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Federal Register / Vol. 86, No. 221 / Friday, November 19, 2021 / Rules and Regulations PART 117DRAWBRIDGE
OPERATION REGULATIONS
1. The authority citation for part 117
continues to read as follows:

Authority: 33 U.S.C. 499; 33 CFR 1.051;
and Department of Homeland Security Delegation No. 0170.1.

2. In 117.400, add paragraph c to read as follows:

117.400

Indiana Harbor Canal.

c The Indianapolis Boulevard Bridge, mile 2.59, at East Chicago, shall open on signal if at least twelve hours notice is given.
M.J. Johnston.
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
FR Doc. 202125268 Filed 111821; 8:45 am BILLING CODE 911004P

Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands in the amended regulatory definitions of States and United States for purposes of the Medicaid Drug Rebate Program MDRP, adopted in the interim final rule with comment period entitled, Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States, published in the November 25, 2019 Federal Register to January 1, 2023. We requested public comment on the proposed delays of the applicable effective date and inclusion date and discuss the comments received in this final rule.
DATES: These regulations are effective on December 20, 2021.
FOR FURTHER INFORMATION CONTACT:
Christine Hinds, 410 7864578.
SUPPLEMENTARY INFORMATION:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid Services 42 CFR Part 447
CMS2482F2
RIN 0938AT82

Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States Centers for Medicare &
Medicaid Services CMS, HHS.
ACTION: Final rule.

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AGENCY:

SUMMARY: This final rule will delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing VBP arrangement, of the final rule entitled, Medicaid Program;
Establishing Minimum Standards in Medicaid State Drug Utilization Review DUR and Supporting Value-Based Purchasing VBP for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability TPL
Requirements, published in the December 31, 2020 Federal Register to July 1, 2022. This final rule will also delay for 9 months the April 1, 2022
effective date of inclusion hereinafter referred to as the inclusion date of the U.S. territories American Samoa,
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A. Summary of Proposed Delays in Effective and Inclusion Dates of Certain Regulation Provisions In the Medicaid Program;
Establishing Minimum Standards in Medicaid State Drug Utilization Review DUR and Supporting Value-Based Purchasing VBP for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability TPL
Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States proposed rule that published in the May 28, 2021 Federal Register 86 FR 28742 hereinafter referred to as the proposed rule, CMS
made two proposals. First, CMS
proposed to delay the January 1, 2022
effective date for amendatory instruction 10.a. of the final rule entitled, Medicaid Program;
Establishing Minimum Standards in Medicaid State Drug Utilization Review DUR and Supporting Value-Based Purchasing VBP for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability TPL
Requirements 85 FR 87000
hereinafter referred to as the December 31, 2020 final rule, for 6 months to July 1, 2022. Second, CMS proposed to delay the April 1, 2022, inclusion date in the amended regulatory definitions of States and United States, adopted in the interim final rule with comment period entitled Medicaid Program;
Covered Outpatient Drugs; Further Delay of Inclusion of Territories in Definitions of States and United States 84 FR 64783, for 2 years until April 1,
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2024, or in the alternative, to a date earlier than April 1, 2024, but not before January 1, 2023 based on public comments.
B. Proposed Delay of Effective Date of Amendatory Instruction 10.a.
The December 31, 2020 final rule advanced CMS efforts to support state flexibility to enter into innovative valuebased purchasing VBP arrangements with drug manufacturers for new and innovative, and often costly therapies, such as gene therapies, and codified new approaches required by section 1004 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment SUPPORT for Patients and Communities Act SUPPORT Act Pub. L. 115271, enacted October 24, 2018 and the existing Medicaid DUR program to improve the clinical use of opioids and reduce the potential for abuse in Medicaid patients. In addition, it codified in regulation several changes made in recent legislation and clarified other provisions of regulations relating to the Medicaid Drug Rebate Program MDRP.
The regulations included in the December 31, 2020 final rule went into effect on March 1, 2021, except for certain amendatory instructions, including instruction 10.a., which is effective on January 1, 2022. In the proposed rule, we proposed to delay the January 1, 2022 effective date for amendatory instruction 10.a. of the December 31, 2020 final rule on manufacturer reporting of multiple best prices connected to a VBP arrangement, to July 1, 2022, and sought public comment on the proposed delay. As discussed in the proposed rule, we believed a delay of 6 months is warranted to assure that stakeholders have the ability to implement the new VBP policy in a manner that assures patient access and quality of care are protected. We sought public comments on this proposed delay in the effective date, including the impact of this delay on affected beneficiaries. The primary reason for the original delay, and the proposed delay, was to provide more time for CMS, states, and manufacturers to make the complex system changes necessary to implement the new best price and VBP program, and assure patient access and quality of care, given the current need to devote resources to the public health emergency PHE
relating to COVID19 that has been in effect, and will likely remain in effect at least through 2021. On April 21, 2021, the Secretary of Health and Human Services the Secretary renewed the PHE initially declared on January 31,
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