Medmarc Blog (blog.medmarc.com)
CMS Issues Final Policy For Breakthrough Device Coverage
The Centers for Medicare & Medicaid Services has delivered its final policy for the Transitional Coverage for Emerging Technologies (TCET) program, which incorporates existing coverage mechanisms....
Supreme Court Ruling Ends Courts’ Deference under Chevron
The Supreme Court of the United States has overturned a landmark legal doctrine of judicial deference to federal government agencies during litigation in federal courts. The 6-3 decision addresses...
FDA Final Rule for LDTs Offers Four-Year Phase-In
The FDA’s final rule for laboratory-developed tests (LDTs) imposes a large compliance burden on clinical laboratory operations, a fact which has sparked renewed interest in legislation. However, the...
Congress Reconsiders Expanding Telehealth Services for Diabetes Prevention
The House of Representatives and the Senate have both reintroduced legislation that would expand Medicare telehealth services for patients at risk for developing diabetes. The PREVENT DIABETES Act...
FDA’s Posts Final Guidance for Remanufacturing
The FDA has issued a final guidance for servicing and remanufacturing services for medical devices, which will end the agency’s enforcement discretion for remanufacturing activities. Manufacturers...
GAO Report Highlights FDA Staff Shortages for BiMo Inspections
The U.S. Government Accountability Office stated in a recent report that the FDA’s ability to fill openings in its Bioresearch Monitoring (BiMo) workforce has been impeded by several factors, such...
White House Announces Women’s Health Research Program
The White House has announced a program titled the Initiative on Women’s Health Research, which among other things will amplify ongoing programs at the FDA designed to improve health outcomes for...
FDA Guidance Promises Closer Scrutiny of Medical Device Cybersecurity
The FDA’s most recent final guidance for medical device cybersecurity represents a significant shift in the agency’s perspectives regarding cybersecurity, which is part of a broader emphasis on...
FTC Seeks to Remove Medical Patents from FDA’s Orange Book
The Federal Trade Commission has challenged more than 100 medical patents the agency believes are improperly listed in the FDA Orange Book, a compendium of drug products the FDA has deemed safe and...
FDA Releases New Draft Guidance for Unapproved Uses
The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available. This is a reissue of a...