In Vivo 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

Quality Should Ride Shotgun As US Auto Makers Rev Engine On Making Ventilators

As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.

PBMI: Managing Specialty Drug Costs, Working With ICER And Promoting Transparency

Despite a reprieve last summer from the Trump administration’s proposed drug price rebate rule, speakers at the 25th annual Pharmacy Benefit Manager Institute kept the focus on price transparency and talked up new ways to manage drug costs for patients in need of treatment. 

UsernamePublicRestriction

Register

MT025042

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