BILL ANALYSIS Ó SB 670 Page 1 SENATE THIRD READING SB 670 (Steinberg) As Amended September 6, 2013 Majority vote SENATE VOTE :35-3 BUSINESS & PROFESSIONS 8-4 APPROPRIATIONS 11-5 ----------------------------------------------------------------- |Ayes:|Bonilla, Bocanegra, |Ayes:|Gatto, Bocanegra, | | |Campos, Dickinson, | |Bradford, | | |Gordon, Holden, Mullin, | |Ian Calderon, Campos, | | |Ting | |Eggman, Gomez, Hall, | | | | |Holden, Quirk, Weber | | | | | | |-----+--------------------------+-----+--------------------------| |Nays:|Jones, Hagman, |Nays:|Harkey, Bigelow, | | |Maienschein, Wilk | |Donnelly, Linder, Wagner | ----------------------------------------------------------------- SUMMARY : Permits the Medical Board of California (MBC) to limit a physician's prescribing privileges for 30 days, permits MBC to inspect and copy a deceased patient's medical records, clarifies language relating to unprofessional conduct, and permits an interim suspension order (ISO) to place restrictions on a physician's prescribing privileges, as specified. Specifically, this bill : 1)Permits MBC to impose limitations on the authority of a physician and surgeon to prescribe, furnish, administer, or dispense Schedule II, III, or IV drugs during a pending investigation if MBC has probable cause to believe that the physician and surgeon has prescribed, furnished, administered, or dispensed Schedule II, III, or IV drugs in violation of the Medical Practice Act (Act), and that not imposing limitations on the authority of that physician and surgeon to prescribe, furnish, administer, or dispense Schedule II, III, or IV drugs will imminently endanger the public health, safety, or welfare. 2)States that proof of imminent danger shall include, but not be limited to, a pattern or practice of prescribing, furnishing, administering, or dispensing Schedule II, III, or IV drugs that has led to, or may lead to, death or great bodily injury. SB 670 Page 2 3)Requires MBC to provide written notice to the affected physician and surgeon by either 24-hour delivery service or personal service at least 10 business days prior to the effective date of any limitation being imposed. 4)Requires the written notice provided to the physician and surgeon to state the effective date of the limitations, and also include the following: a) Affidavits showing that MBC has met the requirements for issuing the prescribing limitations, including a summary of the facts and evidence upon which MBC is relying; b) An explanation of the time and manner in which the physician and surgeon may respond to the notice of limitations at an informal hearing, as specified; and, c) Notice of the physician and surgeon's right to be represented in an informal hearing, as specified. 5)States that, upon the request of the physician and surgeon to whom the limitations would apply, a committee of three MBC members, appointed by the MBC executive director and comprised of two physician and surgeons and one public member, shall conduct an informal hearing prior to the effective date of any limitation imposed. 6)Requires that the informal hearing determine whether or not MBC has met its burden of proof, as specified. 7)Authorizes the committee to delay the effective date of the limitations for good cause in order to complete a hearing and issue a decision. 8)Requires the committee to take into account all materials and testimony submitted by MBC and the physician and surgeon. 9)Declares that the decision by the committee to sustain, reject, or modify the limitations is final. 10)Exempts the committee from the provisions of the Bagley-Keene Open Meeting Act. 11)States that the limitation must be discontinued unless, SB 670 Page 3 within 30 business days, MBC has filed and served a petition for an ISO against the physician and surgeon. 12)Requires MBC to remove any record of a physician and surgeon's prescribing limitations from the board's Internet Web site immediately after the limitations are dissolved or when a petition for an ISO is served. 13)States that limitations imposed pursuant to this bill shall not be deemed a reportable act by a state medical licensing agency or board of medical examiners for purposes of the National Practitioner Data Bank. 14)Authorizes MBC to adopt regulations or policies and procedures to effectuate the ability for MBC to impose limitations on a physician and surgeon's ability to prescribe, furnish, administer, or dispense controlled substances. 15)Permits MBC to inspect and copy the medical records of a deceased patient, in any investigation that involves the death of that patient, without the authorization of the beneficiary or personal representative of the deceased patient, or a court order solely for the purpose of determining the extent to which the death was the result of the physician and surgeon's conduct in violation of the Act, if MBC provides a written request to the physician and surgeon that includes a declaration that MBC has been unsuccessful in locating or contacting the deceased patient's beneficiary or personal representative after reasonable efforts. 16)Prohibits MBC from inspecting a deceased patient's medical records without a court order when the beneficiary or personal representative of the deceased patient has been located and contacted, but has refused to consent to MBC inspecting and copying the medical records. 17)Makes legislative findings and declarations that the authority created in MBC to inspect a deceased's records according to this bill, and a physician and surgeon's compliance with that request, are consistent with the public interest and benefit activities of the federal Health Insurance Portability and Accountability Act. 18)States that the repeated failure by a physician and surgeon SB 670 Page 4 who is the subject of an investigation by MBC, in the absence of good cause, to attend and participate in an interview scheduled by MBC is unprofessional conduct. 19)Permits an administrative law judge (ALJ) of the Medical Quality Hearing Panel to issue an ISO limiting the authority of a physician and surgeon to prescribe, furnish, administer or dispense controlled substances. 20)Makes clarifying and technical amendments. 21)Declares that the informal hearing created by this bill imposes a limitation on the public's right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. 22)Makes findings and declarations that the protection of confidential medical information is of great interest to the state and to the health care system, and that the privacy rights of the patients whose treatment occasioned the hearing would be impaired if the hearing were open to the public. FISCAL EFFECT : According to the Assembly Appropriations Committee: 1)Costs to MBC to adopt regulations, not likely to exceed $100,000. 2)MBC may experience some minor costs associated with use of the tools allowed in this bill, as well as some level of increased efficiency in investigation and enforcement; however, it is unlikely to impact the number of cases or total workload significantly. COMMENTS : 1)Physician interviews . MBC reports that current statutory requirements are too lax and do not encourage physicians to attend mandatory investigatory interviews in a timely fashion. This bill eliminates the "mutual agreement" provision that requires MBC and the physician to jointly determine a meeting time. This bill states that the repeated failure of a physician under investigation to attend and participate in an interview scheduled by MBC, in the absence of good cause, is SB 670 Page 5 unprofessional conduct. 2)Deceased patient records . According to MBC, if it is investigating a physician whose patient has died, MBC must receive written authorization from the patient's next of kin in order to obtain the patient's medical records. However, the next of kin may not be found, and MBC still needs those medical records to determine if a physician is prescribing appropriately. This bill would allow MBC to inspect and copy a deceased patient's medical records if MBC provides a written request to the physician and surgeon that includes a declaration that MBC has been unsuccessful in locating or contacting the deceased patient's beneficiary or personal representative after reasonable efforts. MBC would be prohibited from inspecting and copying those records if the beneficiary or personal representative refuses authorization. 3)Current enforcement options . MBC has a variety of options available to halt the practice of a physician who it determines is a risk to the public: MBC may issue an ISO or a temporary restraining order, require certain conditions as part of bail, or agree to a stipulated agreement to restrict or halt practice. MBC can also require a physician to cease practice if the physician has failed to comply with a term or condition of their probation. This bill is intended to supplement current enforcement actions, especially for those cases in which a physician's prescribing behavior is particularly egregious and available remedies are insufficient. 4)This bill's prescription restriction provisions . This bill would permit MBC to impose limitations on the authority of a physician to prescribe, furnish, administer, or dispense Schedule II, III, or IV drugs during a pending investigation if MBC has probable cause to believe that the physician has used his or her prescribing privileges in violation of the Act, and that the failure to impose such restrictions would imminently endanger the public health, safety or welfare. MBC must give the physician 10 days' notice before the restrictions begin, which shall include information giving the basis for the restrictions. A physician and surgeon has the option of convening an informal hearing of committee of three SB 670 Page 6 MBC members to determine whether the limitations are appropriate based on evidence provided by the MBC and the physician and surgeon. These restrictions would remain in place for 30 days, and would be dissolved unless the physician is served with an ISO. Under current law, this action would be posted on MBC's Web site for 10 years. However, if the temporary restrictions were not followed by an ISO, this bill requires MBC to delete any references to the restriction on MBC's Web site. This bill would not require reporting of the temporary prescribing limitations to the National Practitioner Data Bank. 5)Interim Suspension Orders (ISO) . An ISO is a broad instrument of enforcement that can impose conditions as minor as a drug test or as major as the suspension of a physician's license to practice medicine. The procedural safeguards in the ISO process are designed to protect against inappropriate use of the most severe discipline. Existing law authorizes an ALJ of the Medical Quality Hearing Panel within the Office of Administrative Law to issue an order to suspend for an interim period (an ISO) a physician's license, impose drug testing, require continuing education or supervision of procedures, or other license restrictions. However, an ISO may only restrict a physician's prescribing abilities if the physician is already under probation and prescribing limits are part of the terms and conditions of that probation. To obtain an ISO against a physician, MBC must present affidavits in support of the ISO to the ALJ showing that the physician has, or is about to, violate the Medical Practice Act or that the physician is unable to practice safely due to a mental or physical condition, and that permitting the physician to continue practice will endanger the public health, safety, or welfare. It is at the ALJ's discretion to issue the ISO as requested by MBC, and ALJs have the authority to deny or alter the requested ISO. Current law requires that a physician be notified 15 days in advance of a pending ISO, so that the physician may participate in a hearing about the validity of the ISO's issuance. The notice must include affidavits and all the other information provided in support of the order. However, SB 670 Page 7 an ISO may be granted immediately if MBC can demonstrate that "serious injury to the public" would result otherwise. After the ISO issuance, MBC has 15 days to file and serve an accusation (which is the document enumerating the formal charges against the physician's license) and 30 days to hold a hearing. In practical terms, this requires MBC to have its investigation, evidence, and findings nearly complete before petitioning for an ISO. An ISO effectively imposes restrictions on a physician's practice for 45 days prior to a hearing. According to MBC, it sought 36 ISOs in FY 2011-12 and 28 were granted, out of a population of 126,483 physicians. In discussing the challenges faced with obtaining an ISO, MBC pointed out that it must meet a very high standard of evidence to obtain an ISO, and filing a formal accusation within 15 days of the ISO's issuance is a very tight timeline. MBC defended its low use of ISOs by stating "An ISO is considered extraordinary relief ? [and] 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." 6)SB 670 and the ISO process . This bill creates a more rapid process for MBC to impose limitations on a physician's prescribing ability, compared to the current ISO process. This bill would allow MBC, not an ALJ, to impose limitations using a lower standard of proof (probable cause) than that used in the ISO process (clear and convincing). According to MBC, it is anticipated that most, if not all, restrictions issued according to this bill would be followed by an ISO. To prepare for an ISO requires approximately six months investigation time to gather the evidence necessary to prevail at an ISO hearing (following the accusation). Should MBC issue an order restricting prescribing privileges according to the terms of this bill, and with the further intention of issuing an ISO, MBC will already have had at least four months of investigation time to develop evidence against the physician. By tying this new enforcement tool to the existing ISO process, MBC has to eventually meet the same higher burden of SB 670 Page 8 proof, but this mechanism allows MBC to protect the public for an additional 30 days while it gathers its case against the physician. If followed by an ISO, this bill would restrict a physician's ability to prescribe for 75 days before a hearing. This new enforcement tool does not require MBC to automatically remove a physician's prescription power, but rather gives MBC the ability to limit a physician's prescribing authority within a spectrum. MBC may choose to limit the types of drugs a physician may prescribe, requires certain types of prescriptions be co-signed by another doctor, or limit a physician ability to prescribe to certain patients, among some options. These provisions were originally suggested in the 2013 Joint Sunset Review Committee's analysis, which raised the idea of lowering standard for an ISO in cases of restricting a physician's prescribing privileges and lengthening the timeframes for the filing of an accusation. This bill would also permit an ISO to limit a physician's authority to prescribe, furnish, administer, or dispense controlled substances without those limitations being a condition of a physician's probation. Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916) 319-3301 FN: 0002579