Tag: HHS

HHS

Regulatory/FDA

HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

April 19, 2021 – Calling the basis for proposed medical device exemptions from premarket notification (510(k)) requirements “flawed,” the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing exemptions for 83 class II devices and one unclassified device which were proposed Jan. 15 in the last few days […]

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Washington Focus

Biden’s FY 2022 Proposed Budget Plan Would Boost Spending on Public Health

Biden’s FY 2022 Proposed Budget Plan Would Boost Spending on Public Health

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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Regulatory/FDA

HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

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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Washington Focus

Senate Delay in Confirming HHS Secretary Could Stall Biden’s Healthcare Plans

Senate Delay in Confirming HHS Secretary Could Stall Biden’s Healthcare Plans

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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Regulatory/FDA

HHS OIG Releases Fraud Alert on Speakers Bureaus

HHS OIG Releases Fraud Alert on Speakers Bureaus

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 […]

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Washington Focus

Change in Hospital COVID-19 Case Reporting Raises Fear of Politicization of Data

Change in Hospital COVID-19 Case Reporting Raises Fear of Politicization of Data

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 […]

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Courts/First Amendment

D.C. Circuit Court Affirms Lower Court Ruling on Drug Price Disclosure Rule, Pulls No Punches

D.C. Circuit Court Affirms Lower Court Ruling on Drug Price Disclosure Rule, Pulls No Punches

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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DTC Advertising

DTC Ad Drug Price Rule: Why Did HHS Choose the Wrong Regulations to Amend?

DTC Ad Drug Price Rule: Why Did HHS Choose the Wrong Regulations to Amend?

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 […]

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Washington Focus

Midterms Delivered Divided Government, New Players

Midterms Delivered Divided Government, New Players

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 […]

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DTC Advertising

Mandated Drug Pricing Disclosures in DTC Ads Loom Large

Mandated Drug Pricing Disclosures in DTC Ads Loom Large

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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