BILL ANALYSIS Ó SB 491 Page 1 Date of Hearing: August 13, 2013 ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER PROTECTION Susan A. Bonilla, Chair SB 491 (Hernandez) - As Amended: August 8, 2013 SENATE VOTE : 22-12 SUBJECT : Nurse practitioners. SUMMARY : Permits a nurse practitioner (NP) to practice independently after a period of physician supervision if the NP has national certification and liability insurance, and authorizes the NP to perform various other specified tasks related to the practice of nursing without protocols. Specifically, this bill : 1)Permits a NP to practice without physician supervision if the NP is certified by a national certifying body, maintains professional liability insurance that is appropriate for his or her practice setting, and either: a) He or she has practiced under the supervision of a physician for at least 4,160 hours and is practicing in one of the following settings: i) A clinic, health facility, or county medical facility; ii) An accountable care organization, as specified; or, iii) A group practice, including a professional medical corporation, another form of corporation controlled by physicians and surgeons, a medical partnership, a medical foundation exempt from licensure, or another lawfully organized group of physicians that delivers, furnishes, or otherwise arranges for or provides health care services; or b) He or she has practiced under the supervision of a physician for at least 6,240 hours and maintains a list of licensed health care providers most often used for the purposes of obtaining information or advice. SB 491 Page 2 2)Permits an independent NP to do the following without standardized procedures or protocols: a) Order durable medical equipment, although nothing in this bill shall prohibit a third-party payer from requiring prior approval; b) Certify disability after performing a physical examination; c) Approve, sign, modify, or add to a plan of treatment or plan of care for individuals receiving home health services or personal care services; d) Assess patients, synthesize and analyze data, and apply principles of health care; e) Manage the physical and psychosocial health status of patients; f) Analyze multiple sources of data, including patient history, general behavior, and signs and symptoms of illness; identify alternative possibilities as to the nature of a health care problem; and select, implement, and evaluate appropriate treatment; g) Establish a diagnosis by client history, physical examination, and other criteria; h) Order, furnish, or prescribe drugs or devices; i) Refer patients to physicians or other licensed health care providers; j) Delegate tasks to a medical assistant that are within the medical assistant's scope of practice; aa) Perform additional acts that require education and training and that are recognized by the the Board of Registered Nursing (BRN) as proper to be performed by a NP; bb) Order hospice care as appropriate; and, cc) Perform procedures that are necessary and consistent with the NP's education and training. SB 491 Page 3 3)Requires a NP to refer a patient to a physician and surgeon or another licensed health care provider if a situation or condition of the patient is beyond the NP's education or training. 4)Does not limit a NP's authority to practice nursing or limit the scope of practice of a registered nurse. 5)Requires the Board of Registered Nursing (BRN) to adopt regulations by July 1, 2015 establishing the means of documenting completion of this bill's requirements. 6)Specifies that NPs shall not supplant physicians employed by a clinic, health facility, or county medical facility 7)States that no reimbursement is required by this bill pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. EXISTING LAW : 1)Declares that the intent of the Legislature in amending the Nursing Practice Act is to recognize the existence of overlapping functions between physicians and registered nurses and to permit additional sharing of functions within organized health care systems that provide for collaboration between physicians and registered nurses. (Business and Professions Code (BPC) Code Section 2725 (a)) 2)Defines the practice of nursing as those functions, including basic health care, that help people cope with difficulties in daily living that are associated with their actual or potential health or illness problems or the treatment thereof. (BPC 2725 (a)) 3)Defines "standardized procedures" as either policies and protocols developed by a health facility through collaboration among administration and health SB 491 Page 4 professionals or policies and protocols developed through collaboration among administrators and health professionals by an organized health care system which is not a health care facility. (BPC 2725 (c)) 4)Permits NPs to furnish and order drugs pursuant to standardized procedures developed by the NP and the supervising physician and surgeon when the drugs or devices are consistent with the practitioner's educational preparation or for which clinical competency has been established and maintained. (BPC 2836.1) 5)Requires one physician to supervise every four prescribing NPs. (BPC 2836.1) 6)Permits BRN to employ such personnel as it deems necessary to carry out the nursing law, and permits BRN to adopt, amend, or repeal such rules and regulations as may be reasonably necessary to enable it to carry into effect the provisions of the nursing law. (BPC 2715) FISCAL EFFECT : Unknown COMMENTS : 1)Purpose of this bill . This bill allows a prescribing NP to practice independently of physician supervision and standardized procedures after a period of supervised practice if the NP has national certification and liability insurance. This bill is author-sponsored. 2)Author's statement . According to the author's office, "Independent practice would allow NPs to choose to see Medi-Cal patients, a decision that is now left up to the physician they work for. Due to the excellent safety and efficacy record NPs have earned historically, the Institutes of Medicine and the National Council of State Boards of Nursing have recommended full practice for NPs. Currently, 17 states allow NPs to practice at the full extent of their training and education with independent practice." 3)NP training and educational requirements . A NP is registered nurse who possesses additional preparation and skills in physical diagnosis, psycho-social assessment, and management of health-illness needs in primary health care, and who has SB 491 Page 5 completed a NP program that conforms to BRN standards. NP programs are required to include 12 semester units or 18 quarter units of clinical practice (3 hours of clinical practice each week equals one unit). NPs are required to have a Masters degree, and many further pursue a doctorate in nursing. There are currently 17,531 NPs licensed in CA. NPs may specialize in disciplines such as acute pediatric care, adult gerontological care, family care, women's health, and mental health nursing. 4)This bill in practice . This bill would require NPs who wish to practice independently to be nationally certified. To qualify for national certification, an applicant must have graduated from specified nationally accredited programs, have a minimum of 500 clinical hours of faculty-supervised practice, and demonstrated completed coursework in advanced physical assessment, advanced pharmacology, and advanced pathophysiology. This bill also requires an NP to have worked under physician supervision for the equivalent of two years of full-time work for certain practice models, and three years for solo practice. These timelines are based on the work of Patricia Benner, who described domains and competencies for advanced nursing practice, and the research of Karen Bryckzynski, who explored the clinical practice of NPs. These competencies are referenced by the U.S. Department of Health and Human Services in guidance reports. 5)Standardized procedures . The NP scope of practice is currently determined by standardized procedures, which are the legal mechanism for NPs to perform functions which would otherwise be considered the practice of medicine. The Medical Practice Act authorizes physicians to diagnose mental and physical conditions, to use drugs in or upon human beings, to sever or penetrate tissue, and to use other methods in the treatment of diseases, injuries, deformities, or other physical or mental conditions. As a general rule, the performance of any of these functions by a NP requires a standardized procedure. Standardized procedures are defined as 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. A SB 491 Page 6 NP may perform standardized procedure functions only under the conditions specified in a health care system's standardized procedures, and must provide the system with satisfactory evidence that he or she meets its experience, training, and education requirements. 5)Protocols . Protocols are a part of standardized procedures and are designed to describe the steps of medical care for given patient situations. They are used for management of acute or episodic conditions, trauma, chronic conditions, infectious disease contacts, routine gynecological problems, contraception, health promotion exams, and ordering of medications. Protocols are developed in consultation with a supervising physician. 6)Prescribing authority . NPs may furnish drugs by obtaining a DEA number to prescribe Schedule II-V drugs pursuant to a protocol and standardized procedures. The DEA considers a NP to be a "prescriber," but NPs who write prescriptions are considered a "furnishing" NP under California law. Furnishing is the delegated authority to write prescriptions, and is done in accordance with approved standardized procedures and protocols. Physician supervision is required and the physician must be available, at least by telephonic means, at the time the NP examines the patient. Furnishing NPs are required to be supervised by a physician, but non-furnishing NPs are not. 7)Supervision requirements . Of the 17,500 NPs in California, 12,500 are furnishing NPs. A physician may supervise up to four furnishing NPs. The law does not specify the quality and extent of supervision necessary, only that the physician be available by phone when a NP examines a patient. There is no requirement that the physician work in the same facility with the NP, meets regularly with the NP, review patient charts, or be within a geographic proximity. 8)The Affordable Care Act (ACA) & NP Autonomy . The federal Affordable Care Act (ACA) was passed in March 2010 to provide quality, affordable healthcare for all Americans and improve the quality and efficiency of that care. The January 2014 implementation date of ACA will result in millions more Californians entering the primary care market. Primary care providers will be responsible for health promotion, disease prevention, early diagnosis, and the coordination of care with SB 491 Page 7 other providers for these new entrants to the market. Accessing these providers will be a challenge given the current state of the nation's health care workforce restrictions. The Association of American Medical Colleges estimates a nationwide shortage of 45,000 primary care physicians by 2020. This shortage is exacerbated by the fact that fewer physicians are choosing to enter the field of primary care than are leaving it. The Institute of Medicine (IOM), an independent nonprofit organization which is part of the National Academy of Sciences, published a report in 2011 in which it concluded that NPs deliver the same quality of primary care as physicians. IOM noted that although NPs are most immediately sought for their medical skills in primary care, they integrate practices from several disciplines, including social work, nutrition, and physical therapy. The IOM report notes that some argue that NPs should not be allowed to be independent primary care practitioners because physicians are more qualified due to their extensive academic and clinical training, and unique cognitive and technical skills. However, the IOM report notes that the contention that APRNs are less able than physicians to deliver care that is safe, effective, and efficient is not supported by research. Further, NPs are trained to refer out when conditions rise beyond their competencies and have the ability to coordinate care between providers. NPs have been slowly granted practice autonomy in other states over the last decade. 16 states allow NPs to evaluate patients, diagnose, order and interpret diagnostic tests, and initiate and manage treatment under the exclusive license authority of the state board of nursing. Today, nurse practitioners (which make up slightly less than a quarter of all primary care professionals), together with physicians and physician assistants, provide most of the primary care in the United States. The demand for a larger primary care workforce will grow as access to coverage, service settings, and services increases under the ACA. 11)Improving access to primary care . It is estimated that the majority of the seven million Californians currently without health insurance will be able to access primary care after the SB 491 Page 8 implementation of ACA. According to the sponsor, allowing independent NP practice will likely make that care more accessible, reducing the strain on the already overburdened physician population. NPs have been found to have a greater propensity to care for underserved populations and frequently have less student debt, making them more likely to work in environments with lower profit margins, such as rural areas. There are two major ways in which the independent practice for NPs provided by this bill may provide increased access to primary acre services: a) Retail clinics . Retail clinics have grown substantially over the last decade. Retail clinics are medical clinics who contract to operate out of pharmacies, grocery stores, and "big box" stores, such as Target. California's ban on the corporate practice of medicine limits operation of these clinics to professional medical corporations, so these clinics must be 51% physician owned. Retail clinics primarily provide care for simple acute conditions-such as bronchitis and vaccinations-typically delivered by a nurse practitioner. The Rand Corporation, a nonprofit research organization, reports that the overall cost of care at retail clinics is substantially lower than in physician offices, urgent care centers, and emergency departments - and the care is comparable in quality. The Rand Corporation study further indicates that these clinics do not appear to be disrupting the traditional physician-client relationship, because 60% of retail clinic consumers report having no primary care physician. It is anticipated that these clinics may proliferate if NPs are able to operate without physician supervision because it would become more cost-effective for these clinics to employ greater numbers of NPs. Retail clinics are currently constrained by the 1:4 ratio of physician supervision of prescribing NPs. b) Medi-Cal and Medicare populations . Permitting independent practice by NPs will allow greater access to care for Medi-Cal and Medicare populations. Medi-Cal is the state's Medicaid health insurance program, funded by both the federal and state government for low-income families and children, people with disabilities, pregnant SB 491 Page 9 women, and seniors. Medicare is the federal government health insurance program for seniors and persons with disabilities. ACA is expanding Medi-Cal eligibility and the California HealthCare Foundation estimates that more than 1.4 million Californians will be newly eligible for coverage. The California HealthCare Foundation reports that presently, adults with Medi-Cal are nearly twice as likely to report difficulty getting a doctor appointment than other insured adults in California. In 2008, there were only 50 primary care providers for every 100,000 Medi-Cal beneficiaries in California, well below the federal guidelines of 60 to 80 per 100,000. NPs are limited in their ability to be reimbursed for care covered by Medi-Cal due to physician supervision constraints. According to the Centers for Medicare and Medicaid Services, fewer American doctors are treating patients enrolled in the Medicare health program, reflecting physician frustration with its payment rates and rules. The number of doctors who opted out of Medicare last year nearly tripled from three years earlier. Other doctors are limiting the number of Medicare patients they treat even if they don't formally opt out of the system. NPs in California may only treat Medicare patients if their supervising physician is a Medicare provider. According to an article in the medical journal Health Affairs, Medicare, Medicaid, and private insurers typically reimburse NPs at rates that are just 75-85% of what they pay physicians for the same services. NPs generally have less overhead than physicians (lower educational debt loads and fewer equipment costs because of the lower complexity of procedures performed), and are therefore more likely to work for a lower reimbursement. 14)Accountability provisions . This bill will require independent NPs to have liability insurance. Presently, supervising physicians are partially accountable for an NP's practice and a physician's license is at stake for unprofessional conduct by a supervised NP. Independence will require that the NP be wholly accountable for his or her actions, and the required liability insurance would arguably help protect consumers in the event of a malpractice action. SB 491 Page 10 15)Arguments in support . AARP writes, "With the implementation of the Affordable Care Act and the expansion of Medi-Cal, millions more Californians will be seeking affordable, quality health care. We need to make better use of the health care resources we have in our state. This bill does this by allowing nurse practitioners to practice up to the full extent of their education and training and provide quality health care without (to an extent) unnecessary, restrictive oversight. By removing most of the unnecessary supervision requirements, SB 491 will increase Californians' access to and choice among quality health professionals, reduce wait times and reduce paperwork burdens. "Nurse practitioners are educated and trained to provide high quality primary health care. They diagnose and manage patients' care, prescribe medications and refer patients to specialists. Decades of evidence, recently noted by the Institute of Medicine and the National Governors Association, demonstrate that nurse practitioners provide safe, effective care whether or not they are supervised by physicians." 16)Arguments in opposition . The California Medical Association writes, "Allowing nurse practitioner practice without standardized protocols and physician supervision reduces patient safety and quality of care. Patients are best served by a physician-led team that can provide high quality and cost-effective care. Nurse practitioners are an important part of the healthcare team and, when practicing under physician supervision, can significantly increase access to quality medical care in a community. Current law requires that nurse practitioner practice include the development and use of standardized protocols and physician review and approval of patient treatment plans. These requirements are in place to ensure that patient care includes the involvement and oversight of a physician who is substantially more qualified and experienced to oversee patient care, both in depth and in years of education and training, than a nurse practitioner practicing alone." 17)Author's amendment . The author would like to amend the bill to remove the independent practice pathway in which an NP may practice without physician supervision after at least 6,240 hours of supervised practice. SB 491 Page 11 18)Related legislation . AB 1000 (Wieckowski and Maienschein) would allow patients to self-refer to a physical therapist (PT) and receive treatment for 45 calendar days or 12 visits, whichever comes first, before being seen by a physician and receiving sign off on the treatment plan initiated by a PT. AB 1000 is currently in the Senate Appropriations Committee. AB 1208 (Pan) defines a "medical home" and "patient centered medical home" as a health care delivery model in which a patient establishes an ongoing relationship with a personal primary care physician or other licensed health care provider acting within the scope of his or her practice. The bill states that the provider shall work in a physician-led practice team to provide comprehensive, accessible, and continuous evidence-based primary and preventative care, and to coordinate the patient's health care needs across the health care system in order to improve quality and health outcomes in a cost-effective manner. AB 1208 is currently on the Senate floor. SB 352 (Pavley) authorizes medical assistants to perform technical supportive services in any medical setting upon specific authorization of a physician assistant, NP, or certified nurse-midwife without a physician on the premises. SB 352 is currently on the Assembly floor. 19)Previous legislation . SB 726 (Ashburn) of 2010 was an effort to promote healthcare in rural areas allow qualified health care districts and qualified rural hospitals, as specified, to directly employ physicians under an existing pilot project. SB 726 was held in the Senate Business, Professions, and Economic Development Committee. REGISTERED SUPPORT / OPPOSITION : Support AARP American Nurses Association American Nurses Association, California Association of California Healthcare Districts Bay Area Council Blue Shield of California Board of Registered Nursing SB 491 Page 12 C.W. Brower, Inc. California Association for Nurse Practitioners California Association of Clinical Nurse Specialists California Association of Nurse Anesthetists, Inc. California Association of Physician Groups California Association of Public Hospitals and Health Systems California Family Health Center California Federation of Teachers California Hospital Association California Nurse-Midwives Association California Optometric Association California Pharmacists Association California Primary Care Association California Society of Health-System Pharmacists California State Association of Occupational Health Nurses Californians for Patient Care City of Turlock Congress of California Seniors Dignity Health Indiana State Nurses Association Latino Community Roundtable National Asian American Coalition National Association for the Advancement of Colored People National Association of Pediatric Nurse Practitioners Private Essential Access Community Hospitals Stanford Hospital and Clinics United Nurses Associations of California/Union of Health Care Professionals University of California University of California, San Francisco Western University of Health Sciences 134 individuals Opposition Aesthetic Institute AFSCME Alameda-Contra Costa Medical Association American Academy of Pediatrics, California American Federation of State, County and Municipal Employees, AFL-CIO American Society for Dermatologic Surgery Association Blind Children's Center CalDerm California Academy of Eye Physicians and Surgeons SB 491 Page 13 California Academy of Family Physicians California Chapter of the American College of Emergency Physicians California Medical Association California Podiatric Medical Association California Psychiatric Association California Right to Life Committee, Inc. California Society of Anesthesiologists California Society of Plastic Surgeons Canvasback Missions, Inc. Consumer Attorneys of California Diabetes Coalition of California Here For Them, Inc. Latino Physicians of California Let's Face it Together Lighthouse Mission for Christ Medical Board of California Minority Health Institute, Inc. Osteopathic Physicians and Surgeons of California The Dream Machine Foundation Time for Change Foundation Union of American Physicians and Dentists/AFSCME-Local 206 Ventura County American Chinese Medical Dental Association 111 individuals Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916) 319-3301