Revised TMB Rules Target Nefarious Prescribers, But Physicians Say the Rules Are a Burden
Cover Story — January 2016
Tex Med. 2016;112(1):28-35.
By Joey Berlin
Violating Texas Medical Board (TMB) rules for the treatment of chronic pain may not lead to a criminal conviction. But that doesn't mean law enforcement won't use the rules as a starting point for investigating and catching physician criminals — such as suspected "pill mill" operators.
Last September, when authorities in Conroe charged 68-year-old Ronald Cooper with causing a vehicle crash that killed a family of four, the police turned their sights on a physician who authorities say prescribed Mr. Cooper some of the most widely used opioid painkillers. (See "AMA Group Aims to Reduce Inappropriate Opioid Prescribing.")
Under questioning, according to a court affidavit, Mr. Cooper admitted to taking prescription drugs. The Conroe Police Department (CPD) searched Mr. Cooper's vehicle and found prescription bottles, including bottles of oxycodone and valium bearing the name of Rezik Saqer, MD, as the prescriber, according to a court affidavit. Dr. Saqer was the owner and managing physician of Integra Medical Clinic in Conroe.
To obtain a search warrant of Dr. Saqer's clinic, CPD cited in part its belief Dr. Saqer failed to follow several provisions of TMB rules. Those include part of the board's rules for treating chronic pain — a section that underwent revisions that took effect last August. After authorities executed the search warrant, the state charged Dr. Saqer with three counts of possession of a controlled substance, four counts of fraudulent possession of a controlled substance or prescription form, and three counts of diversion of controlled substances. The U.S. Drug Enforcement Agency (DEA) is also involved in the probe; DEA had been investigating Dr. Saqer since 2014, according to the affidavit.
The case authorities have built against Dr. Saqer is one example of how law enforcement will use TMB rules as a guide for focusing its attention on potential lawbreakers.
Proponents of the revised chronic pain rules touted them as a step specifically to crack down on the proliferation of pill mills. Some argued the old chronic pain rules were merely guidelines, rather than requirements. For physicians treating chronic pain, the revised rules make it clear compliance is not optional.
But after just a few months of attempting to follow the beefed-up requirements, some physicians involved in pain management say adhering to the revised rules is already a burden on practices.
The Rules and Law Enforcement
On Aug. 4, 2015, TMB's revisions to the board's pain management rules took effect. The changes clarified that guidelines in the board's rules were actually requirements, changing numerous chronic pain guidelines from steps a physician "should" take to ones they "must" take. The new requirements include a mandate to refer a patient with chronic pain for further evaluation and treatment "as necessary" and to use a written pain management agreement for any treatment plan that includes extended drug therapy. (See "Regs and Pains," September 2015 Texas Medicine, pages 51-55.)
The affidavit used to obtain the search warrant of Integra Medical Clinic cited the revised rule section requiring the use of a pain management agreement for extended drug therapy. It asserted Dr. Saqer "failed to maintain the proper standard of care" either by continuing to treat Mr. Cooper after the patient failed to follow "any potential Pain Management Agreement, or, in the alternative, failed to actually have a Pain Management Agreement for Cooper to follow."
The affidavit also expressed a belief Dr. Saqer failed to follow specific requirements of the patient-physician pain management agreement, including a provision allowing only one physician to prescribe the patient dangerous and scheduled drugs and a recently revised rule requiring the patient to generally use only one patient-selected pharmacy for chronic pain prescriptions.
The affidavit said a search of Mr. Cooper's history in the state's prescription drug monitoring program, Prescription Access in Texas (PAT), revealed he had received a prescription from Dr. Saqer for oxycodone and valium on Aug. 19, eight days after another physician had written Mr. Cooper a prescription for the opioid hydrocodone.
"Had Dr. Rezik Saqer had a written drug screening policy and compliance plan, he would have caught the hydrocodone prescribed by [another physician] on August 11, 2015," the affidavit said.
When police executed the search warrant at Integra Medical Clinic, according to court documents, they found hydromorphone, oxycodone, and morphine pills stashed in a drawer in Dr. Saqer's office, along with fax cover sheets containing copies of blank prescription forms with Dr. Saqer's signature already on them. Authorities arrested Dr. Saqer on Sept. 22, two days after the vehicle crash involving Mr. Cooper.
"Patient records and diagnoses and medical history and all that sort of thing was part of our ability to get probable cause, to search his facility, and to determine what other evidence we could find," said Montgomery County Assistant District Attorney Tyler Dunman. "Of course, we found a lot."
Though TMB isn't commenting on Dr. Saqer's case because of the pending litigation, on Sept. 28, six days after his arrest, TMB temporarily suspended Dr. Saqer's license effective immediately, citing his arrest. According to a TMB news release, a TMB disciplinary panel "determined that Dr. Saqer's continued practice of medicine, including improper and illegal activities related to his operation of a pain management clinic, and including the method and manner in which controlled substances were prescribed and maintained, poses a continuing threat to public welfare."
Before the Aug. 4 rule changes went into effect, TMB downplayed many of the revisions as semantic, with TMB Executive Director Mari Robinson saying the board always enforced those provisions as requirements. But a number of physicians involved in pain management were apprehensive about what changing "should" to "must" would really do. Just a few months later, some doctors say they're already seeing a negative shift.
Corpus Christi family physician James Stefan Walker, MD, says the lack of time physicians had to prepare for the revised rules compelled him to scramble into compliance. Dr. Walker says he didn't find out about them until seeing last September's Texas Medicine story about them, by which time the rules were already in effect. He says the rules add "another element to the doctor-patient relationship that I really don't like. It's like I'm being asked to be the police." He says he's "routinely working into the late-night hours" as a result of the changes.
"It's been highly destructive to my clinic already," Dr. Walker said. "Without having any kind of time to prepare, basically, I … took seven hours to change my protocols, and then we've been scheduling patients for pain management visits separately because it's too lengthy to do with regular visits.
"Including the [pain management] contract that you have to fill out, for people who have one of those, and the periodic review and all that, to go through that process, it takes me almost half an hour with a patient. All of a sudden our schedule is full of people who really can't get their refills without having this review done because if we do the refills without it, we risk going afoul of the rules," he said.
Houston anesthesiologist Jaideep Mehta, MD, says with the new requirements in place, physicians are now displaying "a lot more reluctance to take patients who may have legitimate chronic pain." He says because doctors are finding the new regulations so burdensome, appropriate use of narcotics for severe pain is "sometimes becoming difficult for patients to receive outside the hospital setting." Physicians have shown concern about potential liability issues from writing prescriptions for narcotics, he says.
"And then you see a lot of pain practices that are just inundated by patients trying to get in to be seen," said Dr. Mehta, chair of the Texas Medical Association Committee on Patient-Physician Advocacy.
The Texas Pain Society (TPS) supported changing the chronic-pain rules. Garland pain management specialist C.M. Schade, MD, a past president and director emeritus of TPS, noted the purpose of the clarifying language was to "provide less wiggle room" for pill mill operators. To that extent, Dr. Schade said, "I would say it worked."
Prescription drug diversion, in terms of the number of dosage units diverted, was an increasing problem in 2014, according to the Texas State Board of Pharmacy's (TSBP's) annual report. TSBP received reports of nearly 750,000 dosage units diverted due to employee theft and loss during fiscal year 2014, an increase of 28 percent over 2013. (See "Prescription Diversion a Problem in Texas.")
Victoria Soto, an Austin health law attorney who has worked with TPS for many years, says she heard from concerned physicians once they saw TMB's rule proposal.
"Doctors were contacting me in the middle of the night. I was getting emails from doctors saying, 'Do you know what's getting ready to happen with this new rule change?'" she said. "These were some of the best doctors who have complied and want to always comply with the rules. These doctors have been putting these checks and balances into place in their pain practices for years before [the chronic pain rule] and its changes were even in place.
"So when they saw the change from the word 'should' to a word like 'must," they were concerned that it may have a significant impact on their practice. My response was just, 'If you've been practicing good medicine, and hopefully you all have been practicing good medicine, stay the course.'"
Ms. Robinson says she hasn't heard many physician complaints since before the board adopted the revised rules.
"I really haven't heard much of anything since that initial concern was raised and the board was able to reassure folks, 'Look, this doesn't change the standard,'" she said. "The board has always considered this to be the standard, and this has not changed any of that."
Problems With PAT
TMB's rule changes feature a new standard for the use of PAT in chronic pain treatment. The rule now requires physicians to "consider" checking a patient's prescription data and history in PAT and to consider obtaining a baseline toxicology screen before prescribing dangerous drugs or controlled substances. If the physician, after considering those steps, decided not to follow through with them, he or she would have to document why in the medical record.
Dr. Walker says he ran into a snag in preparing for compliance with the PAT requirement: He wasn't able to set up an account on the prescription database.
"I've approached the helpdesk, and the helpdesk just stopped replying to me," he said. "This happened the first time I tried to get an account a couple of years ago, when it first came out, and I tried to push them then, and they weren't able to help me, so I just stopped doing it. This time around, I tried it again, and I wasn't able to successfully log in, despite following what they told me to do."
Dr. Mehta says looking up a patient's record on PAT adds precious time to patient encounters.
"It would take five minutes to look up something for each individual patient and make sure that the data reflect that they haven't been seen by other physicians or prescribed anything and they've stayed true to the one-pharmacy rule — that's a minimum of a five-minute additional step for a provider," he said. "And most providers who don't have their workflow optimized for that are really not amenable to adding that to their workflow."
Numerous complaints like Dr. Walker's and Dr. Mehta's spurred TMA to take action. TMA worked with other groups to pass a bill in the 2015 legislative session that shifted control of PAT from the Department of Public Safety (DPS) to the pharmacy board and offered hope for a sounder future for PAT. Senate Bill 195 by Sen. Charles Schwertner, MD (R-Georgetown), transfers control of the database to TSBP, effective Sept. 1, 2016. (See "Prescription Monitoring Reform.")
Gay Dodson, executive director of TSBP, says the pharmacy board is preparing to make big changes to PAT, including a more user-friendly interface; participation in the national InterConnect monitoring program to detect potential patient doctor-shopping across state lines; and push notifications that will alert a prescribing physician if a patient recently received a prescription elsewhere.
"I think the advantages of having it here are that we have health professionals here, so we understand what a health professional is looking for in the system," Ms. Dodson said. "I think just having that knowledge here will really help us to make it more useful to the physicians and pharmacists and everybody else that uses the system."
Despite his troubles implementing the chronic pain mandates, Dr. Walker says the board's intentions are well-meaning. He suggests TMB give physicians a one-year grace period before enforcing the "must" provisions in the chronic pain rule so physicians can have enough time to adjust their protocols and workflow.
"I don't think they're trying to be hard on doctors," he said. "I think they're trying to do what they can to stem the problem of abuse. But I just don't see how this is going to do anything for that problem at all.
"In fact, I think it might make it worse because let's just say that you are a nefarious doctor, that you're running a pill mill and you know it, and you hear about this rule. If I'm a smart, nefarious doctor, all I'm going to do is I'm going to print up a bunch of protocol sheets, just going by the book like they want us to do, and I'm going to just fill out those before the visits. It's as if [they think] by documentation, we're going to stop the problem that's going on."
Austin attorney Mike Sharp says TMB isn't effective at communicating rule changes to the practitioners the board regulates.
"They have a newsletter; they have a press release. Technically and legally, they posted it with the secretary of state. They have the hearings," he said. "But they really depended a lot on other people picking up the news and passing it around, such as the medical associations and specialty organizations. But it's very hard to get the word out. So what do you do when that happens? You try harder, and you give it more time, and you actively seek those entities that communicate with physicians. You seek them out and ask them to help disseminate that information."
Ms. Robinson says TMB is always open to reexamining the rules to improve them, and allows for the possibility that "this may be exactly what they needed, [or] it may be that they have to look at it again."
"As I've said before, the board believes that these have always been the standard for treating chronic pain in the state," she said. "So we'll go forward with the tweaks, and we'll see how it develops."
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.
Prescription Monitoring Reform
On June 20, 2015, Gov. Greg Abbott signed Senate Bill 195 by Sen. Charles Schwertner, MD (R-Georgetown), into law. TMA pushed hard for the measure, which brought major changes to the state's prescription drug monitoring program, Prescription Access in Texas (PAT). The impetus for the bill came, in part, from the numerous complaints Texas physicians filed with TMA over how the Department of Public Safety (DPS) ran PAT and its inability to process controlled substances registration renewals in a timely manner. SB 195:
- Eliminates the state's Controlled Substances Registration program on Sept. 1, 2016, meaning physicians will need only their federal Drug Enforcement Agency identification to prescribe controlled substances in Texas;
- Moves PAT from the control of DPS to the Texas State Board of Pharmacy (TSBP) on Sept. 1, 2016;
- Gives practitioners greater delegating authority to allow practice employees to use PAT to enter and receive information; and
- Allows TSBP to enter into agreements with other states to access prescription monitoring information from those states, paving the way for Texas to join the national prescription monitoring program data-sharing portal InterConnect.
AMA Group Aims to Reduce Inappropriate Opioid Prescribing
Physicians have a professional obligation to reverse the nation's opioid epidemic. That's the message of the American Medical Association Task Force to Reduce Prescription Opioid Abuse. The task force focuses on reducing the inappropriate prescribing of opioids and the growing crisis of heroin overdose and death. The task force, chaired by AMA Chair-Elect Patrice A. Harris, MD, includes physician leaders and staff from across the nation. For more information, AMA members can log in and download the Task Force Overview document.
The five goals of the task force are:
- Increase physicians' registration and use of effective prescription drug monitoring programs.
- Enhance physicians' education on effective, evidence-based prescribing.
- Reduce the stigma of pain and promote comprehensive assessment and treatment.
- Reduce the stigma of substance use disorder and enhance access to treatment.
- Expand access to naloxone in the community and through co-prescribing.
Expanded access to naloxone, which reverses an overdose, is now available in Texas. The drug can be administered in an emergency department but also prescribed as a take-home medication to be used in case of emergency. The new Texas law, strongly supported by TMA, allows doctors to prescribe naloxone directly, or by standing order, to:
- A person at risk of experiencing an opioid-related drug overdose, and
- A family member, friend, or other person in a position to assist a person at risk of experiencing an opioid-related drug overdose.
Naloxone can be supplied as an intramuscular injection, intramuscular auto-injector, or intranasal spray. The intranasal formulation is considered off label and is delivered through an atomizer.
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