Medicare for All unveiled in House. Some things old, some things new, but much left to do

Recently, progressive democrats in the House of Representatives lead by Rep. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) released the long-awaited Medicare for All Act of 2019 (M4A) proposal.  M4A differs from single-payer plans released by Senator Bernie Sanders (I-VT) and various Washington think tanks. One of the most significant differences […]

HHS Proposed Rule Would Remove Safe Harbor Protection for Certain Discounts

On January 31, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule designed to combat rising drug costs (“Proposed Rule”). The Proposed Rule seeks to eliminate rebates paid by pharmaceutical manufacturers to plan sponsors or their pharmacy benefit managers (“PBMs”) […]

AdvaMed Code of Ethics Updated Effective January 1, 2020

The Advanced Medical Technology Association (AdvaMed) announced earlier this month the availability of an updated Code of Ethics on Interactions with U.S. Health Care Professionals (AdvaMed Code). The updated AdvaMed Code becomes effective January 1, 2020. According to AdvaMed, the AdvaMed Code was updated to make examples current, enhance user-friendliness, and address the evolving nature […]

340B Drug Program Price Ceiling and Penalties Moved Up To Start January 1st

On November 30, 2018, the Department of Health and Human Services (HHS) issued a final rule that puts in effect January 1, 2019, rather than July 1, 2019 as previously announced significant changes to the 340B program including a ceiling price on how much drug manufactures can charge hospitals who […]

OIG Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

Federal Sunshine Act Reporting Requirements Expanded to Other Prescribers

Currently, the federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (Applicable Manufacturers) to report annually to the Centers for Medicare and Medicaid Services (CMS) certain payments and transfers […]

Cooley Alert: Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law

Biologic drug makers will soon have to alert the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement is part of the Patient Right to Know Drug Prices Act, which President Trump signed into […]