Medicare Program; Workshop Regarding Accountable Care Organizations, and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback, and Civil Monetary Penalty (CMP) Laws, 57039-57042 [2010-23340]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
Number of
respondents
Type of respondent
Totals ......................................................................................................
1,500
Frequency of
response
Average time
per response
........................
57039
Annual hour
burden
..........................
701
* These individuals are included in the 1,500 above.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
For Further Information Contact: To
request more information on the
proposed project or obtain a copy of the
data collection plans and instruments,
contact Dr. Luigi Ferrucci, Principal
Investigator, NIA Clinical Research
Branch, Harbor Hospital, 5th Floor,
3001 S. Hanover, Baltimore, MD 21225,
or call this non-toll-free number (410)
350–3936 or E-mail your request
including your address to:
Ferruccilu@grc.nia.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: September 8, 2010.
Melissa Fraczkowski,
Project Clearance Liason, NIA, National
Institutes of health.
[FR Doc. 2010–23263 Filed 9–16–10; 8:45 am]
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
BILLING CODE 4140–01–P
VerDate Mar<15>2010
14:46 Sep 16, 2010
Jkt 220001
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 SelfReferral, Anti-Kickback, and Civil
Monetary Penalty (CMP) Laws
Federal Trade Commission
(FTC), Centers for Medicare & Medicaid
Services (CMS), and Office of the
Inspector General (OIG), HHS.
ACTION: Notice of meeting.
AGENCY:
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 https://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.
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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
https://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 https://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-
E:\FR\FM\17SEN1.SGM
17SEN1
57040
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
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:
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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 selfreferral 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 antikickback 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
VerDate Mar<15>2010
14:46 Sep 16, 2010
Jkt 220001
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.
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
1 Stephen M. Shortell, Lawrence P. Casalino,
Elliott Fisher, ‘‘Implementing Accountable Care
Organizations,’’ Policy Brief (May 2010), available
at: https://www.law.berkeley.edu/files/chefs/
Implementing_ACOs_May_2010.pdf.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 selfreferral prohibition, the anti-kickback
statute, and the CMP law in order to
E:\FR\FM\17SEN1.SGM
17SEN1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
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.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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
VerDate Mar<15>2010
14:46 Sep 16, 2010
Jkt 220001
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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
57041
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 https://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 https://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 https://
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
E:\FR\FM\17SEN1.SGM
17SEN1
57042
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Mar<15>2010
14:46 Sep 16, 2010
Jkt 220001
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Skeletal Muscle and Exercise Physiology
Study Section.
Date: October 12–13, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Richard Ingraham, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116,
MSC 7814, Bethesda, MD 20892, 301–496–
8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Risk
Prevention and Intervention Addictions:
Overflow.
Date: October 14–15, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Georgetown Suites, 1000 29th Street,
NW., Washington, DC 20007.
Contact Person: Gabriel B. Fosu, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
MSC 7808, Bethesda, MD 20892, (301) 435–
3562, fosug@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Pathogens and Symbiotes.
Date: October 19–20, 2010.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Richard G Kostriken, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 301–402–
4454, kostrikr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Mechanisms and Circuits Underlying
Arousal.
Date: October 19–20, 2010.
Time: 9 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kristin Kramer, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5205,
MSC 7846, Bethesda, MD 20892, (301) 437–
0911, kramerkm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Toxicology.
Date: October 19, 2010.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Contact Person: Rass M. Shayiq, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, (301) 435–
2359, shayiqr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR10–142:
Interface of the Life and Physical Sciences.
Date: October 20–22, 2010.
Time: 8 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Malgorzata Klosek, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7849, Bethesda, MD 20892, (301) 435–
2211, klosekm@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Services Organization and Delivery
Study Section.
Date: October 20–21, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: InterContinental Mark Hopkins
Hotel, 999 California Street, San Francisco,
CA 94108.
Contact Person: Kathy Salaita, SCD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3172,
MSC 7770, Bethesda, MD 20892, 301–451–
8504, salaitak@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–08–
062: Alzheimer’s Disease Pilot Clinical
Trials.
Date: October 22, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Estina E Thompson, PhD,
MPH, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, 301–496–
5749, thompsone@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Biomedical Technology Research
Resource.
Date: October 24–26, 2010.
Time: 7 p.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: Beacon Hill Hotel, 25 Charles Street,
Boston, MA 02114.
Contact Person: Lee Rosen, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5116, MSC 7854, Bethesda, MD
20892, (301) 435–1171, rosenl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer and
Musculoskeletal Imaging Applications.
Date: October 25, 2010.
Time: 8 a.m. to 5 p.m.
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Notices]
[Pages 57039-57042]
From the Federal Register Online via the Government Printing 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 https://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 https://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
https://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.
---------------------------------------------------------------------------
\1\ Stephen M. Shortell, Lawrence P. Casalino, Elliott Fisher,
``Implementing Accountable Care Organizations,'' Policy Brief (May
2010), available at: https://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
https://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
https://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 https://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
