Tag: HHS

HHS

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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Legislative

House Appropriations Bill Does Not Include Authorization of Mandatory Drug Prices in Ads

House Appropriations Bill Does Not Include Authorization of Mandatory Drug Prices in Ads

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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Legislative

Azar Says FDA Has Authority to Require List Prices in Drug Ads

Azar Says FDA Has Authority to Require List Prices in Drug Ads

June 13, 2018 – At a Senate Committee on Health, Education, Labor & Pensions hearing on drug pricing held yesterday, Department of Health and Human Services (HHS) Secretary Alex Azar told the committee that it is his belief that “we have the authority to require list price disclosure in TV ads,” as proposed in the […]

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General

HHS’ Azar Lists Drug Pricing as One of Four Top HHS Priorities

HHS’ Azar Lists Drug Pricing as One of Four Top HHS Priorities

Feb. 20, 2018 – In President Donald J. Trump’s FY 2019 Budget, drug pricing is one of the top priorities for the Department of Health and Human Services (HHS), according to HHS Secretary Alex Azar. “The President’s budget makes investments and reforms that are vital to making our health and human services programs work for […]

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