Page 55 - Medicare Benefit Policy Manual

A/B MACs (A), (B), and (HHH), and DME MACs should also use these evidentiary
criteria when reviewing requests for making a determination as to whether a drug is
usually self-administered, and requests for reconsideration of a pending or published
determination.

Note that prior to August 1, 2002, one of the principal factors used to determine whether
a drug was subject to the self-administered exclusion was whether the FDA label
contained instructions for self-administration. However, CMS notes that under the new
standard, the fact that the FDA label includes instructions for self-administration is not,
by itself, a determining factor that a drug is subject to this exclusion.

G. Provider Notice of Noncovered Drugs

A/B MACs (A), (B), and (HHH), and DME MACs must describe on their Web site the
process they will use to determine whether a drug is usually self-administered and thus
does not meet the “incident to” benefit category. A/B MACs (A), (B), and (HHH), and
DME MACs must publish a list of the injectable drugs that are subject to the self-
administered exclusion on their Web site, including the data and rationale that led to the
determination. A/B MACs (A), (B), and (HHH), and DME MACs will report the
workload associated with developing new coverage statements in CAFM 21208.

A/B MACs (A), (B), and (HHH), and DME MACs must provide notice 45 days prior to
the date that these drugs will not be covered. During the 45-day time period, A/B MACs
(A), (B), and (HHH), and DME MACs will maintain existing medical review and
payment procedures. After the 45-day notice, A/B MACs (A), (B), and (HHH), and
DME MACs may deny payment for the drugs subject to the notice.

A/B MACs (A), (B), and (HHH), and DME MACs must not develop local coverage
determinations (LCDs) for this purpose because further elaboration to describe drugs that
do not meet the ‘incident to’ and the ‘not usually self-administered’ provisions of the
statute are unnecessary. Current LCDs based solely on these provisions must be
withdrawn. LCDs that address the self-administered exclusion and other information may
be reissued absent the self-administered drug exclusion material. A/B MACs (A), (B),
and (HHH), and DME MACs will report this workload in CAFM 21206. However, A/B
MACs (A), (B), and (HHH), and DME MACs may continue to use and write LCDs to
describe reasonable and necessary uses of drugs that are not usually self-administered.

H. Conferences Between A/B MACs (A), (B), and (HHH), and DME MACs

Contractors’ Medical Directors (CMDs) may meet and discuss whether a drug is usually
self-administered without reaching a formal consensus. Each A/B MAC (A), (B), or
(HHH), or DME MAC uses its discretion as to whether or not it will participate in such
discussions. Each A/B MAC (A), (B, or (HHH) or DME MAC) must make its own
individual determinations, except that A/B MACs (A) or (HHH) may, at their discretion,
follow the determinations of the A/B MAC (B) with respect to the self-administered
exclusion.