Health Law Alert March 31, 2006 About Hall Render Hall, Render, Killian, Heath & Lyman is a full service health law firm with offices in Indiana, Kentucky, Michigan and Wisconsin. Since the firm was founded by William S. Hall in 1967, Hall Render has focused its practice primarily in the area of health law and is now recognized as one of the nation's preeminent health law firms serving clients in 40 states. For more information visit www.hallrender.com. Office Locations Indiana Offices Downtown One American Square Suite 2000 Indianapolis, IN 46282 (317) 633-4884 North Office 8402 Harcourt Road Suite 820 Indianapolis, IN 46260 (317)871-6222 Kentucky Office 614 West Main Street Suite 4000 Louisville, KY 40202 (502) 568-1890 Michigan Office Columbia Center, Suite 315 201 West Big Beaver Road Troy, MI 48084 (248) 740-7505 Wisconsin Office 411 E. Wisconsin Avenue Suite 900 Milwaukee, WI 53202 (414) 721-0442 Contact Us hallrender@hallrender.com Supervision Requirements for CRNAs in Indiana Adele Merenstein Timothy C. Lawson Executive Summary In recent months IHHA General Counsel has become aware of increasing comments from regulatory and/or accrediting body surveyors with regard to the appropriate supervision of certified registered nurse anesthetists ("CRNAs") in Indiana hospitals. In one particular case, a Healthcare Facilities Accreditation Program ("HFAP") accredited hospital was issued a Deficiency Assessment for failing to "properly supervise" its CRNAs, in violation of HFAP Critical Access Hospital ("CAH") Surgical Services Standards and Medicare Conditions of Participation for Hospitals ("CoPs"). Another HFAP accredited hospital, a non-cah facility, recently received a similar citation. While appropriate supervision of CRNAs may not be unduly burdensome for larger hospitals who have anesthesiologists on staff, smaller hospitals are challenged because supervising anesthesiologists (or other physicians willing to assume the responsibility) are scarce or simply unavailable. In light of recent regulatory and accreditation activity in this area, this Memo will review the supervision requirements for CRNAs under Indiana Hospital Licensure Rules, Medicare CoPs for Anesthesia Services, HFAP and Joint Commission on Accreditation of Healthcare Organizations ("JCAHO") standards. Detailed Analysis I. Indiana Hospital Licensure Rules for Anesthesia Services. The Indiana Hospital Licensure Rules ("Rules") address the provision of anesthesia services in a hospital. 410 IAC 15-1.6-1 states as follows: Anesthesia shall be administered by those privileged by the medical staff who are: i. An anesthesiologist; ii. A qualified physician with appropriate training, experience and privileges;
iii. iv. A dentist, oral surgeon or podiatrist who is qualified to administer anesthesia under state law; A CRNA who is under the direction of the operating practitioner or of a qualified physician who is immediately available if needed. (Emphasis added). The Rules make it clear that a CRNA may practice either under the direction of the "operating practitioner" or, alternatively, under the direction of a qualified physician who is immediately available. The definition of "operating practitioner" includes professionals other than physicians (M.D.s or D.O.s) such as podiatrists and dentists. I.C. 25-1- 9-2 defines a "practitioner" as an individual who holds: i. An unlimited license, certificate, or registration; ii. iii. iv. A limited or probationary license, certificate, or registration; A temporary license, certificate, registration or permit; An intern permit; or v. A provisionary license, issued by the board regulating the profession in question, including a certificate of registration issued under I.C. 25-20. Under the Rules, CRNAs may perform epidurals, outside the presence of an operating practitioner or physician, so long as one or the other is immediately available if needed. The "immediate availability" standard will be discussed in Section II below. II. Medicare Hospital Conditions of Participation ("CoPs") for Anesthesia Services (42 C.F.R. 482.52(a)). The CoPs provide in pertinent part as follows: Standard: Organization and staffing. The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered by-- (1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist... who, unless exempted in accordance with paragraph (c) of this
section [via a letter sent by the Governor of a state requesting a state exemption from the CRNA supervision requirement] is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or (5) An anesthesiologist's assistant... who is under the supervision of an anesthesiologist who is immediately available if needed. (Emphasis added). According to Captain David Eddinger, the lead hospital survey and certification analyst of the survey central office of CMS, and the drafter of the CoP Interpretive Guidelines, an "operating practitioner" is not limited to doctors of medicine and osteopathy. The term "operating practitioner" also encompasses podiatrists, dentists, oral surgeons and other practitioners who "operate." Thus, podiatrists, dentists, and oral surgeons may supervise CRNAs. As a practical matter, in smaller hospitals that do not have an anesthesiologist on staff, and in the absence of the operating practitioner (i.e., the patient's attending physician or other practitioner), the emergency department physician ("ED physician") may be the only physician available to supervise the CRNA in the administration of an anesthetic procedure such as an epidural. Under these circumstances, the ED physician could provide the necessary supervision for the CRNA to administer the anesthesia prior to the attending physician arriving at the hospital, assuming the ED physician is "immediately available" if necessary. While Interpretive Guidelines A-0417 for 42 C.F.R. 482.52 appear to require that a hospital privilege an operating practitioner to supervise a CRNA, according to Captain Eddinger of CMS, this is not the case. Captain Eddinger has had discussions with HFAP administrative personnel and surveyors about this issue because HFAP has cited hospitals for failing to privilege the operating practitioners for their supervisory responsibilities for CRNAs. Captain Eddinger has clarified that the privileging of operating practitioners for their supervisory function is not required under the CoPs. As to the requirement that the operating practitioner or anesthesiologist be "immediately available if needed" (and this requirement exists in both the Indiana Rules and the CoPs), the Interpretive Guidelines A- 0417 for 42 C.F.R. 482.52 provide the following: "Immediately available" to intervene includes at a minimum, that the supervising anesthesiologist or operating practitioner, as applicable, is: physically located within the operative suite or in the labor and delivery unit; prepared to immediately conduct hands-on intervention if needed; and
not engaged in activities that could prevent the supervising practitioner from being able to immediately intervene and conduct hands-on interventions if needed. While the "immediate availability standard" is not hard to meet in the course of surgery, CRNAs who perform anesthesia services outside of the operating suite (the classic example being administration of epidurals), must provide for the required supervision by arranging for a designated physician to be immediately available, if needed. III. JCAHO Standards for Supervision of CRNAs. JCAHO Standard PC.13.20, EP11 requires that "before sedating or anesthetizing a patient, a "licensed independent practitioner' with appropriate clinical privileges plans or concurs with the planned anesthesia." Additionally, JCAHO Standard PC.13.40, EP4 requires that, "patients are discharged from the recovery area and the hospital by a qualified licensed independent practitioner or according to rigorously applied criteria approved by the clinical leaders." Finally, JCAHO Standard IM.6.30, EP6 requires that "postoperative documentation records the patient's discharge from the post-sedation or post-anesthesia care area by the responsible licensed independent practitioner or according to discharge criteria." A licensed independent practitioner ("LIP") is defined by JCAHO as:... any individual permitted by law and by the organization to provide care, treatment, and services without direction or supervision, within the scope of the individual's license and consistent with individually granted clinical privileges. There is some debate whether a CRNA constitutes an LIP under the JCAHO standards. It is arguable that a CRNA is not an LIP as that term is defined by JCAHO because the CRNA must be under the direction of the operating practitioner or a qualified physician/anesthesiologist under Indiana Rules and the CoPs. Under this interpretation, a CRNA could not serve as an LIP for purposes of meeting JCAHO Standards. The Rules and CoPs may also be interpreted to allow the independent practice of a CRNA, by virtue of the CRNA's ability to work outside of the immediate presence of a physician (while the physician still must be immediately available in an emergency). Although interpretations of JCAHO Standard PC.13.20, EP11 and the LIP definitions are subject to debate, particularly with respect to the language "direction" and "supervision", to date, we are not aware of any Indiana hospital having been involved in a JCAHO citation of Standard PC.13.20, EP11 based on improper CRNA credentialing or supervision. If this is not the case, IHHA General Counsel would appreciate hearing of any situations where a hospital has been cited for violation of the JCAHO anesthesia standards cited above.
IV. HFAP Standards: HFAP Standard 30.01.03, governing who may administer anesthesia, is identical to the Medicare CoP discussed above. V. Pre- and Post-Anesthesia Services. With regard to the Indiana Rules and the CoPs, both require that a pre-anesthesia evaluation by an individual qualified to administer anesthesia be performed within 48 hours prior to surgery. An intra-operative anesthesia record must be established for each patient. With respect to inpatients, a postanesthesia follow-up report must be written within 48 hours after surgery by the individual who administered the anesthesia. For each outpatient, a post-anesthesia evaluation documenting proper anesthesia recovery must be written in accordance with written policies and procedures approved by the medical staff. According to Captain Eddinger of CMS, under the CoPs, a preanesthesia evaluation by a CRNA must be reviewed and countersigned by the supervising practitioner. Likewise, the intraoperative anesthesia record and post-anesthesia evaluation or follow-up report (as the case may be) must be reviewed and countersigned by the supervising practitioner if completed by the CRNA unless the State obtains a Supervision Exemption through the office of the Governor. (see General Conclusion and Recommendations below). While Captain Eddinger concedes that the pre- and post-anesthesia services are of a less urgent nature and accordingly do not require the supervision of an anesthesiologist or operating practitioner who is immediately available, if needed, nevertheless, some lower level of supervision is required under the CoPs. This interpretation of Captain Eddinger (i.e., requiring a countersignature by a supervising physician) is different than previous advice provided by IHHA Legal Counsel in individual letters to certain IHHA members. Previously, it was the opinion of IHHA Counsel that such a countersignature was not required, given the very specific language present in the Rules. However, given Captain Eddinger's comments, and the HFAP accreditation standards, implementing a policy to have a countersignature by a supervising physician would be prudent. The HFAP standards specifically state, "[i]f the pre-anesthesia evaluation is performed by a non-physician, physician supervision shall be required" unless the State obtains a Supervision Exemption through the office of the Governor.. Further, "[i]f a non-physician performs the anesthesia service and completes the intra-operative record, supervision shall be required." Finally, the HFAP standards do not specifically address the supervision of CRNAs performing postanesthesia follow-up reports, but given Captain Eddinger's comments, supervision would be indicated. Conclusion and General Recommendations The supervision of CRNAs in Indiana hospitals poses regulatory,
operational, and accreditation challenges to hospital administration. In the absence of a physician or operating practitioner being always "immediately available", hospitals will have to be creative to assure that the CRNA supervision requirements are met. Outside of anesthesia provided in the operating suite where an operating practitioner is essentially always present, other arrangements for the required supervision may need to be considered. For example, an ED physician may need to come to the maternity unit during the administration of an epidural by a CRNA. In other instance, if a physician cannot go to the unit, the patient may need to be transported via gurney or wheelchair to the location of the ED physician or other supervising practitioner, when possible. This is an area where there is clearly some degree of confusion between the Indiana Rules, accrediting body standards, and the Medicare CoPs. It is critical that the CRNA and supervising practitioner document all required supervisory intervention in the medical record, especially in the situation where an ED Physician might be providing the required supervision. Written orders for the anesthesia services must also be documented in the record. As the old adage goes, "if it's not in the record, it didn't happen." If a number of Indiana hospitals are having difficulties meeting these requirements, they may want to consider discussing these issues with IHHA General Counsel to have the Governor address this issue pursuant to 42 CFR Section 482.52(c). This regulatory provision in the CoPs provides for a state supervision exemption. Under the exemption provision, the state may submit a letter to CMS signed by the Governor, following consultation with the state Boards of Medicine and Nursing, requesting exemption from supervision of CRNAs. The Governor must attest that he/she has consulted with the Boards about issues related to access to and quality of anesthesia services in the state and has concluded that it is in the best interests of the state's citizens to opt out of the physician supervision requirements and that the opt-out is consistent with state law. The request for exemption and recognition of state laws are effective upon submission of the Governor's request. IHHA General Counsel would be interested in hearing from Indiana hospitals regarding any current difficulties in complying with the CRNA supervision requirements, or accreditation standards. Any such comments may be submitted to the attorneys named below. Should you have any questions, please do not hesitate to contact your local counsel or Adele Merenstein or Timothy C. Lawson at Hall, Render, Killian, Heath & Lyman, P.C. at 317/633-4884. This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader must consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.
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