Tag Archives: CMS

BIO Statement on President-elect Donald Trump’s appointment of Rep. Tom Price (R-GA) as Secretary of Health and Human Services

BIO issued the following statement on President-elect Donald Trump’s appointment of Rep. Tom Price (R-GA) as Secretary of Health and Human Services: BIO applauds the selection of Dr. Tom Price (R-GA) as Secretary of Health and Human Services and looks forward to working with him to ensure innovative biopharmaceutical breakthroughs are accessible to the patients that need them. Dr. Price has been a leader in healthcare policy throughout his career in the U.S. Congress. An orthopedic surgeon by trade, Read More >

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Cancer Docs Weigh in on Medicare Part B Demo

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This week, American Society of Clinical Oncology (ASCO) President Daniel Hayes, MD and CEO Clifford Hudis, MD shared their thoughts in The Hill on how “We can do better than Medicare Part B demo.” At the forefront of oncology, they remind us that we are living in remarkable times of real progress – treatment options are ever-improving as is the number of cancer survivors. However, the experimental nature of Medicare Part B demo poses a Read More >

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Correcting the Record On Politico’s Misinformed Article

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Politico recently explored the relationship between the biopharmaceutical industry and the Affordable Care Act (ACA). The article laments the supposed high cost of drugs and implicitly endorses policies that would not only do little for patients in need of medications, but also stifle innovation through research and development. The implication that the “structural reforms” the story talks about would fundamentally change drug costs in this country is myopic and misinformed. Those so-called “reforms” like top-down, Read More >

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Partners for Healthy Dialogues: Letter to CMS

Partners for Health Dialogues

BIO, a member of Partners for Healthy Dialogues (P4HD), joined 25 medical societies and manufacturers in a letter to the Center for Medicare and Medicaid Services highlighting both their shared commitment to sunshine and the importance of context in the upcoming data release.  As BIO CEO Jim Greenwood said in a Q&A with P4HD: “We believe that part of CMS’s public service function in this area should be to help improve the public’s understanding of the need for Read More >

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What Parallel Review Means for Manufacturers

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By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >

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