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United States

Set Alert for Policy and Regulation United States

US House Panel Advances Bill Allowing Medicare Coverage Of Eyeglasses, Hearing Aids, Dental Services

Bills permitting Medicare coverage of eyeglasses, hearing aids, dental implants and the exams needed for prescriptions for these medical products were approved by the US House Energy and Commerce Committee on 17 October, and passed onto the full House for its consideration.

Policy Legislation Medicare
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Latest From United States, Policy & Regulation

Senators Want Answers From FDA Soon On Device Servicing Versus Remanufacturing

US Senators Elizabeth Warren and Bill Cassidy recently sent a letter to FDA acting commissioner Ned Sharpless prodding him to provide them details by 1 November on how the agency plans to regulate medical device servicers that may actually be remanufacturing devices.

Policy Life Cycle Management

Reimbursement A Top Goal For New Digital Health Lobbying Center

As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.

Regulation Policy

Personalized Medicine Firm Pays $42M On Kickback Allegations Tied To Genetic-Testing Registry

Louisiana-based pharmacogenetic testing company UTC Laboratories and its three principals have agreed to pay $42.6m to resolve allegations that the company violated the False Claims Act by paying kickbacks for referrals and providing tests that were not medically necessary.

Diagnostics Enforcement

Precision Medicine Bill Sponsored By Democrat Eric Swalwell Gains Support In US House

A bill that would promote genetic testing for infants and children, introduced by California Rep. Eric Swallwell, is gaining support in the US House of Representatives.

Policy Legislation

Where's The Beef? Trump Executive Order On Agency Transparency A Nothingburger For FDA, Lacks Teeth To Tackle True Guidance Doc Issues, Expert Says

President Trump signed an executive order on 9 October that aims for government agency transparency around guidance documents, enforcement, inspections and other areas. But longtime industry expert Steve Niedelman of the law firm King & Spalding says the order will have virtually no impact on how the US FDA conducts business. In fact, Trump's order does nothing to tackle legitimate gripes from industry around things like guidance docs.

Policy FDA

MITA Questions MRI, CT, Hospital Cost-Reporting Methods In Comments On Medicare Outpatient Pay Proposal

The Medical Imaging Technology Alliance (MITA) told the US Centers for Medicare and Medicaid Services that hospital cost-reporting practices for advanced imaging procedures do not reflect the true costs of imaging services, in comments on the agency’s outpatient rule.

Policy Reimbursement
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