Association of Device Industry Payments, Physician Supply, and Regional Utilization of Orthopedic and Cardiac Procedures.

BACKGROUND: Geographic variation in high-cost medical procedure utilization in the USA is not fully explained by patient factors but may be influenced by the supply of procedural physicians and marketing payments. OBJECTIVE: To examine the association between physician supply, medical device-related marketing payments to physicians, and utilization of knee arthroplasty (KA) and percutaneous coronary interventions (PCI) within hospital referral regions (HRRs). DESIGN: Cross-sectional analysis of data from the 2018 CMS Open Payments database and procedural utilization data from the CMS Provider Utilization and Payment database. PARTICIPANTS: Medicare-participating procedural cardiologists and orthopedic surgeons. MAIN MEASURES: Regional rates of PCIs and KAs per 100,000 Medicare fee-for-service (FFS) beneficiaries were estimated after adjustment for beneficiary demographics. KEY RESULTS: Across 306 HRRs, there were 109,301 payments (value $17,554,728) to cardiologists for cardiac stents and 68,132 payments (value $40,492,126) to orthopedic surgeons for prosthetic knees. Among HRRs, one additional interventional cardiologist was associated with an increase of 12.9 (CI, 9.3-16.5) PCIs per 100,000 beneficiaries, and one additional orthopedic surgeon was associated with an increase of 20.6 (CI, 16.9-24.4) KAs per 100,000 beneficiaries. A $10,000 increase in gift payments from stent manufacturers was associated with an increase of 26.0 (CI, 5.1-46.9) PCIs per 100,000 beneficiaries, while total and service payments were not associated with greater regional PCI utilization. A $10,000 increase in total payments from knee prosthetic manufacturers was associated with an increase of 2.9 (CI, 1.4-4.5) KAs per 100,000 beneficiaries, while a similar increase in gift and service payments was associated with an increase of 14.5 (CI, 5.0-24.1) and 3.4 (CI, 1.6-5.2) KAs, respectively. CONCLUSIONS: Among Medicare FFS beneficiaries, regional supply of physicians and receipt of industry payments were associated with greater use of PCIs and KAs. Relationships between payments and procedural utilization were more consistent for KAs, a largely elective procedure, compared to PCIs, which may be elective or emergent.

Influence of payer coverage and out-of-pocket costs on ordering of NGS panel tests for hereditary cancer in diverse settings.

The landscape of payment for genetic testing has been changing, with an increase in the number of laboratories offering testing, larger panel offerings, and lower prices. To determine the influence of payer coverage and out-of-pocket costs on the ordering of NGS panel tests for hereditary cancer in diverse settings, we conducted semi-structured interviews with providers who conduct genetic counseling and order next-generation sequencing (NGS) panels purposefully recruited from 11 safety-net clinics and academic medical centers (AMCs) in California and North Carolina, states with diverse populations and divergent Medicaid expansion policies. Thematic analysis was done to identify themes related to the impact of reimbursement and out-of-pocket expenses on test ordering. Specific focus was put on differences between settings. Respondents from both safety-net clinics and AMCs reported that they are increasingly ordering panels instead of single-gene tests, and tests were ordered primarily from a few commercial laboratories. Surprisingly, safety-net clinics reported few barriers to testing related to cost, largely due to laboratory assistance with prior authorization requests and patient payment assistance programs that result in little to no patient out-of-pocket expenses. AMCs reported greater challenges navigating insurance issues, particularly prior authorization. Both groups cited non-coverage of genetic counseling as a major barrier to testing. Difficulty of access to cascade testing, particularly for family members that do not live in the United States, was also of concern. Long-term sustainability of laboratory payment assistance programs was a major concern; safety-net clinics were particularly concerned about access to testing without such programs. There were few differences between states. In conclusion, the use of laboratories with payment assistance programs reduces barriers to NGS panel testing among diverse populations. Such programs represent a major change to the financing and affordability of genetic testing. However, access to genetic counseling is a barrier and must be addressed to ensure equity in testing.

Association of Primary Language and Hospitalization for Ambulatory Care Sensitive Conditions.

BACKGROUND: Limited English proficiency is associated with decreased access to ambulatory care, however, it is unclear if this disparity leads to increased use of emergency departments (EDs) for low severity ambulatory care sensitive conditions (ACSCs). OBJECTIVE: We sought to determine the association between the patient's preferred language and hospital utilization for ACSCs. RESEARCH DESIGN: We conducted a retrospective cohort study of all ED visits in New Jersey in 2013 and 2014. The primary outcome was hospital admission for acute ACSCs, chronic ACSCs, and fractures (a nonambulatory care sensitive control condition). Secondary outcomes included intensive care unit (ICU) utilization and length of stay. Mixed-effect regression models estimated the association between preferred language (English vs. non-English) and study outcomes, controlling for demographics, comorbidities, and hospital characteristics. RESULTS: We examined 201,351 ED visits for acute ACSCs, 251,193 visits for chronic ACSCs, and 148,428 visits for fractures, of which 13.5%, 11.1%, and 9.9%, respectively, were by non-English speakers. In adjusted analyses, non-English speakers were less likely to be admitted for acute ACSCs [-3.1%; 95% confidence interval (CI), -3.6% to -2.5%] and chronic ACSCs (-2.3%; 95% CI, -2.8% to -1.7%) but not fractures (0.4%; 95% CI, -0.2% to 1.0%). Among hospitalized patients, non-English speakers were less likely to receive ICU services but had no difference in length of stay. CONCLUSIONS: These findings suggest non-English-speaking patients may seek ED care for lower acuity ACSCs than English-speaking patients. Efforts to decrease preventable ED and increase access to ambulatory care use should consider the needs of non-English-speaking patients.

The State of State Biomarker Testing Insurance Coverage Laws.

This Viewpoint discusses laws mandating insurance coverage of biomarker testing to broaden access to care for patients with cancer.

Preoperative medical testing in Medicare patients undergoing cataract surgery.

BACKGROUND: Routine preoperative testing is not recommended for patients undergoing cataract surgery, because testing neither decreases adverse events nor improves outcomes. We sought to assess adherence to this guideline, estimate expenditures from potentially unnecessary testing, and identify patient and health care system characteristics associated with potentially unnecessary testing. METHODS: Using an observational cohort of Medicare beneficiaries undergoing cataract surgery in 2011, we determined the prevalence and cost of preoperative testing in the month before surgery. We compared the prevalence of preoperative testing and office visits with the mean percentage of beneficiaries who underwent tests and had office visits during the preceding 11 months. Using multivariate hierarchical analyses, we examined the relationship between preoperative testing and characteristics of patients, health system characteristics, surgical setting, care team, and occurrence of a preoperative office visit. RESULTS: Of 440,857 patients, 53% had at least one preoperative test in the month before surgery. Expenditures on testing during that month were $4.8 million higher and expenditures on office visits $12.4 million higher (42% and 78% higher, respectively) than the mean monthly expenditures during the preceding 11 months. Testing varied widely among ophthalmologists; 36% of ophthalmologists ordered preoperative tests for more than 75% of their patients. A patient's probability of undergoing testing was associated mainly with the ophthalmologist who managed the preoperative evaluation. CONCLUSIONS: Preoperative testing before cataract surgery occurred frequently and was more strongly associated with provider practice patterns than with patient characteristics. (Funded by the Foundation for Anesthesia Education and Research and the Grove Foundation.).

Trends in Hospitalization, Readmission, and Diagnostic Testing of Patients Presenting to the Emergency Department With Syncope.

STUDY OBJECTIVE: Emergency department (ED) visits for syncope are common and routine diagnostic testing is frequently low yield. Our objective is to determine whether recent guidelines emphasizing limiting hospitalization and advanced diagnostic testing to high-risk patients have changed patterns of syncope care. METHODS: This was a retrospective population epidemiology study of syncope-related ED visits and hospitalizations using the National Emergency Department Sample from 2006 to 2014 and the State Inpatient Databases and Emergency Department Databases from 2009 and 2013. Primary outcomes were annual incidence rates of syncope ED visits and subsequent hospitalizations, and rates of hospitalization, observation, 30-day revisits, and diagnostic testing comparing 2009 with 2013. Differences were estimated with multivariable logistic regression modeling adjusted for patient clinical and demographic characteristics. RESULTS: From 2006 to 2014, we identified 15,154,920 survey-weighted ED visits for syncope. Annual rates of ED visits increased from 643 to 771 per 100,000 adults, whereas hospitalizations declined from 36.3% to 24.7% (-11.6% absolute difference; 95% confidence interval [CI] -13.0% to -10.2%). In multistate adjusted analyses, the proportion of ED visits resulting in hospital admission decreased 11.7% (95% CI -11.9% to -11.6%) between 2009 and 2013, whereas the proportion of ED visits resulting in observation care increased by 7.9% (95% CI 7.8% to 8.0%), with no significant change in 30-day ED revisit rates (absolute difference 0.1%; 95% CI -0.1% to 0.3%). The frequency of advanced cardiac testing increased from 13.8% to 17.0%, and neuroimaging increased from 40.6% to 44.3%, driven by increased testing of patients receiving observation and inpatient care. CONCLUSION: Although the incidence of ED visits for syncope has increased, hospitalization rates have declined, without an adverse effect on ED revisits, possibly because of increased use of observation care. Use of advanced cardiac testing and neuroimaging has increased, driven by growth in testing of patients receiving observation and inpatient care.

Patient decision aids for prostate cancer treatment: a systematic review of the literature.

Treatment decision-making can be difficult and complex for patients with low-risk prostate cancer. To the authors' knowledge, there is no consensus regarding an optimal treatment strategy and the choice of therapy involves tradeoffs between differing harms and benefits that are sensitive to patient values. In such situations, patients are often asked to participate actively in the decision-making process, and high-quality decisions require a well-informed patient whose values and preferences have been taken into consideration. Prior studies have indicated that patients have poor knowledge and unrealistic expectations regarding treatment, and physician judgments concerning patient preferences are often inaccurate. Decision aids (DAs) have been developed to help inform patients with low-risk prostate cancer about treatment options and assist in the decision-making process; however, little is currently known regarding the effects of such programs in this population. Thirteen studies of DAs for patients with prostate cancer were reviewed and it was found that the use of DAs can improve knowledge, encourage more active patient involvement in decision-making, and decrease levels of anxiety and distress. The effect of DAs on treatment choice was less clear, although fewer patients chose surgery compared with historical controls, particularly in Europe. Further studies are needed to determine how best to implement DAs into practice, and whether they improve the consistency between patient preferences and treatment choice.

Giving formulary and drug cost information to providers and impact on medication cost and use: a longitudinal non-randomized study.

BACKGROUND: Providers wish to help patients with prescription costs but often lack drug cost information. We examined whether giving providers formulary and drug cost information was associated with changes in their diabetes patients' drug costs and use. We conducted a longitudinal non-randomized evaluation of the web-based Prescribing Guide ( www.PrescribingGuide.com ), a free resource available to Hawaii's providers since 2006, which summarizes the formularies and copayments of six health plans for drugs to treat 16 common health conditions. All adult primary care physicians in Hawaii were offered the Prescribing Guide, and providers who enrolled received a link to the website and regular hardcopy updates. METHODS: We analyzed prescription claims from a large health plan in Hawaii for 5,883 members with diabetes from 2007 (baseline) to 2009 (follow-up). Patients were linked to 299 "main prescribing" providers, who on average, accounted for >88 % of patients' prescriptions and drug costs. We compared changes in drug costs and use for "study" patients whose main provider enrolled to receive the Prescribing Guide, versus "control" patients whose main provider did not enroll to receive the Prescribing Guide. RESULTS: In multivariate analyses controlling for provider specialty and clustering of patients by providers, both patient groups experienced similar increases in number of prescriptions (+3.2 vs. +2.7 increase, p = 0.24), and days supply of medications (+141 vs. +129 increase, p = 0.40) averaged across all drugs. Total and out-of-pocket drug costs also increased for both control and study patients. However, control patients showed higher increases in yearly total drug costs of $208 per patient (+$792 vs. +$584 increase, p = 0.02) and in 30-day supply costs (+$9.40 vs. +$6.08 increase, p = 0.03). Both groups experienced similar changes in yearly out-of-pocket costs (+$41 vs + $31 increase, p = 0.36) and per 30-day supply (-$0.23 vs. -$0.19 decrease, p = 0.996). CONCLUSION: Giving formulary and drug cost information to providers was associated with lower increases in total drug costs but not with lower out-of-pocket costs or greater medication use. Insurers and health information technology businesses should continue to increase providers' access to formulary and drug cost information at the point of care.

Revisit rates and associated costs after an emergency department encounter: a multistate analysis.

BACKGROUND: Return visits to the emergency department (ED) or hospital after an index ED visit strain the health system, but information about rates and determinants of revisits is limited. OBJECTIVE: To describe revisit rates, variation in revisit rates by diagnosis and state, and associated costs. DESIGN: Observational study using the Healthcare Cost and Utilization Project databases. SETTING: 6 U.S. states. PATIENTS: Adults with ED visits between 2006 and 2010. MEASUREMENTS: Revisit rates and costs. RESULTS: Within 3 days of an index ED visit, 8.2% of patients had a revisit; 32% of those revisits occurred at a different institution. Revisit rates varied by diagnosis, with skin infections having the highest rate (23.1% [95% CI, 22.3% to 23.9%]). Revisit rates also varied by state. For skin infections, Florida had higher risk-adjusted revisit rates (24.8% [CI, 23.5% to 26.2%]) than Nebraska (10.6% [CI, 9.2% to 12.1%]). In Florida, the only state with complete cost data, total revisit costs for the 19.8% of patients with a revisit within 30 days were 118% of total index ED visit costs for all patients (including those with and without a revisit). LIMITATION: Whether a revisit reflects inadequate access to primary care, a planned revisit, the patient's nonadherence to ED recommendations, or poor-quality care at the initial ED visit remains unknown. CONCLUSION: Revisits after an index ED encounter are more frequent than previously reported, in part because many occur outside the index institution. Among ED patients in Florida, more resources are spent on revisits than on index ED visits. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Impact of a patient-centered tool to reduce misconceptions about coronary artery disease and its treatment: The CAD roadmap.

Objective: Health misinformation is common and can lead to harmful behaviors such as medication non-adherence. We assessed the impact of a novel patient educational tool focused on overcoming misconceptions among patients with coronary artery disease (CAD). Methods: We developed the CAD Roadmap, an educational tool aimed at explaining the disease trajectory and overcoming common disease misconceptions (such as that statin medications are not beneficial). We designed a pilot survey to assess patients' 1) CAD-related knowledge, 2) medication-taking behavior, and 3) acceptability of the Roadmap. Survey participants were recruited online. CAD knowledge scores were compared with repeated measures t-tests. Results: Among 114 patients with CAD (mean age 67 years, 63% male), average CAD-related knowledge was 79.0% pre-test and 89.7% after review of the CAD Roadmap (p < .001). After review of the Roadmap, 24% indicated they planned to take their medications more regularly, 93% agreed it was helpful in understanding medication benefits, and 77% felt more empowered to participate in medical decisions. Conclusion: The CAD Roadmap was evaluated positively, improved disease-related knowledge, and has the potential to improve adherence to treatments. Innovation: Unlike many other interventions, the CAD Roadmap is specifically designed to overcome common misconceptions to improve health behaviors.

Oral and monoclonal antibody treatments for relapsing forms of multiple sclerosis: Effectiveness and value.

DISCLOSURES: Ms McKenna, Dr Lin, Dr Whittington, Mr Nikitin, Ms Herron-Smith, Dr Campbell, and Dr Peterson report grants from Arnold Ventures, grants from Blue Cross Blue Shield of MA, grants from California Healthcare Foundation, grants from The Commonwealth Fund, and grants from The Peterson Center on Healthcare, during the conduct of the study; other from America's Health Insurance Plans, other from Anthem, other from AbbVie, other from Alnylam, other from AstraZeneca, other from Biogen, other from Blue Shield of CA, other from CVS, other from Editas, other from Express Scripts, other from Genentech/Roche, other from GlaxoSmithKline, other from Harvard Pilgrim, other from Health Care Service Corporation, other from Kaiser Permanente, other from LEO Pharma, other from Mallinckrodt, other from Merck, other from Novartis, other from National Pharmaceutical Council, other from Premera, other from Prime Therapeutics, other from Regeneron, other from Sanofi, other from United Healthcare, other from HealthFirst, other from Pfizer, other from Boehringer-Ingelheim, other from uniQure, other from Envolve Pharmacy Solutions, other from Humana, and other from Sun Life, outside the submitted work.

Geriatricians' Perspectives on the Multiple Dimensions of Utility of Genetic Testing for Alzheimer's Disease: A Qualitative Study.

BACKGROUND: Research advancements in Alzheimer's disease (AD) raise opportunities for genetic testing to improve diagnostic and risk assessment. Despite emerging developments, it is unclear how geriatricians perceive the potential clinical and personal utility of genetic testing for their patients. Geriatricians' perspectives are essential to understanding potential ethical, policy, and clinical challenges. OBJECTIVE: In this paper, we report on geriatricians' perspectives on the utility of genetic testing for AD. METHODS: Semi-structured interviews with California geriatricians within different practices settings to collect and characterize their perspectives on genetic testing for AD. We used an adapted grounded theory approach to analyze recorded and transcribed interviews. RESULTS: We identified geriatricians' (n = 10) perspectives on the clinical and personal utility of testing, alongside their views on clinical care approaches for older adults. Geriatricians perceived minimal clinical utility of genetic testing for AD, though that may change with the availability of disease-modifying therapies. Yet, they recognized the potential personal utility of testing (e.g., assisting with future financial planning). Finally, geriatricians expressed concerns regarding patients' anxiety from learning about genetic status, particularly through direct-to-consumer (DTC) testing. CONCLUSION: Our data highlight that the decision to order genetic testing requires clinical and ethical considerations, including balancing limited clinical utility with the potential personal utility. Although DTC testing is available, geriatricians perceive that they have an important role in managing the decision to test and interpreting the results. Further research is needed to inform policy and ethical guidelines to support geriatricians' critical role to counsel patients considering clinical and DTC genetic testing.

Cost-Effectiveness and Value-Based Pricing of Aducanumab for Patients With Early Alzheimer Disease.

BACKGROUND AND OBJECTIVES: Aducanumab was granted accelerated approval with a conflicting evidence base, near-unanimous Food and Drug Administration Advisory Committee vote to reject approval, and a widely criticized launch price of $56,000 per year. The objective of this analysis was to estimate its cost-effectiveness. METHODS: We developed a Markov model to compare aducanumab in addition to supportive care to supportive care alone over a lifetime horizon. Results were presented from both the health system and modified societal perspective. The model tracked the severity of disease and the care setting. Incremental cost-effectiveness ratios were calculated and a threshold analysis was conducted to estimate at what price aducanumab would meet commonly used cost-effectiveness thresholds. RESULTS: Using estimates of effectiveness based on pooling of data from both pivotal trials, patients treated with aducanumab spent 4 more months in earlier stages of Alzheimer disease. Over the lifetime time horizon, treating a patient with aducanumab results in 0.154 more quality-adjusted life-years (QALYs) gained per patient and 0.201 equal value of life-years gained (evLYG) per patient from the health care system perspective, with additional costs of approximately $204,000 per patient. The incremental outcomes were similar for the modified societal perspective. At the launch price of $56,000 per year, the cost-effectiveness ranged from $1.02 million per evLYG to $1.33 million per QALY gained from the health care system perspective and from $938,000 per evLYG to $1.27 million per QALY gained in the modified societal perspective. The annual price to meet commonly used cost-effectiveness thresholds ranged from $2,950 to $8,360, which represents a discount of 85%-95% off from the annual launch price set by the manufacturer. Using estimates of effectiveness based only on the trial that suggested a benefit, the mean incremental cost was greater than $400,000 per QALY gained. CONCLUSION: Patients treated with aducanumab received minimal improvements in health outcomes at considerable cost. This resulted in incremental cost-effectiveness ratios that far exceeded commonly used value thresholds, even under optimistic treatment effectiveness assumptions. These findings are subject to the substantial uncertainty regarding whether aducanumab provides any true net health benefit, but evidence available currently suggests that an annual price of aducanumab of $56,000 is not in reasonable alignment with its clinical benefits.

Hereditary cancer panel testing challenges and solutions for the latinx community: costs, access, and variants.

Hereditary breast and ovarian cancers (HBOCs) are common among the Latinx population, and risk testing is recommended using multi-gene hereditary cancer panels (HCPs). However, little is known about how payer reimbursement and out-of-pocket expenses impact provider ordering of HCP in the Latinx population. Our objective is to describe key challenges and possible solutions for HCP testing in the Latinx population. As part of a larger study, we conducted semi-structured interviews with key provider informants (genetic counselors, oncologist, nurse practitioner) from safety-net institutions in the San Francisco Bay Area. We used a deductive thematic analysis approach to summarize themes around challenges and possible solutions to facilitating HCP testing in Latinx patients. We found few financial barriers for HCP testing for the Latinx population due to laboratory patient assistance programs that cover testing at low or no cost to patients. However, we found potential challenges related to the sustainability of low-cost testing and out-of-pocket expenses for patients, access to cascade testing for family members, and pathogenic variants specific to Latinx. Providers questioned whether current laboratory payment programs that decrease barriers to testing are sustainable and suggested solutions for accessing cascade testing and ensuring variants specific to the Latinx population were included in testing. The use of laboratories with payment assistance programs reduces barriers to HCP testing among the US population; however, other barriers are present that may impact testing use in the Latinx population and must be addressed to ensure equitable access to HCP testing for this population.

Is Better Patient Knowledge Associated with Different Treatment Preferences? A Survey of Patients with Stable Coronary Artery Disease.

BACKGROUND: In stable coronary artery disease (CAD), shared decision-making (SDM) is encouraged when deciding whether to pursue percutaneous coronary intervention (PCI) given similar cardiovascular outcomes between PCI and medical therapy. However, it remains unclear whether improving patient-provider communication and patient knowledge, the main tenets of SDM, changes patient preferences or the treatment chosen. We explored the relationships between patient-provider communication, patient knowledge, patient preferences, and the treatment received. METHODS: We surveyed stable CAD patients referred for elective cardiac catheterization at seven hospitals from 6/2016 to 9/2018. Surveys assessed patient-provider communication, medical knowledge, and preferences for treatment and decision-making. We verified treatments received by chart review. We used linear and logistic regression to examine relationships between patient-provider communication and knowledge, knowledge and preference, and preference and treatment received. RESULTS: Eighty-seven patients completed the survey. More discussion of the benefits and risks of both medical therapy and PCI associated with higher patient knowledge scores (ß=0.28, p<0.01). Patient knowledge level was not associated with preference for PCI (OR=0.78, 95% CI 0.57-1.03, p=0.09). Black patients had more than four times the odds of preferring medical therapy to PCI (OR=4.49, 1.22-18.45, p=0.03). Patients preferring medical therapy were not significantly less likely to receive PCI (OR=0.67, 0.16-2.52, p=0.57). CONCLUSIONS: While communicating the risks of PCI may improve patient knowledge, this knowledge may not affect patient treatment preferences. Rather, other factors such as race may be significantly more influential on a patient's treatment preferences. Furthermore, patient preferences are still not well reflected in the treatment received. Improving shared decision-making in stable CAD therefore may require not only increasing patient education but also better understanding and including a patient's background and pre-existing beliefs.

The effectiveness and value of aducanumab for Alzheimer's disease.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Whittington, Rind, and Pearson are employed by ICER. Through their affiliated institutions, Synnott and Lin received funding from ICER for the work described in this summary. In addition, Synnott reports support from Biogen for the Tufts Medical Center Cost-Effectiveness Analysis Registry, which is maintained by the Center for the Evaluation of Value and Risk in Health.

The effectiveness and value of bempedoic acid and inclisiran for heterozygous familial hypercholesterolemia and secondary prevention of ASCVD.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Agboola, McKenna, and Pearson are employed by ICER. Lin and Kazi received funding from ICER for work on this report.

Impact of changes in clinical practice guidelines on assessment of quality of care.

BACKGROUND: Measures for pay-for-performance and public reporting programs may be based on clinical practice guidelines. The impact of guideline changes over time-and whether evolving clinical evidence can render measures based on prior guidelines misleading-is not known. OBJECTIVE: To assess the impact of using different percutaneous coronary intervention (PCI) guidelines when evaluating whether PCI was indicated. RESEARCH DESIGN: PCIs from the National Cardiovascular Data Registry's CathPCI registry performed in 2003-2004 were categorized into indication classes (Class I, IIa, IIb, III), using 2001 American College of Cardiology/American Heart Association guidelines for PCI, the guidelines available at the time of the procedures. The same procedures were recategorized using 2005 guidelines, which reflect the best evidence available to clinicians at the time of PCI. Procedures unable to be categorized were labeled as "Not Certain." SUBJECTS: Patients undergoing PCI for stable or unstable angina in 394 hospitals. MEASURES: Number of procedures changing classification categories using 2001 versus 2005 guidelines. RESULTS: A total of 345,779 PCIs were evaluated. Applying 2001 guidelines, 47.9% had Class I indications; 33.3% Class IIa; 5.9% Class IIb; 3.7% Class III; and 9.2% Not Certain. Applying 2005 guidelines to the same procedures, 25.1% had Class I indications; 57.5% Class IIa; 5.5% Class IIb; 3.7% Class III; and 8.3% Not Certain; 41.1% of procedures changed the classification overall. CONCLUSIONS: The changes in guidelines resulted in a marked shift in whether PCIs done in 2003-2004 were considered indicated. Guideline-based performance measures should be carefully evaluated before implementation to avoid incorrect assessments of quality of care.

The Effectiveness and Value of Deflazacort and Exon-Skipping Therapies for the Management of Duchenne Muscular Dystrophy.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, Commonwealth Fund, California Health Care Foundation, National Institute for Health Care Management (NIHCM), New England States Consortium Systems Organization, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, Kaiser Foundation Health Plan, and Partners HealthCare to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Allergan, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Fluetsch, Rind, and Pearson are employed by ICER. Lin reports support from ICER during work on this economic model and grants from Mount Zion Health Fund, National Institutes of Health (National Cancer Institute and National Heart, Lung, and Blood Institute), and the Tobacco-Related Diseases Research Program, unrelated to this work. Walton reports support from ICER for work on this economic model and unrelated consulting fees from Baxter.