National Coverage Decision Research Articles

ICD/CRT-D Registry Ain Shams University Hospitals

Abstract Background The idea of the ICD registry was prompted from the National Coverage Decision that was published by the Centers for Medicare and Medicaid Services (CMS) in 2005 and based on the Sudden Cardiac Death in Heart Failure Trial, Ain Shams University Hospitals aim to take the lead by documenting the first ICD/CRT-D Registry in Egypt. Aim of the Work To capture the characteristics, treatments, and outcomes of patients receiving ICDs to improve care for patients receiving ICDs and CRT-Ds in Egypt. Methods 102 consecutive patient that received an ICD/CRT-D (initial or generator change) for primary or secondary prevention of SCD and came for ICD/CRT-D follow up at Ain Shams University hospitals pacemaker outpatient clinics in a timeline of one year (7-2019 till 11-2020). Results Males were around two thirds of cases (68.6%), and more than half of cases (52%) were smokers. Implantation for primary prevention of SCD was in 58.8% of patients. Most of cases had their ICDs follow-up at a time between 1 to 3 years after implantation. HFrEF was significantly more common in primary prevention group (93.3%) of patients of primary prevention group, while IsHD was the most common comorbidity in patients that had ICD implantation for secondary prevention of SCD (66.7% of them). Total complication rate was 6.86% including, pocket hematoma occurred in 2.9% of cases, and lead dislodgment that required repositioning without a plan to add a transvenous lead occurred in 3.9% of cases. Beta Blockers and Amiodarone were the most common drugs used among patients as regard 88.2% and 65.7% respectively. VTs and NSVTs were the most frequent post implantation events among the studied cases 45.1% and 42.2% respectively. 52% of patients had ATP therapy to events, Failed ATP therapy occurred in 60% of them. 33.3% of patient received ICD shock therapy, Inappropriate Shocks was in 20.6% of them. 50.9% of the patients had a bradycardia pacing as about 34% of patient had CRT-D for pump failure. VF detection zone interval was significantly longer in primary prevention group. No significant differences according to implantation indication regarding VT2 zone interval. Regarding VT1 zone; monitor only was the mainly action in 58.7% of patients. Only 20.6% of patients had VT1 zone off. Conclusion This observational and descriptive study provides strong evidence that ICD has an effective role to improve survival in primary and secondary prevention of SCD. We noticed increase in implantation rate of ICD for primary prevention of SCD who gain great benefits from the device later on, minimal complication rate of ICD implantation.

The National Coverage Decision for MitraClip in Functional Mitral Regurgitation

The National Coverage Decision for MitraClip in Functional Mitral Regurgitation

The association between Medicare’s next generation sequencing (NGS), national coverage decision (NCD), and NGS utilization.

98 Background: In 2018, Medicare released a NGS NCD memo which would facilitate reimbursement for NGS tests for patients (pts) with advanced or metastatic cancer who had not been previously tested using NGS for the same cancer and genetic content. We examined the association between the NCD and: a) NGS utilization trends in commercially-insured and Medicare pts and b) repeat NGS testing. Methods: We conducted a retrospective study of pts with advanced non-small cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), metastatic breast cancer (mBC) or advanced melanoma (aM), diagnosed 2011 (2013 for mCRC) through Dec. 2019 using the Flatiron Health EHR-derived de-identified database, comprising data from over 280 (largely community based) cancer clinics (~800 sites of care). Pts were classified as Medicare or Commercially insured based on age and insurance type, and grouped into quarters based on their advanced or metastatic diagnosis date. NGS testing rates per quarter were based on evidence of first NGS test within 60 days from diagnosis. We used an interrupted time series analysis to assess NGS utilization trends pre- and post-NCD policy effective date (March 2018). The frequency of repeat NGS testing was assessed among those pts with only 1 primary cancer. Results: The utilization analysis included 70,290 pts while the repeat NGS testing analysis included 51,385 pts. Across the 4 tumors combined, the use of NGS was < 1% in 2011 (both insurance types) and increased to 41% in commercially-insured pts and 37% in Medicare in 2019. In each tumor, NGS utilization was < 6% in Q1 2014; however, the rate of increase varied by tumor, with aNSCLC increasing to 58% in commercial and 48% in Medicare, while mBC and aM remained < 20% in Q4 2019. Among pts with aNSCLC, mCRC, or mBC, the quarterly rate of increase in NGS testing was higher post-NCD compared to pre-NCD (p < 0.05 for pre-post difference in rate of NGS increase within each cancer type). The difference in trends pre- and post-NCD was not significantly different between commercial and Medicare in any of the tumors (p > 0.05 within each cancer type). Repeat NGS testing increased over time from 17.8% (in Q3 2014 to Q2 2016) to 29.6% (in Q2 2018 to Q4 2019). Conclusions: NGS utilization trends significantly changed post-NCD, however the rate of change was not significantly different by insurance, indicating private insurers may also be following the guidance of the NCD. We observed an increase in repeat NGS testing, despite the NCD not covering repeat testing with the same NGS test.

Integrating public preferences into national reimbursement decisions: a descriptive comparison of approaches in Belgium and New Zealand

BackgroundPublic health care payer organizations face increasing pressures to make transparent and sustainable coverage decisions about ever more expensive prescription drugs, suggesting a need for public engagement in coverage decisions. However, little is known about countries’ approaches to integrating public preferences in existing funding decisions. The aim of this study was to describe how Belgium and New Zealand used deliberative processes to engage the public and to identify lessons learned from these countries’ approaches.MethodsTo describe two countries’ deliberative processes, we first reviewed key country policy documents and then conducted semi-structured interviews with five leaders of the processes from Belgium and New Zealand. We assessed each country’s rationales for and approaches to engaging the public in pharmaceutical coverage decisions and identified lessons learned. We used qualitative content analysis of the interviews to describe key themes and subthemes.ResultsIn both countries, the national public payer organization initiated and led the process of integrating public preferences into national coverage decision making. Reimbursement criteria considered outdated and changing societal expectations prompted the change. Both countries chose a deliberative process of public engagement with a multi-year commitment of many stakeholders to develop new reimbursement processes. Both countries’ new reimbursement processes put a stronger emphasis on quality of life, the separation of individual versus societal perspectives, and the importance of final reimbursement decisions being taken in context rather than based largely on cost-effectiveness thresholds.ConclusionsTo face the growing financial pressure of sustainable funding of medicines, Belgium’s and New Zealand’s public payers have developed processes to engage the public in defining the reimbursement system’s priorities. Although these countries differ in context and geographic location, they came up with overlapping lessons learnt which include the need for 1) political commitment to initiate change, 2) broad involvement of all stakeholders, and 3) commitment of all to engage in a long-term process. To evaluate these changes, further research is required to understand how coverage decisions in systems with and without public engagement differ.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

Factors Associated With Mortality and Response to Extracorporeal Photopheresis in Lung Allograft Recipients With Bronchiolitis Obliterans Syndrome.

This study was designed to identify factors associated with clinical response to extracorporeal photopheresis (ECP) and mortality after ECP in lung allograft recipients with bronchiolitis obliterans. Forced expiratory volume in 1 second (FEV1) values obtained 6 months before (baseline) and 6 months after initiation of ECP were used to plot the linear relationship between FEV1 versus time before and after ECP. Response to ECP was assigned when a positive integer was derived after subtracting the baseline rate of decline from the rate of decline 6 months after ECP. Univariate and multivariate logistic regression analyses were used to identify demographic, treatment-related factors or spirometric parameters that may be associated with response to ECP or mortality at either 6 or 16 months after initiation of ECP. Forced expiratory volume in 1 second just before ECP was associated with mortality (P = 0.007) at 16 months after ECP initiation. An FEV1 of 1.50 L or less had a sensitivity of 87% and specificity of 60% to identify patients who died within 16 months after ECP initiation. Patients whose FEV1 decline exceeded 40 mL/month were 12 times more likely to have a response to ECP (P = 0.0001). Patients whose decline in FEV1 before ECP was statistically significant (P < 0.05) were nearly 10 times (P = 0.008) more likely to respond to ECP. Forced expiratory volume in 1 second is an important predictor of mortality, and the response to ECP is influenced by both the extent (>40 mL/mo) and statistical significance of the relationship between FEV1 versus time before ECP initiation. Therefore, earlier bronchiolitis obliterans detection and more timely implementation of ECP (ie, when FEV1 values >1.5 L) should be considered especially in patients with a more aggressive rate of decline of lung function.

Bariatric Surgery Outcomes in US Accredited vs Non-Accredited Centers: A Systematic Review

Accreditation for bariatric surgery has been scrutinized recently for its impact on surgical outcomes. This study aimed to systematically examine the medical literature to examine the impact of bariatric accreditation on surgical outcomes. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and checklist were used. The MEDLINE database was searched for the following terms (2000 through September 2014): gastric bypass or bariatric surgery or sleeve gastrectomy or vertical banded gastroplasty or biliopancreatic diversion or duodenal switch or adjustable gastric band or weight loss surgery and accreditation or center of excellence or credentialing or national coverage decision or CMS or Medicare. Only studies in English and articles comparing accredited with non-accredited centers were included. Quality was assessed using the Newcastle-Ottawa scale for evaluation of all studies. Thirteen studies were published in a very short time frame and covered >1.5 million patients. Ten of the 13 studies identified a substantial benefit of Center of Excellence accreditation for risk-adjusted outcomes. Six of the 8 studies reported a considerable reduction in mortality in patients operated on in Centers of Excellence, with odds ratios ranging from 2.26 to 3.57 for non-accredited centers; 2 studies showed no significant difference. Similarly, morbidity was reduced in 8 of 11 studies, although more discreetly, with odds ratios ranging from 1.09 to 1.39. This study found that the preponderance of medical evidence supports accreditation for bariatric surgery.

The Three Definitions of Application for AAC Intervention

This article will address an important issue related to speech-generating devices (SGDs) and augmentative and alternative communication (AAC) software applications (apps) in relation to the widespread adoption of mobile devices. This article will explore each of the three definitions of application including (a) a software application, (b) putting something into practice or operation, and (c) sustained effort. We hope that these three “app” definitions and discussion of our use of the Student, Environments, Tasks, and Tools (SETT) Framework can be a quick, easy, and memorable way to convey to families, therapists, and teachers that tools are made powerful when they are combined with good teaching and processes that sustain the use of AAC. A review of The Centers for Medicare and Medicaid Services updated 2015 National Coverage Decision for SGDs will be included, highlighting the major change to this updated coverage which includes the expansion of the definition of speech.

Impact of a National Bariatric Surgery Center of Excellence Program on Medicare Expenditures

IntroductionIn 2006, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage decision restricting bariatric surgery to designated centers of excellence (COE). Although prior studies show mixed results on complications and reoperations, no prior studies evaluated whether this policy reduced spending for bariatric surgery. We sought to determine whether the coverage restriction to COE-designated hospitals was associated with lower payments from CMS. MethodsWe utilized national Medicare claims data to examine 30-day episode payments for patients who underwent bariatric surgery from 2003 to 2010 (n = 72,117 patients). We performed an interrupted time series analysis, adjusting for patient factors, preexisting temporal trends, and changes in procedure type, to determine whether the 2006 coverage decision was associated with lower Medicare payments above and beyond any existing secular trends. For these analyses, we included payments for the index hospitalization, readmissions, physician services, and post-discharge ancillary care. ResultsAfter accounting for patient factors, preexisting temporal trends, and changes in procedure type, there were no statistically significant improvements in episode payments after (US$14,720) vs before (US$14,283) the coverage decision (+US$437, 95 % CI, −US$10 to +US$883). In a direct assessment of payments for COE-designated hospitals (US$14,481) vs non-COE-designated hospitals (US$14,756), no significant differences in episode payments were found (−US$275, 95 % CI, −US$696 to +US$145). ConclusionsWe found no significant reductions in 30-day episode payments after vs before restricting coverage to COE-designated hospitals. Center of excellence status is not a proxy for savings to the healthcare system.

Value-Based Interventional Pain Management: A Review of Medicare National and Local Coverage Determination Policies

Major policies, regulations, and practice patterns related to interventional pain management are dependent on Medicare policies which include national coverage policies – national coverage determinations (NCDs), and local coverage policies – local coverage determinations (LCDs). The NCDs are Medicare coverage policies issued by the Centers for Medicare and Medicaid Services (CMS). The process used by the CMS in deciding what is and what is not medically necessary is lengthy, involving a review of evidence-based literature on the subject, expert opinion, and public comments. In contrast, LCDs are rules and Medicare coverage that are issued by regional contractors and fiscal intermediaries when an NCD has not addressed the policy at issue. The evidence utilized in preparing LCDs includes the highest level of evidence which is based on published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and general acceptance by the medical community (standard of practice), as supported by sound medical evidence. In addition, the intervention must be safe and effective and appropriate including duration and frequency that is considered appropriate for the item or service in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function. In addition, the safe and effective provision includes that service must be furnished in a setting appropriate to the patient’s medical needs and condition, ordered and furnished by qualified personnel, the service must meet, but does not exceed, the patient’s medical need, and be at least as beneficial as an existing and available medically appropriate alternative. The LCDs are prepared with literature review, state medical societies, and carrier advisory committees (CACs) of which interventional pain management is a member. The LCDs may be appealed by beneficiaries. The NCDs are prepared by the CMS following a request for a national coverage decision after an appropriate national coverage request along with a draft decision memorandum, and public comments. After the request, the staff review, external technology assessment, Medicare Evidence Development and Coverage Advisory Committee (MedCAC) assessment, public comments, a draft decision memorandum may be posted which will be followed by a final decision and implementation instructions. This decision may be appealed to the department appeals board, but may be difficult to reverse. This manuscript describes NCDs and LCDs and the process of development, their development, issues related to the development, and finally their relation to interventional pain management. Key words: Interventional pain management, interventional techniques, national coverage determinations (NCDs), local coverage determinations (LCDs), contractor medical director (CMD), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), guidelines, evidence-based medicine, evidence development with coverage

Two Specialty Societies to Run Their Own Clinical Trial of Heart Valve Replacement

THE AMERICAN COLLEGE OF CARdiology (ACC) and the Society of Thoracic Surgeons (STS) will conduct a clinical trial exploring the safety and efficacy of expanded uses of transcatheter aortic valve replacement (TAVR) in certain types of patients with severe aortic stenosis. The trial is believed to be the first for any medical specialty societies. Aortic stenosis is a long-developing condition that, once symptoms emerge, is highly lethal. Roughly half of all untreated patients die in the first 2 years after symptoms appear. Surgical replacement of the valve reduces symptoms and improves survival, but at least 30% of patients with severe symptoms do not undergo surgery because of advanced age (most patients who develop symptoms are older than 80 years), left ventricular dysfunction, or comorbid conditions. With almost a third of all patients ineligible for surgery, researchers began looking for other means of valve replacement. In 2011, the US Food and Drug Administration (FDA) approved the SAPIEN transcatheter heart valve (Edwards Lifesciences) to treat aortic stenosis. The FDA approved TAVR only through the transfemoral approach for patients deemed inoperable or the transfemoral or transapical approaches for highrisk patients eligible for surgery. Edwards Lifesciences, along with physicians and hospitals, also agreed to participate in the Transcatheter Valve Therapy (TVT) Registry developed and run by the ACC and the STS. Participating in the TVT Registry allows physicians and hospitals to comply with Medicare’s national coverage determination for TAVR that ensures federal reimbursement for FDAapproved use of TAVR. But the national coverage decision was conditional: physicians would be reimbursed for performing TAVR only for the FDA-approved indications, meaning Medicare would not pay for procedures performed in an off-label manner—unless such patients were

Bariatric Surgery Complications Before vs After Implementation of a National Policy Restricting Coverage to Centers of Excellence

Starting in 2006, the Centers for Medicare & Medicaid Services (CMS) has restricted coverage of bariatric surgery to hospitals designated as centers of excellence (COE) by 2 major professional organizations. To evaluate whether the implementation of the COE component of the national coverage decision was associated with improved bariatric surgery outcomes in Medicare patients. Retrospective, longitudinal study using 2004-2009 hospital discharge data from 12 states (n = 321,464 patients) of changes in outcomes in Medicare patients undergoing bariatric surgery (n = 6723 before and n = 15,854 after implementation of the policy). A difference-in-differences analytic approach was used to evaluate whether the national coverage decision was associated with improved outcomes in Medicare patients above and beyond existing time trends in non-Medicare patients (n = 95,558 before and n = 155,117 after implementation of the policy). Risk-adjusted rates of any complication, serious complications, and reoperation. Bariatric surgery outcomes improved during the study period in both Medicare and non-Medicare patients; however, this change was already under way prior to the CMS coverage decision. After accounting for patient factors, changes in procedure type, and preexisting time trends toward improved outcomes, there were no statistically significant improvements in outcomes after (vs before) implementation of the CMS national coverage decision for any complication (8.0% after vs 7.0% before; relative risk [RR], 1.14 [95% CI, 0.95-1.33]), serious complications (3.3% vs 3.6%, respectively; RR, 0.92 [95% CI, 0.62-1.22]), and reoperation (1.0% vs 1.1%; RR, 0.90 [95% CI, 0.64-1.17]). In a direct assessment comparing outcomes at hospitals designated as COEs (n = 179) vs hospitals without the COE designation (n = 519), no significant differences were found for any complication (5.5% vs 6.0%, respectively; RR, 0.98 [95% CI, 0.90-1.06]), serious complications (2.2% vs 2.5%; RR, 0.92 [95% CI, 0.84-1.00]), and reoperation (0.83% vs 0.96%; RR, 1.00 [95% CI, 0.86-1.17]). Among Medicare patients undergoing bariatric surgery, there was no significant difference in the rates of complications and reoperation before vs after the CMS policy of restricting coverage to COEs. Combined with prior studies showing no association of COE designation and outcomes, these results suggest that Medicare should reconsider this policy.

The impact of accreditation on safety and cost of bariatric surgery

BackgroundThe objective of this study was to examine how much of the impact of the Centers for Medicare and Medicaid Services’ national coverage decision (NCD) on bariatric surgery was driven by the restriction of reimbursements to Centers of Excellence (COE). We used inpatient care data of those with employer-sponsored insurance plans across United States using the MarketScan Commercial Claims and Encounter Database (2003–2009). MethodsWe performed a retrospective cohort study evaluating the impact of the accreditation on subjects with a difference-in-difference approach (removing the temporal changes occurring in non-COEs) on rates of inpatient mortality, 90-day reoperations, complications, readmissions, and total payments. ResultsA total of 30,755 patients (43.9±11.0 years; 79.9% women) had bariatric surgery. A total of 17,896 patients underwent procedures at sites that became COEs (8455 pre-NCD and 9441 post-NCD, [+10.4%]) compared with 12,859 at non-COEs (6534 pre-NCD and 6325 post-NCD, [−3.3%]). Of the total number of bariatric procedures, laparoscopic Roux-en-Y gastric bypass and laparoscopic adjustable band procedures increased from 42.9% and 3.1% pre-NCD to 64.5% and 19.7% post-NCD, respectively. In the COEs, there were reductions in inpatient mortality (.3% to .1%; P = .02), 90-day reoperations (.8% to .5%; P = .006), complications (36.4% to 27.6%; P<.001), and readmissions (10.8% to 8.8%; P<.001) while payments remained similar ($24,543±$40,145 to $24,510±$37,769; P = .9). After distinguishing from temporal trends and differences occurring at non-COEs, 90-day reoperation (−.8%; P = .02) and complication rates (−2.7%; P = .01) were lower at the COEs after the NCD. ConclusionsThe accreditation-based NCD in bariatric surgery was associated with lower rates of reoperations and complications. Such policies may become a powerful tool to improve surgical safety and quality.

Age Cutoff for Carotid Artery Stenting May Fall to 65

Milwaukee – The risk for worse outcomes following carotid artery stenting may extend to even younger Medicareage patients than previously reported by such pivotal trials as CREST, a provocative population study suggests. The rate of the composite primary endpoint of death, stroke, or cardiac complications was 5.2% for carotid angioplasty and stenting (CAS) and 3.6% for carotid endarterectomy (CEA) among patients younger than age 65 years, and was 6.3% vs. 4.5% among patients aged 65 years or older, who made up 76% of the study cohort (both P values < .0001). Rates of the primary endpoint were similar between the carotid stenting and endarterectomy groups among asymptomatic patients aged 65 years or older (4.1% vs. 3.8%; P = .25), but were significantly higher in symptomatic patients age 65 years or older who received stenting (22.5% vs. 12.5%; P < .0001). This finding was driven by significantly higher rates of all three individual components of the primary endpoint: death (5.1% vs. 2.2%), stroke (12.5% vs. 7.6%), and cardiac complications (7.5% vs. 4.2%), “which is a little bit different than what we thought, compared with the CREST trial,” lead author Dr. Jeffrey Jim said at the annual Midwestern Vascular Surgical Society meeting. In the lead-in phase of CREST (Carotid Revascularization Endarterectomy vs. Stent Trial), octogenarians were found to be at higher risk of in-hospital death and stroke post-CAS, but not myocardial infarction (J. Vasc. Surg. 2004;40:1106-11). Subsequent CREST analyses have identified an interaction between age and carotid stenting efficacy, with the crossover at an age of approximately 70 years (N. Engl. J. Med. 2010;363:11-23). The current results appear to move that threshold to an even younger age, just as the Centers for Medicare & Medicaid Services starts reconsidering the national coverage decision for carotid-artery stenting. Although he did not present the data, Dr. Jim noted that hospital costs also were higher for stenting patients. “Our results show that carotid angioplasty [with] stenting was associated with a higher rate of adverse outcomes and increased charges among patients of Medicare age, and really don't support the widespread use of carotid stenting over CEA in this general population,” Dr. Jim said. Session moderator Dr. Patrick Geraghty of Barnes–Jewish Health in St. Louis, said the difference in MI rates between arms “basically turns the CREST findings on their head.” The analysis was based on 678,081 hospitalizations for CEA and CAS from 2005 to 2009, the latest available data in the NIS, a comprehensive, inpatient database developed as part of the Healthcare Cost and Utilization Project. The 595,813 CEA patients were more likely to be asymptomatic, whereas the 82,268 CAS patients were more likely to be male, medically high risk, treated at a teaching hospital, and an emergent/urgent admission. The average age was 71 years in the CEA group and 70 years in the CAS group. In the entire study cohort, the composite primary endpoint occurred in 6% of the carotid stenting group and 4.3% of the endarterectomy group (P < .0001), said Dr. Jim, a vascular specialist at Washington University School of Medicine, St. Louis. Patients who underwent carotid stenting experienced significantly higher rates of each individual component of the primary endpoint: death (1.1% vs. 0.5%), stroke (2% vs. 1%), and cardiac complications (3.6% vs. 3.1%). Independent predictors of the primary endpoint were CAS, symptomatic stenosis, and medical high risk, defined as a patient age 80 years or older, or a patient who had renal failure, severe chronic lung disease, recent MI, coronary bypass/valve surgery within 30 days, unstable angina, or class III/IV heart failure. Dr. Jim and Dr. Geraghty reported having no conflict of interest.

A Role for Government: An Observation on Federal Healthcare Efforts in Prevention

A Role for Government: An Observation on Federal Healthcare Efforts in Prevention

Another piece of the puzzle, but still no answer

Implantable cardioverter-defibrillators (ICDs) are one of the most studied therapeutic modalities in cardiology. They have been demonstrated to be lifesaving and cost-effective. ICD therapy has a class 1A indication for the primary prevention of sudden cardiac death in a large number of patients with ischemic and nonischemic cardiomyopathy. In addition, there has been a Centers for Medicare & Medicaid Services National Coverage Decision authorizing payment for this indication since 2005. Despite all this, it is estimated that, at best, only 50% of the eligible patients receive ICD therapy.

Assessing Personalized Medicines in Australia

Background. Since the mapping of the human genome in 2003, the development of biomarker targeted therapy and clinical adoption of “personalized medicine” has accelerated. Models for insurance subsidy of biomarker/test/drug packages (“codependent technologies” or technologies that work better together) are not well developed. Our aim was to create a framework to assess the safety, effectiveness, and cost-effectiveness of these technologies for a national coverage or reimbursement decision. Methods. We extracted information from assessments of recent Australian reimbursement applications that concerned genetic tests and treatments to identify items and evidence gaps considered important to the decision-making process. Relevant international regulatory and reimbursement guidance documents were also reviewed. Items addressing causality theory were included to help explain the relationship between biomarker and treatment. The framework was reviewed by policy makers and technical experts, prior to a public consultation process. Results. The framework consists of 5 components—context, clinical benefit, evidence translation, cost-effectiveness, and financial impact—and a checklist of 79 items. To determine whether the biomarker test, the drug, both, or neither should be subsidized, we considered it crucial to identify whether the biomarker is a treatment effect modifier or a prognostic factor. To aid in this determination, the framework explicitly allows the linkage of different types of evidence to examine whether targeting the biomarker varies the likely clinical benefit of the drug, and if so, to what extent. Conclusions. The first national framework to assess personalized medicine for coverage or reimbursement decisions has been developed and introduced and may be a suitable model for other health systems.

422 PROTON BEAM RADIOTHERAPY IN THE US MEDICARE POPULATION GROWTH IN USE IN PROSTATE AND OTHER CANCERS BETWEEN 2006 AND 2009

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness III1 Apr 2012422 PROTON BEAM RADIOTHERAPY IN THE US MEDICARE POPULATION GROWTH IN USE IN PROSTATE AND OTHER CANCERS BETWEEN 2006 AND 2009 Sean Elliott, Stephanie Jarosek, and Beth Virnig Sean ElliottSean Elliott Minneapolis, MN More articles by this author , Stephanie JarosekStephanie Jarosek Minneapolis, MN More articles by this author , and Beth VirnigBeth Virnig Minneapolis, MN More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.488AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Proton beam radiotherapy (PBR) is an expensive and highly specific form of radiotherapy. It is a small but rapidly growing segment of the radiation oncology practice. Without a national Medicare coverage decision for PBR, local Medicare administrative contractors are free to establish local medical review policies (LMRPs). Generally, these LMRPs consider tumors of the eye, skull base and spine to be ”commonly accepted indications” for PBR. They consider prostate and lung cancer to represent ”conditions of possible benefit” and allow payment as long as special documentation procedures are followed. Because the latter cancers are far more common, we hypothesized that conditions of possible benefit would be largely responsible for the growth in PBR use. METHODS From the 100% Medicare dataset (2006-2009) we isolated claims for receipt of PBR that were associated with any cancer diagnosis. For each year, the number of unique beneficiaries, diagnoses and costs were calculated. We grouped diagnoses by the degree of consistency in LMRP policy regarding PBR. We also described the frequency of PBR at each of the national PBR delivery centers. We assigned PBR recipients to their provider by matching ZIP codes of the service provider to the ZIP codes of the PBR centers operational at the time of the service. RESULTS The number of centers operating in the United States remained constant from 2006 to 2008 at six. One center was added in 2009. However, the number of patients treated increased from 740 patients in 2006 to almost 1300 in 2009 (See Figure). 85% of all proton beam was delivered for conditions of possible benefit (70% for prostate cancer and 7% for lung cancer). Ocular tumors were <7%. Medicare claims for proton beam were $27.2M in 2009. Because prostate cancer is typically treated with 30 sessions vs. only 5 for an ocular tumor, it represents nearly all of the costs to Medicare for PBR. CONCLUSIONS Nearly all PBR is delivered for conditions of possible benefit, rather than for commonly accepted indications. Even though only <1% of men with prostate cancer receive PBR, the high prevalence of prostate cancer establishes it as the most common tumor to be treated with proton beam. Even a minimal growth in future PBR use in prostate cancer will have significant cost implications for the Medicare program. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e173 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sean Elliott Minneapolis, MN More articles by this author Stephanie Jarosek Minneapolis, MN More articles by this author Beth Virnig Minneapolis, MN More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The Use, Safety and Cost of Bariatric Surgery Before and After Medicare's National Coverage Decision

To determine the impact of the Centers for Medicare and Medicaid Services' (CMS) bariatric surgery national coverage decision (NCD) on the use, safety, and cost of care CMS beneficiaries. In February 2006, the CMS issued a NCD restricting reimbursement for bariatric surgery to accredited centers and including coverage for laparoscopic adjustable gastric band (LAGB). A pre/postinterrupted time-series cohort study using nationwide Medicare data (2004-2008) evaluating rates of bariatric procedures/100,000 enrollees, 90-day mortality, readmission rate and payments. Forty-seven thousand thirty patients underwent procedures at 928 sites pre-NCD and 662 post-NCD. The procedure rate/100,000 patients dropped after the NCD to 17.8 (from 21.9 in 2005) increasing to 23.8 and 29.1 in 2007 and 2008, respectively. Open roux-en-y gastric bypass (ORYGB) and laparoscopic roux-en-y gastric bypass (LRYGB) were common pre-NCD (56.0% ORYGB, 35.5% LRYGB) changing post-NCD with LAGB inclusion (12.8% ORYGB, 48.7% LRYGB, 36.7% LAGB). 90-day mortality pre-NCD was 1.5% (1.8% ORYGB, 1.1% LRYGB) and post-NCD was 0.7% (1.7% ORYGB, 0.8% LRYGB, 0.3% LAGB; P < 0.001). The 90-day rates of readmission decreased post-NCD (19.9% to 15.4%), reoperation (3.2% to 2.1%) and payments ($24,363 to $19,746; P for all <0.001). Differences in outcome and cost were largely explained by a shift in procedure type and patient characteristics. The NCD was associated with a temporary reduction in procedure rate and a shift in types of procedures and patients undergoing bariatric surgery. It was associated with a significant decrease in the risk of death, complications, readmissions, and per patient payments.

The Effect of the CMS National Coverage Decision on the Performance and Outcomes of Bariatric Surgery for Medicare Recipients in the U.S.

Department of Surgery, University of Virginia Health System Charlottesville. Reprints: Bruce Schirmer, MD, Department of Surgery, University of Virginia Health System, Private Clinics Bldg, 4th Floor Surgery, PO Box 800709, Charlottesville, VA 22908. E-mail: [email protected]. Disclosure: The author declares that there is nothing to disclose.