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The Medicare agency is proposing changes, including ending “burdensome” data requirements, for implantable heart devices for the first time in over a dozen years.
The Centers for Medicare & Medicaid Services announced last week it was seeking to update coverage decisions for implantable cardioverter defibrillators (ICDs), including eliminating some waiting periods and requiring patient-doctor decision making for some patients. The proposal would be the only major update to Medicare’s ICD coverage since 2005, and hospitals and device groups say an update is long overdue.
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. The devices come with a heavy price tag, costing an average of $30,000 per device according to Medtronic. In order to receive Medicare reimbursement for ICDs, providers currently must submit data sets to the CMS that provide more information about the safety and effectiveness of the device.
The CMS held a brief comment period this summer in anticipation of the proposal. The latest action triggered a comment period ending Dec. 20.
Chandra Branham, vice president of payment and health-care delivery policy at the Advanced Medical Technology Association, told Bloomberg Law the group is still reviewing the proposal but upon first glance it supports the removal of the data collection requirement.
“This is certainly going in the right direction,” she told Bloomberg Law Nov. 27. “We think that coverage based on collection of additional evidence should not come with a large burden.” AdvaMed said it plans to submit a letter to the CMS before the comment period deadline.
The coverage determination data requests were intended to ascertain whether ICDs were safe and necessary enough to perform in clinical settings. Industry groups and hospitals have said the evidence and data the CMS has collected for the past 12 years have supported clinical use of ICDs.
“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,” Ascension Health, a faith-based health-care organization in St. Louis, said in a letter last summer to the agency.
The CMS said removing the data requirements would “reduce burden on providers,” and it encouraged the continuation of a voluntary registry “for purposes of quality improvement, safety, and appropriate use verification.”
Under the proposal, some patients would be exempt from the mandatory 40-day waiting period before receiving an ICD. This includes patients who have a heart attack or undergo a coronary revascularization procedure.
The waiting period would also be waved for patients who need a replacement due to a dead or malfunctioning ICD battery.
The proposal includes a requirement for decision-making interaction between patients and their doctor before ICD implantation for certain patients, including those without a history of cardiac arrest or patients with an existing ICD who qualify for a replacement.
During such conversations, the doctor offers options and describes their risks and benefits, and the patient expresses his or her preferences and values, allowing both participants to share responsibility in the decision about how to proceed.
Shared decision making “is especially important in treatments where there are complex considerations on benefits, harms, indications and existing effective treatments,” the agency said.
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The proposed decision memo is at http://src.bna.com/utc.
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