Drug Coverage:
Plans And PBMs Cheer, Big Pharma Jeers Guidelines
Published on Tue Jan 18, 2005
CMS chooses a compromise for the new Part D formulary.
On Jan. 3, the United States Pharmacopeia released its final drug-classification guidelines for Medicare Part D formularies, and the result pleased insurers and pharmacy benefit managers significantly more than it pleased drug manufacturers.
In the Medicare Modernization Act, Congress tasked USP, a private, non-profit standard-setting organization, with developing drug categories and classes that could be used by Medicare drug plans in developing their formularies. Any plan that uses USP's categories and classes will enjoy a statutory "safe harbor," preventing the Centers for Medicare and Medicaid Services from charging that the plan's formulary drug classifications discriminate against certain beneficiaries on the basis of their medical conditions.
Like the draft version USP released in August, the final categories are based on the indications for which a drug is approved, and the classes within each category are based on a drug's mechanism of action. So, for example, the category for antidepressants includes a class for medications that inhibit the action of the enzyme monoamine oxidase; a class for medications called "reuptake inhibitors" that allow neurotransmitters to linger longer at nerves in the brain, thus increasing the chance that a message will get passed on from one neuron to another; and a class for medications that fight depression through other mechanisms.
In total, the final guidelines contain 146 unique groupings, the same number as the draft guidelines, although there are additions, deletions, and modifications in various categories and classes. "The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed," Karen Ignagni, president and CEO of America's Health Insurance Plans, said in a statement.
The Pharmaceutical Care Management Association, which represents PBMs, said that, "while more expansive than what is typically found in the commercial marketplace, USP's guidelines preserve the ability of PBMs to develop formularies that reflect those found in the commercial marketplace."
The Pharmaceutical Research and Manufacturers of America, which would have preferred a significantly greater number of groupings, issued a short statement minimizing the importance of USP's product. PhRMA pointed out that the classifications would be only "one of several factors" the government will consider in evaluating the adequacy of Medicare formularies.
Separately from its proposed classifications and the associated safe harbor, USP also submitted to Centers for Medicare and Medicaid Services a proposed list of "key drug types." In Dec. 30 comments to CMS, USP recommended that if a Medicare drug plan "does not include at least one drug from each of USP's formulary key drug types," CMS should require that the plan "provide substantial clinical, scientific or other rationale for excluding such drugs."
In a telephone briefing, USP Executive Vice President Roger Williams explained that the key drug [...]
