CMS Pub. 100-16, ch. 4, § 90.2

The contents of this section are governed by statutes and regulations including those set

forth at 42 CFR §422.109. The following definitions related to national coverage

determinations apply:

• A National Coverage Determination (NCD) is a determination by the Secretary

with respect to whether or not a particular item or service is covered under Medicare.

An NCD does not include a determination of what code, if any, is assigned to a

service or a determination about the payment amount for the service. HCPCS and

other codes are assigned through separate guidance.

• An NCD is issued under procedures that are established in the Federal Register and is

published in the Medicare National Coverage Determination (NCD) manual. Each

NCD will contain a specific effective date.

• A legislative change in benefits is a coverage requirement adopted by the Congress

and mandated by statute. The Secretary of Health and Human Services generally

implements a legislative coverage change through regulation and/or sub-regulatory

guidance.

• The term significant cost, as it relates to a particular NCD or legislative change in

benefits, means either of the following:

o The average cost of furnishing a single service exceeds a cost threshold that for a

calendar year is the preceding year’s dollar threshold adjusted to reflect the

national per capita growth percentage described at 42 CFR §422.308(a); or

o The estimated cost of Medicare services furnished as a result of a particular NCD

or legislative change in benefits represents at least 0.1 percent of the national

average per capita costs.