November 19, 2007

The Honorable Michael Leavitt
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C.  20201

Dear Secretary Leavitt:

The Lymphoma Research Foundation (LRF) is a voluntary health agency dedicated to improving the quality of health care and quality of life for those with lymphoma.  LRF is writing to express grave concerns about the payment levels for radioimmunotherapies that are set in the calendar year 2008 hospital outpatient prospective payment system (HOPPS).  Unless extraordinary action is taken to modify these reimbursement rates before they go into effect on January 1, 2008, we fear that patient access to these life-saving therapies may be significantly limited, if not eliminated.

Radioimmunotherapies – tositumomab (Bexxar) and ibritumomab tiuxetan (Zevalin) – represent an important treatment option for individuals with non-Hodgkin lymphoma, including patients who have undergone another treatment that is no longer providing a therapeutic benefit.  For some of these patients, the radioimmunotherapies may truly be the only effective option remaining.  It is also important to note that these therapies are only given to patients for a single course of therapy and are not given in successive cycles of treatment, so the overall cost of treatment is the cost of a single course.  

Administration of the radioimmunotherapies is somewhat complex and must be undertaken in major cancer centers or other health care facilities that are properly equipped for their administration.  This fact presents an initial challenge to patient access, but the proposed payment rates for 2008 represent a much more serious barrier to access.  It is our understanding that the payment rates for 2008 will be significantly less than the cost of acquisition, preparation, and handling of radioimmunotherapies.  If this payment situation is not resolved, hospital outpatient departments will be unable to stock these therapies, and this treatment option will be effectively eliminated for non-Hodgkin lymphoma patients. 
 

We recommend that several specific steps be taken to rectify this situation:

• The Centers for Medicare & Medicaid Services (CMS) should consider the radioimmunotherapy regimen a specified covered outpatient drug, or SCOD.  In the CY 2008 rule, the agency improperly splits the radioimmunotherapy regimen into separate elements and considers the initial doses to be diagnostic rather than therapeutic doses.  This is at odds with the Food and Drug Administration labeling of the products and with current practice.
• CMS should cover the cost of compounding radioimmunotherapies.  Elimination of the compounding fee creates another obstacle to the willingness of institutions to make this therapy available to their patients, because these institutions find the payment inadequate to meet their costs.
•  The agency should consider setting payment for radioimmunotherapies on the basis of 106 percent of average sales price (ASP) or a composite ambulatory payment classification (APC) that would reflect the entire cost of the radioimmunotherapy regimen.  We understand that the APC Advisory Panel reviewed these options at a recent meeting, and we urge CMS to consider these proposals.  Because the effective date of the payment system is imminent, an ASP-based system may represent the most feasible alternative.

Mr. Secretary, this is a matter of public health that demands your personal intervention.  We fear that these radioimmunotherapies will simply not be available for treatment of non-Hodgkin lymphoma patients after the new year if the payment rates for these products are not adjusted.  The payment structure proposed for 2008 will not produce savings to the Medicare program in the long run, and it will certainly not ensure access to health care for lymphoma patients.

We look forward to your immediate response.

Sincerely,

 

Leonard Rosen
Chair
Public Policy Committee
Lymphoma Research Foundation

cc: Kerry Weems
 Administrator
 Centers for Medicare & Medicaid Services