The CMS is proposing sweeping changes to its coverage policy for implantable cardiac devices to speed up patient access and cut regulatory burden for providers using the products.
The proposal posted Monday would be the first major update to Medicare's implantable cardioverter defibrillator, or ICD, coverage in more than a decade. The CMS wants to reduce some of the barriers to care outlined in its most recent coverage determination issued in 2005.
The proposed decision suggests eliminating waiting periods for device implantation and dropping a policy that requires tracking ICD patients in a registry.
It also seeks to require shared decision-making as a condition of ICD use, which the agency says would empower patients.
ICDs have been used since the 1980s, and the CMS began covering them in 1986. Initially, they were mostly used in patients with recurrent cardiac arrest who were not responsive to drug treatments. In 2005, the agency finalized coverage for primary prevention of arrhythmia.
The devices are wired to the heart and deliver an electric shock if they detect an abnormal rhythm. They are a significant revenue driver for hospitals. It's estimated that 10,000 ICDs are implanted every month, and the average hospital stay after placement is eight days. That generates an average of $12,423 in hospitalization costs.
The CMS started looking into whether it should change its ICD reimbursement policy this summer and solicited comments from the industry on potential revisions. The move came after a 2016 study questioned ICDs' benefits. Danish researchers determined that ICDs did not reduce heart failure patients' death rates from issues other than heart disease, including high blood pressure, faulty or damaged heart valves, or heart muscle damage.
Cardiac providers pleaded with the CMS to not reduce coverage for the devices because of the study.
Currently, Medicare beneficiaries with heart failure, regardless of cause, are usually eligible for the devices. There is far more evidence that these devices do improve quality of life and expectancy.
This "is a single trial compared to extensive supporting evidence" Steven Houser, president of the American Heart Association, said in a comment letter.
Moreover, given the study's sample size and demographics he and others questioned whether the results could be extrapolated to the wider U.S. population.
The CMS agreed with their assessment and decided not to alter eligibility for the devices. However, the Danish study and other concerns about the appropriateness of ICDs spurred the agency to want to make patients more a part of the decision-making process on when it is best to use the devices.
"Since there are some outstanding questions regarding the appropriate populations benefiting from ICDs, we are proposing to include a requirement for a patient shared decision making," the CMS said.
Under the proposed change doctors and beneficiaries would look over the clinical evidence and together decide if an ICD should be implanted.
The agency is also looking to hasten access to ICDs. Currently, the devices cannot be implanted within 40 days of a heart attack or 90 days of bypass surgery or angioplasty. Hospitals have gotten into legal trouble in recent years for not honoring the wait period policy.
"The wording in the 2005 decision could inadvertently require a second procedure when only one procedure is needed," the CMS said in its proposed coverage policy.
The agency proposed allowing patients with an existing ICD who suffer a heart attack or undergo a coronary revascularization procedure be allowed to obtain a replacement device without the wait period. Patients would no longer have to wait if their ICDs battery died or malfunctioned as well.
This new exception would also apply to patients without an existing ICD who meet requirements for both a cardiac pacemaker and a defibrillator. If the change were finalized, a patient could get a pacemaker and ICD implanted during one surgery.
With the expanded coverage in 2005, Medicare also mandated an ICD registry to collect information about patients receiving them. The goal of the registry was to track ICDs' effectiveness. Doctors have been pushing for that requirement to end saying it's no longer needed.
"It has been in place for 12 years," said Dr. William Lewis, chief of cardiology at the MetroHealth System, based in Cleveland. "Certainly the answers to the important coverage questions can be determined based on the data already collected."
The CMS agreed with providers and discontinued the registry data collection requirement to reduce provider burdens.
The CMS will accept comments on its proposed coverage decision through Dec. 20.
