April 2019 OPPS Update

on Tuesday, 26 March 2019. All News Items | Outpatient Services | Billing

A Communication Tool

A healthcare claim form is a form which providers of services (hospitals, physicians, etc.) use to tell payors of services (Medicare, Medicaid, commercial payors, etc.) what items, tests, and services were provided to the patient and to request payment for those services. In other words, it is a communication tool between the provider of services and the payor of services that says, “this is what we did; please pay us.” In addition to this basis request for payment, it is sometimes used to communicate other information about the services that may affect payment immediately, or may allow the payors to gather data they could use to affect payment down the road. Medicare, as the largest healthcare payor, provides lots of claim-processing instructions, such as the quarterly updates to the Medicare Outpatient Prospective Payment System (OPPS).

Two of the bigger news items from the April 2019 OPPS Update are instructions on billing for (CAR) T-cell Therapy and reporting of the ER modifier for services performed in an off-campus provider-based emergency department. Along with these items are the other code updates and changes of the types that usually appear in the quarterly updates.

Chimeric Antigen Receptor (CAR) T- Cell Therapy

Chimeric Antigen Receptor (CAR) T- Cell Therapy is a new cancer treatment. To understand billing, you have to have an idea of how the therapy works. The CMS transmittal describes it as:

(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.

In February, CMS released a proposed decision memo that would allow coverage of (CAR) T-Cell therapy under Coverage with Evidence Development (CED) (see a prior Wednesday@One article for more information on the proposed coverage). Until that decision memo is made final, there is no national Medicare policy for covering CAR T-cell therapy, so local Medicare Administrative Contractors (MACs) have discretion over whether to pay for it. The drugs associated with this treatment are currently payable as pass-through drugs and there is also a payable code for the administration of CAR T-cells in the hospital outpatient setting.

HCPCS CodeLong DescriptionStatus Indicator
Q2041 Axicabtagene ciloleucel, up to 200 million autologous anticd 19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Yescarta) G
Q2042 Tisagenlecleucel, up to 600 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Kymriah) G
0540T Chimeric antigen receptor t-cell (car-t) therapy; car-t cell administration, autologous S

Although there are CPT codes for the collection and preparation of the CAR T-cells, Medicare does not generally pay separately for each step used to manufacture a drug or biological. The drug codes above also clearly specify that leukapheresis and dose preparation are included. Because of this, the collection and preparation codes were assigned a status indicator of “B” (Codes that are not recognized by OPPS) and were not to be reported on an outpatient hospital Part B bill type (12x and 13x). Medicare has now decided that in order to track utilization and cost data, they will allow the reporting of these non-payable codes on the claim as non-covered services.  Effective for claims received on or after April 1, 2019, providers should report the following CPT codes, associated revenue codes, and value code when these services are provided.

HCPCS CodeLong DescriptionStatus Indicator
0537T Chimeric antigen receptor t-cell (car-t) therapy; harvesting of blood-derived t lymphocytes for development of genetically modified autologous car-t cells, per day B
0538T Chimeric antigen receptor t-cell (car-t) therapy; preparation of blood-derived t lymphocytes for transportation (eg, cryopreservation, storage) B
0539T  Chimeric antigen receptor t-cell (car-t) therapy; receipt and preparation of car-t cells for administration B

These services may be reported as non-covered charges on the outpatient claim. Also, hospitals may report the CAR T-cell related revenue codes 087X (Cell/Gene Therapy) and 089X (Pharmacy) as well as new value code 86 (Invoice Cost) established by the NUBC on hospital outpatient department claims.

The transmittal even gives examples of what should be reported in different scenarios:

  • CAR T-cells collected, prepared and given in hospital outpatient department
    • Report the appropriate drug code (Q2041 or Q2042) and the administration code (0540T) as covered services
    • Report 0537T, 0538T, and 0539T codes and charges as non-covered
  • CAR T-cells collected and prepared in hospital outpatient department, but not given
    • Report 0537T, 0538T, and 0539T codes and charges as non-covered
  • CAR T-cells collected and prepared in hospital outpatient department, given in subsequent inpatient admission
    • Report charges associated with services described by CPT codes 0537T, 0538T, and 0539T under revenue code 0891 (Special Processed Drugs – FDA Approved Cell Therapy - Charges for Modified cell therapy) on inpatient claim (11x type of bill)
    • Do NOT report drug codes (Q20140 or Q2042) when CAR T-cells are given to inpatients

Modifier “ER”

Another new reporting requirement solely for the benefit of allowing Medicare to collect utilization data is the new modifier “ER.” Hospitals are required to report this modifier on all services provided in an off-campus provider-based emergency department. Additional information about the “ER” modifier:

  • Effective January 1, 2019;
  • Report on every claim line that contains a CPT/HCPCS code for an outpatient hospital service furnished in an off -campus provider-based emergency department;
  • Report on UB-04 (Form 1450) for hospital outpatient services;
  • Not required to be reported by critical access hospitals (CAHs);
  • For off-campus provider-based emergency departments that meet the definition of “a dedicated emergency department”, that is they are:
    • Licensed by the State as an emergency department; OR
    • Held out to the public (by name, posted signs, advertising, or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; OR
    • They provide at least one-third of all of their outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

As if it is not hard enough to report all the codes for which you do get paid, Medicare sometimes requires that we report codes for which there is no payment. Bummer!

Other code updates from the April 2019 OPPS Update are listed in the table below.

April 2019 OPPS Code Updates
HCPCS Code Descriptor OPPS Status IndicatorEffective DateDescription of Change
0080U  Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors (age, smoking status, nodule diameter, nodule-spiculation status and nodule location), utilizing plasma, algorithm reported as a categorical probability of malignancy Q4 January 1, 2019 New Proprietary Laboratory Analyses (PLA) CPT Codes
0081U  Oncology (uveal melanoma), mRNA, gene-expression profiling by real-time RT-PCR of 15 genes (12 content and 3 housekeeping genes), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis A January 1, 2019 New Proprietary Laboratory Analyses (PLA) CPT Codes
0082U  Drug test(s), definitive, 90 or more drugs or substances, definitive chromatography with mass spectrometry, and presumptive, any number of drug classes, by instrument chemistry analyzer (utilizing immunoassay), urine, report of presence or absence of each drug, drug metabolite or substance with description and severity of significant interactions per date of service Q4 January 1, 2019 New Proprietary Laboratory Analyses (PLA) CPT Codes
0083U  Oncology, response to chemotherapy drugs using motility contrast tomography, fresh or frozen tissue, reported as likelihood of sensitivity or resistance to drugs or drug combinations Q4 January 1, 2019 New Proprietary Laboratory Analyses (PLA) CPT Codes
81538 Oncology (lung), mass spectrometric 8-protein signature, including amyloid a, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival A January 1, 2019 Approved as an ADLT (Advanced Diagnostic Laboratory Test)
C9040  Injection, fremanezumab-vfrm, 1mg  G April 1, 2019 New HCPCS Code
C9041  Injection, coagulation factor Xa (recombinant), inactivated (andexxa), 10mg G April 1, 2019 New HCPCS Code
C9141  Injection, factor viii, (antihemophilic factor, recombinant), pegylated-aucl (jivi) 1 i.u. G April 1, 2019 New HCPCS Code
C9043  Injection, levoleucovorin, 1 mg G April 1, 2019 New HCPCS Code
C9044  Injection, cemiplimab-rwlc, 1 mg G April 1, 2019 New HCPCS Code
C9045  Injection, moxetumomab pasudotox-tdfk, 0.01 mg  G April 1, 2019 New HCPCS Code
C9046  Cocaine hydrochloride nasal solution for topical administration, 1 mg G April 1, 2019 New HCPCS Code
Q5108  Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg from K to G April 1, 2019 New Pass-Through Drug Status
J3245  Injection, tildrakizumab, 1 mg from E2 to G April 1, 2019 New Pass-Through Drug Status
Q5110  Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram from K to G April 1, 2019 New Pass-Through Drug Status
Q5111  Injection, Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg from K to G April 1, 2019 New Pass-Through Drug Status
Q4183  Surgigraft, 1 sq cm N April 1, 2019 Skin Substitute reclassified from low to high cost
Q4184  Cellesta, 1 sq cm N April 1, 2019 Skin Substitute reclassified from low to high cost
Q4194  Novachor 1 sq cm N April 1, 2019 Skin Substitute reclassified from low to high cost
Q4203  Derma-gide, 1 sq cm N April 1, 2019 Skin Substitute reclassified from low to high cost

 

Article by Debbie Rubio

Debbie Rubio, BS, MT (ASCP), is the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc.  Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system.  In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers.  You may contact Debbie at This email address is being protected from spambots. You need JavaScript enabled to view it..

This material was compiled to share information.  MMP, Inc. is not offering legal advice.  Every reasonable effort has been taken to ensure the information is accurate and useful.

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