Alexion Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule
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Thank you for the opportunity to submit comments on the
Alexion is a global biopharmaceutical company whose mission is to transform the lives of people affected by rare and devastating diseases by continuously innovating and creating meaningful value in all that we do. We are the foremost leader in complement science and have five approved medicines that transform the lives of people living with paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder, generalized Myasthenia Gravis, hypophosphatasia, lysosomal acid lipase deficiency, and life-threatening or uncontrolled bleeds resulting from Factor Xa inhibitors.
Our comments address Medicare coverage of innovative drugs, biologicals, and drug/device combination products. As a company dedicated to improving the lives of patients with rare and devastating diseases, we are keenly aware of the importance of clear and timely coverage decisions to ensuring that patients have access to innovative care. We also recognize that predictable standards and procedures for securing coverage, coding, and reimbursement are critical to supporting investment in new technologies.
We commend CMS for its efforts to improve its procedures for coverage, coding, and reimbursement for new technologies, including the steps it has taken to implement the Executive Order on Protecting and Improving Medicare for Our Nation's Seniors (Executive Order 13890)./2
1. If CMS codifies the definition of "reasonable and necessary" from the Program Integrity Manual, CMS should continue to cover drugs and biologicals for their
CMS proposes to codify in regulation the longstanding definition of "reasonable and necessary" from chapter 13 of the Program Integrity Manual: an item or service that is
1. safe and effective;
2. not experimental or investigational; and
3. appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is--
* Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;
* Furnished in a setting appropriate to the patient's medical needs and condition;
* Ordered and furnished by qualified personnel;
* One that meets, but does not exceed, the patient's medical need; and
* At least as beneficial as an existing and available medically appropriate alternative./3
Alexion believes this definition, combined with the statutory and manual provisions identifying medically accepted uses of drugs and biologicals,/4 generally has worked well to ensure timely and appropriate coverage of drugs and biologicals as treatment options and standards of care evolve over time. Continued research drives changes in treatment, including identification of new uses of approved drugs, and expands options for patients. This evolution is particularly important for patients with rare diseases, where new uses for existing drugs can offer people longer, healthier lives. CMS's longstanding application of the reasonable and necessary standard to drugs and biologicals has allowed Medicare coverage to adjust with these developments. It also has supported development of and access to care for patients with rare diseases by not applying a single standard for the types or sizes of studies needed to support coverage. Drugs and biologicals for rare diseases often are studied in smaller trials with various types of designs with guidance from the
2. CMS should not finalize the proposal to use commercial insurer coverage policies as an alternative to Medicare's longstanding standards for determining whether an item or service is appropriate for Medicare beneficiaries.
CMS proposes to use commercial insurer coverage policies to determine if an item or service is "appropriate for Medicare patients" when item or service is safe and effective and not experimental or investigational, but does not meet the other criteria under the current definition of "reasonable and necessary."/5
CMS states that the goal of the proposed inclusion of commercial insurance plan policies in the codified definition of "reasonable and necessary" is to expand coverage./6
CMS also recognizes that commercial policies can vary widely and the choice of policy would have a significant effect on the scope of coverage for an item or service./7
Alexion supports the goal of expanding coverage, but we are concerned that use of commercial insurer policies as the basis for Medicare coverage could lead to restrictions on coverage. Commercial plans may cover drugs, biologicals, and technologies under different circumstances with different considerations than Medicare does, and those policies are often developed and communicated with far less transparency than Medicare's policies. The public might not have access to these policies, be able to participate in their development, or have insight into the rationale on which they are based. We urge CMS to not finalize its proposal to use commercial payer policies in its coverage criteria.
3. CMS should not apply the proposed MCIT pathway to drugs and biologicals.
Alexion supports CMS's proposal to accelerate patient access to innovative devices and diagnostics. Timely access to diagnostics in particular could significantly benefit people with rare diseases - whether it is identifying a difficult-to-diagnose condition or pairing the right treatment with the right person. However, as we discussed above, Medicare's longstanding approach to coverage for drugs and biologicals generally works well, and we do not recommend any changes to this approach. We believe the proposed MCIT pathway would not be appropriate for drugs, biologicals, or drug-led drug/device combination products at this time. Changing the coverage process for these technologies could create unintended confusion and delays to patient access. Overall, while Alexion applauds CMS for its visionary approach to ensuring access to future medical technologies and supporting continued innovation, we strongly recommend the agency apply the MCIT pathway only to device and device-led products.
4. CMS should continue to work on improving its processes for making benefit category determinations, assigning codes, and payment decisions to be better aligned with launch of new technologies.
Finally, Alexion applauds CMS for its efforts to support access to innovative technologies, including the recent changes to the HCPCS coding process to offer multiple application cycles each year. We believe that further improvements are warranted, however, and we urge CMS to continue to "build on recent efforts toward transparent, timely, and scientifically up-to-date processes for coding, coverage, and payment" with "a broad-based effort [to] update processes and evidence related to access to new technologies."/8
In particular, we ask CMS to develop a timely and efficient process for making benefit category determinations for new technologies. Health care innovations are being developed outside the paradigms established for prior technologies. New ways of delivering care, and new technological platforms, will face questions about how those innovations fit into Medicare's benefit categories. CMS should work with stakeholders both to develop processes and standards for evaluating these technologies and to conduct those evaluations in a timely, predictable manner to support appropriate adoption of innovative care. These process improvements also could help with CMS's recent improvements in the HCPCS application process by clarifying when a new code is needed for a new technology.
Alexion appreciates CMS's consideration of its comments. We would be happy to discuss our comments with you. If you have any questions, please do not hesitate to contact
Regards,
Senior Director, Health Policy
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Footnotes:
1/ 85 Fed. Reg. 54,327 (
2/ Executive Order on Protecting and Improving Medicare for Our Nation's Seniors,
3/ 85 Fed. Reg. at 54,328.
4/ Social Security Act Sec. 1861(t); Benefit Policy Manual, ch. 15, Secs. 50.4.2, 50.4.5.
5/ 85 Fed. Reg. at 54,332.
6/ Id. at 54,336.
7/ Id. at 54,332.
8/
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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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