Does J7296 require prior authorization?

No, J7296 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for J7296?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J7296`, Levonorgestrel-releasing intrauterine contraceptive system, (kyleena), 19.5 mg

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Covered without prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Daily prospective symptom charting for at least 2 menstrual cycles to confirm luteal-phase confinement of symptoms: "daily symptom charting for at least 2 menstrual cycles (2 periods are studied because of variability between cycles)."
Use of validated rating tools in trials / diagnosis: e.g., Daily Record of Severity of Problems (DRSP) for prospective confirmatory ratings (PMDD trials used 2 consecutive months of DRSP), and symptom scales such as the Zung, Hamilton Depression and Anxiety Rating Scales, Clinical Global Impressions Scale in studies.

Diagnosis confirmation: "An accurate diagnosis of PMS can only be made by confirming that symptoms are confined to the luteal phase of the menstrual cycle."

Diagnostic criteria: PMDD diagnosed per DSM criteria (DSM-IV-TR referenced in studies) and exclusion of current psychiatric comorbidity when appropriate (some studies used the MINI to exclude comorbid conditions).

Documentation of failure of conservative therapy prior to pharmacologic therapy: "Women with PMDD or PMS, who have failed to adequately respond to 2 to 3 months of first-line treatments, may be prescribed medications."

Relevant laboratory tests as clinically indicated: thyroid function measures (e.g., TSH, thyroxine) may be useful to rule out thyroid dysfunction; no routine hormone measurements are recommended for PMS diagnosis.

Key Coverage Criteria

Diagnosis and treatment of pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD).
Assessment services considered medically necessary for PMS/PMDD: "Gynecological consultation".
Assessment services considered medically necessary for PMS/PMDD: "Medical evaluation (complete medical history and physical examination)".
Assessment services considered medically necessary for PMS/PMDD: "Psychiatric/psychological consultation and testing if the member exhibits mental/nervous symptoms".
Assessment services considered medically necessary for PMS/PMDD: "Thyroid function tests (e.g., thyroid stimulating hormone, thyroxine)".
Treatment services considered medically necessary for PMS/PMDD: "Bilateral oophorectomy for members with severe symptoms when all medical therapy has either failed or produced unacceptable side effects".

6 Active Policies

UHC-POL-abnormal-uterine-bleeding-uterine-fibroids, Abnormal Uterine Bleeding and Uterine Fibroids

AETNA-CPB-0512, Premenstrual Syndrome and Premenstrual Dysphoric Disorder

AETNA-CPB-0510, Progestins

CIGNA-A004, Preventive Care Services

UMR-POL-UMR-abnormal-uterine-bleeding-uterine-fibroids, Abnormal Uterine Bleeding and Uterine Fibroids

SUREST-POL-SUREST-abnormal-uterine-bleeding-uterine-fibroids, Abnormal Uterine Bleeding and Uterine Fibroids

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J7296, Levonorgestrel-releasing intrauterine contraceptive system, (kyleena), 19.5 mg