Nearly all states now have a prescription drug monitoring program (PDMP) that requires physicians to report patient data and track patient histories before prescribing controlled substances, but who is watching to ensure such reporting occurs, and what can happen if physicians fail to check the database?

The answer depends on the state.

The agencies that monitor state PDMPs vary from medical boards or health departments to pharmacy boards and law enforcement agencies. How and when the data can be accessed and by whom depends on the jurisdiction.

“States vary on who can access the information,” said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. In some cases, only licensing boards can access the data. In other states, only mental health professionals, the department of corrections, or insurers can access the data, she said.

Complaints that lead to investigations are a top reason that licensing or regulatory boards may review PDMP patient data (or lack thereof) from a specific physician. In many states, law enforcement agencies also can review PDMP data if there is an active investigation involving a health provider or patient.

In at least 10 states, law enforcement officers must have probable cause, a search warrant, or a subpoena to search the database, according to a state summary by the National Alliance for Model State Drug Laws. In Oklahoma and Virginia, judicial officials can review PDMP data only with approval from a grand jury.

Some states, such as Arizona, New Mexico, North Dakota, and Wyoming, allow unsolicited PDMP reports to prescribers, dispensers, licensing boards, and law enforcement agencies, while other states allow unsolicited reports only to one entity or a smaller combination. Other groups that may be able to access PDMP information per state law include:

• State Medicaid programs for Medicaid member or provider reviews.

• State medical examiners or coroners for cause-of-death investigations.

• Research organizations that may be provided de-identified data for analysis and research.

• Patients who are the subject of data and parents of minors prescribed controlled substances.

Case law shapes PDMP access

Recent court rulings also are shaping when PDMP data can be accessed and how physicians can come under the radar of state and federal authorities.

For example, the California Supreme Court ruled in June that a medical board was justified in obtaining a physician’s prescription records through the state’s PDMP without a warrant or subpoena. The case started when a patient made a complaint against Burbank, Calif.–based internist Alwin Carl Lewis, MD, regarding medical advice he offered her about losing weight. The complaint was not related to the prescribing of controlled substances. During the course of the investigation, a Medical Board of California investigator obtained a prescriber report on Dr. Lewis from the state’s CURES database, which contained prescription information for hundreds of his patients.

As a result of the investigation, the medical board charged Dr. Lewis with several violations related to the original patient who complained, as well as five additional patients who were prescribed controlled substances. Charges included unprofessional conduct, prescribing dangerous drugs without an appropriate examination, excessive prescribing, and failure to maintain adequate and accurate medical records, according to court documents.

Dr. Lewis sued the state, arguing that the medical board violated his patients’ privacy rights by obtaining the CURES reports without a warrant, subpoena, or good cause. A lower court found in favor of the board and the state supreme court agreed, ruling the government’s need to protect public safety outweighed any intrusion into privacy.

A similar decision was recently issued in Oregon when the 9th U.S. Circuit Court of Appeals ruled that the federal Drug Enforcement Administration (DEA) does not need a warrant to subpoena prescription drug information from Oregon’s PDMP.

In that case, the DEA sought patient-specific information from Oregon’s PDMP through the use of a federal administrative subpoena, which does not involve judicial review or a showing of probable cause. The Oregon PDMP refused to comply on the grounds that doing so violates Oregon state law, which requires a court order based on probable cause before patient data in the PDMP can be disclosed. Oregon internist James Roe, MD, and several patients sued the DEA, arguing that the request violated patient privacy rights, but the appeals court in June ruled that federal law that grants subpoena power to the agency trumps Oregon law, which requires a court order.

In a court brief, the American Medical Association and eight other medical associations expressed concern that allowing the DEA access to PDMP records without a court order violates patient privacy and jeopardizes the integrity of the patient-physician relationship.

“To the extent that the Drug Enforcement Administration asserts an unfettered right to access data from the PDMP without probable cause or judicial oversight and approval, that not only takes improper advantage of the health care data system – which by its terms in Oregon prohibits such access – but undermines the health care purposes that the state PDMPs were set up to serve,” the associations stated in a court brief.

PDMP violations – what happens next?

Failing to register, report to, or check your state’s PDMP can result in a license suspension, disciplinary action by a state agency, or potential criminal charges if the violation is serious enough.

“Their license is at stake, [and] their business is at stake,” Ms. Mazina said. “Overprescribing [and] overdispensing is the number one reason for administrative actions.”

Physicians also may face civil fines for failing to register with their state PDMP or for violating program regulations. In Kentucky, for example, doctors can be fined $250 for each prescription written while the doctor is not properly registered. In Maine, prescribers and dispensers face a civil fine of up to $5,000 for violating PDMP rules. Violations that lead to criminal investigations also may result in arrest or prosecution by federal authorities.

Education is key to avoiding PDMP penalties and ensuring compliance with state rules, Ms. Mazina stressed. Learn your state’s PDMP regulations, ensure staff members are trained on the proper protocols, and keep up to date on changes. On Twitter @legal_med


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