[Congressional Record Volume 153, Number 160 (Monday, October 22, 2007)]
[Senate]
[Pages S13200-S13202]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BAUCUS (for himself, Mr. Crapo, Mr. Wyden, Mr. Salazar, 
        Ms. Cantwell, Mr. Inhofe, Mrs. Dole, Mr. Burr, Mr. Coburn, and 
        Mrs. Hutchison):
  S.J. Res. 22. A joint resolution providing for congressional 
disapproval under chapter 8 of title 5, United States Code, of the rule 
submitted by the Centers for Medicare & Medicaid Services within the 
Department of Health and Human Services relating to Medicare coverage 
for the use of erythropoiesis stimulating agents in cancer and related 
neoplastic conditions; to the Committee on Finance.
  Mr. BAUCUS. Mr. President, today I am introducing a joint resolution 
to disapprove of the Medicare National Coverage Decision on cancer care 
announced by the Centers for Medicare & Medicaid Services on July 30, 
2007. I am taking this action out of concern for America's seniors who 
are afflicted with cancer, a terrible disease that affects thousands of 
Medicare beneficiaries each year.
  At the outset, I want to make very clear that Congress should not 
wantonly second-guess the scientific processes at CMS. The National 
Coverage Decision process is a very important component of the agency's 
governance of the Medicare program and its mission to protect the 
safety of beneficiaries. The agency makes several National Coverage 
Decisions each year that are implemented without any congressional 
involvement. Several more coverage determinations are made by regional 
Medicare carriers at the local level. When scientific evidence supports 
doing so, CMS clearly has authority to limit Medicare coverage for 
drugs and other medical products and services to an extent less than 
the Food and Drug Administration label would otherwise allow. In fact, 
I am working on a proposal that may provide more clinical evidence to 
guide CMS in making these decisions.
  There are some rare occasions, however, when CMS makes a decision 
that intrudes on the clinical judgment of doctors without the support 
of scientific evidence, prompting virtually unanimous opposition from 
the clinicians who treat the patients whose care is at stake. In these 
cases, I believe that Congress not only may but must intervene. This 
National Coverage Decision regarding the use of erythropoiesis-
stimulating agents, or ESAs, for Medicare beneficiaries with cancer and 
cancer-related conditions is precisely such an instance.
  Mr. President, when a cancer patient receives an ESA, the goal is not 
to manage a person's hemoglobin back to the level of a healthy, non-
anemic person. That is because there can be health risks associated 
with raising the hemoglobin to such a level through ESA use. The FDA 
label makes it clear that patients may only be administered enough of 
an ESA to avoid a transfusion, and that ESAs should never be used to 
bring a patient's hemoglobin level above 12 grams per deciliter. So 
there can be risks when a patient does not get enough of an ESA, 
including severe anemia and the need for blood transfusions. And there 
are

[[Page S13201]]

risks when a patient gets too much of an ESA. The FDA label establishes 
parameters to guard against under-utilization and over-utilization of 
these products.
  Now let us compare the FDA label with the National Coverage Decision 
announced by CMS. The National Coverage Decision limits ESA treatment 
to hemoglobin levels less than 10 grams per deciliter. This cap fails 
to recognize the natural fluctuations in a patient's hemoglobin. This 
cap is simply incongruous with the FDA label, which recommends that 
patients should not be treated over 12. I should note that the FDA 
label was recently changed, with the addition of new ``black box'' 
warnings and recent safety information. If the FDA believes that 
scientific evidence warrants changing the label yet again, then clearly 
Medicare should not cover treatments that are not consistent with that 
new label.

  Furthermore, there are other aspects of the CMS National Coverage 
Decision that are contrary to accepted standards of care and scientific 
evidence. CMS imposed 4-week dose limitations that are not based on the 
clinical needs of patients. The FDA labels allow ESAs to be 
administered three times a week, every week, every 2 weeks, or every 3 
weeks. Also, for patients who are slow to respond to ESAs or do not 
respond, CMS has created a one-time dose escalation rule of 25 percent 
of the initial ESA dose. This limitation is contrary to FDA-approved 
dosing instructions. For instance, the FDA approved labeling allows 
doubling the dose for some regimens.
  Mr. President, over the past months, I have seen an outpouring of 
concern with this National Coverage Decision by patients, providers, 
and the professional scientific community for many reasons. The 
American Society of Clinical Oncology, the world's leading professional 
organization representing physicians of all oncology subspecialties who 
care for cancer patients, wrote this to CMS:

       Under the new CMS policy, a patient's hemoglobin could 
     repeatedly fall below 10 following termination of coverage at 
     the end of 4-week periods. This consequence would be 
     inconsistent with the FDA-approved labeling, which, as noted 
     above, states that ESA dosing should be titrated to the 
     individual patient to maintain the hemoglobin level. . . . We 
     strongly urge CMS to reconsider these restrictions in light 
     of the concerns detailed above.
       The current NCD does not allow for interpretation 
     consistent with clinical practice, national guidelines, or 
     the FDA-approved labels in this area. This reopening [of the 
     National Coverage Decision] should occur as soon as possible 
     to avoid continued confusion and uncertainty [for] both 
     physicians and patients. Until these issues are clarified, we 
     also strongly recommend that CMS delay the effective date for 
     the entire NCD.

  The American Society of Hematology, the leading clinical authority on 
disorders affecting the blood, bone marrow, and the immunologic, 
hemostatic, and vascular systems, has stated:

       Consequently, the clinical scenario that is problematic is 
     when a patient's hemoglobin goes above 10 g/dL after 4 weeks 
     of treatment because the physician would then need to 
     discontinue the ESA treatment entirely. This is of concern 
     because some patients might then drop below 10 g/dL 
     justifying a renewal of the ESA treatment and leading to a 
     `roller coaster' of treatment potentially involving stopping 
     and starting ESA treatment several times. This is extremely 
     difficult for both the patient and the physician.

  The Leukemia and Lymphoma Society wrote this in a recent letter to 
CMS:

       As a reimbursement authority, CMS and the Medicare program 
     it administers should be guided by science and data in order 
     to achieve the best result for cancer patients. Accordingly, 
     CMS should defer to the expertise of FDA and of the academic 
     scientists who contribute to the ASCO/ASH guidelines.

  Additionally, I share the concerns of many in the oncology community 
who worry about exposing seniors to the avoidable safety risks of blood 
transfusions, as well as the effect of this policy on our nation's 
blood supply. It has been clearly documented that certain areas of the 
country are already at risk of running out of their blood supply or 
have ongoing shortages. Some areas have 24 hours worth of blood left 
before they completely run out. According to the 2006 Nationwide Blood 
Collection and Utilization Survey, the number of transfusions of red 
blood cells in 2004 was nearly equivalent to the number of units 
collected. This policy, which patients are already telling us are 
forcing them into transfusion units, could put in jeopardy a U.S. blood 
supply that is already fragile and stretched thin.
  The American Red Cross has indicated in their guidelines that 
transfusions are not appropriate for chemotherapy patients when 
alternative treatments are available:

       Red blood cells should not be used to treat anemia that can 
     be corrected with a non-transfusion therapy such as iron or 
     recombinant erythropoietin.

  To my great concern, the CMS National Coverage Decision responds to 
this vital issue with the following:

       The concern about the adequacy of the nation's blood supply 
     is not a relevant factor for consideration in this national 
     coverage determination. Our focus is whether the use of ESA 
     is reasonable and necessary to treat a particular illness.

  The sole purpose for using ESAs, as stated on the FDA label, is to 
avoid a blood transfusion. But CMS has decided that this issue is not 
relevant to a decision regarding the coverage of ESAs. Well, I can 
guarantee you that it is important to the patients who will now be 
forced to seek transfusions as a result of CMS' shortsighted decision.
  Congress continues to demonstrate that it shares the concerns of 
patients and the clinical community about the new CMS policy and the 
detrimental effect that it could have on patient care. Earlier this 
summer, prior to the CMS issuance of the final National Coverage 
Decision, 52 Senators and 235 Members of the House of Representatives 
wrote to CMS expressing an overwhelmingly bipartisan, bicameral concern 
with the CMS policy. CMS, however, ignored these concerns and issued a 
final National Coverage Decision on July 30 that was even more onerous 
than the one proposed.
  On September 4, the Senate sent a strong message of dissatisfaction 
when we passed S. Res. 305, without one Senator objecting. S. Res. 305 
called on CMS to immediately reconsider the National Coverage Decision. 
But CMS has refused to reopen the National Coverage Decision and work 
with the clinical community to develop an appropriate patient-centered 
policy that is consistent with scientific evidence.
  Because CMS has repeatedly ignored our concerns, we now are forced to 
take legislative action that compels CMS to change this flawed policy. 
That is why today I am asking my Colleagues to support this resolution 
of disapproval.
  Let me tell you what this resolution does not do. This resolution 
does not replace the medical judgment of CMS or the FDA with that of 
Congress. This resolution does not ignore the safety concerns of ESAs 
used when a patient's hemoglobins are above the FDA label. Finally, 
this resolution does not reject the notion of any National Coverage 
Decision related to ESAs. This resolution simply asks CMS to go back to 
the drawing board. It compels CMS to work with the oncology community--
the experts and clinicians and patients--to come up with a policy that 
is based on scientific evidence and that the community can support, or 
at least understand. That is why I ask my Colleagues to join me in 
supporting this important legislation.
  Mr. President, I ask unanimous consent that the text of the joint 
resolution be printed in the Record.
  There being no objection, the text of the joint resolution was 
ordered to be printed in the Record, as follows:

                              S.J. Res. 22

       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 the Centers for Medicare & Medicaid Services 
     submitted to the Congress a copy of the national coverage 
     determination rule, a detailed description of the rule, and 
     the proposed effective date of the rule;
       Whereas 52 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;
       Whereas the leading national medical organization 
     representing physicians who treat patients with cancer has 
     noted that the national coverage determination's hemoglobin 
     level restriction is inconsistent with both the FDA-approved 
     labeling and national guidelines and that its dosing and 
     titration regimen restrictions are inconsistent with 
     established studies, the FDA label, and clinical guidelines 
     and, therefore, has formally

[[Page S13202]]

     requested that the Centers for Medicare & Medicaid Services 
     reconsider these restrictions;
       Whereas the leading national medical organization 
     representing physicians who treat patients with disorders 
     affecting the blood and bone marrow, the Nation's leading 
     health care services network dedicated exclusively to cancer 
     treatment and research, and other national, nonprofit 
     organizations dedicated to improving patient access to care 
     have expressed similar concerns regarding the national 
     coverage determination and have called for its 
     reconsideration; and
       Whereas despite the strong concerns of the oncology and 
     hematology community, the Centers for Medicare & Medicaid 
     Services has failed to take any action: Now, therefore, be it
       Resolved by the Senate and House of Representatives of the 
     United States of America in Congress assembled, That Congress 
     disapproves the rule (CAG-000383N) submitted by the Centers 
     for Medicare & Medicaid Services within the Department of 
     Health and Human Services relating to Medicare coverage for 
     the use of erythropoiesis stimulating agents in cancer and 
     related neoplastic conditions, and such rule shall have no 
     force or effect.

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