Press release

CMS Accelerates Innovation and Promotes Patient Access to Medical Technology

CMS Accelerates Innovation and Promotes Patient Access to Medical Technology
Reforms to Medicare’s Local Coverage Determination process will increase transparency and patient engagement in order to ensure that Medicare beneficiaries have access to the latest therapies and devices

Today, as part of broader efforts to modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) announced changes to the way contractors decide which technologies are covered by publishing a revision to Medicare’s Program Integrity Manual.

Medicare Administrative Contractors (MACs) determine which healthcare items and services meet requirements for Medicare coverage — taking into account local variations in the practice of medicine — through “local coverage determinations” or LCDs. LCDs are issued when national determinations do not exist, or when MACs need to further define a national determination. The updated manual responds to Congress’ requirement in the 21st Century Cures Act for more transparency in the LCD process and aims to ensure an open LCD process that meets patients’ needs. The changes will clarify and simplify the process, helping to ensure that companies can get therapies and devices to patients more efficiently.

“The Trump Administration is committed to strengthening Medicare and bringing the latest medical technologies to beneficiaries, and we cannot allow outdated processes and administrative barriers to stand in the way of this,” said CMS Administrator Seema Verma. “The redesigned local coverage determination process will pave the way to expanded access to new medical technologies. Coverage decisions will be made more transparently with an explanation of the clinical evidence that supports them, and with input from beneficiaries who are affected. This is just the beginning of our efforts to further accelerate medical innovation, improve the quality of care and lower costs for our beneficiaries.”

The Medicare Program Integrity Manual includes instructions, policies and procedures that MACs use to administer the Medicare fee-for-service program. Chapter 13 of the manual addresses LCDs. The manual revisions announced today are the first revisions since August 2015.

CMS has revamped the format of the manual so it can be used as a “roadmap” for the LCD process. The manual now helps stakeholders effectively engage in the process and lays out CMS’s expectations for MACs.

Important changes to the manual include:

  • Requiring a consistent, standardized summary of the clinical evidence supporting LCD decisions
  • Including a beneficiary representative and other healthcare professionals in addition to physicians (e.g. nurses, social workers) on Contactor Advisory Committees that inform LCDs
  • Ensuring that Contractor Advisory Committee meetings are open to the public

The new process takes further steps to be responsive to patient needs by allowing patients to request a new LCD, and by holding open meetings virtually (e.g., by webinar) instead of in-person to allow for broader participation.

As part of CMS’s Patients Over Paperwork initiative, the agency has engaged stakeholders directly through Requests for Information (RFIs) to solicit ideas of ways to reduce administrative burden. Feedback from these RFIs informed the LCD process improvements reflected in the changes to the Program Integrity Manual.

As part of CMS’s commitment to continuous improvement, the agency invites interested stakeholders to submit feedback on their experiences with the revised LCD process. CMS will collect feedback via submissions to LCDmanual@cms.hhs.gov and will consider additional revisions based on the feedback.

For a full list of changes to the manual, refer to fact sheet: https://www.cms.gov/newsroom/fact-sheets/summary-significant-changes-medicare-program-integrity-manual-chapter-13-local-coverage

 

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