81 FR 75090 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 209 (October 28, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 209 (October 28, 2016)
| Page Range | 75090-75092 | |
| FR Document | 2016-26119 |
[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)] [Notices] [Pages 75090-75092] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![75090 Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
county in which the hospital is located; ACTION: Final notice. investment in hospitals. Since March
and 23, 2010, a physician-owned hospital
• The Women’s Hospital certified that SUMMARY: This final notice announces that seeks to avail itself of either
it does not discriminate against our decision to approve the request of exception is prohibited from expanding
beneficiaries of Federal health care Rockwall Regional Hospital, Limited facility capacity unless it qualifies as an
programs and does not permit Liability Company (LLC) doing business ‘‘applicable hospital’’ or ‘‘high Medicaid
physicians practicing at the hospital to as (d/b/a) Texas Health Presbyterian facility’’ (as defined in sections
discriminate against such beneficiaries. Hospital Rockwall (Texas Health 1877(i)(3)(E), (F) of the Act and 42 CFR
Our decision grants The Women’s Rockwall) for an exception to the 411.362(c)(2), (3) of our regulations) and
Hospital’s request to add a total of 75 prohibition on expansion of facility has been granted an exception to the
operating rooms, procedure rooms, and capacity. facility expansion prohibition by the
beds. Pursuant to § 411.362(c)(6), the DATES: Effective Date: This notice is Secretary of the Department of Health
expansion may occur only in facilities effective on October 28, 2016. and Human Services (the Secretary).
on the hospital’s main campus and may Section 1877(i)(3)(A)(ii) of the Act
FOR FURTHER INFORMATION CONTACT:
not result in the number of operating provides that individuals and entities in
POH-ExceptionRequests@cms.hhs.gov.
rooms, procedure rooms, and beds for the community in which the provider
which The Women’s Hospital is SUPPLEMENTARY INFORMATION:
requesting the exception is located must
licensed to exceed 200 percent of its I. Background have an opportunity to provide input
baseline number of operating rooms, with respect to the provider’s request for
procedure rooms, and beds. The Section 1877 of the Social Security
the exception. Section 1877(i)(3)(H) of
Women’s Hospital certified that its Act (the Act), also known as the
the Act states that the Secretary shall
baseline number of operating rooms, physician self-referral law—(1) prohibits
publish in the Federal Register the final
procedure rooms, and beds is 81. a physician from making referrals for
decision with respect to the request for
Accordingly, we find that granting an certain ‘‘designated health services’’
an exception to the prohibition against
additional 75 operating rooms, (DHS) payable by Medicare to an entity
facility expansion not later than 60 days
procedure rooms, and beds will not with which he or she (or an immediate
after receiving a complete application.
exceed the limitation on a permitted family member) has a financial
expansion. relationship (ownership or II. Exception Approval Process
compensation), unless the requirements On November 30, 2011, we published
V. Collection of Information of an applicable exception are satisfied; a final rule in the Federal Register (76
Requirements and (2) prohibits the entity from filing FR 74122, 74517 through 74525) that,
This document does not impose claims with Medicare (or billing another among other things, finalized
information collection requirements, individual, entity, or third party payer) § 411.362(c), which specified the
that is, reporting, recordkeeping or for those DHS furnished as a result of a process for submitting, commenting on,
third-party disclosure requirements. prohibited referral. and reviewing a request for an exception
Consequently, there is no need for Section 1877(d)(2) of the Act provides to the prohibition on expansion of
review by the Office of Management and an exception, known as the rural facility capacity. We published a
Budget under the authority of the provider exception, for physician subsequent final rule in the Federal
Paperwork Reduction Act of 1995 (44 ownership or investment interests in Register on November 10, 2014 (79 FR
U.S.C. 3501 et seq.). rural providers. In order for an entity to 66770) that made certain revisions.
Dated: October 3, 2016. qualify for the rural provider exception, These revisions include, among other
the DHS must be furnished in a rural things, permitting the use of data from
Andrew M. Slavitt
area (as defined in section 1886(d)(2)(D) an external data source or data from the
Acting Administrator, Centers for Medicare
& Medicaid Services.
of the Act) and substantially all the DHS Hospital Cost Report Information
furnished by the entity must be System (HCRIS) for specific eligibility
[FR Doc. 2016–26117 Filed 10–27–16; 8:45 am]
furnished to individuals residing in a criteria.
BILLING CODE 4120–01–P
rural area. As stated in regulations at
Section 1877(d)(3) of the Act provides § 411.362(c)(5), we will solicit
an exception, known as the hospital community input on the request for an
DEPARTMENT OF HEALTH AND
ownership exception, for physician exception by publishing a notice of the
HUMAN SERVICES
ownership or investment interests held request in the Federal Register.
Centers for Medicare & Medicaid in a hospital located outside of Puerto Individuals and entities in the hospital’s
Services Rico, provided that the referring community will have 30 days to submit
physician is authorized to perform comments on the request. Community
[CMS–1661–FN] services at the hospital and the input must take the form of written
ownership or investment interest is in comments and may include
Medicare Program; Approval of
the hospital itself (and not merely in a documentation demonstrating that the
Request for an Exception to the
subdivision of the hospital). physician-owned hospital requesting
Prohibition on Expansion of Facility
Section 6001(a)(3) of the Patient the exception does or does not qualify
Capacity Under the Hospital
Protection and Affordable Care Act as an applicable hospital or high
Ownership and Rural Provider
(Pub. L. 111–148) as amended by the Medicaid facility, as such terms are
Exceptions to the Physician Self-
Health Care and Education defined in § 411.362(c)(2) and (3). In the
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Referral Prohibition for Rockwall
Reconciliation Act of 2010 (Pub. L. 111– November 30, 2011 final rule (76 FR
Regional Hospital, Limited Liability
152) (hereafter referred to together as 74522), we gave examples of community
Company Doing Business as (d/b/a)
‘‘the Affordable Care Act’’) amended the input, such as documentation
Texas Health Presbyterian Hospital
rural provider and hospital ownership demonstrating that the hospital does not
Rockwall
exceptions to the physician self-referral satisfy one or more of the data criteria
AGENCY: Centers for Medicare & prohibition to impose additional or that the hospital discriminates
Medicaid Services (CMS), HHS. restrictions on physician ownership and against beneficiaries of Federal health
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![75092 Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
Dated: October 3, 2016. Authorization for Roche Molecular attack with a biological, chemical,
Andrew M. Slavitt, Systems, Inc., is effective as of August radiological, or nuclear agent or agents;
Acting Administrator, Centers for Medicare 26, 2016. (3) a determination by the Secretary of
& Medicaid Services. ADDRESSES: Submit written requests for HHS that there is a public health
[FR Doc. 2016–26119 Filed 10–27–16; 8:45 am] single copies of the EUAs to the Office emergency, or a significant potential for
BILLING CODE 4120–01–P of Counterterrorism and Emerging a public health emergency, that affects,
Threats, Food and Drug Administration, or has a significant potential to affect,
10903 New Hampshire Ave., Bldg. 1, national security or the health and
DEPARTMENT OF HEALTH AND Rm. 4338, Silver Spring, MD 20993– security of U.S. citizens living abroad,
HUMAN SERVICES 0002. Send one self-addressed adhesive and that involves a biological, chemical,
label to assist that office in processing radiological, or nuclear agent or agents,
Food and Drug Administration your request or include a fax number to or a disease or condition that may be
[Docket No. FDA–2016–N–3330] which the Authorizations may be sent. attributable to such agent or agents; or
See the SUPPLEMENTARY INFORMATION (4) the identification of a material threat
Authorizations of Emergency Use of In section for electronic access to the by the Secretary of Homeland Security
Vitro Diagnostic Devices for Detection Authorizations. under section 319F–2 of the Public
and/or Diagnosis of Zika Virus; Health Service (PHS) Act (42 U.S.C.
FOR FURTHER INFORMATION CONTACT:
Availability 247d–6b) sufficient to affect national
Michael Mair, Office of
security or the health and security of
AGENCY: Food and Drug Administration, Counterterrorism and Emerging Threats,
U.S. citizens living abroad.
HHS. Food and Drug Administration, 10903
Once the Secretary of HHS has
ACTION: Notice. New Hampshire Ave., Bldg. 1, Rm.
declared that circumstances exist
4336, Silver Spring, MD 20993–0002,
justifying an authorization under
SUMMARY: The Food and Drug 301–796–8510 (this is not a toll-free
section 564 of the FD&C Act, FDA may
Administration (FDA) is announcing the number).
authorize the emergency use of a drug,
issuance of four Emergency Use SUPPLEMENTARY INFORMATION: device, or biological product if the
Authorizations (EUAs) (the
I. Background Agency concludes that the statutory
Authorizations) for four in vitro
criteria are satisfied. Under section
diagnostic devices for detection and/or Section 564 of the FD&C Act (21 564(h)(1) of the FD&C Act, FDA is
diagnosis of Zika virus in response to U.S.C. 360bbb–3) as amended by the
the Zika virus outbreak in the Americas. required to publish in the Federal
Project BioShield Act of 2004 (Pub L. Register a notice of each authorization,
FDA issued these Authorizations under 108–276) and the Pandemic and All-
the Federal Food, Drug, and Cosmetic and each termination or revocation of an
Hazards Preparedness Reauthorization authorization, and an explanation of the
Act (the FD&C Act), as requested by Act of 2013 (Pub L. 113–5) allows FDA
Siemens Healthcare Diagnostics, Inc., reasons for the action. Section 564 of the
to strengthen the public health FD&C Act permits FDA to authorize the
Luminex Corporation, InBios protections against biological, chemical,
International, Inc., and Roche Molecular introduction into interstate commerce of
nuclear, and radiological agents. Among a drug, device, or biological product
Systems, Inc. The Authorizations other things, section 564 of the FD&C
contain, among other things, conditions intended for use when the Secretary of
Act allows FDA to authorize the use of HHS has declared that circumstances
on the emergency use of the authorized an unapproved medical product or an
in vitro diagnostic devices. The exist justifying the authorization of
unapproved use of an approved medical emergency use. Products appropriate for
Authorizations follow the February 26, product in certain situations. With this
2016, determination by the Secretary of emergency use may include products
EUA authority, FDA can help assure and uses that are not approved, cleared,
Health and Human Services (HHS) that that medical countermeasures may be
there is a significant potential for a or licensed under sections 505, 510(k),
used in emergencies to diagnose, treat, or 515 of the FD&C Act (21 U.S.C. 355,
public health emergency that has a or prevent serious or life-threatening
significant potential to affect national 360(k), and 360e) or section 351 of the
diseases or conditions caused by PHS Act (42 U.S.C. 262). FDA may issue
security or the health and security of biological, chemical, nuclear, or
U.S. citizens living abroad and that an EUA only if, after consultation with
radiological agents when there are no the HHS Assistant Secretary for
involves Zika virus. On the basis of such adequate, approved, and available
determination, the Secretary of HHS Preparedness and Response, the
alternatives. Director of the National Institutes of
declared on February 26, 2016, that Section 564(b)(1) of the FD&C Act
circumstances exist justifying the Health, and the Director of the Centers
provides that, before an EUA may be for Disease Control and Prevention (to
authorization of emergency use of in issued, the Secretary of HHS must
vitro diagnostic tests for detection of the extent feasible and appropriate
declare that circumstances exist given the applicable circumstances),
Zika virus and/or diagnosis of Zika justifying the authorization based on
virus infection, subject to the terms of FDA 1 concludes: (1) That an agent
one of the following grounds: (1) A
any authorization issued under the referred to in a declaration of emergency
determination by the Secretary of
FD&C Act. The Authorizations, which or threat can cause a serious or life-
Homeland Security that there is a
include an explanation of the reasons threatening disease or condition; (2)
domestic emergency, or a significant
for issuance, are reprinted in this that, based on the totality of scientific
potential for a domestic emergency,
document. evidence available to FDA, including
involving a heightened risk of attack
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data from adequate and well-controlled
DATES: The Authorization for Siemens with a biological, chemical, radiological,
clinical trials, if available, it is
Healthcare Diagnostics, Inc., is effective or nuclear agent or agents; (2) a
reasonable to believe that: (A) The
as of July 29, 2016; the Authorization for determination by the Secretary of
product may be effective in diagnosing,
Luminex Corporation is effective as of Defense that there is a military
August 4, 2016; the Authorization for emergency, or a significant potential for 1 The Secretary of HHS has delegated the
InBios International, Inc., is effective as a military emergency, involving a authority to issue an EUA under section 564 of the
of August 17, 2016; and the heightened risk to U.S. military forces of FD&C Act to the Commissioner of Food and Drugs.
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Document Created: 2018-02-13 16:39:45
Document Modified: 2018-02-13 16:39:45
| 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. | |
| Dates | Effective Date: This notice is effective on October 28, 2016. | |
| Contact | [email protected] | |
| FR Citation | 81 FR 75090 |
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