[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Notices]
[Pages 57039-57042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23340]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1356-N]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Inspector General
Medicare Program; Workshop Regarding Accountable Care
Organizations, and Implications Regarding Antitrust, Physician Self-
Referral, Anti-Kickback, and Civil Monetary Penalty (CMP) Laws
AGENCY: Federal Trade Commission (FTC), Centers for Medicare & Medicaid
Services (CMS), and Office of the Inspector General (OIG), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces a public workshop hosted by the Federal
Trade Commission (FTC), the Centers for Medicare & Medicaid Services
(CMS), and the Office of the Inspector General (OIG) of the Department
of Health and Human Services (DHHS). This workshop will include panel
discussions and a listening session on certain legal issues related to
Accountable Care Organizations (ACOs). Physicians, physician
associations, hospitals, health systems, consumers, and all others
interested in ACOs are invited to participate, in person or by calling
into the teleconference. The meeting is open to the public, but
attendance is limited to space and teleconference lines available. An
agenda will be posted on the CMS Web site at http://www.cms.gov/center/physician.asp prior to the session.
DATES: Meeting Date: The public workshop will be held on Tuesday,
October 5, 2010 from 9 a.m. until 4:30 p.m. Eastern Daylight Time
(E.D.T.).
Deadline for Meeting Registration and Request for Special
Accommodations: Registration opens on September 16, 2010. Registration
must be completed by 5 p.m. e.d.t. on September 27, 2010. Requests for
special accommodations must be received by 5 p.m. e.d.t. on September
27, 2010.
Deadline for Submission of Written Comments or Statements for
Discussion at the Workshop: Written comments or statements to be
considered for discussion at the Workshop may be sent via mail or
electronically to the address specified in the ADDRESSES section of
this notice and must be received by 5 p.m. E.D.T. on September 27,
2010.
ADDRESSES: Meeting Location: The public workshop will be held in the
main auditorium of the Central Building of the Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Registration and Special Accommodations: Persons interested in
attending the meeting in person must register by completing the on-line
registration via the CMS Web site at http://www.cms.hhs.gov/apps/events/event.asp?id=607 Individuals who require special accommodations
should send an e-mail request to [email protected] or via regular
mail to the address specified in the FOR FURTHER INFORMATION CONTACT
section of this notice. Information regarding attending via
teleconference and Web conference will be posted on the CMS Web site at
http://www.cms.gov/center/physician.asp prior to the session.
Written Comments or Statements: Written comments or statements may
be sent via e-mail to [email protected] or sent via regular
mail to: Attn: ACO Legal Issues, Mail Stop C5-15-12, Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD
21244-1850.
All persons planning to make a statement in person at the afternoon
listening session are urged to submit statements in writing in advance
of the listening session and should subsequently submit the information
electronically by the timeframe specified in the DATES section of this
notice.
FOR FURTHER INFORMATION CONTACT:
Kristin Bohl at (410) 786-8680, for issues specific to CMS.
Elizabeth Jex at (202) 326-3273, for issues specific to FTC.
Patrice Drew at (202) 619-1368, for issues specific to OIG.
Thomas Carey at (410) 786-4560, for general and logistical issues. You
may also send general and logistical inquiries about this workshop via
e-
[[Page 57040]]
mail to [email protected] or via regular mail at Centers for
Medicare & Medicaid Services, Mail Stop C5-15-12, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
SUPPLEMENTARY INFORMATION:
I. Background
The Affordable Care Act seeks to improve the quality of health care
services and to lower health care costs by encouraging providers to
create integrated health care delivery systems. These integrated
systems will test new reimbursement methods intended to incentivize
providers to enhance health care quality and lower costs. One important
delivery system reform is the Affordable Care Act's Shared Savings
Program, section 3022 of the Affordable Care Act, which promotes the
formation and operation of Accountable Care Organizations (ACOs). Under
this provision, ``groups of providers . . . meeting the criteria
specified by the Secretary may work together to manage and coordinate
care for Medicare . . . beneficiaries through an [ACO].'' An ACO may
receive payments for shared savings if the ACO meets certain quality
performance standards established by the Secretary. In addition, under
section 3021 of the Affordable Care Act, the Secretary is authorized to
test whether ACOs improve the quality of care for Medicare
beneficiaries and reduce unnecessary costs for the Medicare program.
A variety of legal regimes--such as the antitrust laws, the
physician self-referral prohibition (section 1877 of the Social
Security Act (the Act)), the Federal anti-kickback statute (section
1128B(b) of the Act), and the civil monetary penalty (CMP) law
(sections 1128A(b)(1) and (2) of the Act)--will apply to ACOs,
including those participating in the Medicare Shared Savings Program
pursuant to section 3022 of the Affordable Care Act. The Federal Trade
Commission (FTC) together with the Department of Justice Antitrust
Division enforce the Federal antitrust laws; the Centers for Medicare &
Medicaid Services (CMS) has primary enforcement authority for the
physician self-referral prohibition; and the Office of the Inspector
General (OIG) of the Department of Health and Human Services (DHHS)
enforces the anti-kickback statute and CMP law and imposes CMPs for
knowing violations of the physician self-referral prohibition. Each of
these agencies recognizes the importance of evaluating how to apply
these laws to the creation and operation of ACOs. All of these laws
also are relevant to the regulations that CMS is developing to
implement the Medicare Shared Savings Program.
In addition, an ACO may wish to contract with payers in the private
health care market, as well as with CMS. Experience has shown that
integrating health care delivery among independent providers is a
complex process that requires a substantial commitment of health care
providers' resources and time.\1\ Recent commentary suggests that,
because of the resources and time required to integrate independent
provider practices, health care providers are more likely to integrate
their care delivery for Medicare and Medicaid beneficiaries if they
also use the same delivery system for patients covered by health care
insurance in the private market. The potential for ACOs to operate in
both public and private insurance markets further supports the need to
explore the application to ACOs of the laws discussed above for which
the FTC, CMS, and OIG have enforcement responsibilities.
---------------------------------------------------------------------------
\1\ Stephen M. Shortell, Lawrence P. Casalino, Elliott Fisher,
``Implementing Accountable Care Organizations,'' Policy Brief (May
2010), available at: http://www.law.berkeley.edu/files/chefs/Implementing_ACOs_May_2010.pdf.
---------------------------------------------------------------------------
II. Workshop Format, Discussion Topics, and Solicitation of Public
Comment
A. Format of Panel Discussions and Listening Session
To explore these issues, the FTC, CMS, and OIG will be hosting a
public workshop on October 5, 2010 to obtain information from industry
stakeholders who have an interest in, or experience with, the
development and operation of ACOs. One key focus of the workshop will
be to assess how the variety of possible ACO structures in different
health care markets could affect the prices and the quality of health
care delivered to privately insured consumers, as well as to Medicare
and Medicaid beneficiaries. Another key focus will be whether and, if
so, how the requirements of the laws discussed above could or should be
addressed in the regulations that CMS is developing for the Medicare
Shared Savings Program. Finally, the workshop will focus on whether
and, if so, to what extent any safe harbors, exceptions, exemptions, or
waivers from the laws discussed above may be warranted.
1. FTC Panel Discussions
The two morning sessions will be devoted to exploring antitrust
issues through moderated panel discussions. Panelists for both
antitrust panels will include health care providers with integration
efforts planned and underway, payers (insurers, employers, and
consumers), and experts in health care policy.
At the first session, the panelists will address circumstances
under which collaboration among independent health care providers in an
ACO (not including a merger), permits ACO providers to engage in joint
price negotiations with private payers without running the risk of
engaging in illegal price fixing under the antitrust laws. In
particular, the panel will address the indicia of clinical integration
sufficient to indicate that an ACO is likely to enable participating
providers to improve the quality of their health care services and
whether joint price negotiation is reasonably necessary to achieve
these efficiencies. Such indicia could include, for example, the degree
to which the providers engage in integrated activities, the information
processes used to ensure that providers are coordinating patient care,
incentives for providers to adhere to evidence-based care protocols
such as financial risk sharing, and/or financial and resource
investments made by providers. The panel also will address options for
dealing with Medicare ACOs that fail to achieve CMS-required quality
performance standards and that, therefore, might no longer be eligible
for Medicare Shared Savings Program payments under section 3022 of the
Affordable Care Act.
At the second morning session, the panelists will explore ways to
encourage formation of multiple ACOs among otherwise independent
providers so that competition among ACOs in any given geographic market
will drive improved quality and affordability of health care. For
example panelists will explore: (1) The analysis of arrangements where
providers or facilities are exclusive, or non-exclusive, to an ACO; (2)
the impact, if any, of risk-based contracting (for example, global
payments and/or capitated rates) on market power assessments; (3) ways
to assess whether formation of an ACO among independent providers may
allow the ACO to increase price and reduce the quality of care; and (4)
the financial, utilization, outcome, and patient experience data
necessary to monitor and measure the impact of an ACO on prices and
quality in the relevant markets.
2. CMS and OIG Panel Discussion and Listening Session
The afternoon will consist of two separate sessions regarding how
ACOs will interact with the physician self-referral prohibition, the
anti-kickback statute, and the CMP law in order to
[[Page 57041]]
better inform CMS and OIG (HHS Agencies) decision-making regarding the
application of these laws to ACOs. The first session will be a
moderated panel discussion of industry stakeholders, including
representatives of providers, suppliers, and health policy experts who
will focus on the discussion topics listed below.
During the second session, a listening session, there will be an
opportunity for other attendees to provide brief comments on the same
topics either in person or via the teleconference, as time permits. An
agenda for the moderated panel discussions and the listening session
will be released at a later time.
B. Discussion Topics and Solicitation of Public Comment
The FTC and the HHS Agencies are interested in comments addressing
the intersection of these laws and the various business models
envisioned for ACOs with both the antitrust laws and the fraud and
abuse laws. The FTC and the HHS Agencies are interested in details from
the public concerning the types of contractual and financial
relationships under existing or planned ACOs that might trigger or
implicate the antitrust laws, the physician self-referral prohibition
and/or the anti-kickback statute (for example, compensation and
ownership relationships), as well as payment arrangements that might
implicate the CMP law (for example, gainsharing structures). In
addition to obtaining information on the planned legal structures or
business models of ACOs, the HHS Agencies seek comments addressing
whether the public believes that the incentive payments or shared
savings to ACOs, or the distribution of these payments to the
physicians or other providers and suppliers in the ACO, would trigger
or implicate the physician self-referral prohibition, the anti-kickback
statute, and/or the CMP law. Much of the discussion to date has
involved the integration of group practices, hospitals, and networks of
physicians or other professionals into ACOs, and we are interested in
how these types of arrangements might be constrained by these laws. We
are asking the public to describe in detail any potential impediments,
including an explanation as to how current physician self-referral
prohibition exceptions or anti-kickback statute safe harbors might be
inadequate to address the types of financial arrangements that will be
created by ACOs. We are also interested in explanations about the
extent to which these laws currently accommodate integration and ways
in which existing exceptions and safe harbors might be tailored to
further address integration.
1. Exercise of the Section 3022 Affordable Care Act Waiver Authority
Section 3022 of the Affordable Care Act gives the Secretary
authority to waive such requirements of Title XVIII as well as sections
1128A and 1128B of the Act as may be necessary to carry out the
provisions of section 3022 of the Affordable Care Act. The HHS Agencies
are interested in hearing from the public whether a waiver, to the
extent granted, should apply only to the incentive payments distributed
to the ACOs and participating physicians (and other participating
suppliers or ACO professionals), or whether it would be necessary to
create a broader waiver that would also apply to other financial
relationships created by ACOs that participate in the Medicare Shared
Savings Program under section 3022 of the Affordable Care Act. If the
public believes that a broader waiver is necessary, the HHS Agencies
request that interested stakeholders provide support for this view. For
example, if the public recommends a waiver that applies to all
contractual service relationships between ACOs and ACO professionals,
the HHS Agencies are interested to hear why this is necessary and what
safeguards should be required as part of such a broad waiver.
2. Creation of New Stark Exception and Anti-Kickback Safe Harbor
An alternative to the use of the Secretary's waiver authority under
section 3022 of the Affordable Care Act would be for the Secretary to
use her authority under section 1877(b)(4) of the Act to create a new
shared savings/incentive payment exception to the physician self-
referral prohibition. Similarly, OIG could consider a new safe harbor
under section 1128B(b)(3) of the Act. CMS has attempted to address this
issue in prior proposed rulemaking under section 1877 of the Act, and
the HHS Agencies are interested in the public's recommendations for how
a meaningful exception and safe harbor for the incentive payments
related to the newly created ACOs could be crafted. In particular, they
are interested in how a physician self-referral exception could be
designed given that any new exception under section 1877 of the Act
must present no risk of program or patient abuse.
C. Content and Timeframe for Submission of Written Comments or
Statements
Written comments or statements should not include any sensitive
personal information, such as an individual's Social Security number;
date of birth; driver's license number or other State identification
number or foreign country equivalent; passport number; financial
account number; or credit or debit card number. Comments also should
not include any sensitive health information, such as medical records
and other individually identifiable health information.
Written comments or statements will be accepted and considered for
discussion at the meeting if they are received at the address specified
in the ADDRESSES section of this notice by the date specified in the
DATES section of this notice.
III. Registration Instructions
For security reasons, any persons wishing to attend this meeting
must register by the date listed in the DATES section of this notice.
Persons interested in attending the meeting in person must register by
completing the on-line registration via the designated Web site at
http://www.cms.hhs.gov/apps/events/event.asp?id=607. The on-line
registration system will generate a confirmation page to indicate the
completion of your registration. Please print this page as your
registration receipt.
Individuals may also participate in the listening session by
teleconference or webcast. Information regarding attending via
teleconference and Web conference will be posted on the CMS Web site at
http://www.cms.gov/center/physician.asp prior to the session.
An audio download and transcript of the listening session will be
available 2 weeks after completion of the listening session through the
CMS Web site Physician Center Spotlights at http://www.cms.gov/center/physician.asp.
IV. Security, Building, and Parking Guidelines
This meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend allowing additional time to clear security.
The on-site check-in for visitors will begin at 7:30 a.m. E.D.T. Please
allow sufficient time to complete security checkpoints.
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and
[[Page 57042]]
instructions will be issued after the vehicle inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support a
demonstration, are subject to inspection.
We cannot assume responsibility for coordinating the receipt,
transfer, transport, storage, set-up, safety, or timely arrival of any
personal belongings or items used for demonstration or to support a
demonstration.
Note: Individuals who are not registered in advance will not be
permitted to enter the building and will be unable to attend the
meeting. The public may not enter the building earlier than 90
minutes prior to the convening of the meeting. All visitors must be
escorted in areas other than the lower and first floor levels in the
Central Building. Seating capacity is limited to the first 350
registrants.
Authority: Section 3022 of the Affordable Care Act.
Dated: September 13, 2010.
By Direction of the Commission.
Donald S. Clark,
Secretary, The Federal Trade Commission.
Dated: September 9, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Dated: September 13, 2010.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2010-23340 Filed 9-16-10; 8:45 am]
BILLING CODE 6750-01-P; 4120-01-P; 4152-01-P