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[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Notices]               
[Page 57039-57042]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se10-104]                         

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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.

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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 thomas.carey@hhs.gov 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 ACOlegalissues@cms.hhs.gov 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 thomas.carey@hhs.gov 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.
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    \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.
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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
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