CMS, in its final ruling, disputes this fear, saying
that "given that the Medicare population is such a dominant
portion of the population to which these services are targeted, we do
not believe that hospitals will cease to provide the service."
With all due respect, how does CMS expect hospitals to provide any
service for which they will lose money?
Additionally, CMS warns that "under 42 CFR 489.53(a)(2), CMS
may terminate the provider agreement of any hospital that furnishes
this or any other service to its patients but fails to also furnish it
to Medicare patients who need it."
Surely no hospital will jeopardize its provider agreement. Thus, if
these treatments are unavailable to Medicare patients, they will also
be unavailable to anyone else.
As we understand it, the final reimbursement rate is based on previous
hospital claims. CMS acknowledges that many claims were "incorrectly
submitted" and "some represented unusually low
costs." The agency also acknowledges that some claims were "incorrectly
coded" and thus "unlikely to represent claims for
treatment with the products described as A9543 and A9545"
(Zevalin and Bexxar respectively).
Although CMS removed these "likely incorrectly coded claims in
the rate setting process," CMS cannot be sure which claims
were coded correctly and which were not. Using data that was known to
be flawed, the new rate could not have been set accurately.
Furthermore, under the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA), the BEXXAR Therapeutic Regimen was
classified as a "specified covered outpatient drug" (SCOD)
and the statute directs that CMS must pay for SCOD's at either "the
average acquisition cost for the drug for that year" or "if
hospital acquisition cost data are not available, the average price
for the drug in the year established."
I am not an attorney, but the statute does not seem to authorize CMS
to set rates based on an average of claims, much less ones that are
known to be inaccurate. The methodology used to set this rate was
flawed, incorrect, irresponsible and may not even comply with the
statute.
One thing is certain. The new rate will have long term and devastating
consequences. It will undoubtedly condemn these drugs to medical
history. Millions of dollars and years of hard work will have been
wasted, and several scientists and organizations fear that it will
create a disturbing disincentive for the development of future
innovative therapies.
...
ASH states, "It (the ruling) could have a chilling effect on
the development of future drugs and radiopharmaceuticals for treating
other forms of cancer and other diseases."
As a representative of many thousands of lymphoma
patients and caregivers, I can add that we are fearful and confused by
this ruling. We also feel that the system does not provide an adequate
forum to express our concerns and to address the methods used by CMS.
It's also important for the public, our representatives, and the media
to know how efficacious RIT can be, even in heavily pretreated
patients so we have attached a link to our letter to CMS which
includes abstracts on RIT showing it's efficacy in pretreated
patients.
On a personal note, I believe that my spouse, Joanne, would not
be alive and disease-free today - 3 years in remission with no
evidence of disease - without radioimmunotherapy. Joanne was diagnosed
in 1996, her first remission from CHOP chemotherapy lasting only 6
months. Importantly, durable complete remissions in a sizable
percentage of patients with recurring disease have been reported
across multiple clinical studies.
It's our understanding that if the CMS ruling is not amended within
weeks it cannot be done later. For
this reason we bring this matter to your urgent attention, because
only a Senator has the power to influence CMS at this juncture …
noting that CMS has not provided a venue for public comment on the
final decision and has not answered our calls or letters.
Finally, we note that it is possible for CMS to amend the ruling, as
it has been done at this stage for PET imaging.
We assure you that your constituents will very
grateful for representing cancer patients in this urgent matter.
We remind that one in three men will get a serious cancer in
their lifetime, and one in two women.
Thus, this ruling, based on inaccurate data and methods, if
left to stand, will have negative consequence on every American
family.
Sincerely,
Karl Schwartz (caregiver) & Betsy de Parry (lymphoma survivor)
Karl Schwartz is President and cofounder of Patients Against Lymphoma
Patient Consultant to the FDA/Oncologic Drug Advisory
Committee (ODAC)
Participant: NCI Progress Review Group for Blood Cancers (LMPRG)
Participant: Biospecimen Access and Ethical, Legal, and
Policy Issues Workshop (ELP)
Participant: Custodianship and Ownership Issues in
Biospecimen Research Symposium- Workshop
REFERENCES
* Patients Against Lymphoma's letter to CMS:
http://www.lymphomation.org/CMS-RIT.pdf
For more detail on CMS data sources, methods, and consequences to
patients
WHO TO CONTACT
(updated Nov 21)
You might tell
the receptionist: My name is [NAME]
Please direct my
message to the health staff:
I
am asking the Senator to amend the CMS ruling to restore reimbursement rates for
Bexxar and Zevalin to 2007 rates during 2008. I / my friend
/ my loved-one needs this invaluable
treatment for lymphoma - a common and sometimes fatal blood cancer.
=KEY SENATORS (updated Nov 28)
* indicates what we believe to be most important contacts.
** also on committee
NOTE: FOCUS ON SENATOR LISTED ABOVE THRU DEC 4th
OTHER KEY SENATORS:
Senator Hillary Rodham Clinton
United States Senate
476 Russell Senate Office Building
Washington, DC 20510
Phone: (202) 224-4451
General Fax: (202) 228-0282
Scheduling Req Fax: (202) 228-0121
TTY/TDD: (202) 224-6821
webmail:
http://clinton.senate.gov/contact/webform.cfm
Senator Christopher Dodd (CT)
448 Russell Building | Washington D.C., 20510
Tel: (202) 224-2823
Fax: (202) 224-1083
Senator Herb Kohl, (D - WI)
330 HART SENATE OFFICE BUILDING
WASHINGTON DC 20510
(202) 224-5653
http://kohl.senate.gov/gen_contact.html
-
ACTION STATEMENT: (amended 11/28)
Please amend
the ruling to restore reimbursement rates for
Bexxar and Zevalin to 2007 rates during 2008.
This will allow CMS the time it needs to collect the
necessary data to base
reimbursement rates for 2009 on accurate data and the
appropriate classifications.
We and the patients who need these drugs, now and in the
future, urge you to act
swiftly, before this ruling takes effect on January 1, 2008.
= LOCATE YOUR SENATORS:
http://www.senate.gov/general/contact_information/senators_cfm.cfm
=CONTACT THE MEDIA
1) To locate media contacts in any state:
http://tinyurl.com/2u6r6z
2) Select a news media you think will be responsive and
influential.
3) Copy one of the headlines below.
4) Copy your letter or story.
5) Copy link to background information:
http://www.lymphomation.org/CMS-call.htm#background
6) Submit your request for help.
=OTHERS TO CONTACT:
Herb B. Kuhn
Deputy Administrator
Centers for Medicare and Medicaid Services (CMS)
Department of Health and HumanServices
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
Herb.Kuhn@CMS.hhs.gov
Kerry Weems, CMS
Acting Administrator
Kerry.Weems@CMS.hhs.gov
(Email to say you oppose this ruling)
= LOCATE YOUR SENATORS:
http://www.senate.gov/general/contact_information/senators_cfm.cfm
Write to the Key Committee:
Health, Education, Labor and Pensions Committee
About: http://help.senate.gov/About.html
Email: help_comments@help.senate.gov
(Email to say you oppose this ruling)
=CONTACT THE MEDIA
1) To locate media contacts in any state:
http://tinyurl.com/2u6r6z
2) Select a news media you think will be responsive and
influential.
3) Copy one of the headlines below.
4) Copy your letter or story.
5) Copy link to background information:
http://www.lymphomation.org/CMS-call.htm#background
6) Submit your request for help.
MEDIA HEADLINES
(suggestions appreciated):
Pick one:
* CMS Indifferent to Patients with Lymphoma
Ruling based on Grossly Inaccurate Data
Will Lead to Unnecessary Deaths This Year
* Oncology Societies Predict CMS ruling Will Lead to
Unnecessary Deaths
Patients Making Desperate Appeals to Senators with
Oversight over Medicare Agency
* CMS Forces Hospitals to Subsidize Radioimmunotherpies
Ruling Based on Grossly Inaccurate Cost Data
Patients with Lymphoma Will Be Denied Access
to Life Saving Therapy
* Senators Silent (So Far)
CMS (Medicare) Ruling Will Lead to Unnecessary Deaths
Jeopardizes Future of Radioimmunotherapy
ASCO and ASH cite Inaccurate Data Sources
* CMS Ruling Based on Inaccurate Data
Could Spell End of Radioimmunotherapy
A Life-Saving Treatment for Lymphoma
* Lymphoma Patients Let Down By CMS
Cite Inaccurate Data Sources
And Devastating Impact on Survival
Make Desperate Appeals to Senators
* Medical Science Let Down By CMS
Inaccurate Data Sources
Leads to Grossly inadequate Payments
To Hospitals for Effective Targeted Therapy
