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, 54565-54566 [2015-22856]
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Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
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 SelfReferral Prohibition
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
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:
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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17:28 Sep 09, 2015
Jkt 235001
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
§ 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
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Fmt 4703
Sfmt 4703
54565
notice of the request in the Federal
Register (§ 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
(§ 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 (§ 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 § 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
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10SEN1
54566
Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
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
§ 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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17:28 Sep 09, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1156]
International Conference on
Harmonisation; Guidance on Q3D
Elemental Impurities; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q3D
Elemental Impurities.’’ The guidance
was prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance establishes permitted
daily exposures for 24 elements in drug
products based on evaluation of toxicity
data. Permitted daily exposures are
provided for each element by three
routes of administration—oral,
parenteral and inhalation. The guidance
also provides for a risk-based approach
to assessing the likelihood that
elemental impurities with established
permitted daily exposures will be
present in a pharmaceutical product.
The guidance is intended to provide a
harmonized approach to control of
elemental impurities in pharmaceutical
products in order to avoid the
uncertainty and duplication of work
that results from different requirements
in different ICH regions.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor,
Silver Spring, MD 20993, or the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: John Kauffman,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 645 S. Newstead Ave.,
St. Louis, MO 63110, 314–539–2168;
Regarding the ICH: Michelle Limoli,
CBER International Programs, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7212,
Silver Spring, MD 20993–0002, 301–
796–8377.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
E:\FR\FM\10SEN1.SGM
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Agencies
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54565-54566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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