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

Clinical research policy, take two

This article was originally published in The Gray Sheet

Executive Summary

Both federally funded and private trials would be affected by CMS's latest 1proposal to clarify its coverage of "usual patient care" for beneficiaries participating in clinical studies. Unlike the current policy, the proposal allows study sponsors and principle investigators to self-certify that their studies meet agency criteria in order to receive coverage. Standards require registration on ClinicalTrials.gov, public release of study results within two years after the end of data collection, and discussion of how results are or are not expected to generalize to the Medicare population. CMS issued the proposal July 19. It addresses "confusion and ambiguity" that became apparent after the agency first proposed a revision to the original policy in April (2"The Gray Sheet" July 16, 2007, p. 8). Comments on the new proposal are due Aug. 18, and CMS hopes to finalize the policy in October...

You may also be interested in...



CMS Sticks To Status Quo On Clinical Research Coverage, For Now

Major revisions to CMS' policy on covering clinical research costs were put on hold July 9 in response to stakeholder demands for more input

RECOVERY Coronavirus Study ‘Will Attract Global Players To UK’

A randomized COVID-19 study spanning the whole of the UK could help to bolster the UK’s reputation as a location for future clinical trials. It is also being seen partly as the result of the UK regulator's "decisive action" in fast-tracking trials for potential COVID-19 therapies.

Warning Letter Roundup & Recap – 8 April 2020

Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.

UsernamePublicRestriction

Register

MT025042

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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