Insulin Infusion Doctor Barred From Solo Practice

James Novak, MD, a San Diego family doctor who for years administered a questionable insulin infusion therapy to people with diabetes, is now prohibited from solo practice, writing immunization exemptions, and giving patients those infusions.

That’s the decision from the Medical Board of California, effective Feb. 24, that found Novak had long engaged in practices leading to five causes for discipline: gross negligence, repeated negligent acts, incompetence, failure to maintain adequate and accurate medical records, and unprofessional conduct.

The board placed Novak on seven years of probation, pending satisfactory completion of clinical competency testing of his physical and mental health, and successful completion of numerous other clinical knowledge and performance tests.

The board’s decision was based in part on Novak’s failure to take his diabetes patients’ medical history or consult with their doctors before administering the infusions. The licensing agency said he failed to conduct routine exams for diabetes-related eye or foot problems or other diabetes-related complications, or refer patients for relevant lab tests. He also failed to supervise his family nurse practitioner or review her progress notes on the infusion patients.

The board began investigating Novak after a series of stories in MedPageToday/inewsource in 2018 about the infusion protocol, which CMS in 2009 determined lacked evidence of benefit and refused to pay for. Novak was featured in the series after he administered the infusions to a woman who claimed the treatment endangered her health and put her in a near-comatose state.

Using a strategy developed by a now disbarred Sacramento lawyer, G. Ford Gilbert, Trina Health insulin infusion clinics used a coding workaround to submit claims for the procedure, which paid between $400 and $800 per session each week, until several insurance companies and Medicare caught on and stopped paying. Novak told a reporter for MedPage Today in 2017 that he purchased the pumps and protocols from Gilbert and was infusing about 25 patients a week.

Gilbert was sentenced to prison after he was convicted of trying to bribe an Alabama state official to pass legislation that would require a health insurance company to pay for the Trina procedure after the company had stopped honoring claims.

One aspect of the Trina story focused on how the launch of a Trina clinic impacted the small rural town of Dillon, Montana, and was featured in a segment on PBS NewsHour. Doctors in that town lamented that many diabetes patients were ignoring medical advice in favor of the Trina infusions. The doctors believed those infusions were harmful and “heartbreaking.”

Novak’s involvement with the questionable infusion protocol in his San Diego Trina clinic and his management of those patients was only one of the problems the agency found with his practice. The medical board has launched four accusations against him starting in 2021.

His other deviations from the standard of care included his repeated concomitant prescribing of potentially dangerous drugs, including Suboxone, Soma, Ambien and Adderall, combinations that “posed serious risks” to patient health. The board also charged that he failed to document quantities of those drugs and failed to maintain medication lists in his patient’s progress notes.

In his treatment of another patient, Novak prescribed combinations of drugs that could pose serious risks: naltrexone and oxycodone; naltrexone and Suboxone; opioids and benzodiazepines; and hydroxyzine, selegiline, baclofen, and methocarbamol. State documents say Novak failed to adequately evaluate and monitor the patient’s “polypharmacy.”

He also was found to have written immunization exemptions for a 4-year-old child without getting copies of her medical records from outside providers or copies of lab tests, relying only on information from the child’s parents who wanted the exemption, and having seen the child clinically only once.

In its decision, the state licensing agency ordered Novak to undergo up to 40 hours a year of educational courses to correct knowledge deficiencies during each of his seven years of probation. He also must enroll in courses dealing with prescribing practices, medical record keeping, and ethics, and must complete those courses to the board’s satisfaction.

Novak’s practice, which now must be in partnership with another physician, also must undergo observation by a licensed physician monitor who is approved by the board. Alternatively, he can undergo a “professional enhancement program” involving quarterly chart review and semi-annual practice and other performance assessments.

In its prohibition of Novak’s ability to continue his solo practice, the board said Novak is not allowed to treat patients in an office with other doctors if he is merely sharing space but has no affiliation with those doctors for the purpose of providing care.

He must reimburse the board $35,173 in its investigations costs and also pay the costs of monitoring his probation.