Biogen Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule
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Biogen appreciates this opportunity to comment on the
Biogen is a pioneer in neuroscience. Since our founding in 1978 as one of the world's first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases, including by working to develop transformative new treatments in the areas of Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. Our focus on neuroscience, our deep scientific expertise, and our courage to take risks make us leaders in the research and development of medicines to transform neuroscience to benefit society.
Biogen supports Medicare policies that encourage appropriate and reliable access to the care that Medicare beneficiaries need, including policies that facilitate access to transformative new medicines by changing the treatment paradigm for debilitating degenerative conditions. We strongly support Medicare making changes to ensure prompt access to these therapies.
We write to specifically comment on the following proposals contained in the Proposed Rule:
* Biogen urges CMS to clarify its proposed definition for "reasonable and necessary" and exclude drugs and biologics from being subject to this proposed requirement;
* Biogen supports a voluntary pathway for existing, non-covered diagnostic tests that are critical for patient access to new therapies in the MCIT pathway; and
* Biogen supports a voluntary pathway for inclusion of diagnostics in the MCIT pathway but seeks clarification regarding CMS' definition of breakthrough "device" as it relates to diagnostics.
Biogen Urges CMS to Clarify its Proposed Definition for "Reasonable and Necessary" and Exclude Drugs and Biologics from the Definition
In the Proposed Rule, CMS proposes to codify its current definitions for "reasonable and necessary" and create an alternative mechanism to determine if items or services are appropriate for Medicare patients. As drafted in Proposed Regulation 42 C.F.R. Sec. 405.201, the "reasonable and necessary" definition only would apply to devices, and not drugs or biologics./2,/3
In other words, the rule is only amending the device section of the regulatory text, and not the section applying to drugs and biologics.
Yet, the CMS Fact Sheet states that the Agency is "proposing to codify a definition of 'reasonable and necessary' for items and services that may be covered under Part A and Part B of the Medicare program." The CMS Fact Sheet continues, "The proposed definition would apply to all Medicare items and services not just those covered through the MCIT pathway" [emphasis added]. Therefore, this language is inconsistent with the Proposed Regulation text./4
Based on this contradictory language, Biogen is concerned that the proposed definition would, in fact, apply to all Medicare items and services, including drugs and biologics, not just those covered through the MCIT pathway.
Biogen commends CMS for issuing this Proposed Rule, as it will help bring new, innovative technologies to the Medicare population. As the Proposed Rule does not discuss the implications of the reasonable and necessary proposals relative to drugs and biologics, Biogen believes it is unclear if the Agency intends new requirements for coverage of medicines for their labeled indications; however, the Medicare statute and rigorous
These aforementioned factors, therefore, have generally resulted in the establishment of broad, de-facto coverage for drugs and biologics in the Medicare program.
We are concerned that applying new requirements to drugs and biologics, as outlined in the Proposed Rule, is unnecessary and would complicate Medicare's coverage process for drugs and biologics and create barriers to patient care. Therefore, Biogen urges CMS to clarify explicitly that the "reasonable and necessary" definition, as currently proposed, is only applicable to devices and not drugs or biologics.
If CMS were to (contrary to prior positions) apply the "reasonable and necessary" definition to drugs and biologics and to include a reference to coverage under commercial plans, the Agency should make clear this is an alternative basis for meeting the criteria and does not replace the existing "appropriate" criterion itself. Specifically, CMS should make explicit that the commercial insurance coverage criterion will only expand coverage by adding an additional pathway to coverage rather than imposing additional requirements that an item or service would have to meet to be covered. Medicare should affirm that using commercial coverage standards will only be used to expand access and not restrict patient access.
Biogen contends that a commercial insurer could establish a negative policy, particularly due to cost constraints, which would result in Medicare adopting this policy overnight. Biogen wants to ensure that Medicare beneficiaries have access to all new innovative therapies.
Biogen Supports a Voluntary Pathway for Existing, Non-Covered Diagnostic Tests that are Critical for Patient Access to New Therapies in the MCIT Pathway
Biogen is encouraged that CMS also seeks comments on the scope of the MCIT program and whether it should be expanded to other technologies that use expedited FDA approval pathways. We also appreciate that CMS is seeking comment from manufacturers on whether an opt-in or opt-out approach for MCIT would be most feasible and appropriate./6
Notwithstanding our request for further clarification of the "reasonable and necessary" definition and insistence that status-quo drug and biologic coverage be maintained regardless of finalization of this Proposed Rule, as mentioned elsewhere in our comment letter, Biogen supports a voluntary coverage pathway for existing technologies, including non-covered diagnostic tests, in MCIT if those products experience unique coverage and access issues throughout the patient journey, including but not limited to if an innovative drug or biologic requires confirmation from an existing non-covered diagnostic test.
Although, we do not believe it is appropriate for drugs and biologics to utilize this pathway, MCIT, under certain circumstances, such as the one outlined below, may be warranted to ensure immediate patient access to novel drugs and biologics.
Example: New, Innovative Drug or Biologic with Non-Covered Procedures using Diagnostics and Radiopharmaceuticals Integral to Patient Treatment
Biogen is aware that there may be discrete circumstances under which innovative drugs and biologics rely upon FDA-approved, but CMS non-covered diagnostic tests and associated radiopharmaceuticals to treat patients. In many circumstances, FDA approval of an innovative drug or biologic is based upon clinical literature which uses that diagnostic to appropriately identify patients for treatment. While the diagnostics and associated radiopharmaceuticals themselves may not be new and innovative, for the purposes of MCIT, they are imperative in ensuring beneficiaries are able to access new and innovative drugs and biologics. In situations where there is an existing national noncoverage decision, or no coverage decision, or coverage with evidence development (CED) for a procedure involving FDA-approved diagnostics and radiopharmaceuticals critical to identify appropriate patients for treatment with an innovative drug or biological, Biogen is extremely concerned that Medicare beneficiaries will not have access to that much-needed treatment. Even if a procedure involving FDA-approved or cleared diagnostics and radiopharmaceuticals is covered, Biogen is also aware that certain geographic and financial, and ultimately volume, constraints may still exist as barriers to care.
Based on the example above, it is Biogen's belief that if CMS is considering covering new technologies under MCIT, then the Agency should also cover additional technologies, agnostic of "newness," that are critical to a patient being able to access those new technologies. As science changes, so should existing coverage policies, in a timely manner, so as to not impede patient access to innovation. Therefore, CMS should allow diagnostic tests with unique coverage issues that will impede patient access to utilize the MCIT pathway. CMS should allow a coverage pathway via MCIT for all "reasonable and necessary" services--including, but not limited to, existing radiopharmaceuticals and diagnostics--for patients to be treated with a new, innovative drug and/or biologic. Biogen urges CMS to also address the reimbursement challenges for diagnostic radiopharmaceuticals.
Biogen Supports a Voluntary Pathway for Inclusion of Diagnostic Tests in the MCIT Pathway but Seeks Clarification Regarding CMS' Definition of Breakthrough "Device" as it Relates to Diagnostics
As with drugs and biologics, Biogen is encouraged that CMS is seeking comments on whether MCIT should be expanded to diagnostics. Biogen recognizes the critical role that innovative diagnostics play in patient care, and as such, supports voluntarily broadening the MCIT pathway to breakthrough diagnostics as well.
While Biogen supports including diagnostics as eligible technologies under the MCIT pathway, we are seeking further clarification regarding CMS' definition of a breakthrough device as it relates to a diagnostic. In the Proposed Rule, it appears that the Agency is classifying devices and diagnostics as separate types of technologies, though does not offer a definition of "device" for the purposes of the MCIT pathway; the FDA, in contrast, has codified the definition of a device, derived from statute, to be "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. . ."/7
Based on this regulatory definition, Biogen believes the MCIT pathway includes diagnostics, particularly in vitro diagnostics (IVDs), as part of the definition of "device."
We therefore ask for clarification on CMS' definition of device for the purpose of MCIT to affirm that CMS intends to use the statutory and regulatory definition of a "device", as well as and in addition to the inclusion of diagnostics in the MCIT pathway. Furthermore, innovative diagnostics are eligible for the Breakthrough Devices Program, and a significant portion of devices approved via the breakthrough device pathway have been diagnostics./8
We are also aware that additional diagnostics tests have been announced for inclusion in the Breakthrough Devices Program and are hopeful of future innovation. We urge CMS to include diagnostics for eligibility under the MCIT pathway and encourage the Agency to do so by recognizing diagnostics as medical devices, rather than separate technologies.
Despite the benefits of cutting-edge diagnostic technologies, Biogen is aware of the coverage challenges associated with them. For example, there is uneven Medicare coverage of diagnostics, with certain Medicare Administrative Contractors (MAC) offering more robust coverage and reimbursement policies than others for the same diagnostic services.
We are also concerned that as more complex diagnostic services are created, the frequency of denials will increase as a result. Importantly, denials impede the uptake of certain new drugs and biologics, which often require confirmation of certain diseases via diagnostic tests.
We applaud CMS for issuing the MCIT pathway proposal and urge the Agency to finalize the proposal to include diagnostics in order to foster uniformity of coverage and consistent patient access.
In the Proposed Rule, CMS acknowledges that the National Coverage Determination (NCD) process is lengthy, taking approximately 9 to 12 months to finalize, and "limit[s] CMS' ability to institute immediate national coverage policies for new, innovative medical devices."/9
As a result, there can be coverage uncertainty until CMS finalizes an NCD or a MAC finalizes a Local Coverage Determination (LCD). Biogen agrees with CMS that the NCD process is too lengthy and can impede access to innovative therapies. Biogen encourages CMS to use its flexibility to expediate coverage decisions when an innovative therapy is approved.
Biogen thanks CMS for this opportunity to comment on the Proposed Rule. We look forward to continued engagement with CMS to ensure Medicare coverage and payment policies continue to encourage broad and appropriate access to effective clinical interventions, including innovative treatments for degenerative neurological conditions. If you have any questions regarding our comments or we can provide additional information to assist CMS in its consideration of our comments, please contact me at (202) 741-3961 or [email protected].
Sincerely,
Lead, Federal Executive
[footnotes not provided]
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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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