Inject Infus denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for administration of the authorized Remicade infusions at a hospital-based outpatient infusion facility.Belonephobia (fear of needles), trypanophobia (fear of injections), and aichmophobia (fear of sharp objects) can lead to phobias requiring specific management. In both pediatric and adult patients, these phobias can result in elevated levels of anxiety and fear leading to the avoidance of care, and to interference with clinicians’ ability to perform procedures.

Nature of Statutory Criteria/Case Summary: An enrollee has requested self-injectable testosterone injection (cypionate) for treatment of his medical condition. Findings: The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. Low testosterone can lead to complications including reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue. For these reasons, many providers treat patients with hypogonadism when their testosterone level is less than 350 ng/dL. The general target level for testosterone ranges from 350 to 750 ng/dL, which is roughly the range for healthy, androgen-sufficient adult men.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for the administration in a hospital-based outpatient infusion center setting for authorized Inflectra infusions. The provided clinical documentation does not provide medical reasons to support the medical necessity of subsequent Inflectra infusions in the hospital outpatient facility infusion setting rather than a community-based outpatient facility or home infusion. Inflectra is U.S. Food and Drug Administration (FDA)-approved for induction and maintenance of remission in patients with Crohn's disease. High-quality clinical trials support the use of Inflectra in patients with Crohn's disease. Once initiated, Inflectra should be continued on a maintenance schedule.

Findings: The physician reviewer found that The patient has requested authorization and coverage for home health nurse visits twice a day to assist with total parenteral nutrition (TPN). TPN, which provides life-sustaining support to patients who otherwise are unable to obtain sufficient nutrition via the gut, can be administered in hospitals or in the community, including by responsible, trained laypersons (Worthington and Gilbert). Patients can self-administer TPN, or this can be performed by caregivers. Guidelines for administration of TPN in the community recommend an adequate home environment and appropriate training for patients and caregivers in safe infusion techniques (Pironi, et al.).

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Inject Infus, then check the rights and deadlines that apply to your plan.