Car T-Cell Therapy NCD Updates – Industry News, December 2022

CAR T-cell NCD Updates

The implementation of the initial Chimeric Antigen Receptor (CAR) T-cell Therapy National Coverage Determination (NCD) 110.24 in 2019 only allowed CAR-T claims in Part A inpatient and hospital-affiliate place of service (POS) that were Risk Evaluation and Mitigation Strategies (REMS) approved.

Recognizing a gap in processing CAR-T claims in the Part B physician office setting, CMS has published MLN Matters® article MM12928. The article addresses the constraint in claims processing in the current Multi-Carrier System (MCS) because the field length for the dollar amount in MCS is only 7 digits (line item or total maximum is 99999.99). To bill CAR-T claims correctly in the Part B setting, CMS has advised to divide the CAR-T HCPCS codes by 10 and bill in 0.1-unit fractions

Additionally, CMS outlines the need for the use of three modifiers:

  • Modifier -LU: Fractionalized payment CAR T-cell therapy
  • Modifier -76: Repeat procedure or service by same physician or other qualified healthcare professional
  • Modifier -KX: Requirements specified in the medical policy have been met

The new HCPCS modifier -LU was included in the January 2023 HCPCS Update. The use of the modifier is retroactive for use on claims with dates of service on or after January 1, 2022.

ASTRO, ACR Express Disappointment in Omnibus

The American Society for Radiation Oncology (ASTRO) and the American College of Radiology® (ACR®) expressed their dissatisfied opinion over the radiation oncology and imaging cuts in the 2023 omnibus bill.

While the omnibus bill does include measures to reduce some of the Medicare physician pay cuts, which were finalized in the Medicare Physician Fee Schedule (MPFS) 2023 final ruling and set to take effect January 1, 2023, the specialty societies take issue with the update in conversion factor (CF) within the bill. The legislation set the conversion factor increase of 2.5% in 2023 and 1.25% in 2024, significantly lower than the advocated 4.5% increase by the medical community.

“…we are disappointed Congress has not protected patient access to care by fully offsetting these added cuts.” Said Jacqueline A Bello, MD, FACR, chair of the ACR Board of Chancellors in a statement.

ASTRO stressed the significance of the 2% reduction to Medicare physician payments conversion factor for 2023 with an added stress to radiation oncology reflecting an additional 1% decrease due to clinical labor price changes. ASTRO is urging the new Congress to begin much needed payment reform discussions to create a new payment approach for radiation therapy services. “Radiation oncology has faced among the most significant cuts of any medical specialty, leaving community-based clinics at the breaking point.” – ASTRO

340B Drug Program Modifiers

CMS will continue to require 340B hospitals to report modifiers “JG” and “TB” in calendar year (CY) 2023 for informational purposes. While required to be reported, the modifiers will not affect payment rates, claims identified with the modifiers will be paid at the same rate as non-340B drugs and biologicals, average sales price (ASP) +6%. The revised modifier definitions are below.

Modifier Description
JG Drug or biological acquired with 340b drug pricing program discount, reported for informational purposes
TB Drug or biological acquired with 340b drug pricing program discount, reported for informational purposes for select entities

Rural sole community hospitals, children’s hospitals, and PPS-exempt cancer hospitals will continue to report modifier “TB” for drug acquired through the 340B Program. All other 340B providers will continue to bill modifier “JG.”

Drug Waste Explained

Identifying the discarded drug amount in single dose vial or packages is required of providers by Medicare contractors. Since 2017, all providers including those in hospitals, freestanding centers, and physician offices have been required to report drug waste from single-use packaging with modifier JW, and then are reimbursed for both the administered and discarded amount.

When billing for drug waste from single-use containers or vials, the provider must report the drug administered on the claim as two separate charges: one claim line for the amount administered (with no modifier), and one claim line with the discarded drug amount and the JW modifier.

Data approximates Medicare paid nearly $720 million for drug waste from single-dose containers under Part B and with use of modifier JW. A large percentage are drug doses based on patient weight or body surface. The Infrastructure Investment and Jobs Act requires manufactures to provide a refund to CMS for certain discarded amounts from single-use packaged drugs as signed into law in November 2021.

While CMS requires manufacturers to provide refunds for discarded amounts of applicable refundable single-dose container or single-use package drugs, they understand the JW modifier has historically been underreported or omitted from claims, which would impact accurately calculating refunds by manufacturers. Therefore, for dates of service on or after January 1, 2023, modifier JW will be required on claims for all single-dose container or single-use drugs when any amount is discarded.

Additionally, CMS will require modifier JZ to be appended to the drug code when there were no discarded amounts from the single-dose or single-use package. CMS had delayed the requirement to report modifier JZ in order to allow providers time to incorporate necessary updates to their claims system. If by October 1, 2023, a provider cannot report the JW and JZ modifiers as required, CMS instructs claims should be held until they are able to do so as claims without the appropriate modifiers after this date will not be accepted and returned as non-processable.


JW – Drug amount discarded/not administered to any patient
JZ – Zero drug amount discarded/not administered to any patient

Single-use vials, are defined by The Centers for Disease Control (CDC) as:

A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.

CMS Proposes to Standardize Attachment Transactions and Signature Process

On December 21, 2022, CMS, on behalf of the U.S. Department of Health and Human Services (HHS) released a proposed rule entitled, Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard (CMS-0053-P).

The proposed rule would adopt standards for “healthcare attachments” transactions, such as medical charts, x-rays, and provider notes that contain documentation of physician referrals and office or telemedicine visits. The proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions would support healthcare claims and prior authorization proceedings, standards for electronic signatures used with healthcare attachments, and update the standard for the referral certification and authorization transaction.

It is estimated the proposed rule, if finalized, could save approximately $454 million annually in administrative costs as the current manual processes include utilizing mail, fax, or internet web portals when physicians respond to requests from health plans.

The rule aims to make it easier to submit and adjudicate healthcare claims by providing structured, standardized electronic data to payers. Additionally, the rule proposes to modify the standard for referral certification and authorization transaction, which would reduce potential barriers to implementing value-based payments and further help to reduce “unnecessary administrative costs” according to CMS.

CMS will accept comments until March 22, 2023, and encourages all interested members of the public, particularly patients and their families, providers, clinicians, consumer advocates, health plans, and health care professional associations.


Within the past year and a half, two radioactive diagnostic agents have received Food and Drug Administration (FDA) approval for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions, in med with prostate cancer.

Piflufolastat (F-18) (Pylarify) and Gallium 68 PSMA-11 (Ga 68 gozetotide) (Locametz®/Illuccix®) are similar diagnostic agents with slightly varying FDA indications.

The FDA indications for Pylarify are:

  • PSMA positive lesions in men with prostate cancer:
    • With suspected metastasis who are candidates for initial definitive therapy
    • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.

The FDA indications for Locametz®/Illuccix® are:

  • PSMA positive lesions in men with prostate cancer
    • With suspected metastasis who are candidates for initial definitive therapy
    • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
    • For selection of patients with metastatic prostate cancer, for whom lutetium LU 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

The appropriate radiopharmaceutical HCPCS code (below) is expected to be reported on the same date of service as the PSMA PET scan, which should not be used without prostate cancer present.

A9595 Piflufolastat f-18, diagnostic, 1 mCi .
A9800 Gallium Ga-68 gozetotide, diagnostic, (Locametz), 1 mCi

To ensure the clinical scenario aligns with FDA label indications and appropriate use criteria for PSMA focused diagnostic PET scans, all ICD-10-CM codes that most appropriately described the patient’s clinical condition, symptoms, and documented findings should be reported.

PSMA and Lutetium Lu 177 treatment

Lutetium Lu 177 (Pluvicto™) is a targeted radioligand therapy (RLT) for treatment of progressive, PMSA positive metastatic castration-resistant prostate cancer. RLT combines a targeting compound (ligand) with a therapeutic radioisotope. Lutetium Lu 177 standard dosing is 200mCi each 6 weeks for up to 6 doses.

Coverage Requirements per FDA Approval for Lu 177 treatment:

  • Metastatic castration-resistant prosate cancer
  • Progression after standard treatments
    • Androgen receptor inhibitor (ex. Flutaminde)
    • Taxane based chemotherapy (ex. Taxotere)
  • Requires PSMA-positive PET scan

New EOM Factsheets Available

With an anticipated launch date of July 1, 2023, the Enhancing Oncology Model (EOM) aims to enhance the quality of care to beneficiaries undergoing chemotherapy while reducing Medicare fee-for-service (FFS) spending by building on insights form the Oncology Care Model (OCM).

The EOM Team continually evaluates feedback to develop additional resources to prepare stakeholders for EOM’s launch. They have released two new resources on the EOM website: