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Advocacy > ALERT:  CMS Ruling: Bullet Points

Last update: 01/21/2014

Talking points for discussions with the media or your representatives

Regarding the CMS (Centers for Medicaid and Medicare) Ruling on Radioimmunotherapies (RIT)

  • I am contacting you regarding a CMS ruling that will have 
    a devastating effect on the survival of patients with lymphomas

    The ruling is contained with CMS-1392-FC

    The ruling, if let to stand, will have grave consequences to patients.  
  • The CONSEQUENCES include: 
    1. Patients in need will be denied access to a life saving therapy. 
    2. Future patients will be denied access to RIT and similar targeted drugs. 

            As ASH (The American Society of Hematology) writes: 
    3. it will have “a chilling effect on the development of future drugs 
      and radiopharmaceuticals for treating other forms of cancer and other diseases.”
  • ACTION NEEDED 
    • We are asking that a "legislative fix" be written into the Appropriations Bill 
      that would maintain the 2007 reimbursement rates for Bexxar and Zevalin. 

      This will give CMS the necessary time to correct its methods prior to setting rates for 2009. 

      We urge you to support this revision so that these important treatments will continue 
      to be available to patients.
  • IMPORTANTLY: CMS warns that “it 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.” 

    Thus, if RIT treatments are unavailable to Medicare patients, they will also be unavailable 
    to anyone else.
  • We are not asking for charity - nor is it self-indulgent - to insist that CMS pays for treatments proven effective for lymphomas. We are not asking society to satisfy wasteful appetites and desires.

    To make good decisions we must consider all the information, not just a few parts of it. 

    CMS has failed miserably on this account with it’s decision to cut reimbursements to hospitals 
    in half for radioimmunotherapies (bexxar and zevalin). 
    • CMS has not counted the significant benefits of RIT in their equations:  

      Allowing patients with disease resistant to chemotherapy a good chance to be 
      productive members of society; allowing parents to live longer and better so we 
      can nurture and provide for our families. 

      These are among the many invaluable and incalculable returns on investments —
       the reason our society rewards development of innovative health products. 

      See Letter: We are not asking for charity: http://lymphomation.org/wordpress/?p=14 
       

  • In the spirit of transparency, the sponsor (GlaxoSmithKline) has proposed using the 
    Average Sale Price (ASP) because the data used by CMS was not reflective of the true costs.

    CMS has not accepted this proposal, while it accepts the ASP for other drugs.
  • ASCO (American Society of Clinical Oncology) writes: 

    “As proposed [and now ruled on], the rates for therapeutic radiopharmaceuticals will be significantly
     lower than 2007, and for some hospitals are likely to be lower than their acquisition costs. 

    We are particularly concerned that availability of (Bexxar) and  (Zevalin) not be adversely 
    affected by this proposal.”

    ~ Signed by Joseph S. Bailes, MD, Chair, Government Relations Council
  • ASH (The American Society of Hematology) forceful comment:

     “ASH is extremely concerned about the proposed payment rate for Bexxar … which is a 
    radioimmunotherapy  (RIT) agent. Similar issues apply to Zevalin … which is also an RIT.” … 

    “It is clear that the CMS’ estimate of costs grossly undervalues actual costs of [Bexxar]. 

    Whether this is because [reasons provided] other reasons, unless corrected, this could prove devastating 
    to this important therapy. It may severely limit patient access to this invaluable treatment option since 
    hospitals will not be able to absorb a loss exceeding $16,000 per patient. 

    If this occurs [it did], it will eliminate one of the few treatment options and perhaps the only 
    treatment option for some patient with non-Hodgkins lymphoma who have failed 
    chemotherapy treatment. 

    ~ Signed by Andrew I. Schafer, President
  • EFFICACY and NECESSITY:
    • Notably, the alternative to RIT will many times be death, or rescue via more toxic, 
      less effective or higher-risk therapy and more expensive in-patient treatments, 
      such as stem cell transplantation, which is contraindicated in older patients 
      the population most dependent on Medicare.
    • RIT is highly effective yet underutilized; and that it can lead to durable complete 
      responses in a sizable percentage of patients resistant to standard chemotherapies. 
    • See http://www.lymphomation.org/treatment-rit.htm#durable-remissions 
       

  • In summary, we believe that CMS very low reimbursement rates for RIT:
    (1) will increase pain, suffering, and unnecessary loss of life for patients with lymphomas;
    (2) will limit a physician's ability to prescribe a highly effective therapy today;
    (3) will lead to the termination of radioimmunotherapy in the near future; and
    (4) will be a disincentive to develop urgently needed innovative drugs for all cancers.

    Please help us to ensure that CMS amends the CY2008 reimbursement rates for Zevalin and Bexxar 
    so that hospitals can be adequately paid for providing radioimmunotherapy, which in turn will 
    allow patients to continue to benefit from these highly effective new cancer therapies, 
    which have been described by experts as the
    most potent and effective therapeutic agents 
    ever invented for lymphoma, and arguably for any cancer
    .

Also see 
What is Radioimmunotherapy? & Outcome Data
Letter to CMS http://www.lymphomation.org/CMS-RIT.pdf 
Letter Senator Kennedy http://www.lymphomation.org/RIT-CMS-K.pdf 
Letter: We are not asking for charity: http://lymphomation.org/wordpress/?p=14 
Letter: Is Radioimmunotherapy (RIT) Cost Effective? http://www.lymphomation.org/CMS-RIT-costs.htm 
ASH condemnation of CMS proposal (now ruling)
Public comments on CMS proposal: http://www.cms. hhs.gov/eRulemak ing/downloads/ CMS1392PPC177- 195.pdf

Who to Contact?  See Contacts


Q: What is the cost to hospitals versus reimbursement by CMS? 

This is a very difficult question to find a clear answer to.  

Our reasons for protest are based on our own independent analysis of the CMS proposal, and more importantly, the public comments of ASCO, ASH, and the sponsor.  

We think it's fair to ask why it is that ASH and ASCO, two highly credible professional clinical organizations have gone on the record to forcefully protest payment rates for RIT, and not other drugs?   

Typical hard-to-decipher text from the CMS ruling: 
 

"... unlabeled tositumomab is not approved as either a drug or a radiopharmaceutical, but it is a supply that is required as part of the BEXXAR treatment regimen. ...

The median cost of G3001 from CY 2004 claims is $1,210 based on 69 single claims. 

Based on our CY 2005 claims data that show a final median cost of $1,367 for APC 0442, which contains only the service described by G3001, we had 148 single claims for the service. The median cost of G3001 from CY 2004 claims is $1,210 based on 69 single claims." (

Our comment: The CMS ruling fails to provide readable and clear answers to basic questions: 

  • How much will paid to hospitals this year, versus past years, versus average sales price? 

  • What are the data used by CMS to calculate the Median Cost, and what are the sources?

  • Why has CMS classified part of the bexxar therapy as a diagnostic?  

    Clearly, cold, warm, and hot doses of RIT all have therapeutic effects, and have 
    nothing to do with diagnostics.  Only a biopsy and resulting evaluation of tissue can diagnose a lymphoma.

Based on patient-reported bills, GSK, ASCO, ASH, and investigator comments), the data on which the calculations were based appears to be insufficient, and grossly inaccurate.  

See comments on the CMS proposal, which has become a ruling:
http://www.cms.hhs.gov/eRulemaking/downloads/CMS1392PPC177-195.pdf 
GSK's letter is on pages 1 through 15. | ASH's comments are on pages 18 through 21 
with RIT comments in pages 20 and 21. | ASCO's letter is on pages 32-36, with RIT comments in page 35.

GSK summary of proposed payments by CMS for CY2008:
   G3001 Supply and Admin of Bexxar (is billed twice): $1,925.11 x 2  ($2,250 x 2 in CY2005)
   A9544  Bexxar, diagnostic: no separate payment                                 ($2,241 in CY2005)
   A9545  Bexxar treatment: $8,283                                                           ($19,422 in CY2005)
                                                                   Total: $12,133.63

Compared with rate of  $26,163.00  in CY 2005  (see page 4)

NOTE: It has come to our attention that GSK has offered to provide the Average Sales Price, but CMS has not accepted this offer, which is a way that the payment rates are determined for other drugs.  Thus, confusion about how bexxar is classified (as in part a diagnostic procedure) appears to be central to the bottom-line problem:         
* underpayments to hospitals will lead to diminished access to RIT for patients in need.

Other Reference Points on cost of Bexxar/Zevalin:
  • ASH writes:  "Whether this is because [reasons provided] other reasons, unless corrected, this could prove devastating  to this important therapy. It may severely limit patient access to this invaluable treatment option since hospitals will not be able to absorb a loss exceeding $16,000 per patient. 

  • Our bill for Bexxar was in the year 2005 was: $32,158

  • Another patient reported: "For my Zevalin treatment Medicare was billed $79,075, as best I can
    tell from their summary of my account. Medicare in turn paid the providers $33,111.25.

  • Report on Cost of Zevalin Radioimmunotherapy Versus Cost of Standard Regimens for the 
    Treatment of Relapsed or Refractory Indolent NHL in Switzerland.  http://www.abstracts2view.com/hem07/view.php?nu=HEM07L1_1788&terms 

 
  Costs (CHF)
Treatment option Direct Indirect Total
6 x R-CVP 34,045 3,794 37,839
90Y-ibritumomab tiuxetan (Zevalin) 38,619 1,265 39,884
6 x R-CHOP 36,711 5,691 42,403
8 x R 42,625 2,024 44,649
8 x R-CVP 44,878 5,059 49,937
8 x R-CHOP 48,250 7,589 55,839


Q: Are the sponsors charging too much for Bexxar and Zevalin?

It's worth noting that for RIT there are two approved agents (Bexxar and Zevalin) and therefore, atypically, price competition is already in effect for these new agents - and for Bexxar when it was first approved

Furthermore, the price of Zevalin (as best we can tell) did not edge downward when Bexxar also won marketing approval. 

We think these facts are very good  indications that manufacturing and development costs are the primary reasons these biological agents cost so much to provide ... and that it is not a result of greed.

Finally, CMS policy of cutting reimbursements so far is exclusive to radioimmunotherapy - a treatment for lymphoma. Other similarly expensive targeted biological therapies have not been treated the same. 

CMS discriminates against this "organ," but not others, based on misinformation. The supply is cut despite warnings of ASCO, ASH, the sponsor, and many nonprofit groups that CMS has made an error: has grossly underestimated the costs. http://lymphomation.org/wordpress/?p=14


Q: Can society afford to pay for expensive therapies for cancers? 

We think you have to compare the one-time cost of an effective agent against the costs of repeated use less effective therapies - financial and to the patient.

Regarding the

Notably, the alternative to RIT will many times be death, or rescue via more toxic, less effective or higher-risk therapy and more expensive in-patient treatments, such as stem cell transplantation, which is contraindicated in older patients – the population most dependent on Medicare.  http://www.lymphomation.org/CMS-RIT.pdf 

From our perspective the price of a car (approximately 32K) is not too much to pay for getting your life back. And with your life back you can earn and pay taxes (give back to society, instead being a burden to society and your dependents).  

To make good decisions we must consider all the information, not just a few parts of it. CMS (Centers for Medicaid and Medicare) has failed miserably on this account with it’s decision to cut reimbursements to hospitals in half for radioimmunotherapies (bexxar and zevalin). …

… They have not tallied the significant benefits of RIT in their equations: Allowing patients with disease resistant to chemotherapy a good chance to be productive members of society; allowing parents to live longer and better so they can nurture and provide for their families. These are among the many invaluable and incalculable returns on investments — the reason our society rewards development of innovative health products. 
 
 http://lymphomation.org/wordpress/?p=14 

Furthermore,

Radioimmunotherapy:

as first line therapy (already highly promising - durable remission)

as therapy to achieve responses in patients refractory to chemotherapy (already demonstrated), but also in patients with transformed indolent lymphoma (already suggested)

as consolidation to first primary chemotherapy - already showing improvements in CR rates and durations of remission in controlled trials

as induction therapy to be followed by patient-specific vaccines, or other immunotherapies? 

as conditioning prior to autologous stem cell transplants (already showing promise and improved safety of TBI

as therapy to be combined with adoptive immunotherapy (infusions of NK cells or immune modulating agents to build on the vaccine-like effect?  A vaccine-like effect, which is strongly suggested by the delayed optimal time to response to RIT (well beyond the drugs half life)  - as long as 2 years!

as an effective option for patients who relapse following stem cell transplant 
 

Probably not all targeted biological agents will be as expensive to produce as RIT, but some may be. If our society decides against reimbursing for expensive therapies for cancer, expect a heated argument

You could think of medical products as organs that are invented to sustain life, dependent on blood supply - money supply - for sustenance.  As such, the CMS error is anti-angiogenic; cutting supply of nutrients to RIT in half; requiring hospitals to make up the difference.  CMS discriminates against this organ, but not others, based on misinformation. The supply is cut despite warnings of ASCO, ASH, the sponsor, and many nonprofit groups that CMS has made an error: has grossly underestimated the costs.  http://lymphomation.org/wordpress/?p=14 

Finally, in the "Access to Life-Saving Medicine Act," introduced by  Waxman, Schumer, and Clinton should create a clear pathway for generic biologic drugs, which will help keep costs down in future for this important class of drugs.  Hopefully, however, the correct balance will be achieved so that incentives to develop and market urgently needed new biological therapies is not undermined by the legislation. 

 


Q:  Why are biological therapies more expensive?

We are developing this section. 

For now, see Monoclonal antibodies  for a concise overview of how they are made - http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/M/Monoclonals.html 


Q: Why is it important to everyone that companies make a profit on the therapies they invent and bring to market?

It is estimated that it costs approximately one billion dollars to develop and test a new cancer therapies, and that the failure rate is exceedingly high.   

Because of the benefits we receive from effectively treating disease (touched on above) our society has wisely chosen to provide an incentive system to ensure that

Thus policy that undermines the ability of companies to profit from developing new cancer therapies must be challenged and overturned ... 

As cited above: You could think of medical products as organs that are invented to sustain life, dependent on blood supply - money supply - for sustenance.  As such, the CMS error is anti-angiogenic; cutting supply of nutrients to RIT in half; requiring hospitals to make up the difference.  CMS discriminates against this organ, but not others, based on misinformation. The supply is cut despite warnings of ASCO, ASH, the sponsor, and many nonprofit groups that CMS has made an error: has grossly underestimated the costs.  http://lymphomation.org/wordpress/?p=14 

... particularly now, that we are beginning to see genuine returns on our investments: patients living longer, more productively, and better with lymphomas and other cancers.


 

ASH condemnation of CMS proposal (now ruling):

To assist in your advocacy efforts we have copied the full text scanned from document in public domain:
http://www.cms. hhs.gov/eRulemak ing/downloads/ CMS1392PPC177- 195.pdf
 
American Society of Hematology September 11, 2007
 
RE: CMS 1392-P, Proposed Changes to the Hospital Prospective Payment System and CY2008 Rates
 
“ASH is extremely concerned about the proposed payment rate for Bexxar (I 131 -Tositumomab), which is a radioimmunotherapy (RIT) agent. Similar issues apply to Zevalin (Ibritumomab Tiuxetan), which is also a RIT. The principle use of a RIT is for the treatment of non-Hodgkin's Lymphoma for patients who have not responded well to a prior course of chemotherapy treatment.
 
There are two major problems with the proposed payment for I131- Tositumomab. First, the initial treatment is considered as a diagnostic procedure. Under the proposed rule, the cost of  radiopharmaceuticals for diagnostic as opposed to therapeutic purposes will be "packaged" and not separately paid. Second, the proposed payment level for I131- Tositumomab grossly underestimates the cost .of this product.

The complete I 131 -Tositumomab treatment regimen is provided over 7 to 14 days. After an initial treatment, the patient is evaluated through whole body dosimetry to determine if the biodistribution of the agent is acceptable. If it is not, no further I 131 -Tositumomab treatment is provided.

In the proposed rule, CMS indicates its intention to discontinue separate payment for diagnostic radiopharmaceuticals and to package the cost of the agent in the cost of the nuclear medicine procedure. CMS classified the initial dose of I 131-Tositumomab as a "diagnostic" so that it would be classified as packaged and given “N” status under HOPPS. This decision is erroneous.

All the doses of I 131 Tositumomab are intended to be therapeutic and part of a multi-­day treatment regimen and thus paid separately. This is the case even if the decision is made not to furnish any further doses because the biodistribution .of the initial dose .of the agent was not considered acceptable.
 
It is also our understanding that the proposed payment rate for the therapeutic use of I 131 -Tositumomab would cover less than half of the $30,000 cost to hospitals.
 
It is clear that the CMS' estimate of costs grossly undervalues actual costs of II 31- Tositumomab.
 
Whether this is because of a defect in the cost to charge method (CCR) due to the unwillingness of hospitals to adequately mark up the charges for very costly services (i.e., the phenomenon of charge compression) or for other reasons, unless corrected, this could prove devastating to this important therapy.
 
It may severely limit patient access to this invaluable treatment since hospitals will not be able to absorb a loss exceeding $16,000 per patient.
 
If this occurs it will eliminate one of the few treatment options and perhaps the only treatment option for some patients with non-Hodgkin's Lymphoma who have failed chemotherapy treatment. And, finally, it could have a chilling effect on the development of future drugs and radiopharmaceuticals for treating other forms of cancer and other diseases.

For purposes of the proposed packaging rule. ASH strongly urges CMS to reconsider the classification of 1131- Tositumomab as a diagnostic radiopharmaceutical and to treat all doses of I 131 -Tositumomab as therapeutic.

With respect to the level of payment, ASH is not presenting specific recommendations as to how CMS can best fix this problem. The Society understands that this issue was presented at the meeting of the APC Advisory Committee on September 6, 2007 and that several options were proposed. This included paying for the agent as a drug and not as a radiopharmaceutical so that it would be paid at the rate of 106 percent of average sales price (ASP).

ASH further understands that the manufacturer has indicated a willingness to submit quarterly ASP prices. Also, the APC Advisory Committee and the manufacturer urged CMS to consider establishing a "composite" APC reflecting the full costs for the entire course of therapy including all the procedural services, radiopharmaceuticals, drugs and supplies. All of these methods would seem promising. However, what is critical is that CMS find ways to substantially improve the payment so that patients are not deprived access to this valuable cancer treatment.

Thank you again for the opportunity to offer these comments. If ASH can provide any further assistance including furnishing the actual survey instrument and survey data, please contact Carol Schwartz. ASH Senior Manager of Policy and Practice. at 202-292-0258 or at cschwartz@hematology.org   Sincerely,   Andrew I. Schafer President

 

 


 

Further Reading:

 

  • Practical and clinical benefits of radioimmunotherapy lead to advantages in cost-effectiveness 
    in the treatment of patients with non-Hodgkin's lymphoma.   EDITORIAL 

    Nuclear Medicine Communications. 27(10):753-756, October 2006.
    Otte, Andreas a; Thompson, Sally L. b 
  • Monoclonal antibodies - Overview of how they are made - http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/M/Monoclonals.html 
  • Cost of 90Y-Ibritumomab Tiuxetan Radioimmunotherapy Versus Cost of Standard Regimens 
    for the Treatment of Relapsed or Refractory Indolent Non-Hodgkins Lymphoma 
    in Switzerland. Session Type: Poster Session, Board #539-III  - ASH  http://www.abstracts2view.com/hem07/view.php?nu=HEM07L1_1788&terms 


    In conclusion, 90Y-ibritumomab tiuxetan is not more expensive than other established treatments for relapsed or refractory indolent NHL. Table 1. Per-patient costs by treatment in Switzerland.

.

 

 
 
Disclaimer:  The information on Lymphomation.org is not intended to be a substitute for 
professional medical advice or to replace your relationship with a physician.
For all medical concerns,  you should always consult your doctor. 
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