Surgery on the Wrong Body Part

January 1, 2009

Mr. Kerry N. Weems
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 314-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: CAG-00402N, Surgery on Wrong Body Part; CAG-00403N, Surgery on the Wrong Patient; and CAG-00401N, Wrong Surgery Performed on a Patient (December 2, 2008).

Dear Acting Administrator Weems:

On behalf of the physician and medical student members of the American Medical Association (AMA), we appreciate the opportunity to provide comments concerning the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determinations (NCDs) for Surgery on the Wrong Body Part, Surgery on the Wrong Patient, and Wrong Surgery Performed on a Patient.

We reiterate below our comments that we previously submitted to CMS in response to CMS’ announcement of its plan to develop these proposed NCDs. The AMA is extremely disappointed that CMS is moving forward with the NCDs in this procedural manner. NCDs typically do not generate widespread public comment as does public notice and comment requested through a Federal Register proposed rulemaking. In addition, there is only a 30-day public comment period for these NCDs. This substantially truncated process affords little opportunity for adequate notice and public comment. The failure to elicit thorough public discussion on these important matters results in policies that leave many critical questions unanswered, such as defining the surgical event errors covered by the proposed NCDs, as well as accountability and the scope of non-payment for these events. Physicians and providers must have clear guidance on Medicare coverage and payment policy, but the NCD process in these instances is a complete obstacle to this goal. Without the benefit of public input from those with hands-on expertise in these matters, this NCD process only creates confusion and ill-conceived Medicare policy.

Medicare NCDs set national policy on whether Medicare will cover an item or service and under what conditions. The AMA does not believe that it is appropriate for CMS to use the NCD process to address its concerns regarding the aforementioned surgical procedures.

Rather, CMS should develop a clear payment policy outlining the circumstances under which surgery claims would not be payable by Medicare. For example, if a physician failed to use commonly accepted patient safety practices which resulted in surgery on a wrong body part, a Medicare carrier might deny partial or complete payment for the service claim. The issue at question is not whether surgical procedures will be covered by the Medicare program, but rather under what circumstances the payment for covered surgical procedures will be denied or reduced. Further, because of the many nuances surrounding these surgical conditions, it is important that any payment policy determinations include an appeals process for physicians and hospitals to petition any decisions that they believe were made inappropriately.

CMS typically initiates a coverage review process due to questions about the evidence behind the clinical effectiveness of a service, conflicting local coverage policies, or medical advances in the care or diagnosis of a disease or condition. None of the three surgical conditions presents an issue that generally would qualify them for development of a NCD. Medicare claims processing personnel do not have the expertise necessary to make determinations about whether particular surgical procedures were performed correctly. We are very concerned that patients will wrongly be denied coverage of Medicare services due more to errors in judgment by contractors than errors by a surgical team. Further, coverage decisions are far-reaching. Would coverage denials extend to every facility and health professional involved in the person’s care, or would contractors attempt to assess “blame” on a particular individual? Therefore, we urge CMS to withdraw these NCDs, and explore options for revising Medicare payment policies associated with these three surgical conditions. For example, CMS has established payment polices to address coding edits, as well as global and multiple surgery policy.

The AMA appreciates the opportunity to comment, and we look forward to working with CMS to achieve consensus on the foregoing matters. If you should have questions regarding this correspondence, please contact Jennifer Shevchek, Assistant Director, Federal Affairs, at 202-789-4688, or jennifer.shevchek@ama-assn.org.

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December 31, 2008

Kerry Weems, Acting Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
Hubert H. Humphrey Building
Room 314-G
200 Independence Avenue, SW
Washington, DC 20201

Re: CAG-00401N – Wrong Surgery Performed on a Patient; CAG-00402N – Surgery on the Wrong Body Part; CAG-00403N – Surgery on the Wrong Patient;

Dear Mr. Weems:

The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) appreciate the opportunity to provide comments regarding the Centers for Medicare and Medicare Services’ (CMS) proposal to develop three new National Coverage Determinations (NCDs) that address Medicare coverage of certain surgical procedures, including Surgery on the Wrong Body Part, Surgery on the Wrong Patient, and Wrong Surgery Performed on a Patient. The AANS and CNS, representing 4,000 practicing neurosurgeons across the United States, are dedicated to ensuring that its members provide the highest quality of care to their patients. Patient safety and high quality outcomes are very high priorities of the AANS and CNS, and both organizations have publicly endorsed the Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery, which offer clear, concise solutions to help physicians eliminate preventable surgical errors.

The AANS and CNS believe that serious, truly preventable medical errors are intolerable and that it is not reasonable for Medicare or other payers to reimburse a physician, hospital, or other provider for costs associated with such errors. However, we question whether the Medicare NCD process is the most effective way for CMS to address its concerns about “wrong” surgeries. Medicare NCDs set national policy on whether and under what conditions Medicare will cover an item or service. We request that CMS instead consider the value of developing a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.

For example, if a physician failed to use commonly accepted patient safety practices, which resulted in surgery on a wrong body part, a Medicare carrier might deny partial or complete payment for the service or claim. The issue at question is not whether surgical procedures would be covered by the Medicare program, but rather, under what circumstances the payment for covered surgical procedures would be denied or reduced. Payment determinations, unlike the NCD approach, are more sensitive to the nuanced nature of surgical procedures and include appeal mechanisms through which physicians and other providers can petition decisions that they believe are inappropriate. Under the NCD approach, providers have absolutely no recourse if they believe CMS inaccurately determined that a particular surgery should not be covered.

If CMS proceeds with the NCD approach to “wrong” surgeries, rather than make payment policy changes, it is critical that the NCD language be written in a way that is sensitive to the nuanced nature of surgical procedures. In medicine, but especially in surgery, clinical scenarios are not clear cut and often are not foreseeable. Given this reality, the NCD language must provide flexibility and ensure that those who make a good faith effort to provide high quality of care are not inappropriately penalized. We greatly appreciate that under the proposed NCD language for Surgery on the Wrong Body Part and Wrong Procedure Performed on a Patient, CMS excludes emergent situations that occur in the course of surgery and/or whose exigency preludes obtaining informed consent. This statement is absolutely critical. We also appreciate CMS’ statement that the NCDs are “not intended to capture changes in the surgical plan after surgical entry into the patient based on the discovery of unusual physical configuration or pathology in close proximity to the intended site when the risk of a second surgery outweighs the benefit of patient consultation.” We request that CMS modify this statement so that it reflects changes that occur at anytime following anesthesia induction, rather than simply surgical entry. We also request that CMS strengthen this statement by making it an explicit exclusion to the NCD policy.

The AANS and CNS wholeheartedly agree with CMS that Surgery on the Wrong Body Part, such as operating on the left leg instead of the right leg, is unwarranted and should not be reimbursed by Medicare. However, we are concerned that the proposed NCD language on wrong body part may be too broadly defined. In particular, we are concerned about the inclusion of spine level in the classification of wrong body part. Unlike other events that may fall under this NCD, wrong level surgery in the spine is not completely avoidable, even when using intra-operative imaging. It can be extremely difficult to precisely verify the correct disc level prior to performing lumbar spine surgery on patients with morbid obesity or to correctly identify lower cervical spine levels in patients with large shoulders. These determinations are always going to require some amount of human judgment, which is certainly not error proof. In addition, reinterpretation of preoperative imaging during surgery may result in a correct judgment to extend surgery to alternative or additional spinal levels beyond that planned preoperatively. The AANS and CNS strongly urge CMS to either exempt wrong spine levels from its NCD proposal or to include an additional statement that excludes exceptional circumstances from non-coverage determinations, such as situations where patient characteristics can impede identification of the precise location prior to surgical entry into the patient.

The AANS and CNS commend CMS for attempting to eliminate serious and truly preventable medical errors through its proposed NCDs. We believe this is a much more rational policy proposal than CMS’ current hospital-acquired condition (HAC) non-payment policy. As we have expressed in previous comments, the HAC policy erroneously targets conditions that cannot ever be reduced to zero (e.g., surgical site infections); does not recognize patient case-mix or situations where a complication occurs despite strict adherence to evidence-based guidelines (e.g., a percentage of patients will still develop surgical site infections, despite adherence to the most appropriate prophylactic measures); and does little to recognize the value of quality in relation to the cost of compliance. The AANS and CNS continue to object to the current HAC policy and other future expansions of this policy for conditions that are not 100% preventable even when physicians and hospitals follow all established procedures to eliminate such conditions. We urge CMS to focus its limited resources on more pressing problems, such as wrong person and wrong site surgeries and other more serious, preventable events, rather than attempt to expand its current HAC policy to other health care settings. Providing and delivering the highest possible patient safety standards is an integral component of improving the nation’s healthcare system. We appreciate the opportunity to comment on these proposed NCDs and look forward to continuing a dialogue with CMS on this important matter.

Sincerely,

James R. Bean, MD, President
American Association of Neurological Surgeons

P. David Adelson, MD, President
Congress of Neurological Surgeons

cc: Robert E. Harbaugh, MD, Chairman, AANS/CNS Washington Committee
Gregory Przybylski, MD, Chairman, AANS/CNS Coding and Reimbursement Committee
Daniel K. Resnick, MD, Chairman, AANS/CNS Quality Improvement Workgroup
AANS/CNS Staff Contact:
Rachel Groman
Senior Manager for Quality Improvement and Research
AANS/CNS Washington Office
725 15th Street, NW, Suite 500
Washington, DC 20005
Phone: 202-628-2072
Fax: 202-628-5264
Email: rgroman@neurosurgery.org

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Astellas submits these comments to the Centers for Medicare and Medicaid Services (CMS) in response to the following three proposed national coverage determinations (NCDs) that would establish non-coverage policies for certain medical errors: Surgery on Wrong Body Part (CAG-00402N), Surgery on the Wrong Patient (CAG-00403N), and Wrong Surgery Performed on a Patient (CAG-00401N).

Astellas is a top 20 global pharmaceutical company that has sought FDA approval for an antibiotic that would be used to treat certain serious infections associated with methicillin-resistant Staphylococcus aureus (MRSA) infections. We have carefully examined the issues surrounding CMS’ hospital-acquired conditions (HAC) program under the inpatient prospective payment system (IPPS), and have provided CMS with a series of comment letters intended to help CMS implement that program in a way that promotes the HAC statute’s underlying goals: i.e., encouraging hospitals to take measures that prevent or reduce the incidence of serious conditions such as infections, without penalizing hospitals for treating inpatients who acquire conditions that are not reasonably preventable or jeopardizing their ability to provide high-quality care to hospital inpatients with very serious conditions.

In addition to the goal of reducing preventable hospital-acquired conditions, the HAC program and the proposed NCDs also share the potential for similar unintended, adverse impacts on patient care. With this in mind, we offer the following recommendations to CMS regarding the proposed NCDs:

I agree whole-heartedly with the principles and theory behind Medicare not paying for surgery on the wrong body parts, wrong patients, etc. However, when these type of events occur there are likely subsequent operations and patient care issues that arise. By saying that CMS won''t pay for care related to these operations, CMS may be placing the patient in an unfortunate situation. For example, as a private practice anesthesiologist, if I am called by a surgeon who amputed the wrong foot and now needs to take the patient back to the operating to operate on the correct foot, am I going to want to be involved in this case if there is even a chance that I may not be paid for my services by Medicare? Normally when things like this happen, most physicians will not want to be involved in thes cases PERIOD because they frequently end up in court later. The only real incentive to be involved is a) to help the patient and b) getting paid for your services. CMS needs to make sure that those who are innocent in these situations (the subsequent surgeons, hospitals, surgery centers, anesthesiologists) are still paid for these services and that language in the regulations is specific and without ambiguity that these providers will be reimbursed for their services. I think CMS is potentially placing their patients into a bad situation where doctors are not going to want to be involved in the care of these patients who have suffered an already tragic event.

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In a situation where the wrong kidney was removed and the patient then became anephritic and required dialysis for the rest of their life or until a suitable donor was found, would the hospital removing the incorrect kidney be financially responsible for the patient''s care for the rest of their life, or would those services be considered medically necessary?Also, at what point would the non-covered services end and the medically necessary services begin provided the patient was considered covered after the surgical error? Does the NCD only cover the specific episode of care?

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December 30, 2008

Kerry Weems, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: Proposed Decision Memos for Wrong Surgery Performed on a Patient (CAG-00401N), Surgery on the Wrong Body Part (CAG-00402N) and Surgery on the Wrong Patient (CAG-00403N)

Dear Administrator Weems:

On behalf of our more than 2,600 member facilities and their affiliated health care professionals, the Ambulatory Surgery Center Association (the ASC Association) appreciates this opportunity to comment on the proposed national coverage determinations (NCDs) for wrong surgery performed on a patient, surgery on the wrong body party and surgery on the wrong patient (which we will collectively refer to as “wrong site surgery”) recently released by the Centers for Medicare & Medicaid Services (CMS) for public comment.

High quality care and patient safety are hallmarks of the ASC industry, and over the past decade the ASC Association and its members have been leaders in promoting and adopting proactive measures to prevent wrong site surgery. In particular, we were among the first organizations to endorse the Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery™ and have provided extensive education and training to our members on the protocol’s use in ASCs. As a result, the Universal Protocol has become, in a relatively short period of time, the standard of care in ASCs nationwide. Since the mid-1990s, members of the ASC Association also have participated in a voluntary “Outcomes Monitoring Project” that now involves over 600 ASCs reporting and sharing data on more than 30 clinical outcomes and operations measures, including incidents of wrong site surgery and performance of monthly “correct site audits” to verify compliance with the Universal Protocol. This year, 95 percent of the facilities participating in our Outcomes Monitoring Project submitted data on wrong site surgery measures, which we believe indicates a high level of attention among ASCs to this important issue.

Additional evidence of the ASC industry’s commitment to preventing wrong site surgery is found in its development of standardized quality measures that include the prevention of wrong site surgery as a key component. More specifically, in 2006, leaders from the ASC industry joined with accrediting bodies and associations representing physicians and nurses to form the ASC Quality Collaboration for the purpose of developing a standardized set of ASC quality measures for use in (1) collaborating with CMS and others in the public reporting of quality information, (2) developing pay-for-performance programs, (3) responding to state data collection initiatives, and (4) benchmarking for quality improvement in individual ASCs. Earlier this year, the National Quality Forum (NQF) endorsed five quality measures for ASCs developed by the ASC Quality Collaboration, including incidents of wrong site surgery (the other four ASC measures endorsed by NQF are patient burns, prophylactic intravenous antibiotic timing, patient falls and hospital transfers). The ASC Association continues to urge CMS to adopt these five measures in a comprehensive quality reporting system for ASCs and hospital outpatient departments that we would like to see implemented in 2010. In the meantime, we have partnered with the Missouri ASC Association to develop a website that provides data for the public on patient satisfaction, hospital transfer rates and wrong site surgery for ASCs in Missouri. Again, the fact that wrong site surgery was one of only three measures that we chose to focus on in this pilot project is further evidence of the primary importance of this issue for our members.

We believe a sustained commitment to following and refining the Universal Protocol and to tracking and reporting wrong site surgery as an essential quality measure are the keys to raising awareness and preventing wrong site surgery. We also believe that new NCDs are not needed to sustain the momentum of those efforts. Certainly, our members already understand that claims should not be submitted and Medicare payment should not be made for wrong site surgery that provides no medical benefit to the patient – that is, such surgery clearly is not medically necessary and, thus, not covered under longstanding and well-recognized Medicare payment policy. Our main concern is that the issuance now of detailed and highly-publicized NCDs – long after other, more effective measures to prevent wrong site surgery have been implemented – imply, and send the message to the general public, that billing for wrong site surgery is a major problem and that providers are not sufficiently focused on the issue, neither of which is the case from our perspective.

Moreover, we concur with the American Medical Association (AMA) that the NCD process is not particularly well-suited to addressing the issue of wrong site surgery. Medicare NCDs are designed to set uniform national policies on whether particular items or services should be covered and under what conditions; they are much less appropriate for sorting out more nuanced facts and circumstances, like whether a particular procedure was performed on the wrong site. Consider, for example, a case involving bilateral procedures, such as cataract surgery that is needed for both eyes. If the first surgery is inadvertently performed on the “wrong site” as defined under the proposed NCDs – that is, a cataract is removed from the patient’s left eye when the right eye was scheduled first and was the procedure described in the informed consent – should that procedure necessarily be excluded from Medicare coverage if it was medically necessary and benefited the patient? While such situations admittedly may be rare, they illustrate the shortcomings of trying to address the fact-specific issue of wrong site surgery through blanket coverage policies.

Thus, in our view, a more simple policy statement based on the lack of medical necessity for wrong site surgery would be preferable to the proposed NCDs. Accordingly, we join with the AMA in urging CMS to reconsider the NCD approach.

Thank you for your consideration of our comments. We look forward to continuing to work with CMS on implementing a quality reporting system for ASCs and other measures aimed at helping promote the safety of Medicare beneficiaries.

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December 29,2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

Re: CAG-00403N, CAG-00402N, and CAG-00401N

Cleveland Clinic is a fully integrated, not-for-profit healthcare system with 1,800 salaried physicians and scientists dedicated to patient care, teaching, and research. We appreciate the opportunity to review the decision memoranda referenced above. We have been following the CMS deliberations concerning the possible national coverage decisions related to the wrong surgery performed on a patient, surgery on the wrong body part, and surgery on the wrong patient. We agree with CMS that surgery in these instances do not constitute "reasonable and necessary" care, and therefore the provider should not be compensated.

Despite the careful analyses provided in the memoranda and the reference to NQF definitions and JCAHO conditions, we still find the policy, as defined in the decision memos, too broad. We feel that further clarification of the criteria for decision-making by carriers, intermediaries and providers are necessary. Without further explanation, the memos could lead to considerable confusion in their administration. It did not appear that you had incorporated any of the suggestions provided by AHA and Premier, which may have conveyed the needed clarity.

Accordingly, we recommend that you delay any national coverage decision until such point as the accompanying necessary administrative guidance is complete. Once the revised guidance has been developed, we feel it should be again vetted through the comment and review process prior to its implementation. If you feel compelled to make a decision in the short-term, we would suggest that you provide an effective date that is at least a year from now in order to provide time for the administrative guidance to be completed.

When the above-mentioned never events occur, they are regretted by all and are highly emotional. In such delicate situations, it is important that the rules be detailed, clear and easy to administer. If carriers, intermediaries and providers have to utilize only the current decision memoranda, it appears that there may be some difficulty with implementation.

Thank you for your thoughtful consideration of these comments.

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29 December 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

December 23, 2008

Mr. Kerry N. Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 314-G Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

RE: CAG-00401N, Wrong Surgery Performed on a Patient; CAG-00402N, Surgery on Wrong Body Part; CAG-00403, Surgery on the Wrong Patient

Dear Mr. Weems:

The American College of Cardiology (ACC) is pleased to offer our comments on the three National Coverage Determinations (NCDs) proposed by the Centers for Medicare and Medicaid Services (CMS) to protect patients from prevent surgical errors, released December 3, 2008. These NCDs would establish Medicare nonpayment for three so-called “never events” for wrong surgical or other invasive procedures performed on a patient, surgical or other invasive procedures performed on the wrong body part, and surgical or other invasive procedures performed on the wrong patient.

The ACC is a professional medical society and teaching institution made up of 37,000 cardiovascular professionals from around the world – including 90 percent of practicing cardiologists in the United States and a growing number of registered nurses, clinical nurse specialists, nurse practitioners, physician assistants, and clinical pharmacists. The ACC is committed to improving the health care of all Americans and advocates for quality cardiovascular care through education, research promotion, development and application of standards and guidelines, and aims to influence health care policy.

Our goal in reviewing proposed Medicare coverage changes is to assure access to quality cardiovascular care for Medicare beneficiaries. The ACC is strongly committed to quality improvement and we support collaborative efforts to reduce medical errors to ensure patients receive the appropriate treatment for their medical condition. While it is clear that the medical community must continually strive to establish systems to ensure these surgical “never events” are eliminated, the College would encourage CMS to establish an appeals process to allow physicians and other providers to gain recourse against any agency noncoverage decisions that may be made inappropriately.

Within the surgical system, infrequently, surgeries could have been performed correctly yet coding errors could have occurred. Additionally, attribution of the wrongful surgical event often is not clear.

The ACC believes that setting ambitious goals can challenge health care providers to achieve quality improvement goals they may not have thought possible. However, these goals must be realistic and reasonably achievable. Moreover, providers need practical tools to help them take steps toward achievement of the goal. The College strongly urges CMS to focus its quality improvement efforts for physicians on working with hospitals and other providers to establish effective internal procedures that eliminate the potential for wrongful surgical procedures to occur. CMS may consider programs or policies that encourage adoption of Joint Commission policies of double identification checks, surgical team “time outs” and requiring the surgeon to physically meet with the patient to review the procedure and confirm the correct site prior to scheduled surgery.

The agency has identified a serious challenge to quality health care with its recognition that these events should never occur. Nonetheless, the proposed NCDs should develop processes that provide recourse in instances where coverage should be allowed. The ACC commends CMS efforts to work collaboratively with hospitals, physicians and other providers to ensure these “never events” related to wrongful surgeries and other invasive procedures are eliminated as quickly as possible.

The ACC appreciates the opportunity to comment on these proposed national coverage decisions and we remain eager to assist you and your staff as it considers whether to finalize the NCDs. If you have any questions, please contact Gretchen Wyatt, Sr. Specialist, Regulatory Affairs at 202.375.6392 or via e-mail at gwyatt@acc.org.

Sincerely,

W. Douglas Weaver, M.D., F.A.C.C.
President
American College of Cardiology

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December 23, 2008

Kerry N. Weems
Acting Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., 314G
Washington, DC 20201

RE: National Coverage Determinations for Surgery on Wrong Body Part, Surgery on the Wrong Patient, and Wrong Surgery Performed on a Patient

Dear Mr. Weems:

On behalf of the members of the Federation of American Hospitals (FAH), the investor owned or managed community hospitals and health systems serving urban and rural Americans throughout the United States, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS) proposed national coverage determinations (NCD) of surgery on the wrong patient, wrong surgery on the patient, and surgery on the wrong body part.

The FAH hospitals are committed to providing the highest quality, most appropriate, and safest care to their patients. Our hospitals work diligently to implement nationally recognized quality standards. However, even with the appropriate protocols in place and attention to detail, human error does occur. In these unfortunate and infrequent circumstances, hospitals and their staffs work to evaluate the cause to prevent such occurrences in the future.

The FAH appreciates CMS' attention to these three signi ficant adverse events described in the NCDs. However, FAR members have questions about the implementation of the NCDs, and encourage CMS to provide additional details when issuing the final guidance. A detailed implementation plan would greatly assist the hospital community in understanding how to apply the NCDs.

We appreciate the CMS using the definition of the three surgical events as included in the National Quality Forum (NQF) report "Serious Reportable Events." Clarity and consistency in these definitions is essential to successful implementation of the policy. The NQF definitions benefitted from a consensus process which included public review and comment. As such, FAH members support the agreed to definitions for inclusion in the NCDs. Hospitals are accustomed to the current definitions and often report in local environments using these definitions as guidelines.

Our members have concerns with the lack of clarity for the documentation of the three serious reportable events, surgery on a wrong body part, surgery on the \\'rang patient or wrong surgery on a patient. The issues of concern can be divided into groups of questions: 1) what is included in a specific event? Are there specific ICD-9 codes that should be used to identify such an adverse event? 2) Who is accountable for the event? 3) What costs or services will be covered?

For instance, if corrective action is necessary, will a subsequent surgery or medical treatment be considered a covered service? If a complication occurs as a result of one of the non-covered conditions, will the hospital be paid for treating the complication even if the initial condition was not covered? Will eMS develop specific codes to identify a medical error? If so, what is the timeframe for developing the codes? What would be the implementation date for the NCDs?

The proposed NCD relies on documentation in the "documented infom1ed consent for that patient." How will CMS capture this information if it is generally not reported on claim forms? CMS needs to clarify how the information will be collected in order to identify one of these events. It is likely that a new process for identifying one of these procedures will be needed, and FAH would encourage the eMS to make that procedure public and permit comment on the procedure before it is implemented.

FAH also is concerned that the NCD proposal does not clearly identify how accountability will be attributed for which services and which patients. Often procedures require a number of different care givers in many steps leading up to and including the surgical event. What process will be used to assessing accountability in the system? FAH recommends that CMS provide clear guideline for assigning accountability and define what specific payments will be withheld.

The current proposal does not clearly identify other complexities in the care process such as transferring a patient to a second facility. How will transfers be handled? What process will be used to attribut costs should a patient need post-acute treatment in order to recover from the adverse event? FAH encourages CMS to clarify the processes expected in this case and to seek public comment on a proposed solution.

Finally, FAH recommends that CMS develop an appeals process for hospitals to petition reconsideration if they believe that the policy was applied inappropriately. Implementation of a new national coverage determination often causes confusion. In particular, these proposed NCDs are forging new ground. As SUCh, hospitals should be permitted to appeal a coverage decision if they believe it is in error. FAH encourages CMS to define a specific process for appeals on this issue.

Thank you for the opportunity to comment on the proposed National Coverage Detenninations for the three surgical conditions. If you have questions about our comments, please contact me or Jayne Hart Chambers at (202) 624-1500.

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December 23, 2008

The Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Submitted via email: CAGinquiries@cms.hhs.gov

To Whom It May Concern:

Patient safety is ASA’s paramount goal. We note that the Institute of Medicine recognized anesthesiologists for their leadership in its 1999 report, To Err is Human. The report stated that anesthesiologists were among the first physicians “to improve safety and outcomes for patients.” ASA has and will continue to promote improvement in these areas and collaborate with other organizations as appropriate to work toward the highest possible levels of patient safety and quality.

As anesthesiologists and the rest of medicine work toward elimination of these errors, in rare instances, the present system can fail and one of the “never events” cited in the above memoranda may occur. We agree that performing the wrong surgery on the patient, surgery on the wrong body part or surgery on the wrong patient are preventable errors and CMS’s proposal to deny payment for these procedures is warranted. These are indeed “never events” that should not happen if all proper precautionary measures are followed.

Per the Medicare Benefit Policy Manual, CMS considers care related to a non-covered service to also be non-covered. Chapter 1, section 120 and chapter 16, section 180 both state,

Medical and hospital services are sometimes required to treat a condition that arises as a result of services that are not covered because they are determined to be not reasonable and necessary or because they are excluded from coverage for other reasons. Services "related to" noncovered services (e.g., cosmetic surgery, noncovered organ transplants, noncovered artificial organ implants, etc.), including services related to follow-up care and complications of noncovered services which require treatment during a hospital stay in which the noncovered service was performed, are not covered services under Medicare. Services "not related to" noncovered services are covered under Medicare.

According to the memoranda, this coverage denial would also apply when the wrong procedure is performed, when a surgery is performed on the wrong body part or when a surgery is performed on the wrong patient.

“Never events” are separate and distinct from the situation in which a procedure is known to be a noncovered event from the beginning. In the case of a “never event” the procedure would have been covered by CMS if all had gone as intended. As such, any follow up care required to remedy the result of a “never event” should be considered medically necessary. The patient may need additional care to correct an adverse outcome from the error. Furthermore, the intended intervention may still be required. These patients are deserving of safe, high quality medical care and this, or any other payment policy, should not create barriers to patients receiving such care.

We recommend CMS issue clarification on how it intends to address the scenario in which a separate team of physicians assumes care of the patient after one of these three events occurs. CMS could consider developing a method similar to the Present on Admission (POA) process used for hospital payments where a modifier or other means is used to identify this situation. This would help assure that the patient receives the care s/he requires and also allow CMS to track that care. A physician and members of the medical team that played no part in the error should not be penalized for his/her efforts in correcting or mitigating its consequences.

Thank you for your consideration of our comments. Any questions or requests for additional information may be directed to Chip Amoe, JD, MPA, Assistant Director of Regulatory Affairs at c.amoe@asawash.org.

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NATIONAL BUSINESS GROUP ON HEALTH
50 F Street, NW
Suite 600
Washington, D.C. 20001
202.628.9320
Fax 202.628.9244
www.businessgrouphealth.org
Creative Health Benefits Solutions for Today,
Strong Policy for Tomorrow

December 19, 2008

Mr. Kerry N. Weems
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 314-G Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: CAG-00403N, Surgery on the Wrong Patient; CAG-00402N, Surgery on Wrong Body Part; and CAG-00401N, Wrong Surgery Performed on a Patient.

Dear Acting Administrator Weems:

The National Business Group on Health (Business Group) appreciates the opportunity to provide comments on the Centers for Medicare & Medicaid Services'' (CMS) proposed National Coverage Determination (NCD) not to pay for the 3 following “never events”: 1) surgical and other invasive procedures performed on the wrong patient; 2) surgical and other invasive procedures performed on the wrong body part and 3) the wrong surgical or other invasive procedures performed on a patient.

The Business Group agrees that the costs associated with hospitalizations for surgeries and other invasive procedures performed on the wrong side, wrong site, wrong body part or wrong person should not be reimbursed. More than 40 professional medical associations and organizations have agreed that these events can and should be prevented.¹ Furthermore, the Business Group believes that Medicare must rapidly take many more of these types of actions on payment policy to move decisively toward paying only for effective and efficient care in order to sustain the program and improve the safety and quality of health care delivery for all Americans.

The Business Group applauds CMS’ effort to expand on its policy to stop payments for “never events.” These “never events” should also be added as measures to Medicare’s Reporting Hospital Quality Data for Annual Payment Update Program (RHQDAPU). The NCD for “never events” is a significant step towards improving the quality of care in the Medicare program. These moves are likely to also lead to cost savings and improvements in the quality of health care for people in employer plans as more private insurers follow the federal government’s lead in refusing to pay hospitals for preventable medical errors.

The National Business Group on Health is a member organization representing over 300 members, mostly large employers, who provide health coverage to more than 55 million U.S. employees, retirees and their families and is the nation’s only non-profit organization devoted exclusively to finding innovative and forward-thinking solutions to large employers’ most important health care and related benefits issues. National Business Group on Health members are primarily Fortune 500 companies and large public sector employers, 63 members of which are in the Fortune 100.

Never Events Increase Payers’ Costs

Never events and medical errors cost payers, including patients, employers, health plans states and the federal government 2.4 million extra hospital days, $9.3 billion in excess charges (for all payers) and 32,600 deaths.² Parallel to CMS’ efforts, the Business Group urges employers and other payers to use their payment policies to develop methods to track and stop payments for the most significant “never events” and avoidable medical errors. In addition to the Business Group’s own patient safety initiative, our organization actively participates in the National Quality Forum’s (NQF) Serious Adverse Events Working Group and the National Priorities Partnership.

Hospitals, health care professionals and health plans must all work together to ensure that “never events” never happen, avoidable conditions are always avoided, and every patient receives quality treatment in a safe and caring environment.

CMS Continues to Provide Leadership to Stop Payments for Never Events

As you know, CMS selected and stopped paying for eight preventable hospital-acquired conditions (HACs). CMS is expanding the list by three additional conditions.

Following CMS’ leadership, many major health plans are not reimbursing for the additional cost of “never events.” As a result, employers and employees are no longer paying for costs associated with them and can expect improvements in the quality of health care.

Beginning October 1, 2008 hospitals can no longer assign inpatient hospital discharges to higher paying Medicare Severity diagnosis-related groups (MS–DRG) if selected HACs are not present on admission for the eight serious reportable events. While this policy eliminates additional payments for these errors and is set to expand by several more serious reportable events next year, the NCD takes the policy a step further by not paying at all for these additional three medical error surgeries and not just stopping payment for the additional costs.

Please, contact me or Steven Wojcik, the Business Group’s Vice President of Public Policy, at (202) 585-1812, if you would like to discuss any of these comments or recommendations in more detail. Thank you for the opportunity to provide comments on the proposed NCD for never events.

Sincerely,

Helen Darling
President

cc:
Steve Phurrough, MD, MPA, Director, Coverage and
Analysis Group
Marcel E. Salive, MD, MPH, Director, Division of
Medical and Surgical Services
Madeline Ulrich, MD, MS, Lead Medical Officer
Sarah McClain, MHS, Lead Analyst

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December 19, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) three proposed national coverage decisions (NCDs) on Surgery on the Wrong Body Part (CAG-00402N), Surgery on the Wrong Patient (CAG-00403N), and Wrong Surgery Performed on a Patient (CAG-00401N). America’s Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
We encourage CMS to ensure that all patients receive the most safe, effective and appropriate treatments. Therefore, AHIP strongly supports CMS proposed decision to not provide coverage for the types of wrong surgeries referenced above, as this is a necessary step towards reducing the number of avoidable complications, serious injuries and/or deaths due to these surgical errors. These three events, which are included in the 28 Never Events listed by the National Quality Forum (NQF), can result in serious consequences for the patient and yet are clearly identifiable and preventable. Many states, working with health insurance plans, have begun tracking medical errors and are developing or have adopted non-payment policies for such errors.

Additionally, we concur with CMS’s proposed definition of “surgery,” which includes all codes in the surgery section of the Current Procedural Terminology (CPT) code set and other invasive procedures including minimally invasive biopsies or the placement of probes or catheters requiring the entry into a body cavity through a needle or trocar (surgical tool used in laparoscopic surgeries).

Thank you for the opportunity to comment on this important issue.

Sincerely,

Carmella Bocchino
Executive Vice President, Clinical Affairs and Strategic Planning

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December 19, 2008

Dear Acting Administrator Weems:

On behalf of the 74,000 Fellows of the American College of Surgeons (the College), we appreciate the opportunity to provide comments regarding the Centers for Medicare & Medicaid Services' (CMS) plans to develop three new National Coverage Determinations (NCDs) that address Medicare coverage of certain surgical procedures, including surgery on the wrong body part, surgery on the wrong patient, and wrong surgery performed on a patient.

Medicare NCDs set national policy on whether and under what conditions Medicare will cover an item or service. The College does not believe that it is appropriate for CMS to use the NCD process to address its concerns regarding surgery on the wrong body part, surgery on the wrong patient, and wrong surgery performed on a patient. Instead, we support developing a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare. For example, if a physician failed to use commonly accepted patient safety practices, which resulted in surgery on a wrong body part, a Medicare carrier might deny partial or complete payment for the service claim. The issue at question is not whether surgical procedures will be covered by the Medicare program, but rather under what circumstances the payment for covered surgical procedures will be denied or reduced. In addition, we support the payment policy rather than the NCD approach because, due to the nuanced nature of surgical procedures, payment determinations should allow an appeals process for physicians and hospitals to petition decisions that they believe are incorrect. Under the proposed approach, providers have no recourse if one of the aforementioned surgeries is not covered. Alternatively, under the payment policy approach, providers can appeal decisions that they believe were made inappropriately.

If CMS proceeds with the NCD approach rather than changes to payment policy related to surgery on the wrong body part, surgery on the wrong patient, and wrong surgery performed on a patient, we request that CMS take a flexible approach in drafting the language ofthe NCD.

Regarding the wrong procedure performed on a patient, we approve of CMS' exclusion of emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent. We agree that the NCD should not include changes in the surgical plan, after surgical entry into the patient, based on the discovery of unusual physical configuration or pathology in close proximity to the intended site when the risk of a second surgery outweighs the benefit ofpatient consultation.

Regarding surgery on the wrong body part, we have concerns that this decision might be too broadly defined. In particular, we are concerned about the inclusion of spine level in the classification of"wrong body part." For example, it can be extremely difficult to precisely verify the correct disk level prior to performing spine surgery on patients with morbid obesity. Also, based on the National Quality Forum definition of surgery, which includes any operating room procedure in which the skin has been punctured, many (27% in Pennsylvania) of the procedures classified as "wrong body part surgeries" are partial or complete anesthetic blocks. As such, a high percentage of "wrong body part surgeries" for which the surgeon who bills the procedure may not receive payment under the proposed NCD could result from an anesthesiologist administering anesthesia close to, but not at the intended spine level. We agree with CMS that surgery on the wrong location ofthe body, for example left verses right, should not be fully paid, but we strongly urge CMS to allow flexibility in the proposed NCD to exclude from nonpayment situations such as these where patient characteristics can impede identification of the precise location prior to surgical entry into the patient.

We appreciate the opportunity to comment on these proposed NCDs. The College looks forward to continuing dialogue with CMS on these important issues. If you have any questions about our comments, please contact Elizabeth Hoy in our Washington office. She can be reached at ehoy@facs.org or at (202) 672-1508.

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December 17, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244

Re: National Coverage Assessments CAG-00402N, CAG-00403N, CAG-00401N

On behalf of the Premier healthcare alliance serving more than 2,000 leading not for-profit hospitals and health systems and more than 53,000 other healthcare sites, we appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) national coverage assessments (NCAs) regarding surgery on the wrong patient, surgery on the wrong body part, and wrong surgery performed on a patient.

Per our previous comments, Premier unmistakably agrees with CMS’ proposed national coverage assessment. We also believe that the proposed definition of surgical and other invasive procedures that would be subject to non-coverage based on language from the National Quality Forum is sufficiently clear to implement this policy. However, we still believe that CMS must include additional detail on appeals and billing procedures. Premier recommends that CMS proactively establish an appeals process. We believe providers should be able to request a case review when: 1) the error that lead to the inappropriate procedure was clearly not the fault of the hospital; 2) an unnecessary or unscheduled procedure is performed, but the correct surgery is also performed and there has been no harm to the patient; and 3) code edits erroneously identify a case.

We also urge CMS to clearly lay out whether hospitals are to bill Medicare, but will not receive payment or are not to bill at all. Hospitals also need guidance on how to bill in the case where only a portion of the stay or procedure is not covered.

Premier appreciates the opportunity to submit comments on the NCAs. Please contact me at 202-879-8009 or Blair_Childs@premierinc.com if you would like to discuss further.

Sincerely,

Blair Childs
Senior Vice President, Public Affairs
Premier, Inc.

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