Tag: CMS

CMS

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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Regulatory/FDA

CMS Clarifies Sunshine Act CME Exclusion

CMS Clarifies Sunshine Act CME Exclusion

Oct. 6, 2016 – The Centers for Medicare & Medicaid Services (CMS) recently clarified in a revised FAQ that manufacturers that provide a payment or transfer of value to support continuing medical education (CME) but do not specify that the CME provider should offer payment to a specific physician speaker or faculty member would not […]

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Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open Payments Website and would extend the period during which physicians can review and request corrections to their Physician Sunshine Act records, according to an Aug. 15 article in Policy and Medicine. The agency had taken […]

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Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and medical specialty societies have asked the Centers for Medicare & Medicaid Services (CMS) to consider its “serious concerns with implementation of the Physician Payments Sunshine Act,” which include revising CMS’ recently proposed elimination of the […]

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Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to participate in this year’s CMS/FDA Summit, produced by the editors of The RPM Report. Among the most interesting panel presentations was that titled “Beyond the Label,” featuring Mit Spears, General Counsel of the Pharmaceutical Research […]

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