BILL ANALYSIS Ó SB 337 Page 1 Date of Hearing: June 23, 2015 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Susan Bonilla, Chair SB 337(Pavley) - As Amended June 16, 2015 SENATE VOTE: 38-0 SUBJECT: Physician assistants. SUMMARY: Authorizes a physician supervising a physician assistant (PA) to use two additional mechanisms for the general supervision of a PA, authorizes a physician to use one additional mechanism for the supervision of a PA that administers a Schedule II controlled substance, and requires a PA's patient medical records to identify the PA's supervising physician. EXISTING LAW: 1)Establishes the Physician Assistant Board (PAB) within the jurisdiction of the Medical Board of California (MBC) to license and regulate PAs. (Business and Professions Code (BPC) § 3504) 2)Requires a PA and the supervising physician to establish written guidelines for the adequate supervision of the PA, and the requirement may be satisfied by the supervising physician adopting protocols for some or all of the tasks performed by the PA. (BPC § 3502 (c)(1)) SB 337 Page 2 3)Requires a supervising physician to be available in person or by electronic communication at all times when the PA is caring for patients. (Title 16, California Code of Regulations (CCR) § 1399.545 (a)) 4)Requires a supervising physician to delegate to a PA only the tasks and procedures consistent with the supervising physician's specialty or usual and customary practice and with the patient's health and condition, and requires the supervising physician to observe or review evidence of the PA's performance of all tasks and procedures to be delegated to the PA until the physician is assured of the PA's competency. (16 CCR § 1399.545 (b)(c)) 5)Requires a supervising physician to review, countersign, and date a sample consisting of, at a minimum, five percent of the medical records of patients treated by the PA within 30 days of the date of treatment. Requires the supervising physician to select for review those cases that by diagnosis, problem, treatment, or procedure represent, in his or her judgement, the most significant risk to the patient. (BPC § 3502 (c)(2)) 6)Authorizes the MBC or the PAB to establish other alternative mechanisms for the adequate supervision of the PA. (BPC § 3502 (c)(3)) 7)Requires a supervising physician who delegates the authority to issue a drug order to a PA to first prepare and adopt a formulary and protocols that specify all criteria for the use of a particular drug or device, and any contraindications for the selection. Protocols for Schedule II controlled substances must address the diagnosis of illness, injury, or condition for which the Schedule II controlled substance is SB 337 Page 3 being administered, provided, or issued. (BPC § 3502.1(a)(2)) 8)Requires a supervising physician to review and countersign within seven days the record of any patient cared for by a PA for whom the PA's Schedule II drug order has been issued or carried out. (BPC § 3502.1 (e)) 9)Allows a PA to administer Schedule II, III, IV and V drug orders without advance approval from a supervising physician if the PA has completed an education course that covers controlled substances and that meets standards, including pharmacological content, approved by the PAB. The education course must be provided either by an accredited continuing education provider or by an approved PA training program. For Schedule II controlled substances, the course must contain a minimum of three hours exclusively on Schedule II controlled substances. (BPC § 3502.1 (c)(2)) 10)Requires PAs who are authorized by their supervising physician to issue drug orders for controlled substances to register with the United States Drug Enforcement Administration (DEA). (BPC § 3502.1 (f)) THIS BILL: 11)Revises the definition of "medical records review meeting" to mean a meeting between the supervising physician and the PA during which medical records are reviewed to ensure adequate supervision of the PA functioning under protocols. 12)Authorizes the supervising physician and PA to hold medical records review meetings in person or by electronic communication. SB 337 Page 4 13)Requires the medical record, for each episode of care for a patient, to identify the physician who is responsible for the supervision of the PA. 14)Authorizes a physician to choose from two additional mechanisms to supervise a PA, making a total of three mechanisms: a) Conduct a medical records review meeting at least once a month during at least 10 months of the year-any month in which a medical records review meeting occurs, the supervising physician and PA must review an aggregate of at least 10 medical records of patients treated by the PA. Documentation of medical records reviewed during the month must be jointly signed and dated by the supervising physician and the PA. b) Develop review methods for the review of cases involving treatment by the PA. The review methods must be identified in the delegation of services agreement and include at least an aggregate of 10 cases per month for at least 10 months of the year. Documentation of the cases reviewed during the month must be jointly signed and dated by the physician and PA. 15)States that, in complying with the supervision requirements above (number 4), the physician must select for review those cases that by diagnosis, problem treatment, or procedure represent, in the physician's judgment, the most significant risk to the patient. 16)States that compliance with BPC § 3502 (numbers 3-5 above) will be also considered compliance with § 1399.546 of Title 16 of the California Code of Regulations. SB 337 Page 5 17)Authorizes a physician to use an additional mechanism for the supervision of a PA that prescribes a Schedule II controlled substance. The physician may review, countersign, and date, within seven days, a sample consisting of the medical records of at least 20 percent of the patients with the PA's Schedule II prescriptions if: a) The PA has: i) Completed a controlled substances education course that meets the standards established in the PAB's regulations and is provided either by an accredited continuing education provider or by an approved physician assistant training program; or, ii)The PA has a certificate of completion of the course described BPC § 3502.1(c)(2); and, b) The supervision is verified and documented in the manner established by the PAB's regulations. 18)Makes other minor technical and clarifying changes. FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, this bill will result in negligible state costs. COMMENTS: Purpose. This bill is sponsored by the California Academy of Physician Assistants . According to the author, "[This bill] increases options for the physician/PA team to document supervision. The options included in the bill will strengthen the team-based approach by encouraging more active discussion during the records review. The Patient Protection and Affordable Care Act has resulted in millions of additional people seeking health care services in SB 337 Page 6 California. This increase has created an even greater need for high quality, efficient team-based care across all medical settings. This is especially true for the practice of physician assistants, who are authorized to provide physician exams, diagnose and treat illness, and prescribe medication, under the supervision of a physician. [This bill] recognizes the growing changes in medical practice settings and the use of electronic medical records to update methods for documentation of the supervision of PAs and encourages more interactive review of patient cases." Background. According to the PAB, a PA is a licensed health care professional, trained to provide patient evaluation, education, and health care services. A PA works with a physician to provide medical care and guidance needed by a patient. In order to become a PA, an applicant must attend a specialized medical training program associated with a medical school that includes classroom studies and clinical experience. Upon graduation from the program, an academic degree or certificate is awarded. Many PAs already have two or four year academic degrees before entering a PA training program. Most PA training programs require prior health care experience. While a licensed PA is authorized to perform many of the same health care services as a physician, the services the PA may provide are limited to the services expressly authorized by the PA's supervising physician. The physician's written authorization is known as a delegation of services agreement. In the agreement, the physician is allowed to authorize only the services that the physician determines the PA competent to perform, consistent with the PA's education, training, and experience. SB 337 Page 7 As of June 2013, there were about 9,000 active PA licenses in California. General Supervision Requirements. Existing law requires each PA to be supervised by at least one physician. The physician may supervise the PA either when both are at the same location or by telephone. Further, the physician must be physically or electronically available to the PA at the time of treatment. The PA and the supervising physician must also establish written guidelines for the adequate supervision of the PA. The requirement may be satisfied by adopting protocols for some or all of the tasks performed by the PA. In addition, the physician is responsible for following each patient's progress and must review, countersign, and date a sample of at least five percent of a PA's patient medical records within 30 days of treatment. The physician decides to review cases that represent the most significant risk to the patient. According to the author, the current five percent requirement does not accommodate all care delivery models, which can lead to less access to care and supervision issues. This bill seeks to add two additional mechanisms to allow a supervising physician more options to adequately supervise a PA: 1)Allow the physician to conduct a medical records review meeting at least once a month during at least 10 months of the year. In the months in which a medical records review meeting occurs, the physician and PA must review at least 10 of the PA's patient medical records. This option would allow a SB 337 Page 8 physician to spread the meetings out over the year rather than as the treatments occur. 2)Allow the physician to develop the method for reviewing cases. The review methods must be identified in the delegation of services agreement and include at least an aggregate of 10 cases per month for at least 10 months of the year. This option would allow the physician to combine several months of review, for instance if the physician wants to physically review the records but is only in the area six months out of the year. Supervision of Controlled Substances. Under the United States Controlled Substances Act, the DEA classifies drugs into five categories (schedules), depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. As the schedule number decreases, the higher the concern for potential abuse-Schedule V drugs present the least potential for abuse, while Schedule II drugs are considered to have a high potential. Schedule I drugs typically have no accepted medical purpose. Existing law allows a supervising physician to authorize a PA to prescribe drugs classified as Schedule II, III, IV and V if: 3)The physician develops practice specific, written protocols and formularies. The protocols for Schedule II controlled substances must address diagnosis of illness, injury, or condition for which the drug is being prescribed; 4)The PA registers with the DEA; and, 5)The PA obtains advanced approval from the physician. SB 337 Page 9 In addition, a PA may prescribe controlled substances without advanced approval by the supervising physician if the PA has completed a controlled substance education course that meets standards approved by the PAB. For Schedule II controlled substances, the course must spend at least three hours exclusively on Schedule II controlled substances. There is also an additional supervision requirement for Schedule II controlled substances-the physician must reviews, countersign, and date the medical record of all the PA's patients within seven days of prescribing the drug. Schedule III and IV drugs do not have a countersigning requirement, but the physician is still required to review the medical records of the PA's patients overall. The PAB is also required to consult with the Medical Board of California and report during sunset review the impacts of the exemption. The PAB is up for sunset review in 2016. According to the author, the 100% countersigning requirement is also prohibitive to many new care delivery models. Because existing law allows a physician to provide supervision electronically, PA-lead clinics may be unable to provide Schedule II drugs if the physician must be physically available to countersign the medical records within seven days for every prescription. Further, there are still the general supervision requirements, which may create a duplicative or overlapping signing requirement for Schedule II drugs. The Reclassification of HCP to Schedule II. In August of 2014, the DEA published a final rule, effective October 6, 2014, following recommendations from the U.S. Food and Drug Administration (FDA) to reclassify hydrocodone combination products (HCP) from a Schedule III controlled substance to a Schedule II. HCP products, such as Vicodin, are popular alternatives to Oxycodone for pain management (due to risk of addiction and side effects). According to the author, "the new SB 337 Page 10 ruling restricts the ability of a practice to fully utilize the PAs they employee as there is no other profession with prescribing privileges that has that level of mandate for documentation." Other States. The Schedule II countersigning requirements vary from state-to-state. Some states have no countersigning requirement and others do not permit PAs to administer Schedule II drugs at all. Prior Related Legislation. SB 1069 (Pavley), Chapter 512, Statutes of 2010, authorized a PA, pursuant to a delegation of services agreement, to order durable medical equipment, certify unemployment insurance disability, and for individuals receiving home health services or personal care services, after consultation with the supervising physician, approve, sign, modify, or add to a plan of treatment or plan of care. The bill also authorized PAs to conduct specified medical examinations and sign corresponding medical certificates for various individuals. AB 3 (Bass), Chapter 376, Statutes of 2007, created the "California Team Practice Improvement Act" which deleted the prohibition on the authority of a PA to issue a drug order for specified classes of controlled substances if the PA has completed a specified education course, required a PA and his or her supervising physician to establish written supervisory guidelines and protocols, increased to four the number of PAs a physician may supervise, and specified that services provided by a PA are included as covered benefits under the Medi-Cal program. AB 2626 (Plescia) Chapter 452, Statutes of 2004, removed the requirement for the supervising physician to review, co-sign and date each prescription written by a PA and limited the SB 337 Page 11 co-signature requirement to each Schedule II drug order written by a PA. ARGUMENTS IN SUPPORT: The California Academy of Physician Assistants (sponsor) writes in support, "Established over 30 years ago, existing law stipulates supervision criteria between a supervising physician and surgeon and the [PA]. It narrowly defines documentation of this required supervision in the form of the supervising physician co-signature on the medical record and prescriptions. [This bill] increases the options for documenting supervision between a supervising physician and PA would allow for flexibility at the practice level to reflect current models of team-based care. This bill will allow physicians and PA's to spend more time with patients." ARGUMENTS IN OPPOSITION: The Medical Board of California writes in opposition, "[the MBC] recognizes that the intent of this bill is to provide flexibility and allow for a more team-based approach in PA supervision, which the [MBC] believes is a laudable goal. The recent amendments addressed concerns raised by the [MBC]?. However, the [MBC] still has concerns related to the reduced physician review of Schedule II drug orders from 100 percent to 20 percent, as this is a significant reduction of supervising physician review for types of opioid medications that are prevalent for abuse." REGISTERED SUPPORT: California Academy of Physician Assistance (sponsor) SB 337 Page 12 CAPG, the Voice of Accountable Physician Groups Pacific Pain Medicine Consultants Planned Parenthood 253 PAs 56 M.D.s and D.O.s REGISTERED OPPOSITION: Medical Board of California California Pharmacists Association Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301