Tag Archives: drug manufacturers

Vermont to Require Drug Transparency

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of Vermont Health Access (DVHA) and the Green Mountain Care Board (GMCB) will work together to create a yearly … Continue Reading

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush and Lindsay Holmes on Posted in Uncategorized
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) in October 2014, was recently vacated in favor of PhRMA by the … Continue Reading

340B Guidance: Eight Key Points Covered Entities Should Consider

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Dena Kessler, Nita Garg and Lindsay Holmes on Posted in Uncategorized
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered … Continue Reading

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed rule, if adopted, could open the door to significant financial penalties for manufacturers, even if it is the manufacturer’s wholesaler or other business partner that overcharges the … Continue Reading

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications.  While the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has previously provided some guidance on the use of these coupons, there has … Continue Reading
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