February 17, 2010

Revised Anesthesia Interpretive Guidelines for Hospitals 

EXECUTIVE SUMMARY

On December 11, 2009, CMS issued revised interpretive guidelines for the Hospital Conditions of Participation ("CoPs") governing anesthesia services ("Guidelines").  The Guidelines provide helpful new guidance in a number of areas.  For example, CMS clarifies that the regulatory requirements for administration and supervision of anesthesia services (42 CFR 482.52(a)) and for the pre- and post-anesthesia evaluations and intraoperative anesthesia records (42 CFR 482.52(b)) apply only to general anesthesia, regional anesthesia and monitored anesthesia care or "MAC" (including deep sedation), and not to topical and local anesthetics and minimal or moderate analgesia/sedation.  CMS clearly states that CRNAs may administer epidurals/spinals for labor and delivery analgesia without physician supervision because analgesia is not anesthesia subject to the supervision requirements.  CMS, for the first time, defines each anesthesia service in a clear and precise manner consistent with practice guidelines of the American Society of Anesthesiologists ("ASA").  The Guidelines also provide additional information addressing the minimal requirements for content of anesthesia evaluations and intraoperative reports, and the kinds and scope of anesthesia policies and procedures expected of each hospital providing anesthesia services. 

Overall, the Guidelines provide welcome clarity and demonstrate CMS' effort to align regulatory requirements with industry standards.  Of course, any time an agency addresses questions and ambiguities identified by stakeholders, new questions are inevitably raised.  The updated Guidelines were effective immediately on their publication (December 11, 2009) and we are awaiting word as to whether they apply to critical access hospitals which have their own CoPs and interpretive guidelines. 

DETAILED ANALYSIS

CMS Clearly Defines Categories of Anesthesia Services Subject to the Mandatory Administration and Supervision Requirements Set Forth in the CoPs

In the Guidelines, CMS clarifies that when a hospital provides a full range of "anesthesia services" on a continuum from local - general anesthesia, not all of such anesthesia services are considered to be "anesthesia" for purposes of meeting the administration and supervision requirements of 42 CFR 482.52(a).  CMS defines "anesthesia" as consisting of "general anesthesia", "regional anesthesia", and "monitored anesthesia care" ("MAC") (MAC includes deep sedation/analgesia).  Anesthesia, thus defined, must be administered by a qualified anesthesiologist; an MD/DO not an anesthesiologist; a dentist, oral surgeon or podiatrist qualified to administer anesthesia under State law; a CRNA who unless exempted under a State opt-out provision is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or an anesthesiologist's assistant who is under the supervision of an anesthesiologist who is immediately available if needed. 
The individual categories of anesthesia services are defined in the Guidelines found at:  http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter10_09.pdf

Conversely, topical and local anesthetics for minor procedures, minimal sedation and moderate sedation/analgesia (i.e., conscious sedation) (collectively "Analgesia/Sedation") may be administered by CRNAs without supervision and, in fact, may be administered by other appropriately trained and qualified medical practitioners within state scope of practice law, provided, the hospital assures that Analgesia/Sedation services are provided in a safe, well organized manner and the hospital has policies and procedures governing the provision of Analgesia/Sedation.

Having framed the distinction between anesthesia and Analgesia/Sedation, CMS advises that hospitals must prepare for and be able to "rescue" a patient from the development of deeper levels of sedation than intended, given the fact that patients' responses to various medications employed in anesthesia services can be unpredictable and can include severe adverse consequences to health and safety.  Rescue requires an intervention by a practitioner with expertise in airway management and advanced life support.  The qualified practitioner must be able to correct adverse physiologic consequences of the deeper-than-intended level of sedation and return the patient to the originally intended level of sedation.  So, for example, if a hospital permits a qualified RN, not a CRNA, to perform conscious sedation, it must assure that an appropriately qualified practitioner is standing by prepared to respond if the patient slips into a deep sedation state. 

CRNAs May Provide Labor Epidurals/Spinals for Analgesia Without Supervision

Consistent with its portrayal of the anesthesia services continuum, CMS clearly takes the position that CRNAs may administer epidurals and spinals for labor and delivery analgesia without physician supervision because analgesia is not anesthesia subject to the supervision requirements.  However, the anesthesia supervision requirements of 42 CFR 482.52(a) apply if the obstetrician or other attending physician determines that a C-section is necessary to safely deliver the infant and any subsequent administration of medications is for the purpose of providing anesthesia (i.e., loss of voluntary and involuntary movement and total relief of pain). 

CMS Clarifies that Anesthesia Services in All Locations of the Hospital Must be Organized into One Service; Central Role of Anesthesia Service Policies and Procedures

The previous conditions of participation interpretive guidelines for anesthesia services (10/18/2008) provided that a hospital's anesthesia service is responsible for all anesthesia administered in the hospital and must be integrated into the hospital-wide QAPI program.  The revised Guidelines further clarify this directive by stating that all hospital anesthesia services provided in all departments in all campuses and off-site locations must be organized into one anesthesia service under the direction of a qualified MD or DO. 

The anesthesia service must develop policies and procedures governing the provision of all categories of anesthesia services including specifying the minimum qualifications for each category of practitioner permitted to provide anesthesia services that are not subject to the anesthesia administration requirements of 42 CFR 482.52(a).  So, in the example given above, if a hospital permits an RN, not a CRNA, to administer conscious sedation, it must have a State law-compliant policy which describes such RN's minimum qualifications for performing conscious sedation.

Of note, for the first time, CMS addressed the issue of non-anesthesiologist physicians performing anesthesia.  It stated, a hospital's anesthesia services policies must "address the circumstances" under which a physician not an anesthesiologist, or a dentist, oral surgeon or podiatrist, is permitted to administer anesthesia.  Further, in formulating its policies, hospitals should conform to "generally accepted standards of anesthesia care."  In the revised Guidelines and in previous interpretive guidelines, CMS referenced the practice guidelines of the ASA.  Accordingly, a state surveyor would probably find anesthesia policies consistent with ASA practice guidelines to be compliant with the conditions of participation. 

With reference to the mandatory supervision of CRNAs performing anesthesia by operating practitioners, CMS advised that hospitals should establish CRNA supervision policies that, again, "conform to generally accepted standards of anesthesia care."  When an anesthesiologist supervises the CRNA, he/she must be "immediately available" if needed.  In the Guidelines, CMS modified the definition of "immediately available" as excerpted below.  The modification is mostly stylistic rather than substantive, but it is noteworthy that the new definition of "immediately available" refers only to anesthesiologists and not to operating practitioners, perhaps because it is now recognized that operating practitioners, by definition, are right in the procedure room with CRNAs. 

New Definition of "Immediately Available" under Revised Guidelines

An anesthesiologist is considered "immediately available" when needed by a CRNA under the anesthesiologist's supervision only if he/she is physically located within the same area as the CRNA, e.g., in the same operative suite, or in the same labor and delivery unit, or in the same procedure room, and not otherwise occupied in a way that prevents him/her from immediately conducting hands-on intervention, if needed.

Old Definition of "Immediately Available" under Anesthesia Services Interpretive Guidelines from 10/17/2008

"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.