CMS updates guidelines on anesthesia services
Are you in compliance?
In May, the Centers for Medicare & Medicaid Services (CMS) issued transmittal 59, clarifying the interpretative guidelines for the anesthesia services Conditions of Participation, the latest in a round of changes in the arena of anesthesiology. And this may not be the last. Another set of revisions, a fourth go-around, may be coming, said Sue Dill Calloway, RN, Esq., BSN, MSN, JD, a nurse attorney and medical legal consultant in Columbus, OH. Calloway recently presented an AHC Media audio conference titled "CMS hospital anesthesia standards change again: Are you in compliance?" But she says many aren't familiar yet with the changes made to date. (To view the transmittal go to http://www.asahq.org/Washington/UpdatedCMSIGs5-21-10.pdf.)
And those changes are quite significant, says Abby Pendleton, Esq., founding partner of The Health Law Partners in Southfield, MI, adding that although the guidelines haven't changed, the revised interpretative guidelines provide much clarification.
Anesthesia services under one governance
A big change, she says, "is the issue of having all of anesthesia under one service." She says that there have always been certain areas within hospitals where anesthesia services have been provided "that really haven't been under the general governance of anesthesia services." Now an issue administrators should be aware of, she says, is identifying all the rooms or departments where you might see those services provided.
"I have heard issues with regard to special procedure areas, like with endo suites, certain areas maybe in the pain management clinics, or even other services that may be in the radiology departments where an anesthetic is potentially provided, and maybe those weren't all formally under the governance of a formal anesthesia service," Pendleton says.
"I am surprised each time I go into a hospital they really haven't defined where the different levels of anesthesia can occur. That's a major issue with surveyors," says Robert Cox, president and managing partner of Anesthesia Resources, an anesthesia billing, consulting, and practice management firm in Marietta, GA. He adds that surveyors can be "sneaky" about checking compliance on this. For instance, a surveyor may request to see your pharmacy's chargemaster to find out which departments are using anesthetic agents. "That's a backwards way of saying, 'Tell me where all your anesthetizing locations are.' But if propofol was ever charged out in, let's say, your emergency room, then that's an anesthetizing location. Then they will go back and find out from the hospital's anesthesia department what departments they have defined as anesthetizing locations. So they are looking for inconsistencies."
Supervision requirements
The revision states that all anesthesia services must be under the direction of a "qualified" MD or DO. "The hospital's medical staff establishes criteria for the qualifications for the director of the anesthesia services in accordance with state laws and acceptable standards of practice. The anesthesia service is responsible for developing policies and procedures governing the provision of all categories of anesthesia services, including specifying the minimum qualifications for each category of practitioner who is permitted to provide anesthesia services that are not subject to the anesthesia administration requirements at 42 CFR 482.52(a). A well-organized anesthesia service must be integrated into the hospital's required quality assessment/performance improvement program, in order to assure the provision of safe care to patients," the transmittal reads.
According to the interpretative guidelines, "general anesthesia, regional anesthesia, and monitored anesthesia, including deep sedation/analgesia, may only be administered by:
- a qualified anesthesiologist;
- an MD or DO (other than an anesthesiologist);
- a dentist, oral surgeon or podiatrist who is qualified to administer anesthesia under state law;
- a [certified registered nurse anesthetist] CRNA who is supervised by the operating practitioner or by an anesthesiologist who is immediately available if needed; or
- an anesthesiologist's assistant under the supervision of an anesthesiologist who is immediately available if needed."
Fifteen states have opted out of the physician supervision requirement, including Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, Montana, South Dakota, Wisconsin, and California.
Pendleton says "immediately available" supervision is one area CMS clarifies with its latest revision. The supervising physician must be "located within the same area and the same operative procedural suite or in the same labor and delivery unit. In other words, [he or she] is not occupied in anything that prevents him from immediately conducting hands-on intervention," she says.
She adds that there may be a potential conflict. Before, an anesthesiologist may not have been in the operating suite during the procedure. And while technically the operating practitioner could provide supervision, she says, "the surgeons are going to say, 'No way. We are not taking the responsibility. There is an anesthesia group that holds the exclusive contract. They have the responsibility. That's even their employee, the CRNA.'" This, too, could raise staffing issues for hospitals, she says. Most hospitals have exclusive arrangements with anesthesiologist groups and should have as part of that arrangement a medical director of anesthesia services component.
Administrators should understand all the regulatory requirements "that apply to the anesthesiologists for purposes of billing, and sometimes the way they have approached staffing issues are completely consistent with the way the billing regulations are set up, and now there are other things they have to look at because they have these interpretations about where the location of the anesthesiologist has to be, so it is going to create issues." While "immediately available" has been defined in terms of the clinical guidelines, it has not been defined in terms of billing, and Pendleton says it may be best not to ask for more clarification.
The hospital must have specifically privileged the MD or DO to act as director of anesthesia services if one is not available or the hospital, perhaps a rural hospital, doesn't have one staffed.
Criteria, according to Calloway, could include knowledge of anesthesia procedures, anesthesia/sedation/analgesia medications, state scope of practice rules, national standards of practice, administrative skills, management, and other criteria. Criteria should be in your hospital's medical staff bylaws or rules and regulations, and the hospital board "must approve the specific anesthesia service privilege for each practitioner who does anesthesia services."
Evaluations, documentation, reporting
Pendleton says the new guidelines also deleted the requirement that said for outpatients the post-evaluation must be completed prior to discharge. Now, for both inpatients and outpatients, the post-anesthesia evaluation must be completed within 48 hours of the surgery.
Calloway said hospitals must have a policy to ensure compliance with evaluation timing and documentation and that it be done by a person qualified to administer anesthesia. For the post-anesthesia evaluation, the 48 hours starts once the patient is moved into a designated recovery area and the evaluation can take place once the patient "is sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.," Calloway said. She pointed to the American Association of Nurse Anesthetists's website for sample forms.
Elements that must be included in the evaluations as well as the intraoperative record are included in the May transmittal. "For years," Cox says, "there was really no specific guidelines on what needed to happen during the operation. There's some clear guidelines now that basically say you do have to intraoperatively document and spell out respiratory function, cardiovascular function, temperature, any changes relevant to nausea, vomiting, or hydration. You do have to look for changes and document that there hasn't been any changes to those things intraoperatively."
Cox suggests that you assess your pre- and post-anesthesia evaluation assessments and compare those to the minimum standards to identify any gaps. He adds that not many anesthesia departments use electronic health records yet. "So what my guidance has been to hospitals is take your paper forms and match them up against the standards."
Sedation versus anesthesia
The revision also includes clarification on the distinction between analgesia/sedation and anesthesia, both of which come under the auspice of anesthesia services. Calloway said for those services in which patients do not lose consciousness, a CRNA or anesthesiologist is not required, nor is a pre- or post-evaluation necessary. The Joint Commission has standards in the patient care chapter on pre- and post-sedation evaluation requirements, she added.
Services identified as analgesia/sedation, and, therefore, not subject to the anesthesia requirements and supervision requirements spelled out in the transmittal include:
- topical anesthesia;
- local anesthesia;
- minimal sedation;
- moderate sedation/anesthesia (conscious sedation).
Under the anesthesia services, which require either an anesthesiologist or a CRNA or anesthesiologist assistant supervised by a qualified physician, are:
- general anesthesia;
- regional anesthesia (analgesia via epidurals/spinals for labor and delivery is not considered anesthesia and, therefore, can be administered by CRNAs without physician supervision);
- monitored anesthesia care;
- deep sedation.
CMS also writes: "Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Hence, hospitals must ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended, for example, patients who inadvertently enter a state of deep sedation/analgesia when moderate sedation was intended. 'Rescue' from a deeper level of sedation than intended requires an intervention by a practitioner with expertise in airway management and advanced life support. The qualified practitioner corrects the adverse physiologic consequences of the deeper-than-intended level of sedation and returns the patient to the originally intended level of sedation."
Cox says there is confusion in the field about types of sedation and "each hospital really needs to sit down and make sure that they align the definitions for anesthesia and sedation so that they are compatible with CMS and the American Society of Anesthesiology's guidelines."
He says there has been much debate about whether there's an anesthetic component to doing an epidural. He suggests that his clients go ahead and do the pre- and post-anesthesia evaluation under the adage that it's better to be safe than sorry. "Technically, you do not have to do it... But why wouldn't you do it?"
After determining all areas where anesthesia is provided, "the main thing from a compliance perspective is that hospitals define what privileges are required for each level of anesthesia service. After defining whether a service is anesthesia or not, the hospital must determine both for anesthesia and sedation who can provide the service and in what locations, as well as what kind of training and ongoing training is required," Cox says.
In May, the Centers for Medicare & Medicaid Services (CMS) issued transmittal 59, clarifying the interpretative guidelines for the anesthesia services Conditions of Participation, the latest in a round of changes in the arena of anesthesiology.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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