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CMS-1403-FC
drugs furnished through an item of durable medical
equipment (DME). The “grandfathering” provision in section
1847A(c)(6)(C)(ii) of the Act requires that certain drugs
be treated as multiple source drugs for purposes of
calculating the payment allowance limits. Section 112(b)
of the MMSEA requires that, effective April 1, 2008, the
payment amount for inhalation drugs furnished through an
item of DME is the lesser of the amount determined by
applying the grandfathering provision or by not applying
that provision. We reviewed our payment determinations
effective January 1, 2008 to identify the drugs subject to
this special rule, and implemented this new requirement in
accordance with the statutory implementation date of
April 1, 2008. We identified that albuterol and
levalbuterol, in both the unit dose and concentrated forms,
are subject to the special payment rule. At this time, we
have not identified other inhalation drugs furnished
through an item of DME to which section 112(b) of the MMSEA
applies.
The provisions in section 112 of the MMSEA are
self-implementing for services on and after April 1, 2008.
Because of the limited time between enactment and the
implementation date, it was not practical to undertake and
complete rulemaking on this issue prior to implementing the
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