All posts by Cooley

Final Rule Issued by CMS re: New Enforcement Authorities to Reduce Criminal Behavior in Medicare, Medicaid and CHIP

The Centers for Medicare & Medicaid Services (CMS) issued late last week a final rule with comment period titled, Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-FC) (Final Rule). The Final Rule is intended to proactively prevent fraud and abuse against the Federal health care programs, including Medicare, Medicaid […]

Proposed Rule Issued by CMS re: Expansion of Open Payments Reporting

The Centers for Medicare & Medicaid Services (CMS) issued this week a proposed rule regarding the expansion of Open Payments reporting requirements (Proposed Rule). As we discussed here, the 2018 SUPPORT Act expanded the definition of “covered recipients” to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse […]

Nevada DHHS Releases 2019 Drug Transparency Report

The Nevada Department of Health and Human Services (DHHS) released today its 2019 Drug Transparency Report in connection with the state law requiring transparency related to essential diabetes drugs (EDD). Notably, the Report states that 695 drug national drug codes (NDCs) were included on the February 2019 EDD list published […]

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 […]

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 […]

PhRMA Releases Updated Guiding Principles on DTC Advertising

The Pharmaceutical Research and Manufacturers of America (PhRMA) released today updated Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines (Guiding Principles), which will be effective April 15, 2019. These Guiding Principles replace the prior version. Revisions to the Guiding Principles include a new principle 19 that all product-related direct to […]

New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]