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CMS Says Revisions Will Bring Healthcare Innovation to Patients


By updating Medicare’s Program Integrity Manual, groundbreaking therapies and medical devices could be more likely to be covered, the insurer says.

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Patients might soon benefit from more cutting-edge healthcare innovations, according to the Centers for Medicare & Medicaid Services.

That’s because CMS announced today revisions to Medicare’s Program Integrity Manual, which it says will overhaul local coverage determinations (LCDs) to bring innovative therapies and medical devices to patients more quickly. CMS claims that this will happen because it has simplified the process by which the voices of companies, patients and healthcare stakeholders affect such decisions.

>> READ: CMS Says New Rule Could Save Clinicians 51 Hours of Paperwork Per Year

“We recognize that confusion exists around some of Medicare’s policies in this area, and that certain products may not have a clear pathway to coverage and payment today,” CMS Administrator Seema Verma, M.P.H., wrote in a blog post. “With the new (LCD) process, we are taking the first step toward clarifying and modernizing our coverage and payment policies.”

Notable changes include requiring a standardized summary of clinical evidence for each innovation, bringing in beneficiaries and other clinicians to the decision-making process and ensuring that the public may attend, virtually or in person, Contractor Advisory Committee meetings.

The revisions also call for a process roadmap, the ability for stakeholders to request a new LCD and other administrative updates. (Click here for a complete list from CMS.)

LCDs come into play when Medicare Administrative Contractors, who determine on a regional level which services and products satisfy coverage guidelines, lack a national determination to follow. Through the 21st Century Cures Act, Congress called for greater transparency into this process.

CMS, meanwhile, sees its revisions as a means to better engage patients and meet their needs.

The agency considers this move yet another component of its Patients Over Paperwork push.

The revisions could ultimately bridge the gap between the time the U.S. Food and Drug Administration approves a new therapy, device or software and when Medicare decides to cover it.

“Coverage decisions will be made more transparently with an explanation of the clinical evidence that supports them and with input from the beneficiaries who are affected,” Verma said in a statement. “This is just the beginning of our efforts to further accelerate medical innovation, improve the quality of care and lower costs for our beneficiaries.”

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