As the United States’ largest payor for healthcare services, the Centers for Medicare & Medicaid Services (CMS) exercises unrivaled potential to shape healthcare markets and health outcomes through its Medicare coverage decisions. In coverage decisions set forth in the Federal Register in 2003 and 2013, CMS committed to transparency and clarity in its decision-making process. Still, the national coverage determination (NCD) process remains a source of confusion for many.
Background
Under Title XVIII of the Social Security Act, “Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury.” And having a medical intervention—be it a drug, device, durable medical equipment, or treatment—deemed “reasonable and necessary” and approved for Medicare reimbursement can have far-ranging consequences for manufacturers and patients alike.
The first step lies in defining the arguably imprecise term “reasonable and necessary”—a debate which found its way to the Supreme Court in 1984. In its decision in Heckler v. Ringer, the Court held that the Secretary of Health and Human Services (HHS) has the ultimate authority to determine “whether a particular medical service” meets this nebulous threshold.
Through CMS, HHS exercises this authority in one of two ways. NCDs, which are binding on all Medicare contractors, are made at the national level for medical interventions which can reasonably be expected to have a significant impact on the Medicare program. In the absence of an NCD, local coverage determinations (LCDs) may be made by one of sixteen regional Medicare Administrative Contractors (MACs). Additionally, CMS only makes NCD decisions for items and services that fit into a Medicare Benefit Category.
The NCD process
The NCD process is reasonably straightforward. A request for an NCD may be initiated internally as CMS becomes aware of a new drug or technology, or externally by anyone seeking a change in Medicare’s coverage policy for an item or service. External stakeholders typically include manufacturers, patients, individual providers, or provider associations, but there is no restriction as to who can initiate a request, provided they comply with the NCD process as outlined in the Federal Register.
Requests may be made for new items or services that are not currently included in an NCD or for changes to provisions of an existing NCD. Stakeholders may also ask to establish new NCDs or to entirely remove existing NCDs. Additionally, CMS may choose to remove existing NCDs on its own when the policies are outdated, or when items and services are no longer used in clinical practice.
Statute specifies that CMS must publish a proposed NCD within six months of a formal request. This may be extended to nine months if it is determined that the intervention requires an external technical assessment or consideration by the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
NCDs are made on an evidence-based process and the cost of an intervention is not considered in the decision process. CMS also provides avenues for public input, allowing 30 days for public comment after the publication of any proposed decision.
After a coverage determination is made, CMS publishes a decision memorandum outlining the reasoning behind its decision whether to initiate or modify coverage for a specific intervention. The NCD is a directive instructing claims processing contractors in the payment for items and services included in the policy.
Procedural delays and process anomalies
Unfortunately, CMS is sometimes forced to make adjustments in the implementation of its own policies. Speaking at a Northern Virginia Health Policy Forum in February, Tamara Syrek Jensen, J.D., Director of the Coverage and Analysis Group (CAG), Centers for Clinical Standards and Quality, CMS, acknowledged that CMS receives “more requests than we have people.”
This imbalance can result in longer than expected wait times for some requestors. To manage the number of requests it receives, CMS utilizes a waitlist system which ranks requests not in chronological order of receipt, but in terms of the number of Medicare lives that could be impacted by a policy decision.
CMS policy also provides that “upon acceptance of a complete, formal request, publication of a tracking sheet on the CMS website enables interested individuals to participate and monitor the progress of our review. The tracking sheet is a key element in making our NCD process efficient, open, and accessible to the public.”
In current practice, CMS does not publish tracking sheets for NCD requests which it has received and accepted until it publishes a proposed decision for public comment. The formal evidence review process, which takes place prior to CMS publishing a proposed decision, has recently ranged from six months to two years in length.
For those new to the NCD process, such delays, without communication or explanation, can be confusing. However, it is important to remember that they are neither unusual nor typically indicative of the final decision that will be made. In addition to adherence to procedures, entering the NCD process requires patience.