Attorneys General (AG) from 16 states are putting pressure on CMS to strengthen language in its 2010 call letter that could end a policy allowing Medicare drug plans to force certain beneficiaries to fail on a generic off-label drug before the on-label brand name drug is covered.
The pharmaceutical industry is calling for the same policy change, pharmaceutical sources told /Inside CMS/ in February (see /Inside CMS/, Feb. 5). A source representing the pharmaceutical industry told /Inside CMS/ that the upcoming decision from President Barack Obama's administration on this issue “will give a window into where Obama health policy is heading.”
States have pursued pharmaceutical companies for illegally marketing off-label uses of drugs, and by the same token the AGs said in a March letter http://www.insidehealthpolicy.com/secure/data_extra/dir_09/he2009_0229. to CMS that insurance companies shouldn't be allowed to force beneficiaries to use drugs that aren't FDA approved for the patient's condition.
Charlie Price, a spokesman for Oklahoma Attorney General Drew Edmondson, said the state office got involved as part of its ongoing oversight of Medicare and Medicaid fraud and consumer protection authority. Also signing the letter were AGs from the following other states: Alaska, Utah, Iowa, Colorado, North Carolina, Kansas, Rhode Island, Maine, South Dakota, Missouri, Texas, Nebraska, Virginia, New Mexico and Wyoming.
"This practice of requiring treatment with an off-label drug before reimbursing a patient for using a drug approved by the FDA for that specific condition subverts the legislatively mandated approval process for drug indication by substituting the judgment of health insurance companies," the AGs write in the letter commenting on CMS' draft call letter.
In the draft call letters posted by both the Bush and Obama administrations, Medicare and Medicaid plans could no longer use the so-called "fail-first" policy, similar to step therapy, for covering enrollees' drug prescriptions. But a caveat in the letter is of concern to the attorneys general and pharmaceutical industry, the latter of which wants its more expensive on-label brand drugs covered initially.
According to the call letter, fail-first is no longer allowed “in the absence of widely used treatment guidelines or clinical literature.” That, the AGs say, creates a loophole for plans to continue requiring enrollees to fail on certain off-label generic drugs before covering the on-label drug.
The Attorneys General claim the call letter provision as currently written would be difficult to enforce and wouldn't actually change the policy. They also argue that the fail-first harms the patient-doctor relationship. But some sources say that high drug costs and the stigma attached to diseases subject to the fail-first policy may make it difficult to entirely ban the policy.
Health insurance plans' use of fail-first at least in part began with questions about the legitimacy of certain diseases. For example, doctors prescribe Lyrica for patients with fibromyalgia -- a disease causing muscle and soft tissue pain, but which some don't view as an actual ailment -- but some plans require that the enrollee fail using a generic muscle relaxer not approved specifically for the disease before the plan will pay for Lyrica, an FDA-approved drug for fibromyalgia.
From the AGs perspective, the primary goal is to stop allowing insurance plans from pushing off-label treatments, the same practice that for years states' top law enforcement agencies have attempted to terminate within the pharmaceutical industry. "The same policy considerations that support a ban on off-label marketing by pharmaceutical companies support the prohibition of this insurance company practice," the AGs conclude in the letter. -- /Ashley Richards
To write a letter of support, click on the following link or contact Jacque Thornton or call 404-872-9191 ext. 19.