James Novak, MD, a San Diego family physician who for years administered questionable insulin infusion therapy to people with diabetes, is now forbidden from solo practice, writing immunization waivers and giving patients those infusions.
That is the decision of the California Medical Board, as of February 24, which found that Novak had long engaged in practices that gave rise to five causes of discipline: gross negligence, repeated negligent acts, incompetence, lack of proper and accurate medical record keeping and lack of professionalism. conduct.
The board placed Novak on seven years probation, pending successful completion of clinical competency tests 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 histories or consult their doctors before administering the infusions. The licensing agency said it did not perform routine examinations for diabetes-related eye or foot problems or other diabetes-related complications, nor did it refer patients for appropriate laboratory tests. He also did not supervise his family nurse or review his progress notes on infusion patients.
The board began investigating Novak after a series of stories in MedPageToday/inewsource in 2018 about the infusion protocol, which CMS determined in 2009 lacked evidence of benefit and refused to pay. Novak appeared on the series after she administered the infusions to a woman who claimed that the treatment endangered her health and left her in a near-comatose state.
Using a strategy developed by a now-disabled Sacramento attorney, G. Ford Gilbert, Trina Health’s insulin infusion clinics used a coding solution to file claims for the procedure, which paid between $400 and $800 per session each week. , until various insurance companies and Medicare found out on it and stopped paying. Novak told a reporter from Med Page today in 2017 he purchased Gilbert’s pumps and protocols and was infusing about 25 patients per week.
gilbert what sentenced to prison after he was found guilty of attempting to bribe an Alabama state official into passing legislation that would require a health insurance company to pay for Trina’s procedure after the company had stopped honoring the claims.
One aspect of Trina’s 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 News Hour. Doctors in that city lamented that many diabetes patients ignored medical advice in favor of Trina’s infusions. Doctors believed that these infusions were harmful and “heartbreaking.”
Novak’s involvement in the questionable infusion protocol at his San Diego Trina clinic and his handling of those patients was just one of the problems the agency found in his practice. The medical board has launched four indictments against her as of 2021.
His other deviations from the standard of care included his repeated concomitant prescription of potentially dangerous drugs, including Suboxone, Soma, Ambien and Adderall, combinations that “posed serious risks” to the patient’s health. The board also accused him of failing to document the amounts of those drugs and failing to keep drug lists in his patient’s progress notes.
In his treatment of another patient, Novak prescribed drug combinations 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 test and control for the patient’s “polypharmacy.”
He was also found to have written immunization exemptions for a 4-year-old child without obtaining copies of his medical records from outside providers or copies of laboratory 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. She must also enroll in courses related to prescribing practices, medical record keeping, and ethics, and must complete those courses to the satisfaction of the board.
Novak’s practice, which must now be in partnership with another physician, must also be subject to observation by a licensed, board-approved medical monitor. Alternatively, she can undergo a “career enhancement program” that involves a quarterly record review and a semester practicum and other performance evaluations.
In its ban on Novak’s ability to continue his practice alone, the board said Novak may not treat patients in an office with other doctors if he simply shares space but has no affiliation with those doctors for the purpose of providing care.
He must reimburse the board for $35,173 in investigative costs and also pay the costs of following up on his probation.