81 FR 5463 - Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 21 (February 2, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 21 (February 2, 2016)
| Page Range | 5463-5465 | |
| FR Document | 2016-01830 |
[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)] [Notices] [Pages 5463-5465] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01830] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1661-NC] Medicare Program; 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: Notice with request for comment. ----------------------------------------------------------------------- SUMMARY: The Social Security Act (the Act) prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services (the Secretary) grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity. DATES: Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 3, 2016. ADDRESSES: In commenting, please refer to file code CMS-1661-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the ``Submit a comment'' instructions. 2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1661-NC, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1661-NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments only to the following addresses: a. For delivery in Washington, DC-- Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp- in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. FOR FURTHER INFORMATION CONTACT: [email protected]. SUPPLEMENTARY INFORMATION: Inspection of Public Comments All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments. We will allow stakeholders 30 days from the date of this notice to submit written comments. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of this notice, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, please phone 1-800-743-3951. 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 for physician ownership or investment interests in rural providers (the ``rural provider exception''). 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) 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 and rural providers. Since March 23, 2010, a physician-owned hospital that seeks to [[Page 5464]] 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 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 application for the exception. For further information, we refer readers to the CMS Web site at: http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Physician_Owned_Hospitals.html. II. Exception Request 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 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 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. Hospital Exception Request As permitted by section 1877(i)(3) of the Act and our regulations at Sec. 411.362(c), the following physician-owned hospital has 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. Location: 3150 Horizon Road, Rockwall County, Texas 75032-7805. Basis for Exception Request: Applicable Hospital. We seek comments on this request from individuals and entities in the community in which the hospital is located. We encourage interested parties to review the hospital's request, which is posted on the CMS Web site at: http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Physician_Owned_Hospitals.html. We especially welcome comments regarding whether the hospital qualifies as an applicable hospital. Under Sec. 411.362(c)(2), an applicable hospital is a hospital that satisfies all of the following criteria: The hospital is located in a county that has 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 submits its request. The hospital has 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 12- month period for which data are available as of the date that the hospital submits its request. The most recent 12-month period for which data are available means the most recent 12-month period for which the data source used contains all data from the requesting hospital and each hospital located in the same county as the requesting hospital. The hospital does not discriminate against beneficiaries of Federal health care programs and does not permit physicians practicing at the hospital to discriminate against such beneficiaries. The hospital is located in a State in which the average bed capacity in the State is less than the national average bed capacity during the most recent fiscal year for which HCRIS, as of the date that the hospital submits its request, contains data from a sufficient number of hospitals to determine a State's average bed capacity and the national average bed capacity. The hospital has an average bed occupancy rate that is greater than the average bed occupancy rate in the State in which the hospital is located during the most recent fiscal year for which HCRIS, as of the date that the hospital submits its request, contains data from a sufficient number of hospitals to determine the requesting hospital's average bed occupancy rate and the relevant State's average bed occupancy rate. Individuals and entities wishing to submit comments on the hospital's request should review the DATES and [[Page 5465]] ADDRESSES sections above and state whether or not they are in the community in which the hospital is located. 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.). V. Response to Public Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Dated: January 6, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016-01830 Filed 2-1-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5463
[FR Doc. 2016–01836 Filed 2–1–16; 8:45 am] Health and Human Services, Attention: We will allow stakeholders 30 days
BILLING CODE 4120–01–P CMS–1661–NC, P.O. Box 8010, from the date of this notice to submit
Baltimore, MD 21244–8010. written comments. Comments received
Please allow sufficient time for mailed timely will be available for public
DEPARTMENT OF HEALTH AND comments to be received before the inspection as they are received,
HUMAN SERVICES close of the comment period. generally beginning approximately 3
3. By express or overnight mail. You weeks after publication of this notice, at
Centers for Medicare & Medicaid may send written comments to the the headquarters of the Centers for
Services following address only: Centers for Medicare & Medicaid Services, 7500
[CMS–1661–NC] Medicare & Medicaid Services, Security Boulevard, Baltimore,
Department of Health and Human Maryland 21244, Monday through
Medicare Program; Request for an Services, Attention: CMS–1661–NC, Friday of each week from 8:30 a.m. to
Exception to the Prohibition on Mail Stop C4–26–05, 7500 Security 4 p.m. To schedule an appointment to
Expansion of Facility Capacity Under Boulevard, Baltimore, MD 21244–1850. view public comments, please phone 1–
the Hospital Ownership and Rural 4. By hand or courier. Alternatively, 800–743–3951.
Provider Exceptions to the Physician you may deliver (by hand or courier) I. Background
Self-Referral Prohibition your written comments only to the
following addresses: Section 1877 of the Social Security
AGENCY: Centers for Medicare & Act (the Act), also known as the
a. For delivery in Washington, DC—
Medicaid Services (CMS), HHS. physician self-referral law—(1) prohibits
Centers for Medicare & Medicaid
ACTION: Notice with request for a physician from making referrals for
Services, Department of Health and
comment. Human Services, Room 445–G, Hubert certain ‘‘designated health services’’
H. Humphrey Building, 200 (DHS) payable by Medicare to an entity
SUMMARY: The Social Security Act (the with which he or she (or an immediate
Act) prohibits a physician-owned Independence Avenue SW.,
Washington, DC 20201. family member) has a financial
hospital from expanding its facility relationship (ownership or
capacity, unless the Secretary of the (Because access to the interior of the
Hubert H. Humphrey Building is not compensation), unless the requirements
Department of Health and Human of an applicable exception are satisfied;
Services (the Secretary) grants the readily available to persons without
Federal government identification, and (2) prohibits the entity from filing
hospital’s request for an exception to claims with Medicare (or billing another
that prohibition after considering input commenters are encouraged to leave
their comments in the CMS drop slots individual, entity, or third party payer)
on the hospital’s request from for those DHS furnished as a result of a
individuals and entities in the located in the main lobby of the
building. A stamp-in clock is available prohibited referral.
community where the hospital is Section 1877(d)(2) of the Act provides
located. The Centers for Medicare & for persons wishing to retain a proof of
an exception for physician ownership or
Medicaid Services (CMS) has received a filing by stamping in and retaining an
investment interests in rural providers
request from a physician-owned extra copy of the comments being filed.)
(the ‘‘rural provider exception’’). In
hospital for an exception to the b. For delivery in Baltimore, MD—
order for an entity to qualify for the
prohibition against expansion of facility Centers for Medicare & Medicaid rural provider exception, the DHS must
capacity. This notice solicits comments Services, Department of Health and be furnished in a rural area (as defined
on the request from individuals and Human Services, 7500 Security in section 1886(d)(2) of the Act) and
entities in the community in which the Boulevard, Baltimore, MD 21244–1850. substantially all the DHS furnished by
physician-owned hospital is located. If you intend to deliver your the entity must be furnished to
Community input may inform our comments to the Baltimore address, call individuals residing in a rural area.
determination regarding whether the telephone number (410) 786–9994 in Section 1877(d)(3) of the Act provides
requesting hospital qualifies for an advance to schedule your arrival with an exception, known as the hospital
exception to the prohibition against one of our staff members. ownership exception, for physician
expansion of facility capacity. Comments erroneously mailed to the ownership or investment interests held
DATES: Comment Date: To be assured
addresses indicated as appropriate for in a hospital located outside of Puerto
consideration, comments must be hand or courier delivery may be delayed Rico, provided that the referring
received at one of the addresses and received after the comment period. physician is authorized to perform
provided below, no later than 5 p.m. on FOR FURTHER INFORMATION CONTACT: services at the hospital and the
March 3, 2016. POH-ExceptionRequests@cms.hhs.gov. ownership or investment interest is in
ADDRESSES: In commenting, please refer SUPPLEMENTARY INFORMATION: the hospital itself (and not merely in a
to file code CMS–1661–NC. Because of subdivision of the hospital).
Inspection of Public Comments Section 6001(a)(3) of the Patient
staff and resource limitations, we cannot
accept comments by facsimile (FAX) All comments received before the Protection and Affordable Care Act
transmission. close of the comment period are (Pub. L. 111–148) as amended by the
You may submit comments in one of available for viewing by the public, Health Care and Education
four ways (please choose only one of the including any personally identifiable or Reconciliation Act of 2010 (Pub. L. 111–
ways listed): confidential business information that is 152) (hereafter referred to together as
1. Electronically. You may submit included in a comment. We post all ‘‘the Affordable Care Act’’) amended the
wgreen on DSK2VPTVN1PROD with NOTICES
electronic comments on this regulation comments received before the close of rural provider and hospital ownership
to http://www.regulations.gov. Follow the comment period on the following exceptions to the physician self-referral
the ‘‘Submit a comment’’ instructions. Web site as soon as possible after they prohibition to impose additional
2. By regular mail. You may mail have been received: http:// restrictions on physician ownership and
written comments to the following www.regulations.gov. Follow the search investment in hospitals and rural
address only: Centers for Medicare & instructions on that Web site to view providers. Since March 23, 2010, a
Medicaid Services, Department of public comments. physician-owned hospital that seeks to
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![Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5465
ADDRESSES sections above and state extension of an existing collection of Applications for Food and Drug
whether or not they are in the information, and to allow 60 days for Administration Approval to Market a
community in which the hospital is public comment in response to the New Drug: Patent Submission and
located. notice. This notice solicits comments on Listing Requirements and Application
the reporting requirements for of 30-Month Stays on Approval of
IV. Collection of Information
submission and listing of patent Abbreviated New Drug Applications.’’
Requirements
information associated with a new drug Received comments will be placed in
This document does not impose application (NDA), an amendment, or a the docket and, except for those
information collection requirements, supplement. submitted as ‘‘Confidential
that is, reporting, recordkeeping or DATES: Submit either electronic or Submissions,’’ publicly viewable at
third-party disclosure requirements. written comments on the collection of http://www.regulations.gov or at the
Consequently, there is no need for information by April 4, 2016. Division of Dockets Management
review by the Office of Management and between 9 a.m. and 4 p.m., Monday
ADDRESSES: You may submit comments
Budget under the authority of the through Friday.
as follows:
Paperwork Reduction Act of 1995 (44 • Confidential Submissions—To
U.S.C. 3501 et seq.). Electronic Submissions submit a comment with confidential
V. Response to Public Comments Submit electronic comments in the information that you do not wish to be
following way: made publicly available, submit your
Because of the large number of public comments only as a written/paper
comments we normally receive on • Federal eRulemaking Portal: http://
www.regulations.gov. Follow the submission. You should submit two
Federal Register documents, we are not copies total. One copy will include the
able to acknowledge or respond to them instructions for submitting comments.
Comments submitted electronically, information you claim to be confidential
individually. We will consider all with a heading or cover note that states
comments we receive by the date and including attachments, to http://
www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS
time specified in the DATES section of CONFIDENTIAL INFORMATION’’. The
this preamble, and, when we proceed the docket unchanged. Because your
comment will be made public, you are Agency will review this copy, including
with a subsequent document, we will the claimed confidential information, in
respond to the comments in the solely responsible for ensuring that your
comment does not include any its consideration of comments. The
preamble to that document. second copy, which will have the
confidential information that you or a
Dated: January 6, 2016. claimed confidential information
third party may not wish to be posted,
Andrew M. Slavitt, such as medical information, your or redacted/blacked out, will be available
Acting Administrator, Centers for Medicare anyone else’s Social Security number, or for public viewing and posted on http://
& Medicaid Services. confidential business information, such www.regulations.gov. Submit both
[FR Doc. 2016–01830 Filed 2–1–16; 8:45 am] as a manufacturing process. Please note copies to the Division of Dockets
BILLING CODE 4120–01–P that if you include your name, contact Management. If you do not wish your
information, or other information that name and contact information to be
identifies you in the body of your made publicly available, you can
DEPARTMENT OF HEALTH AND comments, that information will be provide this information on the cover
HUMAN SERVICES posted on http://www.regulations.gov. sheet and not in the body of your
• If you want to submit a comment comments and you must identify this
Food and Drug Administration information as ‘‘confidential.’’ Any
with confidential information that you
[Docket No. FDA–2013–N–0662] do not wish to be made available to the information marked as ‘‘confidential’’
public, submit the comment as a will not be disclosed except in
Agency Information Collection written/paper submission and in the accordance with 21 CFR 10.20 and other
Activities: Proposed Collection; manner detailed (see ‘‘Written/Paper applicable disclosure law. For more
Comment Request; Applications for Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of
Food and Drug Administration comments to public dockets, see 80 FR
Approval to Market a New Drug: Patent Written/Paper Submissions 56469, September 18, 2015, or access
Submission and Listing Requirements Submit written/paper submissions as the information at: http://www.fda.gov/
and Application of 30-Month Stays on follows: regulatoryinformation/dockets/
Approval of Abbreviated New Drug • Mail/Hand delivery/Courier (for default.htm.
Applications Certifying That a Patent written/paper submissions): Division of Docket: For access to the docket to
Claiming a Drug Is Valid or Will Not Be Dockets Management (HFA–305), Food read background documents or the
Infringed and Drug Administration, 5630 Fishers electronic and written/paper comments
Lane, Rm. 1061, Rockville, MD 20852. received, go to http://
AGENCY: Food and Drug Administration,
HHS. • For written/paper comments www.regulations.gov and insert the
submitted to the Division of Dockets docket number, found in brackets in the
ACTION: Notice. heading of this document, into the
Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments, ‘‘Search’’ box and follow the prompts
Administration (FDA) is announcing an except for information submitted, and/or go to the Division of Dockets
opportunity for public comment on the marked and identified, as confidential, Management, 5630 Fishers Lane, Rm.
wgreen on DSK2VPTVN1PROD with NOTICES
proposed collection of certain if submitted as detailed in 1061, Rockville, MD 20852.
information by the Agency. Under the ‘‘Instructions.’’ FOR FURTHER INFORMATION CONTACT: FDA
Paperwork Reduction Act of 1995 (the Instructions: All submissions received PRA Staff, Office of Operations, Food
PRA), Federal Agencies are required to must include the Docket No. FDA– and Drug Administration, 8455
publish notice in the Federal Register 2013–N–0662 for ‘‘Agency Information Colesville Rd., COLE–14526, Silver
concerning each proposed collection of Collection Activities: Proposed Spring, MD 20993–0002, PRAStaff@
information, including each proposed Collection; Comment Request; fda.hhs.gov.
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Document Created: 2016-02-02 00:32:02
Document Modified: 2016-02-02 00:32:02
| 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 | Notice with request for comment. | |
| Contact | [email protected] | |
| FR Citation | 81 FR 5463 |
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