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Substance Abuse and Mental Health Services Administration (SAMHSA) within
the Department of Health and Human Services (“HHS”) issued a final rule on
Medications for the Treatment of Opioid Use Disorder (Final Rule), to be published
on Feb. 2, 2024.

On April 17, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized the 2024
Notice of Benefit and Payment Parameters (NBPP).

On March 15, the Centers for Medicare & Medicaid Services (CMS) released initial guidance
for key elements of the new Medicare Drug Price Negotiation Program. This guidance
describes how CMS intends to implement the Negotiation Program for initial price applicability
year 2026 (Jan. 1, 2026 to Dec. 31, 2026), the first year the negotiated prices will apply.

Under the Medicare Drug Rebate provisions of the Inflation Reduction Act (IRA), beneficiary
coinsurance will be 20% of the inflation-adjusted payment amount for certain Part B drugs and
biologicals with prices that have increased faster than the rate of inflation.

On Jan. 22, 2024, the Department of Health and Human Services (HHS) issued a
letter to Medicare plans, health insurance issuers, and State Medicaid and CHIP
programs (Letter) and a set of Frequently Asked Questions (FAQs) outlining how
plans and issuers can make sure they meet their contraception coverage
obligations.

The Inflation Reduction Act (IRA) requires the establishment of a new Medicare Part D
manufacturer discount program (MDP) beginning Jan. 1, 2025 and requires participating
manufacturers to enter into agreements with CMS by Mar. 1, 2024 in order to participate in the
MDP in 2025. Agreements will be valid for not less than one year and automatically renew
unless terminated by CMS or the manufacturer.

On Feb. 1, the Final Rule, titled Medicare and Medicaid Programs; Policy and Technical
Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of AllInclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care
Programs for Years 2020 and 2021, was published in the Federal Register.