Physician sues Massachusetts over prior authorization rule

As states struggle to control Medicaid prescription drug costs, doctors voice concerns about patient access to medically necessary treatments.

By Tanya Albert, amednews staff. Oct. 27, 2003.

Concerned that he isn't able to give his Medicaid patients the care they are entitled to, Massachusetts psychiatrist George S. Sigel, MD, is suing the state over its prior authorization requirements for some prescriptions he writes.

Since May, Massachusetts Medicaid has required physicians to get prior approval from the state when they prescribe certain antidepressants and antipsychotics, including drugs that don't have FDA approval for the purpose for which they are being prescribed.

Case at a glance
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Although the state has relaxed some of the original requirements -- such as no longer requiring prior authorization when the dosage for a patient's antipsychotic prescription exceeds the FDA recommended amounts -- Dr. Sigel said the state is interfering with his duty to treat all of his patients the same.

"I am forced to discriminate in my practice," said Dr. Sigel, who filed the lawsuit on his own without any formal legal training. "When you come to someone like me, you hope I am going to make an objective assessment and give you the best treatment." Dr. Sigel and others in the mental health field say the program is also disrupting patient care.

"It is causing delays in patients getting their medication," said Bruce Mermelstein, a licensed psychologist who owns and operates Comprehensive Outpatient Services Inc., which has three locations in the Boston area. "And it's causing patients to get more upset and agitated, exacerbating their conditions."

A spokesman for the Massachusetts Office of Human Services declined to comment on the case because of the pending litigation. Phone calls to the Massachusetts Attorney General's office for copies of court documents outlining the state's position were not returned.

A Massachusetts state court said it would not grant a preliminary injunction to stop the program immediately, but the lawsuit, Sigel v. Romney et al., is moving forward into the discovery phase.

Working to improve patient care

In court filings, Dr. Sigel maintains that under the new policies in the state's Medicaid program, Mass Health, patients are put at great risk to "decompensate, lose stability and ultimately require hospitalization."

"It is unlikely that any of this would occur were the defendants to permit the patient to continue a regimen of medication that has already proven successful," Dr. Sigel said in court filings.

In Massachusetts, denial rates are 10% for antidepressants and 5% for antipsychotics.

He also is upset about the way decisions about who will be allowed to get medication are made.

"The decisions are arbitrary and capricious and not based on a standard of medical necessity," he told the court. "If the division's 'medical necessity' standard were the basis for the decision, the fact that the patient's medication regimen was successfully treating the patient's medical problems would be paramount. But the decision appears based primarily on whether more conservative or less costly medical services that are supposedly comparable in effect are available and suitable for the member requesting the service."

Meanwhile, some physicians have been using other means to try to improve the system.

The Massachusetts Psychiatric Society has not joined Dr. Sigel's lawsuit. But the group's president, James Ellison, MD, said the society had high regard for Dr. Sigel and the end results he was trying to achieve, and that it shared his concern that patients receive medically necessary treatment without obstructions.

MPS is also striving to improve the system but is trying to work with the state to make changes, he said.

The psychiatric society has been part of a panel looking at the Medicaid prescription drug cost saving issue for about two years and has been a part of easing some restrictions that were enacted earlier this year.

"We've chosen to work within the system, gathering information from advocacy groups and feeding concerns and problems directly to the project manager and pressing issues we see as important," Dr. Ellison said.

He noted that the denial rate for antidepressants is about 10%, and there is a 5% denial rate for antipsychotics.

Winding through the courts

The Massachusetts case joins several other lawsuits in state and federal courts that challenge states' efforts to save money on prescription drugs. Most of the lawsuits have been filed by the Pharmaceutical Research and Manufacturers of America.

The 11th U.S. Circuit Court of Appeals already has found Florida's preferred drug list program to be acceptable. Other courts are still grappling with programs set up in Michigan and Maine.

A Michigan lawsuit filed in state court challenges the constitutionality of a prior authorization list that a prescription drug is put on if its manufacturer doesn't meet the state's price for the medication. The Michigan Supreme Court said it would not impose a preliminary injunction on the program but sent the case back to the trial court for fact finding.

A separate federal case involving the Michigan program is scheduled for oral argument before the U.S. Court of Appeals for the District of Columbia Circuit Dec. 12. PhRMA filed the lawsuit against the Centers for Medicare & Medicaid Services asking for a preliminary injunction because the group believes that Secretary Tommy Thompson's approval of the Michigan program violates Medicaid law. The lower court sided with the government.

ADDITIONAL INFORMATION:

Case at a glance

Venue: Norfolk (Mass.) Superior Court
At issue: Whether prior authorization for certain medications physicians want to prescribe to Medicaid patients interferes with the doctor-patient relationship and wrongly causes physicians to treat Medicaid patients differently from other patients, in violation of Massachusetts law.
Potential impact: Some physicians say if the current system stands, patients won't have access to medications they need. Also, physicians say they will spend more time on paperwork and less time with patients.