80 FR 54565 - Medicare Program; Approval of 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 175 (September 10, 2015)

Page Range		54565-54566
FR Document		2015-22856

This final notice announces our decision to approve the request from Harsha Behavioral Center, Incorporation (HBC) for an exception to the prohibition against expansion of facility capacity.

Federal Register, Volume 80 Issue 175 (Thursday, September 10, 2015)

[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54565-54566]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22856]



[[Page 54565]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1642-FN]


Medicare Program; Approval of 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: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces our decision to approve the 
request from Harsha Behavioral Center, Incorporation (HBC) for an 
exception to the prohibition against expansion of facility capacity.

DATES: Effective Date: This notice is effective on September 11, 2015.

FOR FURTHER INFORMATION CONTACT:
    Patricia Taft, (410) 786-4561.
    Teresa Walden, (410) 786-3755.

SUPPLEMENTARY INFORMATION:

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, known as the 
rural provider exception, for physician ownership or investment 
interests in rural providers. 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)(D) 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. Since March 23, 2010, a physician-owned 
hospital that seeks to 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 facility 
expansion 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 request for the 
exception. Section 1877(i)(3)(H) of the Act states that the Secretary 
shall publish in the Federal Register the final decision with respect 
to the request for an exception to the prohibition against facility 
expansion not later than 60 days after receiving a complete 
application.

II. Exception Approval 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 Sec.  411.362(c), which specifies 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, 66987 through 66997) that made certain revisions to the 
expansion exception process. Because the Centers for Medicare & 
Medicaid Services (CMS) formally accepted this request prior to the 
effective date of that rule, CMS is reviewing and processing the 
request in accordance with the regulations that were published on 
November 30, 2011 and which were in effect at the time of submission.
    In the November 30, 2011 final rule, we specified that prior to our 
review of the request, we will solicit community input on the request 
by publishing a notice of the request in the Federal Register (Sec.  
411.362(c)(5)). We also stated that individuals and entities in the 
hospital's community have 30 days to submit comments on the request. If 
we receive timely comments from the community, we will notify the 
hospital, and the hospital has 30 days after such notice to submit a 
rebuttal statement (Sec.  411.362(c)(5)(ii)). Section 411.362(c)(5) 
also specfies that a request for an exception to the facility expansion 
prohibition is considered complete if no comments from the community 
are received by the close of the 30-day comment period. If we receive 
timely comments from the community, we consider the request to be 
complete 30 days after the hospital is notified of the comments.
    If we grant the request for an exception to the prohibition against 
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 (Sec.  
411.362(c)(6)).

III. Public Response to Notice With Comment Period

    On June 19, 2015, we published a notice in the Federal Register (80 
FR 35363) entitled ``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.'' In 
the June 19, 2015 notice, we stated that as permitted by section 
1877(i)(3) of the Act and our regulations at Sec.  411.362(c), the 
following physician-owned hospital requested an exception to the 
prohibition on expansion of facility capacity:
    Name of Facility: Harsha Behavioral Center, Inc. (HBC).
    Address: 1420 East Crossing Boulevard, Terre Haute, Indiana 47802.
    County: Vigo County, Indiana.
    Basis for Exception Request: High Medicaid Facility.
    In the June 19, 2015 notice, we also solicited comments from 
individuals and entities in the community in which HBC is located. We 
received no comments during the 30-day public comment period. 
Accordingly, CMS deemed the request complete on July 20, 2015, the end 
date of the public comment period.

IV. Decision

    This final notice announces our decision to approve HBC's request 
for

[[Page 54566]]

an exception to the prohibition against expansion of facility capacity. 
As required by the November 30, 2011final rule and our public guidance 
documents, HBC submitted the data and certifications necessary to 
demonstrate that it satisfies the criteria to qualify as a high 
Medicaid facility. In accordance with section 1877(i)(3) of the Act, we 
have granted HBC's request for an exception to the expansion of 
facility capacity prohibition based on the following criteria:
     HBC is not the sole hospital in Vigo, Indiana, the county 
in which it is located;
     HBC certified that it does not discriminate against 
beneficiaries of Federal health care programs and does not permit 
physicians practicing at the hospital to discriminate against such 
beneficiaries; and
     With respect to each of the 3 most recent fiscal years for 
which data were available as of the date HBC submitted its request, it 
has an annual percentage of total inpatient admissions under Medicaid 
that is estimated to be greater than such percentage with respect to 
such admissions for any other hospital located in Vigo County, Indiana, 
the county in which it is located.
    Our approval grants HBC's request to add a total of 44 beds. 
Pursuant to Sec.  411.362(c)(6), 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 HBC is 
licensed to exceed 200 percent of its baseline number of operating 
rooms, procedure rooms, and beds. HBC certified that its baseline 
number of operating rooms, procedure rooms, and beds is 44. 
Accordingly, we find that granting an additional 44 beds will not 
exceed the limitation on a permitted expansion.

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.).

    Dated: August 18, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-22856 Filed 9-9-15; 8:45 am]
 BILLING CODE 4120-01-P

54566 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices

an exception to the prohibition against DEPARTMENT OF HEALTH AND Submit written comments to the
expansion of facility capacity. As HUMAN SERVICES Division of Dockets Management (HFA–
required by the November 30, 2011final 305), Food and Drug Administration,
rule and our public guidance Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville,
documents, HBC submitted the data and [Docket No. FDA–2013–D–1156] MD 20852.
certifications necessary to demonstrate FOR FURTHER INFORMATION CONTACT:
that it satisfies the criteria to qualify as International Conference on Regarding the guidance: John Kauffman,
a high Medicaid facility. In accordance Harmonisation; Guidance on Q3D Center for Drug Evaluation and
with section 1877(i)(3) of the Act, we Elemental Impurities; Availability Research, Food and Drug
have granted HBC’s request for an Administration, 645 S. Newstead Ave.,
exception to the expansion of facility AGENCY: Food and Drug Administration, St. Louis, MO 63110, 314–539–2168;
capacity prohibition based on the HHS. Regarding the ICH: Michelle Limoli,
following criteria: ACTION: Notice. CBER International Programs, Food and
• HBC is not the sole hospital in Vigo, SUMMARY: The Food and Drug Drug Administration, 10903 New
Indiana, the county in which it is Administration (FDA) is announcing the Hampshire Ave., Bldg. 71, Rm. 7212,
located; availability of a guidance entitled ‘‘Q3D Silver Spring, MD 20993–0002, 301–
Elemental Impurities.’’ The guidance 796–8377.
• HBC certified that it does not SUPPLEMENTARY INFORMATION:
discriminate against beneficiaries of was prepared under the auspices of the
Federal health care programs and does International Conference on I. Background
not permit physicians practicing at the Harmonisation of Technical
Requirements for Registration of In recent years, many important
hospital to discriminate against such initiatives have been undertaken by
beneficiaries; and Pharmaceuticals for Human Use (ICH).
The guidance establishes permitted regulatory authorities and industry
• With respect to each of the 3 most daily exposures for 24 elements in drug associations to promote international
recent fiscal years for which data were products based on evaluation of toxicity harmonization of regulatory
available as of the date HBC submitted data. Permitted daily exposures are requirements. FDA has participated in
its request, it has an annual percentage provided for each element by three many meetings designed to enhance
of total inpatient admissions under routes of administration—oral, harmonization and is committed to
Medicaid that is estimated to be greater parenteral and inhalation. The guidance seeking scientifically based harmonized
than such percentage with respect to also provides for a risk-based approach technical procedures for pharmaceutical
such admissions for any other hospital to assessing the likelihood that development. One of the goals of
located in Vigo County, Indiana, the elemental impurities with established harmonization is to identify and then
county in which it is located. permitted daily exposures will be reduce differences in technical
present in a pharmaceutical product. requirements for drug development
Our approval grants HBC’s request to among regulatory agencies.
add a total of 44 beds. Pursuant to The guidance is intended to provide a
ICH was organized to provide an
§ 411.362(c)(6), the expansion may harmonized approach to control of
opportunity for tripartite harmonization
occur only in facilities on the hospital’s elemental impurities in pharmaceutical
initiatives to be developed with input
main campus and may not result in the products in order to avoid the
from both regulatory and industry
number of operating rooms, procedure uncertainty and duplication of work
representatives. FDA also seeks input
rooms, and beds for which HBC is that results from different requirements
from consumer representatives and
licensed to exceed 200 percent of its in different ICH regions.
others. ICH is concerned with
baseline number of operating rooms, DATES: Submit either electronic or harmonization of technical
procedure rooms, and beds. HBC written comments on Agency guidances requirements for the registration of
certified that its baseline number of at any time. pharmaceutical products among three
operating rooms, procedure rooms, and ADDRESSES: Submit written requests for regions: The European Union, Japan,
beds is 44. Accordingly, we find that single copies of the guidance to the and the United States. The six ICH
granting an additional 44 beds will not Division of Drug Information (HFD– sponsors are the European Commission;
exceed the limitation on a permitted 240), Center for Drug Evaluation and the European Federation of
expansion. Research, Food and Drug Pharmaceutical Industries Associations;
Administration, 10001 New Hampshire the Japanese Ministry of Health, Labour,
IV. Collection of Information
Ave., Hillandale Building, 4th Floor, and Welfare; the Japanese
Requirements
Silver Spring, MD 20993, or the Office Pharmaceutical Manufacturers
This document does not impose of Communication, Outreach and Association; the Centers for Drug
information collection requirements, Development, Center for Biologics Evaluation and Research and Biologics
that is, reporting, recordkeeping or Evaluation and Research (CBER), Food Evaluation and Research, FDA; and the
third-party disclosure requirements. and Drug Administration, 10903 New Pharmaceutical Research and
Consequently, there is no need for Hampshire Ave., Bldg. 71, Rm. 3128, Manufacturers of America. The ICH
review by the Office of Management and Silver Spring, MD 20993–0002. Send Secretariat, which coordinates the
Budget under the authority of the one self-addressed adhesive label to preparation of documentation, is
Paperwork Reduction Act of 1995 (44 assist the office in processing your provided by the International
mstockstill on DSK4VPTVN1PROD with NOTICES

U.S.C. 3501 et seq.). requests. The guidance may also be Federation of Pharmaceutical
obtained by mail by calling CBER at 1– Manufacturers Associations (IFPMA).
Dated: August 18, 2015.
800–835–4709 or 240–402–7800. See The ICH Steering Committee includes
Andrew M. Slavitt, the SUPPLEMENTARY INFORMATION section representatives from each of the ICH
Acting Administrator, Centers for Medicare for electronic access to the guidance sponsors and the IFPMA, as well as
& Medicaid Services. document. observers from the World Health
[FR Doc. 2015–22856 Filed 9–9–15; 8:45 am] Submit electronic comments on the Organization, Health Canada, and the
BILLING CODE 4120–01–P guidance to http://www.regulations.gov. European Free Trade Area.

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Document Created: 2015-12-15 10:04:06
Document Modified: 2015-12-15 10:04:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Final notice.
Contact		Patricia Taft, (410) 786-4561.
FR Citation		80 FR 54565

80 FR 54565 - Medicare Program; Approval of 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 175 (September 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services