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The House of Representatives has passed the American Health Care Act; the measure's prospects in the Senate are uncertain at best.

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Device Stakeholders Meet With White House On Draft Expedited CMS Coverage Rule

Trump administration officials met with medical device lobbyists earlier this month to discuss a draft rule dubbed “ExCITe” that would expedite coverage of innovative technology, and briefing materials from the meeting include an industry proposal that CMS provisionally cover certain medical devices and diagnostics following FDA approval while the manufacturer continues to collect additional data on the technology.

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FDA should draft sample informed consent forms for physicians to use when prescribing drugs off-label and should better educate consumers on what it means when a drug's benefits outweigh its risks, a leading public health researcher and advocate for safe and effective medical treatments said.

House Energy & Commerce Democrats are threatening to vote against FDA user fee reauthorization if Rep. Morgan Griffith (R-VA)’s off-label communication bill is included in the package, a source close to the negotiations tells Inside Health Policy.

House Republicans are considering reauthorizing the Children’s Health Insurance Program separately from extensions of Medicare programs and policies, which would take away a key vehicle for those so-called Medicare extenders.

Lobbyists for hospitals, doctors, patients and insurers are discussing with GOP senators and staff ways to mitigate the steep Medicaid funding cuts that would occur if the American Health Care Act is enacted, coming as Republican senators debate the direction they want to take on the program.

FDA is working closely with medical device manufacturers and other government departments to address any devices that may have been compromised by the WannaCry cyberattack, FDA spokesperson Stephanie Caccomo told Inside Health Policy.

GAITHERSBURG, MD -- HHS has kicked off a new public-private initiative to develop cybersecurity standards for the health sector, aimed at aligning a number of cybersecurity frameworks and standards into a comprehensive package developed by government and industry.

A House subcommittee easily passed FDA user fee legislation Thursday (May 18) with riders allowing over-the-counter hearings aids, requiring risk-based device inspections, offering new exclusivity for a new class of competitive generic drugs and restricting drug imports, and in the process brushed off the Trump administration's call for a doubling of the user fee levels FDA negotiated with industry.