§1862(l) of the Social Security
Act (“the Act”) defines an NCD as a determination by the Secretary of the
Department of Health and Human Services (“HHS”) “with respect to whether or not
a particular item or service is covered nationally under [Title
XVIII-Medicare].”
NCDs are the general rules to
ensure that similar claims for similar items or services are covered similarly,
under Medicare Part A or Part B. In
addition, §1862(l) of the Act also establishes the timeframe for the NCD process
and opportunity for public comment.
The Notice details the process
for: (1) informal contacts and inquiries made prior to requesting an NCD, which
are encouraged but not required by CMS; (2) formal requests for an NCD or
reconsideration of an NCD, including the elements required for a request to be
considered complete; (3) requests for NCDs from external parties, such as
Medicare beneficiaries, manufacturers, physicians, or physician professional
associations; (4) CMS reviews of NCDs that are initiated internally by CMS; and
(5) an expedited process to remove NCDs under certain circumstances to ensure
CMS’ policies and processes remain effective and efficient.
The Notice also reiterates: (1)
the internal and external process for requesting an NCD or NCD reconsideration;
(2) a tracking system that provides public notice of CMS’ acceptance of a
complete, formal request and subsequent actions; (3) the process for public
comment prior to CMS’ issuance of a decision memorandum; and (4) how CMS uses
public comments to inform the NCD final decision.
For additional information on
NCD’s please contact Meghan Linvill McNab at mmcnab@kdlegal.com.