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AMCP Regulatory NewsBreaks

CMS Guidance on Change Healthcare Cyberattack

On March 5, 2024, the Department of Health and Human Services (HHS) issued a statement about a cybersecurity incident in late February impacting Change Healthcare – a unit of UnitedHealth Group (UHG).
AMCP Regulatory NewsBreaks

CMS Releases Medicare Prescription Payment Plan Part Two Draft Guidance

On Nov.7, 2022, the Centers for Medicare & Medicaid Services (CMS) issued guidance about the Inflation Reduction Act (IRA) changes to cost sharing requirements. The requirements are effective April 1, 2023 for Part B drugs with prices increasing faster than inflation and July 1, 2023 for the monthly Part B cost-sharing cap for insulins.
AMCP Regulatory NewsBreaks

CMS Issues Final Rule on Interoperability

On April 1, 2024, the Centers for Medicare and Medicaid Services (CMS) issued CY 2025 Medicare Advantage (MA) and Part D Rate Announcement. T
AMCP Regulatory NewsBreaks

HHS Issues Final Rule on Medications for the Treatment of Opioid Use Disorder

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.
AMCP Regulatory NewsBreaks

HHS Issues Guidance on Contraceptive Care Coverage

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.
AMCP Regulatory NewsBreaks

FDA Authorizes Florida’s Drug Importation Program

On January 5, 2024, the Food and Drug Administration (FDA) issued a letter authorizing the state of Florida’s Section 804 Importation Programs (SIP) proposal (Authorization Letter).
AMCP Regulatory NewsBreaks

ONC Issues Final Rule on Health Data, Technology, and Interoperability

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule on Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (Final Rule), which is scheduled to be published in the Federal Register on Jan. 9, 2024.
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