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The Medicare agency is heading toward possible coverage changes for certain implantable heart devices for the first time in a dozen years.
The Centers for Medicare & Medicaid Services is reviewing (in analysis number CAG-00157R4) how implantable cardioverter-defibrillators (ICDs) are covered under Medicare. The agency said the review came from within the agency, not an external party. An industry group for medical devices praised the CMS’s efforts. “We think it’s overdue, it’s definitely time to revisit this,” Chandra Branham, vice president of payment and health-care delivery policy at the Advanced Medical Technology Association, told Bloomberg BNA Aug. 10.
ICDs are battery-powered devices that treat abnormally fast, life-threatening heart rhythms by delivering a shock to the heart, restoring the heart’s normal rhythm and preventing cardiac arrest. In order to receive Medicare reimbursement for ICDs, providers must submit data sets to the CMS that provide more information about the safety and effectiveness of the device. The CMS announced in January it would provide similar coverage for leadless pacemakers when they are implanted as part of a federal clinical study.
ICD coverage determinations haven’t been updated since 2005, and hospitals and device groups say an update is long overdue. The CMS held a brief comment period this summer in anticipation of the fall 2017 proposed decision.
The coverage determination data requests were intended to ascertain whether ICDs were safe and necessary enough to perform in clinical settings. The evidence and data the CMS has collected for the past 12 years has supported clinical use of ICDs, industry groups and hospitals said during the comment period.
Branham said “it is important to consider when enough data have been collected to address the evidence questions raised by CMS to make a definitive coverage determination, and when it may be appropriate to reconsider the level and type of information that is being collected.”
“The science, research and clinical practice guidelines for the medically appropriate use of this item have advanced substantially over the past twelve years, and there are a number of clinical situations under which it is reasonable and medically necessary to provide for coverage of the implantation of ICDs,” Robert J. Henkel, president and CEO of Ascension Health in St. Louis, said in a June 28 comment.
AdvaMed also said the CMS should require less data to be submitted for coverage determination.
“We think that coverage based on collection of additional evidence should not come with a large burden,” Branham told Bloomberg BNA. “It should require collection of the minimum data necessary for Medicare to determine whether the device ultimately should be covered.” Branham said AdvaMed will provide additional comment once the proposal is released.
Medtronic, a medical device company, is hoping the CMS will reduce the burden on health-care providers and simplify data collection and submission.
“Medtronic supports efforts to simplify and bring clarity to the national coverage determination,” Barbara K. Veath, senior director of economics and reimbursement at Medtronic, said in a June 29 comment. The company urged the CMS to refine the coverage determination with two specific goals in mind: “to simplify the language in order to harmonize coverage with the clinical guidelines and appropriate use criteria, and to minimize administrative burden and simplify program requirements for providers.” Medtronic said about 150,000 patients receive ICDs annually at a cost of about $30,000 per device.
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