1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Legislation

Medtech Provisions Approved In US Budget Agreement

 
• By Sue Darcey

Medtech and funding provisions in a two-year budget deal that the US Senate and House approved early Friday morning and which were signed by the President would extend Medicate telehealth programs, remove a rental cap for speech-generating devices and strengthen competitive bidding rules to assure access to diabetic test strips, among others. 

US Capitol building, Washington DC (f11photo/Shutterstock.com)
Lawmakers passed a budget deal early Feb. 9, avoiding a government shutdown. • Source: f11 photo/Shutterstock

A two-year budget deal Congress approved early on Feb. 9 includes a series of Medicare extenders, provisions to extend and ensure reimbursements for telemedicine, the chronically ill, diabetics, and additional funding for children's health, the National Institutes of Health and those agencies affected by three 2017 hurricane disasters. The measure also includes a short-term spending bill that keeps the government funded through March 23.

The budget deal extends the current funding for the Children's Health Insurance Program from six years to 10 years, and...

More from Legislation

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.