A mother took her 12-month-old infant daughter, “Olivia,” to a dermatology clinic to assess a spot developing on her scalp that was first seen when she was around 8 months old. A physician assistant (PA #1) examined the infant and requested her insurer to approve an “excision and biopsy.” One month later, another physician assistant (PA #2) at the clinic saw the patient and performed a “shave biopsy” of the lesion. The doctor who examined the biopsied tissue found no malignancy.
At a follow-up visit, PA #2 noted that Olivia’s biopsy wound was healing well and told her mother that there was nothing to worry about. Several months later, Olivia’s mother noticed that the lesion was growing back and became concerned. She took Olivia back to the clinic where PA #1 assessed the new growth as “warts” and burned them off with liquid nitrogen.
A few months later, Olivia returned to the clinic because her lesion was “bigger, darker, and varied in color.” PA #2 examined the patient, and concluded once again that the growth was warts, and referred her to a general surgeon to have them removed. The general surgeon excised the lesion and provided the tissue to a pathologist, who did not find any malignancy.
About a year later, the patient developed a bump on her neck and began to complain of neck pain. The surgeon removed the neck mass and referred the mother to an oncologist at a children’s hospital. The oncologist diagnosed metastatic malignant melanoma. Less than a year later, the patient died—she was a little over four years old.1
The patient’s mother sued the physicians and the physician assistants (PAs) for the wrongful death of her daughter. The trial court found that both PA #1 and PA #2 had enforceable agency relationships with the supervising physicians, but that they received little to no actual supervision and therefore failed to operate under required supervisory guidelines.
The court further found that the PAs negligently failed to diagnose Olivia’s condition or to seek necessary physician guidance. The court awarded the patient’s mother $11,200 in economic damages and $4.25 million in noneconomic damages but reduced that amount to $250,000, the maximum allowed at the time under California’s Medical Injury Compensation Reform Act of 1975 (MICRA). The court rejected the mother’s argument that the MICRA limit was inapplicable to the physician assistants because they violated physician supervision regulations. Olivia’s mother filed an appeal.
The Court of Appeal affirmed the application of the MICRA cap in a split decision. California Civil Code Section 3333.2 limits the MICRA cap to “services . . . within the scope of services for which the provider is licensed ...” The patient’s mother argued that the negligent PAs acted outside that scope—without the required supervision of a physician. The majority disagreed, holding that the PAs acted within the scope of their licenses by having legally enforceable agency agreements with a supervising physician regardless of the quantity, quality, or actuality of that supervision. MICRA’s damages cap was therefore properly applied by the trial court. The dissent opined that PAs failed to practice within their license restrictions if they knowingly practiced autonomously without any meaningful physician supervision.1,2
The scope of a PA's practice is defined, not by the PA license itself, but by the scope of the practice of the physician who supervises them.
Although there was little to no supervision of the PAs, in this case, there was still a legal relationship with the supervising physicians. It was determined that the PAs acted within the scope of his or her license for purposes of section 3333.2, subdivision (c)(2) if he or she has a practice agreement in place with a supervising physician, regardless of the quality of actual supervision.2,3
What supervision is required for a physician assistant?
The supervising physician oversees the activities of and accepts responsibility for the medical services rendered by the PA. The supervising physician is required to adhere to the following mechanisms to provide supervision:2-5
Adherence to adequate supervision as agreed to in a practice agreement that meets the requirements of Business and Professions Code Section 3502.3.
The physician must, at a minimum, be available by telephone or other electronic communication method at the time the PA examines the patient. (Laws and Regulations - Physician Assistant Board (ca.gov))
Section 1399.541 of Title 16 of the California Code of Regulations specifies when a physician is required to be “immediately available” as defined, such as acting as first or second assistant in surgery.
What elements should the Practice Agreement contain?
Senate Bill 697 (SB 697) was enacted four years ago. It requires a practice agreement between a PA and a physician that meets specified requirements. The agreement must address policies and procedures to ensure adequate supervision of the physician assistant, including, but not limited to, appropriate communication, availability, consultations, and referrals between a physician and the PA in the provision of medical services. The practice agreement must also establish policies and procedures to identify a physician and/or surgeon (with privileges to practice in that hospital) who is supervising a PA rendering services in a general acute care hospital. SB 697 also provides that any reference to a “delegation of services agreement” in any other law means “practice agreement,” as defined.
The legislation further clarifies that supervision does not require the supervising physician to be physically present, but does require adequate supervision as agreed to in the practice agreement and requires the physician and surgeon be available by telephone or other electronic communication method at the time the PA examines the patient. However, it also prohibits this provision from being construed as barring the Physician Assistant Board from requiring the physical presence of a physician as a term or condition of a PA’s reinstatement, probation, or imposing discipline.3,5
Risk management strategies
On May 23, 2022, Assembly Bill 35 (AB 35) was signed into law by Governor Gavin Newsom. AB 35 altered many of the protections and limits provided by MICRA by raising the number of caps and amounts on noneconomic damages in medical malpractice lawsuits—possibly inviting an increase in the frequency and cost of claims.
Therefore, it is more important now than ever for physicians to review their physician assistant practice agreements:
- Legal Compliance: Physician assistant practice agreements outline the scope of practice for physician assistants, specify the tasks they can perform, and the methods for evaluating qualifications and competency, and set forth the level of supervision required. By reviewing these agreements and updating them when necessary, physicians can ensure that the tasks delegated to PAs are within their authority and comply with state laws and regulations.
- Quality of Care: PAs play a crucial role in providing healthcare services. By reviewing the practice agreements, physicians can ensure that the delegated tasks align with the skills and expertise of the physician assistant. This helps maintain the quality of care provided to patients.
- Patient Safety: PAs work closely with physicians in diagnosing and treating patients. Reviewing practice agreements allows physicians to ensure that appropriate levels of supervision are in place, minimizing the risk of errors or inadequate patient care.
- Professional Responsibility: Physicians have a professional responsibility to supervise and oversee the work of PAs. By reviewing practice agreements, physicians can fulfill this responsibility and ensure that the physician assistant is practicing within the agreed-upon guidelines.
- Liability Protection: In the event of malpractice claims or legal disputes, practice agreements can help physicians demonstrate that they have provided adequate supervision and oversight to physician assistants. This can help protect physicians from potential liability and legal consequences.
In summary, reviewing physician assistant practice agreements and executing the required actions are crucial for legal compliance, maintaining quality of care, ensuring patient safety, fulfilling professional responsibilities, and protecting against liability.
Monica Ludwick, Pharm. D., is a Senior Risk Management and Patient Safety Specialist. Questions or comments related to this article should be directed to MLudwick@CAPphysicians.com.
Sources
¹Lopez v. Ledesma, 46 Cal.App.5th 980, 987 (Cal. Ct. App. 2020) (July 29, 2024)
²Damages for noneconomic losses in action for injury against health care provider based on professional negligence. Civ. Code, § 3333.2, subd. (b).(Jul 29, 2024).
³Laws and Regulations - Physician Assistant Board (ca.gov) (Jul 29, 2024).
https://pab.ca.gov/lawsregs/index.shtml
4Section 1399.541 of Title 16 of the California Code of Regulations. (July 28, 2024).https://govt.westlaw.com/calregs.
5Information Bulletin-SB 697 Frequently Asked Questions. (Jul 29, 2024).
https://pab.ca.gov/forms_pubs/sb697faqs.pdf