Patients
with Medicare will be eligible for claims coverage from CMS if they participate
in this study. View clinical, billing, and reimbursement information
below.
Study Title: Assessment of Allogeneic Hematopoietic
Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic
Syndrome and Related disorders - Part I. (10-CMSMDS-1)
Opened: December 15, 2010
Study Objectives:
- The primary objective of this study is to prospectively examine outcomes of
allogeneic HCT in adults >= 65 years of age with MDS to determine whether
their outcomes are similar to those in younger patients.
- To provide a mechanism to Medicare Beneficiaries with MDS for claims
coverage for allogeneic HCT.
- To provide data requested by Medicare under its CED to make payment on
claims for HCT using the existing research observational database of the
CIBMTR.
Participating Transplant Center are Required to:
- Submit Form 2554 (on-demand form) in FormsNet3 for each subject to be
enrolled.
- Complete Form
2400 (Pre-TED) by first selecting the RCI BMT as the study sponsor, and then
select from the dropdown "10-CMSMDS-1".
- Submit Comprehensive Report Forms to CIBMTR for all registered study
patients.
Patient Eligibility:
- Diagnosis of MDS related disorders, including CMML and therapy-related
MDS.
- Age >= 65 or age <65 and Medicare beneficiary.
- Willingness to participate and sign informed consent for NMDP/CIBMTR's
"Protocol for a Research Database for Hematopoietic Stem Cell Transplantation
and Marrow Toxic Injuries (NCT-01166009)"
Consent Forms:
This study uses the existing research observational database of the CIBMTR to
collect data requested by CMS as part of its payment policy. Participants who
wish to receive coverage from CMS must sign the existing IRB approved standard
consent for the research observational database. (See below). Additional
protocol or consent forms are not required for this study.
The Research Database protocol and CIBMTR/NMDP IRB approvals, can be found on
the Observational
Database and Protocol and Consent Forms page.
Study
Contacts:
- For
clinical research questions contact:
- For
Medicare claims questions contact:
NMDP/Be The Match Payer Policy team, payerpolicy@nmdp.org
Coding
and Billing:
Medicare
has determined allogeneic HCT for MDS to be reasonable and necessary ONLY if
provided in a Medicare approved clinical study under Coverage with Evidence
Development (CED).
For
Standard Medicare, Include the Clinical Trial Identifier
Billing
for patients participating in this study with standard Medicare is generally the
same as billing Medicare for HCT, except you need to always include the clinical
trial identifier on claims.
For
inpatient hospital claims with discharge dates on or after August 4, 2010, your
Inpatient claims (Type of Bill (TOB) 11X) for HSCT for the treatment of MDS in a
clinical study must contain:
TOB
11x and:
If
ICD-9-CM, diagnoses codes are 238.75 and V70.7
If
ICD-10-CM, the diagnosis codes are D46.A, D46.B, D46.C,D46.0, D46.1, D46.20,
D46.21, D46.22, D46.4, D46.9, or D46.Z, and clinical trial ICD-10-CM diagnosis
code Z00.6
To
learn more about specific codes to use for this clinical trial, view
the Medicare
Claims Processing Manual - transplant section 90.3 or
a Medicare Matters
article
(PDF).
For
Medicare Advantage, Bill Medicare Directly
CMS
guidance specifies that costs related to a Medicare approved clinical trial,
such as the MDS CED, should be paid through traditional fee-for-service
Medicare, even when a patient has enrolled in a Medicare Advantage
plan.
When
patients have a Medicare Advantage plan, you need to bill Medicare directly, not
the Medicare Advantage plan for aspects of care that are related to the clinical
trial.
In
the case of the MDS study, this includes the transplant hospitalization and any
associated follow-up care or hospitalizations attributable to the transplant.
This would apply for as long as care is provided that is related to the original
transplant for MDS. Centers are asked to treat this on a patient-by-patient
basis and use their clinical judgment and integrity in discerning which claims
are transplant associated. All such claims should be marked with the 8 digit
clinical trial number: NCT #01166009. See Section L of the attached
reference: 2011 Combined Call Letter for more information about Medicare
Advantage plans and clinical trials administration.
For
Post-Transplant Care, Include Clinical Trial Number
CMS
clarified that all traditional FFS Medicare beneficiaries should also have their
transplant-associated subsequent care and hospitalizations marked with the
clinical trial number. The length of time during which subsequent care is
related to the transplant will vary by patient and is up to the medical
determination of the provider. This will not affect reimbursement; it is for
tracking purposes only.
Remember
that proper documentation of subsequent admissions or care and attribution of
association with transplantation is very important as these claims are subject
to the usual auditing practices.
Denials
If
you receive a denial notice for a patient in the MDS study, the best initial
course of action is to work with your local Medicare contractor to understand
the reason for the denial and the possible course of action or
appeal.
If
the issue is something that cannot be resolved in this manner or is in relation
to what your center believes to be a misinterpretation of the Coverage with
Evidence Determination guidelines, please contact NMDP/Be
The Match Payer Policy team, payerpolicy@nmdp.org
Study Reference
Materials:
