November 2, 2020
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8013
Baltimore, Maryland 21244-8013
Submitted electronically to: http://www.regulations.gov
Re: File Code CMS-3372-P; Federal Register, Volume 85, No. 170 (September 1, 2020)
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” – Proposed Rule
The Center for Medicare Advocacy (the Center) respectfully provides these comments regarding CMS-3372-P and the impact of the proposed rule on Medicare beneficiary access to coverage.
The Center for Medicare Advocacy (the Center) is a national, non-profit, law organization that works to advance health equity, access to comprehensive Medicare coverage, and quality health care for older people and people with disabilities. Founded in 1986, the Center focuses on the needs of people with longer-term and chronic conditions. The organization’s work includes legal assistance, advocacy, education, analysis, policy initiatives, and litigation of importance to Medicare beneficiaries nationwide. Our systemic advocacy is based on the experiences of the real people who contact the Center every day. Headquartered in Connecticut and Washington, DC, the Center also has attorneys in CA, MA, and NJ.
The following comments to the proposed rule will address the Medicare coverage of innovative technology and the Medicare definition of “Reasonable and Necessary” for devices.
- Medicare Coverage of Innovative Technology (MCIT)
The Center for Medicare Advocacy generally agrees with the proposal to provide Medicare beneficiaries with expedited access to new, innovative medical devices. We urge CMS to exercise caution and engage in further consideration about when and how to begin and to end coverage. We recommend CMS develop procedures closely monitoring safety and efficacy of Medicare Coverage of Innovative Technology (MCIT). We endorse CMS’ consideration to expand the MCIT pathway program beyond devices to include biologics, drugs, and diagnostics. We support that NCDs should be initiated by CMS within a year prior to the four-year pathway expiration. Finally, we believe the look-back period, allowing FDA market authorized devices into the pathway, should not be limited to two years.
Executive Order 13890 (E.O.) directs the Secretary to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients” including by “streamlining the approval, coverage, and coding process.” The E.O. explicitly includes making coverage of breakthrough medical devices “widely available, consistent with the principles of patient safety, market-based policies, and value for patients.” The MCIT pathway would accelerate the coverage of new, innovative breakthrough devices to Medicare beneficiaries. (F.R. page 54328.)
The proposed MCIT coverage pathway is specifically for Medicare coverage of devices designated as part of the Food and Drug Administration’s (FDA) breakthrough Devices Program and are FDA market authorized. The MCIT pathway would be voluntary and manufacturers would notify CMS if they wanted to utilize this four year coverage option for expedited coverage. CMS proposes that national Medicare coverage under the MCIT pathway would begin immediately upon the date of FDA market authorization. This coverage would occur unless the device does not have a Medicare benefit category or is otherwise excluded from coverage by the Medicare statute. The proposed rule is limited to medical devices because that is a category of products explicitly identified in the E.O. The MCIT pathway is proposed because prescribed statutory timeframes for the National Coverage Determination (NCD), and Local Coverage Determination (LCD) processes typically take nine to twelve months to finalize. However, shortly after FDA market authorization, Medicare Administrative Contractors (MACs) are currently allowed to make coverage determinations on a case-by-case basis for a particular beneficiary and their health circumstances without having to await an NCD or LCD. (F.R. page 54329.)
Under the proposed MCIT coverage pathway, at the end of the four year coverage period, the device would either have a favorable NCD, have a non-coverage NCD, or have coverage determined by the MACs (case-by-case or through an LCD). CMS recommends manufacturers seeking an NCD initiate the request during the first three years of coverage under the MCIT pathway to ensure seamless national Medicare coverage. (F.R. page 54331.)
To date, 16 breakthrough devices have been FDA market authorized. 10 of these devices experienced variability in coverage due to MAC discretion, or coverage was authorized through DRG or bundled payment mechanism with no separate coverage policy. Several other of these devices were not Medicare coverable.
- CMS should develop safety and monitoring protocols and adopt least restrictive coverage criteria.
Meeting the unique criteria of the FDA Breakthrough Devices Program via a voluntary “fast-track” opportunity in lieu of waiting for an NCD or LCD may provide significantly earlier access to meaningful coverage for beneficiaries who could experience restored health or welcome relief from using such a device. We applaud CMS’ intent to enhance the quality of life for beneficiaries more quickly. This is especially true when there are no existing FDA market authorized alternatives to necessary care.
However, we must echo safety concerns raised by other commenters. Dr. Saty Satya-Murti cited instances where harmful or ineffective treatment became clinically evident over time, even when a device or service had been previously FDA market authorized. (ID: CMS-2020-0098-0015) In order to address any safety concerns, the devices approved for inclusion in the proposed MCIT pathway should be closely monitored throughout the proposed 4-year approval process. A robustly developed and consistently applied evidentiary-based process to track safety and efficacy should be adopted by CMS, clearly articulated, and adhered to by a device’s respective manufacturer.
Even so, as Dr. Satya-Murti describes, adherence to post approval study requirements are not always strict and withdrawing coverage/medical reversals are difficult and unpalatable. (Id.) We leave detailed analytics of how to achieve such monitoring and evaluation to the experts in that field. Through the MCIT pathway process, we encourage CMS to attain a strong balance between access to medically necessary care that improves beneficiary quality of life, and the safety of beneficiaries and the overall integrity of the Medicare program. To the extent that such a balance can be achieved, with necessary “guardrails” in place, the Center for Medicare Advocacy encourages the least restrictive approach to Medicare coverage.
- CMS should broaden the inclusion of items eligible for expedited Medicare coverage.
Assuming the proposed MCIT pathway is conducted with appropriate safety and efficacy guidelines, we support and encourage broadening the definition of items to be considered for the MCIT pathway, or a similar pathway (beyond devices), to include items CMS enumerated in the proposed rule for possible future expedited coverage – biologics, drugs, and diagnostics. Consideration to include these items for beneficiaries is especially important when there are no treatments, or no equally effective treatments, available.
- CMS should automatically open a national coverage analysis to establish an NCD if there is no LCD within a year of the termination of an MCIT pathway device’s four-year coverage period.
Assuming the device has proven to be safe and effective for three years, if circumstances arise when a manufacturer has not begun to pursue an NCD within a year prior to expiration of a device’s four-year coverage period, CMS should open a NCD analysis. If it takes an average of nine to twelve months to secure an NCD, to protect uninterrupted coverage for Medicare beneficiaries, in these circumstances CMS should initiate an analysis twelve months prior to expiration. Perhaps CMS suggested automatically opening an analysis within six months of expiration because the device has achieved a Medicare covered “track record” in the previous three years, but from the beneficiary perspective the need for seamless coverage would suggest not cutting the timing too close to establish an NCD.
- CMS should consider an FDA market authorized device look-back period of longer than two years prior to the effective date of the final rule.
If the proposed MCIT pathway proceeds, there may be valuable devices in the “pipeline” that could immediately benefit Medicare beneficiaries. All FDA market authorized devices should be considered, at least within a longer-time span than only two years prior to the date of the final rule. If a two-year look-back period is adopted, the Center for Medicare Advocacy encourages CMS to create a case-by-case exceptions process to evaluate the value of devices FDA approved prior to that two-year look-back period. If only 16 devices have been FDA market authorized, this does not appear to present an onerous challenge.
- Medicare Definition of “Reasonable and Necessary”
The Center for Medicare Advocacy appreciates the Administration’s commitment to “ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes.” That said, we do not think that commitment would be effectively or safely advanced by the Secretary’s proposal to codify its manual interpretation of the statutory term “reasonable and necessary” and to add commercial insurance coverage as a secondary basis for Medicare coverage. We offer below our general overall concerns about the proposed rule, as well as feedback on some specific issues that the Secretary sought comment on.
- General Concerns About Secretary’s Proposal
With respect to “encouraging innovation for patients,” the Executive Order directs the Secretary to “clarify the application of coverage standards, including the evidence standards CMS uses in applying its reasonable-and-necessary standard, the standards for deciding appeals of coverage decisions, and the prioritization and timeline for each National Coverage Determination process in light of changes made to local coverage determination processes” (E.O. 13890). The proposed rule does not explain how codifying the Program Integrity Manual definition of “reasonable and necessary” serves to clarify the application of the criteria and evidence standards for covering items and services. Moreover, appending to this definition of “reasonable and necessary” an alternative criterion of commercial insurance coverage would create new layers of complexity for parties at every level of the coverage and appeals process. The proposed new definition does less to clarify standards than it does to raise many unanswered questions, as reflected by the breadth of issues and details on which the Secretary sought input. Since this proposal lacks important information and would benefit from more thorough consideration, we believe that issuing a final rule on this matter is, at best, premature.
- Codifying the existing PIM definition of “Reasonable and Necessary”
We oppose the codification of the Program Integrity Manual’s definition of “reasonable and necessary” because elements of it lack clarity and can lead to arbitrary denials of critical medical items or services. The flaws of the current sub-regulatory guidance become more problematic if made into regulation.
In order to satisfy the third criterion of the definition (i.e., appropriate for Medicare patients), five factors must be met, one being that the item or service “meets, but does not exceed, the patient’s medical need.” This factor would be difficult for patients with certain progressive conditions who may benefit from a medical device or therapy that is designed to adapt to or address their future medical need. An example of this is a customizable wheelchair, which may have adaptations that exceed the patient’s immediate medical needs, but would be needed in the future. In view of the limitations on how often Medicare covers a wheelchair for an individual, it may be reasonable to cover a wheelchair that is adapted for the individual’s medically predictable need. Yet, without such a clarification, Medicare contractors and other decision makers are apt to apply an unduly narrow construction of this requirement.
Another factor is that the item/service must be “at least as beneficial as an existing and available medically appropriate alternative.” As there are no guidelines for evaluating this factor, it falls to the discretion of the individual or entity rendering the coverage determination. This may not be as problematic in the context of an LCD or NCD determination. However, we question how, in the absence or interstices of an LCD or NCD, beneficiaries would demonstrate or even know to demonstrate on appeal that the prescribed item/service they are seeking coverage for is “at least as beneficial as an existing and available medically appropriate alternative.” We foresee a multitude of coverage denials by contractors and ALJs who, bound by the regulatory definition, will find that beneficiaries did not present sufficient information or evidence to meet the unclear but exacting burden of establishing this particular element, even if they managed to establish the seven or eight other parts of the “reasonable and necessary” definition. We believe it is prejudicial to Medicare beneficiaries to require proof of facts beyond what is reasonably ascertainable from their own medical records and physicians’ statements.
Historically, due to a variety of factors, relatively few beneficiaries exercise their appeal rights to challenge coverage denials. Holding beneficiaries to this onerous definition of “reasonable and necessary” would operate as a further deterrent to appealing. In short, we see no justification for giving the manual definition the force of law, particularly since the Secretary has not clarified the application of the criteria and evidence standards for coverage.
- Functional Improvement
If the Secretary ultimately proceeds in adding regulatory language to define “reasonable and necessary” for the purpose of coverage, we support the suggestion made in comments submitted by the Independence Through Enhancement of Medicare and Medicaid Coalition (ITEM). ITEM recommends that the statutory language “to improve the function of a malformed body member” be interpreted in the defining regulation as meaning “to improve, maintain, or prevent the deterioration of the function of a malformed body member.” As ITEM explained, such regulatory language would reflect the reality that maintaining existing function is crucial for health outcomes and quality of life for many Medicare beneficiaries, especially those with disabilities, injuries, illnesses, and chronic conditions. This construction would also align with the important principle affirmed in the Jimmo v. Sebelius settlement – that Medicare allows coverage to maintain or prevent deterioration of a patient’s functional status. Thus, if the Secretary decides to codify the PIM definition, we favor ITEM’s proposed revised language, which would ensure that coverage determinations recognize “maintenance of function as a necessary pillar of care under the Medicare program.”
- Adding commercial coverage as a basis for Medicare coverage
We are not fundamentally opposed to consideration of commercial health insurer coverage policies in determining whether Medicare should cover an item or service. We might support an approach that is designed to promote (but not to restrict or deny) coverage, while maintaining the application of clinical standards to protect patient health and safety and the integrity of the Medicare program. That being said, though, we think it is apparent from the proposed rule and the submitted comments that there are enough unknowns and unaddressed concerns in the Secretary’s plan that wisdom would counsel against adopting a final rule on this point at this time.
- Evidentiary concerns
The proposed rule presents and seeks comment on various options that CMS might take to “determine which commercial plan(s) it would rely on for Medicare coverage.” It solicits input on how and whether CMS should limit its consideration of commercial plan offerings or covered lives to specific subsets (e.g., by geography, number enrollees, plan type, etc.); whether Medicare should only cover an item/service that is covered for a majority, plurality, or other proportion of plan offerings or covered lives; whether Medicare should adopt the least restrictive or most restrictive coverage policy, or the coverage restriction employed by a majority, plurality, or other proportion of the commercial offerings examined. These considerations reflect the Secretary’s intention to come up with an efficient bright-line formula for adopting commercial coverage policies. Missing from the equation is whether or how CMS would evaluate the clinical evidence that the commercial insurers relied upon.
We urge CMS and its contractors not to simply defer to the clinical judgment of private health insurers in the interest of “streamlining” the coverage process. The agency should not forsake its important role of evaluating clinical evidence in making coverage policy. In his insightful comments to the proposed rule, Dr. Saty Satya-Murti points out that commercial payers may permit coverage based on “a lower level of evidence, a limited review of evidence, or reviews of controversial quality (for instance a guideline with conflicts of interest or a consensus based guideline)” (ID: CMS-2020-0098-0015). We echo his “call for caution in accepting a commercial payer coverage decision without an analytic and filtering lens before incorporation into Medicare’s decision making process.” We also concur with Dr. Satya-Murti’s recommendation that “[c]ommercial plans’ coverage policies must be available to MACs and CMS. Their clinical and scientific rationale behind affirmative, or negative, coverage decisions must be disclosed to Medicare and MAC medical staff.”
- Potential for decreased coverage and access
We join other commenters in urging that consideration of the commercial market be used to expand, and not to restrict or deny, Medicare coverage. The fact that an item or service is not covered by commercial policies should not be the basis for CMS and its contractors to deny Medicare coverage of that item or service. It would be unfair and illogical to conclude that if commercial insurers do not cover a device then the device is not reasonable and necessary for Medicare beneficiaries. As astutely mentioned in ITEM’s comments, “it is common practice for commercial insurers to model their policies on Medicare coverage determinations or even explicitly link their policies to Medicare…. Medicare plays a special role in establishing important benchmarks for national coverage of benefits.”
We also have concerns about the proposed exception to coverage, when “evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant.” It is unknown what evidence, metrics, and factors would be considered in determining what these clinically relevant differences might be. We strenuously urge CMS not to overlook the Medicare population that is under 65 when making these determinations. As ITEM remarked, “This subset of Medicare beneficiaries may have different needs, and different items and services may be considered appropriate for beneficiaries of different ages.”
- Potential scope of proposed regulation
We are uneasy that the Secretary’s current proposal may signal the beginning of a movement towards modeling Medicare coverage on commercial coverage policies. Although the scope of the proposed definition is limited to medical services coverage decisions that relate to health care technology, it could easily be extended by cross-reference to other areas of coverage in future rulemaking. In light of our above-stated concerns, we do not think this is a favorable direction for the Medicare program and its beneficiaries.
- Ability of beneficiaries to access coverage under this criteria
In the absence or interstices of an NCD or LCD, we wonder how, practically-speaking, Medicare beneficiaries would go about demonstrating that they qualify for coverage of an item or service based on coverage in the commercial insurance market. We question whether the data needed as proof is even available to beneficiaries, as coverage criteria is likely proprietary to private health insurance companies. Even if the information was ascertainable, it is doubtful that many Medicare beneficiaries could access it. Beneficiaries with limitations in health, cognition, communication, sight, digital coordination, English proficiency, and access to technologies and other assistive resources, would be at an even greater disadvantage in this regard.
To summarize, we think a great deal still needs to be fleshed out before the Secretary can tender a viable, fully-formulated plan for the public to meaningfully evaluate. If CMS were to add commercial coverage as a separate basis for Medicare coverage at this stage, it would be akin to carrying out a demonstration project, but on a national level. Although we do not support this move, we offer this additional feedback on the proposed rule:
- In response to the Secretary’s question of whether CMS should adopt the least restrictive or most restrictive coverage policy amongst the commercial plan offerings examined; there should be no bright-line, or rule-of-thumb. Just as adopting the most restrictive coverage policy may pose a danger to certain patients, there may also be risks in adopting the least restrictive coverage policy. If a commercial standard is adopted, it must abide by Medicare law, allowing the needs of each individual to be considered. CMS should independently evaluate the clinical basis for coverage and develop coverage rules that best fit the needs of beneficiaries in light of their actual needs and conditions.
- In response to the Secretary’s questions concerning which commercial plan(s) to rely on for Medicare coverage, we urge CMS to look only to fully credible insurers with a broad base of enrollment (not just “healthy and wealthy” enrollees). These plans should be ones that are and have been meeting the minimum medical loss ratio requirement (85% for large group, 80% for individual and small group insurers), as evidence that they are providing value to their enrollees.
If the Secretary promulgates the proposed rule, we believe the current coverage policies for items and services be grandfathered to avoid inappropriate denials of coverage.
The Center for Medicare Advocacy urges CMS to place the interests of all Medicare beneficiaries in the forefront of its determinations. We appreciate the opportunity to submit these comments on behalf of all those who have the legal right, and urgent need, to obtain Medicare-covered services.
For additional information, please contact Wey-Wey Kwok at Wkwok@MedicareAdvocacy.org; Paul Grabowski @ PGrabowski@MedicareAdvocacy.org, or Kathleen Holt, at Kholt@MedicareAdvocacy.org, or at (860)456-7790.