(reprinted with permission from Texas Medicine Today)
The rule change came about in part because of widespread concerns that patients who cannot access effective treatment for chronic pain from a physician will turn to illicit substances, increasing problems of addiction, overdoses, and overdose deaths from counterfeit pills that contain illegally manufactured fentanyl.
In the past, any physician practices that prescribed opioids could be subject to a random inspection by TMB to determine if the practice should be certified by the agency as a “pain management clinic.” Entities with that certification must comply with specific administrative requirements, audits, background checks, and regulations.
These regulatory hurdles caused many physicians to shy away from pain management, says TMB President Sherif Z. Zaafran, MD, a Houston anesthesiologist.
But in November, TMB rewrote Rule 195.2, which allows certain medical practices to qualify as “gold-designated practices.” This lets them proactively agree to a TMB audit to determine compliance with the law and then grants them a five-year grace period from additional TMB audits or investigations, unless someone lodges a specific complaint against the practice, the clinic changes its location, or the clinic’s ownership structure changes to a majority of new owners.
The rule change allows primary care physicians to coordinate care more easily with psychiatrists, pain specialists, and other related health care professionals to provide patients with a multidisciplinary approach to pain management, Dr. Zaafran says.
“Every [physician] as it stands can manage patients for chronic pain,” he said. “That has not changed. What has changed is incentivizing physicians to have a collaborative-type structure that we know is the best type of structure to manage chronic pain patients.”
The main idea: To improve services that can be provided by telehealth under Texas law.
For instance, a primary care physician in a rural area can more easily partner with psychiatric and pain specialists in urban areas to provide telehealth services that might not be otherwise available, Dr. Zaafran says.
“Even a primary care physician out in rural Texas under this structure would be able to have a collaborative agreement with other entities around the state … to be able to provide care for these chronic pain patients in any type of environment,” he said.
That type of collaborative effort is most effective because it allows patients to address all their pain-related problems in one practice, instead of shopping around to numerous practices that might not be in contact with one another, Dr. Zaafran says.
“For patients, it’s a one-stop shop, and that really helps with access to care,” he said.
The revised Rule 195.2 lifts a big burden from physician practices that have been understandably wary about prescribing opioids for pain management, says Mesquite pain specialist C.M. Schade, MD, who is a past president of the Texas Pain Society (TPS).
“Unless treating pain is all you do, you didn’t want to [be designated a pain management clinic],” Dr. Schade says. “This [new rule] allows for many practices to obtain reassurance from the TMB that they can prescribe valid pain medications without unnecessary interference from the board.”
In September, Dr. Schade testified in support of reforms like the TMB rule revision on behalf of TMA and TPS before the Texas House Committee on Public Health, which was given an interim charge by House Speaker Dade Phelan (R-Beaumont) to study fentanyl-related overdoses and deaths.
Drug-related mortality in Texas continues to rise despite some of the strongest state and federal prescription opioid-specific regulations in recent history, Dr. Schade told the committee. Those regulations have caused a sharp drop in prescriptions for opioid medications. But patients who cannot get legitimate pain relief medication from their physicians are now seeking that relief by taking pills that look just like their pain medication but actually contain illegally produced fentanyl.
Texas policymakers recently have embraced stronger efforts to reduce fentanyl-related deaths. For instance, Gov. Greg Abbott in December announced his support for legalizing fentanyl test strips, which help people identify whether look-alike medications contain fentanyl. The American Medical Association and TMA strongly support these efforts.
On the federal level, the Centers for Disease Control and Prevention (CDC) recently issued guidelines to improve appropriate opioid prescribing while minimizing opioid-related risks. CDC’s previous set of guidelines, issued in 2016, were widely misinterpreted as a rigid set of policies and, as a result, opioid prescriptions became difficult or impossible to obtain for many pain patients, even for those with long-standing problems who had been stable on their medications, Dr. Schade says. The new guidelines are designed in part to provide more flexibility for physicians.
While the CDC guidelines and TMB rule change address similar problems, the timing of their release is not deliberate, a TMB spokesperson says. TMB rewrote Rule 195.2 based on input from an agency-created task force made up of numerous stakeholders in pain management, including physicians from TMA and TPS, other related health care professionals, chronic pain patients, pharmacies, insurance companies, and state and federal policymakers, Dr. Zaafran says.
TMB will monitor the new rule and seek input to ensure it improves patient access to pain management as intended, he says.