On December 22, 2022, the Pennsylvania Department of Human Services released a Medical Assistance (“MA”) Program Bulletin (“Bulletin”) applicable to 340B covered entities enrolled in the MA program. The Bulletin, which took effect on January... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Articles | Life Sciences | Pharmacy Law

The Court of Appeals for the Third Circuit recently issued its decision in the consolidated cases of drug manufacturers Sanofi, Novo Nordisk, and AstraZeneca ruling in the drug manufacturers favor versus the Department of Health & Human Services... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Articles | Chain Pharmacies | Clinically Integrated Networks | Clinically Integrated Networks (CINs) | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Digital Pharmacies | Dispensing Physician Practices and Dispensing Physicians | Fertility Pharmacies | Hospitals and Healthcare Systems | Integrated Delivery Network | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Section 340B In-House and Contract Pharmacies | Specialty Pharmacies | Supermarket Pharmacies

On June 15, 2022, the Supreme Court of the United States ruled unanimously in favor of several hospital groups concluding that the Department of Health and Human Services (HHS) exceeded its statutory authority by implementing a discriminatory... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Articles | Healthcare Litigation | Hospitals and Healthcare Systems | Medicare and Insurance Audits

In part one of this article series, Frier Levitt dissected the May 9, 2022, Centers for Medicare and Medicaid Services (CMS) Final Rule (Final Rule) entitled, “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Administrative and Insurance Defense Law | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Healthcare Law | Life Sciences

Recent CMS agency rulemaking has essentially eliminated pharmacy Direct and Indirect Remuneration (DIR) fees beginning in Plan Year 2024.  Providers “in the know,” however, are not cheering.  Our more technical article on the rulemaking is... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Administrative and Insurance Defense Law | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Healthcare Law | Life Sciences

Earlier this month, the federal government intervened in a qui tam action originally filed in 2017 against a Tennessee hospital system, Methodist Le Bonheur Healthcare and Methodist Healthcare-Memphis Hospitals (collectively, “Methodist”),... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Buying and Selling Medical Practices including Private Equity Transactions | Community Oncology Practices & Other Dispensing Physician Practices | Healthcare | Hospitals and Healthcare Systems | PBM Qui Tam Lawsuits

As Frier Levitt has highlighted in recent articles, independent pharmacies are encouraged to use all available tools to combat unjustified PBM audit findings.  Pharmacies should exhaust their efforts, even in instances where the amount of monies at... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Life Sciences | Pharmacy Law | State and National Pharmacy Associations

On March 24, 2022, Senators Richard Pan and Scott Wiener of California introduced new legislation (SB-939) targeting abusive Pharmacy Benefit Manager (PBM) practices in connection with the federal 340B program. By way of background, the 340B program... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Defending Pharmacies in PBM Audits | Life Sciences | Pharmacy Law

On February 23, 2022, Michigan Governor Gretchen Whitmer signed into law House Bills 4348, 4351, and 4352, each tailored to address Pharmacy Benefit Managers’ (PBMs) discriminatory treatment of 340B entities. The signing of these Bills comes less... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Defending Pharmacies in PBM Audits | Life Sciences | Maximum Allowable Cost Pricing & Appeals | Pharmacy Law | Plan Sponsor PBM Contract Services | Section 340B In-House and Contract Pharmacies

The Section 340B federal discount drug program (340B program) is a federal program under which pharmaceutical manufacturers enter into contracts with the U.S. Department of Health & Human Services (HHS) in exchange for obtaining Medicaid and... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Articles | Life Sciences | Pharmaceutical Manufacturers | Pharmacy Law | Pharmacy Transactions | Section 340B In-House and Contract Pharmacies