Medicare Compliance & Reimbursement

Industry cites safety concerns.

Suppliers should keep news about inhalation drugs on their radar screens.

Sen. Charles Grassley (R-IA) is praising the Centers for Medicare & Medicaid Services' (CMS) proposal to alter the way Medicare reimburses for compounded inhalation drugs.

Representatives for compounding pharmacies are stepping lightly around the issue, reports the FDA Weekly. Industry representatives say they hope CMS will field industry concerns as the new payment system is finalized.

The comments follow CMS' announcement on Aug. 22 that beginning next year, it will make drastic cuts in reimbursements to pharmacies and home health suppliers who concoct their own versions of inhalation drugs.

Though not finalized, the agency says the new system will result in payments for such drugs "at significantly lower payment rates" than under current rules.

In a statement released Aug. 24, Grassley, the Senate Finance Committee chairman, praised the changes as a good first step toward understanding the scope of the dangers posed by compounded respiratory drugs, in the wake of recent concerns that they are more likely than manufactured pharmaceuticals to be contaminated or served up in incorrect dosages.

"Tightening up the payment system will help program administrators get a handle on the magnitude of compounding when it comes to inhalation drugs," said Grassley. "That information will help make it clearer what policy changes need to be made to better ensure what we pay for drugs that are safe and meet legitimate medical needs."

"We hope [CMS] consults with the pharmacy profession and that it considers the impact its policies have on patients who need compounded medicines," said a source with the International Academy of Compounding Pharmacists.

"There are millions of patients out there for whom manufactured drugs are inappropriate," the source notes.

Compounded drugs are often prescribed when a brand name drug is unsuitable, such as when the patient is allergic to one of the secondary ingredients in the brand. But they are also controversial because, unlike brand name and generic pharmaceuticals, they do not require FDA approval.