Washington Scene

STS News, Summer 2012 -- Thanks to the advocacy and expertise of STS President Jeffrey B. Rich, MD, STS Immediate Past President Michael J. Mack, MD, and many other STS leaders, on May 1 CMS published a groundbreaking National Coverage Determination (NCD) that allows for Medicare Coverage with Evidence Development (CED) for transcatheter aortic valve replacement (TAVR).

CED is an evolving policy employed by CMS to provide conditional access to novel medical treatments while collecting additional evidence needed to determine whether unconditional coverage is justified. The TAVR NCD requires that a treating heart team and hospital participate in a prospective, national, audited registry that consecutively enrolls TAVR patients, accepts all manufactured devices, follows patient outcomes for at least one year, and complies with relevant patient privacy protections.

The STS National Database has earned the Society a place at the leading edge of meaningful health care policy that helps to improve quality while improving efficiency in the delivery of care. Clinical registries are a proven resource to assist in both the FDA’s efforts to approve new medical technology and CMS’s mission to bring new medical treatments to beneficiaries more quickly. STS supports the development and use of data collection systems to ensure that patients, providers, and policy-makers like CMS and FDA can make decisions based on the best available clinical evidence. To that end, the Society has strongly supported CMS’s use of CED. The collection of additional information may be useful in determining that a treatment is reasonable and necessary while also serving to validate the safety and effectiveness of the treatment in question. Additionally, CED may better ensure that appropriate beneficiaries have earlier access to new medical technologies and services.

Throughout the TAVR approval and coverage determination processes, STS sent a strong message that the health care community – and the physician community in particular – has the ability and the responsibility to play an active role in the CED process. The Society has taken those lessons learned through the TAVR NCD process and encouraged CMS to adopt the following principles to guide its utilization of CED policy in the future:

  • Coordination among stakeholders
    CED should permit collaboration and generate buy-in from relevant stakeholders, including professional societies, government agencies, industry, private payers, and patients.
  • Early discussions among stakeholders
    Given the limited statutory timeframes for the issuance of an NCD, it is important to start the CED discussion early so that there is sufficient time to set up an appropriate data elements mechanism and engage relevant stakeholders. It is best to address any differences of opinion among stakeholders early in the process and continue conversations throughout.
  • Flexible data collection mechanism
    An individual CED must be adaptable and able to evolve in response to the changing evidentiary and technology landscape, which may introduce new or different indications, outcomes, and subpopulations, among others. Data collection should be useable to identify anomalies, target the causes of adverse events, or identify the reason for changes in outcomes. Data collection through a registry allows for the necessary flexibility and can evolve alongside the changing environment.
  • TAVR NCD Highlights
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