Asset Publisher
Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy)
Policy Number: -90784
(Subcutaneous)
Last Review Date: 10/02/2025
Date of Origin: 02/04/2025
Dates Reviewed: 02/2025, 10/2025
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.
- Length of Authorization ∆ 1,43,47,49,50,52-54,65,68,72,73,79,81,82,89,130,131
- Initial: Prior authorization validity will be provided initially for 6 months, unless otherwise specified.
- Use in the treatment of Cutaneous Melanoma:
- Cutaneous Melanoma neoadjuvant therapy as a single agent: Prior authorization validity may be provided for a maximum of 4 doses.
- Merkel Cell Carcinoma neoadjuvant therapy: Prior authorization validity may be provided for up to a maximum of 2 doses.
- Gastric, Esophageal and Esophagogastric/Gastroesophageal Junction Cancer postoperative therapy after surgery: Prior authorization validity may be provided for a maximum of 36 weeks (9 doses).
- Use in the treatment of Cutaneous Melanoma:
- Renewal: Prior authorization validity may be renewed every 6 months thereafter, unless otherwise specified.
- Non-Small Cell Lung Cancer neoadjuvant treatment followed by optional adjuvant treatment: Prior authorization validity may be provided for a maximum of 4 neoadjuvant doses and 13 adjuvant doses.
- Prior authorization validity may NOT be renewed for the following indications:
- Merkel Cell Carcinoma (neoadjuvant therapy)
- Cutaneous Melanoma (neoadjuvant therapy)
- Gastric, Esophageal and Esophagogastric/Gastroesophageal Junction Cancer: Post-operative therapy after surgery
- Prior authorization validity may be renewed up to a maximum of 1 year of therapy* for the following:
- Cutaneous Melanoma (adjuvant therapy single agent)
- Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (adjuvant therapy following neoadjuvant chemoradiotherapy)
- Urothelial Carcinoma (adjuvant therapy)
- Prior authorization validity may be renewed up to a maximum of 2 years of therapy* for the following:
- Cervical Cancer
- Esophageal and Esophagogastric/Gastroesophageal Junction Cancer [induction, first-line, and subsequent therapy (excluding single agent subsequent therapy for squamous cell carcinoma)]
- Gastric Cancer (first-line therapy or subsequent therapy)
- Renal Cell Carcinoma (in combination with cabozantinib)
- Squamous Cell Skin Cancer
- Vaginal Cancer
- Vulvar Cancer
- Urothelial Carcinoma (first line therapy in combination with gemcitabine and cisplatin, followed by single-agent maintenance therapy)
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*Note: The maximum number of doses is dependent on the dosing frequency and duration of therapy. Refer to Section V for exact dosage. |
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Dosing Frequency |
Maximum length of therapy |
Maximum number of doses |
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2 weeks |
1 year |
26 doses |
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2 years |
52 doses |
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3 weeks |
2 years |
35 doses |
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4 weeks |
1 year |
13 doses |
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2 years |
26 doses |
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- Dosing Limits
Max Units (per dose and over time) [HCPCS Unit]:
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- 600 billable units every 4 weeks
- Initial Approval Criteria 1
Prior authorization validity is provided in the following conditions:
- Patient is at least 18 years of age; AND
Universal Criteria
- Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy unless otherwise specified ∆ (Note: Not applicable when used as switch-therapy from intravenous nivolumab); AND
- Therapy will not be used concomitantly with intravenous nivolumab; AND
- Therapy will not be used concurrently with intravenous chemotherapy agents (not applicable when used for FDA approved combination therapy indicated with †); AND
- Intravenous nivolumab must be used in the following:
- Patients <80 kg; OR
- Patients requiring 900 mg/15,000 units doseα; OR
- Patients receiving therapy in combination with ipilimumab; AND
Substitution/Switch-Therapy for Intravenous Nivolumab ‡ 2,4-6,19,20,24,25,31,33,34,36-39,41,42,47-49,61,63-65,72,79-81,83,84,90,94-97,130,131
- Used as substitution for OR switch-therapy from intravenous nivolumab; AND
- Patient has previously met criteria for use of intravenous nivolumab [see Opdivo IV policy – Document Number: IC-0226]; AND
- Patient has been receiving treatment with intravenous nivolumab and has shown a beneficial disease response and absence of unacceptable toxicity while on therapy; OR
- Patient currently meets criteria for use of intravenous nivolumab [see Opdivo IV policy – Document Number: IC-0226]; AND
- Patient has previously met criteria for use of intravenous nivolumab [see Opdivo IV policy – Document Number: IC-0226]; AND
- Patient has any of the following indications for treatment (may not be all inclusive):
- Ampullary Adenocarcinoma
- Anal Carcinoma
- Urothelial Carcinoma (Bladder Cancer)
- Adult Central Nervous System (CNS) Cancers
- Cervical Cancer
- Colorectal Cancer (CRC)
- Appendiceal Adenocarcinoma – Colon Cancer
- Gastric Cancer/Esophageal Cancer/Gastroesophageal Junction (GEJ) Cancer
- Gestational Trophoblastic Neoplasia
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Hepatocellular Carcinoma (HCC)
- Kaposi Sarcoma
- Renal Cell Carcinoma (RCC)
- Cutaneous Melanoma
- Uveal Melanoma
- Merkel Cell Carcinoma
- Peritoneal or Pleural Mesothelioma (Note: May also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma)
- Non-Small Cell Lung Cancer (NSCLC)
- Small Bowel Adenocarcinoma
- Small Cell Lung Cancer (SCLC)
- Soft Tissue Sarcoma
- Endometrial carcinoma (Uterine Neoplasms)
- Vulvar Cancer
- Thyroid Carcinoma
- Vaginal Cancer
- Squamous Cell Skin Cancer
Urothelial Carcinoma (Bladder Cancer) † 1,2,30,51,62,92
- Used as a single agent; AND
- Used for locally advanced or metastatic disease that progressed during or following platinum-containing chemotherapy* OR progression with 12 months of neoadjuvant or adjuvant treatment with a platinum-containing regimen; OR
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- Used as adjuvant therapy in patients who are at a high risk for disease recurrence** after undergoing surgical resection; OR
- Used in combination with cisplatin and gemcitabine; AND
- Used as first line therapy in patients with unresectable or metastatic disease
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Colorectal Cancer (CRC) † 1,2,31,32
- Patient has microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; AND
- Used as a single agent; AND
- Used as subsequent therapy for metastatic disease; AND
- Patient has disease progression following treatment with a fluoropyrimidine, oxaliplatin and irinotecan regimen
Gastric Cancer/Esophageal Cancer/Gastroesophageal Junction (GEJ) Cancer † 1,2,44,52,56,69
- Used as a single agent; AND
-
- Used as adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).; OR
- Used as subsequent therapy after prior fluoropyrimidine- and platinum-based chemotherapy; AND
- Used for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC); OR
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- Used in combination with fluoropyrimidine- and platinum-containing chemotherapy; AND
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- Used as first-line therapy; AND
- Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA compliant testv; AND
- Used in patients with unresectable, advanced or metastatic esophageal squamous cell carcinoma (ESCC); OR
- Used for advanced or metastatic gastric, GEJ, or esophageal adenocarcinomas
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Squamous Cell Carcinoma of the Head and Neck (SCCHN) † 1,2,29,78
- Used as single-agent therapy; AND
- Patient has metastatic disease with disease progression on or after platinum-based therapy; AND
- Patient does not have disease of the nasopharynx
Hepatocellular Carcinoma (HCC) † 1,2,21,86,87
- Used as a single agent; AND
- Patient was previously treated with sorafenib and following treatment with intravenous nivolumab/ipilimumab
Renal Cell Carcinoma (RCC) † 1,2,25,26
- Used as a single agent; AND
- Used as first line therapy in patients with intermediate or poor risk advanced disease following treatment with intravenous nivolumab/ ipilimumab; OR
- Used as subsequent therapy after prior anti-angiogenic therapy; OR
- Used in combination with cabozantinib (Cabometyx only); AND
- Used as first-line therapy for advanced disease
Cutaneous Melanoma † 1,2,15-18,82,93
- Used as single agent therapy; AND
- Used as first-line therapy for unresectable or metastatic disease; OR
- Used as subsequent therapy for unresectable or metastatic disease following treatment with intravenous nivolumab/ipilimumab; OR
- Used as adjuvant treatment and patient has stage IIB, stage IIC, stage III or metastatic disease and has undergone complete resection
Non-Small Cell Lung Cancer (NSCLC) † 1,2,22,23,43,45,46
- Used as single-agent therapy; AND
- Used for metastatic disease; AND
- Used as subsequent therapy on or after platinum-based chemotherapy (Note: Patients with EGFR or ALK genomic tumor aberrations should have disease progression on targeted therapies prior to receiving subcutaneous nivolumab); OR
- Used in combination with platinum-doublet chemotherapy; AND
- Used as neoadjuvant therapy in patients who have resectable (tumors ≥ 4 cm or node positive) disease; OR
- Used as neoadjuvant therapy in resectable disease with the option of continuing to single-agent subcutaneous nivolumab therapy as adjuvant treatment after surgery
vIf confirmed using an FDA approved assay – http://www.fda.gov/companiondiagnostics
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria ∆ 1,2,4-6,15-42,43,47,49,50,52-54,68,72,73,79,81,82,89
Prior authorization validity can be renewed based upon the following criteria:
- Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Duration of authorization has not been exceeded (refer to Section I); AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis/renal dysfunction, rash/dermatitis [including Stevens-Johnson syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN)], myocarditis, pericarditis, vasculitis, solid organ transplant rejection, etc.), severe infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.
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Δ Notes:
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- Dosage/Administration ∆ 1,14,19,20,27,28,31-42,48-50,52-54,55,58,59,61,65,67,68,71-87,89,91,93,96,98-119,122-125,128-131
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Indication |
Dose |
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Renal Cell Carcinoma |
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Cutaneous Melanoma |
Unresectable or metastatic disease:
Adjuvant treatment:
Neoadjuvant treatment:
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Uveal Melanoma |
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Merkel Cell Carcinoma |
Neoadjuvant treatment:
All other settings:
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NSCLC |
Neoadjuvant treatment: †
Adjuvant treatment:
Single agent:
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Urothelial Carcinoma |
Adjuvant treatment:
Disease progression or second-line treatment:
First-line therapy: †
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Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer |
First-line therapy (MSI-H/dMMR adenocarcinoma and squamous cell carcinoma):
First line therapy (PD-L1 positive disease): †
Subsequent therapy (MSI-H/dMMR adenocarcinoma and squamous cell carcinoma):
Subsequent therapy (squamous cell carcinoma):
Post-operative therapy (MSI-H/dMMR adenocarcinoma following preoperative therapy with intravenous nivolumab/ipilimumab):
Adjuvant therapy following neoadjuvant chemoradiotherapy:
Induction therapy for relieving dysphagia (MSI-H/dMMR squamous cell carcinoma):
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Gastric Cancer |
First-line therapy:
Subsequent therapy:
Post-operative therapy (following preoperative therapy with intravenous nivolumab/ipilimumab):
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Soft Tissue Sarcoma, Kaposi Sarcoma |
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Squamous Cell Skin cancer |
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Vulvar Cancer, Vaginal Cancer, & Cervical Cancer |
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All other indications |
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Note:
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- Billing Code/Availability Information
HCPCS Code:
- J9289 – Injection, nivolumab, 2 mg and hyaluronidase-nvhy; 1 billable unit = 2 mg
NDC(s):
- Opdivo Qvantig single-dose vial providing 600 mg nivolumab and 10,000 units hyaluronidase per 5 mL (120 mg/ 2,000 units per mL): 00003-6120-xx
- References
- Opdivo Qvantig [package insert]. Princeton, NJ; Bristol-Myers Squibb, Inc; June 2025. Accessed September 2025.
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- Scherpereel A, Mazieres J, Greillier L, et al. Second- or third-line nivolumab (Nivo) versus nivo plus ipilimumab (Ipi) in malignant pleural mesothelioma (MPM) patients: Results of the IFCT-1501 MAPS2 randomized phase II trial. [Abstract]. J Clin Oncol 2017;35: Abstract LBA 8507.
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- Tawbi HA-H, Forsyth PAJ, Algazi AP, et al. Efficacy and safety of nivolumab (NIVO) plus ipilimumab (IPI) in patients with melanoma (MEL) metastatic to the brain: Results of the phase II study CheckMate 204. J Clin Oncol 2017;35(15_suppl):abstr 9507.
- Morris VK, Salem ME, Nimeiri H, et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Apr;18(4):446-453. Doi: 10.1016/S1470-2045(17)30104-3. Epub 2017 Feb 18.
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- Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. Doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.
- Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. Doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.
- Armand P, Engert A, Younes A, et al. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018 May 10;36(14):1428-1439. Doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27.
- Ansell SM, Lesokhin AM, Borrello I, et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin’s lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. Doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.
- Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. Epub 2016 Oct 8.
- Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):312-322. Doi: 10.1016/S1470-2045(17)30065-7. Epub 2017 Jan 26.
- Overman MJ, McDermott R, Leach JL, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017 Sep;18(9):1182-1191. Doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19.
- Overman MJ, Lonardi S, Wong KYM, et al. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. Doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.
- Topalian SL, Bhatia S, Hollebecque A, et al. Non-comparative, open-label, multiple cohort, phase ½ study to evaluate nivolumab (NIVO) in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in Merkel cell carcinoma (MCC). DOI: 10.1158/1538-7445.AM2017-CT074 Published July 2017.
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- Scherpereel A, Mazieres J, Greillier L, et al. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. Doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16.
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- Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Non-Small Cell Lung Cancer. Version 8.2025. National Comprehensive Cancer Network, 2025. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed September 2025.
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- Hellmann MD, Paz-Ares L, Bernabe Caro R, et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019;381(21):2020-2031. Doi:10.1056/NEJMoa1910231.
- Reck M, Ciuleanu T-E, Dols MC, et al. Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate 9LA [abstract]. J Clin Oncol 2020;38:Abstract 9501-9501.
- Zalcman G, Peters S, Mansfield AS, et al. Checkmate 743: A phase 3, randomized, open-label trial of nivolumab (nivo) plus ipilimumab (ipi) vs pemetrexed plus cisplatin or carboplatin as first-line therapy in unresectable pleural mesothelioma. Journal of Clinical Oncology 2017 35:15_suppl, TPS8581-TPS8581
- Azad NS, Gray RJ, Overman MJ, et al. Nivolumab Is Effective in Mismatch Repair-Deficient Noncolorectal Cancers: Results From Arm Z1D-A Subprotocol of the NCI-MATCH (EAY131) Study. J Clin Oncol. 2020 Jan 20;38(3):214-222.
- Naumann RW, Hollebecque A, Meyer T, et al. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834.
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- Munhoz RR, Nader-Marta G, de Camargo VP, et al. A phase 2 study of first-line nivolumab in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma. Cancer. 2022;128(24):4223-4231. doi:10.1002/cncr.34463
- Lang R, Welponer T, Richtig E, et al. Nivolumab for locally advanced and metastatic cutaneous squamous cell carcinoma (NIVOSQUACS study)-Phase II data covering impact of concomitant haematological malignancies. J Eur Acad Dermatol Venereol. 2023;37(9):1799-1810. doi:10.1111/jdv.19218
- Harker-Murray P, Mauz-Korholz C, Leblanc T, et al. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood 2023;141:2075-2084.
- Greve P, Beishuizen A, Hagleitner M, et al. Nivolumab plus brentuximab vedotin +/- bendamustine combination therapy: A safe and effective treatment in pediatric recurrent and refractory classical Hodgkin lymphoma. Front Immunol 2023;14:1229558.
Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist
Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.
|
Factor |
Conclusion |
|
Indication |
Yes: Consider for PA |
|
Safety and efficacy |
No: PA not a priority |
|
Potential for misuse/abuse |
No: PA not a priority |
|
Cost of drug |
Yes: Consider for PA |
Appendix 1 – Covered Diagnosis Codes
|
ICD-10 |
ICD-10 Description |
|
C00.0 |
Malignant neoplasm of external upper lip |
|
C00.1 |
Malignant neoplasm of external lower lip |
|
C00.2 |
Malignant neoplasm of external lip, unspecified |
|
C00.3 |
Malignant neoplasm of upper lip, inner aspect |
|
C00.4 |
Malignant neoplasm of lower lip, inner aspect |
|
C00.5 |
Malignant neoplasm of lip, unspecified, inner aspect |
|
C00.6 |
Malignant neoplasm of commissure of lip, unspecified |
|
C00.8 |
Malignant neoplasm of overlapping sites of lip |
|
C00.9 |
Malignant neoplasm of lip, unspecified |
|
C01 |
Malignant neoplasm of base of tongue |
|
C02.0 |
Malignant neoplasm of dorsal surface of tongue |
|
C02.1 |
Malignant neoplasm of border of tongue |
|
C02.2 |
Malignant neoplasm of ventral surface of tongue |
|
C02.3 |
Malignant neoplasm of anterior two-thirds of tongue, part unspecified |
|
C02.4 |
Malignant neoplasm of lingual tonsil |
|
C02.8 |
Malignant neoplasm of overlapping sites of tongue |
|
C02.9 |
Malignant neoplasm of tongue, unspecified |
|
C03.0 |
Malignant neoplasm of upper gum |
|
C03.1 |
Malignant neoplasm of lower gum |
|
C03.9 |
Malignant neoplasm of gum, unspecified |
|
C04.0 |
Malignant neoplasm of anterior floor of mouth |
|
C04.1 |
Malignant neoplasm of lateral floor of mouth |
|
C04.8 |
Malignant neoplasm of overlapping sites of floor of mouth |
|
C04.9 |
Malignant neoplasm of floor of mouth, unspecified |
|
C05.0 |
Malignant neoplasm of hard palate |
|
C05.1 |
Malignant neoplasm of soft palate |
|
C05.8 |
Malignant neoplasm of overlapping sites of palate |
|
C05.9 |
Malignant neoplasm of palate, unspecified |
|
C06.0 |
Malignant neoplasm of cheek mucosa |
|
C06.2 |
Malignant neoplasm of retromolar area |
|
C06.80 |
Malignant neoplasm of overlapping sites of unspecified parts of mouth |
|
C06.89 |
Malignant neoplasm of overlapping sites of other parts of mouth |
|
C06.9 |
Malignant neoplasm of mouth, unspecified |
|
C09.0 |
Malignant neoplasm of tonsillar fossa |
|
C09.1 |
Malignant neoplasm of tonsillar pillar (anterior) (posterior) |
|
C09.8 |
Malignant neoplasm of overlapping sites of tonsil |
|
C09.9 |
Malignant neoplasm of tonsil, unspecified |
|
C10.0 |
Malignant neoplasm of vallecula |
|
C10.1 |
Malignant neoplasm of anterior surface of epiglottis |
|
C10.2 |
Malignant neoplasm of lateral wall of oropharynx |
|
C10.3 |
Malignant neoplasm of posterior wall of oropharynx |
|
C10.4 |
Malignant neoplasm of branchial cleft |
|
C10.8 |
Malignant neoplasm of overlapping sites of oropharynx |
|
C10.9 |
Malignant neoplasm of oropharynx, unspecified |
|
C11.0 |
Malignant neoplasm of superior wall of nasopharynx |
|
C11.1 |
Malignant neoplasm of posterior wall of nasopharynx |
|
C11.2 |
Malignant neoplasm of lateral wall of nasopharynx |
|
C11.3 |
Malignant neoplasm of anterior wall of nasopharynx |
|
C11.8 |
Malignant neoplasm of overlapping sites of nasopharynx |
|
C11.9 |
Malignant neoplasm of nasopharynx, unspecified |
|
C12 |
Malignant neoplasm of pyriform sinus |
|
C13.0 |
Malignant neoplasm of postcricoid region |
|
C13.1 |
Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect |
|
C13.2 |
Malignant neoplasm of posterior wall of hypopharynx |
|
C13.8 |
Malignant neoplasm of overlapping sites of hypopharynx |
|
C13.9 |
Malignant neoplasm of hypopharynx, unspecified |
|
C14.0 |
Malignant neoplasm of pharynx, unspecified |
|
C14.2 |
Malignant neoplasm of Waldeyer’s ring |
|
C14.8 |
Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx |
|
C15.3 |
Malignant neoplasm of upper third of esophagus |
|
C15.4 |
Malignant neoplasm of middle third of esophagus |
|
C15.5 |
Malignant neoplasm of lower third of esophagus |
|
C15.8 |
Malignant neoplasm of overlapping sites of esophagus |
|
C15.9 |
Malignant neoplasm of esophagus, unspecified |
|
C16.0 |
Malignant neoplasm of cardia |
|
C16.1 |
Malignant neoplasm of fundus of stomach |
|
C16.2 |
Malignant neoplasm of body of stomach |
|
C16.3 |
Malignant neoplasm of pyloric antrum |
|
C16.4 |
Malignant neoplasm of pylorus |
|
C16.5 |
Malignant neoplasm of lesser curvature of stomach, unspecified |
|
C16.6 |
Malignant neoplasm of greater curvature of stomach, unspecified |
|
C16.8 |
Malignant neoplasm of overlapping sites of stomach |
|
C16.9 |
Malignant neoplasm of stomach, unspecified |
|
C17.0 |
Malignant neoplasm of duodenum |
|
C17.1 |
Malignant neoplasm of jejunum |
|
C17.2 |
Malignant neoplasm of ileum |
|
C17.3 |
Meckel’s diverticulum, malignant |
|
C17.8 |
Malignant neoplasm of overlapping sites of small intestine |
|
C17.9 |
Malignant neoplasm of small intestine, unspecified |
|
C18.0 |
Malignant neoplasm of cecum |
|
C18.1 |
Malignant neoplasm of appendix |
|
C18.2 |
Malignant neoplasm of ascending colon |
|
C18.3 |
Malignant neoplasm of hepatic flexure |
|
C18.4 |
Malignant neoplasm of transverse colon |
|
C18.5 |
Malignant neoplasm of splenic flexure |
|
C18.6 |
Malignant neoplasm of descending colon |
|
C18.7 |
Malignant neoplasm of sigmoid colon |
|
C18.8 |
Malignant neoplasm of overlapping sites of colon |
|
C18.9 |
Malignant neoplasm of colon, unspecified |
|
C19 |
Malignant neoplasm of rectosigmoid junction |
|
C20 |
Malignant neoplasm of rectum |
|
C21.0 |
Malignant neoplasm of anus, unspecified |
|
C21.1 |
Malignant neoplasm of anal canal |
|
C21.2 |
Malignant neoplasm of cloacogenic zone |
|
C21.8 |
Malignant neoplasm of overlapping sites of rectum, anus and anal canal |
|
C22.0 |
Liver cell carcinoma |
|
C22.8 |
Malignant neoplasm of liver, primary, unspecified as to type |
|
C22.9 |
Malignant neoplasm of liver, not specified as primary or secondary |
|
C24.1 |
Malignant neoplasm of ampulla of Vater |
|
C30.0 |
Malignant neoplasm of nasal cavity |
|
C31.0 |
Malignant neoplasm of maxillary sinus |
|
C31.1 |
Malignant neoplasm of ethmoidal sinus |
|
C32.0 |
Malignant neoplasm of glottis |
|
C32.1 |
Malignant neoplasm of supraglottis |
|
C32.2 |
Malignant neoplasm of subglottis |
|
C32.3 |
Malignant neoplasm of laryngeal cartilage |
|
C32.8 |
Malignant neoplasm of overlapping sites of larynx |
|
C32.9 |
Malignant neoplasm of larynx, unspecified |
|
C33 |
Malignant neoplasm of trachea |
|
C34.00 |
Malignant neoplasm of unspecified main bronchus |
|
C34.01 |
Malignant neoplasm of right main bronchus |
|
C34.02 |
Malignant neoplasm of left main bronchus |
|
C34.10 |
Malignant neoplasm of upper lobe, unspecified bronchus or lung |
|
C34.11 |
Malignant neoplasm of upper lobe, right bronchus or lung |
|
C34.12 |
Malignant neoplasm of upper lobe, left bronchus or lung |
|
C34.2 |
Malignant neoplasm of middle lobe, bronchus or lung |
|
C34.30 |
Malignant neoplasm of lower lobe, unspecified bronchus or lung |
|
C34.31 |
Malignant neoplasm of lower lobe, right bronchus or lung |
|
C34.32 |
Malignant neoplasm of lower lobe, left bronchus or lung |
|
C34.80 |
Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
|
C34.81 |
Malignant neoplasm of overlapping sites of right bronchus and lung |
|
C34.82 |
Malignant neoplasm of overlapping sites of left bronchus and lung |
|
C34.90 |
Malignant neoplasm of unspecified part of unspecified bronchus or lung |
|
C34.91 |
Malignant neoplasm of unspecified part of right bronchus or lung |
|
C34.92 |
Malignant neoplasm of unspecified part of left bronchus or lung |
|
C43.0 |
Malignant melanoma of lip |
|
C43.111 |
Malignant melanoma of right upper eyelid, including canthus |
|
C43.112 |
Malignant melanoma of right lower eyelid, including canthus |
|
C43.121 |
Malignant melanoma of left upper eyelid, including canthus |
|
C43.122 |
Malignant melanoma of left lower eyelid, including canthus |
|
C43.20 |
Malignant melanoma of unspecified ear and external auricular canal |
|
C43.21 |
Malignant melanoma of right ear and external auricular canal |
|
C43.22 |
Malignant melanoma of left ear and external auricular canal |
|
C43.30 |
Malignant melanoma of unspecified part of face |
|
C43.31 |
Malignant melanoma of nose |
|
C43.39 |
Malignant melanoma of other parts of face |
|
C43.4 |
Malignant melanoma of scalp and neck |
|
C43.51 |
Malignant melanoma of anal skin |
|
C43.52 |
Malignant melanoma of skin of breast |
|
C43.59 |
Malignant melanoma of other part of trunk |
|
C43.60 |
Malignant melanoma of unspecified upper limb, including shoulder |
|
C43.61 |
Malignant melanoma of right upper limb, including shoulder |
|
C43.62 |
Malignant melanoma of left upper limb, including shoulder |
|
C43.70 |
Malignant melanoma of unspecified lower limb, including hip |
|
C43.71 |
Malignant melanoma of right lower limb, including hip |
|
C43.72 |
Malignant melanoma of left lower limb, including hip |
|
C43.8 |
Malignant melanoma of overlapping sites of skin |
|
C43.9 |
Malignant melanoma of skin, unspecified |
|
C44.00 |
Unspecified malignant neoplasm of skin of lip |
|
C44.02 |
Squamous cell carcinoma of skin of lip |
|
C44.09 |
Other specified malignant neoplasm of skin of lip |
|
C44.121 |
Squamous cell carcinoma of skin of unspecified eyelid, including canthus |
|
C44.1221 |
Squamous cell carcinoma of skin of right upper eyelid, including canthus |
|
C44.1222 |
Squamous cell carcinoma of skin of right lower eyelid, including canthus |
|
C44.1291 |
Squamous cell of carcinoma of skin of left upper eyelid, including canthus |
|
C44.1292 |
Squamous cell carcinoma of skin of left lower eyelid, including canthus |
|
C44.221 |
Squamous cell carcinoma of skin of unspecified ear and external auricular canal |
|
C44.222 |
Squamous cell carcinoma of skin of right ear and external auricular canal |
|
C44.229 |
Squamous cell carcinoma of skin of left ear and external auricular canal |
|
C44.320 |
Squamous cell carcinoma of skin of unspecified parts of face |
|
C44.321 |
Squamous cell carcinoma of skin of nose |
|
C44.329 |
Squamous cell carcinoma of skin of other parts of face |
|
C44.42 |
Squamous cell carcinoma of skin of scalp and neck |
|
C44.520 |
Squamous cell carcinoma of anal skin |
|
C44.521 |
Squamous cell carcinoma of skin of breast |
|
C44.529 |
Squamous cell carcinoma of skin of other part of trunk |
|
C44.621 |
Squamous cell carcinoma of skin of unspecified upper limb, including shoulder |
|
C44.622 |
Squamous cell carcinoma of skin of right upper limb, including shoulder |
|
C44.629 |
Squamous cell carcinoma of skin of left upper limb, including shoulder |
|
C44.721 |
Squamous cell carcinoma of skin of unspecified lower limb, including hip |
|
C44.722 |
Squamous cell carcinoma of skin of right lower limb, including hip |
|
C44.729 |
Squamous cell carcinoma of skin of left lower limb, including hip |
|
C44.82 |
Squamous cell carcinoma of overlapping sites of skin |
|
C44.92 |
Squamous cell carcinoma of skin, unspecified |
|
C45.0 |
Mesothelioma of pleura |
|
C45.1 |
Mesothelioma of peritoneum |
|
C45.2 |
Mesothelioma of pericardium |
|
C45.7 |
Mesothelioma of other sites |
|
C45.9 |
Mesothelioma, unspecified |
|
C46.0 |
Kaposi’s sarcoma of skin |
|
C46.1 |
Kaposi’s sarcoma of soft tissue |
|
C46.2 |
Kaposi’s sarcoma of palate |
|
C46.3 |
Kaposi’s sarcoma of lymph nodes |
|
C46.4 |
Kaposi’s sarcoma of gastrointestinal sites |
|
C46.50 |
Kaposi’s sarcoma of unspecified lung |
|
C46.51 |
Kaposi’s sarcoma of right lung |
|
C46.52 |
Kaposi’s sarcoma of left lung |
|
C46.7 |
Kaposi’s sarcoma of other sites |
|
C46.9 |
Kaposi’s sarcoma, unspecified |
|
C47.0 |
Malignant neoplasm of peripheral nerves of head, face and neck |
|
C47.10 |
Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder |
|
C47.11 |
Malignant neoplasm of peripheral nerves of right upper limb, including shoulder |
|
C47.12 |
Malignant neoplasm of peripheral nerves of left upper limb, including shoulder |
|
C47.20 |
Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip |
|
C47.21 |
Malignant neoplasm of peripheral nerves of right lower limb, including hip |
|
C47.22 |
Malignant neoplasm of peripheral nerves of left lower limb, including hip |
|
C47.3 |
Malignant neoplasm of peripheral nerves of thorax |
|
C47.4 |
Malignant neoplasm of peripheral nerves of abdomen |
|
C47.5 |
Malignant neoplasm of peripheral nerves of pelvis |
|
C47.6 |
Malignant neoplasm of peripheral nerves of trunk, unspecified |
|
C47.8 |
Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system |
|
C47.9 |
Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified |
|
C48.0 |
Malignant neoplasm of retroperitoneum |
|
C48.1 |
Malignant neoplasm of specified parts of peritoneum |
|
C48.2 |
Malignant neoplasm of peritoneum, unspecified |
|
C48.8 |
Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum |
|
C49.0 |
Malignant neoplasm of connective and soft tissue of head, face and neck |
|
C49.10 |
Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder |
|
C49.11 |
Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder |
|
C49.12 |
Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder |
|
C49.20 |
Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip |
|
C49.21 |
Malignant neoplasm of connective and soft tissue of right lower limb, including hip |
|
C49.22 |
Malignant neoplasm of connective and soft tissue of left lower limb, including hip |
|
C49.3 |
Malignant neoplasm of connective and soft tissue of thorax |
|
C49.4 |
Malignant neoplasm of connective and soft tissue of abdomen |
|
C49.5 |
Malignant neoplasm of connective and soft tissue of pelvis |
|
C49.6 |
Malignant neoplasm of connective and soft tissue of trunk, unspecified |
|
C49.8 |
Malignant neoplasm of overlapping sites of connective and soft tissue |
|
C49.9 |
Malignant neoplasm of connective and soft tissue, unspecified |
|
C4A.0 |
Merkel cell carcinoma of lip |
|
C4A.10 |
Merkel cell carcinoma of eyelid, including canthus |
|
C4A.111 |
Merkel cell carcinoma of right upper eyelid, including canthus |
|
C4A.112 |
Merkel cell carcinoma of right lower eyelid, including canthus |
|
C4A.121 |
Merkel cell carcinoma of left upper eyelid, including canthus |
|
C4A.122 |
Merkel cell carcinoma of left lower eyelid, including canthus |
|
C4A.20 |
Merkel cell carcinoma of unspecified ear and external auricular canal |
|
C4A.21 |
Merkel cell carcinoma of right ear and external auricular canal |
|
C4A.22 |
Merkel cell carcinoma of left ear and external auricular canal |
|
C4A.30 |
Merkel cell carcinoma of unspecified part of face |
|
C4A.31 |
Merkel cell carcinoma of nose |
|
C4A.39 |
Merkel cell carcinoma of other parts of face |
|
C4A.4 |
Merkel cell carcinoma of scalp and neck |
|
C4A.51 |
Merkel cell carcinoma of anal skin |
|
C4A.52 |
Merkel cell carcinoma of skin of breast |
|
C4A.59 |
Merkel cell carcinoma of other part of trunk |
|
C4A.60 |
Merkel cell carcinoma of unspecified upper limb, including shoulder |
|
C4A.61 |
Merkel cell carcinoma of right upper limb, including shoulder |
|
C4A.62 |
Merkel cell carcinoma of left upper limb, including shoulder |
|
C4A.70 |
Merkel cell carcinoma of unspecified lower limb, including hip |
|
C4A.71 |
Merkel cell carcinoma of right lower limb, including hip |
|
C4A.72 |
Merkel cell carcinoma of left lower limb, including hip |
|
C4A.8 |
Merkel cell carcinoma of overlapping sites |
|
C4A.9 |
Merkel cell carcinoma, unspecified |
|
C51.0 |
Malignant neoplasm of labium majus |
|
C51.1 |
Malignant neoplasm of labium minus |
|
C51.2 |
Malignant neoplasm of clitoris |
|
C51.8 |
Malignant neoplasm of overlapping sites of vulva |
|
C51.9 |
Malignant neoplasm of vulva, unspecified |
|
C52 |
Malignant neoplasm of vagina |
|
C53.0 |
Malignant neoplasm of endocervix |
|
C53.1 |
Malignant neoplasm of exocervix |
|
C53.8 |
Malignant neoplasm of overlapping sites of cervix uteri |
|
C53.9 |
Malignant neoplasm of cervix uteri, unspecified |
|
C54.0 |
Malignant neoplasm of isthmus uteri |
|
C54.1 |
Malignant neoplasm of endometrium |
|
C54.2 |
Malignant neoplasm of myometrium |
|
C54.3 |
Malignant neoplasm of fundus uteri |
|
C54.8 |
Malignant neoplasm of overlapping sites of corpus uteri |
|
C54.9 |
Malignant neoplasm of corpus uteri, unspecified |
|
C55 |
Malignant neoplasm of uterus, part unspecified |
|
C58 |
Malignant neoplasm of placenta |
|
C61 |
Malignant neoplasm of prostate |
|
C64.1 |
Malignant neoplasm of right kidney, except renal pelvis |
|
C64.2 |
Malignant neoplasm of left kidney, except renal pelvis |
|
C64.9 |
Malignant neoplasm of unspecified kidney, except renal pelvis |
|
C65.1 |
Malignant neoplasm of right renal pelvis |
|
C65.2 |
Malignant neoplasm of left renal pelvis |
|
C65.9 |
Malignant neoplasm of unspecified renal pelvis |
|
C66.1 |
Malignant neoplasm of right ureter |
|
C66.2 |
Malignant neoplasm of left ureter |
|
C66.9 |
Malignant neoplasm of unspecified ureter |
|
C67.0 |
Malignant neoplasm of trigone of bladder |
|
C67.1 |
Malignant neoplasm of dome of bladder |
|
C67.2 |
Malignant neoplasm of lateral wall of bladder |
|
C67.3 |
Malignant neoplasm of anterior wall of bladder |
|
C67.4 |
Malignant neoplasm of posterior wall of bladder |
|
C67.5 |
Malignant neoplasm of bladder neck |
|
C67.6 |
Malignant neoplasm of ureteric orifice |
|
C67.7 |
Malignant neoplasm of urachus |
|
C67.8 |
Malignant neoplasm of overlapping sites of bladder |
|
C67.9 |
Malignant neoplasm of bladder, unspecified |
|
C68.0 |
Malignant neoplasm of urethra |
|
C69.30 |
Malignant neoplasm of unspecified choroid |
|
C69.31 |
Malignant neoplasm of right choroid |
|
C69.32 |
Malignant neoplasm of left choroid |
|
C69.40 |
Malignant neoplasm of unspecified ciliary body |
|
C69.41 |
Malignant neoplasm of right ciliary body |
|
C69.42 |
Malignant neoplasm of left ciliary body |
|
C69.60 |
Malignant neoplasm of unspecified orbit |
|
C69.61 |
Malignant neoplasm of right orbit |
|
C69.62 |
Malignant neoplasm of left orbit |
|
C73 |
Malignant neoplasm of thyroid gland |
|
C76.0 |
Malignant neoplasm of head, face and neck |
|
C77.0 |
Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck |
|
C78.00 |
Secondary malignant neoplasm of unspecified lung |
|
C78.01 |
Secondary malignant neoplasm of right lung |
|
C78.02 |
Secondary malignant neoplasm of left lung |
|
C78.6 |
Secondary malignant neoplasm of retroperitoneum and peritoneum |
|
C78.7 |
Secondary malignant neoplasm of liver and intrahepatic bile duct |
|
C79.31 |
Secondary malignant neoplasm of brain |
|
C79.89 |
Secondary malignant neoplasm of other specified sites |
|
C7A.1 |
Malignant poorly differentiated neuroendocrine tumors |
|
C7B.1 |
Secondary Merkel cell carcinoma |
|
D09.0 |
Carcinoma in situ of bladder |
|
D37.01 |
Neoplasm of uncertain behavior of lip |
|
D37.02 |
Neoplasm of uncertain behavior of tongue |
|
D37.05 |
Neoplasm of uncertain behavior of pharynx |
|
D37.09 |
Neoplasm of uncertain behavior of other specified sites of the oral cavity |
|
D37.1 |
Neoplasm of uncertain behavior of stomach |
|
D37.8 |
Neoplasm of uncertain behavior of other specified digestive organs |
|
D37.9 |
Neoplasm of uncertain behavior of digestive organ, unspecified |
|
D38.0 |
Neoplasm of uncertain behavior of larynx |
|
D38.5 |
Neoplasm of uncertain behavior of other respiratory organs |
|
D38.6 |
Neoplasm of uncertain behavior of respiratory organ, unspecified |
|
D39.2 |
Neoplasm of uncertain behavior of placenta |
|
O01.9 |
Hydatidiform mole, unspecified |
|
Z85.00 |
Personal history of malignant neoplasm of unspecified digestive organ |
|
Z85.01 |
Personal history of malignant neoplasm of esophagus |
|
Z85.028 |
Personal history of other malignant neoplasm of stomach |
|
Z85.068 |
Personal history of other malignant neoplasm of small intestine |
|
Z85.09 |
Personal history of malignant neoplasm of other digestive organs |
|
Z85.118 |
Personal history of other malignant neoplasm of bronchus and lung |
|
Z85.12 |
Personal history of malignant neoplasm of trachea |
|
Z85.42 |
Personal history of malignant neoplasm of other parts of uterus |
|
Z85.51 |
Personal history of malignant neoplasm of bladder |
|
Z85.59 |
Personal history of malignant neoplasm of other urinary tract organ |
|
Z85.820 |
Personal history of malignant melanoma of skin |
|
Z85.821 |
Personal history of Merkel cell carcinoma |
|
Z85.831 |
Personal history of malignant neoplasm of soft tissue |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
|
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
|
Jurisdiction |
Applicable State/US Territory |
Contractor |
|
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
|
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
|
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
|
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
|
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
|
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
|
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
|
J (10) |
TN, GA, AL |
Palmetto GBA |
|
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
|
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
|
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
|
15 |
KY, OH |
CGS Administrators, LLC |