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Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
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9

Reimbursement Issues

Highlights

  • Reimbursement for TMS has grown considerably in recent years as devices become more widely accepted by the clinical community, and both patients and clinicians are requesting reimbursement for appropriate clinical care. (Demitrack, Maiques, Robinson-Beale)
  • Health plans individually determine whether treatment will be reimbursed based on multiple types of research data—RTC, population-based, comparative effective (often imcomplete or conflicting in this area), comparative efficiencies and cost considerations, and the existence of practice guidelines. These data needs are frequently not available nor included in research protocols. This leads to significant inconsistency in provider application within practice, and variation in medical policies and reimbursement decisions. (Robinson-Beale)
  • The lack of practice guidelines is a barrier to consistent application of the technology in practice, coverage, and reimbursement decisions. Without such guidelines, clinical decisions may be based on the opinions of independent practitioners who may or may not have experience with a technology and health plans setting coverage policy. (Robinson-Beale)
  • Inconsistent reimbursement decisions may limit patient access to treatment and business development. (Hailey, Reppas)
  • Regulatory and reimbursement pathways in different countries complicate the approval process for companies developing non-invasive neuromodulatory devices. (Marjenin, Tariah)

NOTE: The points in this list were made by the individual speakers identified above; they are not intended to reflect a consensus among workshop participants.

Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
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Reimbursement for TMS is constantly evolving as the devices become more widely used and accepted in the clinical community. Rhonda Robinson-Beale, senior vice president and chief medical officer of Blue Cross Idaho, said that pressure from the clinical community has even led payers to consider reimbursement for TMS despite conflicting evidence about efficacy.

Oscar Morales, founding director of the TMS Service at McLean Hospital, described the evolution of coverage for TMS at McLean Hospital, which is a psychiatric affiliate of the Harvard Medical School. The TMS Service at McLean was inaugurated in 2009, following FDA approval in 2008 of the Neuronetics TMS system for depression. For the first 2 years, TMS at McLean was an entirely self-pay service; however, over the years 2011 to 2015, Medicare and insurance companies gradually approved reimbursement, such that there is now universal coverage for TMS. Over the past year, the TMS Service averaged about 200 clinical treatment sessions per month, using the NeuroStar and Brainsway systems for the treatment of depression, noted Morales. In addition, the TMS Lab conducts clinical research.

DECISION-MAKING PROCESSES

Robinson-Beale said most health plans have a technology assessment committee that reviews available information from peer-reviewed sources as well as third-party organizations to decide whether reimbursement is warranted. They will also look at what is generally accepted practice, in particular off-label use of a treatment. Typically, the studies they review are the same as were used to inform the FDA’s decision on granting marketing approval for a therapy, but health plans may reach different conclusions, in part because they must assess the cost of a treatment compared to the cost of standard treatment. Moreover, each health plan conducts its own review process, creating an array of funding policies.

For example, in the case of TMS, the FDA concluded that TMS was appropriate after one failed trial of an antidepressant. Different health plans reached different conclusions: One decided to cover TMS after the fourth failed antidepressant trial; another stipulated that TMS would be covered only in patients who had adverse effects from antidepressant therapy, or who could not tolerate antidepressant treatment, or who preferred TMS as an alternative to ECT. Coverage decisions also differ by

Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×

region, adding to the disparity across the country. In addition, Robinson-Beale said, a decision by the Centers for Medicare & Medicaid Services (CMS) ripples across the reimbursement landscape because it covers approximately 100 million people in the United States, and their associated health care expenditure (CMS, 2015). Other payers thus have to validate why they will not cover something that CMS covers.

Health plans also have to consider how other parameters of treatment affect reimbursement decisions, said Robinson-Beale, such as the dose, duration, and frequency of treatment required for a beneficial effect. For TMS, frequently raised questions include whether TMS is more efficacious than antidepressant medications, and if so, for which patients.

Cost plays an important role in reimbursement decisions, particularly with the high cost of some newer technologies and pharmaceutical products such as biologics that can cost hundreds of thousands of dollars per year per patient, according to Robinson-Beale. To reach decisions on covering these new technologies, health plans may require very good comparative analyses of cost versus efficacy with standard treatments, she said. Indeed, Eric Liebler, vice president of scientific, medical, and governmental affairs at electroCore, suggested that cost may have a positive impact on reimbursement for neurostimulatory devices because the costs of these devices may be materially less than some of the new pharmaceutical therapies coming out today.

Practice guidelines are another important factor in coverage decisions, said Robinson-Beale, but the American Psychiatric Association has provided very little detail regarding TMS other than to mention it as a possible treatment for depression, without identifying a clear target population. The American Medical Association also presents a potential roadblock to reimbursement because it issues Current Procedural Terminology (CPT) codes, which physicians need in order to be reimbursed. According to Ross Jaffe, managing director of Versant Ventures, it can take 2 to 5 years after FDA approval to obtain a CPT code, and the process is heavily influenced by specialty societies such as national medical societies or professional interest medical associations.

IMPROVING THE EVIDENCE BASE FOR REIMBURSEMENT

As noted by Robinson-Beale, the key issue for payers is whether a treatment is medically necessary and whether there is sufficient evidence to support that determination. Most of that evidence comes from peer-

Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×

reviewed journals; however, she maintained that data analysis in published research studies may not be designed to demonstrate effectiveness or comparative effectiveness to standard treatment or in certain subpopulations. For example, many randomized clinical trials exclude patients with co-morbidities, thus failing to answer the question of whether a treatment will be effective in real-life populations. These studies may also lack clarity with regard to dosage, frequency, outcome measures, frequency of relapse, etc. Comparative effectiveness studies, such as the one described by Bradley Gaynes in Chapter 4 to evaluate TMS for depression, are also used by payers in determining reimbursement policies. In addition, some insurers have used FDA reports to evaluate treatment effectiveness, although they lack access to the actual data for further analysis. Administrative claims may provide additional data with regard to outcomes.

Other sources of evidence for payers include consensus guidelines from expert groups or observational data from large registries across heterogeneous populations. Robinson-Beale noted that in the absence of conclusive, comprehensive data, decisions on coverage and reimbursement must be made with gaps in information, resulting in a diversity of interpretations. She said payers would prefer to see comparative effectiveness of a treatment against the standard of care rather than sham treatments, as well as objective efficacy analysis that includes cost as a factor. If researchers and other data sources were able to answer key questions that are important to that application of a technology in real life practice, health plans would have more opportunity to make clear decisions on medical policy, and less of an opportunity to reject coverage reimbursement, she said.

IMPACT OF NON-REIMBURSEMENT

The disparity of coverage across different health systems limits patient access to innovative and potentially beneficial treatments and leads to fragmented and inconsistent care, said Mary Hailey, vice president of health policy and government relations at Neuronetics. It also impedes business development if there is no market for a new device, said John Reppas.

Reppas added that when the value of a technology is the ability to deliver individualized treatment, reimbursement decisions may be further complicated because payers have been slow to value patient-centric as-

Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×

pects of non-invasive approaches. In fact, they may focus instead on the additional costs that will arise from a higher level of patient engagement.

Hailey said the standards that devices must meet to gain coverage continue to rise over the years; several other workshop participants commented on inconsistencies (a “double standard”) between the regulatory and reimbursement requirements for devices compared to drugs. For example, Thomas Insel asked if there is a separate standard for medicine versus behavioral health, citing the insulin pump, a much more expensive device that has received positive reimbursement decisions from CMS and most insurers. Robinson-Beale attributed this disparity to the fact that medical devices enjoy a longer history of acceptance, whereas behavioral devices are relatively new, requiring a new way of thinking on the part of those making decisions. Another factor that may explain a lower level of acceptance for behavioral indications such as depression is the lack of clarity regarding how neurostimulation fits in with existing psychotherapy and pharmacotherapy approaches, said Robinson-Beale. Liebler added that more objective measures are often available for outcomes “below the head,” whereas behavioral outcomes are often more subjective.

Robinson-Beale suggested that as mental illness becomes better defined from a neuro-circuitry perspective, devices will be driven into accepted practice. She said this has started as the American Psychiatric Association working in conjunction with the NIMH on such projects such as the Research Domain Criteria (RDoC) project.1

However, she also predicted that as these devices move into the consumer market and people come to believe that neurostimulation can safely be delivered over the counter, the medically reimbursed landscape may change dramatically.

__________________

1See http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml (accessed June 1, 2015).

Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×

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Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×
Page 65
Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×
Page 66
Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×
Page 67
Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×
Page 68
Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×
Page 69
Suggested Citation:"9 Reimbursement Issues." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.
×
Page 70
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Based on advances in biotechnology and neuroscience, non-invasive neuromodulation devices are poised to gain clinical importance in the coming years and to be of increasing interest to patients, clinicians,health systems, payers, and industry. Evidence suggests that both therapeutic and non-therapeutic applications of non-invasive neuromodulation will continue to expand in coming years, particularly for indications where treatments are currently insufficient, such as drug-resistant depression.

Given the growing interest in non-invasive neuromodulation technologies, the Institute of Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop, inviting a range of stakeholders - including developers of devices and new technologies, researchers, clinicians, ethicists, regulators, and payers - to explore the opportunities, challenges, and ethical questions surrounding the development, regulation, and reimbursement of these devices for the treatment of nervous system disorders as well as for non-therapeutic uses, including cognitive and functional enhancement. This report highlights the presentation and discussion of the workshop.

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