Tag Archives: pharmacy

Drug Manufacturer Discount Cards: Accept With Caution

Photo of Robert M. WolinBy Robert M. Wolin on Posted in Uncategorized
Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years.  In a September 2014 Special Advisory Bulletin, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) stated, “[t]hese coupons constitute remuneration offered to consumers to induce the purchase of specific items.” … 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

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

DEA Authorizes Take-Back Programs for Pharmacies

Photo of Lee H. RosebushBy Dena Kessler and Lee H. Rosebush on Posted in Uncategorized
The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as well as other specified entities. The Final Rule allows these entities to institute prescription drug take-back programs where patients can turn over unused pharmaceuticals either … Continue Reading

A Look Back at 2013

Photo of BakerHostetlerBy BakerHostetler on Posted in Uncategorized
In this posting: A Look Back at 2013 Antitrust and Competition Policy, Advocacy and Legislative Strategy Development FDA and Life Sciences Privacy and Data Protection Enforcement and Compliance Transactions and Finance Reimbursement, Licensing and Certification Fraud and Abuse Laws Tax-Exempt Organizations Honors and Recognition Was it the number 13? There’s an old superstition about the … Continue Reading
LexBlog