On November 20, 2017, CMS announced proposed updates to the coverage policy for Implantable Cardioverter Defibrillators (ICDs). The proposed changes would be the first major update to ICD coverage in over a decade. Over the past few years, ICD coverage has been a key issue in several False Claim Act (FCA) allegations with hundreds of millions of dollars in settlements between the Department of Justice (DOJ) and hospitals nationwide. With these proposed changes, CMS is seeking to reduce burdensome requirements placed on providers and to improve patient access to ICDs.
ICDs are battery-driven electronic devices connected to the heart by leads that are used to detect fast, irregular heartbeats and to provide a “shock” to correct the heart to its normal rhythm if an irregularity is detected. ICDs were first used in the 1980s and Medicare began to cover the devices in 1986. The most recent national coverage determination (NCD) for ICDs, which determines the conditions under which the Medicare program will cover the devices, was released by CMS in 2005. CMS notes in its November 20th proposal that the agency is not substantially changing the 2005 coverage policy for ICDs. Instead, CMS is proposing exceptions to various requirements under the 2005 NCD and placing new requirements on the decision making process to further engage patients.
Since 2015, more than 500 hospitals have settled FCA allegations for violations of the mandatory waiting period requirements found under the 2005 NCD for ICDs. In order to be covered by Medicare, the 2005 NCD requires a waiting period of 40-days for any patient who suffered a heart attack prior to implantation of an ICD. This waiting period increases to 90-days following any bypass surgery or angioplasty. The stated purpose of this waiting period is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary; however, the medical community believes that these standards are outdated and arbitrary and have urged CMS to update the 2005 NCD, including changes to the mandatory waiting period requirement.
CMS’ November 20th proposal would ease the timing requirements for certain patients in obtaining an ICD. Specifically, the proposed changes would allow patients with an existing ICD to obtain a replacement device without having to wait for the 40- and 90-day waiting periods should the patient suffer a heart attack or undergo bypass surgery. CMS’ proposal also includes an exception to the waiting period for patients without an existing ICD, if that patient qualifies for both an ICD and a pacemaker. While CMS aims to increase access to ICDs for certain eligible patients with these proposed changes, whether these changes sufficiently address hospitals’ and treating physicians’ concerns with the mandatory waiting period requirement is still in question.
In addition to changes to the mandatory waiting period, the proposed changes also include revisions to the data collection requirement and include a new mandated shared decision making process. Under the 2005 NCD, providers are required to collect and submit data to CMS on ICDs with the goal of tracking effectiveness. CMS notes in its proposed changes that “[w]hile we agree that some research questions remain, the data and information gathered . . . has substantially contributed to the evidence base and supports our proposal to end the registry data collection requirements from the 2005 NCD.” CMS believes that the removal of the data collection requirement for ICDs will lighten the burden placed on providers.
Additionally, CMS is looking to implement a “shared decision making process” to encourage collaboration between the patient and doctor. This shared decision making process requires doctors to discuss treatment options, including the potential benefits and harms associated with ICDs, and “to incorporate [the patient’s] views and beliefs in choosing the most appropriate treatment.” Under the proposed changes, doctors and patients would both review relevant factors and together would share responsibility in the decision of whether an ICD is the best treatment option. This shared decision making process would need to be documented in the patient’s medical records prior to seeking any ICD implant.
DOJ’s previous press releases on FCA settlements regarding ICDs can be found here and here. CMS’ Proposed Decision Memo for Implantable Cardioverter Defibrillators is available in its entirety here. CMS is seeking public comments on the proposed changes now through December 20, 2017.
