Law Feature – August 2010
Tex Med. 2010;106(8):23-25.
By Crystal Conde
Storefronts disguised as pain medicine centers are popping up throughout Texas, churning out prescriptions for powerful narcotics without requiring so much as a patient exam. These "pill mills" are giving legitimate pain management clinics and pain medicine physicians a bad name.
Cris Schade, MD, PhD, a Garland pain medicine specialist and past president of the Texas Pain Society, says it's insulting that these prescription drug mills call themselves pain management clinics. Commonly, he says, "pill mills" accept only cash, have only a storefront and no medical equipment, aren't owned by a physician, don't conduct any physical examinations or medical procedures, don't keep patient medical records, and often have huge crowds of people waiting to see the doctor.
He adds that Texas and the nation are in the midst of a prescription drug abuse crisis. In fact, according to the U.S. Drug Enforcement Administration (DEA), diversion of hydrocodone 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.
Dr. Schade hopes a new law requiring pain management clinics to be certified by the Texas Medical Board (TMB) by Sept. 1 will put "pill mills" out of business. This past legislative session, the Texas Medical Association supported Senate Bill 911 by Sen. Tommy Williams (R-The Woodlands). The law directs TMB to adopt rules to ensure quality of patient care and to 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.
Before SB 911, TMB had no rules governing the ownership and operation of pain management clinics. Mari Robinson, JD, TMB executive director, says the new regulations give the board authority to inspect pain management clinics, or entities believed to be pain management clinics, to determine whether they're operating legally.
"If we [TMB] become aware of a pain management clinic that is doing business after Sept. 1 without a certificate, we will take action to shut the clinic down until it can meet the requirements of the law," Ms. Robinson said.
She encourages clinic owners who haven't yet obtained a certificate to do so immediately. Registration is free, and the form is available on the TMB website .
Processing time normally takes 10 to 15 business days after TMB receives the form. As of early June, TMB had certified 27 pain management clinics. Ms. Robinson expects that number to rise as the Sept. 1 deadline draws near.
Dr. Schade likens pain management clinic certification to a seal of approval.
"My hope is that certification will be seen as desirable. Certification provides a certain level of quality assurance. Clinics and physicians who meet the criteria developed by TMB become known for providing legitimate, quality care," he said.
Ms. Robinson acknowledges that beginning Sept. 1, some pain management clinic owners may have to make significant changes to their operations.
The new law applies only to clinics that issue prescriptions for opioids, benzodiazepines, barbiturates, or carisoprodol on a monthly basis for at least 50 percent of their patients. Suboxone isn't included.Medical and dental schools, hospitals, hospices, and some other entities aren't subject to regulations. (See "Pain Management Clinic Certification Facts.")
Dr. Schade says that exemption is essential for surgeons and oncologists, for example, who prescribe controlled substances and pain medicine to many, if not all, of their patients.
Under the new law, only Texas physicians with unrestricted medical licenses may own and operate a pain management clinic. Ms. Robinson says nonphysicians who own clinics currently can sell them to physicians meeting the new criteria.
The new regulations also require the owner and operator of a pain management clinic to be on-site at least 33 percent of the clinic's operating hours and to review at least 33 percent of the patient files, including files belonging to a clinic employee or contractor who has the authority to care for patients.
In addition, the clinic owner and operator must not have been disciplined by a licensing entity for inappropriately prescribing, dispensing, administering, supplying, or selling a controlled substance.
Ms. Robinson says TMB notified all physicians with restricted licenses of the new state law.
"The letter sent earlier this year suggested that those currently under restriction review their disciplinary orders to determine whether they'll be able to comply with the new eligibility criteria for owning and operating a pain management clinic," she said.
While TMB doesn't have statistics on disciplinary actions related to inappropriate prescribing of pain medications, Ms. Robinson says the board does act against physicians for nontherapeutic prescribing violations.
In May, the board suspended a physician's license after a DEA investigation found that he or she had prescribed significant quantities of methadone, oxycodone, hydrocodone, and benzodiazepines.
In April, the board entered into a mediated agreed order with a physician for failure to meet the standard of care in prescribing narcotics, benzodiazepines, and muscle relaxants without adequate documentation and treatment plans for two patients.
Power to Save Lives
Ms. Robinson says egregious cases of nontherapeutic prescribing that endanger the public may lead TMB to revoke a physician's license and levy a fine. Dr. Schade says the authority granted to TMB under the law will help stop the illegal flow of prescription drugs earlier and save lives.
Ms. Robinson says one way TMB becomes aware of potentially illegal prescribing of pain medications and controlled substances is through complaints. Anyone can file a confidential complaint on the TMB website by filling out a short form.
In addition, she says, media coverage or contact from the Texas Department of Public Safety (DPS) or other law enforcement agencies can alert the board to possible criminal activity.
In conducting inspections to enforce board rules, TMB may work with another state agency, such as DPS, or work with other law enforcement officials. Board rules stipulate that unless it would jeopardize an ongoing investigation, TMB will give at least five business days notice before conducting 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.
Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail at Crystal Conde .
Pain Management Clinic Certification Facts
A pain management clinic may not operate in Texas unless the owner and operator is a medical director who:
- Is licensed to practice medicine in Texas;
- Has an active, unrestricted medical license; and
- Holds a certificate of registration for the pain management clinic.
In addition, the owner and operator of a pain management clinic, a clinic employee, or a person with whom the clinic contracts for services may not:
- Have been denied, by any jurisdiction, a license issued by the Drug Enforcement Administration (DEA) or a state public safety agency under which the person may prescribe, dispense, administer, supply, or sell a controlled substance;
- Have held a license issued by the DEA or a state public safety agency in any jurisdiction, under which the person may prescribe, dispense, administer, supply, or sell a controlled substance, that has been restricted; or
- Have been subject to disciplinary action by any licensing entity for conduct that was a result of inappropriately prescribing, dispensing, administering, supplying, or selling a controlled substance.
A pain management clinic may not be owned wholly or partly by a person who has been convicted of, pled no contest to, or received deferred adjudication for:
- An offense that constitutes a felony; or
- An offense that constitutes a misdemeanor, the facts of which relate to the distribution of illegal prescription drugs or a controlled substance.
The medical director of a pain management clinic must, on an annual basis, ensure that all personnel are:
- Properly licensed (if applicable);
- Trained with, but not limited to, 10 hours of continuing medical education related to pain management; and
- Qualified for employment.
Certificates are valid for two years. Certificate holders will have a 180-day grace period from the expiration date to renew the certificate; however, a clinic may not continue to operate while the certificate is expired.
Regulations regarding the registration and operation of pain management clinics don't apply to:
- A medical or dental school or an outpatient clinic associated with a medical or dental school;
- A hospital, including any outpatient facility or clinic of a hospital;
- A hospice established under state or federal law;
- A facility maintained or operated by the state of Texas;
- A clinic maintained or operated by the United States;
- A nonprofit health organization certified by the Texas Medical Board under Chapter 177 of board rules;
- A clinic owned or operated by a physician who treats patients within the physician's area of specialty who personally uses other forms or treatment, including surgery, with the issuance of a prescription for a majority of the patients; or
- A clinic owned or operated by an advanced practice nurse licensed in the state who treats patients in the nurse's area of specialty and uses other forms of treatment with the issuance of a prescription for a majority of the patients.
Source: Texas Medical Board.
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