Tag: CMS

CMS

DTC Advertising

Appeals Court Questions CMS Rule for DTC Ad List Prices

Appeals Court Questions CMS Rule for DTC Ad List Prices

Jan. 20, 2020 — A three-judge panel in the U.S. Court of Appeals for the District of Columbia sounded skeptical of the Trump administration’s position when it heard oral arguments last week in the government’s appeal of a U.S. District Court judge’s decision that struck down a Centers for Medicare & Medicaid Services (CMS) rule […]

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Courts/First Amendment

Three Manufacturers and ANA File Suit against CMS over Drug Price Disclosure Rule

Three Manufacturers and ANA File Suit against CMS over Drug Price Disclosure Rule

June 17, 2019 – The Trump administration’s final rule mandating that drug companies include the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) television ads for many drugs “exceeds [the Department of Health and Human Services’ (HHS’)] statutory authority, violates the First Amendment, and should therefore be set aside,” according to a lawsuit filed Friday, less […]

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DTC Advertising

CMS Final Rule Requiring List Prices in DTC TV Ads Virtually the Same as Original Proposal

CMS Final Rule Requiring List Prices in DTC TV Ads Virtually the Same as Original Proposal

May 9, 2019 — The Centers for Medicare & Medicaid Services (CMS) has announced its final rule requiring that drug companies include list prices in direct-to-consumer (DTC) television ads – “the single most significant step any administration has taken toward a simple commitment: American patients deserve to know about the prices of the healthcare they […]

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DTC Advertising

Despite Industry’s Price Transparency Initiatives, CMS Pushes Proposed Rule Forward

Despite Industry’s Price Transparency Initiatives, CMS Pushes Proposed Rule Forward

April 8, 2019 – The first television ads including drug price information are hitting the airwaves, reinforcing the point that list price is a highly misleading metric, and Pharmaceutical Research and Manufacturers of America (PhRMA) members are preparing to voluntarily refer consumers to online drug pricing information in their drug ads within a few weeks. […]

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DTC Advertising

Patients: DTC Ad Drug Price Transparency Proposed Rule Needs More Context, Expanded Scope

Patients: DTC Ad Drug Price Transparency Proposed Rule Needs More Context, Expanded Scope

Feb. 5, 2019 – Patient and disease advocacy groups have weighed in on the Centers for Medicare & Medicaid Services (CMS) proposal to require that drug companies list the wholesale acquisition cost (WAC) for their drugs in televised direct-to-consumer (DTC) ads. Their comments to CMS raise issues about whether the proposed rule asks for disclosure […]

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DTC Advertising

Trade Groups Say CMS Lacks Authority to Mandate Drug Prices in DTC TV Ads

Trade Groups Say CMS Lacks Authority to Mandate Drug Prices in DTC TV Ads

Jan. 15, 2019 – In comments to the Centers for Medicare and Medicaid Services (CMS) regarding its proposal to require that drug companies include the wholesale acquisition cost (WAC) of a drug in direct-to-consumer (DTC) television ads, industry trade groups and pharmaceutical companies largely are in agreement that doing so would confuse consumers, that CMS […]

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DTC Advertising

NEJM: Drug Price Information in DTC Ads Raises Public Health, Legal Concerns

NEJM: Drug Price Information in DTC Ads Raises Public Health, Legal Concerns

Nov. 19, 2018 – In a featured “Perspective” article in The New England Journal of Medicine (NEJM) this week, Stacie B. Dusetzina, Ph.D., and Michelle M. Mello, J.D., Ph.D., state that although providing cost information about prescription drugs is valuable, mandating that companies use the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) ads “raises substantial […]

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CHC News

Coalition to CMS: Reprints, Medical Texts Are Not Sunshine Act Transfers of Value

Coalition to CMS: Reprints, Medical Texts Are Not Sunshine Act Transfers of Value

Nov. 12, 2018 — As part of the Trump administration’s deregulatory approach, the Centers for Medicare & Medicaid Services (CMS) has opened a period for comments on one aspect of the Sunshine Act—specifically, the reporting requirements for distribution of educational materials to physicians by industry. In its response to CMS, the Coalition for Healthcare Communication […]

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Regulatory/FDA

White House Drug Pricing Initiative Could Include Moves on Generics/Biosimilars, Demonstration Projects and an End to Part D Rebates, Rawson Says

White House Drug Pricing Initiative Could Include Moves on Generics/Biosimilars, Demonstration Projects and an End to Part D Rebates, Rawson Says

May 4, 2018 – A drug pricing initiative expected from the White House May 8 is likely to include a number of incremental steps on drug pricing to support a strategy that is trickling down from President Trump to Health & Human Services Secretary Alex Azar and FDA Commissioner Scott Gottlieb, M.D. This initiative may […]

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Washington Focus

Executive Order Seeks Better Odds for Competitive Drug Pricing

Executive Order Seeks Better Odds for Competitive Drug Pricing

June 27, 2017 – A draft Executive Order from President Donald J. Trump indicates the administration may seek to “roll back regulations in pursuit of faster drug approvals, promoting drug competition and new payment models for federal health insurance programs,” according to CQ Roll Call. A CQ Roll Call article stated that some of the […]

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