Oct. 18, 2022 – The Centers for Medicare & Medicaid Services (CMS) is beginning to establish a framework for the Medicare drug pricing negotiations mandated in the recently enacted Inflation Reduction Act (IRA), a process that will be complicated and controversial. “Passage of the Inflation Reduction Act – including provisions to mandate Medicare negotiations on […]
Read more April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the controversial Alzheimer’s drug Aduhelm, last week the Centers for Medicare and Medicaid Services (CMS) announced it will retain the proposal’s coverage plan: Medicare will only fund prescriptions of Aduhelm for patients enrolled in randomized, controlled […]
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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 […]
Read more 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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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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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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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 […]
Read more 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 […]
Read more 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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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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