Existing law, the Knox-Keene Health Care Service Plan Act of 1975, 1975 (the act), provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, under the direction of the Director of the Department of the Managed Health Care, and makes a willful violation of the act a crime.

Existing law requires a prepaid health plan to apply for licensure as a health care service plan if the prepaid health plan operating lawfully under the laws of Mexico elects to operate a health care service plan in this state. Existing law requires the application for licensure to demonstrate compliance with specified requirements, including that the prepaid health plan offers and sells in this state only employer-sponsored group plan contracts exclusively for the benefit of Mexican nationals legally employed in the County of San Diego or the County of Imperial, and for the benefit of their dependents regardless of nationality, that pay for, reimburse the cost of, or arrange for the provision or delivery of health care services that are to be provided or delivered wholly in Mexico, except as specified. Existing law also requires the plan to demonstrate that the plan maintains a specified tangible net equity or is able to demonstrate a reasonable acceptable alternative reimbursement arrangement.

This bill would instead require that application for licensure to demonstrate that the plan offers and sells in this state only employer-sponsored group plan contracts exclusively for the benefit of persons, rather than Mexican nationals, legally employed in the County of San Diego or the County of Imperial. The bill would eliminate the tangible net equity requirement specified for these plans and would instead require these plans to maintain a tangible net equity as required by the director pursuant to the authority granted to the director with respect to health care service plans, generally. The bill would, for policies issued, amended, or renewed on or after January 1, 2019, authorize the director to exempt, for not more than 5 years, a prepaid health plan from requirements of the act, and would authorize exemptions granted prior to January 1, 2019, to remain in effect until January 1, 2021, as specified. The bill would require the director to post the formal decision regarding the exemption on the departments Internet Web site. The bill would also require, if a prepaid health plan that is subject to these provisions is issued or sold to a group subscriber, the group subscriber to offer to enrollees and dependents coverage that is fully consistent with the provisions of the act or federal law, as specified. The bill would also make technical changes. Because a violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

This bill would make legislative findings and declarations as to the necessity of a special statute for the Counties of San Diego and Imperial.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires the operation of CURES to comply with all applicable federal and state privacy and security laws and regulations. Under existing law, data obtained from CURES may only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Existing law allows data obtained from CURES to be provided to public or private entities for statistical or research purposes, as approved by the department.

This bill would prohibit the release of data obtained from CURES to a law enforcement agency except pursuant to a valid court order, warrant based on probable cause, as specified.

Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires the operation of CURES to comply with all applicable federal and state privacy and security laws and regulations. Under existing law, data obtained from CURES may only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Existing law allows data obtained from CURES to be provided to public or private entities for statistical or research purposes, as approved by the department.

Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires the operation of CURES to comply with all applicable federal and state privacy and security laws and regulations. Under existing law, data obtained from CURES may only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Existing law allows data obtained from CURES to be provided to public or private entities for statistical or research purposes, as approved by the department.

This bill would revise and recast the CURES privacy provisions. The bill would specify that, except as specified, information within CURES is confidential, not subject to discovery or admissible in any civil or administrative action, and exempt from public inspection, copying, and disclosure pursuant to the California Public Records Act. The bill would specify to whom the information within CURES may be disclosed or released, including, among others, to a health care practitioner providing care to a current patient, to a pharmacist dispensing a controlled substance to a current patient, and, upon a written request, to certain regulatory boards. The bill would require a pharmacy to provide a specific notification about CURES to each patient who is dispensed a Schedule II, Schedule III, or Schedule IV controlled substance.

Existing law authorizes the department to invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database.

The bill would instead require the department to appoint a multidisciplinary advisory committee, as specified, to assist, advise, and make recommendations for the establishment of rules and regulations relating to the proper administration and enforcement of the CURES database.

Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.

This bill would make legislative findings to that effect.

Date of Hearing: June 26, 2018

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 641

Author:(Lara) – As Amended Ver:June 18, 2018

SENATE VOTE: 40-0

SUBJECT: Mexican prepaid health plans.

SUMMARY: Deletes the requirement that a Mexican prepaid health plan provide benefits only for Mexican Nationals and their dependents and would instead require that it provide benefits for any persons legally employed in the County of San Diego or the County of Imperial, and for the benefit of their dependents, for health care services provided in Mexico, as specified.   Makes other technical changes.  

EXISTING LAW:  

1. Establishes the federal Patient Protection and Affordable Care Act (ACA), which enacts various health care coverage market reforms. 
2. Establishes the Department of Managed Health Care (DMHC) to regulate health plans and to ensure that health plans provide enrollees with access to quality health care services and protect and promote the interests of enrollees and sets forth application requirements for licensure as a health care service plan (health plan) under the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act).  
3. Requires a prepaid health plan to apply for licensure as a health plan if the Mexican prepaid health plan operating lawfully under the laws of Mexico elects to operate a health plan in California. 
4. Requires the application for licensure to demonstrate compliance with specified requirements, including that the Mexican prepaid health plan offers and sells in this state only employer-sponsored group plan contracts exclusively for the benefit of Mexican nationals legally employed in San Diego or Imperial Counties, and for the benefit of their dependents regardless of nationality, that pay for, reimburse the cost of, or arrange for the provision or delivery of health care services that are to be provided or delivered wholly in Mexico, except emergency and urgent care services provided out of area.
5. Requires the Mexican prepaid health plan to meet specified requirements, such as make all of its books and records available to the DMHC Director, and employ or designate a medical director who holds an unrestricted license to practice medicine in California, as specified.  Allows the prepaid health plan to employ or designate medical director operating under the laws of Mexico for health care services that are provided or delivered wholly in Mexico.  
6. Requires health plans to ensure that all services be readily available at reasonable times to each enrollee consistent with good professional practice, and to the extent feasible, a health plan to make all services readily accessible to all enrollees consistent with existing law on timely access to health care services. 
7. Requires a health plan to ensure that there is at least one full-time equivalent primary care physician (PCP) for every 2,000 enrollees, and permits the number of enrollees per PCP to be increased by up to 1,000 additional enrollees for each full-time equivalent nonphysician medical practitioner supervised by that PCP. 
8. Requires DMHC, in developing timely access standards, to consider clinical appropriateness, the nature of the specialty, the urgency of care, and the requirements of other provisions of law, including provisions governing utilization review that may affect timeliness of access.
9. Requires DMHC to develop and adopt regulations to ensure that enrollees have access to health care services in a timely manner and consider the following as indicators of timeliness of access to care:
   1. Waiting times for appointments with physicians, including primary care and specialty physicians;
   2. Timeliness of care in an episode of illness, including the timeliness of referrals and obtaining other services, if needed; and,
   3. Waiting time to speak to a physician, registered nurse, or other qualified health professional acting within his or her scope of practice who is trained to screen or triage an enrollee who may need care.
10. Requires a health plan to establish and maintain a grievance system under which enrollees may submit their grievances to the plan.  
11. Establishes various health arts boards within the Department of Consumer Affairs to license and regulate various health care providers, including physicians, nurses, and pharmacists.
    
12. Establishes the Department of Public Health (DPH) to license and regulate various healthcare facilities, including hospitals.

FISCAL EFFECT:  This bill has not yet been analyzed by a fiscal committee.  

COMMENTS:

1. PURPOSE OF THIS BILL.  According to the author, "as the legislature seeks to improve the quality of health statewide, we must ensure that our rural communities are receiving the proper resources in order to fulfill the needs in these communities. Today, rural areas, including my own district in the Imperial Valley, are plagued with a shortage of healthcare professionals to address the pertinent health issues in areas such as the border region. Considering this region is known for its diversity and dependence on our southern neighbors, it seems practical to allow for the flow of services, such as healthcare services, if it means providing individuals with a cost-friendly alternative. With the lack of accessibility to quality and affordable care in these regions, community members are often forced to seek alternative options, such as crossing the border into Mexico for more timely and affordable health care services. This bill will assist in providing greater accessibility to quality, affordable medical care by allowing employers to partner with Sistemas Medicos Nacionales, S.A. de C.V. (SIMNSA) health plan for their employee’s insurance plans. SIMNSA’s standard benefit plans have proven to be a great alternative to existing health plans, giving individuals more accessible and viable options within the healthcare arena. Also, with SIMNSA’s network of over 133 bilingual physicians, patients who do not consider English to be their primary language are given greater accessibility to medical professionals who they can truly understand and relate to. Lastly, by expanding accessibility to quality, cost-sensitive healthcare options in these rural communities, public health will benefit substantially as a greater number of individuals will seek out these alternative plans."
2. BACKGROUND. A 2012 article describing United States-Mexico cross-border Health initiatives stated that in the 1990s, several local and state organizations in the United States and Mexico began to explore different options for binational health insurance.  Since health care costs in Mexico are considerably lower than those in the United States, cross-border coverage can provide more affordable insurance products utilizing, at least in part, coverage in Mexico. California is currently the only U.S. state that allows private health insurance companies to sell policies with comprehensive coverage provided in Mexico.  This was accomplished through SB 1658 (Peace), Chapter 1025, Statutes of 1998.  SB 1658 allowed employers in California to purchase insurance coverage in Mexico for employees who either live in Mexico or simply prefer to use health services in Mexico.  
   1. All Mexican health services available through these plans are provided by private hospitals in the border cities of Baja California, Mexico. In their provision of these services, the providers must comply with Mexican regulations as well as limited regulatory standards established by California authorities as specified in existing law above. Mexican immigrants can also purchase government-run health insurance for their dependents living in Mexico, through either the Mexican Social Security Institute (Instituto Mexicano del Seguro Social, IMSS) or Seguro Popular, a government-run health insurance program. These plans are available for purchase at Mexican consulates in the United States.
   2. Furthermore, according to an article published in the San Diego Union Tribune, California is the only state on the U.S.-Mexico border that allows such cross-border plans. Today, the DMHC licenses only two Mexican prepaid health plans: SIMNSA and Medi-Excel Health Plan. According to the article, both say they are compliant with the standards of the ACA, and both are reporting growth.
3. Cross Border Health Care Practices.  According to the 2012 article specified above, uninsured Mexican immigrants living in the United States and U.S. retirees living in Mexico, Mexico’s lower health costs provide an affordable alternative to the U.S. health care system. A study cited in the article found that about 1 million adults from California use medical, dental, or prescription services in Mexico, and about half of them are Mexican immigrants living in the United States.  The main predictors of utilization of health services in Mexico are health need, lack of health insurance coverage, employment status, delay seeking care, relatively recent immigration, limited English proficiency, and prescription drug use.  Cultural factors such as language and provider attitudes also influence utilization of health care services south of the border.  
   1. According to previous research, people may seek care outside their country of residence if a particular health care provider location is easily accessible and there is a substantial flow of foreign or expatriate patients to that location. Other studies show that geographic proximity to the border increases the likelihood of cross-border utilization of health services.  Additional incentives to travel abroad for health care are lower costs and better access to services compared to the patients’ area of residence (e.g., many border areas have an inadequate supply of health care professionals).
   2. Mexican Prepaid Health Plans.  According to DMHC’s 2017 financial survey, SIMNSA is a Mexican corporation of variable capital, established on September 25, 1992 in Tijuana, Mexico, under provisions and requirements of the Mexican Corporate Law. SIMNSA provides health care services in Mexico to residents of Mexico and emergency only medical services to Mexican Nationals while they are working in the United States, primarily in California.  SIMNSA is a full service health  plan.  SIMNSA’s provider network includes more than 200 participating physicians covering all specialties of medicine through capitated arrangements with contracted providers. Inpatient services are paid on a fee-for-service basis.  SIMNSA had 43,800 enrollees as of June 30, 2016. SIMNSA had commercial enrollees through direct contracts with employer groups and through contracts with other full service Knox-Keene licensed health care plans. SIMNSA’s service area includes San Diego and Imperial Counties.

According to information provided by SIMNSA, the sponsor of this bill, SIMNSA offers small and large group products.  SIMNSA's small group products includes essential health benefits.  All four of SIMNSA's standard benefit plans have actuarial values above 90% and copayments for office visits range from $5 to $7 for large group products and $5 to $10 for small group products.  SIMNSA states that its premiums are generally one-third of U.S. health plans.  According to SIMNSA, while it is not subject to the timely access requirements set forth in existing law, SIMNSA tracks network adequacy issues through its grievance and complaint processes.  

According to the DMHC’s most recent medical survey of Medi-Excel, S.A. de C.V. (Medi-Excel) is a full service health plan licensed under Section 1351.2 of the Knox-Keene Act serving San Diego and Imperial Counties. Medi-Excel offers its services to California employers for their employees who are Mexican nationals and their eligible dependents who prefer to receive their health care benefit coverage services rendered in Mexico.  Only emergent and urgent healthcare services are rendered in the United States.  Medi-Excel assumes full risk for all United States-based urgent and emergent care services. Medi- Excel received its Knox-Keene license on August 10, 2012 and became operational on December 1, 2012. Medi-Excel’s parent company headquarters is located in Tijuana Mexico and its California office is located in Chula Vista, California.  Medi-Excel operates in two geographic regions, which consist of the border cities of Tijuana and Mexicali, Baja California, Mexico. All primary and specialty healthcare services are provided in the Medi-Excel service areas in Mexico. The initial Medi-Excel provider network consisted of 19 primary care physicians, 56 specialty physicians, one Plan hospital, several ancillary providers, and nine dental care providers. Medi-Excel contract(s) with urgent care facilities and ambulance providers in the United States. As of September 30, 2014, Medi-Excel has a commercial enrollment of 1,358 enrollees. 

• 1. Knox-Keene Act Provisions. In California, health plan enrollees have many rights, including but not limited to the following:
     
     1. Timely Access Regulations require that health plans meet a set of standards which include specific time frames under which enrollees must be able to access care.  These requirements generally include the following standards for appointment availability:
        1. Urgent care without prior authorization: within 48 hours.
        2. Urgent care with prior authorization: within 96 hours.
        3. Non-urgent primary care appointments: within 10 business days.
        4. Non-urgent specialist appointments: within 15 business days.
        5. Non-Urgent mental health appointments: within 15 business days for psychiatrist, within 10 business days for non-physician mental health provider.
        6. Non-urgent appointment for ancillary services for the diagnosis or treatment of injury, illness or other health condition: within 15 business days.
     2. Health plans are also generally required to ensure geographic access such that there are a sufficient number of providers located within a reasonable distance from where each enrollee lives or works.  For example, PCPs and hospitals should be located within 15 miles or 30 minutes from work or home.

Health plans must also ensure provider capacity such that health plan networks have enough of each of the right types of providers to deliver the volume of services needed.  For example, plan networks should include one primary care provider for every 2,000 beneficiaries.

• • 1. Health plan enrollees can also file a complaint (also known as an appeal or grievance) if he or she has a problem with a health plan, for example, if he or she is unable to schedule an appointment pursuant to the above. Additionally, enrollees can apply for an Independent Medical Review (IMR) with the DMHC when a health care service or treatment has been denied, modified or delayed. An IMR is a review by independent doctors who are not part of the health plan.

1. SUPPORT.  SIMNSA, sponsor of this bill, states that it receives inquiries and interest from Non-Mexican Nationals interested in its affordable option, but are forced to deny them due to the nationality requirement.  SIMNSA contends that it does not want to be forced to discriminate against any nationality and that it is time for this restriction to be lifted and provide everyone another choice for affordable health care.  
2. OPPOSE UNLESS AMENDED.  Health Access California (HAC) opposes this bill unless this bill is amended to provide the same consumer protections that apply to other coverage regulated under state law and the ACA.  HAC states that this bill would promote the expanded use of prepaid Mexican health plans that are exempt from important ACA marketplace rules and other basic health care consumer protections. HAC contends that while this bill attempts to provide an alternative health plan option for a designated region, this bill does so in a way that exposes consumers to substandard protections, limited benefits, as well as to financial and health risks.
3. RELATED LEGISLATION.  
   1. SB 974 (Lara) extends full scope Medi-Cal coverage to individuals who are 65 years of age and older who do not have or are unable to establish satisfactory immigration status, as specified. Makes this expansion of eligibility contingent upon an appropriation in the annual Budget Act. SB 974 is pending in Assembly Appropriations Committee.
   2. AB 2965 (Arambula) extends eligibility for full-scope Medi-Cal benefits to an individual who is under 26 years of age and who does not have satisfactory immigration status, as specified. AB 2965 is pending in Senate Health Committee.
4. PREVIOUS LEGISLATION.  
   1. SB 192 (Ducheny), Chapter 196, Statutes of 2007, removes the sunset that required a Mexican prepaid plan to designate a medical director licensed in California and a medical director in Mexico to oversee services delivered in Mexico until January 1, 2008.
   2. SB 1347 (Ducheny), Chapter 491, Statutes of 2004, deletes the requirement that a Mexican health plan provide benefits only for citizens of Mexico and their dependents and would instead require that it provide benefits only for Mexican nationals legally employed in the Counties of San Diego or Imperial, and their dependents, until January 1, 2008.  SB 1347 requires a Mexican prepaid plan to designate a medical director licensed in California and a medical director in Mexico to oversee services delivered in Mexico until January 1, 2008. 
   3.  SB 798 (Cedillo), Chapter 417, Statutes 2003, requires the DMHC director to notify immediately a plan that has ceased to operate legally in Mexico that the plan is required to comply with the laws of Mexico or become licensed in California within a specified time period
   4. SB 1658 (Peace),Chapter 1025, Statutes of 1998, amends the definition of health plan and specialized health care service plan to include contracts that provided health care services wholly or in part in a foreign country. SB 1658 allows health plans licensed in Mexico that elected to operate in California to apply for licensure under the Department of Corporations and meet other specified requirements, including the requirement that the plan provide only employer-sponsored group contracts for Mexican citizens legally employed in the state and their dependents regardless of nationality.
5. POLICY COMMENT.
   
   1. Knox-Keene Requirements. This bill would expand the offering of Mexican prepaid plans to any persons legally employed in San Diego and Imperial Counties. It is unknown how this expanded offering would impact the small and large employer group market with respect to competition and premium rates in the current health insurance marketplace should employers choose to offer these products to eligible employees. Most importantly, the impact to existing network adequacy and access to services is unknown as this bill would allow for a greater number of enrollees to access medical service in Mexico. According to the sponsors of this bill, SIMNSA currently tracks access issues through grievances and complaints to the health plan. Additionally, enrollees are not assigned to primary care physicians and do not need appointments to their contracted clinics and most clinics are open seven days a week and for extended business hours.
      
   2. Consumer Protections. In California, various healing arts providers, such as physicians and surgeons, nurses, and pharmacists are licensed, and regulated by healing arts boards within the Department of Consumer Affairs to protect the public. To achieve this, licensing, disciplinary, and enforcement processes are in place. Under this bill, consumers in San Diego and Imperial Counties would have limited or no recourse because these boards will be unable to investigate and prosecute consumer complaints. This would also hold true for health care facilities, such as hospitals.

REGISTERED SUPPORT / OPPOSITION:

Support

Sistemas Medicos Nacionales, S.A. de C.V. (sponsor)

International Brotherhood of Boilermakers - Iron Ship Builders

Jensen Meat Company, Inc. 

Local 30 UnitedHere San Diego County Hotel and Food Service Workers’ Union

San Ysidro Health 

Opposition

None on file.

Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097

Date of Hearing: July 11, 2017

Counsel: Sandy Uribe

ASSEMBLY COMMITTEE ON PUBLIC SAFETY

Reginald Byron Jones-Sawyer, Sr., Chair

SBPCA Bill Id:SB 641

Author:(Lara) – As Amended Ver:April 20, 2017

As Proposed to be Amended in Committee

SUMMARY: Prohibits the Department of Justice (DOJ) from releasing data in the Controlled Substance Utilization Review and Evaluation System (CURES) to a law enforcement agency except pursuant to a warrant. Specifically, this bill:

1. States that the DOJ shall only provide data obtained from CURES to a federal, state, or local law enforcement agency pursuant to a warrant based on probable cause and issued at the request of a federal, state, or local law enforcement agency engaged in an open and active drug-related criminal investigation regarding the individual to whom the requested information pertains.
   
2. Excludes the United States Drug Enforcement Agency (DEA) from the warrant requirement.

EXISTING LAW:

1. Requires the DOJ to maintain the CURES for the electronic monitoring of the prescribing and dispensing of Schedule II, III, and IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. (Health & Saf. Code, § 11165, subd. (a).)
   
2. States that CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. (Health & Saf. Code, § 11165, subd. (c)(2)(A).)
   
3. Provides that data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by DOJ, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. (Health & Saf. Code, § 11165, subd. (c)(2)(A).)
   
4. Permits data to be provided to public or private entities, as approved by the Department of Justice, for educational, peer review, statistical, or research purposes, provided that patient information, including any information that may identify the patient, is not compromised. (Health & Saf. Code, § 11165, subd. (c)(2)(A).)
   
5. Requires pharmacies or clinics, in filling a prescription for a federally Scheduled II, III or IV drug, to provide information to DOJ including the patient's name, date of birth, the name, form, strength and quantity of the drug, and the pharmacy name, pharmacy number and the prescribing physician information, as soon as reasonably but not more than seven days after the date a controlled substance is dispensed. (Health & Saf. Code, § 11165, subd. (d).)
   
6. Allows a licensed health care practitioner who is eligible to prescribe Schedule II, III, or IV controlled substances, or a pharmacist, to make a written request to DOJ for the history of controlled substances dispensed to an individual under his or her care, and allows DOJ to provide that information to that health care practitioner or pharmacist. (Health & Saf. Code, § 11165.1, subd. (a)(1)(A).)
   
7. Provides that the history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from DOJ shall be considered medical information subject to the provisions of the Confidentiality of Medical Information Act. (Health & Saf. Code, § 11165.1, subd. (d).)
   
8. Requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patient's controlled substance history, as specified. (Health & Saf. Code, § 11165.4, subd. (a).)
   
9. Requires health practitioners who prescribe or administer a controlled substance classified in Schedule II to make a record containing the name and address of the patient, date, and the character, name, strength, and quantity of the controlled substance prescribed, as well as the pathology and purpose for which the controlled substance was administered or prescribed. (Health & Saf. Code, § 11190, subd. (a) and (b).)
   
10. Requires every practitioner, other than a pharmacist, who prescribes or administers a controlled substance classified in Schedule II, III or IV to record specified information relating to the transaction. Requires that this information be provided to DOJ on a monthly basis. (Health & Saf. Code, § 11190, subd. (c).)
    

FISCAL EFFECT: Unknown.

COMMENTS:

1. Author's Statement: According to the author, “SB 641 seeks to establish a statutory construct for law enforcement access to data within the Controlled Substance Utilization Review and Evaluation System – more commonly known as CURES. The CURES database provides prescribers with important information at the point of care, including a more complete picture of a patient’s controlled substance history. This helps them make more informed and better prescribing decisions, helping reduce prescription drug abuse and diversion in California. My bill, SB 482, which was signed into law last year, required all prescribers to consult the CURES system before issuing schedule II, III, or IV drugs. Given the sensitive and confidential nature of the information within this system, there is a need to strengthen patient privacy protections while recognizing the multiple intended and important functions of the database. Similar to the privacy standards for medical records under the Confidentiality of Medical Information Act, SB 641 requires a warrant before a law enforcement agency can access data within CURES. SB 641 upholds California’s longstanding history of protecting patient and consumer privacy without compromising the crucial benefits of this important public health tool.”
   
2. Background: The CURES was established in 1997 by AB 3042 (Takasugi), Chapter 738, Statutes of 1996, in response to recommendations of the Controlled Substance Prescription Advisory Council. The CURES is a state database of dispensed prescription drugs with a high potential for misuse. The program initially was intended to electronically monitor the prescribing and dispensing of Schedule II controlled substances, such as Oxycodone.^[1] The CURES program provides for real-time electronic transmission of specified prescription data to DOJ. Essentially, the data is analyzed for indications that controlled substances are being improperly prescribed, or that drug abusers are obtaining prescriptions from many doctors (doctor shopping).
   
   In September 2009, DOJ launched the Prescription Drug Monitoring Program (PDMP) system allowing pre-registered users, including licensed health care prescribers eligible to prescribe controlled substances, pharmacists authorized to dispense controlled substances, law enforcement, and regulatory boards, to access real-time patient controlled substance history information through a secure website. Prior to the adoption of the PDMP, doctors and pharmacists had to request information by fax, mail, or phone and wait days for a response.
   
   The California Department of Justice Web site describes the current system as such: “CURES 2.0 (Controlled Substance Utilization Review and Evaluation System) is a database of Schedule II, III and IV controlled substance prescriptions dispensed in California serving the public health, regulatory oversight agencies, and law enforcement. CURES 2.0 is committed to the reduction of prescription drug abuse and diversion without affecting legitimate medical practice or patient care. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and confidentiality and disclosure provisions of California law cover the information contained in CURES 2.0. Access to CURES 2.0 is limited to licensed prescribers and licensed pharmacists strictly for patients in their direct care; and regulatory board staff and law enforcement personnel for official oversight or investigatory purposes.” (<https://oag.ca.gov/cures>.)
   
   “CURES contains the following information: patient name, patient date of birth, patient address, prescriber name, prescriber DEA number, pharmacy name, pharmacy license number, date prescription was dispensed, prescription number, drug name, drug quantity and strength, and number of refills remaining.” (<https://oag.ca.gov/cures/faqs>.)
   
   Last year, SB 482 (Lara), Chapter 708, established the requirement that prescribers check CURES before prescribing Schedule II through IV controlled substances to a patient for the first time, except in limited circumstances.
   
3. Current Practice for Accessing Data in CURES: The Department of Justice has informed this committee that access to information in CURES depends on who is conducting the search as well as what information is sought.
   
   When a health care professional that prescribes or dispenses controlled substances checks CURES before prescribing or dispensing a controlled substance to a patient, the physician, dentist, or pharmacist will sign on to the database with a username and password and can query a patient’s records based on last name, first name, and date of birth.
   
   The process for law enforcement differs slightly and depends on whether law enforcement is seeking patient data or prescriber/pharmacist data. If law enforcement is seeking patient data, they must upload a case number, criminal code, and search warrant into the system, in addition to the patient’s last name, first name, and date of birth. In contrast, for prescriber or dispenser data, a search warrant is not required.
   
4. California Privacy Law: The California Constitution expressly provides for the right of privacy. (Cal. Const. art. I, § 1.).
   
   Additionally, prescription medical information, when in a person’s medical record, has the protections of the Confidential Medical Information Act. The Act provides that a health care provider is prohibited from disclosing a patient’s medical information without his or her authorization except in specified circumstances. One such exception exists where a search warrant has been lawfully issued to a governmental law enforcement agency. (Cal. Civ. Code, § 56.10, subd. (b)(6).)
   
   Under existing law, certain protections are put in place to ensure the privacy of patients and consumers whose information are entered into the CURES. Not only is information contained within the CURES expressly subject to the Confidentiality of Medical Information Act, but existing law prescribes under what limited circumstances the DOJ can release CURES data and for what specified purposes. (See Health & Saf. Code, § 11165, subd. (c).)
   
   Although not codified by statute, as noted above, the current practice requires law enforcement to have a warrant, a criminal case number, and a criminal code in order to obtain patient data from CURES. This bill would codify the practice of requiring a warrant for an open criminal investigation.
   
   This bill would also require law enforcement to obtain a warrant in order to obtain data in CURES pertaining to a prescriber or a pharmacist. Currently, there is no warrant requirement for law enforcement to obtain data on a prescriber or pharmacist. Opponents argue that, unlike patients, physicians do not have a privacy interest in the information contained in CURES.
   

The issue of whether a physician’s patients have a protected privacy interest in the controlled substance prescription data contained within CURES when the patient’s physician is being investigated by the California Medical Board is currently being litigated in the California Supreme Court. (Lewis v. Superior Court (2014) 226 Cal.App.4th 933, rev. granted Sept. 17, 2014, S219811.) The Second District Court of Appeal had previously held that in balancing the patient’s right to privacy in their controlled substance prescription records against the state’s interest in protecting public health by regulating controlled substance and protecting the public form negligent or incompetent physicians, CURES does not present an impermissible invasion of a patient’s state constitutional right to privacy because sufficient safeguards exist to prevent unwarranted public disclosure and unauthorized access to CURES data. (Lewis v. Superior Court (2014) 226 Cal.App.4th 933.)

1. Recent Case Law: In Oregon Prescription Drug Monitoring Program v. United States DEA (9th Cir. June 26, 2017) 2017 U.S. App. LEXIS 11292, the Ninth Circuit Court of Appeals ruled that the federal Drug Enforcement Agency does not need a court order to subpoena Oregon’s Prescription Drug Monitoring Program (PDMP). Oregon’s statute requires a court order in order for a federal, state, or local law enforcement agency engaged in a drug-related investigation to obtain prescription monitoring information. (See Or. Rev. Stat. § 431A.865(2)(a)(F).) The DEA sought the PDMP records of a patient and of two doctors. Oregon argued that, under state law, it could not be compelled to produce the records without a federal court order. The American Civil Liberties Union (ACLU) sought to intervene in the case on behalf of four patients and a physician and argued that the use of investigative subpoenas violated the Fourth Amendment.
   
   The court held that Oregon’s statutory requirement for a court order in all cases in which a subpoena conflicted with, and was preempted by, federal law.
   
   The court’s ruling left open the question of whether a subpoena by the DEA of the information in the PDMP would violate Fourth Amendment protections against unreasonable searches and seizures. That claim was not addressed because the court determined that the individuals represented by the ACLU did not have standing to seek relief that was different from the State of Oregon.
   
   As proposed to be amended in this committee, and in order to comply with the recent Ninth Circuit decision which is binding in California, this bill excludes the federal DEA from the warrant requirement. If a Fourth Amendment challenge is successful in the future, the exclusion would need to be revisited.
2. Fourth Amendment Protections: Some federal courts have held that that the DEA need not secure a warrant to access data in a PDMP. In United States v. Zadeh (N.D. Tex., 2014) 2014 U.S. Dist. LEXIS 181500, the question was whether the DEA can access medical records in the absence of a warrant to determine if a provider has acted in violation of prescribing laws in the case of controlled substances prescription. The district court found that the DEA’s subpoenas of physician records satisfied Fourth Amendment requirements, in part because physicians and patients have a reduced expectation of privacy in medical records regarding controlled substances given the pervasive regulation of the pharmaceutical industry.
   
   The district court in Zadeh cited various other cases that had considered the issue. For example, the court noted that in U.S. Dep't of Justice v. Colorado Board of Pharmacy (D. Colo, 2010) U.S. Dist. LEXIS 92778, a Colorado federal district court found, in dicta, that DEA subpoenas of pharmacists’ records met Fourth Amendment requirements and were per se reasonable because they were authorized, properly served, and contained an adequate description of information relevant to the investigations.
   
   Another case cited was In re Subpoenas Duces Tecum Nos. A99-001, A99-002, A 99-003 and A99-004 (W.D. Va. 1999) 51 F. Supp. 2d 726, in which the Sixth Circuit Court of Appeals reversed the granting of a motion to suppress as to an administrative inspection warrants based on a violation of the Fourth Amendment. The Sixth Circuit held that, like the mining, firearms, and liquor industries, the pharmaceutical industry is a "pervasively regulated industry and consequently pharmacists and distributors subject to the Controlled Substances Act have a reduced expectation of privacy in the records kept in compliance with the Act.
   
   The Zadeh court did note that in Oregon Prescription Drug Monitoring Program v. United States DEA (D. Or. 2014) 988 F. Supp. 2d 957, the district court ruled that patients have a reasonable expectation of privacy in their drug prescription records, and that law enforcement must obtain a warrant in order to search such information:
   

“Although there is not an absolute right to privacy in prescription information, as patients must expect that physicians, pharmacists, and other medical personnel can and must access their records, it is more than reasonable for patients to believe that law enforcement agencies will not have unfettered access to their records. The prescription information maintained by PDMP is intensely private as it connects a person's identifying information with the prescription drugs they use. The DEA attempts to draw a distinction between medical records and prescription information in order to distinguish the present case from Tucson Woman's Clinic's conclusion that ‘all provision of medical services in private physicians' offices carries with it a high expectation of privacy.’ This distinction is very nearly meaningless. By obtaining the prescription records for individuals like John Does 2 and 4, a person would know that they have used testosterone in particular quantities and by extension, that they have gender identity disorder and are treating it through hormone therapy. It is difficult to conceive of information that is more private or more deserving of Fourth Amendment protection. That this expectation of privacy in prescription information is protected in ORS 431.966 and advertised on PDMP's public website, makes that expectation all the more reasonable.” (Oregon Prescription Drug Monitoring Program, 998 F. Supp. 2d at 966 [internal footnotes and citations omitted].)^[2]

Despite several federal courts concluding that administrative subpoenas by the DEA do not violate the Fourth Amendment; these cases are not binding in California. The Fourth Amendment claim remains an open question.

1. Controlled Substances: The federal government regulates the manufacture, distribution, and dispensing of controlled substances through the Controlled Substances Act of 1970. The act ranks into five schedules those drugs known to have potential for physical or psychological harm, based on three considerations: (a) their potential for abuse, (b) their accepted medical use, and (c) their accepted safety under medical supervision.
   
   Schedule I controlled substances have a high potential for abuse and no generally accepted medical use such as heroin and LSD. Schedule II controlled substances have a currently-accepted medical use in treatment, or a currently-accepted medical use with severe restrictions, and have a high potential for abuse and psychological or physical dependence. Schedule II drugs can be narcotics or non-narcotic. Examples of Schedule II controlled substances include morphine, methadone, Ritalin, Demerol, Dilaudid, Percocet, Percodan, and Oxycontin. Schedule III and IV drugs include Vicodin, Zanex, Ambien and other anti-anxiety drugs that generally have less potential for abuse than Schedule II drugs but are known to be mixed in specific ways to achieve a narcotic-like end product. Schedule V drugs are available over the counter.
   
2. Arguments in Support:
   
   1. According to the California Medical Association, the sponsor of this bill, “California is one of the few states that does not specify in the statute the authorized recipients of information from the PDMP. The sensitive and confidential nature of the information in the database requires a thoughtful approach that balances California’s longstanding policy of protecting patient privacy while also weighing the needs of the many different types of entities who may use CURES data, including for public health and safety purposes. The explicit delineation of privacy and access to information is a best practice that California has yet to implement and which, given that a law enforcement entity oversees the database, increases the desirability of such clarity.
      
      “Under the Confidentiality of Medical Information Act, absent a warrant, law enforcement generally does not have the authority to access a patient’s medical record without patient authorization. Thus, the existing CURES statutory construct subjects, without the imprimatur of legislative authority, different privacy standards for medical records and the same information in the CURES database. SB 641 seeks to better align these standards for the CURES database, while recognizing the multiple intended functions of the database.
      
      “California has a longstanding history of protecting patient and consumer privacy. It should maintain that standard for the millions of patient records that are housed in the CURES database.”
      
   2. According to the California Chapter of the American College of Physicians, “We believe in the goal of the CURES registry to reduce prescription drug abuse and diversion without compromising valid medical practices and patient care. Data from the registry will help us better understand and address the opioid epidemic. However, it is equally important to us to ensure that patient information is protected and that its use is carefully delineated, i.e., not left to the sole discretion of DOJ to determine which government entities may receive information from CURES or change the criteria for access without the public’s knowledge. By restricting law enforcement agencies from accessing CURES data without a warrant based on probable cause, SB 641 helps maintain patient confidentiality and prevent misuse of database information.”
      
3. Arguments in Opposition:
   
   1. According to the California Police Chiefs Association, “While we understand requiring a warrant to examine a patient’s activity report (patients have an expectation of privacy in their medical and prescribing information); we believe that requiring a warrant for over prescribers is a step too far. Doctors have no expectation of privacy in oversight of their professional activities; nothing justifies this special protection. A warrant requirement on a doctor’s prescribing history places an unnecessary hurdle on effective law enforcement investigations regarding excessive prescribing.
      
      “As amended, SB 641 would severely limit law enforcement’s access to CURES data by requiring the Department of Justice to only provide data obtained from CURES ‘to a federal, state, or local law enforcement agency pursuant to a valid court order or warrant based on probable cause and issued at the request of a federal, state, or local law enforcement agency engaged in an open and active investigation regarding prescription drug abuse or diversion of prescription of controlled substances involving the individual to whom the requested information pertains.’ (Section 11165 (c)(2)(B)). This is an incredibly narrow warrant requirement.
      
      “The narrow warrant requirement would hamper law enforcement’s ability to identify and stop criminal activities, such as doctors who sell prescriptions for cash. Public safety officials are making great strides in the attempt to address the opioid overdose crisis in California, and restricting use of this key tool will set those efforts back.”
      
   2. According to a coalition group including Consumer Attorneys, Consumer Watch, and others, “SB 641 would restrict access to CURES by law enforcement officials investigating complaints of illegal and dangerous prescribing and prevent these peace officers from holding dangerous doctors accountable.
      
      “The Department of Justice has implemented policies to protect the privacy of patient data in CURES, by requiring a warrant or court order to search a patient’s name and obtain a Patient Activity Report. Although doctors have no expectation of privacy when it comes to oversight of their profession, DOJ policy also requires an active investigation in order to search a prescriber or dispenser’s name in CURES and obtain a Prescriber and Pharmacy Activity Report. We believe these policies appropriately balance patient privacy with the state’s obligation to ensure public safety through safe prescribing.
      
      “Our coalition has proposed that rather than requiring a warrant to investigate a doctor for over prescribing, SB 641 should require a regulatory process on the issue or simply codify the DOJ’s current policies that require a warrant to obtain a patient’s, but not a doctor’s information.”
      
4. Related Legislation: AB 40 (Santiago) would require the DOJ to make the electronic history of controlled substances prescribed to an individual by a health care practitioner available to the practitioner based on data from the CURES. AB 40 is pending in the Senate Judiciary Committee.
   
5. Prior Legislation:
   
   1. SB 482 (Lara), Chapter 708, Statutes of 2016, required prescribers to consult the CURES prior to prescribing a drug to a patient, as specified.
      
   2. SB 809 (DeSaulnier), Chapter 400, Statutes of 2013, established a dedicated fund to maintain the CURES, and required all prescribing health care practitioners to apply to access CURED information.

REGISTERED SUPPORT / OPPOSITION:

Support

California Medical Association (Sponsor)
American Academy of Pediatrics
American Civil Liberties Union
American College of Physicians, California Chapters
California Academy of Family Physicians
California Academy of Preventative Medicine
California Dental Association
California Health Advocates
County Behavioral Health Directors Association of California
Electronic Frontier Foundation
Osteopathic Physicians and Surgeons of California

Opposition

Association for Los Angeles Deputy Sheriffs
Association of Deputy District Attorneys
California Association of Code Enforcement Officers
California College and University Police Chiefs Association
California Narcotic Officers Association
California Police Chiefs Association
California State Board of Pharmacy
California State Sheriffs’ Association
California Teamsters Public Affairs Council
Center for Public Interest Law, University of San Diego School of Law
Consumer Attorneys of California
Consumer Federation of California
Consumer Watchdog
Los Angeles County District Attorney
Los Angeles County Probation Officers Union AFSCME Local 685
Los Angeles County Professional Peace Officers Association
Shatterproof
Troy and Alana Pack Foundation

Analysis Prepared by: Sandy Uribe / PUB. S. / (916) 319-3744

1. Under current law, California practitioners and pharmacies are required to report to the DOJ every Schedule II, II, and IV prescription filled. ↑

2. As noted above, the Ninth Circuit reversed this decision because it found that the intervenors did not have to standing to raise the Fourth Amendment claim in that particular case. (See Oregon Prescription Drug Monitoring Program v. United States DEA, supra, 2017 U.S. App. LEXIS 11292.) ↑

 THIRD READING  

Bill No: SB 641

Author:

:

Vote:

SENATE PUBLIC SAFETY COMMITTEE: 7-0, 4/18/17

AYES: Skinner, Anderson, Bradford, Jackson, Mitchell, Stone, Wiener

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/25/17

AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener

SUBJECT:

SOURCE: California Medical Association

DIGEST:

This bill prohibits the Department of Justice (DOJ) from releasing data obtained from the Controlled Substances Utilization Review and Evaluation System (CURES) to a law enforcement agency except pursuant to a warrant, as specified.

ANALYSIS:

Existing law:

1. Defines “prescription” as an oral, written, or electronic transmission order that includes certain information. (Bus. and Prof. Code § 4040.)
2. Establishes the California Uniform Controlled Substances Act which regulates controlled substances. (Health & Saf. Code § 11000 et seq.)
3. Defines “dispense” to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, furnishing, packaging, labeling, or compounding necessary to prepare the substance for that delivery and “dispenser” as a practitioner who dispenses. (Health & Saf. Code §§ 11010 and 11011)
4. Defines an “opiate” as a substance having an addiction-forming or addiction-sustaining effect similar to morphine, or that can be converted into a drug having addiction-forming or addiction-sustaining effects. (Health & Saf. Code § 11020.)
5. Classifies controlled substances in five schedules according to their danger and potential for abuse. (Health & Saf. Code §§ 11054-11058.)
6. Prohibits any person other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor, pharmacist, certified nurse-midwife, nurse practitioner, a registered nurse or physician assistant acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development, an optometrist licensed under the Optometry Practice Act, or an out-of-state prescriber acting in an emergency situation from writing or issuing a prescription for a controlled substance. (Health & Saf. Code § 11150.)
7. Provides that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice and establishes responsibility for proper prescribing of controlled substances upon the prescribing practitioner. A violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (Health & Saf. Code § 11153.)
8. Establishes CURES for electronic monitoring of Schedule II, III and IV controlled substance prescriptions and provides for electronic transmission of this information to DOJ at the time prescriptions are dispensed. (Health & Saf. Code § 11165.)
9. States CURES is intended to assist law enforcement and regulatory agencies in controlling diversion and abuse of Schedule II, III and IV controlled substances and for statistical analysis, education, and research. Requires that the operation of CURES comply with all applicable federal and state privacy and security laws and regulations. (Health & Saf. Code § 11165, subd. (a).)
10. Establishes privacy protections for patient data and specifies that CURES data can only be accessed by appropriate state, local, and federal public agencies or authorized for disciplinary, civil or criminal actions. States that CURES data shall only be provided, as determined by DOJ, to other agencies or entities for educating practitioners and others, in lieu of disciplinary, civil or criminal actions. Non-identifying CURES data can be provided to public and private entities for education, research, peer review and statistical analysis. Provides that data disclosed to any individual or agency as described above shall not be disclosed, sold, or transferred to any third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. (Health & Saf. Code § 11165, subd. (c).)
11. Requires DOJ to establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES. (Health & Saf. Code § 11165, subd. (c).)
12. Prohibits a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances from being provided data obtained from CURES. (Health & Saf. Code § 11165, subd. (c).)
13. Authorizes a health care practitioner, in accordance with federal and state privacy laws and regulations, to provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data is provided. Existing law further authorizes a health care practitioner to keep a copy of the report in the patient’s medical record. (Health & Saf. Code § 11165, subd. (c).)
14. Requires a pharmacy or clinic, in filling a controlled substance prescription, to provide weekly information to DOJ including, the patient’s name, address, gender, and date of birth; the prescriber’s category of license and license number; the pharmacy name and number; the quantity of the drug, number of refills ordered, and whether the drug was dispensed as a refill or first-time request; and date of origin of the prescription and date of dispensing of the prescription. (Health & Saf. Code § 11165, subd. (d).)
15. Requires a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, to submit an application to obtain approval to access CURES Prescription Drug Monitoring Program (PDMP) information online by July 1, 2016. DOJ may deny an application or suspend a subscriber for certain violations and falsifying information. An authorized subscriber is required notify DOJ within 30 days of any changes to the subscriber account. (Health & Saf. Code § 11165.1 (a).)
16. Requires that any request for, or release of, a controlled substance history pursuant to this section be made in accordance with guidelines developed by DOJ. (Health & Saf. Code § 11165.1 (b).)
17. Provides that DOJ may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual in order to prevent the inappropriate, improper, or illegal use of controlled substances. (Health & Saf. Code § 11165.1 (c).)
18. Provides that the history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from DOJ pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act. (Health & Saf. Code § 11165.1, subd. (d).)
19. Provides that DOJ may conduct audits of CURES and its users. (Health & Saf. Code § 11165.2, subd. (a).)
20. Requires health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patient’s controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every four months thereafter if the substance remains part of the treatment of the patient, with specified exemptions. (Health & Saf. Code § 11165.4.)

This bill prohibits the DOJ from releasing CURES data to a federal, state, or local law enforcement agency except pursuant to a warrant. Provides that the law enforcement agency must be engaged in an open and active criminal investigation involving the person to whom the requested information pertains.

Background

For the past several years, abuse of prescription drugs (e.g., taking a prescription medication prescribed to someone else, or taking it for reasons or in dosages other than as prescribed) has become increasingly prevalent. Federal data from 2014 showed that abuse of prescription pain killers now ranks second, just behind marijuana, as the nation’s most widespread illegal drug problem. Research suggests that individuals who misuse prescription drugs, particularly teens, believe these substances are safer than illicit drugs because they are prescribed by a health care professional. A 2013 analysis published by the Center for Disease Control (CDC) found that drug overdose deaths increased for the 11th consecutive year in 2010, and that prescription drugs, particularly opioid analgesics, are the top drugs leading the list of those responsible for fatalities. CDC found that nearly 60% of the overdose deaths in 2010, involved pharmaceutical drugs, with opioids associated with approximately 75% of these deaths.

Currently, 49 states have PDMPs. California’s PDMP, CURES, is the oldest drug monitoring program in the nation. CURES is an electronic tracking program that reports all pharmacy, and specified types of prescriber, dispensing of controlled drugs by drug name, quantity, prescriber, patient, and pharmacy. Data from CURES is managed by DOJ and assists state law enforcement and regulatory agencies in identifying unusual prescribing practices as well as “doctor shopping” (i.e., when a prescription-drug addict visits multiple doctors to obtain multiple prescriptions for drugs, or uses multiple pharmacies to obtain prescription drugs). Information tracked in the system contains the patient name, prescriber name, pharmacy name, drug name, amount and dosage, and is available to law enforcement agencies, regulatory bodies, and qualified researchers. The system can also generate reports on the top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, and pharmacy dispensing data. CURES data can be obtained by the Board of Pharmacy, Medical Board of California, Dental Board of California, Board of Registered Nursing, Osteopathic Medical Board of California and Veterinary Medical Board. DOJ recently released new CURES 2.0 system.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Senate Appropriations Committee:

• DOJ: Moderate costs, potentially in the tens of thousands of dollars (CURES Fund), to DOJ to verify that a law enforcement agency requesting information within CURES has obtained a warrant and is engaged in an open and active criminal investigation of a specified nature on a specific person.
• Local law enforcement: Unknown, potentially moderate to significant workload costs (local funds) to prepare a petition for, have the prosecution review, and present a warrant to the court. Workload is dependent on the number of petitions pursued by law enforcement agencies.
• Courts: Unknown, potentially moderate to significant workload costs (General Fund) to determine whether warrant requests establish sufficient probable cause to request information. Workload is dependent on the number of warrant petitions submitted by law enforcement agencies.

SUPPORT: (Verified 5/25/17)

California Medical Association (source)

American Academy of Pediatrics, California

American College of Physicians- California Services Chapter

California Dental Association

County Behavioral Health Directors Association

Electronic Frontier Foundation

OPPOSITION: (Verified 5/25/17)

California Narcotics Officers Association

California Teamsters Public Affairs Council

Center for Public Interest Law, University of San Diego Law School

Consumer Attorneys of California

Consumer Federation of California

Consumer Watchdog

Shatterproof

Troy and Alana Pack Foundation

ARGUMENT IN SUPPORT: According to the California Medical Association, the sponsor of this bill:

CURES began as a pilot project in 1996 when the DOJ sought to compare the efficiencies of an automated reporting system for Schedule II controlled substances versus Schedule II triplicate reporting….

Though initially intended only to assist law enforcement and regulatory agencies and include only Schedule II, the system was eventually expanded to allow health care providers to access patient information to inform prescribing decisions…and…to cover Schedule III and IV substances. Health care practitioners who can prescribe, furnish, order, administer, and dispense controlled substances now pay for the system through licensing fees. Last year, SB 482 (Lara) established a duty to consult CURES requirement for prescribers, thus further transforming CURES into a clinical tool for health care providers.

…California’s CURES has some qualities that put it outside standard practice….California is one of three states which houses its PDMP in a law enforcement entity. The majority are housed in a health department or Board of Pharmacy. Additionally, California is one of the few states that does not specify in the statute the authorized recipients of information from the PDMP. The sensitive and confidential nature of the information in the database requires a thoughtful approach that balances California’s longstanding policy of protecting patient privacy while also weighing the needs of the many different types of entities who may use CURES data, including for public health and safety purposes. The explicit delineation of privacy and access to the information is a best practice that California has yet to implement and which, given that a law enforcement entity oversees the database, increases the desirability of such clarity….

Under the Confidentiality of Medical Information Act, absent a warrant, law enforcement generally do not have the authority to access a patient’s medical record without patient authorization. Thus the existing CURES statutory construct subjects, without the imprimatur of legislative authority, different privacy standards for medical records and the same information in the CURES database. SB 641 seeks to better align these standards for the CURES database, while recognizing the multiple intended functions of the database.

ARGUMENT IN OPPOSITION: According to the Consumer Attorneys of California:

While we understand requiring a warrant to examine a patient’s activity report (patients have an expectation of privacy in their medical and prescribing information); we believe that requiring a warrant for over prescribers is a step too far. Doctors have no expectation of privacy in oversight of their professional activities. Nothing justifies this special protection. A warrant requirement on a doctor’s prescribing history places an unnecessary hurdle on effective law enforcement investigations into over prescribing.

SB 641 would require a very specific warrant before law enforcement can access a doctor’s prescribing information.

As amended, SB 641 would severely limit law enforcement’s access to CURES data by requiring the Department of Justice to only provide data obtained from CURES “to a federal, state, or local law enforcement agency pursuant to a valid court order or warrant based on probable cause and issued at the request of a federal, state, or local law enforcement agency engaged in an open and active investigation regarding prescription drug abuse or diversion of prescription of controlled substances involving the individual to whom the requested information pertains.” (Section 11165 (c)(2)(B)). This is an incredibly narrow warrant requirement.

The narrow warrant requirement would hamper law enforcement’s ability to identify and stop criminal activities, such as pill mills run by doctors who sell prescriptions for cash. The activity we are talking about is criminal. SB 641 will harm both patients who obtain prescriptions from these doctors and the safety of our communities if physicians are allowed to continue selling drugs unchecked. Public safety officials are making great strides in the attempt to address the opioid overdose crisis in California, and restricting use of this key tool will set those efforts back. Regulatory boards will also lose an important source of information as they often find out about this kind of illegal activity only once law enforcement has taken action.

We remain concerned that the bill would limit law enforcement from identifying and effectively stopping over prescribing doctors.

Prepared by:

5/27/17 18:21:09

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

SB 641 (Lara) - Controlled Substance Utilization Review and Evaluation System: privacy

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

SB 641 would prohibit the Department of Justice (DOJ) from releasing data obtained from the Controlled Substance Utilization Review and Evaluation System (CURES) to a law enforcement agency except pursuant to a warrant.

Fiscal Impact:

• DOJ: Moderate costs, potentially in the tens of thousands of dollars (special fund*), to DOJ to verify that a law enforcement agency requesting information within CURES has obtained a warrant and is engaged in an open and active criminal investigation of a specified nature on a specific person.
• Local law enforcement: Unknown, potentially moderate to significant workload costs (local funds) to prepare a petition for, have the prosecution review, and present a warrant to the court. Workload is dependent on the number of petitions pursued by law enforcement agencies.
• Courts: Unknown, potentially moderate to significant workload costs (General Fund) to determine whether warrant requests establish sufficient probable cause to request information. Workload is dependent on the number of warrant petitions submitted by law enforcement agencies.

*CURES Fund

Background:

Existing law requires DOJ to maintain CURES for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these substances. Existing law allows the department to release CURES data only to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners, statistical or research purposes, and others in lieu of disciplinary, civil, or criminal actions.

Proposed Law:

This bill would prohibit DOJ from releasing data obtained from CURES to a law enforcement agency except pursuant to a warrant based on probable cause and issued at the request of a federal, state, or local law enforcement agency engaged in an open and active criminal investigation regarding prescription drug abuse or diversion of prescription of controlled substances involving the individual to whom the requested information pertains.

Related Legislation:

AB 40 (Santiago, 2017) would require DOJ to make the electronic history of controlled substances prescribed to an individual by a health care practitioner available to the practitioner based on data from CURES. AB 40 is pending in the Assembly Committee on Appropriations.

-- END --

SENATE COMMITTEE ON PUBLIC SAFETY

Senator Nancy Skinner, Chair

2017 - 2018 Regular

Bill No: SB 641 Hearing Date: April 18, 2017

Subject: Controlled Substance Utilization Review and Evaluation System: privacy

HISTORY

Source: California Medical Association

Prior Legislation: SB 482 (Lara) Ch. 708, Stats. 2016

SB 1258 (DeSaulnier) Held in Senate Appropriations (2014)

SB 809 (DeSaulnier) Ch. 400, Stats. 2013

SB 360 (Author:DeSaulnier) Ch. 418, Stats. 2011

AB 2968 (Mullin) Ch. 286, Stats. 2006

SB 734 (Torlakson) Ch. 487, Stats. 2005

SB 151 (Burton) Ch. 406, Stats. 2004

AB 3042 (Takasugi) Ch. 738, Stats. 1996

Support: American College of Physicians- California Services Chapter; California Dental Association

Opposition: California Narcotics Officers Association (unless amended); California Teamsters Public Affairs Council (unless amended); Consumer Attorneys of California (unless amended); Consumer Federation of California (unless amended); Consumer Watchdog (unless amended); Shatterproof (unless amended)

California Retailers Association (earlier); Center for Public Interest Law (earlier); National Association of Chain Drug Stores (earlier); The Troy and Alan Pack Foundation (earlier)

PURPOSE

The purpose of this bill is to prohibit the release of data obtained within the Controlled Substances Utilization Review and Evaluation System (CURES) to a law enforcement agency except pursuant to a valid court order or warrant based on probable cause and issued at the request of a law enforcement agency engaged in an open and active investigation.

Existing law authorizes a physician and surgeon to prescribe for, or dispense or administer to, a person under his or her treatment for a medical condition dangerous drugs or prescription controlled substances for the treatment of pain or a condition causing pain, including, but not limited to, intractable pain. (Bus. & Prof. Code § 2241.5.)

Existing law provides that the Medical Board of California (MBC) may take any action against a physician and surgeon who violates laws related to inappropriate prescribing. Existing law further provides that a physician and surgeon shall exercise reasonable care in determining whether a particular patient or condition, or the complexity of a patient’s treatment, including, but not limited to, a current or recent pattern of drug abuse, requires consultation with, or referral to, a more qualified specialist. (Bus. & Prof. Code § 2241.5.)

Existing law requires the Division of Medical Quality (DMQ) within MBC, to develop standards before June 1, 2002 to ensure competent review in cases concerning the management, including, but not limited to, the under-treatment, under-medication, and overmedication of a patient’s pain. Authorizes DMQ to consult with entities such as the American Pain Society, the American Academy of Pain Medicine, the California Society of Anesthesiologists, the California Chapter of the American College of Emergency Physicians, and any other medical entity specializing in pain control therapies to develop the standards utilizing, to the extent they are applicable, current authoritative clinical practice guidelines. (Bus. & Prof. Code § 2241.6.)

Existing law defines “prescription” as an oral, written, or electronic transmission order that includes certain information. (Bus. and Prof. Code § 4040.)

Existing law establishes the California Uniform Controlled Substances Act which regulates controlled substances. (Health & Saf. Code § 11000 et seq.)

Existing law defines “dispense” to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, furnishing, packaging, labeling, or compounding necessary to prepare the substance for that delivery and “dispenser” as a practitioner who dispenses. (Health & Saf. Code §§ 11010 and 11011)

Existing law defines a drug as:

• A substance recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; and,
• A substances (other than food) intended to affect the structure or any function of the body of man or animals. (Health & Saf. Code § 11014.)

Existing law defines an opiate as a substance having an addiction-forming or addiction-sustaining effect similar to morphine, or that can be converted into a drug having addiction-forming or addiction-sustaining effects. (Health & Saf. Code § 11020.)

Existing law classifies controlled substances in five schedules according to their danger and potential for abuse. (Health & Saf. Code §§ 11054-11058.)

Existing law prohibits any person other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor, pharmacist, certified nurse-midwife, nurse practitioner, a registered nurse or physician assistant acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development, an optometrist licensed under the Optometry Practice Act, or an out-of-state prescriber acting in an emergency situation from writing or issuing a prescription for a controlled substance. (Health & Saf. Code § 11150.)

Existing law specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice and establishes responsibility for proper prescribing of controlled substances upon the prescribing practitioner. A violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (Health & Saf. Code § 11153.)

Existing law requires special prescription forms for controlled substances to be obtained from security printers approved by the Department of Justice (DOJ), establishes certain criteria for features on the forms and requires controlled substance prescriptions to be made on the specified form. (Health & Saf. Code §§ 11161.5, 11162.1, 11164.)

Existing law establishes the Controlled Substances Utilization Review and Evaluation System (CURES) for electronic monitoring of Schedule II, III and IV controlled substance prescriptions.

• CURES provides for electronic transmission of Schedule II, III and IV controlled substance prescription information to the Department of Justice (DOJ) at the time prescriptions are dispensed. (Health & Saf. Code § 11165.)
• CURES is intended to assist law enforcement and regulatory agencies in controlling diversion and abuse of Schedule II, III and IV controlled substances and for statistical analysis, education, and research. (Health & Saf. Code § 11165, subd. (a).)

Existing law requires that the operation of CURES comply with all applicable federal and state privacy and security laws and regulations. (Health & Saf. Code § 11165, subd. (a).)

Existing law establishes privacy protections for patient data and specifies that CURES data can only be accessed by appropriate state, local, and federal public agencies or authorized for disciplinary, civil or criminal actions. CURES data shall also only be provided, as determined by DOJ, to other agencies or entities for educating practitioners and others, in lieu of disciplinary, civil or criminal actions. Non-identifying CURES data can be provided to public and private entities for education, research, peer review and statistical analysis. (Health & Saf. Code § 11165, subd. (c).)

Existing law provides that data disclosed to any individual or agency as described above shall not be disclosed, sold, or transferred to any third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. (Health & Saf. Code § 11165, subd. (c).)

Existing law requires DOJ to establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES. (Health & Saf. Code § 11165, subd. (c).)

Existing law prohibits a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances from being provided data obtained from CURES. (Health & Saf. Code § 11165, subd. (c).)

Existing law authorizes a health care practitioner, in accordance with federal and state privacy laws and regulations, to provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data is provided. Existing law further authorizes a health care practitioner to keep a copy of the report in the patient’s medical record. (Health & Saf. Code § 11165, subd. (c).)

Existing law requires a pharmacy or clinic, in filling a controlled substance prescription, to provide weekly information to DOJ including:

• The patient’s name, address, gender, and date of birth.
• The prescriber’s category of license, license number, and other specified information.
• The pharmacy name, pharmacy number, and other specified information.
• The National Drug Code number of the drug, quantity of the drug, number of refills ordered, and whether the drug was dispensed a s refill or first-time request.
• Date of origin of the prescription and date of dispensing of the prescription. (Health & Saf. Code § 11165, subd. (d).)

Existing law provides that DOJ may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. All prescriber and dispenser invitees be licensed by a board or committee, as specified, in active practice in California, and a regular user of CURES. (Health & Saf. Code § 11165, subd. (e).)

Existing law requires that prior to upgrading CURES, DOJ consult with prescribers licensed by one of the boards or committees, as specified, one or more of the boards or committees, as specified, and any other stakeholder identified by DOJ. (Health & Saf. Code § 11165, subd. (f).)

Existing law authorizes DOJ to a process to educate authorized subscribers on how to access and use CURES. (Health & Saf. Code § 11165, subd. (g).)

Existing law requires a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, to submit an application to obtain approval to access CURES Prescription Drug Monitoring Program (PDMP) information online by July 1, 2016. DOJ may deny an application or suspend a subscriber for certain violations and falsifying information. An authorized subscriber is required notify DOJ within 30 days of any changes to the subscriber account. (Health & Saf. Code § 11165.1 (a).)

Existing law requires that any request for, or release of, a controlled substance history pursuant to this section be made in accordance with guidelines developed by DOJ. (Health & Saf. Code § 11165.1 (b).)

Existing law provides that DOJ may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual in order to prevent the inappropriate, improper, or illegal use of controlled substances. (Health & Saf. Code § 11165.1 (c).)

Existing law provides that the history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from DOJ pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act. (Health & Saf. Code § 11165.1, subd. (d).)

Existing law provides that a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from any false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for any resulting failure of the CURES database to accurately or timely report that information. (Health & Saf. Code § 11165.1, subd. (f).)

Existing law provides that DOJ may conduct audits of the CURES Prescription Drug Monitoring Program system and its users. (Health & Saf. Code § 11165.2, subd. (a).)

Existing law requires health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patient’s controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every four months thereafter if the substance remains part of the treatment of the patient, with specified exemptions. (Health & Saf. Code § 11165.4.)

Existing law authorizes DOJ to seek private, voluntary funds from insurers, health care service plans, qualified manufacturers, and other donors to support CURES. DOJ is required to make all sources and amounts of such contributions available to the public. (Health & Saf. Code § 11165.5.)

Existing law requires health practitioners who prescribe or administer a controlled substance classified in Schedule II to make a record containing the name and address of the patient, date, and the character, name, strength, and quantity of the controlled substance prescribed, as well as the pathology and purpose for which the controlled substance was administered or prescribed. (Health & Saf. Code § 11190, subds. (a) and (b).)

Existing law requires authorized prescribers who dispense Schedule II, III or IV controlled substance in their office or place of practice to record and maintain information for three years for each such prescription that includes the patient’s name, address, gender, and date of birth, prescriber’s license and license number, federal controlled substance registration number, state medical license number, National Drug Code number of the controlled substance dispensed, quantity dispensed, diagnosis code and original date of dispensing. This information shall be provided to DOJ on a monthly basis. (Health & Saf. Code §§ 11190, subd. (c) and 11191.)

This bill requires that the Department of Justice only provide CURES data to a federal, state, or local law enforcement agency pursuant to a valid court order or warrant based on probable cause and issued at the request of a federal, state, or local law enforcement agency engaged in an open and active investigation regarding prescription drug abuse or diversion of prescription controlled substances involving the person to whom the requested information pertains.

This bill makes other non-substantive changes.

COMMENTS

1. Need for This Bill

According to the author:

Every time a prescription for a Schedule II through IV controlled substance is filled, the prescription information is entered into the CURES database. Controlled substances, such as Morphine and Xanax, are prescribed for a wide range of serious medical conditions, including seizure disorders, chronic pain, narcolepsy, obesity, weight loss and nausea associated with AIDS and chemotherapy, testosterone deficiency, attention deficit hyperactivity disorder, and heroin addiction treatment. DOJ has reported that CURES typically receives about one million prescription reports per week.

CURES is intended to assist health care practitioners when working with controlled substances, to assist law enforcement and regulatory agencies in their efforts to control diversion and abuse of controlled substances, and for statistical analysis, education, and research. While the statutory authority established for health care providers’ access is clear, the authority granting government entities access to the data and under what circumstances is unclear. Health and Safety Code Section 11165 says that data from CURES “shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes.”

SB 482 (Lara, 2016) required prescribers to check CURES prior to prescribing Schedule II through IV controlled substances, except in certain circumstances. SB 482 also established a small exclusion to government access for those licensing boards that do not license health care providers who work with controlled substances. However, the overarching statutory construct for privacy within the database is unclear and leaves patients’ information vulnerable to inappropriate disclosure. The law gives DOJ the sole discretion to determine which government entities receive information from CURES and provides wide latitude for DOJ to change the criteria for access without the public’s knowledge. The parameters of who can access Californians’ prescription information and to whom the government can disclose such records – which can reveal information about an individual that is highly personal, sensitive, and private – should be established in statute and not left to agency discretion.

SB 641 seeks to establish a structure for disclosure of information in the CURES database to law enforcement. This prescription information, when in a person’s medical record, has the protections of the Confidential Medical Information Act. In most instances, law enforcement access to it requires a warrant. This bill seeks to more closely align the requirements for law enforcement access to the medical information that is housed in CURES with the disclosure requirements for medical information in medical records. Without this protection, DOJ can change the standard without a public process. The sensitivity of this information warrants clear guidelines for access. Patients believe that their medical information has certain protections; they should know what the parameters for law enforcement access to their information in the database are.

2. Background on Controlled Substances and Prescription Drug Abuse

a. Controlled Substances

Through the Controlled Substances Act of 1970, the federal government regulates the manufacture, distribution and dispensing of controlled substances. The Act groups drugs into five schedules with decreasing potential for physical or psychological harm, based on three considerations: (a) their potential for abuse; (b) their accepted medical use; and, (c) their accepted safety under medical supervision. Federal law includes relatively detailed explanations of the factors and standards for placement of drugs in the various schedules. California law does not explain how the schedules are organized.

• Schedule I controlled substances, such as heroin, ecstasy, and LSD, have a high potential for abuse and no generally accepted medical use.
• Schedule II controlled substances have a currently accepted medical use in treatment, or a currently accepted medical use with severe restrictions, and have a high potential for abuse and psychological or physical dependence. Schedule II drugs can be narcotics or non-narcotic. Examples of Schedule II controlled substances include morphine, methadone, Ritalin, Demerol, Dilaudid, Percocet, Percodan, and Oxycontin.
• Schedule III and IV controlled substances have a currently accepted medical use in treatment, less potential for abuse but are known to be mixed in specific ways to achieve a narcotic-like effect. Examples include drugs include Vicodin, Xanax, Ambien and other anti-anxiety drugs.
• Schedule V drugs have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

The three classes of prescription drugs that are most commonly abused are: opioids, which are most often prescribed to treat pain; central nervous system (CNS) depressants, which are used to treat anxiety and sleep disorders; and stimulants, which are often prescribed to treat the sleep disorder narcolepsy and attention-deficit hyperactivity disorder (ADHD). Most of the drugs in each class of drugs can induce euphoria or intoxication. When administered by routes other than recommended, such as snorting or dissolving into a liquid to drink or inject, the effect of the drug is typically intensified. Synthetic opioids act on the same receptors as heroin and morphine and therefore can be highly addictive. Common opioids are: hydrocodone (Vicodin), oxycodone (OxyContin), propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine (Demerol), and diphenoxylate (Lomotil).

b. Prescription Drug Abuse

For the past several years, abuse of prescription drugs (taking a prescription medication prescribed to someone else, or taking it for reasons or in dosages other than as prescribed) to get high has become increasingly prevalent. According to the 2008 National Survey on Drug Use and Health (NSDUH), approximately 52 million Americans aged 12 or older reported non-medical use of any psychotherapeutic at some point in their lifetimes, representing 20.8% of the population aged 12 or older. The National Institute on Drug Abuse’s (NIDA) research report Prescription Drugs: Abuse and Addiction states that the elderly are among those most vulnerable to prescription drug abuse or misuse because they are prescribed more medications than their younger counterparts. Persons 65 years of age and above comprise only 13 percent of the population, yet account for approximately one-third of all medications prescribed in the United States. Older patients are more likely to be prescribed long-term and multiple prescriptions, which could lead to unintentional misuse. The report also notes that studies suggest that women are more likely (in some cases, 55 percent more likely) than men to be prescribed a drug which can be abused, particularly narcotics and antianxiety drugs. A 2010 report, Monitoring the Future Study, showed that as many as 4 percent of high school students and 3 percent of young adults say they have used OxyContin in the past year.

Abuse can stem from the fact that prescription drugs are legal and potentially more easily accessible, as they can be found at home in a medicine cabinet. Data shows that individuals who misuse prescription drugs, particularly teens, believe these substances are safer than illicit drugs because they are prescribed by a health care professional and thus are safe to take under any circumstances. NIDA data states that in actuality, prescription drugs act directly or indirectly on the same brain systems affected by illicit drugs, thus, their abuse carries substantial addiction liability and can lead to a variety of other adverse health effects.

c. Prescription Drug Deaths

A 2013 CDC analysis found that drug overdose deaths increased for the eleventh consecutive year in 2010 and prescription drugs, particularly opioid 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 overdose deaths in 2010, involved pharmaceutical drugs, with opioids 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.

A Los Angeles Times series, “Dying For Relief,” highlighted the role of prescription drugs in overdose deaths as determined through the examination of coroners’ reports. Reporters conducted an analysis of coroners’ reports for over 3000 deaths occurring in four counties (Los Angeles, Orange, Ventura and San Diego) where 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; the coroner determined that the drug caused or contributed to the death. The analysis found that in nearly half of the cases where prescription drug toxicity was listed as the cause of death, there was a direct connection to a prescribing physician. The Times created a database linking overdose deaths to the doctors who prescribed drugs, and found that more than 80 of the doctors whose names were listed on prescription bottles found at the home of or on the body of a decedent had been the prescribing physician for 3 or more dead patients. Their analysis found that one doctor was linked to as many as 16 dead patients.

3. Prescription Drug Monitoring Programs (PDMPs) and CURES

With rising levels of prescription drug abuse, PDMPs assist law enforcement and regulatory bodies with their efforts to reduce drug abuse and diversion. Forty-nine states currently have monitoring programs. California has the oldest prescription drug monitoring program in the nation. Of these 50 programs throughout the nation, seven are or will be housed at the state’s Department of Justice, 18 are or will be housed at a state Department of Health or substance abuse agency and 25 are or will be housed at a state Board of Pharmacy or state professional licensing agency. There is widespread interest in sharing data from these programs from state to state. The National Boards of Pharmacy (NABP) currently operates a PDMP, InterConnect, that facilitates the transfer of PDMP data across state lines, providing a more effective means of combating drug diversion and drug abuse nationwide. As of April 2017, forty-one states were participating in InterConnect to exchange prescription data, with several additional states intending to or in the process of signing a memorandum of understanding to share data using InterConnect.

In California, CURES is an electronic tracking program that reports all pharmacy (and specified types of prescriber) dispensing of controlled drugs by drug name, quantity, prescriber, patient, and pharmacy. AB 3042 (Takasugi, Chapter 738, Statutes of 1996) established a three-year pilot program, beginning in July 1997, for the electronic monitoring of prescribing and dispensing of Schedule II controlled substances. Subsequent legislation extended the sunset date on the CURES program until it was made permanent in 2003. In 2009, the online CURES system was launched by DOJ. Subsequent legislation established a funding mechanism to update and maintain CURES, required all prescribing health care practitioners to apply to access CURES information, and established processes and procedures for regulating prescribing licensees through CURES and securing private information. Most recently, SB 482 (Lara, Chapter 708, Statutes of 2016) required health care practitioner to consult the CURES database prior to prescribing a controlled substance to the patient for the first time, with specified exemptions.

Data from CURES is managed by DOJ to assist state law enforcement and regulatory agencies in their efforts to reduce prescription drug diversion. DOJ hires a private contractor to actually manage the information in CURES. CURES provides information that offers the ability to identify if a person is “doctor shopping” (when a prescription-drug addict visits multiple doctors to obtain multiple prescriptions for drugs, or uses multiple pharmacies to obtain prescription drugs). Information tracked in the system contains the patient name, prescriber name, pharmacy name, drug name, amount and dosage, and is available to law enforcement agencies, regulatory bodies and qualified researchers. The system can also report on the top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, pharmacy dispensing data, and is a critical tool for assessing whether multiple prescriptions for the same patient may exist. In addition to the Board, CURES data can be obtained by the MBC, Dental Board of California, Board of Registered Nursing, Osteopathic Medical Board of California and Veterinary Medical Board.

Since 2009, more than 8,000 doctors and pharmacists have signed up to use CURES, which has more than 100 million prescriptions. The system also has been accessed more than 1 million times for patient activity reports and has been key in investigations of doctor shoppers and nefarious physicians. According to the AG’s office, CURES assisted in targeting the top 50 doctor shoppers in the state, who averaged more than 100 doctor and pharmacy visits to collect massive quantities of addictive drugs and the crackdown led to the arrest of dozens of suspects. CURES also provided information on the prescribing history of a Southern California physician accused of writing hundreds of fraudulent prescriptions to feed his patients’ drug addictions, seven of whom died from prescription-drug overdoses. The system has also alerted law enforcement and licensed medical professionals to signs of illegal drug diversions, including a criminal ring that stole the identities of eight doctors, illegally wrote prescriptions, stole the identities of dozens of innocent citizens who they designated as patients in order to fill the fraudulent prescriptions, resulting in the group obtaining more than 11,000 pills of highly addictive drugs like OxyContin and Vicodin. DOJ continues to modernize CURES to more efficiently serve prescribers, pharmacists and entities that may utilize the data. The new CURES 2.0 has been operational since 2016.

4. What This Bill Does

This bill requires that a valid court order or warrant based on probable cause be obtained by a federal, state, or local law enforcement agency in order for DOJ to provide CURES data to the law enforcement agency. This bill also requires that the law enforcement agency seeking the court order or warrant in order to access CURES data be engaged in an open and active investigation regarding prescription drug abuse or diversion of prescription controlled substances. The investigation must involve the person to whom the requested information pertains.

5. Fourth Amendment Issues

a. Challenges to Law Enforcement Access to Prescription Drug Records

Historically, it has largely been assumed that allowing law enforcement agencies access to controlled substance prescription information or data does not violate the Fourth Amendment prohibition on unreasonable searches and seizures. There have been recent challenges to law enforcement agencies’ accessing of prescription records and data. In Oregon Prescription Drug Monitoring Program v. United States DEA (2014) 988 F. Supp. 2d 957, the State of Oregon challenged a DEA claim that the agency could obtain Oregon prescription records with a non-judicial administrative subpoena, not a warrant. Although the Oregon prescription drug monitoring statute includes a requirement that law enforcement agencies obtain a warrant to access information in the database for an investigation, the DEA claimed that a federal law allowed it to access the state’s database using only an administrative subpoena. The court ruled that patients have a reasonable expectation of privacy in their drug prescription records, and that law enforcement must obtain a warrant in order to search such information.^[1]

Other federal courts have reached the opposite conclusion regarding whether the Fourth Amendment requires a law enforcement agency to obtain a warrant prior to obtaining confidential pharmacy or prescription records. The district court in Colorado found that DEA subpoenas of pharmacists’ records met Fourth Amendment requirements and were per se reasonable because they were authorized, properly served, and contained an adequate description of information relevant to the investigations. (U.S. Department of Justice v. Colorado Board of Pharmacy (2010) U.S. Dist. LEXIS 92778 at *10). A district court in Texas extended the rationale of Colorado Board of Pharmacy to physicians and their patients in finding that the DEA’s subpoenas of physician records satisfied Fourth Amendment requirements, in part because physicians and patients have a reduced expectation of privacy in medical records regarding controlled substances given the pervasive regulation of the pharmaceutical industry. (U.S. v. Zandeh (2014) U.S. Dist. LEXIS 181500 at *25).

b. Privacy Concerns

The California Constitution expressly provides for the right of privacy. (Cal. Const. art. I, § 1.). Information contained within CURES is subject to the Confidentiality of Medical Information Act. (Cal. Civ. Code §§ 56 to 56.7.) The Act provides that a health care provider is prohibited from disclosing a patient’s medical information without his or her authorization except in specified circumstances. One such exception exists where a search warrant has been lawfully issued to a governmental law enforcement agency. (Cal. Civ. Code § 56.10(b)(6).)

The issue of whether a physician’s patients have a protected privacy interest in the controlled substance prescription data contained within CURES when the patient’s physician is being investigated by the CMB is currently being litigated. The Second District Court of Appeal held that in balancing the patient’s right to privacy in their controlled substance prescription records against the state’s interest in protecting public health by regulating controlled substance and protecting the public form negligent or incompetent physicians, CURES does not present an impermissible invasion of a patient’s state constitutional right to privacy because sufficient safeguards exist to prevent unwarranted public disclosure and unauthorized access to CURES data. (Lewis v. Superior Court (2014) 226 Cal.App.4th 933.). Oral argument in Lewis v. Superior Court^[2] is scheduled to be heard before the California Supreme Court on May 3, 2017.

6. Requirement to Obtain a Valid Court Order or Warrant

Given that this bill addresses the release of CURES data to law enforcement agencies during the course of an open and active investigation, the members of the committee may wish to consider if these agencies should be required to obtain a warrant rather than the proposed requirement that the law enforcement agency obtain a warrant or a court order. A valid court order that is not a warrant may be appropriate in the context of an investigation involving agencies other than law enforcement agencies. However, this bill only pertains to the release of CURES data to law enforcement agencies.

7. Proposed Amendment

The author intends to add the word “criminal” in front of “investigation” on page 4 line 1.

8. Argument in Support

According to the California Medical Association, the sponsor of the bill:

CURES began as a pilot project in 1996 when the DOJ sought to compare the efficiencies of an automated reporting system for Schedule II controlled substances versus Schedule II triplicate reporting. The bill, AB 3042 (Takasugi), established the general framework for disclosure of information in the database to include “appropriate state, local, and federal persons or public agencies for disciplinary, civil, or criminal purposes.” This framework has remained the same despite significant changes to the database over the years.

Though initially intended only to assist law enforcement and regulatory agencies and include only Schedule II, the system was eventually expanded to allow health care providers to access patient information to inform prescribing decisions, first via fax and then through an internet portal, and also expanded to cover Schedule III and IV substances. Health care practitioners who can prescribe, furnish, order, administer, and dispense controlled substances now pay for the system through licensing fees. Last year, SB 482 (Lara) established a duty to consult CURES requirement for prescribers, thus further transforming CURES into a clinical tool for health care providers.

Though each state’s PDMP has its own unique statutory authority, California’s CURES has some qualities that put it outside standard practice. First, according to the National Alliance for Model State Drug Laws (NAMSDL), California is one of three states which houses its PDMP in a law enforcement entity. The majority are housed in a health department or Board of Pharmacy. Additionally, California is one of the few states that does not specify in the statute the authorized recipients of information from the PDMP. The sensitive and confidential nature of the information in the database requires a thoughtful approach that balances California’s longstanding policy of protecting patient privacy while also weighing the needs of the many different types of entities who may use CURES data, including for public health and safety purposes. The explicit delineation of privacy and access to the information is a best practice that California has yet to implement and which, given that a law enforcement entity oversees the database, increases the desirability of such clarity.

Model legislation…are crafted to include a specific articulation of entities to whom PDMP data may be provided. In its “Components of a Strong Prescription Monitoring Program,” NAMSDL states that “direct access to the [PDMP] database should be limited to prescribers, dispensers, and their designees, and any other individual or official who may require direct access for the purpose of patient safety, such as a representative of a drug and alcohol addiction treatment program.” The construct established in SB 641 aligns with that recommendation.

Under the Confidentiality of Medical Information Act, absent a warrant, law enforcement generally do not have the authority to access a patient’s medical record without patient authorization. Thus the existing CURES statutory construct subjects, without the imprimatur of legislative authority, different privacy standards for medical records and the same information in the CURES database. SB 641 seeks to better align these standards for the CURES database, while recognizing the multiple intended functions of the database.

California has a longstanding history of protecting patient and consumer privacy. It should maintain that standard for the millions of patient records that are housed in the CURES database.

9. Argument in Opposition

According to the California Narcotics Officers Association, Consumer Attorneys of California, California Teamsters Public Affairs Council, Consumer Watchdog, and Shatterproof:

While we understand requiring a warrant to examine a patient’s activity report (patients have an expectation of privacy in their medical and prescribing information); we believe that requiring a warrant for over prescribers is a step too far. Doctors have no expectation of privacy in oversight of their professional activities. Nothing justifies this special protection. A warrant requirement on a doctor’s prescribing history places an unnecessary hurdle on effective law enforcement investigations into over prescribing.

SB 641 would require a very specific warrant before law enforcement can access a doctor’s prescribing information.

As amended, SB 641 would severely limit law enforcement’s access to CURES data by requiring the Department of Justice to only provide data obtained from CURES “to a federal, state, or local law enforcement agency pursuant to a valid court order or warrant based on probable cause and issued at the request of a federal, state, or local law enforcement agency engaged in an open and active investigation regarding prescription drug abuse or diversion of prescription of controlled substances involving the individual to whom the requested information pertains.” (Section 11165 (c)(2)(B)). This is an incredibly narrow warrant requirement.

The narrow warrant requirement would hamper law enforcement’s ability to identify and stop criminal activities, such as pill mills run by doctors who sell prescriptions for cash. The activity we are talking about is criminal. SB 641 will harm both patients who obtain prescriptions from these doctors and the safety of our communities if physicians are allowed to continue selling drugs unchecked. Public safety officials are making great strides in the attempt to address the opioid overdose crisis in California, and restricting use of this key tool will set those efforts back. Regulatory boards will also lose an important source of information as they often find out about this kind of illegal activity only once law enforcement has taken action.

We remain concerned that the bill would limit law enforcement from identifying and effectively stopping over prescribing doctors.

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1. This case is currently pending appeal in the U.S. Court of Appeals for the Ninth Circuit. ↑

2. http://appellatecases.courtinfo.ca.gov/search/case/dockets.cfm?dist=0&doc_id=2081730&doc_no=S219811 ↑