In the early 1960’s, changes in federal regulations sparked a revolution in drug research and development, particularly in regard to clinical trial testing when Investigational New Drug designations (INDs) and New Drug Applications were implemented.
Then in 1965, Medicare, the national social insurance program, was established.
While Medicare has had a reputation for covering only the bare essentials, offering minimal coverage to their patients and typically adhering to conventional care services, they recognized that without clinical research, advances in medical therapies could not be made. In order to support patient enrollment in clinical trials and the advancement of drug sciences, they implemented National Coverage Determination (NCD) 310.1: “Coverage for Routine Costs in Clinical Trials” as their Clinical Trial Policy (CTP) in September, 2000 with an update released in July, 2007.
NCD 310.1 is a synopsis of what may or may not be covered for patients enrolled in clinical trials. Its application can be broken down into two steps. First, a clinical trial must be evaluated to determine if it qualifies for coverage of what Medicare determines to be “routine costs.” In order to do so, the purpose of the trial must be one that is itemized in the comprehensive Medicare Benefits Category List, the intent of the trial must be therapeutic, and the trial must include patients diagnosed with the disease under investigation. Addtionally, to be eligible for “routine cost” coverage, the trial must meet a lengthy list of criteria called the seven desirable characteristics.
There are some instances in which the items in the aforementioned lengthy list need not be confirmed again, as they are already assumed or deemed to have been met. This is true in cases where a trial is sponsored or supported by a federal health institution, the trial has an IND number, or is proven to be IND exempt. In these cases, no further inquiry is needed.
Next you might ask, “What does Medicare consider to be ‘routine costs’ of the clinical trial?” The answers can require quite a bit of digging. NCD 310.1 defines a “routine cost” as an item normally offered to Medicare patients with the particular indication and can be determined by citing reputable treatment guidelines for the particular disease (i.e. conventional care). While NCD 310.1 typically does not offer coverage for the investigational item itself, it does offer coverage for the administration of the investigational item and for reasonable and necessary care items used for the clinical management of the patient.
Medicare’s CTP does not apply to medical devices or human cell and tissue products, which are a whole different ballgame. NCD 310.1 also enumerates the limitations to coverage. This includes items that are used solely for data and items that have been offered to be paid for by the research sponsor. If that alone isn’t enough to consider, NCD 310.1 slips in the conditional language “all other Medicare rules apply,” which adds an additional layer of complexity. With this language, the numerous and ever-increasing number of National and Local Coverage Determinations comes into play, which may further limit Medicare coverage of clinical trial items and procedures.
Undoubtedly, coverage analysis for clinical trial costs and interpretation of NCD 310.1 language can be a tricky business.