Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80111 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2020–27226 Filed 12–10–20; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS- 1758–PN] 

Medicare Program; Request for an 

Exception to the Prohibition on 

Expansion of Facility Capacity Under 

the Hospital Ownership and Rural 

Provider Exceptions to the Physician 

Self-Referral Prohibition 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: The Social Security Act 

prohibits a physician-owned hospital 

from expanding its facility capacity, 

unless the Secretary of the Department 

of Health and Human Services grants 

the hospital’s request for an exception to 

that prohibition after considering input 

on the hospital’s request from 

individuals and entities in the 

community where the hospital is 

located. The Centers for Medicare & 

Medicaid Services has received a 

request from a physician-owned 

hospital for an exception to the 

prohibition against expansion of facility 

capacity. This notice solicits comments 

on the request from individuals and 

entities in the community in which the 

physician-owned hospital is located. 

Community input may inform our 

determination regarding whether the 

requesting hospital qualifies for an 

exception to the prohibition against 

expansion of facility capacity. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on January 11, 2021. 

ADDRESSES: In commenting, refer to file 

code CMS–1758–PN. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three 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 ‘‘Submit a comment’’ instructions. 

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-1758-PN, P.O. Box 8010, 

Baltimore, MD 21244–1850. 

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-1758-PN, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Taft at 410–786–4561 or Joi 

Hosley at 410–786–2194; POHExceptionRequests@cms.hhs.gov. 

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 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

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 meets 

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 meets 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). Thus, since March 23, 2010, 

a physician-owned hospital that seeks to 

avail itself of either exception is 


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80112 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

prohibited from expanding 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 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 

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. 

Section 411.362(c)(3)(ii) specifies the 

acceptable data sources for determining 

whether a hospital qualifies as a high 

Medicaid facility. On November 30, 

2011, we published the CY 2012 OPPS/ 

ASC final rule in the Federal Register, 

which set forth the process for a 

hospital to request an exception from 

the prohibition on facility expansion 

(the exception process) at § 411.362(c) 

and related definitions § 411.362(a) (76 

FR 74122). 

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

provides 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. 

III. Exception Request Process 

On November 30, 2011, we published 

a final rule in the Federal Register (76 

FR 74122, 74517 through 74525) that, 

among other things, finalized 

§ 411.362(c), which specified the 

process for submitting, commenting on, 

and reviewing a request for an exception 

to the prohibition on expansion of 

facility capacity. We published a 

subsequent final rule in the Federal 

Register on November 10, 2014 (79 FR 

66770) that made certain revisions. 

These revisions include, among other 

things, permitting the use of data from 

an external data source or data from the 

Hospital Cost Report Information 

System (HCRIS) for specific eligibility 

criteria. 

As stated in regulations at 

§ 411.362(c)(5), 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 November 30, 2011 final rule 

(76 FR 74522), 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. 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 HCRIS data: (1) The end of the 

30-day comment period if the Centers 

for Medicare & Medicaid Services (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 physicianowned 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 physicianowned hospital submitting the request 

submits a rebuttal statement 

(§ 411.362(c)(5)(ii)). 

If we grant the request for an 

exception to the prohibition on 

expansion of facility capacity, under our 

current regulations, the expansion may 

occur only in facilities on the hospital’s 

main campus and may not result in the 

number of operating rooms, procedure 

rooms, and beds for which the hospital 

is licensed to exceed 200 percent of the 

hospital’s baseline number of operating 

rooms, procedure rooms, and beds 

(§ 411.362(c)(6)). The CMS decision to 


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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80113 

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: Solutions Medical 

Consulting, LLC d/b/a Serenity 

Springs Hospital 

Location: 1495 Frazier Road, Ruston, 

Louisiana 71270–1632 

Basis for 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 solicit 

public comments regarding whether the 

hospital qualifies as a high Medicaid 

facility. Under § 411.362(c)(3), a high 

Medicaid facility is a hospital that 

satisfies all of the following criteria: 

• Is not the sole hospital in the 

county in which the hospital is located. 

• With respect to each of the 3 most 

recent 12-month periods for which data 

are available as of the date the hospital 

submits its request, 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. 

• Does not discriminate against 

beneficiaries of Federal health care 

programs and does not permit 

physicians practicing at the hospital to 

discriminate against such beneficiaries. 

Individuals and entities wishing to 

submit comments on the hospital’s 

request should review the ‘‘DATES’’ and 

‘‘ADDRESSES’’ sections above and state 

whether or not they are in the 

community in which the hospital is 

located. 

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 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Seema Verma, 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: December 8, 2020. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2020–27354 Filed 12–10–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; ORR–3 

and ORR–4 Report Forms for the 

Unaccompanied Refugee Minors 

Program (OMB #0970–0034) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, HHS. 

ACTION: Request for Public Comment. 

SUMMARY: The Office of Refugee 

Resettlement (ORR) is requesting a 3- 

year extension of the ORR–3 and ORR– 

4 Report Forms (OMB #0970–0034, 

expiration 01/31/2021). ORR proposes 

revisions to improve clarity, secure 

outcome-based data, increase 

compliance with reporting 

requirements, and reduce burden. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: The ORR–3 Report is 

submitted within 30 days of the minor’s 

initial placement in the state, within 60 

days of a change in the minor’s status 

(e.g., change in legal responsibility, 

change in foster home placement, 

change in immigration data), and within 

60 days of termination from the 

program. The ORR–4 Report is 

submitted every 12 months beginning 

on the first anniversary of the initial 

placement date, to record outcomes of 

the minor’s progress. 

Respondents: Unaccompanied 

Refugee Minors (URM) State Agencies, 

URM Provider Agencies, and Youth 

Participants. 

Annual Burden Estimates: URM State 

Agencies. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

ORR–3 Unaccompanied Refugee Minors Placement Report ................................................................................... 15 432 0.25 1,620 540 

ORR–4 Unaccompanied Refugee Minors Outcomes Report ................................................................................... 15 282 0.50 2,115 705 


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