Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 1.62% Gel pump. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Testosterone 1.62% Gel pump.Testosterone 1.62% Gel pump is requested for treatment of E29.1 - testicular hypofunction in this 47 year old man (DOB 6/2/72). Upon a request for additional information, the prescriber states that the enrollee has primary acquired hypogonadism, then later on, the form indicates that the enrollee has hypogonadotropic hypogonadism as well as age related/late onset hypogonadism. It is stated that the diagnosis was made in September 26, 2018, yet the medical record from a visit on August 5, 2019, states that the enrollee had been on Androgel for 10 years, then was switched to Testosterone injections. The records from March 2020 indicates that the enrollee continued to have symptoms on Testosterone Cypionate; therefore a request was made for coverage of Androgel Gel pump. Regarding the etiology and diagnostic evaluation of the enrollee's condition, medical records indicate that the enrollee was on treatment with Testosterone injections when seen on August 5, 2019 - at that time testosterone level was 349, LH (leutinizing hormone) and FSH (follicle stimulating hormone) were less than 0.2 and less than 0.7 respectively. Free testosterone level was normal (presumably on treatment) on April 7, 2019 - 119, and December 23, 2019 - 201.5. The prescriber states that testosterone was low at 240 mg/dL with symptoms prompting treatment; however the records are not provided for the initial diagnosis. The cause of the enrollee's hypogonadism is not clear - the LH and FSH results provided were associated with a normal testosterone level (August 2019), and the documentation indicates that the values were obtained on treatment. Although the onset of the enrollee's condition was at an early age, the prescriber has not provided sufficient documentation as to the etiology of the enrollee's condition. As noted, contradictory information has been provided. Additionally, there is insufficient documentation provided regarding pre-treatment symptoms, and laboratory data/evaluation. Based on the available information, there is insufficient documentation that the requested drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D based on the available documentation.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Testosterone 1.62% Gel pump for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Testosterone 1.62% Gel pump. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.