83 FR 29524 - Medicare Program; Request for Information Regarding the Physician Self-Referral Law

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 122 (June 25, 2018)

Page Range		29524-29527
FR Document		2018-13529

This request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.

Federal Register, Volume 83 Issue 122 (Monday, June 25, 2018)

[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)]
[Proposed Rules]
[Pages 29524-29527]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-13529]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 411

[CMS-1720-NC]
RIN 0938-AT64

Medicare Program; Request for Information Regarding the Physician
Self-Referral Law

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Request for information.

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SUMMARY: This request for information seeks input from the public on
how to address any undue regulatory impact and burden of the physician
self-referral law.

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 August 24, 2018.

ADDRESSES: In commenting, refer to file code CMS-1720-NC. Because of
staff and resource limitations, we cannot accept comments by facsimile
(FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three 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-1720-NC, P.O. Box 8013,
Baltimore, MD 21244-8013.
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-1720-NC, 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: Lisa O. Wilson, (410) 786-8852.

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
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.

I. Introduction

The Department of Health and Human Services (HHS) is working to
transform the healthcare system into one that pays for value. Care
coordination is a key aspect of systems that deliver value. Removing
unnecessary government obstacles to care coordination is a key priority
for HHS. To help accelerate the transformation to a value-based system
that includes care coordination, HHS has launched a Regulatory Sprint
to Coordinated Care, led by the Deputy Secretary. This Regulatory
Sprint is focused on identifying regulatory requirements or
prohibitions that may act as barriers to coordinated care, assessing
whether those regulatory provisions are unnecessary obstacles to
coordinated care, and issuing guidance or revising regulations to
address such obstacles and, as appropriate, encouraging and
incentivizing coordinated care.
The Centers for Medicare & Medicaid Services (CMS) has made
facilitating coordinated care a top priority and seeks to identify ways
in which its regulations may impose undue burdens on the healthcare
industry and serve as obstacles to coordinated care and its efforts to
deliver better value and care for patients. Through internal discussion
and input from external stakeholders, CMS has identified some aspects
of the physician self-referral law as a potential barrier to
coordinated care. Addressing unnecessary obstacles to coordinated care,
real or perceived, caused by the physician self-referral law is one of
CMS's goals in this Regulatory Sprint. To inform our efforts to assess
and address the impact and burden of the physician self-referral law,
including whether and, if so, how it may prevent or inhibit care
coordination, we welcome public comment on the physician self-referral
law and, in particular, comment on the questions presented in this
Request for Information (RFI).

II. Background

When enacted in 1989, the physician self-referral law (section 1877
of the Social Security Act), also known as the

[[Page 29525]]

``Stark Law,'' addressed the concern that health care decision making
can be unduly influenced by a profit motive. When physicians have a
financial incentive to refer patients for health care services, this
incentive may affect utilization, patient choice, and competition.
Overutilization may occur when items and services are ordered that
would not have been ordered absent a profit motive. A patient's choice
can be affected when he or she is steered to less convenient, lower
quality, or more expensive providers of health care that are sharing
profits with, or providing other remuneration to, the referring
practitioner. Where referrals are controlled by those sharing profits
or receiving other remuneration, the medical marketplace suffers since
new competitors may have more difficulty generating business on
superior quality, service, or price alone.
By design, the physician self-referral law is intended to
disconnect a physician's health care decision making from his or her
financial interests in other health care providers and suppliers.
Specifically, the 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 an exception
applies; and (2) prohibits the entity from filing claims with Medicare
(or billing another individual, entity, or third party payer) for those
referred services. The prohibitions are absolute unless the physician's
referral is permitted under an enumerated exception. The statute
establishes a number of specific exceptions, and grants the Secretary
the authority to create regulatory exceptions for financial
relationships that do not pose a risk of program or patient abuse. For
more information, please refer to the CMS physician self-referral
website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/index.html?redirect=/PhysicianSelfReferral/.
CMS is aware of the effect the physician self-referral law may have
on parties participating or considering participation in integrated
delivery models, alternative payment models, and arrangements to incent
improvements in outcomes and reductions in cost. The President's Budget
for fiscal year (FY) 2019 included a legislative proposal to establish
a new exception to the physician self-referral law for arrangements
that arise due to participation in alternative payment models. In
addition to this legislative proposal, CMS has engaged stakeholders
through comment solicitations in several recent rulemakings. In 2017,
through the annual payment rules, CMS asked for comments on
improvements that can be made to the health care delivery system that
reduce unnecessary burdens for clinicians, other providers, and
patients and their families. In response, commenters shared additional
information regarding the barriers to participation in health care
delivery and payment reform efforts, both public and private, as well
as the burdens of compliance with the physician self-referral law and
our regulations as they exist today. As a result of our review of these
comments, and with a goal of reducing regulatory burden and dismantling
barriers to value-based care transformation, while also protecting the
integrity of the Medicare program, we are requesting additional
information in this RFI. We are particularly interested in your
thoughts on issues that include, but are not limited to, the structure
of arrangements between parties that participate in alternative payment
models or other novel financial arrangements, the need for revisions or
additions to exceptions to the physician self-referral law, and
terminology related to alternative payment models and the physician
self-referral law. We look forward to receiving your input on this RFI.

III. Request for Information

We are requesting public input on the following areas:
1. Please tell us about either existing or potential arrangements
that involve DHS entities and referring physicians that participate in
alternative payment models or other novel financial arrangements,
whether or not such models and financial arrangements are sponsored by
CMS. Please include a description of the alternative payment model(s)
and novel financial arrangements if not sponsored by CMS. We recommend
that you identify concerns regarding the applicability of existing
exceptions to the physician self-referral law and/or the ability of the
arrangements to satisfy the requirements of an existing exception, as
well as the extent to which the physician self-referral law may be
impacting commercial alternative payment models and novel financial
arrangements. Please be specific regarding the terms of the
arrangements with respect to the following:
The categories/types of parties (for example, the parties
are a hospital and physician group with downstream payments to
individual physicians in the group).
Which parties bear risk (and how and to what extent) under
the arrangement (for example, per capita payments from a payor are paid
to a hospital with downstream payments on a discounted fee schedule to
individual physicians; a bundled payment from a payor for all hospital
and physician services is split between a hospital and physicians based
on a predetermined percentage; hospital-sponsored gainsharing program
where participating physicians share in cost savings; physician
incentive payments are available for achieving predetermined metrics;
etc.).
The scope of the arrangement (for example, non-Medicare
beneficiaries only, Medicare beneficiaries only, or all patients
regardless of payor).
The timeframe of the arrangement (for example, ongoing or
for a duration that aligns with a payor-specific initiative).
Items and services provided under the arrangement and by
whom (for example, infrastructure, such as electronic health records
technology; physician services; care coordination services; etc.).
How the arrangement furthers the purpose of the
alternative payment model or novel financial arrangement.
Whether and, if so, how the arrangement mitigates the
financial incentives for inappropriate self-referrals, and/or
overutilization of items and services, and patient choice.
2. What, if any, additional exceptions to the physician self-
referral law are necessary to protect financial arrangements between
DHS entities and referring physicians who participate in the same
alternative payment model? Specifically--
What additional exceptions are necessary to protect
accountable care organization models?
What additional exceptions are necessary to protect
bundled payment models?
What additional exceptions are necessary to protect two-
sided risk models in a FFS environment?
What additional exceptions are necessary to protect other
payment models (please explain the nature and design of such models)?
How (if at all) should a new exception (or exceptions)
protect individual DHS referrals (see 42 CFR 411.355), ownership or
investment interests (see 42 CFR 411.356), or compensation arrangements
(see 42 CFR 411.357)?
3. What, if any, additional exceptions to the physician self-
referral law are necessary to protect financial arrangements that
involve integrating

[[Page 29526]]

and coordinating care outside of an alternative payment model?
Specifically, what types of financial arrangements and/or remuneration
related to care integration and coordination should be protected and
why? How (if at all) should a new exception (or exceptions) protect
individual DHS referrals (see 42 CFR 411.355), ownership or investment
interests (see 42 CFR 411.356), or compensation arrangements (see 42
CFR 411.357)?
4. Please share your thoughts on the utility of the current
exception at 42 CFR 411.357(n) for risk-sharing arrangements.
5. Please share your thoughts on the utility of the special rule
for compensation under a physician incentive plan within the exception
at 42 CFR 411.357(d) for personal service arrangements.
6. Please share your thoughts on possible approaches to address the
application of the physician self-referral law to financial
arrangements among participants in alternative payment models and other
novel financial arrangements. Consider the following:
Would a single exception provide sufficient protection for
all types of financial arrangements?
Would a multifaceted approach that amends existing
exceptions and/or establishes new exceptions be preferable?
Would such a multifaceted approach sufficiently allow
parties to identify and satisfy the requirements of one (or more)
applicable exceptions in order to protect individual DHS referrals,
ownership or investment interests, and/or compensation arrangements?
7. In the context of health care delivery, payment reform, and the
physician self-referral law, please share your thoughts on definitions
for critical terminology such as--

Alternative payment model
Care coordination
Clinical integration
Financial integration
Risk
Risk-sharing
Physician incentive program
Gainsharing
Health plan
Health system
Integrated delivery system
Enrollee

8. Please identify and suggest definitions for other terminology
relevant to the comments requested in this RFI.
9. Please share your thoughts on possible approaches to defining
``commercial reasonableness'' in the context of the exceptions to the
physician self-referral law.
10. Please share your thoughts on possible approaches to modifying
the definition of ``fair market value'' consistent with the statute and
in the context of the exceptions to the physician self-referral law.
11. Please share your thoughts on when, in the context of the
physician self-referral law, compensation should be considered to
``take into account the volume or value of referrals'' by a physician
or ``take into account other business generated'' between parties to an
arrangement. Please share with us, by way of example or otherwise,
compensation formulas that do not take into account the volume or value
of referrals by a physician or other business generated between
parties.
12. Please share your thoughts on when, in the context of
alternative payment models and other novel financial arrangements,
compensation should be considered to ``take into account the volume or
value of referrals'' by a physician or ``take into account other
business generated'' between parties to an arrangement. Please share
with us, by way of example or otherwise, compensation formulas that do
not take into account the volume or value of referrals by a physician
or other business generated between parties.
13. Please share your thoughts regarding whether and, if so, what
barriers exist to qualifying as a ``group practice'' under the
regulations at 42 CFR 411.352.
14. Please share your thoughts on the application and utility of
the current exception at 42 CFR 411.357(g) for remuneration unrelated
to DHS. Specifically, how could CMS interpret this exception to cover a
broader array of arrangements?
15. Please identify any provisions, definitions, and/or exceptions
in the regulations at 42 CFR 411.351 through 411.357 for which
additional clarification would be useful.
16. Please share your thoughts on the role of transparency in the
context of the physician self-referral law. For example, if provided by
the referring physician to a beneficiary, would transparency about
physician's financial relationships, price transparency, or the
availability of other data necessary for informed consumer purchasing
(such as data about quality of services provided) reduce or eliminate
the harms to the Medicare program and its beneficiaries that the
physician self-referral law is intended to address?
17. Please share your thoughts on whether and how CMS could design
a model to test whether transparency safeguards other than those
currently contained in the physician self-referral law could
effectively address the impact of financial self-interest on physician
medical decision-making.
18. Please share your thoughts on the compliance costs for
regulated entities.
19. Please identify any recent studies assessing the positive or
negative effects of the physician self-referral law on the healthcare
industry. To the extent publicly available, please provide a copy of
the study(ies).
20. Please share your thoughts regarding whether CMS should measure
the effectiveness of the physician self-referral law in preventing
unnecessary utilization and other forms of program abuse relative to
the cost burden on the regulated industry and, if so, how CMS could
estimate this.
Respondents are encouraged to provide complete but concise and
organized responses, including any relevant data and specific examples.
However, respondents are not required to address every issue or respond
to every question discussed in this RFI to have their responses
considered. In accordance with the implementing regulations of the
Paperwork Reduction Act at 5 CFR 1320.3(h)(4), all responses will be
considered provided they contain information CMS can use to identify
and contact the commenter, if needed.
Please note, this is a request for information only. As previously
stated, respondents are encouraged to provide complete but concise
responses. This RFI is issued solely for information and planning
purposes; it does not constitute a Request for Proposal (RFP),
application, proposal abstract, or quotation. This RFI does not commit
the U.S. Government to contract for any supplies or services or make a
grant award. Further, CMS is not seeking proposals through this RFI and
will not accept unsolicited proposals. Respondents are advised that the
U.S. Government will not pay for any information or administrative
costs incurred in response to this RFI; all costs associated with
responding to this RFI will be solely at the interested party's
expense. Not responding to this RFI does not preclude participation in
any future procurement, if conducted. It is the responsibility of the
potential responders to monitor this RFI announcement for additional
information pertaining to this request. Please note that CMS will not
respond to questions about the policy issues raised in this RFI. CMS
may or may not

[[Page 29527]]

choose to contact individual responders. Such communications would only
serve to further clarify written responses. Contractor support
personnel may be used to review RFI responses.
Responses to this RFI are not offers and cannot be accepted by the
U.S. Government to form a binding contract or issue a grant.
Information obtained as a result of this RFI may be used by the U.S.
Government for program planning on a non-attribution basis. Respondents
should not include any information that might be considered proprietary
or confidential. This RFI should not be construed as a commitment or
authorization to incur costs for which reimbursement would be required
or sought. All submissions become U.S. Government property and will not
be returned. CMS may publicly post the comments received, or a summary
thereof.

IV. Collection of Information Requirements

This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. However, section III. of this document does contain a
general solicitation of comments in the form of a request for
information. In accordance with the implementing regulations of the
Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4),
this general solicitation is exempt from the PRA. Facts or opinions
submitted in response to general solicitations of comments from the
public, published in the Federal Register or other publications,
regardless of the form or format thereof, provided that no person is
required to supply specific information pertaining to the commenter,
other than that necessary for self-identification, as a condition of
the agency's full consideration, are not generally considered
information collections and therefore not subject to the PRA.
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.).

IV. Response to 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, if we proceed with a subsequent document, we may respond to the
comments in the preamble to that document.

Dated: June 19, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-13529 Filed 6-20-18; 4:15 pm]
BILLING CODE 4120-01-P

$Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Proposed Rules 29527 choose to contact individual responders. IV. Collection of Information collections and therefore not subject to Such communications would only serve Requirements the PRA. Consequently, there is no need to further clarify written responses. This document does not impose for review by the Office of Management Contractor support personnel may be information collection requirements, and Budget under the authority of the used to review RFI responses. that is, reporting, recordkeeping or Paperwork Reduction Act of 1995 (44 third-party disclosure requirements. U.S.C. 3501 et seq.). Responses to this RFI are not offers and cannot be accepted by the U.S. However, section III. of this document IV. Response to Comments Government to form a binding contract does contain a general solicitation of or issue a grant. Information obtained as comments in the form of a request for Because of the large number of public a result of this RFI may be used by the information. In accordance with the comments we normally receive on U.S. Government for program planning implementing regulations of the Federal Register documents, we are not Paperwork Reduction Act of 1995 able to acknowledge or respond to them on a non-attribution basis. Respondents (PRA), specifically 5 CFR 1320.3(h)(4), individually. We will consider all should not include any information that this general solicitation is exempt from comments we receive by the date and might be considered proprietary or the PRA. Facts or opinions submitted in time specified in the DATES section of confidential. This RFI should not be response to general solicitations of this preamble, and, if we proceed with construed as a commitment or comments from the public, published in a subsequent document, we may authorization to incur costs for which the Federal Register or other respond to the comments in the reimbursement would be required or publications, regardless of the form or preamble to that document. sought. All submissions become U.S. format thereof, provided that no person Dated: June 19, 2018. Government property and will not be is required to supply specific returned. CMS may publicly post the information pertaining to the Seema Verma, comments received, or a summary commenter, other than that necessary Administrator, Centers for Medicare & thereof. for self-identification, as a condition of Medicaid Services. the agency’s full consideration, are not [FR Doc. 2018–13529 Filed 6–20–18; 4:15 pm] generally considered information BILLING CODE 4120–01–P amozie on DSK3GDR082PROD with PROPOSALS1 VerDate Sep<11>2014 16:25 Jun 22, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4702 Sfmt 9990 E:\FR\FM\25JNP1.SGM 25JNP1$

Document Created: 2018-06-23 02:29:38
Document Modified: 2018-06-23 02:29:38

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		Proposed Rules
Action		Request for information.
Dates		Comment Date: To be assured consideration, comments must be
Contact		Lisa O. Wilson, (410) 786-8852.
FR Citation		83 FR 29524
RIN Number		0938-AT64

83 FR 29524 - Medicare Program; Request for Information Regarding the Physician Self-Referral Law

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 122 (June 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services