46182 Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Proposed Rules 

Dated: July 21, 2017. 

Demetrios L. Kouzoukas, 

Principal Deputy Administrator and Director, 

Center for Medicare. 

Approved: September 7, 2017. 

Thomas E. Price, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2017–21425 Filed 10–3–17; 8:45 am] 

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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. 

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2016, at 81 FR 13230, is withdrawn.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] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Parts 160 and 162 

[CMS–0037–WN] 

Administrative Simplification: 

Certification of Compliance for Health 

Plans; Withdrawal 

AGENCY: Office of the Secretary, HHS. 

ACTION: Withdrawal of proposed rule. 

SUMMARY: This document withdraws the 

January 2, 2014, proposed rule that 

would have required a controlling 

health plan (CHP) to submit information 

and documentation demonstrating that 

it is compliant with certain standards 

and operating rules adopted by the 

Secretary of Health and Human Services 

(the Secretary) under the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA). 

This proposed rule would have also 

established penalty fees for a CHP that 

failed to comply with the certification of 

compliance requirements. 

DATES: As of October 4, 2017, the 

proposed rule published January 2, 

2014, at 79 FR 298, is withdrawn. 

FOR FURTHER INFORMATION CONTACT: 

Geanelle G. Herring, (410) 786–4466. 

SUPPLEMENTARY INFORMATION: In the 

January 2, 2014, Federal Register (79 FR 

298), we published the proposed rule 

titled ‘‘Administrative Simplification: 

Certification of Compliance for Health 

Plans’’ which would have required 

controlling health plans (CHPs) to 

submit certain information and 

documentation that demonstrated 

compliance with the standards and 

operating rules adopted under the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) for 

three electronic transactions: Eligibility 

for a health plan, health care claim 

status, and health care electronic funds 

transfers (EFT) and remittance advice. 

The proposed rule would have also 

established penalty fees for a CHP that 

failed to comply with the certification of 

compliance requirements. 

We received approximately 72 public 

comments in response to the January 2, 

2014 proposed rule. In light of the 

issues raised in the public comments 

received, we have decided to withdraw 

the January 2014 proposed rule in order 

to re-examine the issues and explore 

options and alternatives to comply with 

the statutory requirements. We note that 

the Secretary has established regulations 

pertaining to compliance with, and 

enforcement of, HIPAA Administrative 

Simplification standards and operating 

rules. The withdrawal of this proposed 

rule does not remove the requirements 

for covered entities to comply with any 

of those regulations codified at 45 CFR 

parts 160 and 162. 

Accordingly, the proposed rule 

published January 2, 2014, at 79 FR 298, 

is withdrawn. 

Dated: August 18, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: August 30, 2017. 

Thomas E. Price, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2017–21424 Filed 10–3–17; 8:45 am] 

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