Medicare Compliance & Reimbursement
Plans And PBMs Cheer, Big Pharma Jeers Guidelines
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 types "represent a further refinement of mechanism of action" beyond classes. Thus, within the class for reuptake-inhibitor antidepressants, USP recommends one key drug type for medications that act selectively on the neurotransmitter serotonin, and another key drug type for medications that act on serotonin and norepinephrine, another neurotransmitter.
As interpreted by CMS, the Medicare Modernization Act mandates that plans include at least two drugs in each category and class. In USP's August draft, the key drug types were presented as "recommended subdivisions" of the classes, and PhRMA argued that the subdivisions should be considered separate classes, subject to the two-drug requirement.
There has been speculation that USP's final guidelines more explicitly separate the key drug types from the drug categories and classes in part to make it harder for PhRMA to pursue its argument through litigation, although Williams said this was not the case.
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