Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

"Reasonable and necessary" redefined for Medicare

This article was originally published in Clinica

Executive Summary

The US Centers for Medicare and Medicaid Services (CMS) is having another stab at defining what criteria it uses for determining whether a product is "reasonable and necessary", and thus fit to be covered by Medicare. But this time, CMS intends to address the subject as a guidance document similar to those issued by the FDA. In 1989 and again in 2000, the agency proposed addressing the issue through regulation, but backed off both times because of industry's objections to the use of cost effectiveness as an important criteria.

You may also be interested in...



QUOTED. 1 December. Rob Field.

UK start-up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country. See what Iceni’s CEO Rob Field said about it here.

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

The Rebate Rule May Not Last, But It Changed The Pricing Debate

Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.

Topics

UsernamePublicRestriction

Register

OM004559

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel