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.