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Part D 2014 Draft Call Letter Addresses Automatic Rx Refills, Drug Safety Issues

 
• By Gregory Twachtman and Cathy Kelly

CMS instructions to Part D sponsors cite elimination of waste as a reason to require plans to confirm members want a refill. Draft call letter also addresses expanding drug utilization reviews beyond opioids, added controls on compounded drugs.

Medicare Part D prescription drug plan sponsors are to instruct pharmacies, both retail and mail-order, to obtain beneficiary consent before refilling a prescription, according to a proposed program change that will go into effect for the 2014 plan year.

The instructions are found in the CMS draft “call letter” for 2014, which informs Part D sponsors on planned changes...

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More from United States

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Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

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The FDA deputy commissioner emailed staff asking anyone interested in the position to send her their curriculum vitae, an unusual method for finding candidates for a high-level position.

Pink Sheet Podcast: Examining George Tidmarsh’s Departure As Head Of US FDA’s Drug Center

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.

More from North America

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.

Novo, Lilly Lower GLP-1 Prices, ‘Enabling’ Medicare, Medicaid Coverage In Obesity

 
• By Cathy Kelly

The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.

Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.