After a contentious Trump-era rule was overturned, the Biden administration is exploring developing a speedier procedure to examine new medical devices for Medicare coverage.
New pathway
A proposal for a new pathway for the device review process, which will be made public in the future months, was written by representatives of the Centers for Medicare & Medicaid Services (CMS) in the Journal of the American Medical Association.
According to the publication, "this method will build on earlier endeavors, including coverage with evidence development." Medicare may pay for some technologies, including medical equipment, as long as they are used in clinical studies that have been approved by the agency (coverage with evidence development).
Some of the guiding principles for the pathway were outlined by CMS, according to the report, including that it will be voluntary and only apply to devices that are relevant to the Medicare population and are covered by the program's statute.
Additional evidence strategy
Before the Food and Drug Administration approves the medicine for the market, CMS could launch a coverage review procedure if the manufacturer agrees. An "additional evidence development strategy and confirmation that there are adequate precautions and protections for Medicare beneficiaries" may be necessary in order to pursue this option.
According to the JAMA journal, if CMS determines that a devicemaker needs to provide more proof of the benefits of the product, it will look into "ways to lessen the burden on manufacturers, physicians, and patients while maintaining strict evidence criteria."
The officials stated that the guidelines could aid in finding a balance between ensuring that any product fulfills "rigorous evidentiary criteria" and reducing the gap for coverage choices.
An order made in the early months of 2021, at the end of the Trump administration, was not deemed to meet these requirements by the agency.
Close time gap
The FDA's breakthrough device designation would have automatically provided devices with four years of Medicare coverage if that rule had been implemented. The intention was to close the time gap between when a device receives FDA approval and when Medicare approves it for coverage, which in certain situations can take up to a year.
However, patient activists and insurers who were concerned that it might make hazardous devices available to Medicare beneficiaries swiftly criticized the rule.
In comments, the organization AHIP stated that the rule allowed for a less stringent review procedure for certified devices and that the FDA and CMS have different standards for evaluating a device.
The medical device industry association AdvaMed stated in response comments that the Trump administration's rule rewards companies for taking a chance on product development and research. According to AdvaMed, the guiding concepts seem positive.
However, it's crucial to keep in mind that details count, according to Scott Whitaker, president and CEO of AdvaMed. "I will again stress the importance of having clarity, openness, and predictability in the final rule for transitional coverage for developing technologies."
Orion Medical is here to help and guide you every step of the way, from delivering medical supplies at the most cost-effective pricing, to information regarding courses and training with regards to new technology. Contact Orion Medical for more information.
Comments