Renal stenting heads to MedCAC
This article was originally published in The Gray Sheet
Executive Summary
CMS will convene its Medicare Evidence Development Advisory Committee July 18 to reconsider coverage for renal artery angioplasty and stenting. The agency opened the national coverage decision in February in response to a comparative effectiveness review from the Agency for Healthcare Research & Quality that questions the evidence in support of stenting (1"The Gray Sheet" March 5, 2007, p. 8). AHRQ is updating its review as part of the coverage decision process. The MedCAC meeting extends CMS' decision timeline, with a proposed coverage policy for the procedure expected Nov. 26 and a final decision due Feb. 23...
You may also be interested in...
Renal Stenting Coverage Reconsidered: AHRQ Comparative Analysis Effect
CMS' decision last week to reconsider its national coverage policy for renal artery angioplasty and stenting is the agency's first coverage action to grow out of the Effective Health Care Program, the Agency for Healthcare Research & Quality's new comparative effectiveness review arm
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.