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Statement Before CMS Advisory Panel on Ambulatory Payment Classification Groups on Bone Marrow and Stem Cell Processing Procedures – 9/6/07

AABB Comments Before the Advisory Panel on Ambulatory Payment Classification Groups September 2007

Presented by Theresa L. Wiegmann, JD 

AABB appreciates the opportunity to comment to the Advisory Panel on Ambulatory Payment Classification (APC) Groups regarding bone marrow and stem cell processing procedures.  AABB (formerly known as the American Association of Blood Banks) is a professional association dedicated to advancing transfusion medicine and cellular therapies.  AABB’s members include approximately 1,800 institutions, including hospital-based blood banks and laboratories, transfusion services and blood and bone marrow collection facilities, as well as approximately 8,000 individuals involved in blood, bone marrow, cord blood and peripheral blood stem cell collection, processing, storage and infusion.


AABB has significant concerns regarding the APC assignment and proposed payments for Codes 38207-38215, which involve procedures for processing bone marrow and stem cells prior to transplantation. As background, since the beginning of the hospital outpatient PPS program, CMS decided not to recognize these CPT codes. Rather, three “G” codes were established (G0265, G0266 and G0267) to report these services. G0265, Cryopreservation, freezing and storage of cells for therapeutic use, and G0266, Thawing and expansion of frozen cells for therapeutic use, were erroneously classified as clinical diagnostic laboratory tests and excluded from HOPPS.  G0267, Bone Marrow or peripheral stem cell harvest, modification or treatment to eliminate cell type(s) (e.g., T-cells, metastatic carcinoma), was covered under HOPPS.


After several years of discussion with the agency, AABB was very pleased when CMS announced in the proposed rule that Codes 38207-38215 would be recognized under HOPPS.  However, we are concerned about the payment grouping to which the codes have been assigned. Codes 38207-38209 were assigned to APC 0344, Level IV Pathology, with a proposed payment rate of $54.69. This APC consists of various anatomic pathology services including Codes 88307 and 88309. However, the steps that are involved in cryopreserving, thawing and washing bone marrow/stem cells which will be used for a potentially life saving transplant are very different than the costs involved in handling and preparing pathology specimens for microscopic evaluation. 


AABB, along with the American Society of Hematology and the American Society for Blood and Marrow Transplantation, recently initiated a survey of a number of hospital centers which perform bone marrow transplantation.  We requested data on direct costs—clinical labor and supplies and reagents. At the APC advisory committee meeting, we would hope to present data for all the surveyed facilities. At this point in time, however, we have data for two facilities showing labor and supply costs as follows:


Code 38207, Cryopreserve stem cells -- $740-$2,300

Code 38208, Thaw preserved stem cells -- $234-$432

Code 38209, Wash harvest stem cells -- $660


If direct costs equal approximately 50 percent of total hospital costs, which seems reasonable, this would double the above cost estimates. AABB recognizes that over time CMS will have charge data for these codes allowing the APC rate to be based on actual costs. However, we presume that the earliest this will be possible is 2010, based on 2008 data. In the interim, AABB urges CMS to place these codes in an APC that pays substantially more than $54, which will not cover even 10 percent of the actual costs. We would suggest that APC 0111, Blood Product Exchange (paying $776) would be an appropriate initial payment level.


As noted above, G0267 is currently paid for under HOPPS and is assigned to APC 0110.  This is the blood transfusion APC and CMS proposes to assign all the cell depletion codes, Codes 38210-38215, to this APC with a payment of $222.44.  These are very low volume codes, particularly in the Medicare population. The median cost data for G0267 indicate only 194 single claims were billed (438 total claims) with a median cost of $405.84.  Again, this is for all the various cell depletion services. However, there are extremely wide differences in the costs of these services and we are confident that most of the billings within G0267 are for the lower cost services such as red blood cell removal (Code 38212).  Two of the codes, 38210 (T-cell depletion) and 38211 (tumor cell depletion) are extremely costly services which are performed by only a limited number of facilities and rarely in the Medicare age group.  We have data for three facilities that indicate that the reagent kits alone used for these services cost from $7,600 to $7,900 per patient with clinical staff costs from $400 to $1,400. Thus, the $222 payment rate would cover only a miniscule portion of the costs. AABB, therefore, asks that these two codes be placed into a much higher paying APC and would suggest, APC 0112, Apheresis and Stem Cell Procedures, with a payment rate of $2.035.93. 


The survey data we have for the other cell depletion codes, 38212-38215 indicate a wide range of direct costs. We would ask that these codes be placed in a separate APC using the median cost data for G0267. This would raise the payment level to the $400 level from the proposed $220 rate based on the transfusion codes. When CMS has adequate claims data for the individual codes it might be appropriate to adjust the APC grouping further.


In sum, AABB commends CMS for recognizing Codes 38207-38215 under HOPPS.  However, we strongly urge the Advisory Panel to recommend that the agency assign APCs and payments that better reflect the actual costs associated with providing these potentially life saving bone marrow and stem cell processing procedures.  We respectfully request that Codes 38207-38209 be moved from APC 0344 to APC 0111, Codes 38211 and 38212 be reassigned from APC 0110 to APC 0112 and that Codes 38212-38215 be placed in its own APC group based on the cost data for Code G0267. 


Thank you again for the opportunity to testify.  AABB appreciates the Advisory Panel’s attention to this important issue.