Impulse Dynamics Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule
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Thank you for the opportunity to provide comments regarding the proposed Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" rule, CMS-3372-P. Additionally, we wish to extend special thanks to the proposed rule's authors,
We also are grateful for their thoughtful considerations on critical topics related to ensuring access to innovative medical technologies for program beneficiaries.
Impulse Dynamics is a medical device manufacturer dedicated to transforming the treatment of chronic heart failure. We have developed the Optimizer(R) Smart System, which provides cardiac contractility modulation therapy for appropriately indicated heart failure patients. The implant procedure for the Optimizer(R) device follows the same surgical steps as an implantable cardiac defibrillator. CCM therapy, however, delivers both well-validated subjective and functional improvement for a population of patients with very limited therapeutic options and relatively poor long-term prognosis.
Optimizer(R) obtained FDA Breakthrough Device Designation in
Under normal circumstances, Impulse Dynamics would not provide such extensive background in a comment letter preamble, though in the case of the MCIT rule, these factors add important context to many of our remarks given that Optimizer(R) will be a potential early application to the MCIT coverage pathway. Impulse Dynamics' comments regarding the proposed rule follow. We look forward to CMS' responses in the final rule and to its implementation shortly thereafter.
SUPPLEMENTARY INFORMATION, I. Background
"We propose that national Medicare coverage under the MCIT pathway would begin immediately upon the date of FDA market authorization (that is, the date the medical device receives Premarket Approval (PMA); 510k clearance; or the granting of a De Novo classification request) for the breakthrough device."
As noted, Optimizer(R) obtained Breakthrough Designation (BD) in
CMS has already considered the difference between FDA approval and market availability in language for both New Technology Add-on Payments and Transitional APC Pass-Through Payment Status when looking at newness criteria. For a multitude of reasons, many BD devices may not be available to beneficiaries immediately upon FDA approval. Application for the incremental payments highlighted above could be one of them. Often small companies introducing a BD device have legitimate reasons for a delay in market availability. CMS should afford companies in that situation time to ramp up manufacturing capability and capacity, build a commercial sales force, adequately promote a new therapy (often available during clinical trials at only a small fraction of facilities with potential to use it), appropriately train providers where required and navigate the process to put a new medical device on contract at hospitals (which frequently takes several months or longer, particularly in periods of undefined coverage), before starting the MCIT timer to maximize beneficiary access to these products and facilitate continued evidence development during the MCIT coverage period.
With these thoughts in mind, we recommend CMS define market availability for a device as the date of the first paid Medicare claim, in either the inpatient or the outpatient setting. We also request that this start date for a BD device's relevant MCIT coverage window be published on the CMS website and that this page of the CMS website be updated on a monthly or more frequent basis for public viewing.
We understand CMS regards the period following FDA approval as a phase to build real-world evidence for a medical device. However, BD devices brought to market in advance of the MCIT rule faced significant access barriers to doing so.
Until
Because of risk and capacity concerns, elective surgery suspensions due to COVID-19 have prevented access for many new and innovative technologies in this recent and unprecedented era, as well, subsequently hampering this evidence-gathering opportunity for the first handful of BD devices to obtain FDA approval.
As this timing change impacts only that first small handful of BD devices to achieve FDA approval, the long-term impact of leveling the playing field in this manner creates minimal impact on the overall spirit, costs or implementation of the MCIT pathway.
Additionally, CMS outlines multiple potential outcomes for coverage extending beyond the MCIT period, one of which is an NCD application. CMS recommends manufacturers who wish to pursue this option make their application during the latter stages of the MCIT window. If the timing guidelines for MCIT are not revisited, a select group of BD device manufacturers likely will need to make decisions to opt-in to the MCIT pathway and to pursue NCD application almost simultaneously. The proposed timing imposes a crunch which does not appear to be within the overarching intent of the MCIT rule or the Executive Order that inspired it. Such timing does not afford some qualifying devices the full benefit of the MCIT coverage period for evidence building that would extend to future applicants to the MCIT coverage pathway.
D. MCIT PATHWAY
"We propose that the MCIT pathway would provide immediate national coverage for breakthrough devices beginning on the date of FDA market authorization and continue for up to 4 years, unless we determine the device does not have a Medicare benefit category as determined by us as part of the MCIT pathway process."
Impulse Dynamics suggests that CMS applies a coverage period of a minimum of 4 years for the MCIT pathway. In most cases, 4 years should prove to be an adequate window of time, however there will be instances that warrant an extension. CMS should make a provision allowing applicants to file for an extension after the start of the final year of the initial 4-year MCIT window.
Additionally, all BD devices that achieve FDA market authorization should have the benefit of eligibility to the full 4-year minimum MCIT coverage window. Devices that achieved FDA market authorization more than two years before the effective date of the rule should not be excluded from participation.
And devices that obtained FDA market authorization within two years from the rule's effective date should not have their MCIT coverage window shortened. Only a small number of devices fall into either of these categories, and there is no objective reason to limit beneficiaries' access to those BD devices subject to the time constraints that appear in the proposed rule. At one point, CMS qualifies the MCIT period as lasting "up to 4 years." Impulse Dynamics reiterates that the MCIT coverage period should last a minimum of 4 years, with discretionary power to lengthen it extended to CAG accordingly.
Impulse Dynamics agrees with CMS's conclusion not to include devices without a benefit category into the MCIT pathway.
"We would subsequently coordinate with the manufacturer regarding the steps that need to be taken for MCIT implementation purposes."
Impulse Dynamics agrees with CMS's suggestion that the MCIT coverage pathway be triggered by an opt-in email from a manufacturer of a BD device and suggests that the opt-in time period (from request to implementation of MCIT coverage for a particular device) be limited to 90 days or less. During this time, CMS, the device manufacturer and other relevant stakeholders can exchange required information (such as procedure codes and HCPCS codes) for claims submission. This window also affords Medicare contractors adequate time to update claims processing software to accommodate for BD devices entering the MCIT pathway.
When an applicant opts-in the MCIT pathway, CMS should take steps with the manufacturer in question to ensure appropriate coding is established in a timely manner. For example, an entrant to the MCIT pathway may not yet have a unique HCPCS code (often issued to a device by CMS as part of the Transitional APC Pass-Through Payment Status award, which could come after MCIT application) or CPT code (which takes approximately 14 months to obtain from AMA). In such a case, special coding considerations may need to be put in place for some entrants to the program. In these instances, absence of an appropriate code could be tantamount to non-coverage at the start of the MCIT pathway, possibly shortening the coverage window unintentionally. Providers offering beneficiaries technologies covered by the MCIT pathway should not be subject to administrative burdens associated with use of unlisted codes.
"We intend to put devices that are covered through the MCIT pathway on the CMS website so that all stakeholders will be aware of what is covered through the MCIT pathway."
Impulse Dynamics vigorously agrees with this suggestion. Explicit coverage declarations are easy for providers and administrators to understand. Too often, Medicare Advantage plans stall prior authorization requests, particularly when no coverage policy - positive or negative - exists at either the national or local level. Having a clear, government source online to document MCIT coverage will help to ameliorate this undue administrative access challenge for beneficiaries enrolled in Part C plans as well as provide greater transparency to all interested stakeholders regarding Medicare coverage of BD technologies.
CMS should take this public declaration of devices in the MCIT pathway one step further by adding language to the MCIT rule requiring Medicare Advantage plans to provide swift prior authorization where required for MCIT devices. Neither providers nor patients should experience undue delays, aggravation or administrative burden when Medicare Advantage plans revert to their commercial coverage policies in the absence of a MAC-level of CMS-level positive coverage policy. Impulse Dynamics has witnessed many Medicare Advantage plans deny authorizations and/or other forms of pre-service appeal for beneficiaries for devices for which silent coverage applies, resulting in unacceptable delays in care and legitimate clinical risk for indicated patients. CMS should use its authority to ensure patients who elect Part C coverage have the same access to BD devices as Medicare beneficiaries do, rather than facing undue pre-service administrative burden during the prior authorization process.
"However, we seek comments as to whether CMS should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study similar to CMS's Coverage with
Companies with devices in the MCIT pathway should not be obligated to enter such a study during the MCIT period. Under the mantle of MCIT coverage, manufacturers should be left to make their own business decisions regarding the means by which they develop additional clinical evidence supporting the use of their devices, including if such additional evidence development is warranted. Further, as creating uniform data collection guidelines proves very challenging given the wide range of BD devices - in terms of patient population, implant approach, clinical endpoints, etc. - that have come to market, requiring start of another study upon entrance into the MCIT pathway could have the effect of slowing access to innovative technologies for Medicare beneficiaries. Design and implementation of such a study would require potential interaction between an MCIT applicant and CMS, further complicated by the fact that some of these discussion may need to be initiated before FDA marketing authorization is obtained for devices to realize the full benefit of the full MCIT coverage period. Design of such a study requirement from CMS may also impact FDA-mandated Post-Approval Studies (PAS) for BD devices.
Managing potential interplay between study populations and enrollment criteria could add another layer of administrative complexity to study framework, thus creating additional friction between indicated program beneficiaries and innovative therapy options. CED has traditionally been a potential outcome of an NCD application and should remain as such when an MCIT pathway applicant makes the decision to opt for that coverage pathway during the MCIT window.
"From our experience with clinical studies conducted as part of an NCD, 4 years is approximately the amount of time it takes to complete a study."
Impulse Dynamics agrees 4 years is a very reasonable period of time over which a BD device could conduct a trial to build evidence to be used in an NCD application in most applications, should the manufacturer choose that coverage option. However, in some cases, 4 years may not afford enough time to do so, in the instance of a very particular niche disease state, for example. With that though in mind, CMS should apply a minimum of 4 years of MCIT coverage. CMS should also allow for extension of that 4-year window based on unique circumstances to be discussed in the final year between participating manufacturers and CAG.
That minimum 4-year window could also allow manufacturers to make the business case that an NCD application does not make the most sense following the MCIT window. Many manufacturers of BD devices conduct PAS and/or real-world data registries during this window that serve the exact noted purpose, most of which complete enrollment and publish outcomes within 4 years from FDA approval.
Allowing for coverage of a BD device via the MCIT pathway may help expedite enrollments into such an FDA-mandated trial. This fact provides further justification to time MCIT pathway eligibility based on market availability or effective date of the MCIT rule, whichever comes second.
We seek public comment on whether CMS should open a national coverage analysis if a MAC has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT period.
CMS always retains the right to initiate a national coverage analysis. Still, we strongly urge that absence of contractor policy within 6 months of the end of the MCIT window should not trigger an automatic NCA. We are concerned that if this were implemented, many manufacturers will not participate in the MCIT pathway given the ramifications of an NCD. Additionally, we are also concerned about the significant burden this would place on the
The MCIT rule affords manufacturers the option to choose "Claim-by-claim Adjudication" under section 1862(a)(1)(A). Requiring an automatic opening of a coverage analysis period due to inaction by a MAC or MACs effectively takes away this option. As MCIT is an 'opt-in' pathway, CMS should preserve BD device manufacturers' option to pursue claim-by-claim adjudication, the method by which a majority of Medicare claims are evaluated, as opposed to triggering an automatic coverage analysis exercise, even if that NCA does not become a prelude to an NCD.
For manufacturers wishing to pursue an NCD at the conclusion of the MCIT window, CMS should publish a list of the NCDs currently in queue, including original submission dates. While the decision to request an NCD is multi-factorial, understanding potential timeframe to develop a policy surely is one of those factors. Additionally, as previously stated, CMS should amend the MCIT pathway timelines to afford all entrants access to the full 4-year coverage period. If CMS elects not to do so, it should create a process to prioritize NCD requests from manufacturers with devices for which the MCIT coverage period lasts less than 4 years. Such a move would help eliminate risk of undue coverage gaps for program beneficiaries. Part of the prioritization strategy could include creating separate NCD queues for MCIT and non-MCIT applicants.
Therefore, we have proposed an opt-in approach with an email to CMS to indicate affirmative interest in coverage. We are interested in whether an opt-out approach would be less burdensome for stakeholders.
Impulse Dynamics prefers an "opt-in approach." Given the amount of time and effort required to ideate, develop and bring a BD device to market, requiring manufactures to elect to enter the MCIT pathway via an affirmative email to CMS does not represent a burden. In general, manufacturers benefit from and enjoy interaction with the Agency, and it is incredibly unlikely that an opt-in process would act as a deterrent for application into the MCIT coverage pathway or create any undue administrative burden for potential applicants.
Also, we seek public comment on whether, once a manufacturer has opted-out of coverage, it can subsequently opt-in to MCIT.
As noted above, entrance into the MCIT pathway should be predicated on an opt-in basis. Silence from a BD device manufacturer during the eligible time period for MCIT application should not be construed as opting out. BD device manufacturers should be afforded the ability to make appropriate business decisions regarding application to such a coverage pathway, so long as they do so within the timeframes stipulated by the MCIT rule and according to its guidelines. As previously noted, Impulse Dynamics suggests market availability (triggered by the first paid Medicare claim) start the MCIT eligibility window.
This should be the case whether a manufacturer opts-in at that point in time or not. If a manufacturer, for example, elected to apply for MCIT two years after market availability, that manufacturer should still retain access to the remaining time period in the eligibility window for MCIT coverage. It should also be noted that a manufacturer's decision to delay entrance into the MCIT pathway alone should not be construed as sufficient rationale to extend the MCIT window beyond 4 years.
II. Provision of Proposed Regulations, A. Defining "Reasonable and Necessary"
"In addition to codifying the above criteria, we propose to include a separate basis under which an item or service would be appropriate under (3) above that is based on commercial health insurers' coverage policies (that is non-governmental entities that sponsor health insurance plans)."
Impulse Dynamics strenuously objects to use of commercial payor policies in the development of Medicare determination on items or services that meet definitions of "reasonable and necessary." First and foremost, many commercial insurance policies likely will not comply with the criteria that delineate what is "reasonable and necessary" in the Medicare definition. Second, commercial payors already have a voice into the Medicare policy making process by way of open comment periods, yet they do not afford reciprocal ability to share feedback on their coverage development processes. On top of these concerns, the motivations and policy-making process for commercial insurance companies vary from Medicare almost diametrically.
Unlike Medicare, commercial payor policies are made essentially in a black box, with little to no visibility or input by outside stakeholders into the process. Many insurers, certainly the largest, publicly traded ones, are primarily obligated to address the needs of shareholders first. The doctrine of shareholder primacy would no doubt have a chilling effect on access to innovative technology given the profit-driven motivations of such firms. Their basis for existence is to produce a financial return to shareholders.
Historically, commercial insurance companies have determined that most new technologies are 'experimental and investigational' or 'not medically necessary' for years beyond FDA approval, sometimes even well after consensus on their use has been reached by the medical community. In the face of such policies, which seem to be applied as a matter of practice, the prior authorization process for a new technology with a commercial insurance company can take several months for a given beneficiary, creating a period of angst and undue clinical risk to patients and reluctance among providers to prescribe innovative products. This operational model and decision-making framework clearly conflict with those of a taxpayer-funded program such as Medicare. While CMS has proposed the MCIT pathway to accelerate access to innovative technologies for its beneficiaries, commercial insurance companies appear to have the exact opposite response to offering such access.
Those concerns aside, the policies drafted by commercial payors vary dramatically in terms of their length, depth of analysis and level of citation. Given the sheer number of commercial health insurers in the country (estimated to exceed 1,000 by some sources), there is no reasonably efficient means by which consensus could be drawn in the event of discrepancies between policies. In this proposed rule, CMS has already cited variations in coverage for BD devices at the MAC level as a troublesome reality, and there are just seven MACs. Opening the Medicare policy-making process to input from the far more disparate commercial insurance community magnifies that dilemma at a factorial level.
Additionally, commercial insurers often rely on analysis from third-party research firms that also draw conclusions and produce reports with no open comment process. In some instances, these entities that conduct this "independent review" of a technology are funded by the insurance industry through subscriptions or the purchase of reports. The entities that create these reviews have no oversight on their review processes and frequently do not include input from other parties including the manufacturer. This is very concerning given the financial relationship between payers and these entities. Conversely, CMS has traditionally gone to great strides to request, synthesize and respond to feedback from its many stakeholders when making policy or program changes.
We recently encountered a perfect case study on the perils of considering commercial payor policies by Medicare in the manner proposed in this rule. A large, national payer recently updated its policy regarding cardiac contractility modulation therapy. The policy may be found at http://www.aetna.com/cpb/medical/data/900_999/0930.html. The new policy made several glaring errors, including:
* It misstated the FDA IFU indications and contra-indications. This information may be found at https://www.fda.gov/medical-devices/recently-approved-devices/optimizer-smart-system-p180036.
* It indicated the device "is limited to investigational use only in
* It implied the trial for which FDA approval was obtained is still enrolling, despite its publication in the
* It overlooked a publication on FDA approval of an iterative version of our device (requiring fewer surgical steps and demonstrating safety and efficacy in patients with atrial fibrillation) from Circulation: Heart Failure in
* It cited obscure case-study publications on small populations (5 or fewer patients) published in the same timeframe as the seminal publications noted in the previous two bullets.
* It directly compares Cardiac Contractility Modulation therapy to Cardiac Resynchronization Therapy (CRT), even though our FDA IFU clearly spells out indication for CRT is, in fact, a contraindication for CCM therapy.
Upon reading this policy, we sent several peer-reviewed manuscripts to the payer, to whom we had recently pointed out retirement of Category III CPT codes that should impact access for beneficiaries enrolled in Medicare Advantage plans. As part of our communication, we offered a call with our Medical Director, who remains board-certified in the sub-specialty discipline that commonly implants our device. However, the payor declined such a call as a matter of practice. Subsequently, we offered to facilitate a direct call between medical directors from the payor and in-network physicians who have experience implanting our device and managing patients with the therapy in both clinical trials and commercially. It was clear Impulse Dynamics would not be a participant in this call, yet the payor still declined to participate. This type of policy behavior - completely devoid of open comment or clinician involvement - would have a chilling effect on innovation for the Medicare population were input from such payors taken into consideration by CMS.
"By considering commercial health insurer coverage policies, CMS would bring together expertise of private payers and CMS."
Despite the fact that expertise exists at both CMS and within the commercial insurance industry when it comes to policy making, the motivations of the two groups often run contrary to each other. In considering whether to invite commercial insurers into the policy making process for Medicare, CMS should consider not just their level of expertise but also their primary motivations for the process.
Companies driven by preserving or growing shareholder value have a voice through the CMS open comment process already. They should not be afforded any more involvement than that level due to their unwillingness to provide the same level of transparency and access to their policy making processes.
"We also seek to comment on whether, given considerations such as the variation and distribution of coverage policies and access to innovations, we should only cover and item of service if it is covered by a majority, or a different proportion, such as a plurality, of covered lives amongst plans or a majority, plurality, or some other proportion of plan offerings in the commercial market."
As noted above, an astounding number of health insurers exist in
"Under this approach, we would only use the current definition of 'appropriate' from the current PIM when the exception for clinical relevant differences between Medicare beneficiaries and commercially insured individuals applies (or if the commercial coverage basis is determined by a proportion like a majority and there is sufficient commercial coverage information available)."
Clinical trials are not typically designed to delineate patient groups based on payor type or age, rather by clinical indications and exclusion criteria. When looking at 'clinically relevant differences,' how would that term be defined if it is not clearly explained in clinical trial enrollment criteria? Impulse Dynamics does not favor incorporation of commercial insurance policies into the Medicare policymaking process. Adding guidelines that imply comparison between Medicare and non-Medicare populations that are not clearly defined in trial enrollment criteria and/or outcomes raises concerns, not the least of which is developing objective metrics to differentiate the two groups that could require interpolation or extrapolation in absence of clear trial data. This type of consideration could lead to conscious changes in trial design that could exclude deserving patients from clinical research protocols unnecessarily. Physicians should be empowered to make clinical decisions based on the needs of patients on a case-by-case basis. Imposing what could be subjective comparisons between Medicare and non-Medicare populations after a trial has been completed may rob them of the ability to do so.
B. Application of the "Reasonable and Necessary" Standard to the MCIT Pathway
"We are proposing that, under the proposed MCIT pathway, an item or service that receives a breakthrough device designation from the FDA would be considered "reasonable and necessary" under section 1862(a)(1)(A) of the Act because breakthrough devices have met the
Impulse Dynamics agrees with this suggestion and proposes CMS take it one step further to indicate that FDA BD devices that obtain required FDA approval or clearance automatically be afforded "reasonable and necessary" status regardless of their entry into the MCIT pathway or not. It stands to reason that if obtaining BD satisfies the 'substantial clinical improvement' criteria required to obtain New Technology Add-on Payment or Transitional APC Pass-Through Payment Status that it should also rise to the level of meeting the definitions for "reasonable and necessary' for coverage purposes. While we understand incremental payment options available through other Medicare Departments such as Outpatient Care and Acute Care may impose different standards when looking at coverage and payment topics, streamlining access to BD devices feels like an apt place for different Departments criteria to coalesce.
2. MCIT Pathway Device Eligibility
"We proposed in 405.603(b) that the breakthrough devices that received FDA market authorization no more than 2 calendar years prior to the effective date of this subpart (the date the final rule is finalized) and thereafter will be eligible for coverage for claims submitted on or after the effective date of this rule."
Impulse Dynamics objects to the 2-calendar year lookback period and suggests no lookback limitation for eligibility be applied to the MCIT coverage pathway. The small number of devices (likely fewer than 5) that obtained BD and FDA market authorization predating that timeframe should not be stripped of eligibility to participate fully in the MCIT pathway. Additionally, Impulse Dynamics suggest the start date for the coverage pathway should be the relevant date of service for the procedure, not the date on which the claim submission takes place.
"Breakthrough devices market authorized prior to the effective date of this rule will not be eligible for all 4 years of coverage."
Impulse Dynamics again suggests the eligibility period for MCIT begins at either market availability or effective date of the rule, whichever comes second. In the spirit of increasing access to innovative technologies, eligibility of all BD devices, regardless of their market availability, should be a full 4 years (or longer based on specific petition to CAG for extension). Market availability should supplant market authorization, as there are many legitimate business cases in which commercialization does not coincide directly with FDA approval. Manufacturers should be afforded the same ability to substantiate market availability with MCIT as they are with NTAP or Pass-Through applications.
"We specifically seek comment on whether off-label use of breakthrough devices should be covered and, if so, under what specific circumstances and/or evidentiary support."
Off-label use should not be covered by the MCIT pathway explicitly. If providers elect to offer a patient a BD device outside of labelled indications, evaluation of that claim should be made at the contractor level based on medical necessity, not expressed coverage through the MCIT pathway. If manufacturers wish to pursue expanded indications for a particular device, the FDA has already created a pathway for them to do so.
Thank you again for the opportunity to comment on Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" proposed rule and for CMS' continued efforts on behalf of both providers and beneficiaries participating in the programs. Impulse Dynamics regards this rule as a watershed moment in the 55-year history of the Medicare program. As previously noted, we sincerely appreciate the time and effort its authors have invested in the rule's very thoughtful drafting and appreciate the opportunity to comment as a stakeholder in the rule-making process. Impulse Dynamics eagerly anticipates release of the final rule in the months to come and look forward to its implementation shortly thereafter.
Respectfully,
Simos Kedikoglou, MD
CEO
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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0098-0002
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