Update on Medical Board of California Investigations Based on Death Certificate/CURES Data November 8, 2018 Medical Board of CA CMA, MBC, update 0 BACKGROUND At the July 2017 meeting of the MBC Enforcement Committee, MBC staff reported that in 2015, pursuant to an interagency agreement with the California Department of Public Health (CDPH), it had received information on deaths in 2012 and 2013 related to opioid prescription drugs. California law requires the MBC to file an accusation within seven years after the act or omission alleged as the ground for disciplinary action occurred. The MBC cited the statute of limitations as the reason for requesting data back to 2012. The CDPH dataset received by the MBC in 2015, which is based on death certificate information, used a set of codes that CDPH used to identify the underlying cause of death and the contributing cause of death to identify opioid pharmaceutical-related deaths. The data identified 2,692 deaths that met the criteria. Once the data file was received, the MBC used the Controlled Substance Utilization Review and Evaluation System (CURES) database to identify physicians who were prescribing to the individuals, as well as the attending physician and the physician who certified the death. Once the CURES information was obtained, the reports were sent to expert reviewers who reviewed the data to determine if there may be inappropriate prescribing. Beginning in December 2017, CMA began receiving inquiries from physicians who received letters from the MBC requesting 1) a written summary of care and treatment rendered to the named deceased patient; and 2) a copy of the physician’s curriculum vitae. In addition, the letter attaches a declaration stating that the MBC is unable to locate the deceased patient’s beneficiary or personal representative and requests that the physician provide certified copies of the deceased patient’s medical records. The letter states that the physician must certify on an attached form that the records are a “true copy” and a complete set. The letter provides the physician 4 weeks to respond with the records, summary, and CV, but also includes a notice that pursuant to Business & Professions Code §2225.5, a “licensee that fails to provide the certified medical records within 15 business days is in violation of the Medical Practice Act and may result in a civil penalty of $1,000 per day for each day that the documents have not been produced.” UPDATE Staff have been monitoring this issue to determine how physicians are being impacted by investigations based on death certificate data and whether the investigations are resulting in disciplinary actions. In meetings with MBC staff, CMA conveyed concerns that licensees and their legal counsel were not aware of the scope of the investigations based on death certificate and CURES data. CMA also requested that the MBC provide educational resources to remind physicians about their legal obligations to respond to requests for medical records and otherwise cooperate with MBC investigations. MBC Education Efforts Based in part on feedback from CMA, the Medical Board recorded a podcast in May 2018 explaining the Medical Board Death Certificate Project and included information in its Spring 2018 Newsletter. The MBC staff has also revised the letter that will be sent to licensees who are identified for further investigation through this project. The revised letter provides significantly more information about the project, the context in which additional information is being requested, and directs the licensee to additional information about the MBC disciplinary process. The MBC staff indicated that while they recognize that licensees will be concerned when they receive a letter from the MBC, they wanted to emphasize that it would not necessarily result in disciplinary action on their license. Updated Data From MBC MBC staff provided the following data on project outcomes as of September 6, 2018. Based on the information the MBC received on deaths in 2012 and 2013 related to opioid prescription drugs, the MBC opened about 522 cases. Of these, the MBC did not have jurisdiction in 72 cases because the licensee was not an allopathic physician, leaving 450 cases involving physicians. Of the 450 cases, 214 cases were closed for a variety of reasons including that no violation was found, there was insufficient evidence, the licensee was already on probation, etc. To date, 11 accusations have been issued and 225 cases are still under investigation or have been transferred to the Attorney General’s office for preparation of the accusation. The MBC expects that there will be additional accusations issued from the 225 cases. It should be noted that some of the Accusations as a result of this project include failure to establish a treatment plan or failure to check CURES as elements of gross negligence on the part of the physician. This is concerning as MBC staff have repeatedly stated that physicians are reviewed based on the standard of care at the time of the prescribing, which in this case, would be between 2012 and 2013. However, prior to MBC opioid prescribing guidelines established in 2014, establishment of a treatment plan was not clearly articulated as part of the standard of care. In addition, prior to the launch of CURES 2.0 in January 2016, the CURES database was virtually inaccessible with no funding, no staffing, and limited utilization. CMA staff believes that physicians should not be held to the current standard of care for actions that occurred prior to the establishment of the MBC guidelines and the launch of CURES 2.0. MBC Investigation Process CMA staff participated in an MBC training for expert reviewers to better understand how the MBC is investigating these types of cases and the direction that they are providing to expert reviewers regarding how to evaluate whether departures from the standard of care with regard to prescribing have occurred. NEXT STEPS CMA is continuing to work with the Medical Board of California on its disciplinary framework to improve effectiveness, prioritize patient safety, while protecting due process for physicians, including appropriate focus and scope of investigations and preserving the ability of physicians to provide appropriate treatment to patients. CMA continues to oppose the MBC’s practice of engaging in data-mining of the CURES database, but at this time the court has determined that the practice is within the MBC’s legal authority. CMA continues to track inquiries from members and work with the MBC staff to gather information about this project .CMA staff is assessing whether the reviews are being conducted appropriately and whether further legislative and regulatory advocacy is required at this time. Comments are closed.
