Important Medicare Updates: MDS CED and new MS-DRG codes for transplant

[Guest guest]

Good morning –

As many of you may have seen, CMS has issued several

different documents in the last few days that will have a large impact on

Medicare reimbursement for allogeneic hematopoietic cell transplant.

Please read carefully and share with the appropriate staff at your facility.

1.

MDS CED: The NMDP, ASBMT and several other

organizations submitted a National Coverage Determination (NCD) request in

November 2009. CMS issued their final decision yesterday, which was to

use the Coverage with Evidence Development (CED) option to provide coverage of

allogeneic transplant for Medicare beneficiaries with MDS while building data

for a final coverage determination. A summary of key points related

to the CED follows. A copy of the talking points that NMDP staff

will be using with MDS patients is attached. Please do not share this

document directly with patients. Also, please note that there is

additional technical information in the notes below that is not appropriate to

share with patients at this point.

Medicare begins coverage for MDS

transplants as part of clinical study.

On August 4, the Centers for Medicare

and Medicaid Services (CMS), announced that they will begin Medicare coverage

of allogeneic hematopoietic cell transplantation (HCT) to treat myelodysplastic

syndromes (MDS) as part of a clinical study to evaluate its efficacy.

Background

·

HCT is the only known curative treatment for

MDS. If HCT is shown to be efficacious in the Medicare population, patients can

benefit from this treatment earlier in their disease and before evolving to

acute leukemia.

·

The majority of Medicare beneficiaries are 65

years of age or older. Adults aged 65+ represent 80% of all patients diagnosed

with MDS.

·

Initial evaluations suggest that HCT is

effective therapy for adults 65+ and outcomes show little difference compared

to younger adults.

·

CIBMTR data shows that there are approximately

100 MDS transplants in the 65+ population per year. This coverage

expansion will likely increase the number of transplants.

·

This does not impact Medicaid coverage of

transplants for MDS. State Medicaid programs make coverage decisions

independent of Medicare.

Clinical study

·

Medicare will only cover the costs of HCT for

MDS as part of a clinical study that meets Medicare-specified criteria.

This is referred to as Coverage with Evidence Development (CED). A CED

decision allows for coverage during an interim period to accrue data for CMS to

make a final national coverage determination (NCD).

·

It may take several years to complete the data

collection and analysis before Medicare makes a final determination.

·

The CIBMTR is preparing to submit a CED study

proposal that would be conducted in two parts. The first part will

utilize standard CIBMTR forms and reporting processes, with some minor

modifications specific to this study, to evaluate the results of HCT in the

Medicare population. The second part will, per Medicare requirements,

include a non-transplant control group.

·

The second part will be designed to include

appropriate non-transplant control patients as required by CMS. The exact

design of this second stage study will be determined with input from clinical

experts in the management of MDS. The CIBMTR intends to convene such a group

over the next few months to begin these deliberations. The study design

will also be influenced by the data generated in Part 1.

·

Transplant center participation will be

voluntary; mechanisms for enrolling centers and patients are still being

determined.

·

Participation in this study will not preclude

participation in other MDS research or co-enrollment in other clinical trials.

·

Chronic myelomonocytic

leukemia (CMML) is one of the

diagnoses included in this study.

Next steps

·

The CIBMTR and the NMDP will work with

transplant centers to support the implementation of this study. It will

take several months before the study plan is approved by CMS and ready to

begin.

·

To read more about Medicare’s decision, please

see the CMS tracking sheet at https://www.cms.gov/mcd/viewtrackingsheet.asp?from2=viewtrackingsheet.asp & id=238 &

o The

final document is linked under “Decision Memo Posted”.

2.

New MS-DRG codes: CMS has created new

MS-DRG codes for reporting inpatient transplants to better account for the cost

differences between auto and allo transplants. Related and unrelated

transplants will reported together under the allo transplant MS-DRG code.

These go into effect on October 1, 2010.

a. MS-DRG

014 – Allogeneic Bone Marrow Transplant

i.

ICD-9-CM Procedure codes: 41.02; 41.03; 41.05; 41.06;

41.08

b. MS-DRG

015 – Autologous Bone Marrow Transplant

i.

ICD-9-CM Procedure codes: 41.00; 41.01; 41.04; 41.07;

41.09

Additional coding notes:

-

CMS has indicated that centers should report an

additional procedure code based on the donor type for the transplant.

Including this code will be very helpful for potential future coding

revisions.

o

00.91 – Transplant from live related donor

o

00.92 – Transplant from live unrelated donor

o

00.93 – Transplant from cadaver

-

Please remember to include all search and donor

charges on the transplant bill under revenue code 0819. See pg 3 of

the attached 2010 OPPS manual guidance document for clarification. Reporting

these charges on the transplant bill are crucial to improving future

reimbursement rates. CMS sets new rates based on the prior year’s

reported costs, so please be sure to include all costs on the bill. This

will be especially useful starting in October, when the new allo-specific DRG

goes into effect.

Please feel free to contact me with any questions.

(Hauge) Farnia, MPH

Manager,

Payor Relations

3001

Broadway Street N.E., Suite 100

Minneapolis,

MN 55413-1753

Phone:

Toll Free: Ext 8640 Fax:

Email:

sfarnia@...

4 of 4 File(s)

MDS Talking Points_patient.doc

2010 OPPS Guidance.pdf

Final rule FY2011_BMT section.pdf

Final MDS Memo_8.4.2010.pdf