Tag: Pharmacy

Q3 GOVERNMENT SETTLEMENTS ROUND-UP: LIFE SCIENCES

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Sept. 26, 2019 $108M Deferred prosecution agreement Forfeiture […]

OIG Advisory Opinion Permits Limited Provision of Free Telemedicine Hardware and Services

On May 31, 2018, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-03 regarding an arrangement in which a not-for-profit Federally qualified health center look-alike (Provider) would provide, at no charge, certain information technology-related equipment and services to a County Department of Health health clinic (County Clinic) for […]

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic […]

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use.  All of the documents are available through the FDA’s website.  Tuesday’s issuances were part of the FDA’s continued implementation of the Drug Quality and Security Act (DQSA), […]

CMS to Congress: “We Do Not Plan to Finalize” Certain Controversial Medicare Part D Proposals – All “Protected Classes” Will Remain Protected. For Now.

Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit.  We previously reported on that proposed rule here.  In a Letter to Representative Sander Levin, Ranking Member of the House […]

CMS Posts Final National Average Drug Acquisition Cost Files – Possible Pharmacy Reimbursement Adjustments to Follow

As you head out for the holiday, you may want to stop by the Centers for Medicare & Medicaid Services (“CMS”) website to check out CMS’s latest gift – the posting of the final National Average Drug Acquisition Cost (“NADAC”) Files.  Along with the final NADAC files posted today (November […]

Grassley Letter to Walgreens Expresses Interest in 340B Contract Pharmacy Arrangments

On July 31, 2013, Senator Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, sent a letter to Walgreens, Inc., requesting additional information about the pharmacy chain’s participation as a contract pharmacy in the 340B Drug Discount Program.  While the letter does not allege any wrongdoing by Walgreens, it […]