Insurance Coverage for Transplant Clinical Trials

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Insurance Coverage for Transplant Clinical Trials

• Unintended Impediments to Research and Improved
  Clinical Care

Roy B. Jones PhD MD Chair , ASBMT Clinical
Outcomes Committee ASBMT
Evidence-Based Reviews Committee
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Medicare National Coverage Determinations (NCD)
Manual
(selected)
Chapter 1 Part 2 section 110.8.1
. a. Covered Indications The following uses of
allogeneic bone marrow transplantation are
covered under Medicare Effective for
services performed on or after August 1, 1978,
for the treatment of leukemia, leukemia in
remission, or aplastic anemia when it is
reasonable and necessary Effective for
services performed on or after June 3, 1985, for
the treatment of severe combined immunodeficiency
disease (SCID), and for the treatment of
Wiskott-Aldrich syndrome.
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Medicare National Coverage Determinations (NCD)
Manual
(selected)
Chapter 1 Part 2 section 110.8.1
. b. Non-covered Indications Effective for
services performed on or after May 24, 1996,
allogeneic stem cell transplantation is not
covered as treatment for multiple myeloma.
Tandem transplantation (multiple rounds of AuSCT)
for patients with multiple myeloma
-2-
All indications for stem cell transplantation not
otherwise noted above as covered or non-covered
nationally remain at local contractor discretion.
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NCD Problems

• NCD are silent for many transplant indications
  considered as standard of care by transplanters
  and most commercial insurers
• myelodysplastic syndrome
• myeloproliferative disorders
• allotransplants for lymphoma
• Local Contractors routinely exclude coverage in
  the absence of an
• affirmative NCD
• NCD excludes coverage where RCT data exists
• tandem auto and reduced intensity
• allotransplants for myeloma

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Plus and Minus of Present Medicare Coverage

• Plus Medicare has attempted to support clinical
  transplant research
• Minus Medicare NCD has not been updated to
  conform to evidence-based reviews and does not
  conform to commercial disease and modality-based
  coverage or standard practice

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Medicare Clinical Trials Policies
On June 7, 2000, the President of the United
States issued an executive memorandum directing
the Secretary of Health and Human Services to
"explicitly authorize Medicare payment for
routine patient care costs...and costs due to
medical complications associated with
participation in clinical trials."
Routine costs of a clinical trial include all
items and services that are otherwise generally
available to Medicare beneficiaries (i.e., there
exists a benefit category, it is not statutorily
excluded, and there is not a national
noncoverage decision) that are provided in
either the experimental or the control arms of a
clinical trial
Question
Do Medicare clinical trials policies override
local contractor discretion for diagnoses
where no NCD exists?
Answer
NO
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Effective September 19, 2000, clinical trials
that are deemed to be automatically qualified
are 1. Trials funded by NIH, CDC, AHRQ, CMS,
DOD, and VA 2. Trials supported by centers or
cooperative groups that are funded by the NIH,
CDC, AHRQ, CMS, DOD and VA 3. Trials conducted
under an investigational new drug application
(IND) reviewed by the FDA and 4. Drug trials
that are exempt from having an IND under 21 CFR
312.2(b)(1) will be deemed automatically
qualified until the qualifying criteria are
developed and the certification process is in
place. At that time the principal investigators
of these trials must certify that the trials meet
the qualifying criteria in order to maintain
Medicare coverage of routine costs. This
certification process will only affect the future
status of the trial and will not be used to
retroactively change the earlier deemed status
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Suggested ClarificationsClinical Trials Policy

• Options
• Clarify that this clinical trials policy governs
  where no NCD exists
• Clarify that the clinical trials policy was
  intended to cover trials designed to define or
  compare therapeutic activity

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NCD is needed for the following

• Allotransplant
• Lymphoma
• Hodgkins
• Myelodysplastic syndrome
• Myeloproliferative disorders
• Myeloma (noncoverage)
• Autotransplant
• Tandem transplant for myeloma (noncoverage)
• lymphoma

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Commercial Insurance Problems ?Yes !

• Increasing numbers of insurance carriers exclude
  coverage for patients participating in clinical
  trials, irrespective of trial Phase
• Clarifying that the Medicare Clinical Trials
  Policy covers any indication for which there is
  not a national noncoverage decision would be
  extremely helpful

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Case StudyMyelodysplastic Syndrome (MDS)

• No NCD exists for MDS
• Medicare usually does not reimburse for BMT
• Reduced intensity allotransplant can be given to
  older patients
• BMT can cure MDS no cure is available with
  standard therapy
• Predictable subgroups of MDS evolve to acute
  leukemia or die of complications within lt 2 yr.

So, what do we do with these patients?
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-2-

• Patient MS
• 68yo, no comorbidities
• Wbc 2.1, hgb 7.8. plts 21K
• Marrow 12 blasts
• Iron overload, receiving plt and rbc transfusions
• HL-A matched sibling, age 62, good health
• Has Medicare with supplementary advantage plan
• Patient asks should I take standard therapy or
  decline it and allow my blast count to rise more
  quickly?

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NCCN MDS Treatment Algorithm
High-risk MDS
No age limit specified
http//www.nccn.org/professionals/physician_gls/PD
F/mds.pdf
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ASBMT Evidence-Based Review
Transplant for Myelodysplastic Syndrome
In preparation to be published late summer 2008
Biol. Blood and Marrow Transplant.
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BMT vs. Viagra

• Cure of deadly disease vs. quality of life
  medical support
• Both are expensive
• Shouldnt a curative treatment receive some
  special consideration?
• Benefits of cure derive in part to society
  (Medicare) but less so to commercial insurers
• Naïve, but shouldnt science be a more important
  driver of public policy?

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Summary of Suggestions

• Update NCDs to reflect available studies and
  standard practice
• Lymphoma
• Myeloma tandem and allo
• MDS, MPD
• Clarify Clinical Trials Policy to include
• Therapeutic activity studies of any type
• Support for studies where NCD is silent