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Centers for Medicare & Medicaid Services

View Public Comments for Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement (CAG-00250R3)

Commenter:
Purcell, Frank
Date:
02/22/2013
Comment:

Dear Ms. O’Connor:

The American Association of Nurse Anesthetists (AANA) submits this comment on behalf of our more than 45,000 Certified Registered Nurse Anesthetist (CRNA) and student nurse anesthetist members who have been affected or are potentially affected by the Medicare National Coverage Determination (NCD) for bariatric surgery. As long as Medicare coverage for bariatric surgery hinges upon a bariatric certification requirement that mandates anesthesiologist supervision of CRNAs, the AANA supports removing the bariatric facility certification requirement included in the NCD for the following reasons:

  • Numerous studies find no difference in the quality of care provided by CRNAs or anesthesiologists, dismissing any justification for an anesthesiologist supervision mandate in bariatric surgery centers.
  • The proposed anesthesia accreditation standard, which requires anesthesiologist supervision of CRNAs, is more burdensome than current CMS requirements, state law, and other accrediting bodies’ standards, without benefit of quality improvement or cost efficiency.
  • The proposed anesthesia accreditation standard would impair patient access to care and drive up healthcare costs.
  • The proposed anesthesia accreditation standard increases burdens in a manner counter to efforts by the Administration and the CMS to reduce regulatory burden.

Background of the AANA and CRNAs

CRNAs are advanced practice registered nurses (APRNs) who personally administer more than 33 million anesthetics to patients each year in the United States, according to the 2011 AANA Practice Profile Survey. CRNAs are Medicare Part B providers and since 1989, have billed Medicare directly for 100 percent of the physician fee schedule amount for services.

CRNA services include providing a preanesthesia patient assessment, obtaining informed consent for anesthesia administration, developing a plan for anesthesia administration, administering the anesthetic, monitoring and interpreting the patient's vital signs, and managing the patient throughout the surgery and in the postoperative period. CRNAs also provide acute and chronic pain management services. CRNAs provide anesthesia for a wide variety of surgical cases and in some counties are the sole anesthesia providers in nearly 100 percent of rural hospitals, affording these medical facilities obstetrical, surgical, trauma stabilization, and pain management capabilities. According to a May/June 2010 study published in the journal of Nursing Economic$, CRNAs acting as the sole anesthesia provider are the most cost-effective model for anesthesia delivery, and there is no measurable difference in the quality of care between CRNAs and other anesthesia providers or by anesthesia delivery model.[1] Furthermore, an August 2010 study published in Health Affairs shows no differences in patient outcomes when anesthesia services are provided by CRNAs, physicians, or CRNAs supervised by physicians.[2]

According to a 2007 Government Accountability Office (GAO) study, CRNAs are the principal anesthesia provider where there are more Medicare beneficiaries and where the gap between Medicare and private pay is less.[3] Nurse anesthesia predominates in Veterans Hospitals and in the U.S. Armed Forces. CRNAs work in every setting in which anesthesia is delivered including hospital surgical suites and obstetrical delivery rooms, ambulatory surgical centers (ASCs), pain management facilities, and the offices of dentists, podiatrists, and all types of specialty surgeons.

Numerous Studies Find No Difference in the Quality of Care Provided by CRNAs or Anesthesiologists, Dismissing Any Justification for an Anesthesiologist Supervision Mandate in Bariatric Surgery Centers.

The AANA supports the proposal to remove the bariatric facility certification requirement included in the NCD so long as there is any accreditation standard that impedes CRNA provision of care in bariatric facilities such as an anesthesiology or physician supervision requirement. No evidence supports a mandate for anesthesiologist or physician supervision of CRNA services. Such a mandate increases cost without improving quality of care. In fact, recent evidence demonstrates that bariatric surgery has few serious complications and has become so safe that the data shows no difference between COE and non COE.[4] This evidence flies in the face of a professional group trying to impose additional supervision requirements on CRNAs for a procedure with low complication rates and low mortality.

As you are aware, CMS recognizes bariatric surgery centers that have been certified by either American College of Surgeons (ACS) or the American Society for Metabolic and Bariatric Surgery (ASMBS), and covers bariatric surgical procedures only to the extent that they are provided in such recognized facilities. The American College of Surgeons (ACS) Level I standard has required anesthesiologist direct provision of anesthesia care or anesthesiologist supervision of CRNAs. The ASMBS Center of Excellence outpatient center anesthesia accreditation requirement also mandates anesthesiologist supervision of CRNAs. In contrast, the current ASMBS hospital accreditation standard does not require that an anesthesiologist participate in, or supervise, anesthesia services when CRNAs deliver anesthesia care nor does it require physician supervision of CRNAs. As the ACS and ASMBS bariatric accreditation programs have merged, the new program has proposed an accreditation requirement for all hospital and outpatient bariatric programs that an anesthesiologist provide anesthesia services or supervise anesthesia services when CRNAs deliver anesthesia care.

The AANA strongly opposes these anesthesiologist requirements as they have no valid scientific basis, and numerous studies dismiss the need for such requirements.

An August 2010 study published in the nation’s leading health policy journal Health Affairs finds no differences in patient outcomes of anesthesia services delivered by solo CRNAs, by solo anesthesiologists, or by CRNAs being supervised by anesthesiologists.[5] The authors analyzed nearly 500,000 hospitalizations in 14 opt-out states (i.e., the 14 states that, at the time of the study, had opted out of the Medicare physician supervision requirement for CRNAs; there are now a total of 17 opt-out states) and concluded that allowing CRNAs to administer anesthesia services without physician supervision does not put patients at risk. In fact, the authors found no increase in the odds of a patient dying or experiencing complications in states that had opted out.

A study in the May-June 2010 issue of the Journal of Nursing Economic$ had similar findings.[6] This article stated that research studies have found “no significant differences in rates of anesthesia complications or mortality between CRNAs and anesthesiologists or among delivery models for anesthesia that involve CRNAs, anesthesiologists, or both after controlling for other pertinent factors.…” The article further noted that “[g]iven the low incidence of adverse anesthesia-related complications and anesthesia-related mortality rates in general, it is not surprising that there are no studies that show a significant difference between CRNAs and anesthesiologists in patient outcomes.” Based on current quality of care evidence, the article concluded that CRNAs can perform the same set of anesthesia services as anesthesiologists.

These studies also correspond with a recommendation from the Institute of Medicine’s (IOM) report The Future of Nursing: Leading Change, Advancing Health, which outlines several paths by which patient access to care may be expanded, quality preserved or improved, and costs controlled through greater use of APRNs.[7] The IOM report specifically recommends that, “advanced practice registered nurses should be able to practice to the full extent of their education and training.”[8]

For additional information regarding anesthesia quality of care studies, see the AANA publication titled Quality of Care in Anesthesia (available at http://www.aana.com/resources2/professionalpractice/Pages/Professional-Practice-Manual.aspx.) The Quality of Care synopsis includes evidence that directly concerns the high quality of anesthesia care that CRNAs deliver, regardless of whether they are supervised by anesthesiologists.

The Proposed Accreditation Standard Requiring Anesthesiologist Supervision is More Burdensome than Current CMS Rules, State Law, and Other Accrediting Bodies’ Standards, Without Benefit of Quality Improvement or Cost Efficiency.

We note that the ACS/ACMBS proposed accreditation standard for anesthesiologist delivered care and anesthesiologist supervision is more burdensome and costly than the current CMS Conditions of Participation (CoP) and Conditions of Coverage (CfCs) for hospitals, critical access hospitals, and ambulatory surgery centers. By law, states may opt out of the Medicare physician supervision requirements for CRNA services; 17 have opted out thus far, in part because the evidence demonstrates that Part A physician supervision requirements do not advance patient safety and do increase healthcare costs. If that is the case, then there is no justification for CMS to hinge Medicare coverage of bariatric surgery upon ACS/ACMBS accreditation standards that require anesthesiologist supervision of CRNAs – a requirement that does not exist in current CMS rules.

This proposed accreditation standard is also more burdensome than state law, without providing advantages in patient safety or cost effectiveness. Forty-nine states do not require that CRNAs work under anesthesiologist supervision (New Jersey is the only state that does, and only in the ambulatory surgery center setting) and the vast majority of states do not require any physician supervision of CRNA services. The National Council of State Boards of Nursing (NCSBN) Model Nursing Practice Act and Model Nursing Administrative Rules for APRNs do not require anesthesiologist or physician supervision. All state boards of nursing belong to the NCSBN, which serves as primary policy advisers to the boards. The NCSBN’s “APRN Model Act/Rules and Regulations” (NCSBN APRN models) do not include supervision of APRNs such as CRNAs, nor do they include a requirement that a physician be “onsite” or “present.” This is further evidence that such restrictions are unnecessary.[9]

National accreditation standards of The Joint Commission, the Accreditation Association for Ambulatory Health Care (AAAHC), and the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) do not require anesthesiologist supervision of CRNAs. None of these accrediting agencies require physician supervision of CRNAs unless federal or state law imposes such a requirement. A hospital that provides a range of surgical services with anesthesia care provided exclusively by CRNAs should not be required by Medicare to hire an anesthesiologist at considerable cost to supervise those CRNA services solely because one of the service types the facility offers is bariatric surgery.

The Proposed Anesthesia Accreditation Standard Would Impair Patient Access to Care and Increase Health Care Costs

The AANA remains concerned that the ACS/ASMBS proposed standards would severely limit patient access to care and drive up healthcare costs. Adoption of the merged program’s proposed requirements for anesthesia services would disqualify from accreditation hospital bariatric programs currently accredited by the ASMBS that have long provided anesthesia services exclusively by CRNAs to bariatric patients safely and effectively. This will negatively affect patients in communities that rely on CRNA-only staffing models to deliver anesthesia for their bariatric care. For example, an ASMBS accredited bariatric surgery program in a rural Minnesota critical access hospital and staffed with a CRNA-only model faces closure if the anesthesiologist supervision mandate is adopted. A similar bariatric program in Kansas faces the same fate if the merged program draft standard is approved.

Among all anesthesia delivery models, anesthesia care delivered by CRNAs is extremely safe and 25 percent more cost effective than the next least costly model.[10] By contrast, instituting anesthesiologist supervision of four concurrent CRNA cases where it did not previously exist increases the cost of anesthesia care by more than 60 percent. When anesthesiologist supervision is required, facilities have to bear the expense. The cost burden of hiring anesthesiologists and maintaining their salaries could put healthcare facilities, including needed rural hospitals, out of business.

The Proposed Anesthesia Accreditation Standard Would Increase Burdens in a Manner Counter to Efforts by the Administration and the CMS to Reduce Regulatory Burden

The AANA notes that the proposed anesthesia accreditation standard would increase regulatory burden for facilities without improving healthcare quality or reducing its cost. This action is counter to the efforts by the Administration and the CMS efforts to reduce regulatory burden. In January 2011, President Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review” recognizing that our regulatory system should be designed to promote “economic growth, innovation, competitiveness, and job creation.” CMS has also issued various rules to reduce regulatory burden.[11] Imposing these additional burdensome requirements on facilities would impair the Administration’s other efforts toward regulatory reform.

Conclusion

In summary, adoption of the proposed anesthesia accreditation standard and approval by CMS will have an immediate and significant anticompetitive effect in the market for the provision of anesthesia care for bariatric procedures, by negatively impacting patient choice and access to care, increasing cost of care and impairing innovation in care models for bariatric patients, and by restricting competition between qualified anesthesia professionals.

We thank you for the opportunity to comment. Should you have any questions regarding these matters, please feel free to contact the AANA Senior Director of Federal Government Affairs, Frank Purcell, at 202.484.8400, fpurcell@aanadc.com.

Sincerely,

Janice J. Izlar, CRNA, DNAP, AANA President
American Association of Nurse Anesthetists
222 S. Prospect Ave.
Park Ridge, IL 60068-4001
____________________
[1] Paul F. Hogan et. al, “Cost Effectiveness Analysis of Anesthesia Providers.” Nursing Economic$. 2010; 28:159-169.
[2] B. Dulisse and J. Cromwell, “No Harm Found When Nurse Anesthetists Work Without Physician Supervision.” Health Affairs. 2010; 29: 1469-1475.
[3] U.S. Government Accountability Office (GAO). Medicare Physician Payments: Medicare and Private Payment Differences for Anesthesia Services. Report to Subcommittee on Health, Committee on Ways and Means, U.S. House of Representatives. GAO-07-463. July 2007;15. http://www.gao.gov/new.items/d07463.pdf.
[4] Birkmeyer NO, Dimick JM, Share D: “Hospital Complication Rates With Bariatric Surgery in Michigan” JAMA. 2010;304(4):435-442.
[5] B. Dulisse and J. Cromwell op cit.
[6] Paul F. Hogan et. al, op cit.
[7] IOM (Institute of Medicine). The Future of Nursing: Leading Change, Advancing Health (Washington, DC: The National Academies Press, 2011), p. 10.
[8] IOM op. cit., p. 9.
[9] See APRN Act and Rules at https://www.ncsbn.org/APRN_leg_language_approved_8_08.pdf.
[10] Paul F. Hogan et. al, op cit.
[11] See for example 77 Fed. Reg. 29034, May 16, 2012 and 78 Fed. Reg. 9217, February 7, 2013.
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