Knowledge Base Article

It is important to maintain balance in life, for example, people need to balance their job responsibilities with their family and personal lives. In healthcare, it is important to balance the risks of new innovations against their efficacy and safety. Medicare has detailed processes for evaluating and approving coverage of new items and services through the National Coverage Determination (NCD) process. A final NCD describes the covered indications and any contraindications for a particular item or service. Even using the NCD process, Medicare sometimes determines there is not yet enough evidence available to make a coverage decision. In these situations, Medicare must balance offering the new technology to those in need, while being careful not to cover services that may not be effective or safe enough for the benefits to outweigh the risks. They have another process for these scenarios – coverage with evidence development (CED).

According to a Medicare document, “Coverage with Evidence Development (CED) allows coverage of certain items or services where additional data gathered in the context of clinical care would further clarify the impact of these items and services on the health of Medicare beneficiaries. Medicare coverage may be extended to patients enrolled in a clinical research study. CED allows Medicare to provide coverage for an item or service because it is provided within a research setting where there are added safety, patient protections, monitoring, and clinical expertise. CED projects provide the necessary new evidence to influence clinical practice and help Medicare beneficiaries and providers make more informed diagnostic and therapeutic decisions.”

In mid-February, CMS released one final and one proposed decision memo allowing coverage with evidence development for two services.

Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD):

The final decision memo allows coverage of “FDA approved vagus nerve stimulation (VNS) devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings.” The studies must be approved by CMS and must address whether VNS improves health outcomes for TRD patients compared to a control group. The policy delineates specific research questions, patient criteria and contraindications for trial participation.

Chimeric Antigen Receptor (CAR) T-cell Therapy:

CMS proposes to cover autologous treatment with T-cells expressing at least one chimeric antigen receptor (CAR) through coverage with evidence development (CED)

• when prescribed by the treating oncologist,
• performed in a hospital,
• for patients who have relapsed or refractory cancer and have not currently been experiencing any comorbidity that would otherwise preclude patient benefit, and
• when certain hospital and treatment criteria are met.

CAR T-cell therapy is a new form of cancer therapy that uses a patient’s own immune system to fight the disease. It is the first FDA-approved gene therapy. According to the CMS announcement, “The proposed National Coverage Determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. Evidence from the registries and studies would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing a future decision by the agency regarding the types of cases in which Medicare would cover the treatment with no registry or trial requirement.”

Both of these decision memos will improve access to treatment options and maintain patient safety while deepening CMS’s understanding of how patients in Medicare respond. This will allow CMS to ensure that it is paying for treatments in which the benefits outweigh the risks.

Coverage updates over the last month from local Medicare Administrative Contractors are listed below. Notice that 9 of the 12 MACs have released a coverage article on Coding and Billing for Implantable Automatic Defibrillators (ICDs).