Pain doctors, TMA concerned about new clinic inspection rules
Law Feature — January 2018
Tex Med. 2018;114(1):42-44.
By Joey Berlin
Drug diversion. Doctor shopping. So-called "pill mills."
The Texas Medical Association and Texas pain doctors see these as problem that drive the nation's opioid crisis and that won't go away unless the state catches the illicit prescribers.
But TMA and members of the Texas Pain Society (TPS) have real questions about how the Texas Medical Board (TMB) plans to determine whether uncertified pain clinics should be certified with the board.
TMB's new rule on inspecting facilities for failure to certify as a pain clinic ― adopted in early December ― appears to give the board the green light to investigate based on a broad, far-reaching, and sometimes puzzling list of circumstances.
Among those circumstances: a clinic that treats "multiple" patients from outside its "geographical area of service" ― whatever that might be ― or that treats several patients at the same address. Under the new rule, board inspectors could require an uncertified clinic to produce and copy medical and billing records immediately. That's a serious point of contention for C.M. Schade, MD, a Mesquite pain management specialist and TPS director emeritus, who wondered before the rule was adopted whether clinics would have to shut down as soon as an investigator shows up in order to produce those records.
"It could be terribly disruptive. Patients need refills; patients have medical problems. I can't be in two places at one time," Dr. Schade said in November.
"The DEA, the FDA, they do their undercover work. A lot of work goes into this before they shut a place down," Dr. Schade added. [The TMB is] talking about, maybe I've got three [patients] outside of the county, and so they're going to shut me down? This could be abused or could be misdirected. Those things are very, very worrisome to us."
However, TMB took into consideration suggestions from TMA and other stakeholders before adopting the rule, and the conversation is ongoing. The board plans to hold a stakeholder meeting this month to take a further look at the rule.
TMB President Sherif Zaafran, MD, told Texas Medicine in December that the adopted rule serves as a starting point.
"We understand that it's not going to be perfect the first time around," Dr. Zaafran said.
The New Rule
The passage of Senate Bill 315 during last year's session of the Texas Legislature prompted TMB's proposed rule. That bill included a legislative finding that "there is a compelling state interest in the board closely regulating the prescribing of opioids and other controlled substances by physicians and their delegates."
TMB requires a clinic to certify as a pain management clinic if a majority of its patients are issued a prescription for opioids, benzodiazepines, barbiturates, or carisoprodol. That rule excludes suboxone, a drug used to treat narcotic addiction. Pain management clinic certificates are valid for two years.
SB 315, which is already in effect, gives the board authority to inspect an uncertified clinic or facility. It also establishes grounds for inspection based on a clinic's patient population, the volume or combination of drugs it prescribes, and "any other criteria" the board believes are sufficient to trigger an inspection.
The new rule allows TMB to inspect uncertified clinics to see if they should be certified. Under the rule, TMB can inspect an uncertified clinic or facility if it "reasonably believes" the clinic isn't certified based on an evaluation of eight criteria. Among those are:
- The clinic's patient population includes multiple patients from outside the clinic's geographic service area, based on reports from the state's prescription monitoring program (PMP).
- The patient population includes "several patients at the same address" who are being treated for chronic pain.
- Data from the PMP shows a physician at the clinic or a midlevel provider supervised by a physician at the clinic is among the state's top 50 prescribers in the previous 12 months for opioids, benzodiazepines, barbiturates, or carisoprodol (excluding prescribers at certified clinics, hospice facilities, and clinics treating cancer patients).
- There are non-anonymous "complaints and/or information" related to inappropriate prescribing practices at a clinic, including complaints or information from law enforcement or health care regulators.
- An arrest of a physician or midlevel practitioner related to improper or fraudulent prescribing of controlled substances has occurred.
When inspecting uncertified clinics, under the new rule, the board may use an instant subpoena "requiring immediate production, inspection, and copying of medical and billing records." If the clinic doesn't produce the records in compliance with the subpoena immediately, the board can sue to enforce the subpoena in a Travis County district court.
Concern and Confusion
Before the rule was adopted, which occurred just before press time, TMA and pain physicians on the TPS board had misgivings about the proposed rule for a number of reasons. Among the troubling provisions are the rule's undefined "geographical area(s) of service" and language that would allow clinics to be flagged for prescribing to "several patients at the same address."
Gatesville pain physician Richard Hurley, MD, president of TPS, said in November that specialty practices can draw patients from all over the state. The nine-member TPS board initially considered suggesting a 100-mile radius as a defined geographical area, but eventually decided it should either be statewide or not defined at all, Dr. Hurley says.
Because spouses sometimes receive pain prescriptions at the same clinic, Dr. Hurley and Dr. Schade suggested the criteria for inspection should be more than two people in the same household.
"If it's two, no problem. If it's three, I think you ought to look at that. Because that suggests another problem," Dr. Hurley said. "If you always do two, then you're going to be looking at husband and wife. That's rare, but it's not unusual, and to my opinion, two is not a flag," he said.
The language that would authorize TMB to investigate based on non-anonymous "complaints and/or information" did not limit the source of that information to law enforcement or regulators. So the rule could be interpreted as giving the board authority to investigate based on information from literally any source.
Dr. Schade noted instances where insurance companies have filed complaints against physicians out of "pure retaliation." For example, a workers' compensation "legacy" patient still might be receiving care for an older injury, he says, but the health plan decides to do what it can to cut that patient off.
"So they'll target the physicians who are taking care of them, basically just because it costs too much, and they file a complaint," Dr. Schade said. "If that's going to allow the [TMB] to trigger [an investigation], that's really bad."
But the most concerning language to him was the subpoena the board could issue that would require an inspected clinic to produce and copy its records immediately.
"I've got a busy day, clinic has started, these people show up. Am I supposed to shut the clinic down in order to facilitate immediate production, inspection, and copying? And 'copying', in the era of electronic health records, what does that mean?" Dr. Schade said. "It's not like the old days where you could just take a chart and make a copy of it."
Catching the Bad Actors
TMB's pain-clinic rule is just its latest attempt to address drug diversion and doctor-shopping. It comes two years after amended rules for treating chronic pain went into effect. (See "Pain Rules Are a Pain for Doctors," January 2016 Texas Medicine, pages 28–35.)
"We want to make sure that as (SB 315) has been passed and as the implementation of it is statutorily mandated to start at a certain time, that we at least start it off with a certain set of common-sense rules, understanding that we just need to continue that process with the stakeholders to further refine it and just improve on it," Dr. Zaafran said in December.
TMA attorney Jared Livingston says the association sees the importance of proper certification, "but we would like to see the rules sufficiently tailored to that end. We do not want broadly written rules to interfere with legitimate prescriptions or to be used as a means to conduct fishing expeditions on unrelated issues."
TPS was comfortable with much of the language of the original rule proposal, Dr. Hurley said in November, including the provision allowing the board to inspect a clinic if a physician there is among the state's top 50 prescribers for four drug classes.
"It is a tough thing for them, and I think we've certainly got to be proactive in shutting these guys down," Dr. Hurley said. "But we also need to be looking at some of our colleagues, and so [inspecting] the 50 top prescribers, we were all comfortable with that number."
Still, he was wary of the proposal's unintended consequences.
"We want to give the TMB more teeth for the bad guys," Dr. Hurley said. "But when you do that, sometimes it's more teeth for the good guys."
Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.
Legal articles in Texas Medicine are intended to help physicians understand the law by providing legal information on selected topics. These articles are published with the understanding that TMA is not engaged in providing legal advice. When dealing with specific legal matters, readers should seek assistance from their attorneys.
SIDEBAR: Prescription Drug Diversion