Billing Tocilizumab and Alternatives

Delta variant is creating some commotion to say the least. Tocilizumab (Actemra) used to treat rheumatoid arthritis among other things is now being used to treat hospitalized patients with Covid-19 under an EUA. The storm has created a world wide shortage leaving organizations up to their own devices to battle hospitalized Covid-19 patients and patients who were actively being treated with tocilizumab for other indications. While you focus on treating patients, we are here to help iron out the billing implications whichever method you choose.

While we do not provide recommendations for clinical alternatives, here are some things to consider when transitioning patients to a new therapy in outpatient departments (hospital or physician office).

Do you have an updated prior authorization in place for the alternative?

Commercial payers may require a new prior authorization to be obtained when transitioning therapy to an alternative.

Does the alternative meet medical necessity?

CMS does not have prior authorization requirements for these agents, but should search for any LCD/NCD to ensure medical necessity is covered.

Commercial payers may have additional requirements or policies for individual drugs that must be met to meet medical necessity.

If the alternative is a subcutaneous formulation, is the medication considered a self-administered drug?

Subcutaneous alternatives to tocilizumab may have a high propensity to be listed on the self-administered exclusion lists outlined by individual MACs. Neither the drug nor the administration of the drug may be billed to a Medicare beneficiary when listed as a self-administered drug.

Denials for SAD may not be appealed since they are considered statutorily excluded from Medicare Part B payment.

Reference our previous newsletter regarding billing for SADs.

The alternative chosen did NOT have an FDA labeled indication for my patient and did not meet the medical necessity requirements in the policies. What should I do?

Despite best efforts, there may be alternatives that are chosen that do not have an FDA approved indication for the respective patient diagnosis or the alternative did not meet all the requirements in the medical necessity policies.

Ensure there is appropriate documentation in the chart that justifies why the alternative was chosen and document that the preferred agent, tocilizumab, is on a national shortage.

Follow the claim and monitor for a potential denial. Upon receiving a denial, submit an appeal and provide the clinical justification for the alternative selected during a shortage.

Reference our previous newsletter regarding billing when FDA off-labeled.

Shout Outs! Pre-access, pharmacy, revenue integrity and appeals teams – coordinated efforts among the entire pharmacy revenue cycle process should be involved depending on the alternative therapy selected for tocilizumab during the shortage.

Reference back to our previous newsletters regarding SAD and FDA off-label indications for more details on billing in these situations.