CMS Drops Coverage of All Compounded Inhalation Solutions

BALTIMORE–In yet another hit to the nebulizer medications
sector, CMS last week issued a revised policy that denies coverage
for compounded inhalation solutions on the basis that they are
medically unnecessary.

The policy change takes effect July 1.

In its draft policy, CMS had proposed eliminating coverage for
inhalation solutions that are available only as compounded
solutions. A compounded inhalation solution is produced by a
pharmacy rather than an FDA-approved manufacturer and has,
therefore, not been approved for either safety or efficacy,
according to CMS.

As a result of comments on the draft proposal “and the absence
of any published clinical literature defining the need for compound
inhalation solutions for an individual patient, the final policy
extends noncoverage of compounded solutions beyond the specific
drugs listed in the draft policy,” according to the March Bulletin
posted on the TriCenturion Region A/B DME PSC Web site.

On Friday, officials with the International Academy of
Compounding Pharmacies had not yet had a chance to formulate an
official response to the policy change. But spokesman Josh
Wenderoff noted that “ultimately, it could be a real serious
concern for pharmacies and for doctors who prescribe and patients
who take compounded solutions.”

Wenderoff said that in November, IACP, together with the
American Pharmacists Association, sent CMS a letter supporting the
agency’s revision of its reimbursement policies for compounded
inhalation preparations as long as the resulting rates fairly
reflected the cost of medication ingredients and labor.

The letter, signed by L.D. King, executive director of IACP, and
John A. Gans, PharmD, executive vice president of APA, concluded:
“Our primary concern … is the need to make sure that patients
with a legitimate medical need for compounded preparations will
still be able to obtain them.”

The fact that CMS cited the absence of clinical literature for
an individual patient concerned Wenderoff, since it indicates that
CMS does not feel there is a legitimate medical need for compounded
inhalation solutions. “Are they going to start requiring medical
literature in order to reimburse?” he questioned, noting that such
a thought was “alarming.”

Wenderoff said the IACP has already mustered forces and
organized patients to fight what it believes to be potentially
damaging legislation regarding compounding drugs, noting that
further information on that effort is available at www.savemymedicine.org. The revised nebulizer
medication policy also includes the new HCPCS codes and coding
guidelines that became effective January 1 of this year.

TriCenturion also noted that a decision on the pay rates for
levalbuterol and DuoNeb has been deferred pending results of a
national coverage analysis. The draft local coverage determination
proposed paying for levalbuterol at rates comparable to albuterol
and for DuoNeb at rates comparable to individual unit dose vials of
albuterol and ipratropium. But CMS initiated a national coverage
analysis on nebulized beta adrenergic agonist therapy for lung
disease, prompting the deferment, TriCenturion said.