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On January 31, 2020, HHS declared a public health emergency (Declaration) pursuant to the
Public Readiness and Emergency Preparedness Act (PREP Act), in response to the COVID–
19 outbreak.

The Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug
Enforcement Administration (DEA) are issuing this temporary rule to extend certain exceptions
granted to existing DEA regulations in March 2020 because of the COVID-19 Public Health
Emergency (COVID-19 PHE).

On April 5, 2023, the Centers for Medicare and Medicaid Services (CMS) issued a Final Rule,
titled “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan
Program, and Programs of All-Inclusive Care for the Elderly” (Final Rule).

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.