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Arkansas Restricts PBM Ownership of Pharmacies and Limits Manufacturers’ Use of Limited Distribution Networks

On April 16, Arkansas Governor Sarah Huckabee Sanders signed into law HB1150 and HB1531, two significant pieces of legislation affecting pharmacy benefit managers (PBMs) and pharmaceutical manufacturers operating within the...more

Illinois Board of Pharmacy Adopts New Licensure Requirement for Out-of-State Pharmacists-in-Charge

Beginning January 1, 2026, the Illinois Board of Pharmacy will require “out-of-state” (non-resident) pharmacies licensed or seeking licensure in Illinois to have a pharmacist-in-charge (PIC) who is licensed in Illinois....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

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

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

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

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

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

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

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

FDA Issues Key Guidance on the Drug Supply Chain Security Act

On June 3, the U.S. Food and Drug Administration (FDA) issued a series of four documents (two final guidance documents and two draft documents) to provide trading partners guidance on its interpretation of certain...more

OIG Issues Favorable Advisory Opinion (No. 21-01) on Free Drug Program

On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more

Back to the Basics: Government Enforcement for Invalid Prescriptions and Auto-Refills

Recent enforcement actions focus attention on the importance of fundamental operational processes to ensure only valid prescriptions and refills are processed. This month, Omnicare, Inc. (Omnicare), a subsidiary of CVS...more

Boards of Pharmacy Responses to the COVID-19 Pandemic and Remote Working Needs

In the face of these unprecedented times brought on by the COVID-19 pandemic, pharmacies are grappling to find ways to protect patients and employees. In response, state officials and boards of pharmacies have reacted in a...more

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

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