Lung Volume Reduction Surgery

I am writing in support of Dr Keith Naunheim's request that CMS reconsider the plan to limit coverage of LVRS to centers that are approved lung transplant centers or approved by the JACHO Joint Commission. I and my colleagues have worked with Dr Naunheim and his group since December 1996, through our participation in the National Emphysema Treatment Trial (NETT) as the study's coordinating center. Dr Naunheim and his group randomized 51 patients in NETT, 25 of whom received LVRS.

The risk experienced by the St Louis University patients is similar to that for other NETT centers. As noted in our paper on the safety and efficacy of median sternotomy versus video-assisted thoracic surgery, all centers had similar percentages of patient deaths within 30 days after surgery (P=0.37) and similar percentages of patients without postoperative complications (P=0.51) (J Thorac Cardiovasc Surg 2004;127:1350-60). The St Louis University data were consistently of high quality and transmitted to the Coordinating Center in a timely fashion.

Dr Naunheim has also been a key leader in the dissemination of NETT results. He was a leader in drafting and shaping the primary outcome paper (New Engl J Med 2003;348:2059-73), being one of the four clinical investigators to be made privy to the results in advance of the other Steering Committee members so that work on the paper could progress in a timely fashion. He also was one of the clinical investigators to participate in the presentation of the results to CMS in October 2002. Dr Naunheim is the lead author on the NETT paper identifying predictors of surgical mortality and cardiopulmonary morbidity (J Thorac Cardiovasc Surg, in press) and has taken the initiative in identifying a forum for presentation and publication of the long term results of the NETT. The abstract prepared and submitted by Dr Naunheim has been accepted for presentation at the January 2006 meetings of the Society of Thoracic Surgeons, and the presentation and paper will be given the J Maxwell Chamberlain award by the Society of Thoracic Surgery. Dr Naunheim has been a member of the NETT Executive Committee since 1998.

In addition to these specific areas of activity and leadership, Dr Naunheim has been a leader at meetings and in the trenches to assure that NETT met its goals, that its results were fairly and appropriately interpreted, and that these findings were disseminated. We all are aware that these fragile emphysema patients benefit when this complicated surgery is performed by experienced surgeons. NETT imposed an experience requirement for certification for surgeons in NETT that was above and beyond what NHLBI required for awarding the contract for NETT. We urge CMS to reconsider their planned qualifications that a center must have a transplant program or meet new JCAHO requirements to be approved to provide LVRS for Medicare patients. We feel that the vetting originally required to participate in the NETT in combination with the clinical excellence demonstrated in Dr Naunheim's results in LVRS NETT patients warrant his continued inclusion as a CMS approved LVRS center.

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I am the director of Thoracic surgery at St. Louis university. My name is Keith S. Naunheim and I am Professor and Chief of Thoracic Surgery at St.Louis University. In addition, I was one of the early investigators in the field of thoracoscopic LVRS and have published extensively in the field since 1995. Because of my interest in the field I submitted a proposal when NHLBI first called for proposals for participation in a multi-institutional collaborative study to determine the clinical value of lung volumereduction for the treatment of end stageemphysema. Fortunately our proposal was acceptedand I was the Principal Investigator for St. LouisUniversity Health Sciences Center, one of 17clinical centers that participated in the NationalEmphysema Treatment Trial.

Our institution has been performing successfulthoracoscopic LVRS procedures since 1994. My ownclinical experience in the field of LVRS isextensive and I have performed over 100 suchprocedures with low levels of morbidity andmortality. These figures are available through theNETT Coordinating Center and are in line with orbetter than most other institutions. Since theJanuary 1st 2004 decision in which CMS coverage ofLVRS became effective, I have performed threesuccessful LVRS procedures with no deaths.

My own academic interest in LVRS has continuedunabated and I have been on the writing Committeefor both major NETT publications published in theNew England Journal of Medicine. In addition Ihave been first author or coauthor on twoadditional surgical papers, one in the Annals ofThoracic Surgery (published) and one in theJournal of Thoracic and Cardiovascular Surgery (inpress). I will personally present yet anothermajor NETT publication (Long=Term Mortality andFunctional Results) in January of 2006 at theupcoming Society of Thoracic Surgeons. Although itsounds unfortunately immodest, it is certainlyreasonable to suggest that I am one of the mostexperienced and informed thoracic surgeons in thecountry regarding LVRS in the areas of evaluation,preparation, surgical and postoperative care.

I was therefore surprised and dismayed to read therecent decision proposal memorandum ending paymentfor LVRS for those programs that had participatedin the NETT. Apparently the plan is to allowcontinuation of payment to any program thatcurrently has a CMS approved lung transplantprogram or a JCAHO certified LVRS program. Perhapsmy surprise came from the fact that the rulingappears not only arbitrary, but also appears to befocused on the participation of a singleinstitution e.g. St. Louis University HealthScience Center. Since 16 of the 17 participatingNETT centers are indeed lung transplant centers,this decision memorandum would appear to be aimedat and effective regarding only the institution atwhich I practice. In essence, this memorandum willaffect the ability to perform LVRS in just onelocale.

It seems less than logical that CMS mightdecertify my institution’s ability to bereimbursed for LVRS while allowing many lungtransplant centers with little or no LVRSexperience (documented in the literature orotherwise) to continue the ability to be coveredfor this procedure. Quite frankly, it just doesn’tpass the sniff test. If the intent is to ensurethe quality of LVRS performance in “covered”programs, the logical step would seem to eliminatethose programs without a proven track record inthis field rather than producing a decision thatwould affect a single institution with adocumented record of excellence. The way in whichCMS is currently proceeding is simply not rational.

While I am very curious regarding the originalinstigation or motivation behind this particularmemorandum, it certainly is not in my purview toask who began this specific “quest for quality”. Ican however comment on the process itself. Inshort, while this decision may very well have beenmade with the best of intentions and for thehighest purpose (patient safety), the resultingeffect will not be what was intended. In fact itwill be counterproductive in that a center ofestablished excellence will not be allowed tocontinue provision of LVRS while at the same timemany transplant centers with little or noexperience can proceed with LVRS and expectreimbursement regardless of their track record orlack thereof.

I would urge CMS to reconsider this memorandum.While it certainly was meant to be of benefit tothe public safety, it would appear to accomplishjust the opposite by preventing the provision ofcare to fragile and elderly population whichalready has a difficult time obtaining access toexperienced practitioners.

Keith S. Naunheim, M.D.
The Vallee and Melba Willman Professor of Surgery
Chief of Thoracic Surgery
St. Louis University Health Sciences Center

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The Joint Commission on Accreditation of Healthcare Organizations appreciates the opportunity to comment on CMS’s August 18, 2005 proposed decision memorandum for lung volume reduction surgery (LVRS) facility requirements. In response to CMS’s January 2004 National Coverage Determination (NCD) for LVRS, the Joint Commission developed a certification program for facilities performing this surgery. In the 2004 NCD, CMS announced that when such a program became available, LVRS would be reimbursable under Medicare—considered reasonable and necessary—only if performed at accredited facilities.

We would like to offer a few specific comments and clarifying language on the following components of the August 18, 2005 proposed decision memorandum:

• Impact of New Transplant CoPs on LVRS Reimbursement
• Requirements for Previous Experience and Competency
• Time Period for Certification and Updating Requirements

Impact of New Transplant CoPs on LVRS Reimbursement

The decision memo’s language should clarify CMS’s intent to require Joint Commission certification (or another third party entity that is approved by CMS for LVRS certification) after the agency issues the final conditions for participation (CoP) for transplant centers. Specifically, CMS should make clear that the new CoPs will rescind the option of being approved for LVRS reimbursement under Medicare by virtue of being a lung or heart-lung transplantation center. On page 11 of the decision memo, CMS discusses the impact the transplant CoPs are expected to have on LVRS approved facilities. In the final decision memorandum, CMS should modify the language on page 11 to more clearly state that CMS will only reimburse organizations that are certified by the Joint Commission, or similarly approved entity, and meet any relevant CoPs. You may wish to consider using the following language:

When the (transplant) regulation becomes final, there will no longer be any transplant center criteria that would provide alternative facility standards to demonstrate that a facility is capable of performing LVRS in a reasonable and necessary manner. In order to continue to be eligible to receive reimbursement for LVRS performed on Medicare beneficiaries, transplant facilities will need to be certified for LVRS by the Joint Commission (or similarly approved entity).

Requirements for Previous Experience and Competency

The Joint Commission is concerned about the criteria CMS proposes to use to demonstrate competency for performing LVRS procedures. CMS will reimburse facilities for LVRS procedures if they are performed in Medicare-approved lung or heart-lung transplant centers, without requiring a minimal level of experience performing these specific procedures. Thus Medicare will reimburse a facility for LVRS that has little or no case experience in the specific procedures.

Furthermore, CMS assumes that heart-lung and lung transplant centers have the necessary competency to perform LVRS because they perform a significant number of heart-lung and lung transplants. However, 2003 data showed that about 69 percent of heart-lung transplant centers performed no heart-lung transplants that year.

The Joint Commission believes that facilities—not only physicians—that perform LVRS procedures should be required to demonstrate competency by performing a minimum number of procedures. Joint Commission’s LVRS facility standards would address this inconsistency by requiring a minimum number of LVRS procedures be performed in order to receive certification.

Time Period for Certification and Updating Requirements

The Joint Commission is concerned about the length of time that facilities that participated in the National Emphysema Treatment Trial (NETT) will operate without quality monitoring. Although the NETT study concluded in August 2003, CMS proposes that study participants will have 18 months in which to become Joint Commission certified. This is a window of more than 3 years (August, 2003 through April, 2007) during which NETT hospitals will have the opportunity to perform LVRS procedures without oversight. We suggest shortening the time period for certification to 12 months, in order to minimize any quality concerns.

Furthermore, some of the requirements to participate in the NETT study that remain in effect are out-of-date relative to current medical practice. For example, the requirements for an integrated team expert in pulmonary medicine, a close working relationship with a lung or heart-lung transplantation center, and an active program around patient outcome data, but have changed since August, 2003.

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As Chair of the American Thoracic Society (ATS) Clinical Practice Committee, I want to express my appreciation for the opportunity to comment on behalf of the ATS on the CMS proposal to adopt the Joint Commission on Accreditation of Health Care Organization (Joint Commission) standards for certifying institutions that provide lung volume reduction surgery (LVRS). The ATS represents over 14,000 physicians, researchers and allied health professionals who are actively engaged in diagnosis, treatment, training, and research in the area respiratory disease and critical care medicine, including emphysema – the primary medical condition leading patients to consider LVRS. Therefore, the ATS is very interested in CMS’s proposal to adopt the Joint Commission standards and LVRS facilities.

The ATS agrees with the need to create a process where additional medical facilities can demonstrate their competency in performing LVRS and qualify as a provider of LVRS for Medicare beneficiaries. In general, the ATS has concerns with the Joint Commissions standards and feels that Joint Commission standard makes several inappropriate departures from the NETT criteria. These criteria should be part of the CMS requirements for LVRS qualifying providers.

Patient Selection Criteria
The NETT data clearly showed that patients with FEV1 < 20% and either diffuse disease or DLCO < 20% were at high risk and should not be considered viable candidates for LVRS. The Joint Commission criteria seems to be silent on this important patient selection criterion. If left silent, the ATS is concerned that some LVRS providers will perform the surgery on patient from the high-risk group. Inclusion of patients from the high risk group will likely lead to needless mortality from the LVRS procedure.

The ATS strongly recommends that CMS qualifying LVRS providers be required exclude patients from the high risk group (patients with FEV1 < 20% and either diffuse disease or DLCO <20%) as candidates for LVRS.

The Role of Pulmonary Rehabilitation
The Joint Commission document describes the number post-surgical pulmonary rehabilitation sessions that LVRS patients should receive. However the document implies, but does not articulate, the specific role of pulmonary rehabilitation prior to surgery. As you may know, the NETT study included a rigorous pulmonary rehabilitation program for all patients, both pre- and post-operative. Pulmonary rehabilitation, both pre-operative and post-operative, is an essential component of the services offered to LVRS patients. Any reduction of pre-operative services to LVRS is an inappropriate departure from the standard of care developed by the NETT protocol.

Current CMS policy requires, pre-operatively, 16 two-hour pulmonary rehabilitation sessions to be delivered 6-10 weeks prior to surgery.

The ATS strongly recommends that pre-operative pulmonary rehabilitation services, as described in the NETT protocol and current CMS policy, be specifically required as a condition to become a CMS qualifying LVRS provider.

90-Day Post Surgical Mortality
The Joint Commission standard has dropped the NETT requirement of a minimum mortality threshold to qualify as an LVRS provider. The ATS believes that a mortality threshold should be a requirement for Medicare approved LVRS providers. The ATS feels there is appropriate precedent for such a requirement and note that transplant centers are expected to meet mortality thresholds to maintain certification as Medicare transplantation facility.

Including a mortality threshold in the CMS requirement for Medicare LVRS facilities would have three positive effect including: 1) encourage facilities to perform surgery on only that patients with high expectation of survival and benefit 2) reduce that likelihood that low volume/high mortality providers will perform LVRS on Medicare beneficiaries, and 3) provide Medicare beneficiaries with an important indicator to evaluate the LVRS providers.

The ATS notes that the NETT study reported 90-day surgical mortality rate of 7.9% (95% confidence interval 5.9 to 10.3%). We further note that the mortality rate reported by the NETT study included in the high risk group (low DLco group) which was subsequently excluded from considerations, which likely increased the 90-day surgical mortality rate in the NETT above what should be expected when only the appropriate risk groups are considered for LVRS surgery. Based on the NETT 90-day surgical mortality data, the ATS would recommend a 90-day surgical mortality threshold of 10%.

The ATS strongly encourages CMS to use a 90-day post surgical mortality rate of 10% as a threshold for CMS qualifying LVRS providers.

Again, the ATS appreciates the opportunity to comment on the CMS proposal to adopt the Joint Commission standards on LVRS. We look forward to working with CMS to ensure Medicare beneficiaries have access to this important procedure from high quality facilities with demonstrated experience in providing LVRS.

Sincerely,

Alan L. Plummer MD
Chair, ATS Clinical Practice Committee

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