August 22, 2017—The Medicare Advisory Panel on Hospital Outpatient Payment has recommended that CMS not move forward with its July 20 proposed rule that would substantially reduce how much Medicare pays hospitals in the 340B drug discount program for separately payable Part B drugs under the Outpatient Prospective Payment System (OPPS). Medicare currently reimburses such drugs … [Read more...]
Mylan to Pay $19.3 Million Plus Interest for 340B Overcharges
August 18, 2017—Hospitals and other healthcare providers in the 340B drug discount program will receive $19.3 million plus interest from drug manufacturer Mylan for overcharges due to Mylan’s misclassification of its epinephrine auto-injector EpiPen as a generic rather than brand-name product. The 340B payment is part of Mylan’s $465 million settlement of a False Claims Act … [Read more...]
HRSA Updates Public About New 340B Info System
August 17, 2017—The Health Resources and Services Administration Office of Pharmacy Affairs posted an update on its website today about the registration component of its new 340B program information system, 340B OPAIS. “The 340B OPAIS will have two separate components – a new registration system and a new secure pricing system,” OPA said. “The registration component of the … [Read more...]
Mylan EpiPen Settlement Provides for 340B Overcharging Claims
August 17, 2017—The U.S. Justice Department, CMS, and EpiPen manufacturer Mylan announced today that Mylan has reached a $465 million settlement with the government to resolve claims it knowingly misclassified EpiPen as a generic drug to avoid paying Medicaid drug rebates. Mylan said the settlement provides for “potential claims by certain hospitals and other covered … [Read more...]
Hospitals Oppose Delay of Federal Rule to Punish Prescription Drug Overcharging
August 17, 2017— 340B Health, the association of hospitals and health systems in the 340B drug discount program, strongly disagrees with the Trump administration’s proposal today to again delay – this time to July 1, 2018 – a long overdue regulation to punish drug manufacturers that illegally overcharge safety-net hospitals and other healthcare providers for lifesaving … [Read more...]
340B Database Going Offline From Aug. 15 Through Mid-September
August 9, 2017—Healthcare providers in the 340B drug discount program will not be able to submit 340B program change requests or terminations from Aug. 15 through mid-September as the Office of Pharmacy Affairs phases out its current 340B database and phases in the new 340B OPA Information System, 340B OPAIS. … [Read more...]
Administration Ditches 340B Dispute Resolution Rule and Mega-Guidance
July 27, 2017—As part of a government-wide deregulatory push, the Trump administration has ditched plans to publish dispute resolution regulations for the 340B drug discount program and to publish guidelines for much of the rest of the program. The head of the 340B program’s parent agency, however, recently told the hospital association 340B Health and members of the 340B … [Read more...]