Medicare Dx Payment System Will Be Market-Based, More Transparent Under New Law

A new law makes vast changes to how clinical laboratory tests will be reimbursed by Medicare over the long term. Although the changes ultimately may lead to payment reductions, both test kits makers and laboratories applaud the new provisions. Reimbursement will better reflect the value that lab tests bring to the health care system, they say.

Major reforms to the Medicare system for diagnostic tests signed by the president April 1 are expected to reduce overall payments for tests in the coming years, but both test kit manufacturers and clinical laboratories are optimistic about the new law.

Their reasoning: the new provisions include protections from overly drastic cuts, while greatly expanding transparency and public input into a historically opaque reimbursement process

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Policy & Regulation

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

FDA Announces Classifications On 8 Device Types

 
• By 

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By 

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

More from Medtech Insight

FDA Announces Classifications On 8 Device Types

 
• By 

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By 

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.