April 12, 2021 – President Joe Biden signaled his administration’s public health priorities in an outline of the fiscal year 2022 (FY 22) budget released last week. These proposed investments include substantial increases in funding for the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC), creation of […]
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March 22, 2021 – The Department of Health and Human Services (HHS) has postponed for one year the effective date of its Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule – put in place in the final days of the Trump administration – pending judicial review of a lawsuit filed March 9. In […]
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Jan. 25, 2021 – As of Jan. 25, and five days after the inauguration of President Joe Biden, the Senate has not yet scheduled confirmation hearings for Xavier Becerra, Biden’s nominee for Secretary of the Department of Health and Human Services (HHS). Any delay in his confirmation will cause a leadership gap at a critical […]
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Nov. 20, 2020 – In a rare special fraud alert issued Nov. 16, the Department of Health and Human Services Office of Inspector General (OIG) expresses skepticism about the value of company-sponsored speaker bureau events, outlines its concerns about “inherent fraud and abuse risks” associated with these programs, and offers a non-exhaustive list of the […]
Read more July 20, 2020 – The Trump administration instructed hospital systems and providers last week that they should no longer report data on COVID-19 cases, hospitalizations, deaths, positive test results, etc. to the Centers for Disease Control and Prevention’s (CDC’s) National Healthcare Safety Network site, and instead should send this information to a newly launched data […]
Read more June 17, 2020 – The U.S. Court of Appeals for the D.C. Circuit yesterday affirmed the U.S. District Court for the District of Columbia opinion that set aside the Center for Medicare and Medicaid Services (CMS) rule calling for drug manufacturers to disclose drug list prices in direct-to-consumer television ads. In the June 16 opinion, […]
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Oct. 21, 2019 — What is next in the effort to require inclusion of list prices in direct-to-consumer (DTC) promotion of pharmaceuticals? A variety of scenarios were outlined by James Czaban, chair of the FDA Practice Group at DLA Piper in Washington, during a panel at last week’s Food and Drug Law Institute conference on […]
Read more Nov. 30, 2018 – The 2018 midterm elections resulted in a divided Congress, questions about possible agency changes, and uncertainty related to drug pricing policy and the Affordable Care Act, according to Kate Rawson, senior editor, Prevision Policy and The RPM Report, who spoke at the Coalition for Healthcare Communication’s “2018 Post-election Conference on Healthcare […]
Read more Sept. 10, 2018 – Movement toward mandating that drug companies include product prices in consumer-directed ads continues this fall as Congress and the Trump administration push for greater transparency in drug pricing. On Aug. 23, the Senate voted to include an amendment sponsored by Sens. Dick Durbin (D-Ill.) and Chuck Grassley (R-Iowa) to a spending […]
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July 13, 2018 – On the “no news is good news” front, the House Appropriations Committee voted this week on next year’s funding level for the U.S. Department of Health and Human Services (HHS) without taking up an amendment to give HHS and FDA explicit authority to mandate drug list prices in consumer advertising. “What […]
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