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Healthcare providers billing for drug services must consider the drug and dosage form that was provided to the patient, the patient’s medical record, the coding requirements of each health insurer, and best coding practices. Billing and coding guidance provided on this website does not provide a guarantee of reimbursement and should be considered together with all applicable guidance and standards.

YERVOY™ (ipilimumab) Coding and Billing Units

FAQs:

Healthcare providers should code healthcare claims based upon the service that is rendered, the patient's medical records, the coding requirements of each health insurer, and best coding practices. Coding guidance under this heading does not provide a guarantee of reimbursement and should be considered together with all applicable coding guidance and standards.

  1. Which HCPCS codes should be used for billing YERVOY to health insurers? Click For Answer
    • Professional claims:
      The Center for Medicare & Medicaid Services (CMS) granted a Healthcare Common Procedure Coding System (HCPCS) code for YERVOYTM (ipilimumab), J9228, injection, ipilimumab, 1 mg, effective JANUARY 1, 2012.1
      • For CMS-1500, Ver. 08/05, enter “J9228” under column heading “CPT/HCPCS”2
      • For ASC 837P, enter “J9228” to Segment SV101-2, with Segment SV101-2 entered as “HC” (this is a qualifier Segment, meaning the entry to SV101-2 is a HCPCS code)3
    • Institutional claims filed to Medicare:
      Effective January 1, 2012 J9228 should be used for all claims and replace the hospital outpatient code: C9284

      Institutional claims filed to all payers should use J9228, injection, ipilimumab, 1 mg, effective January 1, 2012 according to payer guidelines.
      • On the CMS-1450 claim form, enter a Revenue Code such as 0636 (drugs requiring detailed coding) in FL42, under column heading “REV CD.” (Although CMS recommends that Revenue Code 0636 be used by hospitals, other Revenue Codes, such as 025x and 062x, may be appropriate as well.)5 Enter HCPCS code “J9228” in FL44, under column heading “HCPCS / Rates / HIPPS Rate Codes”6
  2. Is there a need to further identify the drug service when billing YERVOY on the Professional or Institutional claim forms using HCPCS codes J9228? Click For Answer
    • Some payers require the submission of a drug NDC (National Drug Code), in addition to an HCPCS code. The NDC is entered into paper and electronic claim forms in different locations, depending on the instruction of the payer. Claim preparers should reference each payer's instruction for entering the NDC in claim forms.

    • National Drug Codes (NDCs) Listing for YERVOY
    • The NDCs for YERVOY, listed in the table below, are often necessary in addition to the appropriate J-code when filing a claim for reimbursement.
    •  Description  NDC Codes9
       One 50 mg vial (5 mg/mL), single-use vial  0003-2327-11 (10 digit)
       00003-2327-11 (11 digit)
       One 200 mg vial (5 mg/mL), single-use vial  0003-2328-22 (10 digit)
       00003-2328-22 (11 digit)
    • This coding guide is not intended to provide specific directions on requesting prior authorization or submitting claims for YERVOY. Oncology practices need to make coding decisions on the diagnosis and treatment of each patient and the specific insurer requirements. The coding guidance does not provide a guarantee of receiving prior authorization or reimbursement.
  3. How are billing units reported with HCPCS code J9228? Click For Answer
    • Professional Claims:
      • For Form CMS-1500, the amount of YERVOY used to treat the patient (including any unavoidable wastage in single-use vials, but excluding any overfill) should be reported in Box 19, along with other information that the payer may require.2
      • The billing units reported in Box 24G are typically entered as “1” because health plans use the information in Box 19 (not Box 24G) to determine the amount to be paid for a covered service. This may vary by health plan, however.10
      • For Form ASC 837P, billing units are reported in the narrative section, along with the name of the drug, the NDC(s), and the route of administration.
    • Institutional Claims:
      • For Form CMS-1450, the amount of YERVOY used to treat the patient (including any unavoidable wastage in single-use vials, but excluding any overfill) should be reported to Medicare in Box 80, along with the name of the drug and the quantity administered.4 Other payers may also require additional information, such as the NDC(s) and the route of administration.
      • The service units reported in Field Locator (FL) 46 are typically entered as “1” because health plans use the information in FL80 (not FL46) to determine the amount to be paid for a covered service. This may vary by health plan, however.10
      • For Form ASC 837I, billing units are reported in the narrative section, along with the name of the drug, the NDC(s), and the route of administration.4
  4. Are there any HCPCS code modifiers that should be reported with the use of HCPCS codes YERVOYTM (ipilimumab), J9228, injection, ipilimumab, 1 mg on either the Professional or Institutional claims? Click For Answer
    • Professional Claims:
    • Currently, for claims submitted to Medicare, no modifiers are routinely required when reporting J9228. Other payers also typically do not require modifiers with these codes, but payer policies may vary.
    • At least one Medicare Administrative Contractor (MAC), Trailblazer Health Enterprises, LLC, requires providers to report wasted drug as a separate line item on claim forms. The modifier “JW” is attached to the drug code on the line item for the wasted drug (e.g., J9228-JW). Thus, the amount administered is reported on one line with the appropriate units, and the amount wasted is reported on a second line with modifier “JW” with the appropriate units.11
    • Other MACs will accept this modifier, but most do not require it.7 If a practice opts to report modifier “JW” to a MAC that does not require it, the practice should pay close attention to the individual MAC's reporting requirements to determine whether the drug administered and the drug discarded should be reported as one line item or two.
  5. How is the service component of treatment coded on Professional and Institutional claims? Click For Answer
    • Professional Claims:
      • View CMS-1500 Form
      • In a hospital-based outpatient clinic, the hospital bills Medicare for the administration; the physicians do not.12 Other payers' policies may vary.
    • Institutional Claims:
  6. YERVOY is supplied as 50-mg or 200-mg single-use vials each containing 10 mL or 40 mL, respectively, of a 5 mg/mL, sterile, ipilimumab solution.9 If a patient requires less than a full vial, can the wasted drug be billed? Click For Answer
      • Each vial of YERVOY is labeled “Single Use.” Medicare accepts billing for drug that is wasted from a single-use vial if certain conditions are met, including efficient use. “CMS encourages providers to schedule patients in such a way that they can use drugs or biologics most efficiently, in a clinically appropriate manner.”4
      • Some Medicare Administrative Contractors (MACs) may require providers to report wasted drug as a separate line item on claim forms. The modifier “JW” is attached to the drug code on the line item for the wasted drug (e.g., J9228-JW). Thus, the amount administered is reported on one line with the appropriate units, and the amount wasted is reported on a second line with modifier “JW” with the appropriate units.11
      • Other MACs will accept this modifier, but most do not require it. If a practice opts to report modifier “JW” to a MAC that does not require it, the practice should pay close attention to the individual MAC's reporting requirements to determine whether the drug administered and the drug discarded should be reported as one line item or two.7

Indication and Important Safety Information

Indication

YERVOY™ (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

Important Safety Information

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Recommended Dose Modifications

Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.

Permanently discontinue YERVOY for any of the following:

  • Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
  • Failure to complete full treatment course within 16 weeks from administration of first dose
  • Severe or life-threatening adverse reactions, including any of the following
    • Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation
    • AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN
    • Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations
    • Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis
    • Severe immune-mediated reactions involving any organ system
    • Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy

Immune-mediated Enterocolitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients
  • Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis
  • Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids
  • Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms
  • Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients
  • Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)

Immune-mediated Hepatitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%
  • 13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2)
  • Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution
  • Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids
  • Withhold YERVOY in patients with Grade 2 hepatotoxicity

Immune-mediated Dermatitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients
    • 1 (0.2%) patient died as a result of toxic epidermal necrolysis
    • 1 additional patient required hospitalization for severe dermatitis
  • There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis
  • Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated
  • Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids
    (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms
  • Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week

Immune-mediated Neuropathies:

  • In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported
  • Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported
  • Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes
  • Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)

Immune-mediated Endocrinopathies:

  • In the pivotal Phase 3 study in YERVOY- treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients
    • All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism
    • 6 of the 9 patients were hospitalized for severe endocrinopathies
  • Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome
  • Median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY
  • Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism
    • Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated
    • Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland
  • Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:

  • In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia
  • Across the clinical development program for YERVOY, immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis
  • Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions
  • Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy

Pregnancy & Nursing:

  • YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus
  • It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue
    nursing or to discontinue YERVOY

Common Adverse Reactions:

  • The most common adverse reactions (≥5%) in patients who received YERVOY at
    3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and
    colitis (8%)

References:

  1. HCPCS release and code sets, alpha-numeric HCPCS, 2012 alpha-numeric HCPCS file. Centers for Medicare and Medicaid Services. http://www.cms.gov/HCPCSReleaseCodeSets/ANHCPCS/list.asp. Accessed December 15, 2011.
  2. Completing and processing the form CMS-1500 data set. Centers for Medicare and Medicaid Services. http://www.cms.gov/manuals/downloads/clm104c26.pdf. Accessed December 15, 2011.
  3. 1500 claim form map to the X12 837 health care claim: professional. National Uniform Claim Committee. http://www.nucc.org/images/stories/PDF/1500_form_map_to_837p_4010a1_v1-0_112008.pdf. Accessed December 15, 2011.
  4. Drugs and biologicals. Centers for Medicare and Medicaid Services. http://www.cms.gov/transmittals/downloads/R2234CP.pdf. Accessed December 15, 2011.
  5. Medicare program: hospital outpatient prospective payment system and CY 2011 payment rates; ambulatory surgical center payment system and CY 2011 payment rates; payments to hospitals for graduate medical education costs; physician self-referral rules and related changes to provider agreement regulations; payment for certified registered nurse anesthetist services furnished in rural hospitals and critical access hospitals. Fed Regis. 2010;75(226):71965-71966. http://edocket.access.gpo.gov/2010/pdf/2010-27926.pdf. Accessed December 15, 2011.
  6. Completing and processing the form CMS-1450 data set. Centers for Medicare and Medicaid Services. https://www.cms.gov/manuals/downloads/clm104c25.pdf. Accessed December 15, 2011.
  7. Publication 100-20: discarded drugs and biologicals at contractor discretion. Centers for Medicare and Medicaid Services. http://www.cms.gov/transmittals/downloads/R758OTN.pdf. Revised August 20, 2010. Accessed December 15, 2011.
  8. Subpart K—payment for drugs and biologicals under part B. Fed Regist. 2010;75(228):73626.
  9. YERVOY™ (ipilimumab) Full Prescribing Information. Princeton, NJ: Bristol-Myers Squibb; March 2011.
  10. National Government Services. CMS-1500 claim form instructions.
    http://www.ngsmedicare.com/wps/portal/ngsmedicare/!ut/p/c5/fY3BCoJAGISfxRdwftfdtY6bpmaogUK6l7CQEFr1EAY-fXsIOtUMzGXmY6BhPXbLcO-ewzR2DzTQ8kJZFapYcKJ8S3RQsoqThHx-4jij3dnQf2ZlwT79DylCCx18-TKJI8t79aY85nuPBGq0ITLo4Wrc18245PpMMCZ5QFxI-8jRRCjSyfSYzTKna7P2ynHelNaJ6A!!/dl3/d3/L2dBISEvZ0FBIS9nQSEh/?clearcookie&pcid=35256600443b8ce6bb1fffe46ee7c6fe®ION&LOB=Part%20B&digest=N_5daMHgbyRiOPvt7gua6g. Accessed December 15, 2011.
  11. Drug wastage. Trailblazer Health Enterprises. http://www.trailblazerhealth.com/Publications/Job%20Aid/Drug%20Wastage.pdf. Accessed December 15, 2011.
  12. NCCI Policy Manual for Medicare Services. Evaluation and management services CPT codes 90000-99999. Centers for Medicare and Medicaid Services. http://www.cms.gov/NationalCorrectCodInitEd/01_overview.asp. Accessed December 15, 2011.

Please see YERVOY US Full Prescribing Information including Boxed WARNING regarding immune-mediated adverse reactions.

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