Editor's note: This article by Tony Mira, president and CEO of Anesthesia Business Consultants, an anesthesia & pain management billing and practice management services company, originally appeared in Anesthesia Business Consultants eAlerts, a free electronic newsletter. Sign-up to receive this newsletter by clicking here.
Around this time a year ago, our readers were struggling to understand and adapt to a newly-revised set of Interpretive Guidelines (IGs) for anesthesia departments (pdf). The IGs are part of the CMS State Operations Manual that gives hospital surveyors detailed instructions on ensuring that hospitals comply with the Medicare rules. Hospital compliance and hospital payment are Medicare Part A issues; Part B governs physician payment. Part A matters greatly to physicians, however, when it imposes obligations on hospitals that must be fulfilled by members of the medical staff.
This has always been the case with the IGs for anesthesia services. It became an acute problem when the CMS Department of Survey and Certification revised the IGs in December 2009. The 2009 version contained a number of modifications that would require major changes to the normal operations of the anesthesiology service, without any gains in safety or efficiency. Throughout 2010, ASA worked to have CMS better align the IGs with normal sound anesthesiology practice. CMS issued the first revision to the 2009 IGs in May 2010. The latest two revisions were published in January 2011, effective immediately.
The three areas of interest and the principles spelled out by the latest IGs are listed below.
1. Labor epidurals
The 2009 IGs astonished the anesthesiology community by announcing a categorical distinction between “anesthesia” and “analgesia” and classifying labor epidurals as “analgesia.” As a result, the requirement at 42 C.F.R. § 482.52(a) that a physician supervise nurse anesthetists or anesthesiologist assistants in the administration of anesthesia would not apply to “the administration of medication via an epidural or spinal route for the purpose of analgesia, during labor and delivery.” In the case of cesarean sections, however, the epidural or spinal would be considered “anesthesia.”
The 2011 revision has eliminated the categorical anesthesia vs. analgesia distinction, recognizing that “Anesthesia exists along a continuum. For some medications there is no bright line that distinguishes when their pharmacological properties bring about the physiologic transition from the analgesic to the anesthetic effects. Furthermore, each individual patient may respond differently to different types of medications.”
The 2011 revision accordingly requires hospitals individually to “establish policies and procedures, based on nationally recognized guidelines, that address whether specific clinical situations involve anesthesia versus analgesia.” This means that the anesthesia services policies and procedures must address “what clinical applications are considered to involve analgesia, in particular moderate sedation, rather than anesthesia, based on identifiable national guidelines.” A hospital may classify labor epidurals as analgesia and credential nurse anesthetists and other non-anesthesiologists to perform these procedures—even in states that have not opted out of the requirement for physician supervision of nurse anesthetists—as long as the classification is based on “national guidelines.”
Note that the specific instructions to the hospital surveyors include the question, “What are the national guidelines that they are following and how is that documented?” The anesthesia policies and procedures must also delineate “the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services.”
The net effect of the 2011 revision is to allow hospitals to forego physician supervision of labor epidurals administered by nurse anesthetists as long as the practice is supported by documented national guidelines.
2. Pre- and post-anesthesia evaluations
The December 2009 and May 2010 IG revisions required the pre-anesthesia evaluation to be performed within the 48 hours prior to induction of anesthesia for surgery or another procedure. They also required a post-anesthesia evaluation within 48 hours from the time the patient is moved into the recovery area. The original language suggested that the post-anesthesia evaluation must occur in the PACU, ICU or other formally-designated recovery location. The 2009 version also specified that “for outpatients, the post-anesthesia evaluation must be completed prior to the patient’s discharge.”
2011 IGs:
(a) Pre-anesthesia evaluation. The patient interview (if possible) and examination and review of the medical history must be performed within the 48-hour timeframe, but notation of anesthesia risk, identification of potential anesthesia problems (e.g. difficult airway) and any additional pre-anesthesia information may be obtained within the 30 days prior to the 48-hour time period. These additional elements must be reviewed and updated as necessary within the 48-hour time period before surgery.
(b) Post-anesthesia evaluation. The current standard provides:
While the evaluation should begin in the PACU/ICU or other designated recovery location, it may be completed after the patient is moved to another inpatient location or, for same day surgeries, if State law and hospital policy permits, after the patient is discharged, so long as it is completed within 48 hours. The 48 hour timeframe for completion and documentation of the postanesthesia evaluation is an outside parameter. Individual patient risk factors may dictate that the evaluation be completed and documented sooner than 48 hours. This should be addressed by hospital policies and procedures.
The current IGs have also clarified that for those patients who are unable to participate in the post-anesthesia evaluation, e.g. because they are on ventilators or sedated, the evaluation must still be completed and documented within 48 hours, with a notation that they were unable to participate.
The latest IGs explicitly reaffirm the rule that the post-anesthesia evaluation may be completed by a practitioner other than the anesthesiologist, CRNA, AA or resident who administered the anesthesia.
3. Immediate availability
In the 2009 revised IGs, CMS enunciated a Part A hospital standard of “immediate availability,” required of the anesthesiologist supervising a CRNA or AA. This standard went beyond the language of Part B physician payment rules and required the anesthesiologist to be physically in the same procedure room as the CRNA or AA.
The May 2010 version changed the language so as to allow the supervising anesthesiologist to be located in the procedure suite.
Throughout all three sets of revisions, the IGs have consistently made it clear that the anesthesia services must be under the direction of “one individual who is a qualified doctor of medicine (MD) or doctor of osteopathy (DO).” The qualifications for the director of anesthesia services are approved by the hospital’s governing body. Furthermore, “Anesthesia services throughout the hospital (including all departments in all campuses and off-site locations where anesthesia services are provided) must be organized into one anesthesia service.” The director is encouraged to develop the hospital’s anesthesia policies and procedures in collaboration with other departments such as surgery, pharmacy, nursing, etc., but s/he is not required to do so.
There have been quite a few twists and turns in the rewrites of the IGs beginning with the December 2009 version. In few instances has the choice of specific words been as important or meaningful. While the IGs impose duties on hospitals and not directly on the medical staff, anesthesia departments generally appreciate the need to help the hospital meet its obligations under the Medicare Conditions of Participation. A January 14 memorandum (pdf) accompanying the latest revision and a set of FAQs (pdf) will provide further details on the latest version of the IGs. We hope that this summary has been helpful.
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