Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

7500 Security Boulevard

Baltimore, Maryland 21244-1850

Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure

Coding System (HCPCS) Application Summaries and Coding Recommendations

Fourth Quarter, 2023 HCPCS Coding Cycle

This document presents a summary of each HCPCS code application and CMS’ coding

decision for each application processed in CMS’ Fourth Quarter 2023 Drug and Biological

HCPCS code application review cycle. Each individual summary includes the request

number; topic/issue; summary of the applicant's submission as written by the applicant with

occasional non-substantive editorial changes made by CMS; and CMS' final HCPCS coding

decision. All new coding actions will be effective April 1, 2024, unless otherwise indicated.

The HCPCS coding decisions below will also be included in the April 2024 HCPCS

Quarterly Update, pending publication by CMS in the coming weeks at:

https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update

For inquiries regarding coverage, please contact the insurer(s) in whose jurisdiction(s)

claim(s) would be filed. Specifically, contact the Medicaid agency in the state in which a

Medicaid claim is filed, the individual private insurance entity, the Department of Veterans

Affairs, or, for local Medicare coverage determinations, contact the Medicare contractor in

the jurisdiction the claim would be filed. For detailed information describing CMS’ national

coverage determination process, refer to information published at

https://www.cms.gov/Medicare/Coverage/DeterminationProcess and

https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.

CMS has a long-standing convention to assign dose descriptors in the smallest amount that

could be billed in multiple units to accommodate a variety of doses and support streamlined

billing. This long-standing policy makes coding more robust and facilitates accurate payment

and reporting of the exact dose administered, as only 999 units can appear on a claim line for

Medicare fee-for-service using the CMS-1500 form. In addition, CMS will use the generic or

chemical name if there are no other similar chemical products on the market. If there are

multiple products on the market with the same generic or chemical name, and a unique code

is warranted based on the statutory definition of “single source drug” in section 1847A(c)(6)

of the Social Security Act, CMS will further distinguish a new code by using the brand name

or manufacturer name. CMS generally creates codes for products themselves, without

specifying a route of administration in the code descriptor, as there might be multiple routes

of administration for the same product. Drugs that fall under this category should be billed

with either JA modifier for the intravenous infusion of the drug or billed with JB modifier for

subcutaneous injection of the drug. The dose descriptors assigned to codes established in this

quarterly coding cycle are in alignment with these policies.

Table of Contents

Final Determinations for the Fourth Quarter 2023 Drug and Biological HCPCS Applications.

1. BALFAXAR® - HCP230914LXYJ9 .................................................................................. 3

2. POMBILITI™ - HCP2309296TFRY .................................................................................. 5

3. OPFOLDA™ - HCP2309293Q0XD ................................................................................... 6

4. VEOPOZ™ - HCP230925FQYFA ...................................................................................... 7

5. EYLEA® HD - HCP230828GPB3B ................................................................................... 8

6. TYRUKO® - HCP230927ENYE4 ...................................................................................... 9

7. TALVEY™ - HCP230829U2RCH ................................................................................... 10

8. ABECMA® - HCP2309298FDFB .................................................................................... 11

9. APHEXDA™ - HCP23092829FLC .................................................................................. 12

10. TOFIDENCE™ - HCP230930EXAUT ............................................................................. 13

11. DAXXIFY™ - HCP230922DBN27 .................................................................................. 14

12. ELFREXIO™ - HCP230922GDMUD .............................................................................. 15

13. ENTYVIO® - HCP2309291G1UY ................................................................................... 16

14. HEPZATO - HCP230929E3F4W ...................................................................................... 17

15. RYKINDO® - HCP23092711Y54 .................................................................................... 18

16. FOCINVEZ™ - HCP2309291Y73D ................................................................................. 19

17. Melphalan Hydrochloride Injection - HCP230928M647F ................................................ 20

18. Cyclophosphamide Injection - HCP230929Y89KX .......................................................... 21

19. BRIXADI™ - HCP230524M0HG0 .................................................................................. 22

20. IZERVAY™ - HCP2309123TW9W ................................................................................. 24

21. YCANTH™ - HCP2308253MDW8 .................................................................................. 25

22. American Amnion™ - HCP231002YT3ER ...................................................................... 26

American Amnion AC™ - HCP231002BLWWV ............................................................ 27

American Amnion AC Tri-Layer™ - HCP231002755DK ................................................ 28

23. Procenta®- HCP231002TYWBY ...................................................................................... 29

24. Sanopellis - HCP2309260RN86 ........................................................................................ 30

25. VIA Matrix - HCP230929HVGKV ................................................................................... 31

26. HCPCS Level II Codes for Various FDA Approvals under the 505(b)(2) or Biologics

License Application (BLA) Pathways and Products “Not Otherwise Classified” -

HCP220517FAENJ ............................................................................................................ 32

27. Appendix A: HCPCS Level II Codes for Products Approved by the FDA Under the

505(b)(2) NDA or BLA Pathways and Products “Not Otherwise Classified” .................. 34

BALFAXAR® - HCP230914LXYJ9

Topic/Issue

Request to establish a new HCPCS Level II code to identify BALFAXAR®.

Applicant’s suggested language: JXXXX, “Prothrombin complex concentrate, human-lans, 1

mcg”

Summary of Applicant's Submission

Octapharma submitted a request to establish a new HCPCS Level II code to identify

BALFAXAR® (Prothrombin complex concentrate, human-lans). BALFAXAR® was

approved by the Food and Drug Administration (FDA) under the Biologics License

Application (BLA) pathway on July 21, 2023. BALFAXAR® is a human plasma-derived,

purified, virus inactivated and nanofiltered non-activated Prothrombin Complex Concentrate

(PCC) containing the coagulation factors II, VII, IX, and X and antithrombotic proteins C and

S. BALFAXAR® is supplied as a lyophilized powder for reconstitution for intravenous use.

The actual potency printed on the vial label represents the potency of factor IX.

BALFAXAR® is sterile, endotoxin-free, and does not contain preservatives. No albumin is

added as a stabilizer, and the excipients are heparin and sodium citrate. The diluent for

reconstitution of the lyophilized powder is sterile water for injection. The administration of

BALFAXAR® provides a rapid increase in plasma levels of the vitamin K-dependent

coagulation factors (FII, FVII, FIX, FX) and antithrombotic proteins C and S. Together they

are referred to/known as the prothrombin complex. BALFAXAR® can temporarily correct

the coagulation defect of patients with deficiency of one or several of these factors.

Measurement of INR prior to treatment and close to the time of dosing is important because

coagulation factors may be unstable in patients with need for an urgent surgery and other

invasive procedures. The dosing for BALFAXAR® is individualized based on the patient’s

current pre-dose international normalized ratio (INR) value, and body weight. The actual

potency per vial of factor IX is stated on the carton. The potencies of factors II, VII, IX and

X, proteins C and S are indicated as ranges. Vitamin K is administered concurrently to

patients receiving BALFAXAR® to maintain vitamin K-dependent clotting factor levels once

the effects of BALFAXAR® have diminished. Dose ranging within pre-treatment INR

groups has not been studied in randomized clinical trials of BALFAXAR®. Intravenous

BALFAXAR® is a sterile, white to ice-blue lyophilized powder for reconstitution for

intravenous use. It is provided in a single-dose vial with a nominal strength of 500 factor IX

units in 20 mL reconstitution volume and 1000 Factor IX units in 40 mL reconstitution

volume per vial.

CMS Final HCPCS Coding Decision

1. Establish a new HCPCS Level II code J7165, “Injection, prothrombin complex

concentrate, human-lans, per i.u. of factor ix activity”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9159, “Injection, prothrombin complex

concentrate (human), balfaxar, per i.u. of factor ix activity”

Effective March 31, 2024

POMBILITI™ - HCP2309296TFRY

Topic/Issue

Request to establish a new HCPCS Level II code to identify POMBILITI™.

Applicant's suggested language: JXXXX, “Injection, cipaglucosidase alfa-atga

(POMBILITI), per 5 mg”

Summary of Applicant's Submission

Amicus Therapeutics submitted a request to establish a new HCPCS Level II code to identify

POMBILITI™ (cipaglucosidase alfa-atga). POMBILITI™ was approved by the Food and

Drug Administration (FDA) under the Biologics License Application (BLA) pathway on

September 28, 2023. POMBILITI™ is a hydrolytic lysosomal glycogen specific enzyme that,

in combination with OPFOLDA™, is indicated for the treatment of adult patients with late-

onset Pompe disease, weighing ≥40 kg and who are not improving on their current enzyme

replacement therapy. Pompe disease is caused by deficiency of the lysosomal enzyme acid-

alpha glucosidase (GAA). Deficiency of GAA leads to the accumulation of glycogen in the

lysosomes of various tissues which leads to progressive loss of muscle and respiratory

function. POMBILITI™, which must be used in combination with the enzyme stabilizer

OPFOLDA™, provides an exogenous source of GAA to degrade accumulated glycogen.

POMBILITI™ is internalized into cells and is transported into the lysosome where it can

degrade the accumulated glycogen. OPFOLDA™ binds with, stabilizes, and reduces

inactivation of POMBILITI™ in the blood after infusion. The recommended dosage of

POMBILITI™ is 20 mg/kg (of actual body weight) administered every other week as an

intravenous infusion over approximately 4 hours. The POMBILITI™ infusion should begin

approximately 1 hour after, but no more than 3 hours after, oral administration of

OPFOLDA™. If the POMBILITI™ infusion cannot be started within 3 hours of oral

administration of OPFOLDA™, it should not be administered. POMBILITI™ is packaged in

105 mg single-dose vials for reconstitution.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J1203, “Injection, cipaglucosidase alfa-atga, 5 mg”

OPFOLDA™ - HCP2309293Q0XD

Topic/Issue

Request to establish a new HCPCS Level II code to identify OPFOLDA™.

Applicant's suggested language: JXXXX, “Miglustat (OPFOLDA™), oral, 65 mg”

Summary of Applicant's Submission

Amicus Therapeutics submitted a request to establish a new HCPCS Level II code to identify

OPFOLDA™ (miglustat). OPFOLDA™ was approved by the Food and Drug Administration

(FDA) under a 505(b)(2) New Drug Application (NDA) on September 28, 2023.

OPFOLDA™ is approved for use in combination with POMBILITI™ (cipaglucosidase alfa-

atga) injection, as a treatment for late onset Pompe disease (LOPD). Pompe disease is caused

by deficiency of the lysosomal enzyme acid-alpha glucosidase. OPFOLDA™ is a N-

alkylated iminosugar, a synthetic analog of D-glucose. The pharmacologic class is enzyme

stabilizer. OPFOLDA™ is indicated, in combination with POMBILITI™, for the treatment

of adult patients with LOPD, weighing ≥ 40 kg and who are not improving on their current

enzyme replacement therapy. OPFOLDA™ binds with, stabilizes, and reduces inactivation of

POMBILITI™ in the blood after infusion. The recommended dosage of OPFOLDA™ (based

on actual body weight) is 260 mg (4 capsules) for patients weighing ≥ 50 kg and 195 mg (3

capsules) for patients weighing ≥ 40 kg and < 50 kg. For patients with moderate or severe

renal impairment, the recommended dose is 195 mg (3 capsules) for patients weighing > 50

kg and 130 mg (2 capsules) for patients weighing ≥ 40 kg and < 50 kg. OPFOLDA™ is

administered orally every other week approximately 1 hour before the start of each

POMBILITI™ infusion (also administered every other week). Prior to administration of

OPFOLDA™, the patient must fast for at least two hours. This fast should continue for two

hours after OPFOLDA™ administration. If the POMBILITI™ infusion cannot be started

within 3 hours of oral administration of OPFOLDA™, POMBILITI™ in combination with

OPFOLDA™ should be rescheduled at least 24 hours after OPFOLDA™ was last taken.

OPFOLDA™ is supplied in 65 mg capsules, packaged in a 4-count bottle, a 25-count bottle,

or a 100-count bottle.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J1202, “Miglustat, oral, 65 mg”

To facilitate beneficiary access treatment of late-onset Pompe disease with miglustat in

combination with cipaglucosidae alfa-atga, we are creating a new code, G0138, describing

the service of administration of cipaglucosidase alfa-atga (Pombiliti), which includes the

intravenous administration of cipaglucosidase alfa-atga, the provider or supplier’s acquisition

cost of miglustat, clinical supervision, and oral administration of miglustat.

Establish a new HCPCS Level II code G0138, “Intravenous infusion of cipaglucosidase alfa-

atga, including provider/supplier acquisition and clinical supervision of oral administration of

miglustat in preparation of receipt of cipaglucosidase alfa-atga”

VEOPOZ™ - HCP230925FQYFA

Topic/Issue

Request to establish a new HCPCS Level II code to identify VEOPOZ™.

Applicant's suggested language: JXXXX, “pozelimab-bbfg (VEOPOZ), 1mg”

Summary of Applicant's Submission

Regeneron submitted a request to establish a new HCPCS Level II code to identify

VEOPOZ™ (pozelimab-bbfg). VEOPOZ™ was approved by the Food and Drug

Administration under the Biologics License Application (BLA) pathway on August 18, 2023.

VEOPOZ™ is a human, monoclonal immunoglobulin G4^P (IgG4^P) antibody directed

against the terminal complement protein C5 that inhibits terminal complement activation by

blocking cleavage of C5 into C5a (anaphylatoxin) and C5b, thereby blocking the formation of

the membrane-attack complex (C5b-C9, a structure mediating cell lysis). VEOPOZ™ is a

complement inhibitor indicated for the treatment of adult and pediatric patients 1 year of age

and older with CD55-deficient protein-losing enteropathy, also known as CHAPLE disease.

The recommended dose of VEOPOZ™ is a loading dose of 30 mg/kg by intravenous infusion

followed by weekly weight-based doses by subcutaneous injection. Each vial contains 400

mg pozelimab-bbfg in 2 mL of solution with a pH of 5.8.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J9376, “Injection, pozelimab-bbfg, 1 mg”

EYLEA® HD - HCP230828GPB3B

Topic/Issue

Request to establish a new HCPCS Level II code to identify EYLEA® HD.

Applicant's suggested language: JXXXX, “Injection, aflibercept, 8mg”

Summary of Applicant's Submission

Regeneron Pharmaceuticals Inc. submitted a request to establish a new HCPCS Level II code

to identify EYLEA® HD (aflibercept). EYLEA® HD was approved by the Food and Drug

Administration (FDA) under the Biologics License Application (BLA) pathway on August

18, 2023. EYLEA® HD is supplied as 8 mg in 0.07 mL solution and indicated for the

treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular

edema (DME), and diabetic retinopathy (DR). The recommended dose for EYLEA® HD for

nAMD and DME is 8 mg administered by intravitreal injection every 4 weeks (approximately

every 28 days plus or minus 7 days) for the first three doses, followed by 8 mg via intravitreal

injection once every 8 to 16 weeks, plus or minus 1 week. The recommended dose for

EYLEA® HD for DR is 8 mg administered by intravitreal injection every 4 weeks

(approximately every 28 days plus or minus 7 days) for the first three doses, followed by 8

mg via intravitreal injection once every 8 to 12 weeks, plus or minus 1 week. EYLEA® HD

is supplied in two presentations: a vial-only presentation consisting of a single-dose vial

containing a solution of 8 mg in 0.07 mL as the primary container in a carton, and a

convenience-kit presentation consisting of a single-dose vial containing a solution of 8 mg in

0.07 mL co-packaged in a carton with a syringe, filter needle, and injection needle.

CMS Final HCPCS Coding Decision

1. Establish a new HCPCS Level II code J0177, “Injection, aflibercept hd, 1 mg”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9161, “Injection, aflibercept hd, 1 mg”

Effective March 31, 2024

TYRUKO® - HCP230927ENYE4

Topic/Issue

Request to establish a new HCPCS Level II code to identify TYRUKO®.

Applicant's suggested language: QXXXX, “Injection, natalizumab-sztn, biosimilar, (tyruko),

1 mg”

Summary of Applicant's Submission

Sandoz Inc. submitted a request to establish a new HCPCS Level II code to identify

TYRUKO® (natalizumab-sztn). TYRUKO® was approved by the Food and Drug

Administration (FDA) under the Biologics License Application (BLA) pathway on August

24, 2023. It is approved as a biosimilar to TYSABRI® (natalizumab). TYRUKO® is an

integrin receptor antagonist indicated as a monotherapy for the treatment of adults with

relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-

remitting disease, and active secondary progressive disease. TYRUKO® is also indicated for

inducing and maintaining clinical response and remission in adult patients with moderately to

severely active Crohn's disease (CD) who have had inadequate response to, or are unable to

tolerate, conventional CD therapies and inhibitors of tumor necrosis factor alpha.

TYRUKO® is a sterile, preservative-free, colorless and clear to slightly opalescent solution

for dilution prior to intravenous infusion and is supplied as one 300 mg per 15 mL single-

dose vial per carton. TYRUKO® is infused intravenously over one hour, every four weeks.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code Q5134, “Injection, natalizumab-sztn (tyruko),

biosimilar, 1 mg”

TALVEY™ - HCP230829U2RCH

Topic/Issue

Request to establish a new HCPCS Level II code to identify TALVEY™.

Applicant's suggested language: XXXXX, “Injection, talquetamab-tgvs, per mg, for

subcutaneous injection”

Summary of Applicant's Submission

Johnson & Johnson Health Care Systems Inc. submitted a request to establish a new HCPCS

Level II code to identify TALVEY™ (talquetamab-tgvs). TALVEY™ was approved by the

Food and Drug Administration (FDA) under the Biologics License Application (BLA)

pathway on August 9, 2023. TALVEY™ is a bispecific G protein–coupled receptor, family

C, group 5, member D (GPRC5D)-directed CD3 T-cell engager indicated for the treatment of

adult patients with relapsed or refractory multiple myeloma who have received at least four

prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-

CD38 monoclonal antibody. This indication is approved under accelerated approval based on

response rate. Patients receiving TALVEY™ undergo step-up dosing through subcutaneous

injection on either a weekly or biweekly (every two weeks) basis. Patients on the weekly

dosing schedule will receive three priming doses (dosage determined by body weight) during

the five-day step-up phase of treatment. The first step-up dose (0.01 mg/kg) on day 1, a

second step-up dose (0.06 mg/kg) on day 3, a third step-up dose (0.4 mg/kg) on day 5, and

their first treatment dose (0.4 mg/kg) once per week thereafter. Patients on the biweekly

dosing schedule receive four priming doses during the seven-day step-up phase of treatment.

The first step-up dose (0.01 mg/kg) on day 1, the second step-up dose (0.06 mg/kg) on day 3,

the third step-up dose (0.4 mg/kg) on day 5, and the fourth step-up dose (0.8 mg/kg) on day 7,

and treatment doses once every 2 weeks thereafter. Patients must maintain a minimum of 6

days between weekly doses and a minimum of 12 days between biweekly (every two weeks)

doses. TALVEY™ is provided in two dosage forms and strengths: 3 mg/ 1.5 mL (2 mg/mL)

in a single-dose vial and 40 mg/mL (40 mg/mL) in a single-dose vial.

CMS Final HCPCS Coding Decision0F

1. Establish a new HCPCS Level II code J3055, “Injection, talquetamab-tgvs, 0.25 mg”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9163, “Injection, talquetamab-tgvs, 0.25 mg”

Effective March 31, 2024

Revised on February 5, 2024 to correct the code language for C9163.

ABECMA® - HCP2309298FDFB

Topic/Issue

Request to revise existing HCPCS Level II code Q2055, “Idecabtagene vicleucel, up to 460

million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including

leukapheresis and dose preparation procedures, per therapeutic dose” to identify ABECMA®.

Applicant's suggested language: Q2055, “Idecabtagene vicleucel, up to 510 million

autologous b-cell maturation antigen (bcma) directed car-positive t cells, including

leukapheresis and dose”

Summary of Applicant's Submission

Bristol Myers Squibb submitted a request to revise existing HCPCS Level II code Q2055 to

increase the maximum dosage in the code descriptor for ABECMA® (idecabtagene

vicleucel). ABECMA® was approved by the Food and Drug Administration (FDA) under the

Biologics License Application (BLA) pathway on March 26, 2021. The current indication for

ABECMA® is for the treatment of adult patients with relapsed or refractory multiple

myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a

proteasome inhibitor, and an anti-CD38 monoclonal antibody. A supplemental BLA

supporting a new indication for the treatment of adult patients with relapsed or refractory

multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor,

and an anti-CD38 monoclonal antibody and a new recommended dose range of 300 to 510 x

10^6 CAR-positive T-cells was approved by the FDA on April 4, 2024. The route of

administration is intravenous infusion, and ABECMA® is for autologous use. In terms of

packaging, ABECMA® is supplied in one or more infusion bag(s) containing a frozen

suspension of genetically modified autologous T-cells in 5% dimethyl sulfoxide. Each

infusion bag of ABECMA® is individually packaged in a metal cassette.

CMS Final HCPCS Coding Decision1F

Revise existing HCPCS Level II code Q2055, “Idecabtagene vicleucel, up to 460 million

autologous b-cell maturation antigen (bcma) directed car-positive t cells, including

leukapheresis and dose preparation procedures, per therapeutic dose” to instead read Q2055,

“Idecabtagene vicleucel, up to 510 million autologous b-cell maturation antigen (bcma)

directed car-positive t cells, including leukapheresis and dose preparation procedures, per

therapeutic dose.”

Effective April 4, 2024

Revised on April 25, 2024 to update the long descriptor for Q2055 with an effective April 4, 2024.

APHEXDA™ - HCP23092829FLC

Topic/Issue

Request to establish a new HCPCS Level II code to identify APHEXDA™.

Applicant’s suggested language: JXXXX, “Injection, motixafortide, 1 mg”

Summary of Applicant's Submission

BioLineRx, Ltd. submitted a request to establish a new HCPCS Level II code to identify

APHEXDA™ (motixafortide). APHEXDA™ was approved by the Food and Drug

Administration (FDA) under a new drug application (NDA) on September 8, 2023.

APHEXDA™ is a hematopoietic stem cell mobilizer indicated for use in combination with

filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection

and subsequent autologous transplantation in patients with multiple myeloma. For

APHEXDA™, the recommended dosage is 1.25 mg/kg actual body weight, administered via

subcutaneous injection 10 to 14 hours prior to initiation of apheresis. If medically necessary,

a second dose of APHEXDA™ can be administered 10 to 14 hours prior to a third apheresis.

APHEXDA™ is packaged in single use vials of 62 mg as a lyophilized powder in a single-

dose vial for reconstitution prior to patient administration.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J2277, “Injection, motixafortide, 0.25 mg”

TOFIDENCE™ - HCP230930EXAUT

Topic/Issue

Request to establish a new HCPCS Level II code to identify TOFIDENCE™.

Applicant's suggested language: QXXXX, “Injection, tocilizumab-bavi, biosimilar

(tofidence) for intravenous use, 1 mg”

Summary of Applicant's Submission

Biogen Inc. submitted a request to establish a new HCPCS Level code to identify

TOFIDENCE™ (tocilizumab-bavi). TOFIDENCE™ was approved by the Food and Drug

Administration (FDA) under the Biologics License Application (BLA) pathway on

September 29, 2023. It is approved as a biosimilar to ACTEMRA® (tocilizumab).

TOFIDENCE™ is indicated for treatment of patients with rheumatoid arthritis (RA),

polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis

(sJIA). For patients with RA, the recommended starting dose is 4 mg per kg every 4 weeks

followed by an increase to 8 mg per kg every 4 weeks based on clinical response, but doses

exceeding 800 mg per infusion are not recommended. For patients with pJIA, the

recommended dose is 8 mg per kg or 10mg per kg every 4 weeks. For patients with sJIA, the

recommended dose is 8 mg per kg or 12mg per kg every 2 weeks. TOFIDENCE™ is

supplied in single-dose vials containing 80 mg/4 mL, 200 mg/10 mL, or 400 mg/20 mL for

further dilution prior to intravenous infusion.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code Q5133, “Injection, tocilizumab-bavi (tofidence),

biosimilar, 1 mg”

DAXXIFY™ - HCP230922DBN27

Topic/Issue

Request to establish a new HCPCS Level II code to identify DAXXIFY™.

Applicant's suggested language: JXXXX, “daxibotulinumtoxinA-lanm, for injection 0.1mL”

Summary of Applicant's Submission

Revance Therapeutics submitted a request to establish a new HCPCS Level code to identify

DAXXIFY™ (daxibotulinumtoxinA-lanm). DAXXIFY™ was approved by the Food and

Drug Administration (FDA) under a Biologics License Application (BLA) on September 7,

2022, and a supplemental BLA on August 11, 2023. The original indication for DAXXIFY™

is for adults with glabellar lines, which is an aesthetics indication; and the newer indication is

to treat adults with cervical dystonia (CD). For CD, the recommended dose is 125 units to

250 units given intramuscularly as a divided dose among affected muscles. DAXXIFY™ is a

sterile lyophilized powder supplied in a single-dose vial containing 50 units or 100 units.

CMS Final HCPCS Coding Decision

1. Establish a new HCPCS Level II code J0589, “Injection, daxibotulinumtoxina-lanm, 1

unit”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9160, “Injection, daxibotulinumtoxina-lanm, 1

unit”

Effective March 31, 2024

ELFREXIO™ - HCP230922GDMUD

Topic/Issue

Request to establish a new HCPCS Level II code to identify ELFREXIO™.

Applicant’s suggested language: JXXXX, “Injection, elranatamab-bcmm, 1 mg”

Summary of Applicant's Submission

Pfizer, Inc. submitted a request to establish a new HCPCS Level II code to identify

ELREXFIO™ (elranatamab-bcmm). ELFREXIO™ was approved by the Food and Drug

Administration (FDA) under the Biologics License Application (BLA) pathway on August

14, 2023. ELREXFIO™ is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-

cell engager. ELREXFIO™ is indicated for the treatment of adult patients with relapsed or

refractory multiple myeloma who have received at least four prior lines of therapy, including

a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal

antibody. ELFREXIO™ binds BCMA on plasma cells, plasma blasts, and multiple myeloma

cells and CD3 on T-cells leading to cytolysis of the BCMA-expressing cells. ELFREXIO™

activated T-cells, caused proinflammatory cytokine release, and resulted in multiple myeloma

cell lysis. Step-up dose on day 1 of 12 mg and step-up on day 4 of 32 mg may be

administered in the hospital outpatient or inpatient setting. The full treatment dose of 76 mg

weekly, from week 2 to week 24, is administered in the hospital outpatient setting. For

patients who have received at least 24 weeks of treatment with ELREXFIO™ and have

achieved a response, the 76 mg dose interval should transition to an every-2-week schedule

starting on week 25. Treatment should continue with ELREXFIO™ 76 mg until disease

progression or unacceptable toxicity. ELREXFIO™ is administered via subcutaneous

injection only. ELREXFIO™ should be administered by a qualified healthcare professional.

Pre-treatment medications should be administered prior to each dose in the ELREXFIO™

step-up dosing schedule. ELREXFIO™ is supplied at a concentration of 40 mg/mL in either

76 mg/1.9 mL or 44 mg/1.1 mL single-dose vials.

CMS Final HCPCS Coding Decision

1. Establish a new HCPCS Level II code J1323, “Injection, elranatamab-bcmm, 1 mg”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9165, “Injection, elranatamab-bcmm, 1 mg”

Effective March 31, 2024

ENTYVIO® - HCP2309291G1UY

Topic/Issue

Request to revise an existing HCPCS Level II code J3380, “Injection, vedolizumab, 1 mg” to

identify ENTYVIO®.

Applicant’s suggested language: J3380, “injection, vedolizumab, intravenous, 1 mg”

Summary of Applicant's Submission

Takeda Pharmaceuticals America, Inc. submitted a request to revise an existing HCPCS

Level II code J3380, “Injection, vedolizumab, 1 mg” to identify ENTYVIO® (vedolizumab).

ENTYVIO® was approved by the Food and Drug Administration (FDA) under Biologics

License Application (BLA) pathway on May 20, 2014. ENTYVIO® is a humanized

monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting

the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1

(MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1). ENTYVIO®

intravenous (IV) is indicated in adults for the treatment of moderately to severely active

ulcerative colitis (UC) and moderately to severely active Crohn's disease. The recommended

dosage is 300 mg administered via a 30-minute intravenous infusion at 0, 2 and 6 weeks and

then thereafter every 8 weeks. It is packaged in an individual carton containing a 300 mg

single-dose vial. The current HCPCS Level II code and descriptor were first effective on

January 1, 2016. ENTYVIO® injection, for subcutaneous use and ENTYVIO® PEN

injection, for subcutaneous use (referred to collectively as ENTYVIO® SC) were approved

by the FDA on September 27, 2023. ENTYVIO® SC is packaged in an individual carton as

either a single-dose prefilled syringe with needle safety device or a single-dose prefilled pen

that contains 108 mg/0.68 mL solution. Both dosage forms are for use only in adults with UC

in clinical response or remission after at least two initial doses of ENTYVIO® IV. The

recommended ENTYVIO® SC maintenance dosage in UC is 108 mg administered every two

weeks. The ENTYVIO® SC BLA (761133) is separate from the ENTYVIO® IV BLA

(125476). This request is to revise the descriptor for HCPCS Level II code J3380 to make

clear that this HCPCS Level II code is specific to ENTYVIO® IV by distinguishing it from

ENTYVIO® SC.

CMS Final HCPCS Coding Decision

CMS is approving the applicant’s request to revise existing HCPCS Level II code J3380, to

make clear that this HCPCS Level II code is specific to ENTYVIO® IV by distinguishing it

from ENTYVIO® SC, because each of these products is approved under its own BLA,

125476 and 761133 respectively.

Revise existing HCPCS Level II code J3380, “Injection, vedolizumab, 1 mg” to read,

“Injection, vedolizumab, intravenous, 1 mg”

HEPZATO - HCP230929E3F4W

Topic/Issue

Request to establish a new HCPCS Level II code to identify HEPZATO.

Applicant's suggested language: XXXXX, “Injection, melphalan (HEPZATO), 1 mg”

Summary of Applicant's Submission

Delcath Systems Inc. submitted a request to establish a new HCPCS Level II code to identify

HEPZATO (melphalan). HEPZATO™ KIT was approved by the Food and Drug

Administration (FDA) under a 505(b)(2) New Drug Application (NDA) on August 14, 2023.

HEPZATO™ KIT consists of melphalan (HEPZATO) for injection and the hepatic delivery

system (HDS). HEPZATO is an alkylating drug indicated as a liver-directed treatment for

adult patients with uveal melanoma with unresectable hepatic metastases affecting less than

50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone,

lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. The

HDS is used to perform percutaneous hepatic perfusion (PHP), an intensive local hepatic

chemotherapy procedure in which melphalan is delivered intra-arterially to the liver with

simultaneous extracorporeal filtration of hepatic venous blood return (hemofiltration). The

HEPZATO™ KIT allows for isolation of the hepatic arterial inflow and venous outflow,

which allows melphalan to be delivered directly to unresectable liver metastases, while

sparing healthy liver tissue. Patients will receive up to 6 treatments. The recommended dose

is 3 mg/kg based on ideal body weight, with a maximum absolute dose of 220 mg during a

single HEPZATO treatment. The drug is infused over 30 minutes followed by a 30-minute

washout period. The HEPZATO™ KIT, including HEPZATO (melphalan) for injection for

intra-arterial use with the HDS, is FDA approved and sold as a co-packaged single kit. There

is a single National Drug Code number for the entire kit. HEPZATO includes 50 mg freeze-

dried (lyophilized) melphalan powder per vial in 5 single dose vials, intended for

reconstitution with the supplied diluents. HEPZATO™ KIT will come in two sizes, 50 mm

and 62 mm. These lengths describe the distance between the balloons on the double balloon

catheter. Melphalan, the drug constituent part of the combination product, confers the

primary mode of action. Existing melphalan hydrochloride is FDA approved at 0.25 mg/kg

via intravenous infusion for patients with multiple myeloma and is not substitutable for the

melphalan hydrochloride in the HEPZATO™ KIT which is approved at 3.0 mg/kg via

intraarterial delivery for patients with metastatic ocular melanoma.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J9248, “Injection, melphalan (hepzato), 1 mg”

RYKINDO® - HCP23092711Y54

Topic/Issue

Request to establish a new HCPCS Level II code to identify RYKINDO®.

Applicant's suggested language: JXXXX, “Injection, risperidone, (RYKINDO), 0.5 mg”

Summary of Applicant's Submission

Luye Pharma USA, Ltd submitted a request to establish a new HCPCS Level II code to

identify RYKINDO® (risperidone). RYKINDO® was approved by the Food and Drug

Administration (FDA) under a 505(b)(2) New Drug Application (NDA) on January 13, 2023.

RYKINDO® is an atypical antipsychotic for extended-release injectable suspension, for

intramuscular use. RYKINDO® is indicated for the treatment of adults with schizophrenia,

and as a monotherapy or adjunctive therapy to lithium or valproate for the maintenance

treatment of adults with bipolar I disorder. RYKINDO® is a monoaminergic antagonist.

RYKINDO® extended-release injectable suspension, for intramuscular use is, when fully

mixed, a white suspension, available in strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg.

RYKINDO® should be administered every 2 weeks by intramuscular gluteal injection. Each

injection should be administered by a health care professional. RYKINDO® is provided as a

single-dose kit consisting of a vial containing a white to almost white powder, a pre-filled

syringe containing 2 mL of a colorless, clear diluent, a vial adapter, and a needle.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J2801, “Injection, risperidone (rykindo), 0.5 mg”

FOCINVEZ™ - HCP2309291Y73D

Topic/Issue

Request to establish a new HCPCS Level II code to identify FOCINVEZ™.

Applicant's suggested language: JXXXX, "Injection, fosaprepitant (amneal), not

therapeutically equivalent to J1453, per 1mg"

Summary of Applicant's Submission

Amneal Pharmaceuticals, Inc. submitted a request to establish a new HCPCS Level II code to

identify FOCINVEZ™ (fosaprepitant injection). FOCINVEZ™ was approved by the Food

and Drug Administration (FDA) under a 505(b)(2) New Drug Application (NDA) on August

22, 2023. FOCINVEZ™ is a single-dose, ready-to-use formulation of fosaprepitant injection

indicated for use in adults and pediatric patients 6 months of age and older, in combination

with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting

associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC)

including high-dose cisplatin and with initial and repeat courses of moderately emetogenic

cancer chemotherapy (MEC). FOCINVEZ™ is supplied as a clear and colorless 150 mg per

50 mL solution in a single-dose glass vial that is ready-to-use for intravenous infusion, and

dilution is not required. FOCINVEZ™ is administered approximately 30 minutes prior to

chemotherapy. In adults, the recommended dose of FOCINVEZ™ is 150 mg, which is the

entire volume of the single-dose vial (50 mL), administered over 20 to 30 minutes. In

pediatrics, the volume to be administered from the injection vial is based on the required dose

per the patient’s age and/or weight in kilograms (kg). The recommended dosage for pediatrics

is 150 mg administered over 30 minutes for patients ages 12 years to 17 years; 4 mg/kg

administered over 60 minutes for patients ages 2 years to less than 12 years; or 5 mg/kg

administered over 60 minutes for patients ages 6 months to less than 12 years.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J1434, “Injection, fosaprepitant (focinvez), 1 mg”

Melphalan Hydrochloride Injection - HCP230928M647F

Topic/Issue

Request to establish a new HCPCS Level II code to identify Melphalan Hydrochloride

Injection.

Applicant's suggested language: JXXXX, “Melphalan hydrochloride injection (apotex)

90mg/ml”

Summary of Applicant's Submission

Apotex submitted a request to establish a new HCPCS Level II code to identify Melphalan

Hydrochloride Injection. Melphalan Hydrochloride Injection was approved by the Food and

Drug Administration (FDA) under a 505(b)(2) New Drug Application (NDA) on August 18,

2023. Melphalan Hydrochloride Injection is indicated for the palliative treatment of patients

with multiple myeloma for whom oral therapy is not appropriate. The recommended dosage

is 16 mg/m

administered intravenously over 15 to 20 minutes at 2-week intervals for 4

doses, then, after adequate recovery from toxicity, at 4-week intervals. Melphalan

Hydrochloride Injection is supplied as a clear colorless to yellow solution in a carton

containing one 90 mg per 1 mL amber glass multiple-dose vial for dilution.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J9249, “Injection, melphalan (apotex), 1 mg”

Cyclophosphamide Injection - HCP230929Y89KX

Topic/Issue

Request to establish a new HCPCS Level II code to identify Cyclophosphamide injection.

Applicant's suggested language: JXXXX, “Injection, cyclophosphamide (sandoz), 100mg”

Summary of Applicant's Submission

Sandoz Inc. submitted a request to establish a new HCPCS Level II code to identify

cyclophosphamide injection. Cyclophosphamide injection was approved by the Food and

Drug Administration (FDA) under a 505(b)(2) New Drug Application (NDA) on September

12, 2023. Cyclophosphamide injection is indicated for the treatment of adult patients with

malignant diseases, including malignant lymphomas: Hodgkin’s lymphoma, lymphocytic

lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple

myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary,

retinoblastoma, breast carcinoma. This cyclophosphamide product is not indicated for use in

pediatric patients due to the alcohol and propylene glycol content in this product.

Cyclophosphamide injection is administered intravenously. Cyclophosphamide injection is

supplied as a sterile ready-to-dilute, clear, colorless to pale-yellow solution in a multiple-dose

vial available as 500 mg/5 mL, 1,000 mg/10 mL, and 2,000 mg/20 mL.

CMS Final HCPCS Coding Decision

Establish a new HCPCS Level II code J9074, “Injection, cyclophosphamide (sandoz), 5 mg”

BRIXADI™ - HCP230524M0HG0

Topic/Issue

Request to establish a new HCPCS Level II code to identify BRIXADI™.

Applicant’s suggested language:

1. JXXXX, “Buprenorphine extended-release, weekly, less than or equal to 32mg

[BRIXADI 8mg, 16mg, 24mg, and 32mg], each”

2. JXXXX, “Buprenorphine extended-release, monthly, 64mg or greater [BRIXADI

64mg, 96mg, and 128mg], each”

Summary of Applicant's Submission

Braeburn Inc. submitted a request to establish two new HCPCS Level II codes to identify

BRIXADI™. BRIXADI™ was approved by the Food and Drug Administration (FDA) under

a 505(b)(2) New Drug Application (NDA) on May 23, 2023. BRIXADI™ contains

buprenorphine, a partial opioid agonist. BRIXADI™ is indicated for the treatment of

individuals with moderate to severe opioid use disorder who have initiated treatment with a

single dose of a transmucosal buprenorphine product or who are already being treated with

buprenorphine. BRIXADI™ should be used as part of a complete treatment plan that includes

counseling and psychosocial support. Again, BRIXADI™ contains buprenorphine, a partial

agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. The opioid

blockade study assessed the blockade of subjective opioid drug-liking effects and

pharmacokinetics (PK) of BRIXADI™ (weekly) in 47 patients with moderate or severe

opioid dependence. The primary endpoint was the maximum rating (Emax) on the visual

analogue scale (VAS) for drug-liking. After stabilization on immediate-release morphine, all

patients completed a 3-day qualification/baseline hydromorphone challenge session

consisting of 3 intramuscular doses of hydromorphone (0 mg, [placebo], 6 mg, and 18 mg)

once daily for 3 consecutive days in a randomized, double-blind, crossover manner.

Following the qualification phase, eligible patients received 2 injections of BRIXADI™

(weekly) for two weeks at either the 24 mg or 32 mg level. Two hydromorphone challenge

sessions (3 consecutive days each) were conducted throughout the week after each weekly

injection of BRIXADI™ (weekly). Both weekly BRIXADI™ doses produced immediate and

sustained blockade of hydromorphone effects, including both drug-liking effects and

suppression of withdrawal. BRIXADI™ (weekly) and BRIXADI™ (monthly) are different

formulations. Doses of BRIXADI™ (weekly) cannot be combined to yield an equivalent

BRIXADI™ (monthly) dose. BRIXADI™ should be injected slowly, into the subcutaneous

tissue of the buttock, thigh, abdomen, or upper arm. Clinicians should strongly consider

prescribing naloxone at the time BRIXADI™ is initiated or renewed because patients being

treated for opioid use disorder have the potential for relapse, putting them at risk for opioid

overdose. Furthermore, injection sites for BRIXADI™ (weekly) should be alternated/rotated

for each injection. In patients who are not currently receiving buprenorphine treatment, for

BRIXADI™ (weekly), the upper arm site should only be used after steady-state has been

achieved (4 consecutive doses). Injection in the arm site was associated with approximately

10% lower plasma levels than other sites. BRIXADI™ is packaged as a single-use pre-filled

syringe.

CMS Final HCPCS Coding Decision2F

CMS has reviewed its Q3 2023 published determination to establish one HCPCS Level II

code for BRIXADI™. After further consideration of the complexities related to the weekly

and monthly dosing under the same NDA, which differs from most other drugs that are

weight-based in their dosing, CMS will finalize the decision to:

1. Establish a new HCPCS Level II code J0577, “Injection, buprenorphine extended-

release (brixadi), less than or equal to 7 days of therapy"

Effective April 1, 2024

2. Establish a new HCPCS Level II code J0578, “Injection, buprenorphine extended

release (brixadi), greater than 7 days and up to 28 days of therapy"

Effective April 1, 2024

3. Discontinue HCPCS Level II code J0576, “Injection, buprenorphine extended-release

(brixadi), 1 mg"

Effective March 31, 2024

Because all versions of a single source drug or biological product (or National Drug Codes

(NDCs)) marketed under the same FDA approval number (for example, NDA or Biologics

License Application (BLA), including supplements) are considered the same drug or

biological for purposes of payments made under section 1847A of the Social Security Act,

the payment limits for both J0577 and J0578 will be calculated using all the NDCs marketed

under the applicable FDA approval.

Revised on March 4, 2024, to update the code descriptor for HCPCS Level II code J0578.

IZERVAY™ - HCP2309123TW9W

Topic/Issue

Request to establish a new HCPCS Level II code to identify IZERVAY™.

Applicant's suggested language: JXXXX, “Injection, avacincaptad pegol intravitreal solution,

0.1 mL”

Summary of Applicant's Submission

Iveric Bio submitted a request to establish a new HCPCS Level II code to identify

IZERVAY™. IZERVAY™ was approved by the Food and Drug Administration (FDA)

under a New Drug Application (NDA) on August 4, 2023. IZERVAY™ is indicated for the

treatment of geographic atrophy secondary to age-related macular degeneration (AMD).

IZERVAY™ contains avacincaptad pegol sodium, a complement inhibitor. Avacincaptad

pegol is a ribonucleic acid (RNA) aptamer, covalently bound to an approximately 43-

kiloDalton branched polyethylene glycol molecule. IZERVAY™ is a sterile, clear to slightly

opalescent, colorless to slightly yellowish solution. The recommended dose for IZERVAY™

is 2 mg/ 0.1 mL (20 mg/mL single-dose vial) administered by intravitreal injection to each

affected eye once monthly (approximately every 28 plus or minus 7 days) for up to 12

months. Each dose of 0.1 mL solution contains 2 mg avacincaptad pegol (oligonucleotide

basis), 0.198 mg dibasic sodium phosphate heptahydrate, 0.0256 mg monobasic sodium

phosphate monohydrate, and 0.83 mg sodium chloride. IZERVAY™ is formulated in water

for injection, with a target potential of hydrogen (pH) of 7.3. IZERVAY™ does not contain

an anti-microbial preservative. Following a single dose of avacincaptad pegol, maximum

avacincaptad pegol plasma concentrations (Cmax) are estimated to occur approximately 7

days post-dose and mean coefficient of variation (CV%) free avacincaptad pegol plasma

Cmax is estimated to be 68.4 ng/mL (57.8%) in patients with neovascular AMD (nAMD).

Based on a population pharmacokinetic analysis of patients with nAMD, predicted steady

state avacincaptad pegol Cmax is 83.9 ng/mL after monthly intravitreal administration of

avacincaptad pegol 2 mg. In humans, avacincaptad pegol plasma concentrations are predicted

to be approximately 7,000-fold lower than vitreal concentrations.

CMS Final HCPCS Coding Decision3F

1. Establish a new HCPCS Level II code J2782, “Injection, avacincaptad pegol, 0.1 mg”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9162, “Injection, avacincaptad pegol, 0.1 mg”

Effective March 31, 2024

Revised on March 4, 2024, to correct the code description for HCPCS Level II code J2782.

YCANTH™ - HCP2308253MDW8

Topic/Issue

Request to establish a new HCPCS Level II code to identify YCANTH™.

Applicant's suggested language: JXXXX, “Cantharidin for topical administration, 0.7%, per

3.2 mg single-use applicator”

Summary of Applicant's Submission

Verrica Pharmaceuticals Inc. submitted a request to establish a new HCPCS Level II code to

identify YCANTH™. YCANTH™ was approved by the Food and Drug Administration

(FDA) under a New Drug Application (NDA) on July 21, 2023. YCANTH™ is indicated for

the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age

and older. YCANTH™ contains a proprietary formulation of cantharidin delivered via a

single-use applicator, allowing for precise topical dosing and targeted administration.

YCANTH™ topical solution is a light violet to dark purple, slightly viscous liquid for topical

administration. Each mL of YCANTH™ topical solution contains 7 mg of active ingredient

cantharidin (0.7%), a lipophilic compound. Cantharidin is a vesicant. The pharmacodynamics

of cantharidin in the treatment of molluscum contagiosum and its mechanism of action are

unknown. YCANTH™ is administered topically by a healthcare professional every 3 weeks

as needed. No more than two YCANTH™ applicators can be used during a single treatment

session. All healthcare professionals should receive a training prior to preparation and

administration of YCANTH™. YCANTH™ is supplied as a topical solution in a sealed glass

ampule contained within a single-use applicator and enclosed in a protective paperboard

sleeve. Each ampule of YCANTH™ contains approximately 0.45 mL of 0.7% cantharidin

solution. Each YCANTH™ single-use applicator contains 3.2 mg of cantharidin (0.7%).

YCANTH™ is available in a carton of 6 single-use applicators and a carton of 12 single-use

applicators.

CMS Final HCPCS Coding Decision

1. Establish a new HCPCS Level II code J7354, “Cantharidin for topical administration,

0.7%, single unit dose applicator (3.2 mg)”

Effective April 1, 2024

2. Discontinue HCPCS Level II code C9164, “Cantharidin for topical administration,

0.7%, single unit dose applicator (3.2 mg)”

Effective March 31, 2024

American Amnion™ - HCP231002YT3ER

Topic/Issue

Request to establish a new HCPCS Level II code to identify American Amnion™.

Applicant's suggested language: XXXXX, “American Amnion™, per square centimeter”

Summary of Applicant's Submission

BioStem Technologies submitted a request to establish a new HCPCS Level II code to

identify American Amnion™. American Amnion™ is a decellularized human amniotic

allograft product derived from placental tissues are sterilized by e-beam irradiation. American

Amnion™ is intended for use as a protective covering for soft tissue wounds. American

Amnion™ is dehydrated, packaged in different size sheets and terminally sterilized by e-

beam irradiation.

CMS Final HCPCS Coding Decision

After review of the Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG)

letter submitted by the applicant, “American Amnion, when intended for use as a

protective barrier from the surrounding environment for acute and chronic wounds including

partial and full thickness wounds,” appears to meet the criteria for regulation solely under

section 361 of the Public Health Service (PHS) Act and the regulations in 21 CFR part 1271.

As a result of our review of the TRG’s feedback, CMS has decided to:

Establish a new HCPCS Level II code Q4307, "American amnion, per square centimeter"

This coding decision applies to the American Amnion™ product described in the application

and accompanying FDA TRG Letter dated August 28, 2023, when intended for use as a

“protective barrier from the surrounding environment for acute and chronic wounds including

partial and full thickness wounds.”

American Amnion AC™ - HCP231002BLWWV

Topic/Issue

Request to establish a new HCPCS Level II code to identify American Amnion AC™.

Applicant's suggested language: XXXXX, “American Amnion AC™, per square centimeter”

Summary of Applicant's Submission

BioStem Technologies submitted a request to establish a new HCPCS Level II code to

identify American Amnion AC™. American Amnion AC™ is a decellularized human

amniotic and chorionic allograft product derived from placental tissues are sterilized by e-

beam irradiation. American Amnion AC™ is intended for use as a protective covering for

soft tissue wounds. American Amnion AC™ is dehydrated, packaged in different size sheets

and terminally sterilized by e-beam irradiation.

CMS Final HCPCS Coding Decision

After review of the Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG)

letter submitted by the applicant, “American Amnion AC™, when intended for use as a

protective barrier from the surrounding environment for acute and chronic wounds including

partial and full thickness wounds,” appears to meet the criteria for regulation solely under

section 361 of the Public Health Service (PHS) Act and the regulations in 21 CFR part 1271.

As a result of our review of the TRG’s feedback, CMS has decided to:

Establish a new HCPCS Level II code Q4306, “American amnion ac, per square centimeter”

This coding decision applies to the American Amnion AC™ product described in the

application and accompanying FDA TRG Letter dated August 28, 2023, when intended for

use as a “protective barrier from the surrounding environment for acute and chronic wounds

including partial and full thickness wounds.”

American Amnion AC Tri-Layer™ - HCP231002755DK

Topic/Issue

Request to establish a new HCPCS Level II code to identify American Amnion AC Tri-

Layer™.

Applicant's suggested language: XXXXX, “American Amnion AC Tri-Layer™, per square

centimeter”

Summary of Applicant's Submission

BioStem Technologies submitted a request to establish a new HCPCS Level II code to

identify American Amnion AC Tri-Layer™. Amnion AC Tri-Layer™ is a decellularized

human amniotic, intermediate, and chorionic allograft product derived from placental tissues

are sterilized by e-beam irradiation. American Amnion AC Tri-Layer™ is intended for use as

a protective covering for soft tissue wounds. American Amnion AC Tri-Layer™ is

dehydrated, packaged in different size sheets and terminally sterilized by e-beam irradiation.

CMS Final HCPCS Coding Decision

After review of the Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG)

letter submitted by the applicant, American Amnion AC Tri Layer™, when intended for use

as a “protective barrier from the surrounding environment for acute and chronic wounds

including partial and full thickness wounds,” appears to meet the criteria for regulation solely

under section 361 of the Public Health Service (PHS) Act and the regulations in 21 CFR part

1271. As a result of our review of the TRG’s feedback, CMS has decided to:

Establish a new HCPCS Level II code Q4305, "American amnion ac tri-layer, per square

centimeter"

This coding decision applies to the American Amnion AC Tri-Layer™ product described in

the application and accompanying FDA TRG Letter dated August 28, 2023, when intended

for use as a “protective barrier from the surrounding environment for acute and chronic

wounds including partial and full thickness wounds.”

Procenta®- HCP231002TYWBY

Topic/Issue

Request to revise existing HCPCS Level II code Q4244, “Procenta, per 200 mg” to identify

other various dosage options available for Procenta®.

Applicant's suggested language: Q4244, “Procenta® 100mg, coverage ≤2cm2; Procenta®

200mg, coverage >2cm2 up to 6 cm2; Procenta® 300mg, coverage >6 cm2 up to 10 cm2;

Procenta® 400mg, coverage >10 cm2 up to 14 cm2”

Summary of Applicant's Submission

Lucina BioSciences, LLC submitted a request to revise existing HCPCS Level II code

Q4244, “Procenta, per 200 mg” to identify other dosage options for Procenta®. Procenta® is

a sterile, human placental tissue allograft, which is non-viable, hydrated, fully conformable,

and intended to serve as a cover, to offer protection from the surrounding environment, or to

retain fluid when applied to soft tissue defects. Existing HCPCS Level II code Q4244

established in 2020 for Procenta® pre-dates receipt by Lucina BioSciences of the Final

Response Letter from Food and Drug Administration’s (FDA’s) Tissue Reference Group

(TRG) on August 19, 2020. This revision is to ensure that the language in the HCPCS Level

II code is consistent with that of the TRG Final Response Letter.

CMS Final HCPCS Coding Decision

1. Establish a new HCPCS Level II code Q4310, “Procenta, per 100 mg”

Effective April 1, 2024

2. Discontinue HCPCS Level II code Q4244, “Procenta, per 200 mg”

Effective March 31, 2024

This coding decision applies to the Procenta® product described in the application and

accompanying FDA TRG Letter dated August 19, 2020, when intended to “serve as a cover,

to offer protection from the surrounding environment, or to retain fluid.”

Sanopellis - HCP2309260RN86

Topic/Issue

Request to establish a new HCPCS Level II code to identify Sanopellis.

Applicant's suggested language: XXXXX, “Sanopellis, per square centimeter”

Summary of Applicant's Submission

ReNu LLC submitted a request to establish a HCPCS Level II code to identify Sanopellis.

Sanopellis, an amniotic membrane product used as a wound covering and to act as a barrier

for full and partial-thickness, chronic and acute wounds.

CMS Final HCPCS Coding Decision

After review of the Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG)

letter submitted by the applicant, “Sanopellis product, when intended for use to serve as a

covering and a barrier”, appears to meet the criteria for regulation solely under section 361 of

the Public Health Service (PHS) Act and the regulations in 21 CFR part 1271. As a result of

our review of the TRG’s feedback, CMS has decided to:

Establish a new HCPCS Level II code Q4308, "Sanopellis, per square centimeter"

This coding decision applies to the Sanopellis product described in the application and

accompanying FDA TRG Letter dated November 29, 2021, when intended for use as a

“covering and a barrier.”

VIA Matrix - HCP230929HVGKV

Topic/Issue

Request to establish a new HCPCS Level II code to identify VIA Matrix.

Applicant's suggested language: QXXXX, “Via matrix, per square centimeter”

Summary of Applicant's Submission

VIVEX Biologics submitted a request to establish a new HCPCS Level II code to identify

VIA Matrix. VIA Matrix is a semi-transparent, collagenous membrane allograft obtained

with consent from healthy mothers during cesarean section delivery. The VIA Matrix amnion

allograft is a full thickness amnion-chorion allograft. The intended use of VIA Matrix

includes the management of wounds, to protect wounds or burns from the surrounding

environment to acute and chronic wounds.

CMS Final HCPCS Coding Decision

After review of the Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG)

letter submitted by the applicant, “VIA Matrix, when intended for use to protect wounds or

burns from the surrounding environment to acute and chronic wounds,” appears to meet the

criteria for regulation solely under section 361 of the Public Health Service (PHS) Act and

the regulations in 21 CFR part 1271. As a result of our review of the TRG’s feedback, CMS

has decided to:

Establish a new HCPCS Level II code Q4309, "Via matrix, per square centimeter"

This coding decision applies to the Via Matrix product described in the application and

accompanying FDA TRG Letter dated September 14, 2023, when intended for use “to protect

wounds or burns from the surrounding environment to acute and chronic wounds.”

HCPCS Level II Codes for Various FDA Approvals under the 505(b)(2) or Biologics

License Application (BLA) Pathways and Products “Not Otherwise Classified” -

HCP220517FAENJ

CMS has been reviewing its approach for establishing HCPCS Level II codes to identify

products approved under the 505(b)(2) New Drug Application (NDA) or the Biologics

License Application (BLA) pathways after October 2003. These products are not rated as

therapeutically equivalent to their reference listed drug in the Food and Drug

Administration’s (FDA) Orange Book4F

, and are therefore considered single source products.

Also, this effort will help reduce use of the not otherwise classified (NOC) codes.

In order to conform with the general approach used for the assignment of products paid under

section 1847A of the Social Security Act (the Act) to HCPCS codes as described at the

following CMS link:

https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_an

noucement.pdf. CMS is making several code changes, including manufacturer specific codes

to identify products approved under separate 505(b)(2) NDA or BLA pathways. Since the

products are approved under separate 505(b)(2) NDAs and are not rated as therapeutically

equivalent by the FDA in the Orange Book, they are single source drugs based on the

statutory definition of “single source drug” in section 1847A(c)(6) of the Act. Because these

are single source drugs, there is a programmatic need for each product to have a unique

billing and payment code.

In cases where certain products meet the statutory definition of “multiple source drug” in

section 1847A(c)(6) of the Act, CMS will remove the brand name of the drug from any

existing HCPCS code as needed as it will accommodate any associated generic product(s), if

approved and marketed, that are rated as therapeutically equivalent.

Due to the complexity and nuanced nature of the differences between each product, we

encourage providers to rely on the Average Sales Price (ASP) HCPCS-National Drug Code

(NDC) crosswalk5F

to identify the correct billing and payment code for each applicable

product.

CMS Final HCPCS Coding Decision

Establish eight new HCPCS Level II codes, revise three existing HCPCS Level II, and delete

nine HCPCS Level II codes to separately identify products approved by the FDA after

October 2003, and not rated as therapeutically equivalent to a reference listed product in an

existing code.

See Appendix A for a complete list of new HCPCS Level II codes that we are establishing.

We will be accepting feedback on the language in the code descriptors for each code in an

upcoming biannual public meeting.

The FDA’s Orange Book, officially entitled, Approved Drug Products With Therapeutic Equivalence

Evaluations, identifies drug products approved on the basis of safety and effectiveness by the FDA, and is

published at the following FDA link: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

The ASP crosswalks are maintained by CMS on a quarterly basis to support ASP-based Medicare Part B

payments only. The quarterly ASP crosswalks are published at the following CMS

link:https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2022-asp-drug-pricing-files

CMS intends to continue our review in subsequent HCPCS code application quarterly cycles

to separately identify products approved under the 505(b)(2) NDA or the BLA pathways after

October 2003, and not rated as therapeutically equivalent to a reference listed product in an

existing code, as well as products that have been “not otherwise classified”.

Appendix A: HCPCS Level II Codes for Products Approved by the FDA Under the

505(b)(2) NDA or BLA Pathways and Products “Not Otherwise Classified”

HCPCS

Code

Action

Long Descriptor

J0208

Revise

Injection, sodium thiosulfate (pedmark), 100 mg

J0209

Add

Injection, sodium thiosulfate (hope), 100 mg

J0612

Revise

Injection, calcium gluconate, not otherwise specified, 10 mg

J0613

Revise

Injection, calcium gluconate (wg critical care) not therapeutically

equivalent to J0612, 10 mg

J0650

Add

Injection, levothyroxine sodium, not otherwise specified, 10 mcg

J0651

Add

Injection, levothyroxine sodium (fresenius kabi) not therapeutically

equivalent to J0650, 10 mcg

J0652

Add

Injection, levothyroxine sodium (hikma) not therapeutically

equivalent to J0650, 10 mcg

J1010

Add

Injection, methylprednisolone acetate, 1 mg

J1020*

Delete

Injection, methylprednisolone acetate, 20 mg

J1030*

Delete

Injection, methylprednisolone acetate, 40 mg

J1040*

Delete

Injection, methylprednisolone acetate, 80 mg

J1840*

Delete

Injection, kanamycin sulfate, up to 500 mg

J1850*

Delete

Injection, kanamycin sulfate, up to 75 mg

J3424

Add

Injection, hydroxocobalamin, intravenous, 25 mg

J2919

Add

Injection, methylprednisolone sodium succinate, 5 mg

J2920*

Delete

Injection, methylprednisolone sodium succinate, up to 40 mg

J2930*

Delete

Injection, methylprednisolone sodium succinate, up to 125 mg

J9073

Add

Injection, cyclophosphamide (ingenus), 5 mg

J9070*

Delete

Cyclophosphamide, 100 mg

J9075

Add

Injection, cyclophosphamide, not otherwise specified, 5mg

J9250*

Delete

Methotrexate sodium, 5 mg

* The effective date for the discontinuation of this code is March 31, 2024.

Revised on February 16, 2024 to update the dose descriptor to represent the least common denominator.