Omadacycline for Injection, for Intravenous Use (Nuzyra™) HCPCS code J3490 - Unclassified drugs: Billing Guidelines

<p>Nuzyra is available as 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion.</p>

Author: GDIT Call Center, (800) 688-6696

Nuzyra is available as 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion

Indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

• Community-acquired bacterial pneumonia (CABP)
• Acute bacterial skin and skin structure infections (ABSSSI)

Recommended Dose:

 Dose for CABP and ABSSSI in adult patients:

• 200 mg loading dose by intravenous infusion over 60 minutes on day 1, or
• 100 mg loading dose by intravenous infusion over 30 minutes twice on day 1
• 100 mg maintenance dose by intravenous infusion over 30 minutes once daily starting on day 2 for a total duration of 7 to 14 days

See full prescribing information for further detail.

For North Carolina Medicaid and NC Health Choice Billing:

  • The ICD-10-CM diagnosis code(s) required for billing is/are:   

Community Acquired Bacterial Pneumonia (CABP)

J13 - Pneumonia due to Streptococcus pneumoniae; J14 - Pneumonia due to Hemophilus influenzae; J15.0 - Pneumonia due to Klebsiella pneumoniae; J15.211 - Pneumonia due to Methicillin susceptible Staphylococcus aureus; J15.6 - Pneumonia due to other Gram-negative bacteria; J15.7 - Pneumonia due to Mycoplasma pneumoniae; J16.0 - Chlamydial pneumonia

Acute bacterial skin and skin structure infections (ABSSSI)

A46 - Erysipelas; A49.01 - Methicillin susceptible Staphylococcus aureus infection, unspecified site; A49.02 - Methicillin resistant Staphylococcus aureus infection, unspecified site; A49.1 - Streptococcal infection, unspecified site; H00.031 - Abscess of right upper eyelid; H00.032 - Abscess of right lower eyelid; H00.033 - Abscess of eyelid right eye, unspecified eyelid; H00.034 - Abscess of left upper eyelid; H00.035 - Abscess of left lower eyelid; H00.036 - Abscess of eyelid left eye, unspecified eyelid; H00.039 - Abscess of eyelid unspecified eye, unspecified eyelid; H05.011 - Cellulitis of right orbit; H05.012 - Cellulitis of left orbit; H05.013 - Cellulitis of bilateral orbits; H05.019 - Cellulitis of unspecified orbit; H60.00 - Abscess of external ear, unspecified ear; H60.01 - Abscess of right external ear; H60.02 - Abscess of left external ear; H60.03 - Abscess of external ear, bilateral; H60.10 - Cellulitis of external ear, unspecified ear; H60.11 - Cellulitis of right external ear; H60.12 - Cellulitis of left external ear; H60.13 - Cellulitis of external ear, bilateral;  J34.0 - Abscess, furuncle and carbuncle of nose; K12.2 - Cellulitis and abscess of mouth; K61.0 - Anal abscess; K61.1 - Rectal abscess; K61.2 - Anorectal abscess; K61.31 - Horseshoe abscess; K61.39 - Other ischiorectal abscess; K61.4 - Intrasphincteric abscess; K61.5 - Supralevator abscess; L01.00 - Impetigo, unspecified; L01.01 - Non-bullous impetigo; L01.02 - Bockhart's impetigo; L01.03 - Bullous impetigo; L01.09 - Other impetigo; L01.1 - Impetiginization of other dermatoses; L02.01 - Cutaneous abscess of face; L02.02 - Furuncle of face; L02.03 - Carbuncle of face; L02.11 - Cutaneous abscess of neck; L02.12 - Furuncle of neck; L02.13 - Carbuncle of neck; L02.211 - Cutaneous abscess of abdominal wall; L02.212 - Cutaneous abscess of back [any part, except buttock]; L02.213 - Cutaneous abscess of chest wall; L02.214 - Cutaneous abscess of groin; L02.215 - Cutaneous abscess of perineum; L02.216 - Cutaneous abscess of umbilicus; L02.219 - Cutaneous abscess of trunk, unspecified; L02.221 - Furuncle of abdominal wall; L02.222 - Furuncle of back [any part, except buttock]; L02.223 - Furuncle of chest wall; L02.224 - Furuncle of groin; L02.225 - Furuncle of perineum; L02.226 - Furuncle of umbilicus; L02.229 - Furuncle of trunk, unspecified; L02.231 - Carbuncle of abdominal wall; L02.232 - Carbuncle of back [any part, except buttock]; L02.233 - Carbuncle of chest wall; L02.234 - Carbuncle of groin; L02.235 - Carbuncle of perineum; L02.236 - Carbuncle of umbilicus; L02.239 - Carbuncle of trunk, unspecified; L02.31 - Cutaneous abscess of buttock; L02.32 - Furuncle of buttock; L02.33 - Carbuncle of buttock; L02.411 - Cutaneous abscess of right axilla; L02.412 - Cutaneous abscess of left axilla; L02.413 - Cutaneous abscess of right upper limb; L02.414 - Cutaneous abscess of left upper limb; L02.415 - Cutaneous abscess of right lower limb; L02.416 - Cutaneous abscess of left lower limb; L02.419 - Cutaneous abscess of limb, unspecified; L02.421 - Furuncle of right axilla; L02.422 - Furuncle of left axilla; L02.423 - Furuncle of right upper limb; L02.424 - Furuncle of left upper limb; L02.425 - Furuncle of right lower limb; L02.426 - Furuncle of left lower limb; L02.429 - Furuncle of limb, unspecified; L02.431 - Carbuncle of right axilla; L02.432 - Carbuncle of left axilla; L02.433 - Carbuncle of right upper limb; L02.434 - Carbuncle of left upper limb; L02.435 - Carbuncle of right lower limb; L02.436 - Carbuncle of left lower limb; L02.439 - Carbuncle of limb, unspecified; L02.511 - Cutaneous abscess of right hand; L02.512 - Cutaneous abscess of left hand; L02.519 - Cutaneous abscess of unspecified hand; L02.521 - Furuncle right hand; L02.522 - Furuncle left hand; L02.529 - Furuncle unspecified hand; L02.531 - Carbuncle of right hand; L02.532 - Carbuncle of left hand; L02.539 - Carbuncle of unspecified hand; L02.611 - Cutaneous abscess of right foot; L02.612 - Cutaneous abscess of left foot; L02.619 - Cutaneous abscess of unspecified foot; L02.621 - Furuncle of right foot; L02.622 - Furuncle of left foot; L02.629 - Furuncle of unspecified foot; L02.631 - Carbuncle of right foot; L02.632 - Carbuncle of left foot; L02.639 - Carbuncle of unspecified foot; L02.811 - Cutaneous abscess of head [any part, except face]; L02.818 - Cutaneous abscess of other sites; L02.821 - Furuncle of head [any part, except face]; L02.828 - Furuncle of other sites; L02.831 - Carbuncle of head [any part, except face]; L02.838 - Carbuncle of other sites; L02.91 - Cutaneous abscess, unspecified; L02.92 - Furuncle, unspecified; L02.93 - Carbuncle, unspecified; L03.011 - Cellulitis of right finger; L03.012 - Cellulitis of left finger; L03.019 - Cellulitis of unspecified finger; L03.021 - Acute lymphangitis of right finger; L03.022 - Acute lymphangitis of left finger; L03.029 - Acute lymphangitis of unspecified finger; L03.031 - Cellulitis of right toe; L03.032 - Cellulitis of left toe; L03.039 - Cellulitis of unspecified toe; L03.041 - Acute lymphangitis of right toe; L03.042 - Acute lymphangitis of left toe; L03.049 - Acute lymphangitis of unspecified toe; L03.111 - Cellulitis of right axilla; L03.112 - Cellulitis of left axilla; L03.113 - Cellulitis of right upper limb; L03.114 - Cellulitis of left upper limb; L03.115 - Cellulitis of right lower limb; L03.116 - Cellulitis of left lower limb; L03.119 - Cellulitis of unspecified part of limb; L03.121 - Acute lymphangitis of right axilla; L03.122 - Acute lymphangitis of left axilla; L03.123 - Acute lymphangitis of right upper limb; L03.124 - Acute lymphangitis of left upper limb; L03.125 - Acute lymphangitis of right lower limb; L03.126 - Acute lymphangitis of left lower limb; L03.129 - Acute lymphangitis of unspecified part of limb; L03.211 - Cellulitis of face; L03.212 - Acute lymphangitis of face; L03.213 - Periorbital cellulitis; L03.221 - Cellulitis of neck; L03.222 - Acute lymphangitis of neck; L03.311 - Cellulitis of abdominal wall; L03.312 - Cellulitis of back [any part except buttock]; L03.313 - Cellulitis of chest wall; L03.314 - Cellulitis of groin; L03.315 - Cellulitis of perineum; L03.316 - Cellulitis of umbilicus; L03.317 - Cellulitis of buttock; L03.319 - Cellulitis of trunk, unspecified; L03.321 - Acute lymphangitis of abdominal wall; L03.322 - Acute lymphangitis of back [any part except buttock]; L03.323 - Acute lymphangitis of chest wall; L03.324 - Acute lymphangitis of groin; L03.325 - Acute lymphangitis of perineum; L03.326 - Acute lymphangitis of umbilicus; L03.327 - Acute lymphangitis of buttock; L03.329 - Acute lymphangitis of trunk, unspecified; L03.811 - Cellulitis of head [any part, except face]; L03.818 - Cellulitis of other sites; L03.891 - Acute lymphangitis of head [any part, except face]; L03.898 - Acute lymphangitis of other sites; L03.90 - Cellulitis, unspecified; L03.91 - Acute lymphangitis, unspecified; L04.0 - Acute lymphadenitis of face, head and neck; L04.1 - Acute lymphadenitis of trunk; L04.2 - Acute lymphadenitis of upper limb; L04.3 - Acute lymphadenitis of lower limb; L04.8 - Acute lymphadenitis of other sites; L04.9 - Acute lymphadenitis, unspecified; L05.01 - Pilonidal cyst with abscess; L05.02 - Pilonidal sinus with abscess; L05.91 - Pilonidal cyst without abscess; L05.92 - Pilonidal sinus without abscess; L08.0 - Pyoderma; L08.1 - Erythrasma; L08.81 - Pyoderma vegetans; L08.82 - Omphalitis not of newborn; L08.89 - Other specified local infections of the skin and subcutaneous tissue; L08.9 - Local infection of the skin and subcutaneous tissue, unspecified; N48.21 - Abscess of corpus cavernosum and penis; N48.22 - Cellulitis of corpus cavernosum and penis;  N61.0 - Mastitis without abscess; N61.1 - Abscess of the breast and nipple; N76.4 - Abscess of vulva

Code also organism if applicable: B95.0 - Streptococcus, group A, as the cause of diseases classified elsewhere; B95.1 - Streptococcus, group B, as the cause of diseases classified elsewhere; B95.2 - Enterococcus as the cause of diseases classified elsewhere; B95.4 - Other streptococcus as the cause of diseases classified elsewhere; B95.5 - Unspecified streptococcus as the cause of diseases classified elsewhere; B95.61 - Methicillin susceptible Staphylococcus aureus infection as the cause of diseases classified elsewhere; B95.62 - Methicillin resistant Staphylococcus aureus infection as the cause of diseases classified elsewhere; B95.7 - Other staphylococcus as the cause of diseases classified elsewhere; B95.8 - Unspecified staphylococcus as the cause of diseases classified elsewhere; B96.1 - Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere; B96.89 – Other specified bacterial agents as the cause of disease classified elsewhere.

  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid and NCHC unit of coverage is: 1 mg
  • The maximum reimbursement rate per unit is: $3.73
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units.  The NDCs are: 71715-0001-01, 71715-0001-02
  • The NDC units should be reported as "UN1".
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy No. 1B, Attachment A, H.7 on DHB's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid and NCHC beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA).  Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
  • The fee schedule for the Physician Administered Drug Program is available on DHB's PADP web page.

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