```

[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Proposed Rules]
[Pages 70165-70166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28996]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Chapter IV

[CMS-1345-NC]

Medicare Program; Request for Information Regarding Accountable 
Care Organizations and the Medicare Shared Saving Program

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

ACTION: Request for information.

-----------------------------------------------------------------------

SUMMARY: This document is a request for comments regarding certain 
aspects of the policies and standards that will apply to accountable 
care organizations (ACOs) participating in the Medicare program under 
section 3021 or 3022 of the Affordable Care Act.

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 December 3, 2010.

ADDRESSES: In commenting, please refer to file code CMS-1345-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
     Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow ``Submit a comment'' 
instructions.
     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-1345-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.
     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-1345-
NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
     By hand or courier. Alternatively, you may deliver (by 
hand or courier) your written comments ONLY to one of the following 
addresses prior to the close of the comment period:
    a. For delivery in Washington, DC-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.

FOR FURTHER INFORMATION CONTACT: Thomas Carey, (410) 786-4560 or 
Thomas.Carey@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

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

[[Page 70166]]

create incentives for health care providers to enhance health care 
quality and lower costs. One important delivery system reform is the 
Medicare Shared Savings Program under 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 and cost savings 
requirements established by the Secretary. We are developing rulemaking 
for the establishment of the Shared Savings Program under section 3022 
of the Affordable Care Act. In addition, section 3021 of the Affordable 
Care Act establishes a Center for Medicare and Medicaid Innovation 
(CMMI) within CMS, which is authorized to test innovative payment and 
service delivery models to reduce program expenditures while preserving 
or enhancing the quality of care. We are considering testing innovative 
payment and delivery system models that complement the Shared Savings 
Program in the CMMI. In both of these efforts, we are seeking to 
advance ACO structures that are organized in ways that are patient-
centered and foster participation of physicians and other clinicians 
who are in solo or small practices.
    We have already conducted substantial outreach and had discussions 
with and received feedback from a wide array of physician groups, as 
well as groups representing other clinicians, hospitals, employers, 
consumers, and other interested parties, about how ACO programs can 
best be structured. In particular, CMS, along with the Office of the 
Inspector General (OIG) of the Department of Health and Human Services 
(DHHS) and the Federal Trade Commission hosted a public workshop on 
October 5, 2010, to discuss the application and enforcement of the 
antitrust laws, physician self-referral prohibition, Federal anti-
kickback statute, and civil monetary penalty law to the variety of 
possible ACO structures under the Shared Savings Program and other 
innovative payment models that CMMI is authorized to test under section 
3021 of the Affordable Care Act. Prior to the public workshop, the 
three agencies solicited written comments and statements from industry 
stakeholders regarding a variety of issues, including the planned legal 
structures and business models of ACOs.

II. Solicitation of Comments

    As we develop our initial rulemaking for the Shared Savings Program 
and begin the development of potential models in the CMMI, we are 
seeking additional information, particularly from the physician 
community, on the following questions:
     What policies or standards should we consider adopting to 
ensure that groups of solo and small practice providers have the 
opportunity to actively participate in the Medicare Shared Savings 
Program and the ACO models tested by CMMI?
     Many small practices may have limited access to capital or 
other resources to fund efforts from which ``shared savings'' could be 
generated. What payment models, financing mechanisms or other systems 
might we consider, either for the Shared Savings Program or as models 
under CMMI to address this issue? In addition to payment models, what 
other mechanisms could be created to provide access to capital?
     The process of attributing beneficiaries to an ACO is 
important to ensure that expenditures, as well as any savings achieved 
by the ACO, are appropriately calculated and that quality performance 
is accurately measured. Having a seamless attribution process will also 
help ACOs focus their efforts to deliver better care and promote better 
health. Some argue it is necessary to attribute beneficiaries before 
the start of a performance period, so the ACO can target care 
coordination strategies to those beneficiaries whose cost and quality 
information will be used to assess the ACO's performance; others argue 
the attribution should occur at the end of the performance period to 
ensure the ACO is held accountable for care provided to beneficiaries 
who are aligned to it based upon services they receive from the ACO 
during the performance period. How should we balance these two points 
of view in developing the patient attribution models for the Medicare 
Shared Savings Program and ACO models tested by CMMI?
     How should we assess beneficiary and caregiver experience 
of care as part of our assessment of ACO performance?
     The Affordable Care Act requires us to develop patient-
centeredness criteria for assessment of ACOs participating in the 
Medicare Shared Savings Program. What aspects of patient-centeredness 
are particularly important for us to consider and how should we 
evaluate them?
     In order for an ACO to share in savings under the Medicare 
Shared Savings Program, it must meet a quality performance standard 
determined by the Secretary. What quality measures should the Secretary 
use to determine performance in the Shared Savings Program?
     What additional payment models should CMS consider in 
addition to the model laid out in Section 1899(d), either under the 
authority provided in 1899(i) or the authority under the CMMI? What are 
the relative advantages and disadvantages of any such alternative 
payment models?

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: November 10, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-28996 Filed 11-12-10; 4:15 pm]
BILLING CODE 4120-01-P
```