Medicare

FDA on Monday (July 1) eliminated postmarket requirements that makers of HIV prevention drug Truvada and its generics provide training materials to health care professionals and educational information to consumers, due to evidence that most providers and at-risk individuals are aware of the risks of the drug and know how to use it properly.

The White House Office of Management and Budget on Friday (June 28) began its review of a final Medicare and Medicaid burden reduction rule that also now includes updates to hospital and critical access hospital requirements that CMS delayed finalizing earlier in June.

The White House Office of Management and Budget on Wednesday (June 26) finished a seven-month long review of a burden reduction rule aimed at nursing homes.

Kidney Care Partners calls for a legislative and regulatory overhaul of renal disease treatment, including changes to the Medicare end-stage renal disease prospective payment system, an expansion of the Medicare Kidney Disease Education benefit, an extension of Medigap access for those with kidney disease and an HHS study on the social, behavioral and biological factors that lead to the disease.

CMS on Friday (June 21) finalized a streamlined coverage policy for transcatheter aortic valve replacements that reduces the number of procedures required to start or maintain a TAVR program.

Sens. Bill Cassidy (R-LA) and Sherrod Brown (D-OH) are leading a Senate letter asking CMS to reconsider its plan to add non-invasive ventilators to the durable medical equipment competitive bidding program -- or at least include patient safeguards in the bidding process -- and lawmakers in the House have been collecting signatures for a similar letter, which the American Association for Homecare estimates has about 180 lawmakers on board.

Senate health committee Chair Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA) ultimately decided not to include drug-pricing provisions that would tie patient coinsurance to net prices instead of list prices and require drug makers to justify price hikes in the committee’s final package on lowering health care costs.

Senators and stakeholders on Tuesday (June 18) said parts of the Senate health committee’s bipartisan package to lower health costs would particularly help rural areas, including provisions on maternal health and telemedicine, but some said more could be done.

CMS on Monday (June 17) offered Inpatient Rehabilitation Facilities the option to settle certain Part A appeals for partial payment -- and in certain instances full payment -- as the agency seeks to cut down the backlog of Medicare appeals.