CMS Tweaks Hospital Sedation Policy, Again

The Centers for Medicare and Medicaid Services has revised its recently updated anesthesia guidelines, following complaints the policy was unworkable.

Hospitals are now directed to develop their own internal policies concerning what is anesthesia versus analgesia, which leaves open the option of using different guidelines in different clinical departments. The revisions also provide greater flexibility regarding pre- and postanesthesia evaluations, while particularly problematic references to propofol and labor epidural anesthesia were dropped entirely.

Following the December 2009 release of the updated interpretive guidelines for hospital anesthesia services, practitioners called for clarifications regarding the distinction between anesthesia and analgesia, suggesting that some of the examples didn’t fall clearly on one side or the other of the anesthesia/analgesia spectrum. The use of propofol (Diprivan) during screening colonoscopy was cited as an example of deep sedation, which meant it could only be delivered by providers trained in general anesthesia.

"The examples caused a lot of consternation," acknowledged Marilyn Dahl, director of the Centers for Medicare and Medicaid Services (CMS) survey and certification division of acute care services. "What the current guidelines say is that we are going to leave it up to the hospital, relying on nationally recognized guidelines, to decide which things fall on the anesthesia side of the continuum."

The guidelines retain the six broad categories of anesthesia and analgesia, but acknowledge that the level of sedation for a particular medication may vary on the basis of such factors as dosage and route and timing of administration. Thus, it’s possible for the same drug to be used for general anesthesia in the operating room and for sedation in the emergency department (ED) or a procedure room. In what could be considered a mea culpa, the CMS stressed that "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."

Under the current guidelines, hospital policies should address whether specific clinical situations involve anesthesia versus analgesia, and specify the qualifications for each category of practitioner who administers analgesia and their supervision requirements. Federal regulations regarding who may administer anesthesia continue to apply for procedures that require anesthesia.

Hospital policies must be based on nationally recognized guidelines, even though the CMS recognizes that the issuing organizations "may not always fully agree with each other." A hospital could use the American College of Emergency Physicians (ACEP) guidelines in its ED and follow those of the American Society of Anesthesiologists (ASA) for its surgical services.

"There’s more flexibility in terms of a hospital deciding what type of personnel need to be present and involved depending on what type of sedation is used," Ms. Dahl said.

ACEP’s federal affairs director Barbara Tomar agreed that the current revisions provide hospitals with greater flexibility than the 2009 update, which she said was overly restrictive in its interpretation of federal regulations.

"If there is some controversy or disagreement between anesthesiologists and the emergency department, this will provide some clarification and additional evidence that the guidelines developed by the emergency physicians are more than adequate for use in the emergency department," Ms. Tomar said. "We have no qualms about the anesthesiology guidelines being used for surgical services. That’s their bailiwick."

ACEP, jointly with the Emergency Nurses Association and American Academy of Emergency Medicine, wrote to the CMS in March 2010 expressing concern over what constituted anesthesia, particularly with regard to propofol. The college noted that ED physicians are trained to provide resuscitation should propofol administration accidentally result in deep sedation, and that propofol administration by emergency nurses in the presence of an emergency physician complies with current Joint Commission standards.

Propofol is no longer cited as an example of deep sedation, and there is a particular reference in the guidelines to the "unique environment" in the ED, as well as acknowledgment that emergency physicians have "very specific skill sets" that allow them to provide patient rescue and "all levels of analgesia/sedation and anesthesia (moderate to deep to general)."

The failure to specifically address the issue of propofol leaves unfinished business, said sedation expert Dr. John Vargo, a member of the governing board of the American Society for Gastrointestinal Endoscopy (ASGE) and acting chair of the gastroenterology and hepatology department at the Cleveland Clinic.

"The endoscopy society has been collecting evidence-based data over the past 15 years on endoscopist-directed propofol sedation, and frankly, there is no evidence on the other side showing that monitored anesthesia care is safer, more effective, or better tolerated than endoscopist-directed propofol sedation," he said.

Dr. Vargo said he hoped that hospitals would use the evidence available in order to craft an appropriate anesthesia policy regarding propofol and other types of procedural sedation. He also observed that an evidence-based position paper on non-anesthesiologist administration of propofol for GI endoscopy was recently jointly published by the ASGE, American Association for the Study of Liver Disease, American College of Gastroenterology, and American Gastroenterological Association (Gastrointest. Endosc. 2009;70:1053-9).

Dr. Douglas K. Rex, a vocal opponent of the CMS’s position on propofol and director of endoscopy at Indiana University Hospital, Indianapolis, said the CMS guidelines still state that deep sedation is the domain of anesthesia specialists, a concept for which there is virtually no evidence and plenty of evidence that the policy is wrong and unnecessary.

"CMS’s handling of this process has been tragic," he said. "They stuck their noses in an issue they did not and still do not understand."

Dr. Alexander A. Hannenberg, ASA immediate past-president and associate chair of anesthesia at Newton-Wellesley Hospital in Newton, Mass., said the ASA met with CMS officials in April 2010 to contest its position that a labor epidural was not considered anesthesia, and therefore could be administered without physician supervision by certified registered nurse anesthetists (CRNAs).

Dr. Hannenberg said the CMS appeared not to understand the physiology of epidural pain relief, and that epidurals for labor, just as those used as anesthesia for surgery, produce a sympathetic block, or block the nerves that control circulation. He went on to say that the CMS’s previous position appeared to lower the standard of care for laboring women.

"I think they appreciated the physiology lesson, and went back and realized that the distinction was not as crisp or clear as they had originally thought, and removed the language that said it’s different and that the requirement for physician supervision is therefore different," he said.

CRNAs can still administer anesthesia if the hospital is located in one of 16 states that have elected to opt out of the CRNA physician supervision requirement. Ms. Dahl noted, however, that in theory, the updated guidance does not preclude a hospital in a non-opt-out state from choosing to make a determination that labor epidurals are not anesthesia, if it could point to support in nationally recognized guidelines when doing so, and as long as this would not be in violation of the state’s scope of practice law.

Dr. Hannenberg said the ASA also sought changes to the CMS pre- and postanesthesia evaluations. Preanesthesia evaluation must be completed within 48 hours prior to surgery or a procedure requiring anesthesia services, but the CMS clarified that some elements may be performed before then, as long as they are reviewed and appropriately updated within the 48-hour time frame. Dr. Hannenberg said the new wording recognizes that tests are often performed before the 48-hour time frame, and that it is standard of care for all elements of a case to be reassessed by anesthesiologists immediately before anesthesia administration.

The postanesthesia evaluation previously had to be completed before discharge, but may now be completed within 48 hours after a patient is moved to another inpatient location within the hospital or is discharged. This flexibility allows for a more complete evaluation of a patient because some things, such as adverse events, may not be fully knowable until after a patient is sent home, he said.

Ms. Dahl, Dr. Hannenberg, and Dr. Vargo reported no conflicts of interest. Dr. Rex reported consulting and advisory arrangements with American BioOptics, Avantis Medical Systems, CheckCap, Epigenomics, Given Imaging, and SoftScope. He receives grant support from Braintree Laboratories and Given Imaging, and a salary as well as speaking and teaching fees from Olympus America.

The Centers for Medicare and Medicaid Services has revised its recently updated anesthesia guidelines, following complaints the policy was unworkable.

Hospitals are now directed to develop their own internal policies concerning what is anesthesia versus analgesia, which leaves open the option of using different guidelines in different clinical departments. The revisions also provide greater flexibility regarding pre- and postanesthesia evaluations, while particularly problematic references to propofol and labor epidural anesthesia were dropped entirely.

Following the December 2009 release of the updated interpretive guidelines for hospital anesthesia services, practitioners called for clarifications regarding the distinction between anesthesia and analgesia, suggesting that some of the examples didn’t fall clearly on one side or the other of the anesthesia/analgesia spectrum. The use of propofol (Diprivan) during screening colonoscopy was cited as an example of deep sedation, which meant it could only be delivered by providers trained in general anesthesia.

"The examples caused a lot of consternation," acknowledged Marilyn Dahl, director of the Centers for Medicare and Medicaid Services (CMS) survey and certification division of acute care services. "What the current guidelines say is that we are going to leave it up to the hospital, relying on nationally recognized guidelines, to decide which things fall on the anesthesia side of the continuum."

The guidelines retain the six broad categories of anesthesia and analgesia, but acknowledge that the level of sedation for a particular medication may vary on the basis of such factors as dosage and route and timing of administration. Thus, it’s possible for the same drug to be used for general anesthesia in the operating room and for sedation in the emergency department (ED) or a procedure room. In what could be considered a mea culpa, the CMS stressed that "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."

Under the current guidelines, hospital policies should address whether specific clinical situations involve anesthesia versus analgesia, and specify the qualifications for each category of practitioner who administers analgesia and their supervision requirements. Federal regulations regarding who may administer anesthesia continue to apply for procedures that require anesthesia.

Hospital policies must be based on nationally recognized guidelines, even though the CMS recognizes that the issuing organizations "may not always fully agree with each other." A hospital could use the American College of Emergency Physicians (ACEP) guidelines in its ED and follow those of the American Society of Anesthesiologists (ASA) for its surgical services.

"There’s more flexibility in terms of a hospital deciding what type of personnel need to be present and involved depending on what type of sedation is used," Ms. Dahl said.

ACEP’s federal affairs director Barbara Tomar agreed that the current revisions provide hospitals with greater flexibility than the 2009 update, which she said was overly restrictive in its interpretation of federal regulations.

"If there is some controversy or disagreement between anesthesiologists and the emergency department, this will provide some clarification and additional evidence that the guidelines developed by the emergency physicians are more than adequate for use in the emergency department," Ms. Tomar said. "We have no qualms about the anesthesiology guidelines being used for surgical services. That’s their bailiwick."

ACEP, jointly with the Emergency Nurses Association and American Academy of Emergency Medicine, wrote to the CMS in March 2010 expressing concern over what constituted anesthesia, particularly with regard to propofol. The college noted that ED physicians are trained to provide resuscitation should propofol administration accidentally result in deep sedation, and that propofol administration by emergency nurses in the presence of an emergency physician complies with current Joint Commission standards.

Propofol is no longer cited as an example of deep sedation, and there is a particular reference in the guidelines to the "unique environment" in the ED, as well as acknowledgment that emergency physicians have "very specific skill sets" that allow them to provide patient rescue and "all levels of analgesia/sedation and anesthesia (moderate to deep to general)."

The failure to specifically address the issue of propofol leaves unfinished business, said sedation expert Dr. John Vargo, a member of the governing board of the American Society for Gastrointestinal Endoscopy (ASGE) and acting chair of the gastroenterology and hepatology department at the Cleveland Clinic.

"The endoscopy society has been collecting evidence-based data over the past 15 years on endoscopist-directed propofol sedation, and frankly, there is no evidence on the other side showing that monitored anesthesia care is safer, more effective, or better tolerated than endoscopist-directed propofol sedation," he said.

Dr. Vargo said he hoped that hospitals would use the evidence available in order to craft an appropriate anesthesia policy regarding propofol and other types of procedural sedation. He also observed that an evidence-based position paper on non-anesthesiologist administration of propofol for GI endoscopy was recently jointly published by the ASGE, American Association for the Study of Liver Disease, American College of Gastroenterology, and American Gastroenterological Association (Gastrointest. Endosc. 2009;70:1053-9).

Dr. Douglas K. Rex, a vocal opponent of the CMS’s position on propofol and director of endoscopy at Indiana University Hospital, Indianapolis, said the CMS guidelines still state that deep sedation is the domain of anesthesia specialists, a concept for which there is virtually no evidence and plenty of evidence that the policy is wrong and unnecessary.

"CMS’s handling of this process has been tragic," he said. "They stuck their noses in an issue they did not and still do not understand."

Dr. Alexander A. Hannenberg, ASA immediate past-president and associate chair of anesthesia at Newton-Wellesley Hospital in Newton, Mass., said the ASA met with CMS officials in April 2010 to contest its position that a labor epidural was not considered anesthesia, and therefore could be administered without physician supervision by certified registered nurse anesthetists (CRNAs).

Dr. Hannenberg said the CMS appeared not to understand the physiology of epidural pain relief, and that epidurals for labor, just as those used as anesthesia for surgery, produce a sympathetic block, or block the nerves that control circulation. He went on to say that the CMS’s previous position appeared to lower the standard of care for laboring women.

"I think they appreciated the physiology lesson, and went back and realized that the distinction was not as crisp or clear as they had originally thought, and removed the language that said it’s different and that the requirement for physician supervision is therefore different," he said.

CRNAs can still administer anesthesia if the hospital is located in one of 16 states that have elected to opt out of the CRNA physician supervision requirement. Ms. Dahl noted, however, that in theory, the updated guidance does not preclude a hospital in a non-opt-out state from choosing to make a determination that labor epidurals are not anesthesia, if it could point to support in nationally recognized guidelines when doing so, and as long as this would not be in violation of the state’s scope of practice law.

Dr. Hannenberg said the ASA also sought changes to the CMS pre- and postanesthesia evaluations. Preanesthesia evaluation must be completed within 48 hours prior to surgery or a procedure requiring anesthesia services, but the CMS clarified that some elements may be performed before then, as long as they are reviewed and appropriately updated within the 48-hour time frame. Dr. Hannenberg said the new wording recognizes that tests are often performed before the 48-hour time frame, and that it is standard of care for all elements of a case to be reassessed by anesthesiologists immediately before anesthesia administration.

The postanesthesia evaluation previously had to be completed before discharge, but may now be completed within 48 hours after a patient is moved to another inpatient location within the hospital or is discharged. This flexibility allows for a more complete evaluation of a patient because some things, such as adverse events, may not be fully knowable until after a patient is sent home, he said.

Ms. Dahl, Dr. Hannenberg, and Dr. Vargo reported no conflicts of interest. Dr. Rex reported consulting and advisory arrangements with American BioOptics, Avantis Medical Systems, CheckCap, Epigenomics, Given Imaging, and SoftScope. He receives grant support from Braintree Laboratories and Given Imaging, and a salary as well as speaking and teaching fees from Olympus America.

The Centers for Medicare and Medicaid Services has revised its recently updated anesthesia guidelines, following complaints the policy was unworkable.

Hospitals are now directed to develop their own internal policies concerning what is anesthesia versus analgesia, which leaves open the option of using different guidelines in different clinical departments. The revisions also provide greater flexibility regarding pre- and postanesthesia evaluations, while particularly problematic references to propofol and labor epidural anesthesia were dropped entirely.

Following the December 2009 release of the updated interpretive guidelines for hospital anesthesia services, practitioners called for clarifications regarding the distinction between anesthesia and analgesia, suggesting that some of the examples didn’t fall clearly on one side or the other of the anesthesia/analgesia spectrum. The use of propofol (Diprivan) during screening colonoscopy was cited as an example of deep sedation, which meant it could only be delivered by providers trained in general anesthesia.

"The examples caused a lot of consternation," acknowledged Marilyn Dahl, director of the Centers for Medicare and Medicaid Services (CMS) survey and certification division of acute care services. "What the current guidelines say is that we are going to leave it up to the hospital, relying on nationally recognized guidelines, to decide which things fall on the anesthesia side of the continuum."

The guidelines retain the six broad categories of anesthesia and analgesia, but acknowledge that the level of sedation for a particular medication may vary on the basis of such factors as dosage and route and timing of administration. Thus, it’s possible for the same drug to be used for general anesthesia in the operating room and for sedation in the emergency department (ED) or a procedure room. In what could be considered a mea culpa, the CMS stressed that "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."

Under the current guidelines, hospital policies should address whether specific clinical situations involve anesthesia versus analgesia, and specify the qualifications for each category of practitioner who administers analgesia and their supervision requirements. Federal regulations regarding who may administer anesthesia continue to apply for procedures that require anesthesia.

Hospital policies must be based on nationally recognized guidelines, even though the CMS recognizes that the issuing organizations "may not always fully agree with each other." A hospital could use the American College of Emergency Physicians (ACEP) guidelines in its ED and follow those of the American Society of Anesthesiologists (ASA) for its surgical services.

"There’s more flexibility in terms of a hospital deciding what type of personnel need to be present and involved depending on what type of sedation is used," Ms. Dahl said.

ACEP’s federal affairs director Barbara Tomar agreed that the current revisions provide hospitals with greater flexibility than the 2009 update, which she said was overly restrictive in its interpretation of federal regulations.

"If there is some controversy or disagreement between anesthesiologists and the emergency department, this will provide some clarification and additional evidence that the guidelines developed by the emergency physicians are more than adequate for use in the emergency department," Ms. Tomar said. "We have no qualms about the anesthesiology guidelines being used for surgical services. That’s their bailiwick."

ACEP, jointly with the Emergency Nurses Association and American Academy of Emergency Medicine, wrote to the CMS in March 2010 expressing concern over what constituted anesthesia, particularly with regard to propofol. The college noted that ED physicians are trained to provide resuscitation should propofol administration accidentally result in deep sedation, and that propofol administration by emergency nurses in the presence of an emergency physician complies with current Joint Commission standards.

Propofol is no longer cited as an example of deep sedation, and there is a particular reference in the guidelines to the "unique environment" in the ED, as well as acknowledgment that emergency physicians have "very specific skill sets" that allow them to provide patient rescue and "all levels of analgesia/sedation and anesthesia (moderate to deep to general)."

The failure to specifically address the issue of propofol leaves unfinished business, said sedation expert Dr. John Vargo, a member of the governing board of the American Society for Gastrointestinal Endoscopy (ASGE) and acting chair of the gastroenterology and hepatology department at the Cleveland Clinic.

"The endoscopy society has been collecting evidence-based data over the past 15 years on endoscopist-directed propofol sedation, and frankly, there is no evidence on the other side showing that monitored anesthesia care is safer, more effective, or better tolerated than endoscopist-directed propofol sedation," he said.

Dr. Vargo said he hoped that hospitals would use the evidence available in order to craft an appropriate anesthesia policy regarding propofol and other types of procedural sedation. He also observed that an evidence-based position paper on non-anesthesiologist administration of propofol for GI endoscopy was recently jointly published by the ASGE, American Association for the Study of Liver Disease, American College of Gastroenterology, and American Gastroenterological Association (Gastrointest. Endosc. 2009;70:1053-9).

Dr. Douglas K. Rex, a vocal opponent of the CMS’s position on propofol and director of endoscopy at Indiana University Hospital, Indianapolis, said the CMS guidelines still state that deep sedation is the domain of anesthesia specialists, a concept for which there is virtually no evidence and plenty of evidence that the policy is wrong and unnecessary.

"CMS’s handling of this process has been tragic," he said. "They stuck their noses in an issue they did not and still do not understand."

Dr. Alexander A. Hannenberg, ASA immediate past-president and associate chair of anesthesia at Newton-Wellesley Hospital in Newton, Mass., said the ASA met with CMS officials in April 2010 to contest its position that a labor epidural was not considered anesthesia, and therefore could be administered without physician supervision by certified registered nurse anesthetists (CRNAs).

Dr. Hannenberg said the CMS appeared not to understand the physiology of epidural pain relief, and that epidurals for labor, just as those used as anesthesia for surgery, produce a sympathetic block, or block the nerves that control circulation. He went on to say that the CMS’s previous position appeared to lower the standard of care for laboring women.

"I think they appreciated the physiology lesson, and went back and realized that the distinction was not as crisp or clear as they had originally thought, and removed the language that said it’s different and that the requirement for physician supervision is therefore different," he said.

CRNAs can still administer anesthesia if the hospital is located in one of 16 states that have elected to opt out of the CRNA physician supervision requirement. Ms. Dahl noted, however, that in theory, the updated guidance does not preclude a hospital in a non-opt-out state from choosing to make a determination that labor epidurals are not anesthesia, if it could point to support in nationally recognized guidelines when doing so, and as long as this would not be in violation of the state’s scope of practice law.

Dr. Hannenberg said the ASA also sought changes to the CMS pre- and postanesthesia evaluations. Preanesthesia evaluation must be completed within 48 hours prior to surgery or a procedure requiring anesthesia services, but the CMS clarified that some elements may be performed before then, as long as they are reviewed and appropriately updated within the 48-hour time frame. Dr. Hannenberg said the new wording recognizes that tests are often performed before the 48-hour time frame, and that it is standard of care for all elements of a case to be reassessed by anesthesiologists immediately before anesthesia administration.

The postanesthesia evaluation previously had to be completed before discharge, but may now be completed within 48 hours after a patient is moved to another inpatient location within the hospital or is discharged. This flexibility allows for a more complete evaluation of a patient because some things, such as adverse events, may not be fully knowable until after a patient is sent home, he said.

Ms. Dahl, Dr. Hannenberg, and Dr. Vargo reported no conflicts of interest. Dr. Rex reported consulting and advisory arrangements with American BioOptics, Avantis Medical Systems, CheckCap, Epigenomics, Given Imaging, and SoftScope. He receives grant support from Braintree Laboratories and Given Imaging, and a salary as well as speaking and teaching fees from Olympus America.