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California Department of Public Health's (CDPH) Limits On CRNA Scope of Practice Reminds Hospitals Nationwide to Revisit Anesthesia Staffing

The California Department of Public Health (CDPH) issued a letter on September 6, 2024, to all general acute care hospitals clarifying the scope of practice for Certified Registered Nurse Anesthetists (CRNAs) following confusion and issues at hospitals in Modesto, California earlier this year. This clarification emphasizes that CRNAs must operate under physician oversight and cannot practice medicine independently. This guidance comes after federal and state surveys criticized the lack of oversight for CRNAs in certain hospitals, leading to patient safety concerns and compliance issues.
 

Differences in Understanding of CRNA Scope of Practice

The CDPH's clarification in the All Facilities Letter (ALF) contrasts sharply with the understanding held by CRNA advocacy groups.[i] The California Association of Nurse Anesthesiology (CANA) has long argued that state policy allows CRNAs to practice independently, citing a 2009 decision by the state to opt out of a Centers for Medicare & Medicaid Services (CMS) rule requiring physician supervision.  However, the CDPH maintains that CRNAs must practice under the order of a physician, dentist, or podiatrist, and cannot replace anesthesiologists. [ii]
 

Issues and Citations at Hospitals

Hospitals in Modesto, specifically Stanislaus Surgical Hospital and Doctors Medical Center, were cited for several issues related to their use of CRNAs during surveys for CDHP in which the surveyors acted on behalf of CMS.[iii]  The CDPH issued "Immediate Jeopardy" citations, noting that CRNAs were operating beyond their scope of practice by ordering and administering anesthesia drugs independently without physician oversight and developing or modifying treatment plans independently which violated state law and federal law enforced by CMS.[iv] The hospitals were also criticized for not having proper bylaws and policies for the use of CRNAs, relying instead on outdated policies meant for anesthesiologists.[v]
 
The violations caused both hospitals to cancel or reschedule hundreds of surgeries and Stanislaus suspended the use of CRNAs while they were recredentialed.[vi] This led to negative health outcomes for several patients, who required transfer to higher levels of care. Stanislaus Surgical Hospital had two Immediate Jeopardy citations, in August 2023 and January 2024.[vii] CDPH highlighted one instance where a CRNA changed a physician’s orders for general anesthesia for a high-risk spinal case. During the case, the patient became unresponsive and had to be transferred to another hospital.[viii] Doctors Medical Center received an Immediate Jeopardy Notice in May 2024 partly due to CRNA sedation and monitoring of surgical patients.[ix] However,  the official CMS-2567 Plan of Corrections for both hospitals has not been publicly released.
 

Violations of State and Federal Laws

According to the CDPH, the hospitals violated several state and federal laws, including CMS requirements. The key violations included:
 

• California Business and Professions Code (BPC) sections 2725 and 2825-2833.6: These sections outline that CRNAs are not authorized to practice medicine or surgery independently. CRNAs were found to be practicing independently without the required physician supervision.
• Non-compliance with CMS Conditions of Participation 42 CFR § 482.52: The hospitals failed to meet the CMS requirement that anesthesia services be provided under the direction of a qualified doctor.
• Inadequate Policies and Procedures: The hospitals did not have updated bylaws and policies for the use of CRNAs, leading to non-compliance with state regulations. [x]
• Credentialing 42 CFR § 410.69: This regulation specifies that CRNAs must be legally authorized to perform services by the state in which they are furnished and must meet specific credentialing criteria.

 

AANA vs. ASA Understanding of CRNA Scope of Practice

The American Association of Nurse Anesthesiology (AANA) believes that CRNAs have the ability to provide anesthesia services independently, citing studies that show no difference in patient safety between CRNA and physician anesthesiologist services. They argue that CRNAs should not be required to be supervised by a surgeon or anesthesiologist but must provide services within their scope of practice.[xi] Additionally, the California Association of Nurse Anesthesiology (CANA) challenged CDPH findings by citing the state’s 2009 Medicare opt-out of the CMS physician supervision rule as a basis for independent practice for CRNAs.[xii]

In contrast, the American Society of Anesthesiologists (ASA) maintains that physician-led anesthesia care is essential for patient safety.[xiii]  ASA notes that anesthesiologists can’t be replaced by CRNAs as the ALF Letter confirms that CRNAs can’t practice medicine, and CRNAs must practice under the supervision of a physician, dentist, or podiatrist.[xiv] They argue that CRNAs must operate under the supervision or direction of an anesthesiologist or other qualified physician.[xv]
 

Medicare Opt-Out and Lack of Prescriptive Authority

Under CMS Conditions of Participation, a CRNA may be the primary provider of anesthesia care, but an anesthesiologist or other qualified physician must be immediately available if needed.[xvi] The supervising physician does not need to be physically present in the operating room.  However, the regulation allows for a state to opt out of this requirement listed at 42 CFR § 482.52(a)(4) if the state’s Governor and Medicine and Nursing Boards agree it is in the best interest of the state’s citizens and consistent with state law. [xvii] California opted out of the federal Medicare supervision requirement in 2009 under Governor Arnold Schwarzenegger, although the opt-out was highly contested in court for two years.[xviii]  This opt-out allows CRNAs to provide services without physician supervision during the administration of anesthesia.[xix] However, the regulation is drafted in that the requirement for an anesthesiologist or physician involvement is listed twice in different sections and the opt-out is only applicable to (a)(4). The other requirement for anesthesiologist involvement is listed at the outset of the regulation -“if a hospital furnishes aesthesia service, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital”. 42 CFR § 482.52. Again, there is no opt-out for this requirement. Additionally, the opt-out does not override state laws requiring physician involvement in ordering anesthesia care as CRNA prescriptive authority is dependent on a physician. The lack of independent prescriptive authority means that CRNAs cannot independently prescribe medications, further limiting their autonomy.
 

Medical Direction versus Medical Supervision Reimbursement Models

Medical direction involves a higher level of physician involvement. The directing physician must be involved in the pre-anesthetic evaluation, prescribe the anesthesia plan, remain physically present during critical portions of the procedure, and follow the patient into the immediate postoperative period until stable.[xx] The CMS Conditions of Payment does not have requirements for reimbursement under the medical supervision model, although individual plans often do have requirements. Medical supervision applies when a physician is overseeing more than four CRNAs (or other non-physicians) who are concurrently administering anesthesia care or when the requirements for medical direction cannot be met. There are no requirements for the physician to provide hands-on care under medical supervision; instead, the physician is available to assist in any of the concurrent cases.
 

Impact on Billing, Documentation, and Reimbursement

CMS allows for heightened reimbursement under its Conditions of Payment if “medical direction” requirements are met. “Medical direction” has significant implications for billing and reimbursement:
 

• Billing: Under medical direction, CRNA services are billed using specific modifiers (e.g., "QX" for directed services), and the directing physician bills using the modifier “QY” or “QK”, which often results in higher combined reimbursement than other services. For supervision, the CRNA will bill using "QZ" for CRNA non-directed services personally performed and the physician will bill using the modifier “AD”.
• Documentation: Under 42 CFR § 415.110, Medicare pays for medically directed anesthesia services if specific the following conditions are met and documented:
  • The physician performs a pre-anesthetic examination and evaluation.
  • The physician prescribes the anesthesia plan.
  • The physician participates in the most demanding aspects of the anesthesia plan.
  • The physician ensures that procedures not performed by them are done by a qualified individual.
  • The physician monitors the course of anesthesia administration at frequent intervals.
  • The physician remains physically present and available for emergencies.
  • The physician provides indicated post-anesthesia care. [xxi]  

 

• Reimbursement: Directed services typically receive higher reimbursement rates due to the increased level of physician involvement When an anesthesiologist provides medical direction, Medicare reimburses at 50% of the allowable fee for the anesthesiologist and 50% for the CRNA. Medically Supervised Services: When an anesthesiologist provides medical supervision, the reimbursement rate is lower, often around 3 base units plus one-time units per hour for the anesthesiologist, while the CRNA may receive a separate payment.

 
Note, that “medical direction” under the CMS Conditions of Payment is an optional reimbursement model where the physician directs no more than four procedures at one time, but the CMS Conditions of Participation are not optional. The interplay between the Conditions of Payment and Conditions of Participation can be confusing as “medically directed services” are optional and the Conditions of Participation allow for supervision of CRNAs at 42 CFR § 482.52(a)(4) to be opted-out, but the same regulation has a provision that can’t be opted-out which again states “if a hospital furnishes aesthesia service, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy”.[xxii]
 

Nationwide Impact and Recommendations for Providers

The revised guidance from the CDPH will likely influence CRNA scope of practice nationwide by reinforcing the need for physician oversight in anesthesia care as the CDPH was surveying and acting on behalf of CMS in addition to enforcing state-specific laws. The push for independent and autonomous CRNA Scope of Practice has largely gained traction by pushing for reform of the state laws. In the past advocates for CRNA have cited the existing CMS Medicare Opt-Out provision as support for continued state-level reform, but with CDHP working in conjunction and enforcing on behalf and with CMS, whose regulations apply to all hospitals participating in Medicare and Medicaid across the country, the ALF marks a clear setback for independent and autonomous practice nationwide. Considering the new guidance, providers should take several measures to comply with this new guidance:
 

• Revise Policies and Procedures: Hospitals should update their bylaws and policies to ensure compliance with state and federal regulations regarding CRNA practice.
• Review Credentials: Make sure that all CRNAs have appropriate documentation to allow for their level of practice.
• Enhance Staffing Models: Facilities may need to adjust their staffing models to ensure adequate physician oversight for CRNAs, potentially hiring more anesthesiologists or other qualified physicians.
• Training and Education: Providers should invest in training and education programs to ensure that all staff members understand the updated scope of practice requirements and documentation standards.

 
Understanding state and federal requirements for anesthesia care that are all financially feasible given ongoing and historical staffing shortages is a delicate matter. If you need assistance understanding how to reform your current practice, please contact rcarey@whiteforlaw.com.