Applies to Medicaid and ACA Marketplace plans.
Covered with requirementsQualification pathways
You can qualify through any one of these.
Step therapy for formulary drugs
All of:
- Medication is being used for treatment of type 2 diabetes mellitus
Plus any one of:
- Documentation or prescriber attestation that metformin has been ineffective in the treatment of the member's disease or medical condition OR is likely to be ineffective
- Documentation or prescriber attestation that metformin has caused or is likely to cause a clinically significant adverse reaction or other harm
Type 2 Diabetes Mellitus — initial approval
All of:
- Documentation of diagnosis of type 2 diabetes mellitus
- Documentation of inadequate treatment response, contraindication, or serious side effects to 3 consecutive months of metformin (inadequate response = not achieving adequate glycemic control after 3 continuous months of maximal daily doses)
- Documentation by prescriber of baseline disease activity and individualized goals for therapy (e.g., A1C, weight management, glycemic targets)
- Prescriber attests no unaddressed FDA-labeled contraindications (hypersensitivity to product; history/family history of MTC; MEN2)
Plus any one of:
- FOR NON-FORMULARY/NON-PREFERRED SINGLE AGENTS: Documented inadequate response, serious side effects, or contraindication to ALL formulary/preferred agents within the same therapeutic class
- FOR COMBINATION PRODUCTS: Documented inadequate response, serious side effects, or contraindication to ALL formulary/preferred combination agents with matching therapeutic class OR to ALL matching class formulary single agents within the requested combination product
Documentation to bring
- Documentation of diagnosis of type 2 diabetes mellitus
- Documentation of inadequate treatment response, contraindication, or serious side effects to 3 consecutive months of metformin at maximal daily doses
- Prescriber documentation of baseline disease activity and individualized therapeutic goals (e.g., A1C, weight, glycemic targets)
- Prescriber attestation of no unaddressed FDA-labeled contraindications
- For non-preferred/non-formulary agents: Documentation of failure, intolerance, or contraindication to all formulary/preferred agents in the same class
- For CA/FL/KY/WA Marketplace: Approval letter or coverage documentation showing the step-therapy formulary drug was covered by the member's previous insurer
Quantity limits
- 0.25mg/dose, 0.5mg/dose, 1mg/dose, 2mg/dose — 3 mL
Approval and renewal
- Initial approval: 12 months
- Renewal: every 12 months
- Renewal: Improvement in A1C.
- Renewal: Documentation of positive clinical response as demonstrated by improvement in hemoglobin A1C OR member has reached individualized goals. Also requires adherence ≥ 85% and no evidence of intolerable adverse effects.
Not covered when
- Hypersensitivity to requested product or any component of the formulation
- History of or family history of medullary thyroid carcinoma (MTC)
- Multiple endocrine neoplasia syndrome type 2 (MEN2)
- Pre-diabetes
- Any disorder of glucose not classified specifically as type 2 diabetes (e.g., impaired fasting glucose, hyperglycemia, impaired glucose tolerance, unspecified insulin resistance, abnormal glucose)
- Obstructive sleep apnea (off-label unsupported)
- Polycystic ovary syndrome (PCOS) (off-label unsupported)
- Atherosclerosis (off-label unsupported)
- Heart disease (off-label unsupported)
- Hypertension (off-label unsupported)
- Lymphedema (off-label unsupported)
- Metabolic disorder or syndrome (off-label unsupported)
- Fatty liver disease / NASH / MASH (off-label unsupported)
- Alcohol use disorder (off-label unsupported)
- Type 1 diabetes
Exceptions
- Illinois_Marketplace: Off-formulary exception shall not be denied if: (1) formulary drug is contraindicated; (2) patient tried formulary drug under current or previous plan and prescriber submits evidence of failure or intolerance; or (3) patient is stable on a drug selected by their provider under current or previous plan. Approvals honored for 12 months or until plan renewal.
- CA_FL_KY_WA_Marketplace: Approval letter or other coverage documentation showing the formulary step-therapy drug was covered by previous insurer also meets the step therapy criteria.
Policy note: Policy covers Ozempic for type 2 diabetes mellitus, including when indicated for T2DM AND cardiovascular disease or chronic kidney disease (per Molina Reviewer Note under Section A and B). Weight loss and obesity are explicitly excluded from coverage per Social Security 1927(d)(2)(A). All other off-label uses are considered experimental/investigational. Ozempic FDA label also includes CV risk reduction and CKD indications, but these are covered under the T2DM indication criteria when the patient also has T2DM. Step therapy initial authorization is 12 months with no continuation; all other indications have 12-month initial and 12-month continuation.
Policy effective May 30, 2026 · verified June 11, 2026 · source: 831 B5446 D9 D44 Edca352296 E84 F1 Dcd5 · View policy document (PDF)