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 for Rockwall Regional Hospital, Limited Liability Company Doing Business as (d/b/a) Texas Health Presbyterian Hospital Rockwall, 75090-75092 [2016-26119]
Download as PDF
75090
Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
county in which the hospital is located;
and
• The Women’s Hospital 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 The Women’s
Hospital’s request to add a total of 75
operating rooms, procedure rooms, and
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 The Women’s Hospital is
licensed to exceed 200 percent of its
baseline number of operating rooms,
procedure rooms, and beds. The
Women’s Hospital certified that its
baseline number of operating rooms,
procedure rooms, and beds is 81.
Accordingly, we find that granting an
additional 75 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: October 3, 2016.
Andrew M. Slavitt
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–26117 Filed 10–27–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
mstockstill on DSK3G9T082PROD with NOTICES
[CMS–1661–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 for Rockwall
Regional Hospital, Limited Liability
Company Doing Business as (d/b/a)
Texas Health Presbyterian Hospital
Rockwall
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
VerDate Sep<11>2014
18:12 Oct 27, 2016
Jkt 241001
ACTION:
Final notice.
This final notice announces
our decision to approve the request of
Rockwall Regional Hospital, Limited
Liability Company (LLC) doing business
as (d/b/a) Texas Health Presbyterian
Hospital Rockwall (Texas Health
Rockwall) for an exception to the
prohibition on expansion of facility
capacity.
SUMMARY:
Effective Date: This notice is
effective on October 28, 2016.
FOR FURTHER INFORMATION CONTACT:
POH-ExceptionRequests@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
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
PO 00000
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Fmt 4703
Sfmt 4703
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 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
E:\FR\FM\28OCN1.SGM
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Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
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 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. Public Response to Notice With
Comment Period
On February 2, 2016, we published a
notice in the Federal Register (81 FR
5463) entitled ‘‘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.’’ In the notice, we
stated that, as permitted by section
1877(i)(3) of the Act and our regulations
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18:12 Oct 27, 2016
Jkt 241001
at § 411.362(c), the following physicianowned hospital 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.
Address: 3150 Horizon Road,
Rockwall County, Texas 75032–7805.
County: Rockwall County, Texas
Basis for Exception Request:
Applicable Hospital.
In the notice, we solicited comments
from individuals and entities in the
community in which Texas Health
Rockwall is located. We received 43
comments during the 30-day public
comment period. Forty-two comments
were in favor of the request and one was
in opposition.
The commenter that opposed the
expansion request asserted that Texas
Health Rockwall did not meet the
inpatient Medicaid admissions criterion
at § 411.362(c)(2)(ii). The commenter
expressed concern that the HCRIS, the
data source used by Texas Health
Rockwall to demonstrate satisfaction of
the inpatient Medicaid admissions
criterion, does not accurately reflect all
Medicaid admissions and discharges.
The commenter expressed its belief that
information from a different source, the
Texas Health Care Information
Collection (THCIC), does not indicate
that Texas Health Rockwall’s satisfied
the inpatient Medicaid admissions
criterion.
On April 13, 2016, Texas Health
Rockwall submitted a rebuttal statement
in response to the comment opposing its
request. The statement satisfactorily
rebutted the commenters’ assertions
regarding the inpatient Medicaid
admissions criterion and addressed the
concerns expressed by the commenter
regarding HCRIS and THCIC data.
IV. Decision
This final notice announces our
decision to approve Texas Health
Rockwall’s request for an exception to
the prohibition against expansion of
facility capacity. As required by the
November 30, 2011 final rule (76 FR
74122) and our public guidance
documents, Texas Health Rockwall
submitted the data and certifications
necessary to demonstrate that it satisfies
the criteria to qualify as an applicable
hospital. In accordance with section
1877(i)(3) of the Act, we are granting
Texas Health Rockwall’s request for an
exception to the expansion of facility
capacity prohibition based on the
following criteria:
• Texas Health Rockwall is located in
a county that had a percentage increase
in population that is at least 150 percent
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Fmt 4703
Sfmt 4703
75091
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 submitted its
request;
• Texas Health Rockwall had 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 fiscal year for which data are
available as of the date that the hospital
submitted its request;
• Texas Health Rockwall 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;
• Texas Health Rockwall is located in
a State in which the average bed
capacity in the State was less than the
national average bed capacity during the
most recent fiscal year for which data
are available as of the date that the
hospital submitted its request; and
• Texas Health Rockwall had an
average bed occupancy rate that was
greater than the average bed occupancy
rate in the State in which the hospital
is located during the most recent fiscal
year for which data are available as of
the date that the hospital submitted its
request.
Our decision grants Texas Health
Rockwall’s request to add a total of 60
operating rooms, procedure rooms, and
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 Texas Health Rockwall is
licensed to exceed 200 percent of its
baseline number of operating rooms,
procedure rooms, and beds. Texas
Health Rockwall certified that its
baseline number of operating rooms,
procedure rooms, and beds is 60.
Accordingly, we find that granting an
additional 60 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.).
E:\FR\FM\28OCN1.SGM
28OCN1
75092
Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
Dated: October 3, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–26119 Filed 10–27–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3330]
Authorizations of Emergency Use of In
Vitro Diagnostic Devices for Detection
and/or Diagnosis of Zika Virus;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of four Emergency Use
Authorizations (EUAs) (the
Authorizations) for four in vitro
diagnostic devices for detection and/or
diagnosis of Zika virus in response to
the Zika virus outbreak in the Americas.
FDA issued these Authorizations under
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by
Siemens Healthcare Diagnostics, Inc.,
Luminex Corporation, InBios
International, Inc., and Roche Molecular
Systems, Inc. The Authorizations
contain, among other things, conditions
on the emergency use of the authorized
in vitro diagnostic devices. The
Authorizations follow the February 26,
2016, determination by the Secretary of
Health and Human Services (HHS) that
there is a significant potential for a
public health emergency that has a
significant potential to affect national
security or the health and security of
U.S. citizens living abroad and that
involves Zika virus. On the basis of such
determination, the Secretary of HHS
declared on February 26, 2016, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostic tests for detection of
Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of
any authorization issued under the
FD&C Act. The Authorizations, which
include an explanation of the reasons
for issuance, are reprinted in this
document.
DATES: The Authorization for Siemens
Healthcare Diagnostics, Inc., is effective
as of July 29, 2016; the Authorization for
Luminex Corporation is effective as of
August 4, 2016; the Authorization for
InBios International, Inc., is effective as
of August 17, 2016; and the
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:12 Oct 27, 2016
Jkt 241001
Authorization for Roche Molecular
Systems, Inc., is effective as of August
26, 2016.
ADDRESSES: Submit written requests for
single copies of the EUAs to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorizations.
FOR FURTHER INFORMATION CONTACT:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4336, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces of
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
under section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 1 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that: (A) The
product may be effective in diagnosing,
1 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
E:\FR\FM\28OCN1.SGM
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Agencies
[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Notices]
[Pages 75090-75092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26119]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1661-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 for Rockwall Regional Hospital, Limited Liability Company
Doing Business as (d/b/a) Texas Health Presbyterian Hospital Rockwall
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
request of Rockwall Regional Hospital, Limited Liability Company (LLC)
doing business as (d/b/a) Texas Health Presbyterian Hospital Rockwall
(Texas Health Rockwall) for an exception to the prohibition on
expansion of facility capacity.
DATES: Effective Date: This notice is effective on October 28, 2016.
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 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 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 Sec. 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 Sec.
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
[[Page 75091]]
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 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 (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 Federal Register in accordance with our
regulations at Sec. 411.362(c)(7).
III. Public Response to Notice With Comment Period
On February 2, 2016, we published a notice in the Federal Register
(81 FR 5463) 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: Rockwall Regional Hospital, LLC, d/b/a Texas
Health Presbyterian Hospital Rockwall.
Address: 3150 Horizon Road, Rockwall County, Texas 75032-7805.
County: Rockwall County, Texas
Basis for Exception Request: Applicable Hospital.
In the notice, we solicited comments from individuals and entities
in the community in which Texas Health Rockwall is located. We received
43 comments during the 30-day public comment period. Forty-two comments
were in favor of the request and one was in opposition.
The commenter that opposed the expansion request asserted that
Texas Health Rockwall did not meet the inpatient Medicaid admissions
criterion at Sec. 411.362(c)(2)(ii). The commenter expressed concern
that the HCRIS, the data source used by Texas Health Rockwall to
demonstrate satisfaction of the inpatient Medicaid admissions
criterion, does not accurately reflect all Medicaid admissions and
discharges. The commenter expressed its belief that information from a
different source, the Texas Health Care Information Collection (THCIC),
does not indicate that Texas Health Rockwall's satisfied the inpatient
Medicaid admissions criterion.
On April 13, 2016, Texas Health Rockwall submitted a rebuttal
statement in response to the comment opposing its request. The
statement satisfactorily rebutted the commenters' assertions regarding
the inpatient Medicaid admissions criterion and addressed the concerns
expressed by the commenter regarding HCRIS and THCIC data.
IV. Decision
This final notice announces our decision to approve Texas Health
Rockwall's request for an exception to the prohibition against
expansion of facility capacity. As required by the November 30, 2011
final rule (76 FR 74122) and our public guidance documents, Texas
Health Rockwall submitted the data and certifications necessary to
demonstrate that it satisfies the criteria to qualify as an applicable
hospital. In accordance with section 1877(i)(3) of the Act, we are
granting Texas Health Rockwall's request for an exception to the
expansion of facility capacity prohibition based on the following
criteria:
Texas Health Rockwall is located in a county that had 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 submitted its request;
Texas Health Rockwall had 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 fiscal year for which data are available as of the date that the
hospital submitted its request;
Texas Health Rockwall 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;
Texas Health Rockwall is located in a State in which the
average bed capacity in the State was less than the national average
bed capacity during the most recent fiscal year for which data are
available as of the date that the hospital submitted its request; and
Texas Health Rockwall had an average bed occupancy rate
that was greater than the average bed occupancy rate in the State in
which the hospital is located during the most recent fiscal year for
which data are available as of the date that the hospital submitted its
request.
Our decision grants Texas Health Rockwall's request to add a total
of 60 operating rooms, procedure rooms, and 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 Texas Health Rockwall is
licensed to exceed 200 percent of its baseline number of operating
rooms, procedure rooms, and beds. Texas Health Rockwall certified that
its baseline number of operating rooms, procedure rooms, and beds is
60. Accordingly, we find that granting an additional 60 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.).
[[Page 75092]]
Dated: October 3, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-26119 Filed 10-27-16; 8:45 am]
BILLING CODE 4120-01-P