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

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

A piece of legislation aimed at regulating pharmacy benefit managers (PBMs) and protecting Independent Pharmacies in the State of Tennessee recently passed through the State’s House and Senate and was subsequently signed into law by Governor Bill... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Articles | Defending Pharmacies in PBM Audits | Life Sciences | Pharmacy Law | Section 340B In-House and Contract Pharmacies | Specialty Pharmacies

Under the Section 340B federal discount drug program (340B program), pharmaceutical manufacturers enter into contracts with the Health & Human Services (HHS) in exchange for having their drugs covered by Medicaid and Medicare.  Pursuant to... Read More
Articles | Life Sciences | Manufacturers | Pharmacy Law | Section 340B In-House and Contract Pharmacies

A drug pricing program authorized under a 1992 amendment to the Public Health Service Act (Pub. L. 102-585 (1992); 42 U.S.C. § 256b), named 340B, requires drug manufacturers, in exchange for having its drugs covered by Medicaid, to sell outpatient... Read More
Articles | Community, Retail Pharmacies | Life Sciences | Section 340B In-House and Contract Pharmacies

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Healthcare | Hospitals and Healthcare Systems | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Section 340B In-House and Contract Pharmacies

Ohio legislators have introduced bipartisan Senate and House bills aimed at curbing excessive fees charged by insurers and Pharmacy Benefit Managers to pharmacies and providers participating in the 340B Drug Pricing Program. The 340B Program,... Read More
Defending Pharmacies in PBM Audits | DIR Fees | Pharmacy Law | Section 340B In-House and Contract Pharmacies