Pill Mill Regulation Price Tag in Florida: $65 Million; Medicine Board Approves New Rules

Carol Gentry
Health News Florida

Regulations on Florida pain-management clinics that will impose an estimated $65 million in costs on the private sector passed the Florida Board of Medicine unanimously last week, despite Gov. Rick Scott’s edict to ban rule-making this year.

Board members asked their staff to send letters to both the Legislature and the governor’s Office of Fiscal Accountability and Regulatory Reform, explaining the need for immediate implementation of these rules, given the significant threat to public health and safety that some “pill mills” have created in the state.

The four rules adopted on Friday set out the requirements for standards of care, inspections,accreditation and training in pain-management practices.

Several members, who met by conference call, mentioned that they support Scott’s call for a halt to rule-making to make sure that the process doesn’t unduly impose a burden on small businesses and the public. In fact, the board voted unanimously to suspend rule-making other than the regulations on pain clinics.

The $65 million in estimated cost derives almost entirely from the requirement that clinics perform periodic urine screens. The estimate came from a study by the Center for Economic Forecasting and Analysis at Florida State University. The Department of Health commissioned the study after the Legislature required them for all pending rules with at least a $200,000 impact on business.

The Center churned out the study in just one month in order to leave time for the board to decide whether to submit the rules by the Feb. 4 deadline for consideration during this year’s legislative session.

Paul Sloan, a clinic owner in southwest Florida who helped the Center gather information, said he knew the total would be substantial, but even he was surprised.

“The number’s far higher than I expected,” he said.

On the other hand, he said, the regulations are necessary to stamp out pill mills that are just about profit and feeding the addiction pipeline. “It’s worth doing,” he said.

Those who are horrified by the toll of phony pain-management practices say it’s unfair to look only at the down side of regulations. In this case, rules could save money in law enforcement and reduce the death toll from the narcotic painkillers prescribed and often dispensed by “pill mills.”

In its report, the Center noted that it was asked only to count the cost of the regulations for private companies and government agencies, not the offsetting savings that might accrue if the rules were imposed.

About seven deaths a day in Florida are caused by overdoses of prescription drugs, such as the painkiller oxycodone, according to state officials. Lax laws in Florida have made it the destination for addicts and drug dealers from other states.

The cost of leaving the pain-clinic industry unregulated is high in both dollars and emotional turmoil for the families of those who die, said pharmacist Larry Golbom of Clearwater, host of Prescription Addiction Radio.

“I can’t believe our new governor and Legislature would be so callous as to allow this study to influence moving forward on stopping the pill mills,” Golbom said.

The Board of Medicine concluded that it had to get the official economic analysis – called a Statement of Estimated Regulatory Costs, or SERC – to meet requirements of a bill that lawmakers passed last year to more closely scrutinize regulations. Former Gov. Charlie Crist vetoed the bill, but lawmakers overrode his veto in November.

The study counted the number of clinics registered with the state as of Dec. 9. The vast majority of the 932 clinics qualify as small businesses under state law – the group that the Legislature set out to protect from over-regulation by freezing the rules to determine the economic burden they’d impose.

Two-thirds of the clinics in the database had five employees or fewer, and three-fourths had only one physician.

Altogether, the study estimated that as of December, Florida had a little more than 1,300 physicians working in pain management clinics.

The cost statewide for the rule: $69 million in the first year, and about $65 million a year after that.

The per-patient cost in the first year would be close to $44, and after that about $41.

As Sloan noted, “The person who’s going to pay for this is the patient.”

The $65-million rule – “Standards of Practice for Physicians Practicing in Pain-Management Clinics” – calls for signs and good lighting, life-support training for at least one staff member, an infection control program and more. But the dollar signs are clustered around the requirement for urine tests.

The idea behind the drug test is to make sure that new patients aren’t just painkiller addicts looking for a fix, and that long-term patients are taking their meds as prescribed and aren’t taking other drugs.

The cost of conducting one in-office urine test is just $17, the study estimates, counting staff time. But the sheer volume of pain patients runs up the bill. For an average clinic, the study says, the first-year cost would be around $69,000.

Two other rules had a six-figure impact: setting a maximum number of prescriptions that can be written per day, with a statewide impact estimated at $932,000, and the mandated use of counterfeit-resistant prescription blanks, with an impact of $422,600.

Those that were determined to have no negative economic impact include those on registration, inspection or accreditation, and training requirements. But the Board of Medicine decided to send those to the Legislature for ratification as well, just as a precaution.

For each rule, the economists estimated the number of persons who would be required to comply, the cost to them and to local and state agencies of enforcement.

The FSU Center won the project with a bid of $27,000; a private economist in Orlando bid $100,000, and a University of Florida professor said he wouldn’t even attempt such a rush job.