80 FR 35363 - 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 80, Issue 118 (June 19, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 118 (June 19, 2015)
| Page Range | 35363-35364 | |
| FR Document | 2015-15141 |
[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)] [Notices] [Pages 35363-35364] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15141] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1642-PN] 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: Proposed notice. ----------------------------------------------------------------------- SUMMARY: The Social Security 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 in which 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 July 20, 2015. ADDRESSES: In commenting, please refer to file code CMS-1642-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this exception request to http://www.regulations.gov. Follow the instructions under the ``More Search Options'' tab. 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-1642-PN, P.O. Box 8010, Baltimore, MD 21244-1850. 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: Department of Health and Human Services, Attention: CMS-1642-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Patricia Taft, (410) 786-4561 or Teresa Walden, (410) 786-3755. 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 [[Page 35364]] 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 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 request 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 to the expansion exception process; however, because this particular request was received prior to the effective date of that rule, it is being processed in accordance with the regulations that were in place at the time of submission. 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)). In the November 30, 2011 final rule (76 FR 74522 through 74523), this request for an exception to the facility expansion prohibition will be considered complete and ready for CMS review if no comments from the community are received by the close of the 30-day comment period. If we receive timely comments from the community, we will consider this request to be complete 30 days after the hospital is notified of the comments. If we grant the request for an exception to the prohibition 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 exceeding 200 percent of the hospital's baseline number of operating rooms, procedure rooms, and beds (Sec. 411.362(c)(6)). Our decision to grant or deny a hospital's request for an exception to the prohibition on expansion of facility capacity will 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: Harsha Behavioral Center, Incorporation. Address: 1420 East Crossing Boulevard, Terre Haute, Indiana 47802. County: Vigo County, Indiana. Basis for Exception Request: High Medicaid Facility. 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 a high Medicaid facility. In November 30, 2011 final rule (76 FR 74521 through 74522), a high Medicaid facility is a hospital that satisfies the following criteria:The hospital is not the sole hospital in the county in which it is located; 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; and With respect to each of the 3 most recent fiscal years for which data are available as of the date the hospital submits its request, has an annual percent of total inpatient admissions under Medicaid that is estimated to be greater than such percent with respect to such admissions for any other hospital located in the county in which the hospital is located. Individuals and entities wishing to submit comments on the hospital's request should review the DATES and 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 We will consider all comments we receive by the date and time specified in the DATES section of this preamble. Dated: June 5, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015-15141 Filed 6-18-15; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices 35363
template will include topics to assess an request from individuals and entities in Web site as soon as possible after they
issuer’s compliance in creation on a the community in which the hospital is have been received: http://
payment structure that provides located. The Centers for Medicare & www.regulations.gov. Follow the search
increased reimbursement or other Medicaid Services (CMS) has received a instructions on that Web site to view
incentives to improve the health request from a physician-owned public comments.
outcomes of plan enrollees, prevent hospital for an exception to the We will allow stakeholders 30 days
hospital readmissions, improve patient prohibition against expansion of facility from the date of this notice to submit
safety and reduce medical errors, capacity. This notice solicits comments written comments. Comments received
promote wellness and health, and on the request from individuals and timely will be available for public
reduce health and health care entities in the community in which the inspection as they are received,
disparities, as described in Section physician-owned hospital is located. generally beginning approximately 3
1311(g)(1) of the Affordable Care Act. Community input may inform our weeks after publication of this notice, at
The Quality Improvement Strategy determination regarding whether the the headquarters of the Centers for
Plan and Reporting Template will allow requesting hospital qualifies for an Medicare & Medicaid Services, 7500
(1) HHS to evaluate the compliance and exception to the prohibition against Security Boulevard, Baltimore,
adequacy of QHP issuers’ quality expansion of facility capacity. Maryland 21244, Monday through
improvement efforts, as required by DATES: Comment Date: To be assured
Friday of each week from 8:30 a.m. to
Section 1311(c) of the Affordable Care consideration, comments must be 4 p.m. To schedule an appointment to
Act, and (2) HHS will use the issuers’ received at one of the addresses view public comments, please phone 1–
validated information to evaluate the provided below, no later than 5 p.m. on 800–743–3951.
issuers’ quality improvement strategies July 20, 2015. I. Background
for compliance with the requirements of
ADDRESSES: In commenting, please refer Section 1877 of the Social Security
Section 1311(g) of the Affordable Care
Act. Form Number: CMS–10540 (OMB to file code CMS–1642–PN. Because of Act (the Act), also known as the
control number: 0938–NEW); staff and resource limitations, we cannot physician self-referral law—(1) prohibits
Frequency: Annually; Affected Public: accept comments by facsimile (FAX) a physician from making referrals for
Individuals and Households; Private transmission. certain ‘‘designated health services’’
sector (Business or other for-profits and You may submit comments in one of (DHS) payable by Medicare to an entity
Not-for-profit institutions); Number of three ways (please choose only one of with which he or she (or an immediate
Respondents: 251,681; Total Annual the ways listed): family member) has a financial
1. Electronically. You may submit relationship (ownership or
Responses: 251,681; Total Annual
electronic comments on this exception compensation), unless the requirements
Hours: 82,800. (For policy questions
request to http://www.regulations.gov. of an applicable exception are satisfied;
regarding this collection contact
Follow the instructions under the ‘‘More and (2) prohibits the entity from filing
Kimberly Kufel at 410–786–1750).
Search Options’’ tab. claims with Medicare (or billing another
Dated: June 16, 2015. 2. By regular mail. You may mail individual, entity, or third party payer)
William N. Parham, III, written comments to the following for those DHS furnished as a result of a
Director, Paperwork Reduction Staff, Office address ONLY: Centers for Medicare & prohibited referral.
of Strategic Operations and Regulatory Medicaid Services, Department of Section 1877(d)(2) of the Act provides
Affairs. Health and Human Services, Attention: an exception for physician ownership or
[FR Doc. 2015–15125 Filed 6–18–15; 8:45 am] CMS–1642–PN, P.O. Box 8010, investment interests in rural providers
BILLING CODE 4120–01–P Baltimore, MD 21244–1850. (the ‘‘rural provider exception’’). In
Please allow sufficient time for mailed order for an entity to qualify for the
comments to be received before the rural provider exception, the DHS must
DEPARTMENT OF HEALTH AND close of the comment period. be furnished in a rural area (as defined
HUMAN SERVICES 3. By express or overnight mail. You in section 1886(d)(2) of the Act) and
may send written comments to the substantially all the DHS furnished by
Centers for Medicare & Medicaid following address ONLY: Department of
Services the entity must be furnished to
Health and Human Services, Attention: individuals residing in a rural area.
[CMS–1642–PN] CMS–1642–PN, Mail Stop C4–26–05, Section 1877(d)(3) of the Act provides
7500 Security Boulevard, Baltimore, MD an exception, known as the hospital
Medicare Program; Request for an 21244–1850. ownership exception, for physician
Exception to the Prohibition on For information on viewing public ownership or investment interests held
Expansion of Facility Capacity Under comments, see the beginning of the in a hospital located outside of Puerto
the Hospital Ownership and Rural SUPPLEMENTARY INFORMATION section. Rico, provided that the referring
Provider Exceptions to the Physician FOR FURTHER INFORMATION CONTACT: physician is authorized to perform
Self-Referral Prohibition Patricia Taft, (410) 786–4561 or Teresa services at the hospital and the
AGENCY: Centers for Medicare & Walden, (410) 786–3755. ownership or investment interest is in
Medicaid Services (CMS), HHS. SUPPLEMENTARY INFORMATION: the hospital itself (and not merely in a
ACTION: Proposed notice. subdivision of the hospital).
Inspection of Public Comments Section 6001(a)(3) of the Patient
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY: The Social Security Act All comments received before the Protection and Affordable Care Act
prohibits a physician-owned hospital close of the comment period are (Pub. L. 111–148) as amended by the
from expanding its facility capacity, available for viewing by the public, Health Care and Education
unless the Secretary of the Department including any personally identifiable or Reconciliation Act of 2010 (Pub. L. 111–
of Health and Human Services (the confidential business information that is 152) (hereafter referred to together as
Secretary) grants the hospital’s request included in a comment. We post all ‘‘the Affordable Care Act’’) amended the
for an exception to that prohibition after comments received before the close of rural provider and hospital ownership
considering input on the hospital’s the comment period on the following exceptions to the physician self-referral
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![35364 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
prohibition to impose additional against beneficiaries of Federal health • The hospital is not the sole hospital
restrictions on physician ownership and programs; however, we noted that these in the county in which it is located;
investment in hospitals and rural were examples only and that we will • The hospital does not discriminate
providers. Since March 23, 2010, a not restrict the type of community input against beneficiaries of Federal health
physician-owned hospital that seeks to that may be submitted. If we receive care programs and does not permit
avail itself of either exception is timely comments from the community, physicians practicing at the hospital to
prohibited from expanding facility we will notify the hospital, and the discriminate against such beneficiaries;
capacity unless it qualifies as an hospital will have 30 days after such and
‘‘applicable hospital’’ or ‘‘high Medicaid notice to submit a rebuttal statement • With respect to each of the 3 most
facility’’ (as defined in sections (§ 411.362(c)(5)). recent fiscal years for which data are
1877(i)(3)(E), (F) of the Act and 42 CFR In the November 30, 2011 final rule available as of the date the hospital
411.362(c)(2), (3) of our regulations) and (76 FR 74522 through 74523), this submits its request, has an annual
has been granted an exception to the request for an exception to the facility percent of total inpatient admissions
prohibition by the Secretary of the expansion prohibition will be under Medicaid that is estimated to be
Department of Health and Human considered complete and ready for CMS greater than such percent with respect
Services (the Secretary). Section review if no comments from the to such admissions for any other
1877(i)(3)(A)(ii) of the Act provides that community are received by the close of hospital located in the county in which
individuals and entities in the the 30-day comment period. If we the hospital is located.
community in which the provider receive timely comments from the Individuals and entities wishing to
requesting the exception is located must community, we will consider this submit comments on the hospital’s
have an opportunity to provide input request to be complete 30 days after the request should review the DATES and
with respect to the provider’s request for hospital is notified of the comments. ADDRESSES sections above and state
the exception. For further information, If we grant the request for an whether or not they are in the
we refer readers to the CMS Web site at: exception to the prohibition on community in which the hospital is
http://www.cms.gov/Medicare/Fraud- expansion of facility capacity, the located.
and-Abuse/PhysicianSelfReferral/ expansion may occur only in facilities
IV. Collection of Information
Physician_Owned_Hospitals.html. on the hospital’s main campus and may
Requirements
II. Exception Request Process not result in the number of operating
rooms, procedure rooms, and beds for This document does not impose
On November 30, 2011, we published which the hospital is licensed exceeding information collection requirements,
a final rule in the Federal Register (76 200 percent of the hospital’s baseline that is, reporting, recordkeeping or
FR 74122, 74517 through 74525) that, number of operating rooms, procedure third-party disclosure requirements.
among other things, finalized rooms, and beds (§ 411.362(c)(6)). Our Consequently, there is no need for
§ 411.362(c), which specified the decision to grant or deny a hospital’s review by the Office of Management and
process for submitting, commenting on, request for an exception to the Budget under the authority of the
and reviewing a request for an exception prohibition on expansion of facility Paperwork Reduction Act of 1995 (44
to the prohibition on expansion of capacity will be published in the U.S.C. 3501 et seq.).
facility capacity. We published a Federal Register in accordance with our
subsequent final rule in the Federal V. Response to Public Comments
regulations at § 411.362(c)(7).
Register on November 10, 2014 (79 FR We will consider all comments we
66770) that made certain revisions to III. Hospital Exception Request receive by the date and time specified
the expansion exception process; As permitted by section 1877(i)(3) of in the DATES section of this preamble.
however, because this particular request the Act and our regulations at Dated: June 5, 2015.
was received prior to the effective date § 411.362(c), the following physician- Andrew M. Slavitt,
of that rule, it is being processed in owned hospital has requested an Acting Administrator, Centers for Medicare
accordance with the regulations that exception to the prohibition on & Medicaid Services.
were in place at the time of submission. expansion of facility capacity: [FR Doc. 2015–15141 Filed 6–18–15; 8:45 am]
As stated in regulations at Name of Facility: Harsha Behavioral
§ 411.362(c)(5), we will solicit BILLING CODE 4120–01–P
Center, Incorporation.
community input on the request for an Address: 1420 East Crossing
exception by publishing a notice of the Boulevard, Terre Haute, Indiana 47802.
request in the Federal Register. DEPARTMENT OF HEALTH AND
County: Vigo County, Indiana.
Individuals and entities in the hospital’s Basis for Exception Request: High HUMAN SERVICES
community will have 30 days to submit Medicaid Facility. Centers for Medicare & Medicaid
comments on the request. Community We seek comments on this request Services
input must take the form of written from individuals and entities in the
comments and may include community in which the hospital is [CMS–5514–N2]
documentation demonstrating that the located. We encourage interested parties
physician-owned hospital requesting to review the hospital’s request, which Medicare Program; Oncology Care
the exception does or does not qualify is posted on the CMS Web site at: http:// Model: Request for Applications;
as an applicable hospital or high www.cms.gov/Medicare/Fraud-and- Extension of the Submission Deadline
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Medicaid facility, as such terms are Abuse/PhysicianSelfReferral/Physician_ for Applications
defined in § 411.362(c)(2) and (3). In the Owned_Hospitals.html. We especially AGENCY: Centers for Medicare &
November 30, 2011 final rule (76 FR welcome comments regarding whether Medicaid Services (CMS), HHS.
74522), we gave examples of community the hospital qualifies as a high Medicaid ACTION: Notice.
input, such as documentation facility. In November 30, 2011 final rule
demonstrating that the hospital does not (76 FR 74521 through 74522), a high SUMMARY: This notice extends the
satisfy one or more of the data criteria Medicaid facility is a hospital that application submission deadline for
or that the hospital discriminates satisfies the following criteria: organizations to participate in the
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Document Created: 2018-02-22 11:10:21
Document Modified: 2018-02-22 11:10:21
| 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 | Proposed notice. | |
| Dates | Comment Date: To be assured consideration, comments must be | |
| Contact | Patricia Taft, (410) 786-4561 or Teresa Walden, (410) 786-3755. | |
| FR Citation | 80 FR 35363 |
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