[Congressional Record (Bound Edition), Volume 153 (2007), Part 16]
[Senate]
[Page 22899]
[From the U.S. Government Publishing Office, www.gpo.gov]




SENATE RESOLUTION 305--TO EXPRESS THE SENSE OF THE SENATE REGARDING THE 
MEDICARE NATIONAL COVERAGE DETERMINATION ON THE TREATMENT OF ANEMIA IN 
                            CANCER PATIENTS

  Mr. SPECTER (for himself, Mr. Harkin, and Mr. Lautenberg) submitted 
the following resolution; which was referred to the Committee on 
Finance:

                              S. Res. 305

       Whereas the Centers for Medicare & Medicaid Services issued 
     a final Medicare National Coverage Determination on the Use 
     of Erythropoiesis Stimulating Agents in Cancer and Related 
     Neoplastic Conditions (CAG-000383N) on July 30, 2007;
       Whereas 52 United States Senators and 235 Members of the 
     House of Representatives, representing bipartisan majorities 
     in both chambers, have written to the Centers for Medicare & 
     Medicaid Services expressing significant concerns with the 
     proposed National Coverage Determination on the Use of 
     Erythropoiesis Stimulating Agents in Cancer and Related 
     Neoplastic Conditions, issued on May 14, 2007, regarding the 
     use of erythropoiesis stimulating agent therapy for Medicare 
     cancer patients;
       Whereas, although some improvements have been incorporated 
     into such final National Coverage Determination, the policy 
     continues to raise significant concerns among physicians and 
     patients about the potential impact on the treatment of 
     cancer patients in the United States;
       Whereas the American Society of Clinical Oncology, the 
     national organization representing physicians who treat 
     patients with cancer, is specifically concerned about a 
     provision in such final National Coverage Determination that 
     restricts coverage whenever a patient's hemoglobin goes above 
     10 g/dL;
       Whereas the American Society of Clinical Oncology has 
     written to the Centers for Medicare & Medicaid Services to 
     note that such a ``restriction is inconsistent with both the 
     FDA-approved labeling and national guidelines'', to express 
     deep concerns about such final National Coverage 
     Determination, and to urge that the Centers for Medicare & 
     Medicaid Services reconsider such restriction;
       Whereas such restriction could increase blood transfusions 
     and severely compromise the high quality of cancer care 
     delivered by physicians in United States; and
       Whereas the Centers for Medicare & Medicaid Services has 
     noted that the agency did not address the impact on the blood 
     supply in such final National Coverage Determination and has 
     specifically stated, ``[t]he concern about the adequacy of 
     the nation's blood supply is not a relevant factor for 
     consideration in this national coverage determination'': Now, 
     therefore, be it
       Resolved, That it is the sense of the Senate that--
       (1) the Centers for Medicare & Medicaid Services should 
     begin an immediate reconsideration of the final National 
     Coverage Determination on the Use of Erythropoiesis 
     Stimulating Agents in Cancer and Related Neoplastic 
     Conditions (CAG-000383N);
       (2) the Centers for Medicare & Medicaid Services should 
     consult with members of the clinical oncology community to 
     determine appropriate revisions to such final National 
     Coverage Determination; and
       (3) the Centers for Medicare & Medicaid Services should 
     implement appropriate revisions to such final National 
     Coverage Determination as soon as feasible and provide a 
     briefing to Congress in advance of announcing such changes.

  Mr. SPECTER. Mr. President, I have sought recognition today to 
introduce a sense of the Senate regarding a recent Centers for Medicare 
and Medicaid Services, CMS, national coverage determination on the 
treatment of anemia in Medicare cancer patients.
  On June 29, 2007, I wrote to Secretary of Health and Human Services 
Michael Leavitt concerning the proposed CMS coverage determination that 
limits access to erythropoiesis-simulating agents which increases the 
red blood cell counts of chemotherapy patients who have become anemic. 
Further, 51 other Senators sent similar letters to Department of Health 
and Human Services officials.
  On July 30, 2007, CMS issued the final coverage determination, and 
while some of the proposed restrictions were substantially altered in 
favor of patients, I remain concerned about the impact that this 
decision will have on Medicare beneficiary access to needed therapies. 
The new policy requires that patients have lower red blood cell counts 
before being able to receive treatment with an erythropoiesis-
simulating agent, resulting in patients that are unnecessarily weaker 
and may not be able to maintain their chemotherapy treatment regimens 
without having to turn to costly and time-consuming blood transfusions.
  This restriction is inconsistent with both the FDA-approved label and 
prescribing instructions and is also contrary to national professional 
society oncology guidelines. For instance, the American Society of 
Clinical Oncology, the national organization representing physicians 
who treat patients with cancer, has written to CMS to express deep 
concerns about the coverage determination, urging CMS to reconsider 
these restrictions.
  I encourage my colleagues to support this sense of the Senate that I 
introduce with Senators Harkin and Lautenberg to have CMS reconsider 
the final national coverage determination on the use of erythropoiesis-
simulating agents.

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