Asset Publisher
Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy)
Policy Number: VP-0784
(Subcutaneous)
Last Review Date: 02/04/2025
Date of Origin: 02/04/2025
Dates Reviewed: 02/2025
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
Coverage will be provided for 6 months and may be renewed (unless otherwise specified).
- Neoadjuvant treatment of NSCLC without adjuvant treatment may be authorized for a maximum of three (3) neoadjuvant doses
- Neoadjuvant treatment followed by optional adjuvant treatment of NSCLC may be authorized for a maximum of four (4) neoadjuvant doses and thirteen (13) adjuvant doses.
- Adjuvant treatment of the following indications may be renewed up to a maximum of one (1) year of therapy*:
- Cutaneous Melanoma (single agent)
- Esophageal and Esophagogastric/Gastroesophageal Junction Cancer
- Urothelial Carcinoma
- The following indications may be renewed up to a maximum of two (2) years of therapy:
- Esophageal Squamous Cell Carcinoma
- Esophageal and Esophagogastric/Gastroesophageal Junction Cancer
- Gastric Cancer
- Renal Cell Carcinoma (in combination with cabozantinib)
-
- Urothelial Carcinoma (first line therapy in combination with gemcitabine and cisplatin, followed by single-agent maintenance therapy)
- Dosing Limits
*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 |
2 weeks |
1 year |
26 doses |
2 years |
52 doses |
|
3 weeks |
2 years |
35 doses |
4 weeks |
1 year |
13 doses |
2 years |
26 doses |
- Max Units (per dose and over time) [HCPCS Unit]:
- 1,200 mg/20,000 units every 4 weeks
- Initial Approval Criteria 1
Coverage 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 (e.g., atezolizumab, pembrolizumab, durvalumab, avelumab, cemiplimab, dostarlimab, nivolumab/relatlimab, retifanlimab, toripalimab, tislelizumab, etc.) unless otherwise specified ∆ (Note: Not applicable when used as switch-therapy with intravenous nivolumab); AND
- Therapy will not be used concomitantly with intravenous nivolumab; AND
- IV formulation of Opdivo must be used in the following:
- Patients <80 kg; OR
- Patients requiring 900 mg/15,000 units dose*; OR
- Patients receiving therapy in combination with ipilimumab; AND
Urothelial Carcinoma (Bladder Cancer) † 1,2,30,51,62,92
- Used as a single agent; AND
- Used for 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
-
- 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 patient with unresectable or metastatic disease
** Note: 1,62
|
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
-
- Used in combination with fluoropyrimidine- and platinum-containing chemotherapy; AND
-
-
- Used as first-line therapy; 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
- Used as first-line therapy; AND
-
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 following treatment with 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 disease following previous treatment with nivolumab and ipilimumab combination therapy; 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 after prior nivolumab/ipilimumab combination therapy; 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 Opdivo Qvantig); 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 Opdivo Qvantig 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
§ Genomic Aberration/Mutational Driver Targeted Therapies (Note: not all inclusive, refer to guidelines for appropriate use) |
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EGFR exon 19 deletion or exon 21 L858R tumors |
EGFR S768I, L861Q, and/or G719X mutation positive tumors |
EGFR exon 20 insertion mutation positive tumors |
NTRK1/2/3 gene fusion positive tumors |
|
|
|
|
ALK rearrangement-positive tumors |
ROS1 rearrangement-positive tumors |
BRAF V600E-mutation positive tumors |
ERBB2 (HER2) mutation positive tumors |
|
|
|
|
PD-L1 tumor expression ≥ 1% |
MET exon-14 skipping mutations |
RET rearrangement-positive tumors |
KRAS G12C mutation positive tumors |
|
|
|
|
- Renewal Criteria ∆ 1,6
Coverage 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
- 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.
NSCLC (neoadjuvant/adjuvant treatment)
Patient has not exceeded a maximum of twelve (12) months (13 cycles) of therapy
Δ Notes:
|
- Dosage/Administration ∆ 1,14,27,28
Indication |
Dose |
Renal Cell Carcinoma |
|
Melanoma |
Note: For adjuvant therapy, treat until disease recurrence or unacceptable toxicity for up to 1 year |
NSCLC |
Neoadjuvant and adjuvant treatment
Metastatic non-small cell lung cancer
|
SCCHN |
|
Urothelial Carcinoma |
Urothelial carcinoma
Note: For adjuvant therapy, treat until disease recurrence or unacceptable toxicity for up to 1 year First-line unresectable or metastatic urothelial carcinoma
|
Colorectal Carcinoma |
|
Hepatocellular Carcinoma |
|
Esophageal Squamous Cell Cancer |
|
Gastric Cancer, GEJ Cancer, and Esophageal Adenocarcinoma |
Note: For adjuvant therapy in esophageal and GEJ, treat until disease recurrence or unacceptable toxicity for up to 1 year |
Note:
|
- Billing Code/Availability Information
HCPCS Code:
- J9999 – Not otherwise classified, antineoplastic drugs
- C9399 – Unclassified drugs or biologicals (hospital outpatient use only)
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
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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 |
C18.0 |
Malignant neoplasm of cecum |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Z85.118 |
Personal history of other malignant neoplasm of bronchus and lung |
Z85.51 |
Personal history of malignant neoplasm of bladder |
Z85.59 |
Personal history of malignant neoplasm of other urinary tract organ |
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 |