[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Proposed Rules]
[Page 46182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21420]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 511

[CMS-1670-WN]
RIN 0938-AS85


Medicare Program; Part B Drug Payment Model; Withdrawal

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

ACTION: Withdrawal of proposed rule.

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SUMMARY: This document withdraws a proposed rule that was published in 
the Federal Register on March 11, 2016. The proposed rule discussed our 
proposal to implement a new Medicare payment model under section 1115A 
of the Social Security Act (the Act).

DATES: As of October 4, 2017, the proposed rule published March 11, 
2016, at 81 FR 13230, is withdrawn.

FOR FURTHER INFORMATION CONTACT: Rasheeda Johnson, (410) 786-3434.

SUPPLEMENTARY INFORMATION: On March 11, 2016, we published a proposed 
rule in the Federal Register entitled ``Medicare Program; Part B Drug 
Payment Model'' (81 FR 13230). The rule proposed the Part B Drug 
Payment Model as a two-phase model that would test whether alternative 
drug payment designs will lead to a reduction in Medicare expenditures, 
while preserving or enhancing the quality of care provided to Medicare 
beneficiaries. In the first phase, CMS would test a change to the 6 
percent add-on to Average Sales Price (ASP) that is used to make drug 
payments under Part B such that the add-on would be 2.5 percent plus a 
flat fee (in a budget neutral manner). In the second phase, we would 
implement a collection of value-based purchasing tools similar to those 
employed by commercial health plans, pharmacy benefit managers, 
hospitals, and other entities that manage health benefits and drug 
utilization. We proposed to operate the model for 5 years; phase I 
would begin in the fall of 2016 (no earlier than 60 days after the rule 
was finalized), and phase II would begin no sooner than January 1, 
2017. The proposed goal was to have both phases of the model in full 
operation during the last 3 years of the proposed 5-year duration to 
fully evaluate changes and collect sufficient data.
    We received 1,350 timely public comments in response to the March 
11, 2016, proposed rule. Some commenters signaled their support for the 
proposed rule, however, a number of commenters expressed concerns about 
the proposed model. As we worked to address these concerns, the 
complexity of the issues related to the proposed model design and the 
desire to increase stakeholder input led us to the decision to withdraw 
the March 11, 2016 proposed rule. Moving forward, we want to ensure 
agency flexibility in re-examining these important issues and exploring 
new options and alternatives with stakeholders as we develop potential 
payment models that support innovative approaches to improve quality, 
accessibility, and affordability, reduce Medicare program expenditures, 
and empower patients and doctors to make decisions about their health 
care.
    Accordingly, the proposed rule published March 11, 2016, at 81 FR 
13230, is withdrawn.

    Dated: July 17, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: August 25, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-21420 Filed 10-3-17; 8:45 am]
 BILLING CODE 4120-01-P