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, 3185-3186 [2019-01927]
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Federal Register / Vol. 84, No. 28 / Monday, February 11, 2019 / Notices
[FR Doc. 2019–01928 Filed 2–8–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1721–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 of
St. James Behavioral Health Hospital Inc
for an exception to the prohibition on
expansion of facility capacity.
APPLICABLE DATES: This notice is
effective on February 11, 2019.
FOR FURTHER INFORMATION CONTACT:
POH-ExceptionRequests@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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
VerDate Sep<11>2014
18:05 Feb 08, 2019
Jkt 247001
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 our
regulations at 42 CFR 411.362(c)(2) and
(3)) 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, 74517–74525) 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.
Our regulations at § 411.362(c)(5)
require us to 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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
3185
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 74122), 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 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 physician-owned 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 CMS grants 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
E:\FR\FM\11FEN1.SGM
11FEN1
3186
Federal Register / Vol. 84, No. 28 / Monday, February 11, 2019 / Notices
Federal Register in accordance with our
regulations at § 411.362(c)(7).
III. Public Response to Notice With
Comment Period
On October 24, 2018, we published a
notice in the Federal Register (83 FR
53634) 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 notice,
we stated that, as permitted by section
1877(i)(3) of the Act and our regulations
at § 411.362(c), the following physicianowned hospital requested an exception
to the prohibition on expansion of
facility capacity:
Name of Facility: St. James Behavioral
Health Hospital Inc.
Address: 3136 S Saint Landry Ave.,
Gonzales, Louisiana 70737–5801.
County: Ascension Parish.
Basis for Exception Request: High
Medicaid Facility.
In the notice, we solicited comments
from individuals and entities in the
community in which St. James
Behavioral Health Hospital Inc is
located. During the 30-day public
comment period, we received one
comment. However, the comment was
out of scope because it expressed only
general views regarding the expansion
exception process and was not
community input on St. James
Behavioral Health Hospital Inc’s
exception request.
IV. Decision
This final notice announces our
decision to approve St. James
Behavioral Health Hospital Inc’s request
for an exception to the prohibition
against expansion of facility capacity.
St. James Behavioral Health Hospital Inc
submitted the data and certifications
necessary to demonstrate that it satisfies
the criteria to qualify as a high Medicaid
facility as specified in the November 30,
2011 final rule. In accordance with
section 1877(i)(3) of the Act, we are
granting St. James Behavioral Health
Hospital Inc’s request for an exception
to the expansion of facility capacity
prohibition based on the following
criteria:
• St. James Behavioral Health
Hospital Inc 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
submitted its request, St. James
Behavioral Health Hospital Inc had an
annual percent of total inpatient
admissions under Medicaid that is
VerDate Sep<11>2014
18:05 Feb 08, 2019
Jkt 247001
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
• St. James Behavioral Health
Hospital Inc 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.
Our decision grants St. James
Behavioral Health Hospital Inc’s request
to add a total of 28 operating rooms,
procedure rooms, and beds. Under
§ 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 St. James
Behavioral Health Hospital Inc is
licensed to exceed 200 percent of its
baseline number of operating rooms,
procedure rooms, and beds. St. James
Behavioral Health Hospital Inc certified
that its baseline number of operating
rooms, procedure rooms, and beds is 28.
Accordingly, we find that granting an
additional 28 operating rooms,
procedure rooms, and beds will not
exceed the limitation on a permitted
expansion.
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.).
Dated: January 31, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–01927 Filed 2–8–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–E–5052 and FDA–
2017–E–5054]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EXONDYS 51
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00050
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for EXONDYS 51 and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 12, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 12, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 12, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://www.regulations.gov.
E:\FR\FM\11FEN1.SGM
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Agencies
[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3185-3186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1721-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 of St. James Behavioral Health Hospital Inc for an exception to
the prohibition on expansion of facility capacity.
APPLICABLE DATES: This notice is effective on February 11, 2019.
FOR FURTHER INFORMATION CONTACT: POH-ExceptionRequests@cms.hhs.gov.
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 our regulations at 42 CFR
411.362(c)(2) and (3)) 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, 74517-74525) that, among other things, finalized
Sec. 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.
Our regulations at Sec. 411.362(c)(5) require us to 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 Sec.
411.362(c)(2) and (3). In the November 30, 2011 final rule (76 FR
74122), 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 (Sec. 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 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 physician-owned hospital submitting the
request submits a rebuttal statement (Sec. 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 physician-owned hospital
submitting the request submits a rebuttal statement (Sec.
411.362(c)(5)(ii)).
If CMS grants 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 (Sec.
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
[[Page 3186]]
Federal Register in accordance with our regulations at Sec.
411.362(c)(7).
III. Public Response to Notice With Comment Period
On October 24, 2018, we published a notice in the Federal Register
(83 FR 53634) 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 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: St. James Behavioral Health Hospital Inc.
Address: 3136 S Saint Landry Ave., Gonzales, Louisiana 70737-5801.
County: Ascension Parish.
Basis for Exception Request: High Medicaid Facility.
In the notice, we solicited comments from individuals and entities
in the community in which St. James Behavioral Health Hospital Inc is
located. During the 30-day public comment period, we received one
comment. However, the comment was out of scope because it expressed
only general views regarding the expansion exception process and was
not community input on St. James Behavioral Health Hospital Inc's
exception request.
IV. Decision
This final notice announces our decision to approve St. James
Behavioral Health Hospital Inc's request for an exception to the
prohibition against expansion of facility capacity. St. James
Behavioral Health Hospital Inc submitted the data and certifications
necessary to demonstrate that it satisfies the criteria to qualify as a
high Medicaid facility as specified in the November 30, 2011 final
rule. In accordance with section 1877(i)(3) of the Act, we are granting
St. James Behavioral Health Hospital Inc's request for an exception to
the expansion of facility capacity prohibition based on the following
criteria:
St. James Behavioral Health Hospital Inc 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 submitted its
request, St. James Behavioral Health Hospital Inc had 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
St. James Behavioral Health Hospital Inc 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.
Our decision grants St. James Behavioral Health Hospital Inc's
request to add a total of 28 operating rooms, procedure rooms, and
beds. Under 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 St.
James Behavioral Health Hospital Inc is licensed to exceed 200 percent
of its baseline number of operating rooms, procedure rooms, and beds.
St. James Behavioral Health Hospital Inc certified that its baseline
number of operating rooms, procedure rooms, and beds is 28.
Accordingly, we find that granting an additional 28 operating rooms,
procedure rooms, and beds will not exceed the limitation on a permitted
expansion.
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.).
Dated: January 31, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-01927 Filed 2-8-19; 8:45 am]
BILLING CODE 4120-01-P