Model Guidelines for Classes and Categories of Drugs (Medicare Modernization Act)


Model Guidelines for Classes and Categories of Drugs (Medicare Modernization Act)

Thank you for providing Consumers Union with the opportunity to present our views today on the USP draft model guidelines for drug categories and classes for Part D prescription drug benefits under the Medicare Modernization Act. We appreciate the effort that USP has made to seek broad input. We are concerned that as the USP and the Centers for Medicare & Medicaid Services (CMS) continue to work to implement this legislation, the voices of powerful special interests will be loud and clear, and could potentially drown out the voice of Medicare beneficiaries who will continue to be confused by the complex and ever-changing choices in the marketplace and who are not in a position to understand the significance of the fine-points of therapy definition that are posed by these guidelines. The challenge of finding the right balance between too few categories (which could restrict access to drugs) and too many categories (which would make it more difficult to contain costs) will be difficult. We are concerned that the drug companies’ interest in having a shot at marketing their latest and most expensive products will put pressure to expand the list of categories; the financial stakes of the pharmaceutical industry are impossible to over-estimate. Failing to constrain costs would create pressure to cut drug benefits and/or increase cost-sharing. We are concerned that the financial incentives that pharmaceutical benefit managers (PBM’s) and insurance companies have to narrow the list of categories, if these lead to overly restrictive categorization, could ultimately reduce access of Medicare beneficiaries to needed medicines. In short, we are concerned that Medicare beneficiaries could end up being the losers – caught in the squeeze between powerful special interests, and without the expertise and loud voice to rise above the special interests. In order to end up with a system that best meets Medicare beneficiaries’ needs, we urge you to establish a watchdog committee of independent experts to look out for the best interest of consumers and police against inappropriate influence by pharmaceutical interests.
Click here for the full testimony (PDF format only).