CMS sued for its Part D marketing guidelines

October 9, 2006

A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.

The guidelines, first issued last year, say providers must not direct, urge, or attempt to persuade beneficiaries to enroll in a specific plan. The Washington Legal Foundation (WLF), which filed the suit, said this means providers can answer focused questions about plans, but "they cannot orally provide any information unless asked, even if it is obvious to them that a beneficiary is enrolled in the wrong prescription drug plan for his or her situation."

The suit was filed in the U.S. District Court for the District of Columbia, on Aug. 24.

Samp said the rules allow providers to give general oral advice when solicited by their patients, distribute materials for the various CMS-approved plans, and refer people to the government Web sites. "But giving unsolicited advice or recommending a particular plan is simply not permitted," he said.

Thomas DeVille, president and CEO of DeVille Pharmacies, a community pharmacy that also serves long-term care patients, also spoke at the conference. He said that while serving mentally ill and mentally retarded patients in group homes, providers are prohibited from suggesting a plan. He said many of those patients "do not have a legal guardian, other than the state, because they have outlived the family that placed them in the state institution in the first place."

With Medicare's random assignment of many patients, DeVille said, the coverage for patients' drugs has at times been very poor. Often the challenge is to get psychiatric medications paid for. That results in psychiatrists and medical directors spending time trying to get prior approval for coverage; or patients being put on drugs they don't really need and the facility risking regulatory trouble; or facilities and pharmacies covering the costs themselves, for which some are still seeking reimbursement. "If we were allowed to share information with our patients, these problems could have been averted," he asserted.

Asked to comment on the suit, Thomas Clark, R.Ph., MHS, director of policy and advocacy for the American Society of Consultant Pharmacists, said, "It certainly appears that legal action is needed." He said that ASCP and other pharmacy groups have met with CMS on the issue and described the detrimental effects of the guidelines when the agency asked for comments on the draft version. He noted, however, that the rules did not change.

The guidelines state that CMS is concerned about provider activities because "providers may not be fully aware of all the plan benefits and costs" and "may confuse the beneficiary if the provider is perceived as acting as an agent of the plan versus acting as the beneficiary's provider."

The guidelines also state providers may face conflicting incentives, if, for example, they might gain financially from a beneficiary selecting a particular plan. Samp, however, argued that although pharmacists might have a financial interest at stake, "in most cases, the amount of money the pharmacy is going to get from that plan, assuming that the drug is covered, is roughly the same." Further, he said, although pharmacies do have an interest in making sure their patients get enrolled in a plan with which the pharmacy has contractual relationships, "the financial interests of the pharmacies are really virtually identical to those of the patients."

The agency is declining to answer questions about the suit or about comments it had received when it revised the marketing guidelines this year.

THE AUTHOR is a writer based in Maryland.