Tag Archives: 340B

Discounted Drugs under the 340B Program

Photo of Lee H. RosebushPhoto of Laura MacherelliPhoto of Marc WagnerBy Lee H. Rosebush, Laura Macherelli and Marc Wagner on Posted in Healthcare
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing restrictions on how their drugs are distributed. Read the full Alert.… Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
Democrats and Some Republicans Say Congress Must Restore Insurer Subsidies President Trump’s announcement Friday that he would stop cost-sharing payments to insurance companies triggered a firestorm on Capitol Hill, with lawmakers in both parties calling on Congress to restore the funding quickly. House Democratic Leader Nancy Pelosi (D-Calif.) said lawmakers could leverage upcoming must-pass budget … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
ACA Stabilization Effort Continues Amid Uncertain Senate Fate The chairman of a Senate healthcare committee outlined a key test for stabilizing the Affordable Care Act’s (ACA) shaky individual marketplace: Both Republicans and Democrats will have to give a little. That formula has been wildly unsuccessful not only this year but also in recent years as … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
At HHS, Price will lead Trump’s efforts on ACA repeal Three weeks into President Trump’s administration, the Senate on Friday narrowly approved Tom Price as Secretary of the U.S. Department of Health and Human Services (HHS), elevating the former orthopedic surgeon as Trump’s point person on repealing and replacing the Affordable Care Act (ACA). Price … Continue Reading

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released the proposed rule on June 17, 2015, and the original comment period ended August 17, 2015. The 340B Drug Pricing Program requires drug manufacturers … Continue Reading

Rosebush and Holmes Author Article on Contract Pharmacies and 340B Compliance in Journal of Health Care Compliance

Photo of BakerHostetlerBy BakerHostetler on Posted in Uncategorized
Partner Lee Rosebush and Associate Lindsay Holmes authored an article published in the November-December 2015 issue of the Journal of Health Care Compliance. The article, “340B Compliance Issues: Contracting with Contract Pharmacies,” analyzes the compliance issues associated with the use of contract pharmacies by a covered entity in the 340B setting. Rosebush and Holmes emphasize that such covered entities must … 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

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling price regulations. The Rule, proposed by the Health Resources and Services Administration (HRSA), rule seeks to enforce the … Continue Reading

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing Program. The mega rule was expected to cover contract pharmacy compliance and eligibility criteria for patients, hospitals and off-campus … Continue Reading

The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA

Photo of Lee H. RosebushBy Lee H. Rosebush and Susan Feigin Harris on Posted in Uncategorized
On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and the Section 340B Drug Pricing Program (340B Program), would not prevent the agency from moving forward with its … Continue Reading

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

Photo of Lee H. RosebushBy Susan Feigin Harris and Lee H. Rosebush on Posted in Uncategorized
On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an injunction and the granting of a motion for summary judgment brought by the Pharmaceutical Research and … Continue Reading
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