[Ip-health] New medicare rules for CAR T payments

James Love james.love at keionline.org
Sat Dec 1 00:23:03 PST 2018


$50 to someone who can explain to me what this means.

Jamie

https://www.federalregister.gov/documents/2018/11/21/2018-24243/medicare-program-changes-to-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center

Medicare Program: Changes to Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting Programs

Final rule with comment period.

4. CHIMERIC ANTIGEN RECEPTOR T-CELL (CAR T) THERAPY (APCS 5694, 9035, AND
9094)

Chimeric Antigen Receptor (CAR) T-cell therapy is a cell-based gene therapy
in which T-cells are collected and genetically engineered to express a
chimeric antigen receptor that will bind to a certain protein on a
patient's cancerous cells. The CAR T-cells are then administered to the
patient to attack certain cancerous cells and the individual is observed
for potential serious side effects that would require medical intervention.

Two CAR T-cell therapies received FDA approval in 2017. KYMRIAH®
(manufactured by Novartis Pharmaceuticals Corporation) was approved for use
in the treatment of patients up to 25 years of age with B-cell precursor
acute lymphoblastic leukemia (ALL) that is refractory or in second or later
relapse. In May 2018, KYMRIAH® received FDA approval for a second
indication, treatment of adult patients with relapsed or refractory large
B-cell lymphoma after two or more lines of systemic therapy, including
diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and
DLBCL arising from follicular lymphoma. YESCARTA® (manufactured by Kite
Pharma, Inc.) was approved for use in the treatment of adult patients with
relapsed or refractory large B-cell lymphoma and who have not responded to
or who have relapsed after at least two other kinds of treatment.

As indicated in the CY 2019 OPPS/ASC proposed rule (83 FR 37114), the HCPCS
code to describe the use of KYMRIAH® (HCPCS code Q2040) has been active
since January 1, 2018 for OPPS, and the HCPCS code to describe the use of
YESCARTA® (HCPCS code Q2041) has been active since April, 1, 2018 for OPPS.
The HCPCS coding for the currently approved CAR T-cell therapies include
leukapheresis and dose preparation procedures because these services are
included in the manufacturing of these biologicals. Both of these CAR
T-cell therapies were approved for transitional pass-through payment
status, effective April 1, 2018. The HCPCS codes that describe the use of
these CAR T-cell therapies were assigned status indicator “G” in Addenda A
and B to the CY 2019 OPPS/ASC proposed rule.

As discussed in section V.A.4. (Drugs, Biologicals, and
Radiopharmaceuticals with New or Continuing Pass-Through Payment Status in
CY 2019) of this final rule with comment period, we are finalizing our
proposal to continue pass-through payment status for HCPCS code Q2040
(which is being deleted and replaced with HCPCS code Q2042, effective
January 1, 2019) and HCPCS code Q2041 for CY 2019. In section V.A.4. of
this final rule with comment period, we also are finalizing our proposal to
determine the pass-through payment rate following the standard ASP
methodology, updating pass-through payment rates on a quarterly basis if
applicable information indicates that adjustments to the payment rates are
necessary.

The AMA created four Category III CPT codes that are related to CAR T-cell
therapy, effective January 1, 2019. As listed in Addendum B of the CY 2019
OPPS/ASC proposed rule, we proposed to assign procedures described by these
CPT codes, 0537T, 0538T, 0539T, and 0540T, to status indicator “B” (Codes
that are not recognized by OPPS when submitted on an outpatient hospital
Part B bill type (12x and 13x)) to indicate that the services are not paid
under the OPPS. We note that, these codes were listed as placeholder CPT
codes 05X1T, 05X2T, 05X3T, and 05X4T in both Addendum B and O to the CY
2019 Start Printed Page 58905OPPS/ASC proposed rule. Addendum B listed the
short descriptor, with the proposed status indicator of “B”, while Addendum
O listed the complete long descriptors under placeholder CPT codes 05X1T,
05X2T, 05X3T, and 05X4T. The final CPT codes and long descriptors, with
their respective proposed OPPS status indicators, are listed in Table 23 at
the end of this section.

At the summer 2018 meeting of the HOP Panel, the HOP Panel recommended that
CMS reassign the status indicator for procedures described by these
specific CPT codes from “B” to “S”. The Panel further recommended that CMS
assign the procedures described by CPT code 0537T and CPT code 0540T to APC
5242 (Level 2 Blood Product Exchange and Related Services), and the
procedures described by CPT code 0538T and CPT code 0539T to APC 5241
(Level 1 Blood Product Exchange and Related Services).

Comment: Some commenters disagreed with the proposed status indicator
assignment of “B” for the procedures described by CPT codes 0537T, 0538T,
0539T, and 0540T, and requested that CMS recognize these procedures and the
services described by the CPT codes under the OPPS and pay separately for
them. Some of these commenters urged CMS to accept and finalize the HOP
Panel's recommendations for assignment of these CPT codes. Commenters
stated that providers may currently use the unlisted code (38999) to bill
for the services described by the new CPT codes because the currently
available CPT codes fail to accurately describe the procedure being
rendered. The commenters indicated that these services are similar to stem
cell transplant services, and suggested that the similarities between
various codes, including similarities between the procedures described by
CPT code 05X1T (0537T) and CPT code 38206 (Blood-derived hematopoietic
progenitor cell harvesting for transplantation, per collection;
autologous), which is assigned to APC 5242 (Level 2 Blood Product Exchange
and Related Services); CPT code 05X2T (0538T) and CPT code 38207
(Transplant preparation of hematopoietic progenitor cells; cryopreservation
and storage), which is assigned to APC 5241 (Level 1 Blood Product Exchange
and Related Services); CPT code 05X3T (0539T) and CPT code 38208
(Transplant preparation of hematopoietic progenitor cells; cryopreservation
and storage; thawing of previously frozen harvest, without washing, per
donor), which is assigned to APC 5241 (Level 1 Blood Product Exchange and
Related Services), and finally CPT code 05X4T (0540T) and CPT code
38241(Hematopoietic progenitor cell (hpc); autologous transplantation),
which is assigned to APC 5242 (Level 2 Blood Product Exchange and Related
Services), be validly recognized and considered when determining applicable
policy and assignments.

A few commenters believed that there are possible similarities between the
CAR T-cell procedure CPT code 0540T and chemotherapy codes, in general.
However, other commenters asserted that CAR T-cell services were distinct
from the services associated with chemotherapy and stem cell transplant
codes, but noted that the codes suggested were the best available
approximations for payment at present and could provide useful benchmarks
of resource utilization. Some commenters also supported the creation of a
new Autologous HCT C-APC to adequately compensate providers for providing
CAR T-cell related services. Some commenters requested that the existing
Q-codes for CAR T-cell therapies be revised to reference only the CAR
T-cell products, and that leukapheresis and other services related to the
preparation, collection and treatment be separately coded and paid.

A few commenters referenced the National Coverage Decision (NCD) for
apheresis (effective 1992), which provides coverage only under limited
conditions for therapeutic apheresis, and asked CMS to clarify whether it
applies to harvesting blood-derived T-lymphocytes for development of
genetically modified autologous CAR T-cells. Some commenters referenced the
ongoing National Coverage Analysis (NCA) for CAR T-cells, and asked CMS to
provide guidance in the interim on how to bill for CAR T-cells and its
therapies' administration.

The commenters also suggested additional modifications to HCPCS codes Q2040
and Q2041, such as adopting HCPCS J-codes instead of HCPCS Q-codes. Some
commenters requested guidance on how to bill for specific services,
incomplete services, or partial services related to CAR T-cell therapy,
including but not limited to, billing for pre-infusion steps, billing for
services provided a number of days before the infusion, billing if the CAR
T-cell product is not infused, and billing if services are provided at
different facilities, such as both inpatient and outpatient facilities.

Finally, another commenter supported the proposal not to pay separately for
procedures described by CPT codes 0537T, 0538T and 0539T because the
commenters maintained that payment for these CPT codes and the performance
of the services describe various steps of the manufacturing process and,
therefore, are appropriately included and conveyed in the descriptors of
and the existence of Q-codes for CAR T-cell therapies. The commenter
supported the appropriateness of including these steps in the payment for
the drug as a means to ensure the manufacturer can preserve the integrity
of the process and to maximize the quality of therapy. Finally, one
commenter believed that separate payments for leukapheresis would increase
beneficiary cost-sharing.

Response: We do not believe that separate payment under the OPPS is
necessary for procedures described by CPT codes 0537T, 0538T, and 0539T.
The existing CAR T-cell therapies on the market were approved as biologics
and, therefore, provisions of the Medicare statute providing for payment
for biologicals apply. The procedures described by CPT codes 0537T, 0538T,
and 0539T describe various steps required to collect and prepare the
genetically modified T-cells, and Medicare does not generally pay
separately for each step used to manufacture a drug or biological. We note
that the HCPCS coding for the currently approved CAR T-cell therapy drugs,
HCPCS codes Q2040 and Q2041, includes leukapheresis and dose preparation
procedures because these services are included in the manufacturing of
these biologicals. We also note that, for OPPS billing purposes, the
Q-codes are treated in the same manner as J-codes, and a procedure
assignment conversion to a J-code for payment classification purposes would
not affect payment by Medicare. Q-codes can be updated quarterly, which
allows for greater frequency of modifications and, therefore, we believe
are appropriate for these new therapies. HOPDs can bill Medicare for
reasonable and necessary services that are otherwise payable under the
OPPS, and we believe that the comments in reference to payment for services
provided in settings not payable under OPPS are outside the scope of the
proposed rule.

With respect to NCD 110.14 for apheresis (Therapeutic Pheresis)

(
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=;82&ncdver=1&bc=AAAAgAAAAAAA&),
we note that it refers only to therapeutic treatments where blood is taken
from the patient, processed, and returned to the patient as Start Printed
Page 58906part of a continuous procedure and is distinguished from
situations where a patient is transfused at a later date. With respect to
comments referencing the ongoing NCA for CAR T-cells, we remind readers
that coverage analysis and determination do not determine what code or
payment is assigned a particular item or service, but information on this
NCA and process may be found at:
https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=291.
Accordingly, we are not revising the existing Q-codes for CAR T-cell
therapies to remove leukapheresis and dose preparation procedures, and we
are not accepting the HOP Panel's recommendations for procedures described
by CPT codes 0537T, 0538T and 0539T.

In regard to comments concerning CPT code 0540T, we were persuaded by
commenters that the administration of CAR T-cell services would be more
specifically described by CPT code 0540T. Because CPT code 0540T is a new
code for CY 2019, we do not have any claims data on which to base our
proposed payment rate. In the absence of claims data, we reviewed the
clinical characteristics of the procedures to determine whether they are
similar to existing procedures. After reviewing information from public
commenters and input from our medical advisors, we believe that new CPT
code 0540T is clinically similar to the services assigned to APC 5694
(Level IV Drug Administration), with a proposed payment rate of
approximately $291, such as the procedure described by CPT code 96413
(Chemotherapy administration, intravenous infusion technique; up to 1 hour,
single or initial substance/drug). We acknowledge commenters' supporting
data and indications that CAR T-cell service is complex, distinct from
chemotherapy, and has the potential for highly adverse reactions. However,
we note that CPT's prefatory language for the “Chemotherapy and Other
Highly Complex Drug or Highly Complex Biologic Agent Administration”
section in which the procedure described by CPT code 96413, and some other
services assigned to APC 5694 are listed, describes these procedures as
administration of highly complex drugs or biologic agents with greater
incidence of severe adverse patient reaction. We also note that the unique
toxicities associated with CAR T-cell therapies tend not to occur at time
of infusion, and services to monitor or treat adverse reactions on a
subsequent day would not be included in the procedure described by CPT code
0540T. Therefore, we are accepting the HOP Panel's recommendation and the
commenters' request to reassign the status indicator assignment of the
procedure described by CPT code 0540T from “B” to “S.” However, we are not
accepting the HOP Panel's recommendation and the commenters' request to
assign the procedure described by CPT code 0540T to APC 5242 (Level 2 Blood
Product Exchange and Related Services), but instead are assigning the
procedure described by CPT code 0540T to APC 5694 (Level IV Drug
Administration) for CY 2019. We remind hospitals that every year, we review
the APC assignments for all services and items paid under the OPPS, and we
will reevaluate the APC assignment for the procedures described by CPT code
0540T once sufficient claims data for this code become available.

Comment: Some commenters suggested that separately paying for the services
described by new CPT codes for CAR T-cell therapy under the OPPS would
allow Medicare and others to track utilization and cost data of these
specific services. Some commenters also noted that the National Uniform
Billing Committee (NUBC) established two new revenue codes and a value code
related to CAR T-cell therapy, and expressed support for CMS' creation of a
new CAR T-cell-related cost center (or centers) to assist with tracking CAR
T-cell-related costs.

Response: The existing HCPCS codes for CAR T-cell therapies include both
leukapheresis and dose-preparation procedures, and for the reasons stated
previously, there is no separate payment by Medicare for these steps in the
manufacturing process. However, it will be possible for Medicare to track
utilization and cost data from hospitals reporting these services, even for
codes reported for services in which no separate payment is made. The CAR
T-cell related revenue codes and value code established by the NUBC will be
reportable on HOPD claims, and will be available for tracking utilization
and cost data, effective for claims received on or after April 1, 2019. At
this time, we do not believe that the additional creation by CMS of a new
cost center is necessary as the currently established methods for tracking
CAR T-cell related costs are sufficient. However, we will monitor for this
issue to determine if a distinct cost center should be established in the
future.

Comment: Some commenters noted that HCPCS code Q2040 describes doses of “up
to 250 million” cells, and requested guidance on how to bill for an adult
indication that may require doses of “up to 600 million cells.”

Response: HCPCS code Q2040 (which is being replaced by HCPCS code Q2042,
effective January 1, 2019) is billed only once per infusion. For CY 2019,
we revised the descriptor for HCPCS code Q2042 to describe doses “up to 600
million cells . . . per therapeutic dose.” For CY 2019, we also revised the
descriptor for HCPCS code Q2041, in order to maintain consistency in the
HCPCS coding for CAR T-cells.

In summary, after consideration of the public comments we received, we are
adopting as final, without modification, the proposal to assign status
indicator “B” to CPT codes 0537T, 0538T, and 0539T for CY 2019. We are
revising our proposal and finalizing the policy to assign status indicator
“S” to CPT code 0540T and to assign CPT code 0540T to APC 5694 for CY 2019.
Additionally, for CY 2019, we are assigning status indicator “D” to CPT
code Q2040, status indicator “G” to HCPCS code Q2041, and status indicator
“G” to HCPCS code Q2042, as summarized in Table 22 below. We refer readers
to Addendum B to this final rule with comment period for the payment rates
for all codes reportable under the OPPS. Addendum B is available via the
internet on the CMS website. In addition, we refer readers to Addendum D1
to this final rule with comment period for the complete list of the OPPS
payment status indicators and their definitions for CY 2019.

Start Printed Page 58907

... Table 22

Start Printed Page 58908

.... Table 23


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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