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According to the U.S. Drug Enforcement Administration (DEA), diversion of hy- drocodone products and pseudoephedrine continues to be a problem in Texas.


Primary methods of diversion are illegal sale and distribution by health care professionals and workers, “doctor shopping” (going to a number of doctors to obtain prescriptions for a controlled pharmaceutical), forged prescriptions, pharmacy theft, and the Internet.


The Texas Medical Board (TMB) is cracking down on physician involvement in pill mills. These are illegitimate businesses that Dr. Schade says accept only cash, have only a storefront and no medical equipment, don’t conduct any physical examina- tions or medical procedures, don’t keep patient medical re- cords, and often have huge crowds of people waiting to see the doctor. TMB’s authority over the ownership and operation of pain management clinics stems from legislation the Texas Medi- cal Association supported during the 2009 legislative session. Senate Bill 911 by Sen. Tommy Williams (R-The Woodlands) directed TMB to adopt rules to ensure quality patient care and set personnel requirements at pain management clinics. “Senate Bill 911 was a response to a need to find a balance between access to quality pain medicine care and preventing diversion,” said Dr. Schade, who testified for the bill on behalf of TMA and TPS. Mari Robinson, TMB executive director, says the board sees a wide range of physician involvement in pill mills. “Some doctors we investigate were involved in a pill mill for a short period of time and had been recruited to work at the clinic for just a few months. Others own several clinics and are making millions of dollars,” she said. Ms. Robinson explains that simply being associated with a pill mill in some way doesn’t lead to suspension or revocation of a physician’s license. She says the board weighs the merits of each case to determine its actions. “Some complaints the board receives involve nontherapeutic


prescribing, not pill mill activity. Physicians engaged in non- therapeutic prescribing may need more education or may re- quire having their charts monitored,” she said. Before agreeing to purchase, serve as medical director, or join a pain management clinic or any medical practice for that matter, physicians should perform due diligence to make cer- tain the business is legitimate and financially solvent. They also should be aware of some red flags that may give them reason to pause.


STIFF RULES The law requires the owner of a pain management clinic to be a physician practicing in Texas with an unrestricted license. He or she must be on site at least 33 percent of the clinic’s operat- ing hours and review at least 33 percent of the patient files. In addition, the clinic owner must not have been disciplined for


20 TEXAS MEDICINE April 2013


inappropriately prescribing, dispensing, administering, supply- ing, or selling a controlled substance. Before SB 911, TMB had no rules on owning and operating pain management clinics. “I am personally very pleased with the work TMB has been doing in regard to these rogue, illegal clinics,” Dr. Schade said. The law applies only to clinics that issue prescriptions for opioids, benzodiazepines, barbiturates, or carisoprodol month- ly for at least 50 percent of their patients. Suboxone isn’t in- cluded. Medical and dental schools, hospitals, hospices, and some other entities aren’t subject to regulations. (See “Pain Management Clinic Certification Facts,” page 23.) Dr. Schade says the exemption is essential for surgeons and oncologists, for example, who prescribe controlled substances and pain medicine to many, if not all, of their patients. Ms. Robinson says pill mill operators have developed schemes to try to get around the law. For instance, the board has investigated clinics that require every patient to bring a friend along to the appointment. “One patient receives a prescription for opioids, for example, and the friend gets an allergy medication prescription. That way, the percentage of opioids prescribed falls below the 50-percent threshold for pain management clinics. Criminals are trying to circumvent the law by staying below the radar,” Ms. Robinson said. Ms. Robinson says complaints are the primary way TMB learns of potentially illegal prescribing of pain medications and controlled substances. In addition, she says, media cov- erage or contact from the Texas Department of Public Safety (DPS) or other law enforcement agencies can alert the board to possible criminal activity. Board rules stipulate that unless it would jeopardize an ongoing investigation, TMB will give a clinic at least five business days’ notice before an on-site investigation. In addition to inspecting a pain management clinic, TMB rules authorize the board to examine a physician’s documents, such as medical records. TMB has conducted education and outreach for physicians


related to pain management clinic regulations. Ms. Robinson says the board has information about the rules on its website, www.tmb.state.tx.us, and in its bulletin.


TMB TAKES ACTION At press time, TMB had received 453 pain management clinic applications and issued active certificates to 219. According to


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