Regenesis position on ced to cms011812

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Regenesis Biomedical, Inc. (“Regenesis”) letter of support to the Centers for Medicare & Medicaid Services (“CMS”) on the National Coverage with Evidence Development (“CED”) Guidance Document …

Regenesis Biomedical, Inc. (“Regenesis”) letter of support to the Centers for Medicare & Medicaid Services (“CMS”) on the National Coverage with Evidence Development (“CED”) Guidance Document solicitation. Regenesis supports the use of CED as a way to improve health outcomes through timely adoption of new technologies.

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  • 1. January 17, 2012VIA EMAILCAGinquiries@cms.hhs.govLouis Jacques, M.D.Director, Coverage Analysis GroupOffice of Clinical Standards & QualityCenters for Medicare & Medicaid Services7500 Security BoulevardMail Stop S3-02-01Baltimore, MD 21224 Re: CED Public Solicitation: Comments on Guidance Document for National Coverage with Evidence DevelopmentDear Dr. Jacques: Regenesis Biomedical, Inc. (“Regenesis”) appreciates this opportunity to present its commentsto the Centers for Medicare & Medicaid Services (“CMS”) on the National Coverage with EvidenceDevelopment (“CED”) Guidance Document solicitation. Regenesis supports the use of CED as a way toimprove health outcomes through timely adoption of new technologies. In particular, our commentsaddress some of the unique circumstances facing small companies offering promising new technologies.Our comments also address suggestions for establishing a CED guidance document that takes intoaccount how stakeholders of all sizes can partner with CMS to develop needed evidence for Medicarecoverage, as well as the importance to the Medicare population of improving quality of life in the homesetting. In addition, we would suggest that CMS continue to work with stakeholders in refining the CEDprocess to reduce barriers to innovation. Regenesis is a privately held medical technology company focused on developing and marketingnoninvasive regenerative medicine products. Regenesis developed, patented, and now markets theProvant® Therapy System, cleared by the Food and Drug Administration for the palliative treatment ofpost-operative pain and edema in superficial soft tissue. We are particularly interested in CMS’sproposed refinements of the current CED process so that small companies can be included in anyapproach adopted by the Agency. Only through workable CED pathways to coverage can meaningful
  • 2. access and choices be made available to Medicare beneficiaries. Regenesis believes that to best serve and maximize benefits to the Medicare population, theCED process should reflect flexible approaches, as described further below. With this letter, we aresubmitting comments in the following areas: (1) The CED Process Should Be Expanded and Should Consider the Resources Available to Small Manufacturers; and (2) The CED Process Should Encourage Coverage in the Home Setting for New Technologies Otherwise Covered.The CED Should Be Expanded and Should Consider the Resources Available to Small Manufacturers Because the CED process remains important for early access to new technologies, we believethat CMS should retain this tool. Indeed, the use of the process should be expanded so that it plays amore prominent role in national coverage. This may be accomplished through avenues other than thenational coverage determination process, including through local coverage. Even if its implementationremains within the context of the national coverage analysis procedures, however, the CED processshould be sufficiently simplified and streamlined so that adoption of new technologies is encouraged,and barriers to innovation may be simultaneously reduced. To promote the efficient implementation of the CED process, CMS should adopt a flexibleapproach that can tailor specific evidentiary requirements to the particular circumstances. Recognizingthat high-level quality controls are a key to collecting meaningful data, going forward, CMS shouldconsider how the process can become more practical, particularly given some of constraints on smallmanufacturers bringing new technologies to market. Perhaps the greatest challenge for manufacturersposed by the CED process is the amount of resources required to develop well-powered clinical trialsand registries. We recognize that CMS and the Medicare population would be best served with clinicaltrials and registries that are developed and maintained by qualified entities. We believe that oftenmanufacturers are experienced in coordinating registries and, therefore, would recommend that CMSconsider the use of manufacturer registries. Further stakeholder collaboration should also beconsidered to help identify the specific criteria that would ensure appropriate safeguards areincorporated into software or other data collection tools for registries. CMS should also consider developing more formalized partnerships with other governmentagencies and independent third parties. The coordination for CED evidence-gathering with agencieswithin the Department of Health and Human Services that have experience with research and datacollections, including the National Institutes of Health and the Agency for Healthcare Research andQuality, may help to limit barriers.
  • 3. In addition, to promote practical implementation—without compromising the integrity ofdata—consideration should be given to the expanded use of the electronic claim form for datacollection activities. This would also help reduce burdens on providers. For example, information maybe recorded for easy reviews by CMS using the claim form (e.g., the “NTE segment”) to relay informationabout progress and key observations from the use of a product under review. The electronic formatcould then streamline the ability of CMS to evaluate outcomes data. As to evaluation of data, CMS should identify scheduled intervals—such as 18 to 24 months—after which time, the agency will assess whether there is sufficient information to make a final nationalcoverage determination decision, or whether additional information should continue to be developedand gathered. For some technologies, CMS may determine that continuation of the data-gathering isappropriate, whereas for others the NCD process may come to a close.The CED Process Should Reinforce the Use of New Technologies in the Home Setting We also urge CMS to adopt the CED process for evaluating and collecting data to demonstratehow advances in technologies can be applied to alternative settings. As our population ages,technologies that permit individuals to remain at home become more critical. When patients can becared for in the home or community setting, not only does the patient’s quality of life benefit, but alsothe Medicare program stands to achieve cost savings. Particularly for technologies that have alreadybeen recognized and accepted by Medicare in one setting—and for which there is a defined benefitcategory—CMS should consider using a streamlined CED process to obtain clinical evidence for homeuse. Extending coverage to this setting could proceed with the appropriate safeguards, adapted to thespecial circumstances associated with the specific technology and other applicable factors. On behalf of Regenesis, thank you for your consideration of our comments. Should you haveany questions or need additional information from us, we can be reached at [telephone #] Sincerely, William P. Gittinger Vice President, Reimbursement & Health Economics REGENESIS BIOMEDICAL, INC.