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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

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more

Key Takeaways from 2024 Asembia Specialty Pharmacy Summit

Asembia’s 20th Annual Specialty Pharmacy Summit once again brought investors and operators in the specialty pharmacy ecosystem to Las Vegas for learning sessions and networking. Bass, Berry & Sims brought a team of four...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

Alaska Adopts New Out-of-State Pharmacy Requirements

On January 19, the Alaska Board of Pharmacy (Board) announced statutory and regulatory changes that significantly impact “Out-of-State” (non-resident) Pharmacy registration requirements, impose additional licensure...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

Pushing a Balloon Into or Against the Jet Stream? Key Takeaways from the J.P. Morgan Healthcare Conference

The 42nd annual J.P. Morgan Healthcare Conference started with clear skies and overall optimism from investors. But with Jamie Dimon’s prediction of a recession in 2024 on Tuesday morning, the climate shifted to an on-again,...more

2024 Healthcare Private Equity Outlook & Trends

W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...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

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Alaska Board of Pharmacy Issues Notice Altering the Notification of Facility Changes

On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...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

While Remote Supervision Remains Available for Direct Supervision, Be Mindful of the Other “Incident to” Requirements

With the May 11, 2023 expiration of the federal public health emergency (PHE) for COVID-19, many operational flexibilities healthcare providers used during the PHE will now sunset. Some flexibilities end immediately while...more

Recap of Webinar: Billing, Coding, and Collecting for Infusion Services

Bass, Berry & Sims attorney Shannon Wiley, with Carine Leslie and Katie Garmon of PYA, P.C., recently discussed the complexities associated with billing, coding, and collecting for infusion services as part of the Infusion...more

OIG Approves Free Drug Program for Ultra-Rare Condition in Advisory Opinion 23-02

On February 23, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion 23-02, approving a pharmaceutical company’s program to provide a free 14-day supply of an...more

Lead Generation Prosecution Reminds Pharmacies of Higher Risk Arrangements

In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more

Third Circuit Ruling Allows Restrictions on 340B Contract Pharmacies

On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more

Summary of Medicare Drug Negotiation Program in Inflation Reduction Act and Impact on Pharmacies and Providers

The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...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

FCA Lawsuit Against Walgreens Dismissed Because Government Fails to Plead Materiality

On December 2, the U.S. District Court for the Western District of Virginia granted a motion to dismiss a False Claims Act (FCA) lawsuit brought by the United States and the Commonwealth of Virginia, which alleged that a...more

Kentucky Federal Court Temporarily Bars CVS from Imposing Block on Interventional Pain Doctor’s Prescriptions

In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...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

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