Over the past several years, the number of pharmacies participating as "Contract Pharmacies" for 340B Covered Entities has grown exponentially. Under the 340B program, Covered Entities - such as Federally Qualified Health Centers and... Read More
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
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
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
The 340B program is a federal discount drug program which requires pharmaceutical manufacturers to enter into an agreement, called a Pharmaceutical Pricing Agreement (PPA), with the Secretary of the Department of Health & Human Services in... Read More
The impact of Direct and Indirect Remuneration ("DIR") fees on the specialty pharmacy industry cannot be overstated and has been widely reported in White Papers and industry news reports. However, the impact of DIR fees on the 340B sector is only... Read More
On January 30, 2017, the United States Department of Health and Human Services (HHS) decided to withdraw "Mega Guidance" related to the 340B drug discount program. This withdrawal comes after the Trump administration put a freeze on new... Read More
