BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 464| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- UNFINISHED BUSINESS Bill No: SB 464 Author: Hernandez (D) Amended: 5/22/15 Vote: 21 PRIOR SENATE VOTES NOT RELEVANT SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 8/27/15 (pursuant to Senate Rule 29.10) AYES: Hill, Berryhill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski NO VOTE RECORDED: Bates ASSEMBLY FLOOR: 73-1, 8/20/15 - See last page for vote SUBJECT: Healing arts: self-reporting tools SOURCE: Planned Parenthood Affiliates of California DIGEST: This bill permits a physician, registered nurse (RN), certified nurse-midwife (CNM), nurse practitioner (NP), physician assistant (PA), and pharmacist to use a self-screening tool to aid the prescription of self-administered hormonal contraceptives. Assembly Amendments delete the contents of the bill and replace it with the current version. ANALYSIS: Existing law: 1)Prohibits a person or entity from prescribing, dispensing, or furnishing, or causing to be prescribed, dispensed, or SB 464 Page 2 furnished, dangerous drugs or dangerous devices on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as specified. (BPC § 2242.1) 2)Authorizes a RN to dispense a self-administered hormonal contraceptive (SAHC) in accordance with standardized procedures, which shall include demonstration of competency in providing the appropriate prior examination comprised of checking blood pressure, weight, and patient and family health history, including medications taken by the patient. The appropriate prior examination shall be consistent with the evidence-based practice guidelines adopted by the federal Centers for Disease Control and Prevention (CDC) in conjunction with the United States Medical Eligibility Criteria for Contraceptive Use (USMEC). (BPC § 2725.2) 3)Authorizes a pharmacist to furnish SAHC in accordance with standardized procedures developed and approved by both the Board of Pharmacy (BOP) and the Medical Board of California (MBC) in consultation with other entities, as specified, and requires that the protocol mandate the use of a patient self-screening tool to identify risk factors for the use of SAHC, based on current USMEC developed by the federal CDC. (BPC § 4052.3) This bill: 1)Authorizes a physician, RN, CNM, NP, PA, and pharmacist to use a self-screening tool that will identify patient risk factors for the use of SAHC by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, SAHC to the patient. 2)Permits blood pressure, weight, height, and patient health history to be self-reported using the self-screening tool. Background Telehealth and Self-Screening Tools. Current law defines telehealth as "the mode of delivering health care services and SB 464 Page 3 public health via information and communication technologies to facilitate the diagnosis, consultation, treatment, education, care management, and self-management of a patient's health care while the patient is at the originating site and the health care provider is at a distant site." Telehealth is neither a distinct technology nor a type of care; it is the remote provision of healthcare services according to the same professional standards governing in-person care. Telehealth may be facilitated by many mediums, including telephone, videoconferencing, store-and-forward technology, and increasingly, by mobile devices connected to the Internet. A self-screening tool is not defined in law; it is any instrument by which an individual reports health information. BOP is developing a paper checklist as its self-screening tool, and there exist mobile apps that record consumers' answers in response to online prompts that are also considered self-screening tools. Requirements for Prescribing SAHC. Current law authorizes a physician, RN, CNM, NP, PA, or a pharmacist to prescribe, furnish, or dispense SAHC. However, current laws and regulations are not specific as to the exact protocols required for each licensee to provide SAHC to patients. Physician: An appropriate prior examination is mandated by law prior to a physician prescribing a SAHC. However, an in-person examination is not required and a physician is expected to use his or her professional judgment in determining the appropriate standard of care for each patient. RN, CNM, NP, PA: These licensees are required to furnish or dispense SAHC pursuant to standardized procedures, which are the legal mechanism for non-physicians to perform functions which would otherwise be considered the practice of medicine, including prescribing drugs. Standardized procedures are policies and protocols developed by a health facility or organized health care system, with input from administrators and health professionals, which establish parameters for medical care. These licensees are also required to conduct an appropriate prior examination before dispensing or furnishing SB 464 Page 4 SAHC on the Internet for delivery to any person in this state, but what constitutes an appropriate prior examination is undefined. As part of their standardized procedures for dispensing SAHC, RNs are required to demonstrate competency in providing an appropriate prior examination, which is comprised of checking blood pressure, weight, and collecting patient and family health history. Current law further states that the appropriate prior examination by a RN shall be consistent with the evidence-based practice guidelines adopted by the CDC. The CDC recommended in their June 14, 2013 Morbidity and Mortality Weekly Report that, "among healthy women, few examinations or tests are needed before initiation of combined hormonal contraceptives." They recommend that blood pressure be measured and that weight and body mass may be useful for monitoring SAHC use over time. However, nothing in the CDC recommendation states that a RN must measure blood pressure and weight for each patient prior to furnishing SAHC, and it is reasonable to infer that an accurate self-reporting of the same information would yield the necessary information. Pharmacist: Pharmacists may furnish SAHC in accordance with standardized procedures developed and approved by the BOP and MBC. These standardized procedures have not yet been adopted, but the law states they must include a patient self-screening tool to identify risk factors based on the same CDC guidelines as required by RN protocols. The initial regulations formalizing the standardized procedures approved by the MBC and BOP required that the pharmacist also measure a patient's seated blood pressure, in addition to the information collected by the self-screening tool. However, at the July 29, 2015 BOP meeting, the BOP voted to modify the protocol so that a pharmacist may accept self-reported blood pressure at his or her discretion. This modification must now be approved by the MBC. This bill acknowledges the need for patient health information, including blood pressure and weight, to appropriately recommend a SAHC, but permits practitioners to rely on information provided by the patient, rather than measured by the practitioner. SB 464 Page 5 Self-Reported Health Metrics and Safety of SAHC. Accepting self-reported medical information for SAHC is supported by numerous medical reports and journals because of the nature of the drugs themselves, effective self-screening, and the greater risks of unintended pregnancies. For example, the American College of Obstetricians and Gynecologists (ACOG) advocated for over-the-counter availability of SAHCs in 2014, noting that the primary risk associated with SAHC, venous thromboembolism (blood clots) is "extremely low," and that women can self-screen for contraindications. Further, the risk of blood clots due to SAHC is lower than the same risk of clotting in pregnancy. A 2014 article in the American Journal of Obstetrics and Gynecology reported on a study indicating that on average, there is a low prevalence of medical contraindications in women of reproductive age overall, so there is a very small portion of the population for whom information on a self-screening tool is truly vital. This bill aims to clarify that existing and potential telehealth providers operate in accordance with current law by stating that practitioners who are currently authorized to provide SAHC may do so by relying on self-reported health information. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: No According to the Assembly Appropriations analysis, this bill will have negligible costs to affected professional licensing boards within the Department of Consumer Affairs. SUPPORT: (Verified8/27/15) Planned Parenthood Affiliates of California (source) California Medical Association California Primary Care Association SB 464 Page 6 Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties Icebreaker Health NARAL Pro-Choice California Planned Parenthood Action Fund of Santa Barbara, Ventura and San Luis Obispo Counties Planned Parenthood Action Fund of the Pacific Southwest Planned Parenthood Advocacy Project Los Angeles County Planned Parenthood Mar Monte Planned Parenthood Northern California Action Fund Planned Parenthood Pasadena and San Gabriel Valley Numerous individuals. OPPOSITION: (Verified8/27/15) California Catholic Conference California Nurses Association California Right to Life Committee, Inc. ARGUMENTS IN SUPPORT: "Planned Parenthood supports efforts to better serve our patients through the development and expansion of telehealth services. Telehealth is a safe, effective delivery system that expands access to health care for people who otherwise would have to travel a long distance to see a provider. "SB 464 seeks to help improve preventive health services by increasing access to services in rural communities through the utilization of telemedicine by allowing patients to provide information to a health provider through a self-screening tool, including family history, blood pressure, or weight. As technology advances, telehealth will include models where patients communicate directly with a distant provider and are not physically present in a provider's office." ARGUMENTS IN OPPOSITION:The California Catholic Conference writes in opposition, "Young girls, and other minors under the age of 18, would be able to receive contraceptives ? without an actual medical exam and without the consent of their parent(s) or guardian(s). Further, without any oversight, these dangerous SB 464 Page 7 drugs could easily get into the wrong hands of human traffickers or the hands of young people." ASSEMBLY FLOOR: 73-1, 8/20/15 AYES: Achadjian, Alejo, Baker, Bigelow, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Weber, Wilk, Williams, Wood, Atkins NOES: Gallagher NO VOTE RECORDED: Travis Allen, Brough, Chu, Harper, Patterson, Waldron Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104, Sarah Huchel / B., P. & E.D. / (916) 651-4104 8/28/15 15:24:23 **** END ****