January 17, 2012

VIA EMAIL CAGinquiries@cms.hhs.gov Louis Jacques, M.D. Director, Coverage Analysis Group Office of Clinical Standards & Quality Centers for Medicare & Medicaid Services 7500 Security Boulevard Mail Stop S3-02-01 Baltimore, MD 21224

Re: CED Public Solicitation: Comments on Guidance Document for National Coverage with Evidence Development

Dear Dr. Jacques: Regenesis Biomedical, Inc. (“Regenesis”) appreciates this opportunity to present its comments

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. In particular, our comments

address 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 into

account how stakeholders of all sizes can partner with CMS to develop needed evidence for Medicare

coverage, as well as the importance to the Medicare population of improving quality of life in the home

setting. In addition, we would suggest that CMS continue to work with stakeholders in refining the CED

process to reduce barriers to innovation.

Regenesis is a privately held medical technology company focused on developing and marketing

noninvasive regenerative medicine products. Regenesis developed, patented, and now markets the

Provant® Therapy System, cleared by the Food and Drug Administration for the palliative treatment of

post-operative pain and edema in superficial soft tissue. We are particularly interested in CMS’s

proposed refinements of the current CED process so that small companies can be included in any

approach adopted by the Agency. Only through workable CED pathways to coverage can meaningful

access and choices be made available to Medicare beneficiaries.

Regenesis believes that to best serve and maximize benefits to the Medicare population, the

CED process should reflect flexible approaches, as described further below. With this letter, we are

submitting 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 believe that CMS should retain this tool. Indeed, the use of the process should be expanded so that it plays a more prominent role in national coverage. This may be accomplished through avenues other than the national coverage determination process, including through local coverage. Even if its implementation remains within the context of the national coverage analysis procedures, however, the CED process should 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 flexible

approach that can tailor specific evidentiary requirements to the particular circumstances. Recognizing

that high-level quality controls are a key to collecting meaningful data, going forward, CMS should

consider how the process can become more practical, particularly given some of constraints on small

manufacturers bringing new technologies to market. Perhaps the greatest challenge for manufacturers

posed by the CED process is the amount of resources required to develop well-powered clinical trials

and registries. We recognize that CMS and the Medicare population would be best served with clinical

trials and registries that are developed and maintained by qualified entities. We believe that often

manufacturers are experienced in coordinating registries and, therefore, would recommend that CMS

consider the use of manufacturer registries. Further stakeholder collaboration should also be

considered to help identify the specific criteria that would ensure appropriate safeguards are

incorporated into software or other data collection tools for registries.

CMS should also consider developing more formalized partnerships with other government

agencies and independent third parties. The coordination for CED evidence-gathering with agencies

within the Department of Health and Human Services that have experience with research and data

collections, including the National Institutes of Health and the Agency for Healthcare Research and

Quality, may help to limit barriers.

In addition, to promote practical implementation—without compromising the integrity of

data—consideration should be given to the expanded use of the electronic claim form for data

collection activities. This would also help reduce burdens on providers. For example, information may

be recorded for easy reviews by CMS using the claim form (e.g., the “NTE segment”) to relay information

about progress and key observations from the use of a product under review. The electronic format

could 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 national

coverage determination decision, or whether additional information should continue to be developed

and gathered. For some technologies, CMS may determine that continuation of the data-gathering is

appropriate, 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 demonstrate how 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 be cared for in the home or community setting, not only does the patient’s quality of life benefit, but also the Medicare program stands to achieve cost savings. Particularly for technologies that have already been recognized and accepted by Medicare in one setting—and for which there is a defined benefit category—CMS should consider using a streamlined CED process to obtain clinical evidence for home use. Extending coverage to this setting could proceed with the appropriate safeguards, adapted to the special circumstances associated with the specific technology and other applicable factors.

On behalf of Regenesis, thank you for your consideration of our comments. Should you have any 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.