[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Rules and Regulations]
[Pages 62356-62358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24663]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Chapter IV

Office of Inspector General

42 CFR Chapter V

[CMS-1439-RCN]
RIN 0938-AR30


Medicare Program; Final Waivers in Connection With the Shared 
Savings Program; Continuation of Effectiveness and Extension of 
Timeline for Publication of Final Rule

AGENCY: Centers for Medicare & Medicaid Services (CMS) and Office of 
Inspector General (OIG), HHS.

ACTION: Interim final rule; continuation of effectiveness and extension 
of timeline for publication of final rule.

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

SUMMARY: This document announces the continuation of effectiveness of 
an interim final rule and the extension of the timeline for publication 
of the final rule. This document is issued in accordance with section 
1871(a)(3)(C) of the Social Security Act (the Act), which allows an 
interim final rule to remain in effect after the expiration of the 
timeline specified in section 1871(a)(3)(B) of the Act if the Secretary 
publishes a notice of continuation prior to the expiration of the 
timeline.

DATES: This document is effective on October 17, 2014.

FOR FURTHER INFORMATION CONTACT: 

Catherine Bernstein (410) 786-6887 or Lisa Ohrin (410) 786-8852, for 
general issues and issues related to the Physician Self-Referral Law.
Patrice Drew (202) 619-1368, for general issues and issues related to 
the Federal anti-kickback statute or civil monetary penalties law.

SUPPLEMENTARY INFORMATION:

[[Page 62357]]

I. Background

    Section 1871(a)(3)(A) of the Social Security Act (the Act) sets 
forth certain procedures for promulgating regulations necessary to 
carry out the administration of the insurance programs under Title 
XVIII of the Act. Section 1871(a)(3)(A) of the Act requires the 
Secretary, in consultation with the Director of the Office of 
Management and Budget (OMB), to establish a regular timeline for the 
publication of a final rule based on the previous publication of a 
proposed rule or an interim final rule. In accordance with section 
1871(a)(3)(B) of the Act, such regular timeline may vary among 
different final rules, based on the complexity of the rule, the number 
and scope of the comments received, and other relevant factors. The 
timeline for publishing the final rule, however, cannot exceed 3 years 
from the date of publication of the proposed or interim final rule, 
unless there are exceptional circumstances. After consultation with the 
Director of OMB, the Department, through CMS, published a notice in the 
December 30, 2004 Federal Register (69 FR 78442) establishing a general 
3-year timeline for publishing Medicare final rules after the 
publication of a proposed or interim final rule.
    Section 1871(a)(3)(C) of the Act states that a Medicare interim 
final rule shall not continue in effect if the final rule is not 
published before the expiration of the regular timeline, unless the 
Secretary publishes at the end of the regular timeline a notice of 
continuation that includes an explanation of why the regular timeline 
was not met. Upon publication of such a notice, the timeline for 
publishing the final rule is extended for 1 year.

II. Notice of Continuation

    Section 1899 of the Act establishes the Shared Savings Program to 
encourage the development of Accountable Care Organizations (ACOs) in 
Medicare. The Shared Savings Program is one of the first initiatives 
implemented under the Affordable Care Act aimed specifically at 
improving value in the Medicare program--that is, both higher quality 
and lower total expenditures for individual Medicare beneficiaries and 
the Medicare program. The Shared Savings Program final rule appeared in 
the November 2, 2011 Federal Register (76 FR 67801), and the first 
performance year concluded on December 31, 2013.
    In connection with the Shared Savings Program, section 1899(f) of 
the Act authorizes the Secretary to waive certain specified fraud and 
abuse laws. Specifically, section 1899(f) of the Act provides that 
``[t]he Secretary may waive such requirements of sections 1128A and 
1128B and title XVIII of [the] Act as may be necessary to carry out the 
provisions of [section 1899 of the Act].'' The Secretary determined 
that certain waivers were ``necessary,'' consistent with this statutory 
standard, and, CMS and OIG jointly published an interim final rule with 
comment period (hereinafter referred as ``Waiver IFC'') (76 FR 67992; 
November 2, 2011) in conjunction with the issuance of the Shared 
Savings Program final rule.\1\ The Waiver IFC established waivers of 
the application of the Federal physician self-referral law (section 
1877 of the Act), the Federal anti-kickback statute (section 1128B(b) 
of the Act), and certain civil monetary penalties (CMP) law provisions 
(sections 1128A(a)(5), (b)(1), and (b)(2) of the Act) to specified 
arrangements involving ACOs participating in the Shared Savings 
Program.
---------------------------------------------------------------------------

    \1\ The Waiver IFC was issued as part of a cross-agency, 
coordinated effort by several Federal agencies to issue documents 
addressing legal issues regarding ACOs participating in the Shared 
Savings Program.
---------------------------------------------------------------------------

    Because the Waiver IFC was issued under the authority at section 
1899(f) of the Act, it is considered a Medicare rule subject to the 
conditions of section 1871(a)(3)(C) of the Act. This document extends 
the timeline for publication of a final rule concerning Shared Savings 
Program waivers promulgated in the Waiver IFC. In the absence of this 
continuation notice, the Waiver IFC would expire, creating legal 
uncertainty for ACOs participating in the Shared Savings Program and 
potentially disrupting ongoing business plans or operations of some 
ACOs.
    Our goal is to ensure that the regulations setting forth waivers of 
the fraud and abuse laws continue to be closely aligned with the Shared 
Savings Program regulations.
    Based on stakeholder feedback and CMS's experience operating the 
Shared Savings Program, CMS determined that certain modifications to 
the Shared Savings Program regulations were necessary. Therefore, CMS 
is currently developing a proposed rule regarding the Shared Savings 
Program. In light of the planned issuance of a proposed rule and the 
importance of final waiver regulations that align with the Shared 
Savings Program, we believe the prudent course of action at this time 
is to extend the effectiveness of the Waiver IFC. In addition, we 
believe that an extension of the Waiver IFC will avoid impediments to 
the development of innovative care models envisioned by the Shared 
Savings Program and new approaches to the delivery of health care for 
beneficiaries (see 76 FR 68008). As noted previously, the Secretary has 
determined that the waivers are necessary to carry out the Shared 
Savings Program.
    Our decision to extend the Waiver IFC, rather than issue a final 
rule at this time, should not be viewed as a diminution of the 
Department's commitment to establish waivers ``to foster the success of 
the Shared Savings Program, the purposes of which are to promote 
accountability for a Medicare patient population, manage and coordinate 
care for Medicare fee-for-service beneficiaries, and encourage 
redesigned care processes to improve quality'' (76 FR 68008). Our goal 
remains ``to balance effectively the need for ACO certainty, 
innovation, and flexibility in the Shared Savings Program with 
protections for beneficiaries and the Medicare program'' (76 FR 68008). 
At this time, we believe we can best achieve this balance by issuing 
this continuation notice.
    We also believe that we would benefit from additional input from 
stakeholders to inform our understanding of --(1) how and to what 
extent ACOs are using the waivers; (2) whether the existing waivers 
serve the needs of ACOs and the Medicare program; (3) whether the 
waivers adequately protect the Medicare program and beneficiaries from 
the types of harms associated with referral payments or payments to 
reduce or limit services; and (4) whether there are new or changed 
considerations that should inform the development of additional notice 
and comment rulemaking.
    This document extends the timeline for publication of a final rule 
through November 2, 2015. In accordance with section 1871(a)(3)(C) of 
the Act, the Waiver IFC shall remain in effect through November 2, 
2015, unless a final waiver rule becomes effective on an earlier date.
    This document was approved by the Administrator for the Centers for 
Medicare and Medicaid Services and the Inspector General for the 
Department of the Health and Human Services as it relates to the 
authorities that fall within the respective purviews of their offices. 
This includes, without limitation, section 1877(a) of the Act for the 
Administrator and sections 1128A(a)(5), (b)(1), and (b)(2) and 
1128B(b)(1) and (b)(2) of the Act for the Inspector General.

    Authority:  Section 1871 of the Social Security Act (42 U.S.C. 
1395hh).
(Catalog of Federal Domestic Assistance Program No. 93.773 
Medicare--Hospital

[[Page 62358]]

Insurance Program; and No. 93.774, Medicare--Supplementary Medical 
Insurance Program)

    Dated: October 10, 2014.
C'Reda Weeden,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2014-24663 Filed 10-16-14; 8:45 am]
BILLING CODE 4120-01-P