All posts by Kathleen Peterson

HHS: Qualified Health Plans are NOT “Federal Health Care Programs” – Implications for Anti-Kickback, CMP, and Exclusion Analyses

In an October 30, 2013, letter to Representative Jim McDermott (D-WA), U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, stated that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to […]

FDA “Bad Ads” – Now for CME Credit…

On October 25, 2013, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) updated its “Bad Ad Program” website to add an accredited CME module and case studies, designed to “educate healthcare professionals and students about the role they can play in helping the FDA ensure that […]

FDA Seeking Comments on DTC Aimed at Adolescents

On October 30, 2013, the U.S. Food and Drug Administration (FDA) announced that it is seeking public comments on research titled: “Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.”  The pre-publication notice is available here, and final publication is expected in the October 31, 2013 Federal Register.  According to the […]

Equal Opportunity Exclusion from Federal Health Care Programs

On October 25, 2013, the U.S. Department of Health & Human Services Office of Inspector General (“OIG”) updated its “Frequently Asked Questions” webpage regarding exclusions from federal health care programs to address the implications of United States v. Windsor (570 U.S. __, 113 S. Ct. 2675 (2013)).  By way of background, on […]

PhRMA Sues to Enjoin HRSA Implementation of Controversial 340B Program Orphan Drug Rule

On September 27, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA), a major drug industry trade organization filed suit in the U.S. District Court for the District of Columbia to enjoin the Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan […]

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 […]

CMS Releases New Information About State Medicaid Drug Utilization Review Practices

On July 30, 2013, the Centers for Medicare & Medicaid Services (“CMS”) posted state annual Medicaid DUR reports for fiscal year 2012.  States are required to complete annual Medicaid drug utilization review (“DUR”) surveys outlining prescribing habits, and describing cost savings generated from state Medicaid DUR programs and their Medicaid program’s […]