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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

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

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

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

Sunny Days Ahead? Key Takeaways from Bass, Berry & Sims Connect During the Annual the J.P. Morgan Healthcare Conference

Even the threat of an unprecedented atmospheric river storm could not stop the tried and true from attending the 41st annual J.P. Morgan Healthcare Conference. With a break of sunshine on Monday, we found ourselves asking,...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

Healthcare Transactions Q1 2022

2022 started strong for healthcare transactions with some reports suggesting a record-breaking January. Although deal activity cooled in February and March, transaction pipelines still indicate that 2022 is on pace to match...more

Government Appeals Decisions in 340B Contract Pharmacy Litigation

On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...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

Key Takeaways from Bass, Berry & Sims Connect During the Annual J.P. Morgan Healthcare Conference

For the fifth consecutive year, the Bass, Berry & Sims Healthcare Private Equity Team hosted BBS Connect, a forum to connect healthcare dealmakers during the annual J.P. Morgan Healthcare Conference. Over three days –...more

Healthcare Transactions: Year in Review - January 2021

2020 was a tumultuous year for the healthcare industry, which continues to confront the effects of the COVID-19 pandemic. Despite these unprecedented and unpredictable times, healthcare merger and acquisition (M&A) activity...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

Specialty Pharmacy Compliance During COVID-19 Pandemic

The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...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

DOJ Moves to Dismiss 11 Patient Assistance Services FCA Cases

In a remarkable move, the Department of Justice (DOJ) recently sought dismissal of 11 False Claims Act (FCA) cases, each of which assert that patient assistance services supplied by pharmaceutical manufacturers constitute...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

Tennessee Rule Change: Prohibition on Prescription Transfer Incentives

Tennessee pharmacies can no longer offer patients financial rewards in exchange for the transfer of the patient's prescriptions. Effective February 20, 2017, the Tennessee Board of Pharmacy enacted a new rule providing that...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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