BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:April 15, 2013 |Bill No: SB | | |670 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Curren D. Price, Jr., Chair Bill No: SB 670Author:Steinberg As Amended:April 8, 2013 Fiscal: Yes SUBJECT: Physicians and surgeons: drug prescribing privileges: investigation. SUMMARY: Authorizes the Medical Board of California to inspect medical records of a patient who died of a prescription drug overdose without the consent of the patient's next of kin or a court order, as specified; makes it unprofessional conduct for a licensee who is under investigation to fail to attend and participate in an interview within 30 days from notification, as specified; authorizes an administrative law judge to issue an interim suspension order limiting the authority of a physician to prescribe, furnish, administer, or dispense controlled substances; requires the Medical Board of California to impose limitations on the authority of a physician and surgeon to prescribe, furnish, administer, or dispense controlled substances during a pending investigation if there is a reasonable suspicion that the physician and surgeon has engaged in overprescribing drugs, or other drug prescribing behavior that has resulted in the death of a patient. Existing law: 1)Licenses and regulates physicians and surgeons under the Medical Practice Act (Act) by the Medical Board of California (MBC) within the Department of Consumer Affairs (DCA) and states that the protection of the public is the highest priority of the MBC in exercising its functions. (Business and Professions Code (BPC) § 2000 et. seq.) 2)Authorizes investigators and representatives of the MBC, among others, to inquire into any alleged violation of the Act or any SB 670 Page 2 other federal or state law, regulation, or rule relevant to the practice of medicine or podiatric medicine, and to inspect documents relevant to those investigations, including the inspection and copying of any document relevant to an investigation where patient consent is given. (BPC § 2225) 3)Provides for the professional review of specified healing arts licentiates by a peer review body, as defined, including: (BPC § 805) a) A medical or professional staff of any health care facility or a licensed clinic, or a facility certified to participate in the federal Medicare Program as an ambulatory surgical center. b) A health care service plan or a disability insurer, as specified. c) Any medical, psychological, marriage and family therapy, social work, dental, or podiatric professional society, as specified. d) A committee organized by any entity that functions for the purpose of reviewing the quality of professional care provided by members or employees of that entity. 4)Defines a licentiate, for purposes of item # 3) above, as a physician and surgeon, doctor of podiatric medicine, clinical psychologist, marriage and family therapist, clinical social worker, or dentist. (BPC § 805) 5)Requires an 805 report to be filed by the chief of staff, chief executive officer, medical director, or administrator of any peer review body and the chief executive officer or administrator of a health facility or clinic, as defined, with the MBC, among other agencies having regulatory jurisdiction over a licensee within 15 days after the effective date of any specified action taken against a licensee for a medical disciplinary cause or reason. (BPC § 805) 6)Requires a coroner to make a report to the MBC, among other specified entities, when he or she receives information that indicates that a death may be the result of a physician and surgeon's, podiatrist's, or physician assistant's gross negligence or incompetence. (BPC § 802.5) SB 670 Page 3 7)Requires the MBC to take action against any licensee who is charged with unprofessional conduct. Unprofessional conduct is defined to include, among other things, the repeated failure by a licensee who is the subject of an MBC investigation, in the absence of good cause, to attend and participate in an interview scheduled by the mutual agreement of the licensee and the board. (BPC § 2234) 8)Under the Administrative Procedure Act (APA), establishes within the Office of Administrative Hearings (OAH) a Medical Quality Hearing Panel to conduct adjudicative hearings and proceedings relative to licensees of the MBC under the terms and conditions set forth in the APA, except as provided in the Medical Practice Act. (Government Code (GC) §§ 11371, 11373) 9)Authorizes an administrative law judge of the Medical Quality Hearing Panel to issue an interim suspension order (ISO) suspending a license, or imposing drug testing, continuing education, supervision of procedures, or other licensee restrictions. (GC § 11529) 10)Requires that the burden and standards of proof to obtain an ISO shall be those applicable to a preliminary injunction under Section 527 of the Code of Civil Procedure. (GC § 11529 (e)) This bill: 1)Authorizes the MBC, when it receives an 805 Report, or a Coroner's Report as described above, that involves the death of a patient from a prescription drug overdose, to inspect and copy the medical records of the deceased patient without the consent of the patient's next of kin or a court order in order to determine the extent to which the death was the result of a prescriber's inappropriate conduct. 2)Revises the definition of unprofessional conduct under the Act to include the failure by a licensee who is the subject of an MBC investigation, in the absence of good cause, to attend and participate in an interview scheduled within 30 days of notification from the MBC. 3)Authorizes an administrative law judge to issue an ISO limiting the authority of a physician to prescribe, furnish, administer, or dispense controlled substances. SB 670 Page 4 4)Requires the MBC, notwithstanding the authority of an administrative law judge, to impose limitations on the authority of a physician and surgeon to prescribe, furnish, administer, or dispense controlled substances during a pending investigation if there is a reasonable suspicion that the physician and surgeon has engaged in either of the following: a) Overprescribing drugs. b) Other behavior related to his or her drug prescribing privileges that has resulted in the death of a patient. FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by Legislative Counsel. COMMENTS: 1.Purpose. This bill is sponsored by the Author, President Pro Tem Darrell Steinberg, who was prompted to pursue the legislation following the recent Los Angeles Times investigation that uncovered significant issues with physicians, overprescribing and patient deaths. According to the Author's staff, to speed up investigations in cases where patients have died as a result of prescription drug overdose, this measure seeks to: Authorize the MBC, if it receives an 802.5 Report or 805 Report that involves the death of a patient from a prescription drug overdose, to inspect and copy the medical records of the deceased patient without the consent of the patient's next of kin or a court order in order to determine the extent to which the death was the result of a prescriber's inappropriate conduct. Revise definition of unprofessional conduct to include the failure by a licensee who is the subject of an MBC investigation, in the absence of good cause, to attend and participate in an interview scheduled within 30 days of notification from the MBC. In order to ensure potentially dangerous doctors are not able to continue prescribing, while an investigation is pending, this measure seeks to: Require the MBC to impose limitations on the authority of a SB 670 Page 5 physician and surgeon to prescribe, furnish, administer, or dispense controlled substances during a pending investigation if there is a reasonable suspicion that the physician has engaged in overprescribing drugs or other behavior related to his or her drug prescribing privileges that has resulted in the death of a patient. 1.Need For This Bill. The Author describes the need for the bill as follows: a) Obtaining Patient Information . Per existing law above, in circumstances where patients (often times suffering from addiction) have died as a result of a physician abusing his/her prescribing privileges, the MBC can only access the deceased patient's medical records with authorization from a "next of kin" or through a subpoena. The lack of a concerned patient releasing his/her medical records (the patient is deceased) and difficulties finding the next of kin in addiction cases creates a significant barrier to the ability of the MBC to quickly investigate and potentially pursue disciplinary action against a physician whose abuse of prescribing privileges has led to patient death. A more direct mechanism for the MBC to access patient records is necessary in these unique circumstances. b) Physician Interviews . BPC Section 2234 (h) was written to incentivize physicians to attend physician interviews by making non-compliance unprofessional conduct. The reason this provision was placed in statute was that the failure of physicians to attend necessary interviews was adding to the MBC's investigatory timelines, and many times subpoenas would be needed to compel physicians to attend. However, the law only allows the MBC to pursue unprofessional conduct if the physician mutually agrees to the interview and then fails to show up repeatedly. This creates a significant loophole where physicians can significantly lengthen the time of investigations, and the time to potential disciplinary action by failing to mutually agree on an interview time. To expedite investigations and potential disciplinary action, this provision needs to be updated to make it unprofessional conduct for a physician's failure, in the absence of good cause, to attend and participate in an interview scheduled within 30 days of notification from the MBC. This issue was raised in the MBC 2012 Sunset Report. c) Interim Suspension Orders (ISO) . In order for the MBC to stop a physician from practicing before disciplinary action is taken, they must obtain an interim suspension order (ISO). The ISO can SB 670 Page 6 fully restrict a physician's license, or place prescribing or other restrictions on the license, but not fully prohibit the physician from practicing. An ISO is considered extraordinary relief and pursuant to Government Code Section 11529, a standard of proof must be met in order to be granted an ISO. The standard of proof is relatively high, and must be consistent with the burden and standards of proof applicable to a preliminary injunction entered under Section 527 of the Code of Civil Procedure. Before an ISO can be requested, there are a number of steps that must be taken (gathering medical records, obtaining patient consent, medical consultant review, etc.) in order to prove that a licensee's continued practice presents an immediate danger to public health, safety, or welfare. As the investigation progresses and the Attorney General's office reviews the case, a determination is made as to whether there is enough evidence to warrant requesting an ISO. Even after the ISO is requested, if an Administrative Law Judge (ALJ) determines there is insufficient evidence, the ISO request can be denied. Also, due to a 15-day time restraint to file an accusation after being granted an ISO, and a 30-day time restraint between the accusation being filed and a hearing being set, this means an investigation must be nearly complete in order to file for an ISO. Depending on the case, gathering the appropriate materials necessary to complete the investigation and request an ISO can be a time-consuming process. This process allows patients (often times suffering from addiction) to remain at significant risk of inappropriate prescribing behavior, even when the MBC may have reasonable suspicion to believe that the physician and surgeon has engaged in overprescribing drugs, or other behavior related to his or her drug prescribing privileges, that has resulted in the death of a patient. It is necessary, in these limited circumstances , to provide the MBC with a better, more expedient, fair interim tool for protecting patients from physicians who may be engaging in inappropriate prescribing. 3. Prescription Drug Deaths. A recent Centers for Disease Control (CDC) analysis found that drug overdose deaths increased for the 11th consecutive year in 2010 and prescription drugs, particularly opiod analgesics, are the top drugs leading the list of those responsible for fatalities. According to CDC, 38,329 people died from a drug overdose in 2010, up from 37,004 deaths in 2009, and 16,849 deaths in 1999. CDC found that nearly 60 percent of the SB 670 Page 7 overdose deaths in 2010, involved pharmaceutical drugs, with opiods associated with approximately 75 percent of these deaths. Nearly three out of four prescription drug overdoses are caused by opioid pain relievers. CDC recommends the use of Prescription Drug Monitoring Programs (PDMPs) with a focus on both patients at highest risk in terms of prescription painkiller dosage, numbers of prescriptions and numbers of prescribers as well as prescribers who deviate from accepted medical practice and those with a high proportion of doctor shoppers among their patients. CDC also recommends that PDMPs link to electronic health records systems so that the information is better integrated into health care providers' day-to-day practices. CDC believes that state benefits programs like Medicaid and workers' compensation should consider monitoring prescription claims information and PDMP data for signs and inappropriate use of controlled substances. The organization also acknowledges the value of PDMPs in taking regulatory action against health care providers who do operate outside the limits of appropriate medical practice when it comes to prescription drug prescribing. 4. Drug Deaths and MBC Enforcement Issues. In November and December of 2012, the Los Angeles Times published a series of four articles titled "Dying For Relief," which were the outcome of an intensive review of the epidemic of prescription drug-related deaths in four Southern California counties (Los Angeles, Orange, Ventura and San Diego). In the investigation, reporters examined coroners' records and interviewed doctors, regulators, law enforcement officials and relatives of those who died from overdoses. In these cases toxicology tests found a prescription drug in the deceased's system, usually a painkiller, anti-anxiety drug or other narcotic; coroners' investigators reported finding a container of the same medication bearing the doctor's name, or records of a prescription; and the coroner determined that the drug caused or contributed to the death. The investigators also created and analyzed a searchable database of 3,700 drug related deaths during a 5-year span (2005-2011) in Southern California to identify those tied to doctors' prescriptions. An examination of coroner records by the Times found that: " In 47% of those cases (1,762 deaths) drugs for which the deceased had a prescription were the sole cause or a contributing cause of death. " A small number of doctors were associated with a disproportionate number of those fatal overdoses. 0.1% of the practicing physicians (71 physicians) in the 4 counties wrote SB 670 Page 8 prescriptions for drugs that caused or contributed to 298 deaths. That is 17% of the total deaths linked to doctors' prescriptions. " Each of the 71 physicians prescribed drugs to 3 or more patients who died. " 4 of the physicians had 10 or more patients who fatally overdosed. " One physician had 16 patients who died. The Times found that the 71 physicians with 3 or more fatal overdoses among their patients are primarily pain specialists, general practitioners and psychiatrists. Four of the physicians have been convicted of drug offenses in connection with their prescriptions, and a fifth is awaiting trial on second-degree murder charges in the overdose deaths of 3 patients. The remaining physicians had clean records with the MBC, according to the Times. 1. Sunset Review Oversight Hearing. Earlier this year, the Senate Business, Professions and Economic Development Committee and the Assembly Business, Professions and Consumer Protection Committee held a Joint Oversight Hearing of the MBC. At that hearing, testimony was heard from the MBC, consumers, parents, consumer groups, professional associations and the public at large. That hearing primarily focused on the enforcement program of the MBC. The question was raised about the MBC's effectiveness in protecting consumers from dangerous practitioners in the medical field. This bill is closely related to other bills that impact the MBC's enforcement processes. See "Related Legislation" below. 2. Related Legislation. SB 62 (Price) requires coroners' reports to be transmitted to various health practitioner boards in the event that cause of death is determined to be prescription drug overdose. The bill is also up for consideration in this Committee today. SB 616 (DeSaulnier) makes various changes to the funding and operation of the Controlled Substances Utilization Review and Evaluation System (CURES) Prescription Drug Monitoring Program (PDMP). Establishes the CURES Fund in the State Treasury. Requires practitioners who prescribe Schedule II, III and IV controlled substances and pharmacists to enroll in and consult the CURES PDMP. Increases licensing fees for prescribing health practitioners, dispensers and wholesalers of controlled substances for the purpose of providing ongoing funding to maintain the CURES PDMP. Levies a one-time tax assessment on health insurance plans and workers compensation insurers to fund the CURES modernization upgrade. SB 670 Page 9 Imposes annual taxes on drug manufacturers of Schedule II, III, and IV controlled substances doing business in California to maintain the CURES PDMP. The bill is also up for consideration in this Committee today. SB 304 (Price) makes changes stemming from the Committee's Sunset Oversight Hearing of the MBC on March 11, 2013. That bill has been referred to this Committee for consideration. SUPPORT AND OPPOSITION: Support :None received as of April 9, 2013 Opposition: None received as of April 9, 2013 Consultant:G. V. Ayers