BILL ANALYSIS Ó SB 464 Page 1 Date of Hearing: June 30, 2015 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Susan Bonilla, Chair SB 464(Hernandez) - As Amended May 22, 2015 SENATE VOTE: 27-2 SUBJECT: Healing arts: self-reporting tools. SUMMARY: Authorizes a physician, a registered nurse (RN), a certified nurse-midwife (CNM), a nurse practitioner (NP), a physician assistant (PA), or a pharmacist, in accordance with existing law for each practitioner, to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. EXISTING LAW: 1)Defines "dangerous drug" or "dangerous device" as any drug or device unsafe for self-use in humans or animals, and includes the following: (Business and Professions Code (BPC) § 4022) a) Any drug that bears the legend: "Caution: federal law prohibits dispensing without prescription," "Rx only," or words of similar import. b) Any device that bears the statement: "Caution: federal SB 464 Page 2 law restricts this device to sale by or on the order of a ____," "Rx only," or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device. c) Any other drug or device that by federal or state law can be lawfully dispensed only on prescription or furnished pursuant to BPC § 4006. 2)Makes it unprofessional conduct for a physician and surgeon to prescribe, dispense, or furnish dangerous drugs without an appropriate prior examination and medical indication, with exceptions. (BPC § 2242) 3)Makes it unlawful for a person or entity to prescribe, dispense, or furnish, or cause to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices, as defined in BPC § 4022, on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as authorized by BPC § 2242. (BPC § 2242.1) 4)Authorizes a registered nurse (RN) to dispense self-administered hormonal contraceptives, as specified. The RN must follow standardized procedures and protocols (SPPs), including demonstrating competency in providing the appropriate prior examination comprised of checking blood pressure, weight, patient history and medication taken, and family health history. 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 (US MEC) for Contraceptive Use. (BPC § 2725.2) 5)Authorizes a certified nurse-midwife (CNM) to furnish or order SB 464 Page 3 drugs or devices, including controlled substance in accordance with SPPs, as specified. (BPC § 2746.51) 6)Authorizes a nurse practitioner (NP) to furnish or order drugs or devices, including controlled substance in accordance with SPPs, as specified. (BPC § 2836.1) 7)Authorizes a physician assistant (PA) to administer or provide medication to a patient or to transmit a drug order in accordance with the PA's delegated services agreement (DSA), as specified. (BPC § 3502.1) 8)Authorizes a pharmacist to furnish self-administered hormonal contraceptives in accordance with SPPs. The SPPS must require a patient to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives, based on the current US MEC for Contraceptive Use developed by the CDC. (BPC § 4052.3) 9)Defines "telehealth" as the mode of delivering health care services and 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. States that telehealth facilitates patient self-management and caregiver support for patients and includes real-time interactions and the transmission of patient medical information. (BPC § 2290.5(a)(6)) 10)Requires a health care provider initiating the use of telehealth to inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the SB 464 Page 4 use of telehealth as an acceptable mode of delivering health care services and public health. The consent must be documented. (BPC § 2290.5(b)) THIS BILL: 11)Authorizes six types of healing arts licensees to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. 12)Authorizes the patient to self-report blood pressure, weight, height, and patient health history with the self-screening tool that identifies patient risk factors. 13)This bill includes the following licensees: a) Physician and surgeons; b) RNs acting in accordance with BPC § 2725.2; c) CNMs acting within the scope of BPC § 2746.51; d) NPs acting within the scope of BPC § 2836.1; e) PAs acting within the scope of BPC § 3502.1; and, f) Pharmacists acting within the scope of BPC § 4052.3. SB 464 Page 5 FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel. COMMENTS: Purpose. This bill is sponsored by Planned Parenthood Affiliates of California . According to the author, "In California, about half of all pregnancies are unintended. Women with unintended pregnancies are less likely to receive prenatal care, and health outcomes are worse for both mother and baby. According to a 2015 study by the Guttmacher Institute, the annual public cost of unintended pregnancies in California is more than $1.75 billion. Hormonal contraception has been proven safe and effective at preventing pregnancy, and the American College of Obstetricians and Gynecologists recently recommended that women should self-screen for contraindications using checklists to increase their access to hormonal contraceptives. Existing law is not clear as to whether self-screening tools can be used to transmit relevant medical and family history information from a patient to her provider for the purposes of accessing hormonal contraception. Enabling the use of self-screening tools will allow health care providers to make greater use of existing and developing technology, and will increase access to oral contraception for all women." Background. Existing law allows the six healing arts licensees included in this bill to provide self-administered hormonal contraceptives to patients through varying mechanisms: 1)Physicians are required to perform an appropriate prior examination. 2)PAs must be authorized by a supervising physician through a DSA and perform an appropriate prior examination. SB 464 Page 6 3)The NPs, CNMs, and RNs must follow SPPs developed with a supervising physician and perform an appropriate prior examination. 4)Pharmacists must follow SPPs developed with an authorized prescriber, which require a patient to use a self-screening tool to screen for counter-indications, and must refer the patient to a primary care provider or clinic after denial or provision of the drug. Every provider besides a pharmacist is required to perform an appropriate prior exam. However, existing law does not specifically define an appropriate prior exam. According to the Medical Board of California (MBC), a physician has complete authority to determine what type of prior exam would be appropriate, so long as the exam fits the standard of care for the patient. The standard of care is an objective test used to determine the quality of the services a physician is expected to provide. According to the 2013 MBC Expert Reviewer Guidelines, the standard of care means "the level of skill, knowledge and care in diagnosis and treatment ordinarily possessed and exercised by another reasonably careful and prudent physician in the same or similar circumstances." The standard is objective because it takes into account current, medically-acceptable behavior, not an individual physician's subjective opinion. Therefore, an appropriate exam is what would be considered acceptable for the particular patient, based on current evidence and practices. As a result, under existing law, a physician could determine that, given the patient's prior medical history and situation, an appropriate prior examination would be to require a patient to fill out a questionnaire, if similarly SB 464 Page 7 situated physicians would do the same. Other possible appropriate prior exams could range from blood pressure checks to full physical exams, depending on what the physician believed was needed to ensure the patient's medical need, safety, and the efficacy of the drug. Prior Exams by Non-Physicians. An appropriate prior examination differs for PAs and nurses because they must follow written guidelines developed with a supervising physician or entity. The guidelines will be based on the standard of care for varying types of patients and situations. For PAs, the written guidelines are called DSAs, which include a formulary. For nurses, they are called SPPs. Because PAs and nurses must follow the guidelines, they are limited to a prior examination that adheres to the guidelines. PAs, CNMs, and NPs and the supervising physician have broad discretion in determining drug prescribing guidelines. RNs, however, have specific requirements for the prior examination for providing hormonal contraceptives. For instance, the SPPs must require RNs to demonstrate 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. While the SPP must require that RNs demonstrates "competency" in providing an appropriate prior exam that consists of checking various patient health measures, the actual type of prior exam that is appropriate is not defined. Existing law only specifies that an appropriate prior examination must be consistent with the evidence-based practice guidelines adopted by the CDC in conjunction with the US MEC. The CDC's US MEC is a set of recommendations on who can safely use contraceptives (essentially a list of risk factors). It is SB 464 Page 8 unclear which evidence-based practice guidelines the language refers to, but it may refer to the US MEC companion document adopted by the CDC, the U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), which is discussed in the next section. Finally, pharmacists (besides advanced practice pharmacists) are different from the other providers because their scope of practice does not ordinarily permit them to perform an appropriate prior exam to the same extent as the other practitioners. Instead, existing law requires them to operate under SPPs that require them to use a self-screening tool that is consistent with the CDC's US MEC. Self-Screening Tools. The sponsors argue that it is not clear that a provider may have a patient self-report data using a self-screening tool to provide self-administered hormonal contraception. Therefore, this bill aims to clarify that a provider may do so. Existing law does not define "self-screening tool." However, according to the federal National Institutes of Health (NIH), screenings are medical tests that look for indications or risk factors for a particular condition. A self-screening tool would be a tool that a patient uses to alert a provider of those conditions. For instance, filling out a medical history form could be a type of self-screening tool. For contraceptives, the screening tool would identify risk factors in a patient that would suggest which contraceptives may not be safe for the patient to take. That is why pharmacists are required to use a self-screening tool instead of performing an appropriate prior exam. Pharmacists ask the patient to use a screening tool in order to screen the patient for the risk factors identified in the US MEC for a particular form of SB 464 Page 9 contraception. For physicians, nurses, and PAs, the standard of care for self-administered hormonal contraceptives could allow for a self-screening tool. For example, according to the CDC's US SPR (noted above), the companion document to the US MEC, some forms of hormonal contraceptives need minimal or no initial examinations. The US SPR is a set of evidence-based practice recommendations on how a provider should use the US MEC risk factors. The CDC adapted both documents for U.S. practices from the recommendations of the World Health Organization (WHO). According to the US SPR recommendations, self-administered hormonal contraceptives are generally safe and effective and require minimal examinations. The only recommended initial examination for combined hormonal contraceptives is a blood pressure test. However, women with limited access to healthcare can take the measure in a nonclinical setting (such as a pharmacy) and self-report the data to a provider. For progestin-only pills, there are no initial exams that would make taking the pill safer or more effective. For all contraceptives, body weight is never needed for an initial prescription. Therefore, the standard of care for starting hormonal oral contraceptives requires very little examination and testing. As a result, existing law could allow a physician to determine that an appropriate prior examination for a combined oral contraceptive prescription is a self-screening tool that reported blood pressure data from the patient to the physician. Further, existing law already requires RN SPPs to be consistent with the evidence-based practice guidelines adopted by the CDC in conjunction with the US MEC, which may be the CDC's US SPR. SB 464 Page 10 If so, a set of RN SPPs could potentially allow a RN provide progestin-only pills after a brief phone consultation without taking any measurements, where the consultation is considered the prior examination. The defining factors are the standard of care (US MEC) and the adequacy of the screening tool as a prior examination, which this bill does not address. Internet and Phone Applications for Self-Reporting. According to the sponsors, this bill will allow providers to prescribe self-administered hormonal contraceptives through phone and internet applications (mobile apps) that are used as self-screening tools. However, because self-reporting through self-screening tools is already permitted, there is currently no prohibition against the use of a mobile app for that purpose. Existing law allows internet prescribing for direct delivery after an appropriate examination and medical indication. It also permits the use of telehealth after written consent. The reason for the explicit requirement for internet prescribing, which is duplicative of the regular prescription requirements, is due to the fear of online pharmacies illegally providing dangerous drugs to patients without medical need. In 2004, the MBC issued an action report that stated, "Internet prescribing is illegal when a legitimate physician-patient relationship does not exist. Some physicians have attempted to legitimize their Internet prescribing by engaging in the review of questionnaires, which Internet users will complete, although there is no way to confirm the patient is reporting accurate or truthful information." "In-person examinations not only enhance the opportunity to confirm if a patient needs the identified medication or to rule out other medical conditions, but ensures the patient is advised of alternative treatment options and is aware of potential side effects. For some patients, certain drugs are contraindicated and serious injury, including death, can follow." SB 464 Page 11 However, at the time, the MBC cited drugs like Vicodin and Viagra being sold at discounted prices without a doctor-patient relationship. However, drugs like Vicodin are prone to abuse and additional screening is important in those situations (see DEA Schedule II-III categorization). In addition, drugs like Viagra have many risk factors and are counter-indicated for many medications. On the other hand, the efficacy for hormonal contraceptives is well-known and accepted, and the risk factors are minimal. Therefore, the standard of care would require a more stringent prior exam for a scheduled drug like Vicodin than it would for hormonal contraceptives. While in-person examinations would be useful in many situations, the law does not require it. Further, technology and internet security have progressed in the eleven years since the MBC report. Therefore, internet prescribing and the use of mobile applications as a self-screening tool are already allowed if the appropriate prior examination was performed. Other States. Oregon H 2879, of this legislative session, would permit pharmacists to prescribe hormonal contraceptive patches and self-administered oral hormonal contraceptives. Prior Related Legislation. SB 493 (Hernandez), Chapter 469, Statutes of 2013, among other things, authorized a pharmacist to furnish self-administered hormonal contraception in accordance with SPPs that require the patient to use a self-screening tool to identify patient risk factors for the contraceptives. ARGUMENTS IN SUPPORT: SB 464 Page 12 Planned Parenthood Affiliates of California (sponsors) write in support, "[this bill] 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 Union of American Physicians and Dentists writes in opposition, "[this bill] provides for no "prescribing" safeguards, and disperses oversight across several State Boards. State lawmakers have an obligation to enact legislation, which places patient safety as a number one priority." POLICY ISSUE FOR CONSIDERATION: Because the use of a self-screening tool for the purposes of providing contraceptives is already permitted, the Committee may wish to consider the necessity of this bill. REGISTERED SUPPORT: Planned Parenthood Affiliates of California (sponsor) California Primary Care Association California Women's Law Center SB 464 Page 13 Icebreaker Health Planned Parenthood Los Angeles Planned Parenthood Mar Monte Planned Parenthood Northern California Planned Parenthood Orange and San Bernardino Counties Planned Parenthood Pasadena and San Gabriel Valley Planned Parenthood Santa Barbara, Ventura, & San Luis Obispo Counties Five MDs REGISTERED OPPOSITION: Union of American Physicians and Dentists Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301 SB 464 Page 14