After “breakthrough” devices are approved or approved by the Food and Drug Administration, Medicare coverage for these devices is no longer required. On Friday, the Medicare and Medicaid Services Center cancelled a final rule citing safety concerns.
CMS administrator Chiquita Brooks-LaSure said in the news: “Although we continue to support increased access to new technologies, we have noticed that they may have unknown or unexpected risks. Therefore, we must first ensure that such technologies improve health insurance beneficiaries’ Healthy results.” Released. “Medical insurance plans need to implement policies that balance access and appropriate protection.”
Since the first release in the last few days of the previous government, the medical insurance coverage rules of innovative technologies have been in a state of uncertainty for several months. Medical insurance will cover Devices that received breakthrough designation and subsequently received FDA marketing approval for up to four years.
this FDA’s Breakthrough Device Program Designed to expedite the review of equipment that can provide more effective treatment or diagnosis for life-threatening or debilitating health conditions. It is suitable for a large number of devices: as of last year, nearly 300 units, According to MedTech Dive.
Medical device companies, especially those with breakthrough devices, are supporters of the CMS rules. However, Doctors and insurance groups are more skeptical, Noting that Medicare-covered patients are usually under-represented in clinical trials, this requirement may remove some protections for patients.
After postponing the implementation date to December, CMS once talked about scrapping The final rule. On Friday, the decision became final.
The agency stated that the types of clinical research required for FDA market authorization may not take into account the specific needs of medical insurance patients, including differences in clinical characteristics or complex medical conditions.
“According to the rules we are repealing, CMS may insure that the device is reasonable and necessary for the diagnosis or treatment of specific medical conditions in Medicare populations without sufficient evidence,” Dr. Lee Fleisher, Chief Medical Officer and Director of CMS Clinical Standards And the Quality Center said in a press release.
For now, equipment manufacturers still need to obtain local coverage decisions or national coverage decisions for medical insurance coverage. However, CMS is opening the door to creating new strategies to speed up this process.
The agency said it plans to work with the FDA, healthcare research and quality agencies, and medical device manufacturers to develop a process to more quickly cover innovative devices that benefit medical insurance patients. It plans to hold stakeholder meetings next year when drafting future policies.
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