GRASSLEY ASKS CMS TO CLARIFY ITS COMPOUNDING POLICY
Sen. Chuck Grassley (R-Iowa) is calling on the Centers for Medicare & Medicaid Services (CMS) to clarify its new policy on compounded inhalation drugs, following the agency's earlier decision to change how it reimburses for the products.
The CMS had pledged to change its Medicare reimbursement policy in response to Grassley and the FDA's concerns that its current system created an incentive for inappropriate compounding.
Drug compounding, a practice in which pharmacists manufacture prescription drugs from bulk ingredients, is traditionally done for medical reasons, such as when a patient is allergic to an inactive ingredient in the commercially manufactured drug. But it has come under fire recently from a number of lawmakers who are concerned there may be other motives behind it.
Grassley lauded the CMS' decision to change its policies, but he is requesting further details on the changes. "Both government agencies with responsibility are finally taking matters seriously when it comes to compounded inhalation drugs," Grassley said in an Oct. 13 statement. The senator wants a briefing by Oct. 18.
The CMS is considering new drug codes to cover these medications and will prioritize by the volume of the drugs produced. Grassley wants the CMS to explain how it will define high-volume compounding, he said in an Oct. 4 letter.
The agency is also considering new payment rates for the products. The senator wants the agency to explain how the CMS and its Medicare carriers will determine the appropriate payment rates for compounded inhalation drugs. Additionally, Grassley requested an explanation of the process available for the agency to notify the FDA of possible inappropriate compounding.