Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5463 

[FR Doc. 2016–01836 Filed 2–1–16; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1661–NC] 

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 (the 

Act) prohibits a physician-owned 

hospital from expanding its facility 

capacity, unless the Secretary of the 

Department of Health and Human 

Services (the Secretary) 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 (CMS) 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: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

March 3, 2016. 

ADDRESSES: In commenting, please refer 

to file code CMS–1661–NC. 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 ‘‘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–1661–NC, 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–1661–NC, 

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 only 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.) 

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. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

FOR FURTHER INFORMATION CONTACT: 

POH-ExceptionRequests@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 

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. 

We will allow stakeholders 30 days 

from the date of this notice to submit 

written comments. Comments received 

timely will be available for public 

inspection as they are received, 

generally beginning approximately 3 

weeks after publication of this notice, 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, please phone 1– 

800–743–3951. 

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’’ 

(DHS) payable by Medicare to an entity 

with which he or she (or an immediate 

family member) has a financial 

relationship (ownership or 

compensation), 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 those DHS furnished as a result of a 

prohibited referral. 

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

an exception for physician ownership or 

investment interests in rural providers 

(the ‘‘rural provider exception’’). In 

order for an entity to qualify for the 

rural provider exception, the DHS must 

be furnished in a rural area (as defined 

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

substantially all the DHS furnished by 

the entity must be furnished to 

individuals residing in a rural area. 

Section 1877(d)(3) of the Act provides 

an exception, known as the hospital 

ownership exception, for physician 

ownership or investment interests held 

in a hospital located outside of Puerto 

Rico, provided that the referring 

physician is authorized to perform 

services at the hospital and the 

ownership or investment interest is in 

the hospital itself (and not merely in a 

subdivision of the hospital). 

Section 6001(a)(3) of the Patient 

Protection and Affordable Care Act 

(Pub. L. 111–148) as amended by the 

Health Care and Education 

Reconciliation Act of 2010 (Pub. L. 111– 

152) (hereafter referred to together as 

‘‘the Affordable Care Act’’) amended the 

rural provider and hospital ownership 

exceptions to the physician self-referral 

prohibition to impose additional 

restrictions on physician ownership and 

investment in hospitals and rural 

providers. Since March 23, 2010, a 

physician-owned hospital that seeks to 


wgreen on DSK2VPTVN1PROD with NOTICES
5464 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 

avail itself of either exception is 

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 of the 

Department of Health and Human 

Services (the Secretary). 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 Web site at: http://

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

Owned_Hospitals.html. 

II. 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)(ii)). 

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 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, 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 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). 

III. 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: Rockwall Regional 

Hospital, LLC, d/b/a Texas Health 

Presbyterian Hospital Rockwall. 

Location: 3150 Horizon Road, 

Rockwall County, Texas 75032–7805. 

Basis for Exception Request: 

Applicable Hospital. 

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 Web site at: 

http://www.cms.gov/Medicare/Fraudand-Abuse/PhysicianSelfReferral/ 

Physician_Owned_Hospitals.html. We 

especially welcome comments regarding 

whether the hospital qualifies as an 

applicable hospital. Under 

§ 411.362(c)(2), an applicable hospital is 

a hospital that satisfies all of the 

following criteria: 

• The hospital is located in a county 

that has a percentage increase in 

population that is at least 150 percent of 

the percentage increase in population of 

the State in which the hospital is 

located during the most recent 5-year 

period for which data are available as of 

the date that the hospital submits its 

request. 

• The hospital has an annual percent 

of total inpatient admissions under 

Medicaid that is equal to or greater than 

the average percent with respect to such 

admissions for all hospitals located 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. The most recent 12- 

month period for which data are 

available means the most recent 12- 

month period for which the data source 

used contains all data from the 

requesting hospital and each hospital 

located in the same county as the 

requesting hospital. 

• The hospital 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 hospital is located in a State in 

which the average bed capacity in the 

State is less than the national average 

bed capacity during the most recent 

fiscal year for which HCRIS, as of the 

date that the hospital submits its 

request, contains data from a sufficient 

number of hospitals to determine a 

State’s average bed capacity and the 

national average bed capacity. 

• The hospital has an average bed 

occupancy rate that is greater than the 

average bed occupancy rate in the State 

in which the hospital is located during 

the most recent fiscal year for which 

HCRIS, as of the date that the hospital 

submits its request, contains data from 

a sufficient number of hospitals to 

determine the requesting hospital’s 

average bed occupancy rate and the 

relevant State’s average bed occupancy 

rate. 

Individuals and entities wishing to 

submit comments on the hospital’s 

request should review the DATES and 


wgreen on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5465 

ADDRESSES sections above and state 

whether or not they are in the 

community in which the hospital is 

located. 

IV. 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.). 

V. Response to Public 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. 

Dated: January 6, 2016. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2016–01830 Filed 2–1–16; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0662] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Applications for 

Food and Drug Administration 

Approval to Market a New Drug: Patent 

Submission and Listing Requirements 

and Application of 30-Month Stays on 

Approval of Abbreviated New Drug 

Applications Certifying That a Patent 

Claiming a Drug Is Valid or Will Not Be 

Infringed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements for 

submission and listing of patent 

information associated with a new drug 

application (NDA), an amendment, or a 

supplement. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 4, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–0662 for ‘‘Agency Information 

Collection Activities: Proposed 

Collection; Comment Request; 

Applications for Food and Drug 

Administration Approval to Market a 

New Drug: Patent Submission and 

Listing Requirements and Application 

of 30-Month Stays on Approval of 

Abbreviated New Drug Applications.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION’’. The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on http:// 

www.regulations.gov. Submit both 

copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 


wgreen on DSK2VPTVN1PROD with NOTICES