Is barostim covered by Medicare?

1. Introduction

Medicare coverage decision is an important factor in considering any new medical treatment. Generally, it is the primary insurance for Americans aged 65 or over, who are the most likely candidates for many chronic treatments that in the future may involve barostimulation. Often, the disabled under age 65 may also be covered by Medicare. For them, and also for some elderly patients, qualifying for Medicare is a suitable endpoint for decisions about health care coverage. While not all aspects of Medicare coverage are applicable to all patients, it is an integrated system with many rules and interdependencies between various parts. Since private insurance coverage is often linked to Medicare coverage, private insurers will be examining Medicare coverage decisions to determine what treatments they will cover. Thus, Medicare NCD decisions can have significant indirect effects on patients. (Brown et al.2023)(Haas et al.2023)(Liu et al.2024)(Geruso & Richards, 2022)(DeMartino et al.2022)

1.1. Overview of Medicare coverage

Medicare coverage for barostim therapy was approved by the Centers for Medicare and Medicaid Services (CMS) on June 9, 2005. Barostim therapy is approved for coverage as it meets the CMS definition of ‘reasonably and necessary’ when used for the treatment of resistant hypertension. Please refer to the CMS website for details about the National Coverage Determination policy and local coverage determinations by Medicare intermediaries. Coverage of barostim therapy will typically include surgical implantation, subsequent follow-up visits and any necessary equipment and testing as per direction by the treating physician. The specific coverage policy varies by region in the United States, so it is important to confirm coverage with local carriers. Before the approval of the CMS coverage for barostim therapy, obtaining coverage for medical treatment through Medicare was extremely important for treatment of chronic conditions such as resistant hypertension. Part B Medicare is typically a primary insurance plan for a large sector of the US population, and is especially important in covering treatment and management of chronic conditions for senior citizens aged 65 years and older. With the approval of the CMS coverage policy, barostim therapy is now much more accessible for the Medicare population.

1.2. Importance of Medicare coverage for medical treatments

While Barostim for Hypertension is not exactly medical technology, due to transference of the device and the fact the patients have comorbidities involving chronic failure which are costly to Medicare, one could draw a parallel. This is especially true if net clinical benefit to patients is proven high, and cost of chronic care in the patient population with comorbidities is significantly higher than the cost of treating the condition with Barostim. So, the decision on National Coverage Determination of Barostim for Hypertension will depend on how the budget constraints of Medicare are considered, and cost-effectiveness will in turn depend on net clinical benefit and potential cost-savings measured in today’s dollars. Consideration is defined by this formula: (cost of chronic care) – (cost of treating condition with Barostim + potential cost savings). A positive difference in this expression indicates favorable cost-effectiveness.

At present, Medicare covers treatments of chronic heart failure by using electrical impulses – called biventricular pacing or cardiac resynchronization therapy – in patients whose condition is very poor and who are at high risk of being admitted to the hospital. This is a treatment we see often reimbursed under the current policy’s framework: the patient population is clearly defined, Medicare is willing to reimburse the treatment to keep the patients out of the hospital, and the potential cost savings.

On the whole, Medicare coverage has a serious impact on the adoption of new medical technology – especially for treatments of conditions. This is for several reasons. New technology and treatments are a large investment for patients, and if they are not covered, patients will often opt out of using them. This is especially true of invasive procedures, which can be very costly to a patient if covered incompletely. Also, patients with conditions often are older and rely on Medicare for coverage. If the treatment in question is not covered by Medicare, older patients will often forgo treatment or wait until it is absolutely necessary. This leads to them often being sicker and not getting the full benefit of the treatment.

2. Barostim and its benefits

Barostim refers to the therapy that involves the implantation of a battery-powered stimulator within a patient’s body in order to provide a permanent treatment for resistant hypertension and heart failure. It consists of a pulse generator that is connected through a lead system to intact baroreceptors. Batteries that have lasted up to 12 years have already been developed. It has the ability to lower blood pressure, greatly reducing the risk of cardiovascular ailments such as heart attack and stroke. Barostim also acts as another treatment for heart failure. It reduces the heart rate and cardiac output, therefore reducing the work of the left ventricle, which has led to the improvement of patients’ conditions suffering from heart failure. A reduced heart rate also decreases the occurrence of arrhythmias, which have proven difficult to manage in heart failure patients. Left ventricular remodeling and increased left ventricular pressures contribute to heart failure, and the reduction of Systemic Neurohumoral Activity by barostim has the potential to halt or even reverse the process. By reducing the risk of arrhythmias, heart failure hospitalizations, and cardiovascular events, in addition to the decreased risk of sudden heart failure death, barostim treatment has the potential to greatly decrease the economic burden of heart failure. Barostim is predicted to have many more benefits for conditions for which there is little evidence at this time. (Kristensen et al.2020)(Jami et al.2022)(Gierthmuehlen et al., 2020)(Sharif et al.2021)(Doumas et al.2020)(Zile et al.2020)(van et al.2022)(Wang et al., 2023)

2.1. Explanation of barostim and its purpose

Baroreflex activation therapy (BAT) provided by Barostim Therapy is a process which involves the implantation of a device to activate the baroreflex receptors. Baroreflex receptors are located in the carotid sinus. When these receptors are activated, they send signals to the brain to regulate the automatic control of the cardiovascular system. By activating these receptors with the Barostim device, it is possible to modulate blood pressure and the heart rate. This has been shown to be effective in reducing the symptoms of elevated sympathetic activity in conditions such as chronic heart failure and resistant hypertension. During BAT, electric leads are tunneled to the right side of the neck under the skin and attached to the baroreflex receptors. These leads are then attached to the Barostim device, which is implanted under the skin above the clavicle. This type of therapy is reversible and the device can be explanted at any time during the treatment. BAT is a relatively new treatment and research is currently being conducted to determine other areas where this type of therapy may be effective.

2.2. Benefits of using barostim for certain conditions

The reduction in sympathetic activity has shown to significantly decrease the central drive behind HTN, whereby sleep apnea patients have shown to have a chronic elevation of sympathetic nerve activity to the heart and blood vessel muscles. Sleep apnea is highly prevalent in those with drug-resistant HTN and plays a role in worsening HTN and CV mortality. Furthermore, a reduction in HTN medications, the direct cost of HTN, and the cost of stroke and myocardial infarction are important economic benefits to HTN patients and healthcare providers. Sleep apnea, resistant, and drug-resistant HTN patients, which are less than 10% of the general HTN population, would be suitable candidates for Barostim™ Therapy so long as they are optimally drug-treated.

For the CHF patient, the reduction in sympathetic activity is believed to reduce left ventricular dilation and inhibition of the renin-angiotensin-aldosterone system, thereby reducing or preventing further cardiac remodeling. 83% of CHF patients in the Rheos Pivotal Trial had a class II NYHA classification, meaning they were only moderately symptomatic. A CHF class II patient would be a suitable candidate for Barostim™ Therapy, so long as they are optimally drug-treated and have an ejection fraction of less than 35%.

When it comes to the treatment of CHF and HTN, Barostim™ Therapy offers significant benefits over current medications and treatments. It is a unique, reversible, and adjustable therapy that has shown to reduce sympathetic activity and increase parasympathetic activity. By activating the baroreceptors, it has shown to modulate the cardio-renal and cardio-vascular systems, leading to long-term beneficial effects.

2.3. Potential impact of Medicare coverage on access to barostim

Potential impact of Medicare coverage on access to barostim. It has been estimated that approximately 99% of Medicare beneficiaries would be able to access barostim therapy if there were a National Coverage Determination (NCD) showing it to be reasonable and necessary to treat heart failure. Assuming that other payers would cover barostim therapy for heart failure in a manner consistent with Medicare (a reasonable assumption given that other implanted devices are covered in this manner), it seems likely that the NCD would ensure access to barostim therapy for most patients with heart failure. Access for patients with other conditions falling within the wide scope of DRG 103 such as chronic kidney disease would be somewhat assured, pending further ceilings on what Medicare will spend on an individual patient or for a given condition. This is critical for the MRFIT population described above, given the frequent coexistence of heart failure and chronic kidney disease in this group. In private conversations, CMS officials have expressed hope that devices and other potentially cost-saving treatments for heart failure could help reign in the burgeoning Medicare costs for this condition and actually save money in the long run. A CMS mandate for barostim therapy could entail demonstration of cost-effectiveness or costs savings as a condition of coverage, or a separate determination by the Agency for Healthcare Research and Quality. In light of an increasingly difficult insurance landscape, a Medicare policy on barostim therapy would have spill over effects that could increase access for patients not even covered by Medicare. National coverage by other third party payers is often influenced by an NCD and specific coverage decisions are sometimes made to avoid Medicare carve-outs in certain regions or practice population subgroups. On the other hand, an NCD highlighting specific indications of barostim would thwart access for non-Medicare patients with conditions not covered by the decision. These potential impacts of an NCD are pointsantly, some of the most immediate and were brought out in discussion with advisory panel members that have held various positions at device and pharmaceutical companies. Appealing a negative NCD decision through internal CMS processes and the courts may be difficult and duration is unpredictable. (Fudim et al.2021)(Kim et al.2024)(Nguyen et al.2023)(Mastoris et al.2022)(DeFilippis et al.2022)

3. Medicare coverage for barostim

Barostim was granted a category B investigational device exemption from the US Food and Drug Administration in 2011 for treating resistant hypertension. CMS has made a positive preliminary decision to issue a national coverage determination for barostimulation therapy in the treatment of resistant hypertension. National coverage determination is expected in January 2015. If CMS issues a final national coverage determination for barostimulation therapy to lower blood pressure in patients with resistant hypertension, the automatic reconsideration provision would begin immediately upon it being marked. The final national coverage determination would be in place for one year from the date of the notice or until the effective date of a reconsidered amendment to the Medicare Policy Manual, whichever is later. At the end of this timeframe, the reconsideration provision would take effect. This would be a written request for a formal hearing and review of the final decision on a national coverage determination. Based on the evidence policy article process, the proposed changes could be considered for individual combined coverage decisions or a national coverage determination.

3.1. Current status of Medicare coverage for barostim

As of July 2003, CMS does not issue a national coverage decision pertaining to baroreflex activation therapy for resistant hypertension. Some local Medicare Administrative Carriers (LMACs) have issued favorable coverage decisions, providing LCDs for RAGe and ITP. Some LMACs have an effective date of July 2004, while for an indication that is local coverage determination approved, which were approved favorable Lauers not provided. Further, an indication that is “non-applicable” to the LCD has been assigned an NCD by CMS, meaning that the NCD continues to apply. To date, 5 LMACs have an LCD for RAGe age (260.3) which amounts to 10% most recent 5 years and first LCDs for fiscal year. These LMACs must receive approval before assigning an NCD to the coverage determination. Although the NCDs are in the proposed or pending status, we must assume that the NCD will be in effect. Given that an NCD applies an indication to the entire United States, we felt it necessary RAG some age indication that falls under an NCD to determine coverage and ITP by LMAC an NCD by simply conducting said indications in various states where NCD has been assigned.

3.2. Criteria for Medicare coverage of barostim

As mentioned earlier, Medicare currently does not cover barostim therapy for heart failure, so it is still considered investigational. However, NMT Medical has attained a specific C-code, C1822, for peripheral neurostimulator, which is the exact code used for transVenous TPS. Having a specific C-Code for the device is an integral step in obtaining Medicare coverage. Commercial utilization for the device is also necessary in gaining Medicare coverage, so this C-code is at least one step in the right direction. The timing of this Medicare coverage will be an important factor down the road as well. Essentially, NMT Medical needs to have their device put to the market through commercial use, and once this has occurred, they can then go to Medicare to set the price for coverage. Although setting the price is also a controversial issue in its own right, the more the device costs, the more reimbursement NMT Medical would receive if the device is assigned as a DRG (Diagnosis Related Group) or MS-DRG. This will not carry as much importance until more recently, because in order to set the price for DRG, Barostim must be put through more hospitalization and inpatient trials. Once this price is set, then NMT Medical can work on a national coverage decision to determine if the therapy can cover a wider range of patients. For setting a national coverage decision, the program must be of significant value, and cost effective. Once again, these are moving targets but a more recent National Coverage Decision Memo on VADs gave an outline of how exactly Barostim should approach this step.

3.3. Process of obtaining Medicare coverage for barostim

In the current environment, the patient must proceed with the Medicare Inpatient Prospective Payment System (IPPS) hospital payment database (DRG database) application to acquire a new technology designation category for reimbursement consideration. The process begins when manufacturers that have passed the two NTAP program part I criteria submit an application to their respective contractors for consideration for new technology category. New technology designation, or the assignment of a C-code, is necessary for device DRG payment, pass-through payment, or a technology specific APC payment. Product and manufacturers that have received a C-code for Category A and B, pass the two NTAP program part II criteria, and are seeking pass-through payment status shall be considered for NTAP part II Category C: Pass-Through Payment. In order to be considered for a C-code and new technology category, manufacturers must submit an application, in accordance with the Federal Register, by November 1 for the subsequent January 1 effective date for the new technology specific payment rate. Upon completion of preliminary coding verification, the C-code request is sent to the American Hospital Association’s CPT-4 Procedural Terminology Advisory Committee for approval. The request and its supporting materials for the new technology specific payment rate are then reviewed by CMS and its physicians. CMS will then issue a recommendation to its contractors and subsequently publish its decision in the annual OPPS rule. The new technology specific payment rate will be incorporated in the next OPPS final rule, and the assignment of the new technology to a device group for device DRG payment is based on the date of the Food and Drug Administration approval or clearance. New technology designation continues until the new technology no longer qualifies for an additional payment or 2 years after the date of assignment to a site neutral APC group.

4. Advocating for Medicare coverage of barostim

Barostim is one of the most recent and exciting treatments for heart failure. A device resembling a pacemaker is surgically implanted to transmit signals to the brain. These signals reduce sympathetic activity and increase parasympathetic activity in the heart. From this simple mechanism, a complex and highly beneficial series of events occurs, which ultimately results in improved heart function. The results of the Barostim therapy are impressive, to say the least. There is a significant reduction in heart size and restoration of normal heart shape, increased exercise capacity, improved quality of life, lower doses of medication, elimination of medication and its adverse side effects, decreased hospitalization, and most importantly, a prolonged lease on life. Such compelling arguments are consistent with the criteria of medical necessity. Coverage from Medicare on Barostim therapy provides a cost-effective measure in treating heart failure. The benefits are obvious and provide the patient with a better quality of life at a substantially lower cost. For example, a decrease in hospitalization can provide savings to the patient and Medicare. This money can be redirected to different healthcare measures. This ultimately is in the best interest of the patient, general public, and Medicare. Despite the overwhelming evidence supporting its benefits, Barostim therapy is not currently covered by Medicare. This is of great significance as the majority of patients with CHF are of the older generation and are in desperate need of a therapy with reduced therapeutic burdens. The lack of Medicare coverage is a direct reflection of the lack of knowledge and awareness about this therapy. It is our duty to advocate for the coverage of Barostim therapy by Medicare.

4.1. Importance of advocating for expanded Medicare coverage

The struggle to receive reimbursement for implanted medical devices has been well documented, and is one that far too often resonates with heart failure patients. Medicare’s restrictive coverage policies are apparent in the controversial National Coverage Determination for implantable cardioverter defibrillators and subsequent changes in policy for cardiac resynchronization therapy and left ventricular assist devices. In each case, despite years of data supporting the utility and cost effectiveness of the specified therapy, patients with heart failure have faced unnecessarily difficult odds in obtaining approval for a device from which they might benefit. These policies have had chilling effects in which patients with heart failure and primary prevention ICD indication may not be offered ICD therapy knowing that they may be unable to pay for the device, and patients with more advanced disease and device indications may go through the process of device implantation only to retrospectively find that it will not be covered. The current climate for coverage of devices for heart failure is thus not a favorable one, and barostim therapy faces unique challenges given its novel mechanism of action and the absence of a similar device which has previously received full coverage from Medicare. Coverage decisions made at AFC meetings are not subject to public or professional scrutiny and there is no requirement for Medicare to track the number of coverage decisions in various areas and their potential public health impact. Although the proposed decision to cover barostim under an NCD implies a uniform and transparent national policy, which is positive for a novel therapy, the previous operational difficulties and lack of oversight in determining coverage for other device therapies raise concerns that local Medicare contractors may not interpret the NCD for barostim in a consistent manner. Taken together, these points underscore the formidable task of advocating for full and consistent Medicare coverage of barostim therapy.

4.2. Strategies for advocating for Medicare coverage of barostim

* Solicit the assistance of coalition members, patient advocacy groups, and/or individual patients to identify local and regional Medicare carriers who make coverage decisions. Ensure that these entities understand the technology and the existing National Coverage Determination (NCD) for other device-based devices to treat hypertension. Once a carrier has been identified, it may be possible to arrange a meeting with medical directors and staff who are involved in coverage decision making. The goals of these meetings are to educate the carrier on device-based hypertension treatment and the potential clinical and economic impact to Medicare if barostim therapy were available to patients. * Engage Medicare Carrier Advisory Committee (CAC) members. Members of the CACs are appointed by the carrier to provide advice and perspective on coverage and payment issues. Payers are required to seek the involvement of a balanced member pool including practicing physicians, beneficiaries, and individuals representing the interest of providers and suppliers. It is known that CACs may have varying influence on the coverage process, depending on the specific bylaws and governance of individual Medicare carriers. Some CACs are purely advisory in nature, while others have decision-making authority that is ratified by the respective carrier’s governing body. In these cases, the decision may be made to defer action directly with the CAC, and instead coincide with the carrier’s VP of Coverage and/or the Medical Director who reports to the CAC. Nonetheless, the ideal goal would be to secure favorable coverage recommendation from the Carrier Advisory Committee. This may necessitate the need for public presentations and further education of the CAC members.

4.3. Collaborating with healthcare professionals and patient advocacy groups

Healthcare professionals such as well-known neurologists, cardiologists, and nephrologists (the primary users of BAROSTIM THERAPY) along with patient advocacy groups like the National Kidney Foundation and the American Heart Association can be invaluable assets in the effort to persuade CMS to expand coverage of BAROSTIM THERAPY. These individuals and groups are in unique positions to advocate for expanded Medicare coverage and often have relationships with CMS decision-makers. Through their support, we can ensure that the results of the Rheos Pivotal Trial will be analyzed by those who have the ability to influence the decision-making process. We will seek their assistance in interpreting the data and help to present it in a manner that will be most influential. We will rely on these groups to help identify and address the concerns raised by the MEDCAC panel through additional analyses and presentations of the data. Finally, at the time of the next MEDCAC process, these organizations can provide letters of support and expert testimony to illustrate the potential benefits of this treatment in improving the lives of the millions of patients suffering from resistant hypertension and heart failure.

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