June 20, 2019
The Honorable Seema Verma
Administrator
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201
Re: CMS-1716-P: Medicare Program; Hospital Inpatient Prospective Payment
Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates
Dear Administrator Verma:
On behalf of National Marrow Donor Program (NMDP)/Be The Match®, we thank you for
the opportunity to provide our comments on the proposed rule entitled, “Medicare
Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals
and the Long-Term Care Hospital Prospective Payment System and Proposed Policy
Changes and Fiscal Year 2020 Rates” (Proposed Rule). This comment letter focuses
specifically on our recommendations related to the way CMS reimburses transplant
centers for the acquisition costs associated with bone marrow and cord blood, as well
as payment for CAR-T therapies.
For the thousands of Americans diagnosed every year with life-threatening blood
cancers like leukemia and lymphoma, a cure exists. NMDP manages the largest and
most diverse marrow registry in the world through a competitively-bid contract with the
Health Resources and Services Administration (HRSA). Each year, Congress
appropriates funds to operate this federal program, which is designated by the
Congress as the C.W. Bill Young Cell Transplantation Program (Program). Since the
mid-1980s, Congress has reauthorized the Program with virtually unanimous support.
Today, there are 19 million U.S. volunteers listed on the registry and willing to donate, in
addition to more than 249,000 cord blood units, making the cure available through
transplant a reality for thousands of Americans each year.
As the steward of this critical federal public health program, we work to identify and
eliminate barriers faced by those patients in need of one of these life-saving transplants.
In addition to being a core component of our contracts with HRSA, assisting with thirdparty payer matters is a function of the Office of Patient Advocacy as outlined by
Congress in the statute authorizing the Program. NMDP also partners with nearly 200
hospital transplant programs in assisting them with efforts to protect access to
transplant.

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 The Honorable Seema Verma
June 20, 2019

Allogeneic Hematopoietic Cell Transplant (HCT) Payment Policy
a. DRG Split for Related and Unrelated HCT
NMDP appreciates CMS’ review of our request from last year, and that CMS conducted
its own analysis to understand what the results would be of splitting MS-DRG 014 into
two separate groups based on whether related or unrelated donor cells were used in
transplant cases. We are particularly interested in the conclusions CMS drew from this
analysis, and the thoughts of its clinical advisors on the potential for a MS-DRG split.
Understanding the agency’s view of this data is important, and we appreciate the
information that CMS provided in the Proposed Rule.
In the Proposed Rule, CMS’ clinical advisors commented that patients assigned to MSDRG 014 are clinically similar because they all received allogeneic transplant. The table
that CMS printed in the proposed rule showed length of stay averages and average
costs. While we acknowledge the accuracy of this information in a vacuum and
understand why, based on these figures alone, CMS has at present chosen not to split
the DRG, it remains the case that unrelated donor stem cell transplants typically involve
more resources due to the donor work up process and procurement costs.
We are interested in CMS’ analysis in the FY2020 proposed rule which shows an
approximately $7,700 difference in the average cost of an unrelated donor case versus
a related donor case in MS-DRG 014. CMS’ willingness to share additional statistics
would give greater visibility into that calculation, such as the standard deviation, the
median, and any further information about whether or not the agency trimmed out
statistical outliers when calculating averages in the analysis. This additional information
would help inform our own analysis as we continue to communicate with the agency
about appropriate rate-setting and reimbursement for allogeneic transplants.
As CMS is aware, the billing instructions in Chapter 4, Section 231.11.1, of the
Medicare Claims Processing Manual require hospitals to report donor search and cell
acquisition charges in revenue code 0815 on the recipient’s transplant claim. Through
our analysis, it is apparent that revenue code 0815 is not always reported or is
sometimes reported with a zero-dollar charge. To address this, we request that CMS
create an edit, similar to what was implemented in the CY 2017 Hospital Outpatient
Prospective Payment System (HOPPS) final rule, which states outpatient claims
assigned to C-APC 5224 with CPT code 38240 must be reported with revenue code
0815, and if that code is missing, the claim is returned by an edit to the provider.
Implementing a similar change for inpatient claims utilizing ICD-10-PCS codes and
revenue code 0815 will better inform CMS future rate-setting and reimbursement. More
robust data in revenue code 0815 allows CMS to do a meaningful analysis on the
differences between search and procurement costs for related versus unrelated
transplants.
b. Claims Processing Manual Updates
NMDP thanks CMS for reviewing the Claims Processing Manual and identifying
duplicative instructions. We support CMS’ efforts to update and modernize this manual,
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 The Honorable Seema Verma
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as providers rely on it for instructions. CMS created the dedicated cost center 77 to
capture donor search and cell acquisition costs as of January 1, 2017. However, CMS
has not provided any manual instruction to hospitals on how to correctly aggregate
donor search and cell acquisition costs to this cost center. Since CMS is reviewing the
Claims Processing Manual for clarity and correctness, we ask CMS to issue instructions
on cost capture for this cost center. Specifically, there is no guidance on how costs
should be aggregated for related donors when they receive services. Donor search and
cell acquisition costs are enumerated in section 231.11.1 of Chapter 4 of the Medicare
Claims Processing Manual, but there are no instructions on how expenses should be
reclassified from the various departments such as lab, clinic, etc. that provide donors
with services to the dedicated cost center 77. Based on our discussions with numerous
transplant centers, providers would benefit from clarification on how to appropriately
report related donor transplant services in their cost reports.
Additionally, CMS republished transmittal 1805 on March 22, 2018, which instructs
providers to bill physician services for stem cell donors, which would include “physician
pre-procedure donor evaluation services”, to MACs for Part B payment under the
recipient’s name and number. The transmittal indicates that physician pre-procedure
donor evaluation services are Part B professional services. If such services are under
Part B then they are billed real-time, and should not be held to be put on the transplant
recipient’s claim and should not be reported as a hospital “cost” on the claim or in cost
center 77. We ask that CMS look at bone marrow and stem cell transplant services
holistically and consider the process that providers must follow in order to correctly code
and submit a claim.
c. Coding Related Issues
Removal of ICD Codes
NMDP appreciates CMS’ thorough review of the following codes, and its reassignment
of these autologous codes from the allogeneic MS-DRG 014 back into MS-DRG 016 or
017. We agree with this change and fully support this proposal.
ICD-10-PCS
Code
30230X0
30233X0
30240X0
30243X0

Code Description
Transfusion of autologous cord blood stem cells into peripheral vein,
open approach
Transfusion of autologous cord blood stem cells into peripheral vein,
percutaneous approach
Transfusion of autologous cord blood stem cells into central vein, open
Approach
Transfusion of autologous cord blood stem cells into central vein,
percutaneous approach

Furthermore, we agree with the removal for clinically invalidity of the diagnosis codes for
transfusion of stem cells via the central and peripheral artery for an autologous

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transplant listed on page 90 of the Proposed Rule and appreciate CMS’ diligence in
ensuring the clinical appropriateness of ICD-10 codes.
Downgrading of Neoplasm Secondary Diagnosis Codes from CC to Non-CC
In the FY 2020 Proposed Rule, CMS proposed significant changes to its CC/MCC lists
of ICD-10 secondary diagnosis codes and discussed its analysis of the codes it
proposed changing. Most of the proposed changes reduce the assigned severity level
for the codes.
Many of the codes proposed to be downgraded are neoplasm diagnosis codes. CMS’
clinical advisors counseled that the presence of such codes as secondary diagnoses
would not represent greater resource utilization. NMDP respectfully disagrees as
lymphomas and other neoplasms involve numerous clinical considerations and
resources. We reviewed the data file CMS released along with the proposed rule and
note there are many neoplasm codes for which the resource utilization calculation
appears to contradict the decision of CMS’ clinical advisors. Before finalizing such a
large change to the MS-DRG classification system, we recommend CMS provide more
analytic and clinical rationale, and guidance on how the NMDP and others can provide
more input.
Chimeric Antigen Receptor T-Cell (CAR-T) Payment Policy
a. MS-DRG Assignment for CAR-T
In the Proposed Rule, CMS asked for specific feedback about the MS-DRG assignment
for CAR-T, along with comments from stakeholders on how to handle payment policy for
FY 2020. The NMDP has several recommendations on this point.
First, in 2009, NMDP worked with CMS to create three distinct MS-DRGs for stem cell
transplant, resulting in MS-DRGS 014 (Allogeneic), 016 (Autologous w/ CC/MCC) and
017 (Autologous w/o CC/MCC) from MS-DRG 009 (Bone Marrow Transplant). These
classifications made it possible for CMS to differentiate costs between allogeneic and
autologous transplants in the inpatient setting for analysis and rate-setting. Furthermore,
as discussed previously, the release of a dedicated revenue code (0815) and cost
center (77) further allowed the isolation of costs that are specific to transplant cases.
Similarly, we believe it is important to isolate CAR-T cases, so they are contained in a
single MS-DRG rather than appearing in multiple medical MS-DRGs. It is our opinion
that CMS should maintain the integrity of MS-DRG 016 for future rate-setting of
transplant by not including CAR-T cases.
However, our reading of the Proposed Rule is that CMS desires to collect more data on
CAR-T cases before deciding whether or not to create a separate MS-DRG. We
respectfully request that CMS finalize such a decision when issuing the rule for FY
2021, as the New Technology Add On Payment (NTAP) for CAR-T is set to expire at
that time. Otherwise, transplant centers will be left without a mechanism to recoup
considerable costs for CAR-T products.
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 The Honorable Seema Verma
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We appreciate that CMS is requesting public comment on how to handle the creation of
a new MS-DRG for CAR-T, and we understand the importance of getting the
reimbursement methodology correct. One of the first steps CMS could take to improve
the data used for rate-setting for a new CAR-T DRG would be to remove clinical trial
cases from the rate-setting process. Much of the challenge posed by CAR-T payments
are directly related to the product cost. However, in a clinical trial, the provider receives
the product at no cost. Thus, those cases do not adequately reflect the typical high
costs of providing CAR-T to patients, and a future DRG that is based primarily on CART clinical trial cases would not produce an adequate payment rate.
b. Revising the NTAP Cap
In addition, we appreciate CMS requesting further comment and information on
alternative ideas for how to handle the reimbursement challenges posed by CAR-T, as
well as CMS raising some topics for discussion, such as a CAR-T specific uniform
NTAP payment. We have continued our dialogue with other professional organizations
and stakeholders and continue to support the requests made by ASH and ASTCT in
their respective comment letters. The following outlines where our perspective aligns
with ASH and ASTCT.
First, we appreciate CMS’ acknowledgment of the limitations that the 50% cap on NTAP
presents for providers, and that such a cap may no longer be serving the purpose of the
new technology payment designation. We would agree with CMS that the 50% cap is no
longer sufficient. However, based on our review, the increase to a 65% cap proposed by
CMS is also insufficient to meet the demand for encouraging the adoption of CAR-T.
Instead, we join ASH and ASTCT in proposing that the cap be set at 80% of the list
price, rather than 65%. Looking beyond CAR-T, NMDP believes that innovations in the
transplant space will continue to come to market, and it is important to ensure these
innovations will be available to Medicare beneficiaries when approved. New drugs and
devices, being increasingly costly, involve large risks and case purchases up front. We
believe that setting the NTAP cap at 80% will hit a threshold for many providers that will
reduce a portion of that risk in a way that a 65% cap cannot.
Second, we recognize that increasing the NTAP payment is a temporary solution to the
high cost of CAR-T therapy, so just as we supported CMS’ creation of new revenue
code (0815) and new cost center (77) for allogeneic transplant in 2016, we continue to
support CMS’ creation of similar policies for CAR-T, to ensure the agency has the
information it needs to create an appropriately leveled new MS-DRG, or consider an
alternative to an MS-DRG in the future. To that end, we request that CMS require the
CAR-T product’s National Drug Code (NDC) to print in the description field on the
inpatient claim, as this will provide visibility about which CAR-T product was used, and
to create a dedicated cost center for CAR-T in the cost report. This information will be
necessary to develop a 20th national cost group for cellular therapy, which could be
important for future rate-setting.
c. Use of Product Acquisition Cost Through Use of Value Code 86 in the NTAP and
Outlier Calculations for CAR-T
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 The Honorable Seema Verma
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Beyond the revision of the NTAP cap for all drugs and devices designated as new
technologies, there remain significant reimbursement challenges for providers who
choose to offer CAR-T services. To that end, we support ASH and ASTCT’s request for
two key components: first, to require the use of value code 86 to report the acquisition
cost of the CAR-T product, and second, to utilize the information from that value code to
calculate the total cost of the case—that is, to replace the line item CAR-T product
charge with the actual acquisition cost of the product, adding that cost to the computed
patient cost. This solution provides the most cost transparency and will not cause undue
provider burden, while protecting CMS from potential overpayment situations.
The value code for CAR-T is unique and presents an opportunity that is not available
when calculating payment for other NTAP designated drugs and devices. Currently,
reporting of value code 86 is not mandatory; therefore, we request that CMS require
value code 86 to be reported on CAR-T infusion claims. The value code will allow CMS
to see the actual acquisition cost for the CAR-T product and would provide
accountability and visibility into which cases are clinical trial cases, as the cost would
equate to $0 for clinical trial cases. Given how costly these therapies are we believe it is
imperative for all providers to review their claims carefully and to submit accurately and
completely coded claims which can be aided by CMS creating edits.
In this Proposed Rule, the agency again asked for comments on utilizing a CCR of 1.0.
In the case of CAR-T, we believe an opportunity exists to use value code 86 in a
manner that supersedes any further discussion of using a CCR of 1.0 as a proxy for
product acquisition cost.
We believe that CMS should pair the change in its NTAP formula with the actual product
acquisition cost when computing the NTAP and outlier payment calculations. This would
occur by CMS subtracting the CAR-T line item billed charge from the total charges and
adding in the actual product acquisition cost (as reported through the value code 86) to
the patient care cost. Then CMS would use this new total cost sum to calculate NTAP
and outlier. Performing this simple mathematical step would generate a more accurate
total case cost that is reflective of the true cost of acquiring the drug and would protect
the agency from overpayment (either because of the markup of the charge, or the
hospital somehow received the product at a discount). We believe this change meets
the spirit of what was always meant by requesting a CCR of 1.0, but without having to
rely on that as a proxy for the actual cost. This method will generate more accurate
payment to providers while reducing usage of the outlier pool to make up for the
shortfall of NTAP payment.
We reiterate our appreciation of CMS’ continued engagement on the CAR-T issue and
look forward to further dialogue about how to protect beneficiary access to novel cellular
therapies.
Modernizing Medicare Payment Model for HCT
NMDP appreciates the efforts CMS has made during the last several years to address
the inequities in the funding for hematopoietic stem cell transplants. Despite these
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 The Honorable Seema Verma
June 20, 2019

efforts, the underlying problems remains unresolved. We are pleased that Senators
Debbie Stabenow (D-MI), Richard Burr (R-NC), Sherrod Brown (D-OH), and Tim Scott
(R-SC) and Representatives Ron Kind (D-WI), Kenny Marchant (R-TX), Gus Bilirakis
(R-FL), and Doris Matsui (D-OH) have introduced the “Patient Access to Cellular
Transplant Act” (S. 1268 and H.R. 2498). This legislation would align the reimbursement
policies used in the bone marrow, cord blood, and peripheral blood stem cell (cellular)
transplant context with that used in the solid organ.
As we have discussed, the current Medicare payment policy has created a barrier to
access for patients for whom one of these cellular transplants is their only hope for a
cure. We ask that CMS work directly with the Congress to pass the PACT Act quickly by
highlighting its passage as an Administrative priority to Congressional leadership.
We continue to hear through our federally-mandated Office of Patient Advocacy that the
financial losses transplant hospitals incur are placing them in the difficult position of
potentially having to stop providing transplants to Medicare beneficiaries. While the
majority of transplant centers are trying to maintain access for Medicare beneficiaries,
there is no question that unless this problem is fixed these patients will have limited
access to these transplants and could be forced into expensive, likely futile, alternative
treatment options. In most cases, no access to transplant will result in death.
The desire to ensure access to medically necessary cellular transplant for those
Medicare beneficiaries in need should be a high priority for the Medicare program, as it
was, and continues to be, the case for solid organs. Communicating that this is a priority
would be extremely helpful in achieving passage of this legislation this summer.
Conclusion
Thank you again for providing us with the opportunity to provide comments on the
proposed rule. We look forward to being a resource for CMS on any cellular therapy
issues, particularly around Medicare beneficiary access to care. Please feel free to
contact me with any questions at blindber@nmdp.org or (763) 406-8566, or contact
Susan Leppke at sleppke@nmdp.org or (763) 406-8522.
Sincerely,

Brian L. Lindberg, JD
Chief Policy Officer

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