under Medicaid that is 

estimated to be greater than such 

percent with respect to such admissions 

for any other hospital located in the 

county in which the hospital is located; 

and (3) does not discriminate against 

beneficiaries of Federal health care 

programs and does not permit 

physicians practicing at the hospital to 

discriminate against such beneficiaries. 

The regulation at § 411.362(c)(3)(ii) 

specifies the acceptable data sources for 

determining whether a hospital qualifies 

as a high Medicaid facility. 

III. Exception Request Process 

In the Calendar Year (CY) 2012 

Outpatient Prospective Payment 

System/Ambulatory Surgical Centers 

(OPPS/ASC) final rule (76 FR 74121), 

we published regulations establishing 

the process for a hospital to request an 

exception from the prohibition on 

facility expansion (the ‘‘exception 

process’’) at § 411.362(c)(4), community 

input related to a hospital’s request at 

§ 411.362(c)(5), and related definitions 

at § 411.362(a). In the CY 2021 OPPS/ 

ASC final rule (85 FR 85866), we 

revised the regulations that set forth the 

exception process with respect to high 

Medicaid facilities to remove certain 

regulatory restrictions that are not 

included in the Act. As of January 1, 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 7473 

2021, a high Medicaid facility may 

request an exception to the prohibition 

on expansion of facility capacity more 

frequently than once every 2 years; may 

request to expand its facility capacity 

beyond 200 percent of the hospital’s 

baseline number of operating rooms, 

procedure rooms, and beds; and is not 

restricted to locating approved 

expansion capacity on the hospital’s 

main campus. 

Section 1877(i)(3)(A)(ii) of the Act 

and our regulations at § 411.362(c)(5) 

provide that individuals and entities in 

the community in which the provider 

requesting the exception is located must 

have an opportunity to provide input 

with respect to the provider’s 

application for the exception. For 

further information, we refer readers to 

the CMS website at: http://

www.cms.gov/Medicare/Fraud-andAbuse/PhysicianSelfReferral/Physician_

Owned_Hospitals.html. As stated in our 

regulations, we will solicit community 

input on the request for an exception by 

publishing a notice of the request in the 

Federal Register. Individuals and 

entities in the hospital’s community 

will have 30 days to submit comments 

on the request. Community input must 

take the form of written comments and 

may include documentation 

demonstrating that the physician-owned 

hospital requesting the exception does 

or does not qualify as an ‘‘applicable 

hospital’’ or ‘‘high Medicaid facility,’’ as 

such terms are defined in § 411.362(c)(2) 

and (3). In the CY 2012 OPPS/ASC final 

rule, we gave examples of community 

input, such as documentation 

demonstrating that the hospital does not 

satisfy one or more of the data criteria 

or that the hospital discriminates 

against beneficiaries of Federal health 

programs; however, we noted that these 

were examples only and that we will 

not restrict the type of community input 

that may be submitted (76 FR 74522). If 

we receive timely comments from the 

community, we will notify the hospital, 

and the hospital will have 30 days after 

such notice to submit a rebuttal 

statement (§ 411.362(c)(5)). 

A request for an exception to the 

facility expansion prohibition is 

considered complete as follows: 

• If the request, any written 

comments, and any rebuttal statement 

include only filed Medicare hospital 

cost report data (Healthcare Cost Report 

Information System (‘‘HCRIS’’) data): (1) 

The end of the 30-day comment period 

if CMS receives no written comments 

from the community; or (2) the end of 

the 30-day rebuttal period if CMS 

receives written comments from the 

community, regardless of whether the 

hospital submitting the request submits 

a rebuttal statement (§ 411.362(c)(5)(i)). 

• If the request, any written 

comments, or any rebuttal statement 

include data from an external data 

source, no later than: (1) 180 days after 

the end of the 30-day comment period 

if CMS receives no written comments 

from the community; and (2) 180 days 

after the end of the 30-day rebuttal 

period if CMS receives written 

comments from the community, 

regardless of whether the hospital 

submitting the request submits a 

rebuttal statement (§ 411.362(c)(5)(ii)). 

The CMS decision to grant or deny a 

hospital’s request for an exception to the 

prohibition on expansion of facility 

capacity must be published in the 

Federal Register in accordance with our 

regulations at § 411.362(c)(7). 

IV. Hospital Exception Request 

As permitted by section 1877(i)(3) of 

the Act and our regulations at 

§ 411.362(c), the following physicianowned hospital has requested an 

exception to the prohibition on 

expansion of facility capacity: 

Name of Facility: Doctors Hospital at 

Renaissance, Ltd. 

Location: 5501 South McColl Road, 

Edinburg, Texas 78539 

Basis for this Exception Request: High 

Medicaid Facility 

We seek comments on this request 

from individuals and entities in the 

community in which the hospital is 

located. We encourage interested parties 

to review the hospital’s request, which 

is posted on the CMS website at: http:// 

www.cms.gov/Medicare/Fraud-andAbuse/PhysicianSelfReferral/Physician_

Owned_Hospitals.html. We especially 

welcome comments regarding whether 

the hospital qualifies as a high Medicaid 

facility. 

Individuals and entities wishing to 

submit comments on the hospital’s 

request should state whether or not they 

are in the community in which the 

hospital is located. We suggest that 

parties review the DATES and ADDRESSES

sections above to ensure timely 

submission of their comments. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

VI. Response to Comments 

We will consider all comments we 

receive by the date and time specified 

in the DATES section of this preamble. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: February 4, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–02739 Filed 2–8–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3404] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Drug User 

Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 11, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https:// 

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0727. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 


lotter on DSK11XQN23PROD with NOTICES1