On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a memorandum (the “Memorandum”) setting forth CMS’s proposed methods for calculating so-called “Inflation Rebates” as mandated by the recent Inflation... Read More
Articles | Manufacturers | Medicare and Insurance Audits | Medicare Audit Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Professional Practice Representation

On January 15, 2023, the Vermont Department of Financial Regulation (the “Department”) issued a report titled “Act No. 131 (2022) Report: Pharmacy Benefit Management” (the “Report”). As the title suggests, the Department was required... Read More
Antitrust Review and Compliance | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Biotech Companies | Chain Pharmacies | Clinically Integrated Networks (CINs) | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | DIR Fees | 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 | Manufacturers | Outsourcing Facilities (503B) | PBM Qui Tam Lawsuits | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Physician Dispensing | Plan Sponsor PBM Contract Services | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Urologist | Veterinary Compounders

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

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

The New York State Department of Financial Services’ recently established Pharmacy Benefits Bureau (“Bureau”) has requested additional Public Comments regarding Pharmacy Benefit Managers (“PBMs”) in New York. The Bureau, as an... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Defending Pharmacies in PBM Audits | Life Sciences | News | Pharmacy Law | Plan Sponsor PBM Contract Services | Section 340B In-House and Contract Pharmacies

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

On May 9, 2022, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule (Final Rule) entitled, “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.” ... Read More
All types of single and multi-specialty medical practice groups | Articles | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Digital Pharmacies | DIR Fees | Dispensing Physician Practices and Dispensing Physicians | Healthcare | Healthcare Law | Healthcare Practice Compliance | Life Sciences | Medicare and Insurance Audits | Medicare Audit Appeals | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Wholesalers | Physician Dispensing | Physician Dispensing | Physicians and Medical Practices of all Specialties | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

Pharmacy Benefits Managers (PBMs) often make changes to their contracts with pharmacies through notice alone that does not require a signature from the pharmacy.  At least one PBM recently issued such a notice to pharmacies regarding a new Medicare... Read More
Articles | Defending Pharmacies in PBM Audits | DIR Fees | Life Sciences | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmacy Law