BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:June 23, 2014 |Bill No:AB | | |1841 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Ted W. Lieu, Chair Bill No: AB 1841Author:Mullin As Amended: June 2, 2014Fiscal: No SUBJECT: Medical assistants. SUMMARY: Authorizes a medical assistant to hand out properly labeled and prepackaged prescription drugs to patients as part of their existing authorization to provide "technical supportive services." Existing law: 1)Establishes the Medical Practice Act (Act) which licenses and regulates physicians and surgeons as well as regulating medical assistants (MAs) by the Medical Board of California (MBC) within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 2000 et seq.) 2)Defines a MA as a person who may be unlicensed, who performs basic administrative, clerical, and technical supportive services, as specified, for a licensed physician and surgeon or a licensed podiatrist, a physician or podiatrist group, a medical or podiatry corporation, a physician assistant, a nurse practitioner, a certified nurse-midwife or for a health care service plan. (BPC § 2069 (b) (1)) 3)Requires a MA to be at least 18 years of age and have at least the minimum amount of hours of appropriate training pursuant to standards established MBC, and further requires a MA to have a certificate by the training institution or instructor indicating satisfactory completion of the required training, and for each employer to retain a copy of this certificate. (BPC § 2069 (b) (1)) AB 1841 Page 2 4)Authorizes a MA to administer medication only by intradermal, subcutaneous, or intramuscular injections and perform skin tests and additional technical supportive services upon the specific authorization and supervision of a licensed physician and surgeon or podiatrist. A MA may also perform all these tasks and services upon the specific authorization of a physician assistant, nurse practitioner, or certified nurse-midwife. (BPC § 2069 (a) (1)) 5)Permits a supervising physician and surgeon to provide written instructions to be followed by a MA in performing tasks or supportive services. The written instructions may delegate the supervision of the MA in performing the tasks or services to a nurse practitioner, certified nurse-midwife, or physician assistant within the standardized procedures or protocols. (BPC § 2069 (a) (2) 6)Defines "technical supportive services" as simple routine medical tasks and procedures that may be safely performed by a MA who has limited training and who functions under the supervision of a licensed physician and surgeon, podiatrist, physician assistant, nurse practitioner or a certified nurse-midwife, as specified. (BPC § 2069 (b) (4)) 7)Permits a MA to perform venipuncture or skin puncture for the purposes of withdrawing blood upon specific authorization and supervision of a licensed physician and surgeon, podiatrist, physician assistant, nurse practitioner or nurse-midwife if the MA has met minimum training requirements established by MBC. (BPC § 2070) 8)Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy (BOP) within the DCA. 9)Governs the prescribing, dispensing, or furnishing of dangerous drugs by prescribers, defined to include a physician and surgeon, podiatrist and certified nurse-midwife, as specified. (BPC § 4170). 10)Authorizes a pharmacy to employ a non-licensed person to type a prescription label or otherwise enter prescription information into a computer record system, but the responsibility for the accuracy of the prescription information and the prescription as dispensed lies with the registered pharmacist who initials the prescription or prescription record. At the direction of the registered pharmacist, a non-licensed person may also request and receive refill AB 1841 Page 3 authorization. (California Code of Regulations, Title 16, Division 17, Article 11, Section 1793.3 (a)) 11)Authorizes a licensed nonprofit community clinic or free clinic, a county owned or operated primary care clinic, a clinic operated by a federally recognized Indian tribe or tribal organization, a clinic operated by primary care community or free clinic, a student health center, a nonprofit multispecialty clinic, as specified, to be licensed by the BOP to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic, as specified. (BPC § 4180) 12)Authorizes a surgical clinic, as specified, to be licensed by the BOP to purchase drugs to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic, as specified. (BPC § 4190) This bill: 1)Expands the definition of "technical supportive services" carried out by a MA in a clinic described in Items 11 and 12 above, other than a facility operated by the state, to include the following: a) Handing a patient a properly labeled and prepackaged prescription drug, excluding a controlled substance, ordered by a licensed physician and surgeon, podiatrist, physician assistant, nurse practitioner or certified nurse-midwife, as specified. b) Requires that prior to a MA handing the medication to a patient, a licensed physician and surgeon, podiatrist, physician assistant, nurse practitioner, or certified nurse-midwife shall verify that the medication and dosage for that specific patient is correct, that the patient's name is affixed to the package and shall provide the appropriate patient consultation regarding the use of the drug. FISCAL EFFECT: This bill has been keyed "non-fiscal" by Legislative Counsel. COMMENTS: 1.Purpose. This bill is sponsored by Planned Parenthood Affiliates of AB 1841 Page 4 California to increase patient access to care by specifying medical assistants' ability to include handing to a patient medication that has already been packaged and labeled by the dispensing provider. This authority is limited to facilities that are licensed by the State Board of Pharmacy, excluding those operated by the state. The bill also excludes controlled substances, and requires the medication be properly labeled by the ordering provider who has appropriately counseled the patient on the medication. 2.Background. According to the Author, "Medical Assistants are currently allowed to provide a range of supportive and medical services like administer medication (including narcotics) orally, topically, or through injection; perform skin tests; apply bandages, remove casts and stitches, perform simple lab/ screening tests; and perform technical supportive services upon training and authorization of a licensed physician and surgeon. MAs cannot dispense and are not allowed to hand over medication of any kind to patients." The Author further states that current practice in community health centers relies on the use of MAs to support physicians and clinicians (nurse practitioners, certified nurse-midwives, and physician assistants). Since MAs are not permitted to hand medication to a patient, that administrative task must be done by the physician or clinician, taking their time away from seeing more patients and focusing on the care they have been trained to provide. The Author states, "After examining a patient, diagnosing them, discussing options and providing education on any recommended medication, the clinician must go back to the locked pharmacy closet to select, package and label the appropriate medication and then returns to the patient exam room to physically hand the patient the medication. This bill would allow a MA to take the medication, after it has been pulled, packaged, and labeled, and physically hand it to the patient." The Author indicates that although this takes only several minutes for each patient, it adds up significantly over time ultimately limiting patient access. "This minor increase in MAs ability to hand over medication will free up other providers to see additional patients. More fully utilizing the abilities of [MAs] will increase efficiency in health facilities like community health centers and by seeing more patients, health facilities will be able to reduce waiting times and expand patient access to care. With millions of Californians newly enrolled in health care coverage under the ACA [Affordable Care Act] and millions more eligible for AB 1841 Page 5 coverage, expanding access to care is essential to ensuring that these individuals have meaningful coverage. California needs to utilize all health care professionals and those that assist them to the fullest extent of their abilities and potential to increase access, improving our health care delivery system to better serve the newly enrolled population and providing coverage for the remaining uninsured." 3.Medical Assistants. MAs are unlicensed, but certificated, individuals. MAs must have a high school diploma or GED equivalent and take a certificate course at an approved school. Prior to performing technical supportive services, a medical assistant must receive training, as necessary, and it is the responsibility of the supervising physician, podiatrist or instructor to assure the MA's competence in performing that service at the appropriate standard of care. The MBC regulations establish the requirements which allow certifying organizations to certify medical assistants. According to the MBC, the training may be administered under a licensed physician, podiatrist, registered nurse, licensed vocational nurse, physician assistant or qualified medical assistant, or in a secondary, post-secondary, or adult education program in a public school authorized by the Department of Education, in a community college program, or a post-secondary institution accredited or approved by the Bureau for Private Postsecondary Education. To administer medications by intramuscular, subcutaneous and intradermal injections, perform skin tests, perform venipuncture or skin puncture to withdraw blood, a MA must complete specified training prescribed by the MBC regulations. MA's may perform specific functions as part of "technical supportive" services in addition to administrative functions, including: a) Administer medications orally, sublingually, topically, vaginally or rectally, or by providing a single dose to a patient for immediate self-administration; b) Administer medication by inhalation; c) Perform electrocardiogram, electroencephalogram, or plethysmography tests; d) Apply and remove bandages and dressings; e) Remove sutures or staples from superficial incisions or AB 1841 Page 6 lacerations; f) Collect by non-invasive techniques and preserve specimens for testing, including urine, sputum, semen and stool; g) Prepare patients for and assist the physician, podiatrist, physician assistant or registered nurse in examinations or procedures including positioning, draping, shaving and disinfecting treatment sites, and prepare a patient for gait analysis testing; h) As authorized by the physician or podiatrist, provide patient information and instructions; i) Collect and record patient data including height, weight, temperature, pulse, respiration rate and blood pressure, and basic information about the presenting and previous conditions; j) Perform simple laboratory and screening tests customarily performed in a medical office. This bill clarifies that MAs may hand out properly labeled and prepackaged prescription drugs to patients as part of "technical supportive services" in specified types of clinics. Based upon currently authorized abilities, this appears to be well within a MA's scope of practice. 4.Related Legislation. SB 352 (Pavley, Chapter 352, Statutes of 2013) authorized MAs to perform technical supportive services in any medical setting upon specific authorization of a physician assistant, nurse practitioner, or certified nurse-midwife without a physician on the premises. This bill removed the requirement that a MA be supervised by a physician assistant, nurse practitioner, or certified nurse-midwife only in specified community clinics. SB 1852 (Alpert, 2000) would have allowed MAs to perform specified tasks and services which they were only permitted to perform upon the specific authorization and under the direct supervision of a physician or podiatrist upon the specific authorization of a physician's assistant, a nurse practitioner or a nurse-midwife in a licensed clinic, as specified, that is enrolled as a Medi-Cal provider in the Family Planning, Access, Care, and Treatment Waiver Program. ( Status : SB 1852 died in Assembly Health Committee.) SB 252 (Alpert, Chapter 234, Statutes of 2003) specified that MAs are not authorized to perform a clinical laboratory test or examination AB 1841 Page 7 and does not authorize a nurse practitioner, nurse-midwife or physician assistant to be a laboratory director of a clinical laboratory. ( Note : This bill originally included a provision for MAs to provide technical supportive services under the supervision of a physician assistant, nurse practitioner or nurse midwife, but those provisions were removed from the bill in response to opposition.) SB 111 (Alpert, Chapter 358, Statues of 2001) authorized a medical assistant to perform specified services in community and free clinics under the supervision of a physician assistant, nurse practitioner or nurse-midwife. This bill authorized a physician and surgeon in these specified clinics to provide written instructions for MAs, regarding the performance of tasks or duties, while under the supervision of a physician assistant, nurse practitioner or nurse midwife when the supervising physician and surgeon was not on site. 5.Arguments in Support. In sponsoring the bill, Planned Parenthood Affiliates of California writes that this minor expansion of MA duties will increase access to care in health care settings, including Planned Parenthood, by reducing waiting times caused, in part, by clinicians who must package the medications and then themselves hand it to the patient. "Authorizing MAs to hand over pre-packaged/pre-labeled medication is consistent with (if not less complicated than) the level and complexity and range of medical and technical support services they are already authorized to perform, including administering narcotics and giving injections." Finally, Planned Parenthood argues that authorizing MAs to hand over medication frees up the clinician from this administrative duty and allows them to see more patients and spend more time with each patient answering questions. Medical Board of California (MBC) believes the bill will help further the Board's mission of increasing access to care, and writes in support that allowing MAs to hand over properly labeled, pre-packaged medication is a minor increase in the MAs duties, and one that does not compromise consumer protection, since the physician would have to label the medication for the patient, package the medication, and provide the appropriate consultation. California Association for Nurse Practitioners (CANP) states that with millions of Californians entering the health care system due to ACA implementation, healthcare providers' ability to deliver care as efficiently as possible is essential to meet the often pent-up AB 1841 Page 8 demand for services of these newly eligible individuals. The already strained delivery system is experiencing increased pressure, particularly in underserved areas, where NPs play a critical role in providing care. AB 1841 will assist with this problem by allowing medical assistants to furnish patients with pre-labeled, pre-packaged medication, only after the medication has been selected and packaged by a physician or advanced practice clinician, such as an NP. This will allow primary care practitioners, including NPs, to dedicate more time to providing patient care. The Association of California Healthcare Districts (ACHD) states that millions of Californians rely on public health facilities and programs for vital health care services. Additionally, many of our Community Based Healthcare Districts specialize in promoting community health care, focusing on prevention, food access, and disease management. In many parts of California, Healthcare Districts act as the sole provider of health care services in their communities. ACHD states: "As more Californians are now eligible for care, it is important that health care staff is utilized efficiently to accommodate patients as they seek care and medical services. AB 1841 creates greater staffing efficiency by utilizing medical assistants to assist with handing patients a pre-packaged and pre-authorized prescription. By allowing medical assistants to assist in this responsibility, doctors, nurses and other medical staff can focus on other patient needs" 6.Oppose Unless Amended. California Society of Health-System Pharmacists (CSHP) opposes this bill unless it is amended, stating, "we support the intent of the bill to reduce waiting times, expand access, and improve patient care and satisfaction in community clinics, and we appreciate the recent amendments to specify patient education, we are still concerned by the language, especially as it lacks recognition of pharmacists as providers in community clinics." CSHP indicates that with the passage of SB 493 (Hernandez, Chapter 469, Statutes of 2013) pharmacists are recognized as providers and may offer certain services that are often provided telephonically and collaboratively with physicians in clinic settings. CSHP has indicated a willingness to work with the Author in his efforts to expand access and improve patient care. 7.Arguments in Opposition. California Right to Life Committee, Inc. argues that allowing unlicensed healthcare professionals to hand a patient "a properly labeled and prepackaged prescription drug," creates a completely unnecessary barrier to Doctor/ patient communication. AB 1841 Page 9 "Even the most educated Medical Assistants with the highest certifications do not receive pharmacy training, neither are Medical Assistants allowed to diagnose or to perform any task that requires assessment - including commenting on the safety and/or efficacy of a prescribed drug. This bill makes it much harder for a patient to obtain a consultation with a professional qualified to address their questions and assess their health needs." Committee staff notes that the bill explicitly requires the licensed physician and surgeon, podiatrist, physician assistant, nurse practitioner, or certified nurse-midwife to provide the appropriate patient consultation regarding the use of the drug prior to the MA handing it to the patient. SUPPORT AND OPPOSITION: Support: Planned Parenthood Affiliates of California (Sponsor) Association of California Healthcare Districts California Association for Nurse Practitioners Medical Board of California Oppose Unless Amended: California Society of Health-System Pharmacists Opposition: California Right to Life Committee, Inc. Consultant:G. V. Ayers