The Scope of Medicare Reimbursement for New Medical Devices: Impact on Device Availability and the Standard of Care

Evolving standards of care motivated by advances in medical technology alter the characteristics and costs of delivered health care. Faced with shifting reimbursement demands, the Health Care Financing Administration (HCFA) has promulgated regulations setting forth criteria and procedures for making coverage decisions about health care technology and setting prospective payment limits for health care services including those related to new technology. The effects of such regulations extend beyond the Medicare program due to the tendency of other health insurers to mirror HCFA coverage, the impact of Medicare payments on cross-subsidization and other effects of Medicare reimbursement decisions on the demand for and supply of health care. The principle statutory authority for rules limiting coverage of health care technology is Section 1862(a)( 1) of the Social Security Amendments of 1965 (codified in 42 U.S.C. § 1395y(a)( 1)) which provides that no Medicare payment shall be made for items or services, including medical devices, "which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." In 1989 HCFA proposed a rule describing criteria and procedures for health care technology Medicare coverage decisions. The rule defines a reasonable and necessary service as one which is safe and effective, cost-effective, appropriate, and not experimental or investigational. A provision of the rule categorizes a medical device that has not been approved by the FDA as experimental or investigational and hence not reimbursible under the reasonable and necessary standard. In this paper I will (1) consider the legal force and implications of the provision excluding Medicare coverage of all unapproved medical devices, (2) discuss HCFA's recent efforts to investigate billing for investigational cardiac devices, (3) consider the impact of reimbursement for investigational device on device availability and (4) consider ways to reconcile prudent control of health care expenditures with expeditious promotion of high standards of health care

Accuracy of electrocardiographic criteria for atrial enlargement: validation with cardiovascular magnetic resonance

<p>Abstract</p> <p>Background</p> <p>Anatomic atrial enlargement is associated with significant morbidity and mortality. However, atrial enlargement may not correlate with clinical measures such as electrocardiographic (ECG) criteria. Past studies correlating ECG criteria with anatomic measures mainly used inferior M-mode or two-dimensional echocardiographic data. We sought to determine the accuracy of the ECG to predict anatomic atrial enlargement as determined by volumetric cardiovascular magnetic resonance (CMR).</p> <p>Methods</p> <p>ECG criteria for left (LAE) and right atrial enlargement (RAE) were compared to CMR atrial volume index measurements for 275 consecutive subjects referred for CMR (67% males, 51 ± 14 years). ECG criteria for LAE and RAE were assessed by an expert observer blinded to CMR data. Atrial volume index was computed using the biplane area-length method.</p> <p>Results</p> <p>The prevalence of CMR LAE and RAE was 28% and 11%, respectively, and by any ECG criteria was 82% and 5%, respectively. Though nonspecific, the presence of at least one ECG criteria for LAE was 90% sensitive for CMR LAE. The individual criteria P mitrale, P wave axis < 30°, and negative P terminal force in V1 (NPTF-V1) > 0.04s·mm were 88–99% specific although not sensitive for CMR LAE. ECG was insensitive but 96–100% specific for CMR RAE.</p> <p>Conclusion</p> <p>The presence of at least one ECG criteria for LAE is sensitive but not specific for anatomic LAE. Individual criteria for LAE, including P mitrale, P wave axis < 30°, or NPTF-V1 > 0.04s·mm are highly specific, though not sensitive. ECG is highly specific but insensitive for RAE. Individual ECG P wave changes do not reliably both detect and predict anatomic atrial enlargement.</p

Cardiovascular Magnetic Resonance Characterization of Mitral Valve Prolapse

ObjectivesThis study sought to develop cardiovascular magnetic resonance (CMR) diagnostic criteria for mitral valve prolapse (MVP) using echocardiography as the gold standard and to characterize MVP using cine CMR and late gadolinium enhancement (LGE)-CMR.BackgroundMitral valve prolapse is a common valvular heart disease with significant complications. Cardiovascular magnetic resonance is a valuable imaging tool for assessing ventricular function, quantifying regurgitant lesions, and identifying fibrosis, but its potential role in evaluating MVP has not been defined.MethodsTo develop CMR diagnostic criteria for MVP, characterize mitral valve morphology, we analyzed transthoracic echocardiography and cine CMR images from 25 MVP patients and 25 control subjects. Leaflet thickness, length, mitral annular diameters, and prolapsed distance were measured. Two- and three-dimensional LGE-CMR images were obtained in 16 MVP and 10 control patients to identify myocardial regions of fibrosis in MVP.ResultsWe found that a 2-mm threshold for leaflet excursion into the left atrium in the left ventricular outflow tract long-axis view yielded 100% sensitivity and 100% specificity for CMR using transthoracic echocardiography as the clinical gold standard. Compared with control subjects, CMR identified MVP patients as having thicker (3.2 ± 0.1 mm vs. 2.3 ± 0.1 mm) and longer (10.5 ± 0.5 mm/m2 vs. 7.1 ± 0.3 mm/m2) indexed posterior leaflets and larger indexed mitral annular diameters (27.8 ± 0.7 mm/m2 vs. 21.5 ± 0.5 mm/m2 for long axis and 22.9 ±0.7 mm/m2 vs. 17.8 ± 0.6 mm/m2 for short axis). In addition, we identified focal regions of LGE in the papillary muscles suggestive of fibrosis in 10 (63%) of 16 MVP patients and in 0 of 10 control subjects. Papillary muscle LGE was associated with the presence of complex ventricular arrhythmias in MVP patients.ConclusionsCardiovascular magnetic resonance image can identify MVP by the same echocardiographic criteria and can identify myocardial fibrosis involving the papillary muscle in MVP patients. Hyperenhancement of papillary muscles on LGE is often present in a subgroup of patients with complex ventricular arrhythmias

Atherosclerotic Biomarkers and Aortic Atherosclerosis by Cardiovascular Magnetic Resonance Imaging in the Framingham Heart Study

Background: The relations between subclinical atherosclerosis and inflammatory biomarkers have generated intense interest but their significance remains unclear. We sought to determine the association between a panel of biomarkers and subclinical aortic atherosclerosis in a community‐based cohort. Methods and Results: We evaluated 1547 participants of the Framingham Heart Study Offspring cohort who attended the 7th examination cycle and underwent both cardiovascular magnetic resonance imaging (CMR) and assays for 10 biomarkers associated with atherosclerosis: high‐sensitivity C‐reactive protein, fibrinogen, intercellular adhesion molecule‐1, interleukin‐6, interleukin‐18, lipoprotein‐associated phospholipase‐A2 activity and mass, monocyte chemoattractant protein‐1, P‐selectin, and tumor necrosis factor receptor‐2. In logistic regression analysis, we found no significant association between the biomarker panel and the presence of aortic plaque (global P=0.53). Using Tobit regression with aortic plaque as a continuous variable, we noted a modest association between biomarker panel and aortic plaque volume in age‐ and sex‐adjusted analyses (P=0.003). However, this association was attenuated after further adjustment for clinical covariates (P=0.09). Conclusions: In our community‐based cohort, we found no significant association between our multibiomarker panel and aortic plaque. Our results underscore the strengths and limitations of the use of biomarkers for the identification of subclinical atherosclerosis and the importance of traditional risk factors

Prognostic value of pulmonary vein size in prediction of atrial fibrillation recurrence after pulmonary vein isolation: a cardiovascular magnetic resonance study

Background: The relationship between pulmonary vein (PV) anatomy and successful catheter ablation of atrial fibrillation (AF) is poorly understood Methods: First-pass contrast enhanced PV magnetic resonance angiography was performed in 71 consecutive patients prior to PV isolation. PV diameter and cross-sectional area (CSA) were measured prior to PV isolation. Any symptomatic or asymptomatic AF >10s was considered a recurrence. Early recurrence was defined as recurrent AF ≤30 days after PV isolation, while late recurrence of AF was defined as recurrent AF >30 days after. Results: At 1 year, 57 % had any recurrence of AF while 41 % had late recurrence of AF. Study subjects with one or more PV diameter in the top 10th percentile had trend toward more early recurrent AF (HR 1.99, p = 0.053). Study subjects with one or more PV CSA in the top 10th percentile had more late recurrent AF (HR 2.25, p = 0.039) and a trend toward more early recurrent AF (HR 1.94, p = 0.064). With multivariate analysis, PV size was not associated with early recurrent AF, but late recurrent AF was associated with one or more large PV, increased left atrial size, and non-paroxysmal AF. Study subjects with all three of these risk factors had a 100 % rate of late recurrent AF at 1 year, while those with none had a 7 % rate of late recurrent AF. Conclusions: Larger PV size is independently associated with more late recurrent AF after PV isolation. Determination of PV size prior to PV isolation may predict procedural success

A systematic approach to performing a comprehensive transesophageal echocardiogram. A call to order

<p>Abstract</p> <p>Background</p> <p>While the order for a clinical transthoracic examination is fairly standardized, there is considerable variability between laboratories and even among physicians in the same laboratory with regard to the order for transesophageal echocardiograms (TEE). A systematic approach is desirable for more efficient use of physician and patient time, avoidance of inadvertent omission of important views, and to facilitate study review.</p> <p>Methods</p> <p>We propose a standardized approach to TEE data acquisition in which cardiac structures are systematically identified and characterized at sequential positions and imaging planes to facilitate organized, efficient and comprehensive assessment.</p> <p>Results</p> <p>Our approach to TEE study begins in the mid-esophagus with the imaging plane at 0°. Based on the specific indication for the TEE, a cardiac structure (e.g., mitral valve, left atrial appendage, or interatrial septum) is chosen as the primary focal point for a comprehensive, multiplane analysis. This structure is assessed in 20° – 30° increments as the imaging plane is advanced from 0° to 165°. Using the aortic valve as a reference point, pertinent cardiac structures are then assessed as the imaging plane is reduced to 135°, to 90°, to 40 – 60° and then back to 0°. The probe is then advanced into the stomach to obtain transgastric images at 0°, 90°, and 120°. Finally, the thoracic aorta and pulmonary artery are assessed as the probe is withdrawn from the body. Using this method, an organized and comprehensive TEE can be performed in 10 – 15 minutes.</p> <p>Conclusion</p> <p>A standardized and systematic TEE approach is described for efficient and comprehensive TEE study.</p