Extracorporeal Photopheresis (ECP)

As a lung transplant physician, I believe that extracorporeal photopheresis (ECP) has an important role in the management of chronic lung allograft rejection (BOS). Unfortunately, BOS is the leading cause of death beyond the first year after transplantation and the main obstacle to better long-term outcomes. In many cases, BOS is unresponsive to traditional intensification of immunosuppression. In my clinical experience, ECP has been particularly effective in this setting. Therefore, I support this proposed decision to cover ECP with evidence development. However, I would point out that in most cases the loss of lung function characteristic of BOS is irreversible. So, improvement in lung function would be an unlikely and unrealistic endpoint. In clinical practice, the goal of treatment for BOS is stabilizing lung function or arresting the decline in lung function. Although improvement in lung function is unlikely in most cases, arresting the decline in lung function often results in prolonging life. Nevertheless, I support this proposal and look forward to contributing to the development of evidence.

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Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Mr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed decision memo for Extracorporeal Photopheresis (ECP) (CAG-00324R2). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments
AHIP and our member health plans encourage the use of robust evidence-based research to ensure safe and effective treatments. Our members support CMS’s proposed decision for limiting coverage for ECP to Medicare beneficiaries who have developed Bronchiolitis Obliterans Syndrome (BOS) refractory to standard immunosuppressive therapy following lung allograft transplantation and are enrolled in statistically robust, well-designed, and appropriately-sponsored clinical trials. After the first year of transplantation, chronic rejection is the most common cause of death in lung transplant recipients. Estimates suggest that chronic rejection occurs in 50% - 70% of recipients.^[1] Furthermore, patients with lung allografts who develop progressive BOS refractory to immunosuppressive drug treatment have limited treatment options.

While promising results have been seen in patients with life-threatening recurrent lung graft rejection, more robust data is needed to support the use of ECP for this indication. The proposed decision memo currently does not address the protocol for disclosure to beneficiaries. Our members recommend that CMS include a detailed process for disclosing coverage restrictions for this treatment. Specifically, we encourage CMS to include a protocol for disclosing that coverage is limited to beneficiaries enrolled in clinical trial and a protocol for ensuring full understanding and consent of the beneficiary.

In conclusion, our members support coverage for this treatment only under well-designed and statistically robust clinical trials and strongly encourage CMS to include protocols for disclosure to beneficiaries in its final decision memo.

Thank you for the opportunity to comment on this important issue.

Sincerely,

/s/
Carmella Bocchino
Executive Vice President
Clinical Affairs and Strategic Planning

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[1] Szczepiorkowski ZM, Winters JL, Bandarenko N, Kim HC, Linenberger ML, Marques MB, et al. Guidelines on the use of therapeutic apheresis in clinical practice: evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher. 2010;25(3):83-177.

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March 2, 2012

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C 1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Extracorporeal Photopheresis (ECP)(CAG-00324R2)

Dear Dr. Jacques:

The Advanced Medical Technology Association is offering the following comments on the Centers for Medicare & Medicaid Services' (CMS) Proposed Coverage Decision Memorandum for Extracorporeal Photopheresis (ECP).¹ In the proposed decision memorandum, CMS proposes to limit Medicare coverage for ECP for a new indication under Coverage with Evidence Development (CED).²

AdvaMed's member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier di sease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

AdvaMed member companies have seen a marked increase in the hurdles that they must overcome in order to enter the U.S. market. Companies in this sector are increasingly finding that Medicare coverage and reimbursement are additional hurdles to providing patients access to innovative, life-saving technologies. The proposed ECP decision has implications for the medical device industry beyond the therapy it addresses, and we urge CMS to consider the following comments as it proceeds.

As noted in previous correspondence, AdvaMed supports the use of sound evidence to inform medical practice, and has generally believed that CED may be a means to generate additional evidence in cases where the available evidence regarding a promising medical technology or procedure is not sufficient to support national coverage. In these limited circumstances, coverage contingent on the development of additional evidence can enable beneficiaries to access to innovative medical treatments when the alternative may be noncoverage.

CED allows CMS to provide coverage with in the context of studies that conform to standards detailed in Medicare's Clinical Trial Policy.³ The research meeting these standards can include a range of research approaches.

AdvaMed recently submitted comments to CMS regarding its CED guidance generally, and many of the concerns we raised at that time are relevant with respect to the proposed ECP coverage proposal. We want to reiterate that when Medicare coverage is contingent on the collection of additional clinical or scientific evidence (beyond FDA requirements for safety and efficacy), CMS should:

1. collaborate with stakeholders to clearly identify the data col lection objectives,
2. consider the minimum data necessary to achieve those objectives, and
3. collaborate with stakeholders to clearly identify scientifically supported study endpoints and the duration of data collection in advance.

If you have questions regarding these comments or if you require additional information, please contact Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-72 19 or cbranham@AdvaMed.org.

Sincerely,

/s/
Ann-Marie Lynch
Executive Vice President
Payment and Health Care Delivery Policy

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1 "Proposed Decision Memo for EXlracorporeal Pholopheresis (CAG-00324R2)," February 2, 2012; see https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=255&ver=4&NcaName=Extracorporeal+Photopheresis+(ECP)+(2nd+Recon)&bc=ACAAAAAAIAAA&
2 See id. The NCD proposes LO cover ECP treatment for patients who have received lung allografts and then developed progressive bronchi ol itis obliterans syndrome (BOS) refrac tory to immunosuppressive drug treatment.
3 National Coverage Determination (NCD) for Routine Costs in Cli nical Trials (3 10.1), effective 7/912007 ; see http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=AAAAgAAAAAAA&

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