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CMS Solicits Comments to Clarify Parameters on MAC Downcoding of Complex Drug Administration Infusion Services

In the proposed CY 2025 Physician Fee Schedule (PFS) published in the Federal Register on July 31, the Centers for Medicare & Medicaid Services (CMS) is soliciting comments on a proposal to revise the Medicare Claims...more

CMS Proposes to Extend Virtual Direct Supervision

On July 10, the Centers for Medicare & Medicaid Services (CMS) proposed to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person...more

CMS & HHS Withdraw Appeal to Recent Copay Accumulator Federal District Court Decision: 2020 Accumulator Rule Still in Effect

On January 16, the Centers for Medicare & Medicaid Services (CMS) & the U.S. Department of Health and Human Services (HHS) withdrew an appeal to a recent copay accumulator court decision, HIV and Hepatitis Policy Institute et...more

The New Year Brings New Opportunity for Coding Complex Administration Infusions and Injections

Effective December 21, 2023, the Centers for Medicare & Medicaid Services (CMS) has directed A/B MACs to not make downward adjustments to claims for CPT Codes for complex therapy administration (96401-96549) based solely on...more

CMS Extends Virtual Direct Supervision Through 2024

On November 2, the Centers for Medicare & Medicaid Services (CMS) extended virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person presence)...more

Final Rule to Allow for "One-Time Only" Transfer of Electronic Controlled Substance Prescriptions Between Pharmacies

On August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V controlled...more

Supreme Court Strikes Down Medicare Cuts to 340B Hospitals

On June 15, the U.S. Supreme Court issued a unanimous decision finding Medicare payment cuts to hospitals participating in the 340B drug pricing program illegal. The decision in favor of 340B hospitals is the culmination of a...more

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more

New California Rules Limit Prescription Auto-Refill Programs

Starting next summer, California licensed pharmacies offering automatic prescription refill programs will be subject to new constraints and limitations. California recently approved new Board of Pharmacy regulations, which go...more

CMS and the OIG Issue Final Rules Modernizing and Clarifying the Federal Stark and Anti-Kickback Laws

In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more

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