A retroactive effective date of April 1 has been assigned to a newly introduced code.
The Centers for Medicare & Medicaid Services (CMS) has released the results of its review cycle for drug and biological HCPCS Level II codes in the first quarter of 2023. Out of the 36 applications received, 23 have been approved by CMS and will be included in the July 2023 quarterly update with an effective date of July 1, 2023. However, there is one code which will have a different effective date, as an exception to the rest.
In addition, CMS has released a catalogue of HCPCS Level II codes that cover FDA-approved products under the 505(b)(2) new drug application (NDA) or biologics license application (BLA) process, along with products that are not classified under any other category (NEC).
Late Entry for April 2023 Update
A new code has been introduced by CMS for a blood clotting factor product, which will take effect from April 1, 2023, owing to its unique programmatic requirements in hospital outpatient settings. HEMGENIX®, which received FDA approval in November 2022, is the first and only one-time gene therapy for adults with hemophilia B, according to the applicant, CSL Behring, LLC. This drug is intended for use as a one-time treatment in adults with hemophilia B who currently rely on Factor IX prophylaxis therapy, have experienced life-threatening hemorrhages, or have suffered repeated, serious spontaneous bleeding episodes in the past.
Per therapeutic dose, the injection for etranacogene dezaparvovec-drlb is identified as J1411
New Codes for July 2023 Update
The rest of the new codes established during the first quarter 2023 drug and biological review cycle will go into effect July 1, 2023.
J9347 Injection, tremelimumab-actl, 1 mg
J2329 Injection, ublituximab-xiiy, 1 mg
J9029 Injection, nadofaragene firadenovec-vncg, per therapeutic dose
Q5131 Injection, adalimumab-aacf (idacio), biosimilar, 20 mg J9063, “Injection, mirvetuximab soravtansine-gynx, 1 mg
J9350 Injection, mosunetuzumab-axgb, 1 mg
J1440 Fecal microbiota, live -jslm, 1 ml
J9380 Injection, teclistamab-cqyv, 0.5 mg
Discontinue C9148, “Injection, teclistamab-cqyv, 0.5 mg
J9381 Injection, teplizumab-mzwv, 5 mcg
Discontinue C9149, “Injection, teplizumab-mzwv, 5 mcg
J9058 Injection, bendamustine hydrochloride (apotex), 1 mg
J9259 Injection, paclitaxel protein-bound particles (american regent) not therapeutically equivalent to j9264 1 mg
J2249 Injection, remimazolam, 1 mg
J9059 Injection, bendamustine hydrochloride (baxter), 1 mg
J9056 Injection, bendamustine hydrochloride (vivimusta), 1 mg
J2561 Injection, phenobarbital sodium (sezaby), 1 mg
J1961 Injection, lenacapavir, 1 mg
J9323 Injection, pemetrexed (hospira) not therapeutically equivalent to j9305, 10 mg
J2806 Injection, sincalide (maia) not therapeutically equivalent to j2805, 5 micrograms
Q4278 Epieffect, per square centimeter
Q4276 Orion, per square centimeter
Q4277 Woundplus membrane or e-graft, per square centimeter
Q4280 Xcell amnio matrix, per square centimeter
Q4282 Cygnus dual, per square centimeter
Q4281 Barrera sl or barrera dl, per square centimeter
Q4272 Esano a, per square centimeter
Q4273 Esano aaa, per square centimeter
Q4274 Esano ac, per square centimeter
Q4275 Esano aca, per square centimeter
Q4283 Biovance tri-layer or biovance 3l, per square centimeter
Q4284 Dermabind sl, per square centimeter
CMS is set to receive feedback on the code descriptors’ language during an upcoming biannual public meeting and will release an official quarterly update before July 1. In the case of drugs with multiple administration routes, CMS advises using modifier JA for intravenous infusion or modifier JB for subcutaneous injection. Any inquiries regarding coverage should be directed to the payer.
Additionally, CMS is introducing 27 new HCPCS Level II codes, which are aimed at distinguishing products that have been approved through the 505(b)(2) NDA or the BLA process. The list of these codes can be found in Appendix A of the April 27 announcement.