A Comparison of Web-Based Cancer Risk Calculators That Inform Shared Decision-making for Lung Cancer Screening.

INTRODUCTION: To align patient preferences and understanding with harm-benefit perception, the Centers for Medicare & Medicaid Services (CMS) mandates that providers engage patients in a collaborative shared decision-making (SDM) visit before LDCT. Nonetheless, patients and providers often turn instead to the web for help making decisions. Several web-based lung cancer risk calculators (LCRCs) provide risk predictions and screening recommendations; however, the accuracy, consistency, and subsequent user interpretation of these predictions between LCRCs is ambiguous. We conducted a systematic review to assess this variability. DESIGN: Through a systematic Internet search, we identified 10 publicly available LCRCs and categorized their input variables: demographic factors, cancer history, smoking status, and personal/environmental factors. To assess variance in LCRC risk prediction outputs, we developed 16 hypothetical patients along a risk continuum, illustrated by randomly assigned input variables, and individually compared them to each LCRC against the empirically validated "gold-standard" PLCO risk model in order to evaluate the accuracy of the LCRCs within identical time-windows. RESULTS: From the inclusion criteria, 11 calculators were initially identified. The analyzed calculators also vary in output characteristics and risk depiction for hypothetical patients. There were 13 total instances across ten hypothetical patients in which the sample standard error exceeded the mean risk percentage across all general samples and set standard calculations. The largest measured difference is 16.49% for patient 8, and the smallest difference is 0.01% for patient 2. The largest measured difference is 16.49% for patient 8, and the smallest difference is 0.01% for patient 2. CONCLUSION: Substantial variability in the depiction of lung cancer risk for hypothetical patients exists across the web-based LCRCs due to their respective inputs and risk prediction models. To foster informed decision-making in the SDM-LDCT context, the input variables, risk prediction models, risk depiction, and screening recommendations must be standardized to best practice.

Under Azar and Boehler, CMMI Gets Its Groove Back.

It seems that under HHS Secretary Alex Azar, the Center for Medicare and Medicaid Innovation-that ACA-enabled office given almost carte-blanche authority to experiment with new payment and care models-may be getting its groove back. Adam Boehler, hired last April as CMMI director, has cranked up output with a flurry of new models.

The Medicare Advantage Advantage-For Insurers, It's a Sweet Deal, Indeed!

Let the good times roll! CMS overpays for MA coverage, and that allows insurers to give enrollees extra benefits that traditional Medicare does not cover. But there's this thing called "politics," with rumblings that insurers have too sweet a deal. Will the spigot be turned off?

MA Part B Makes Controversial Jump Into Step Therapy.

Step therapy is common in commercial insurance but new to MA. Insurers defend it as an evidence-based way to put some guardrails on ill-advised, costly prescribing. Practitioners, medical societies, and drugmakers complain, though, that CMS's guidance is vague, and gives plans too much latitude in dictating step edits.

Thanks to CMS Rule Change, MA Takes SDOH to a Whole New Level.

CMS and insurers talked about what needed to be done to better address the social determinants of health (SDOH) for beneficiaries. That led to a policy, implemented last year by CMS, that allows for the provision of daily maintenance care using nonskilled in-home providers, the kind of services usually given in assisted-living facilities.

And with MIPS, we just don't know yet.

It may take a little while longer to ferret out whether MIPS is having CMS's self-described effect-to "drive improvement in care processes and health outcomes, increase the use of health care information, and reduce the cost of care." Already concluding that cost reduction is unlikely, Medpac recommended scraping MIPS altogether.

Why Medicare Advantage enrollment will keep on growing, whatever the politics.

In 2019, a record 36% of Medicare beneficiaries will be getting their benefits in a Medicare Advantage plan. CMS has broadened the services such plans can provide-services that may reduce expensive treatments and injuries. Insurers continue to see the market as a business opportunity. Critics see a slow-motion privatization of the entitlement.

With CMS Demanding More Accountability in the MSSP, Will It Be 'ACOs Overboard'?

For 169 ACOs, time is up to take on downside risk. This group-30% of all of those in the Medicare Shared Savings Program (MSSP)-are Track 1, upside risk-only ACOs and are nearing the end of their contracts with CMS.

The quality of Medicaid and Medicare data obtained from CMS and its contractors: implications for pharmacoepidemiology.

BACKGROUND: Administrative claims of United States Centers for Medicare and Medicaid Services (CMS) beneficiaries have long been used in non-experimental research. While CMS performs in-house checks of these claims, little is known of their quality for conducting pharmacoepidemiologic research. We performed exploratory analyses of the quality of Medicaid and Medicare data obtained from CMS and its contractors. METHODS: Our study population consisted of Medicaid beneficiaries (with and without dual coverage by Medicare) from California, Florida, New York, Ohio, and Pennsylvania. We obtained and compiled 1999-2011 data from these state Medicaid programs (constituting about 38% of nationwide Medicaid enrollment), together with corresponding national Medicare data for dually-enrolled beneficiaries. This descriptive study examined longitudinal patterns in: dispensed prescriptions by state, by quarter; and inpatient hospitalizations by federal benefit, state, and age group. We further examined discrepancies between demographic characteristics and disease states, in particular frequencies of pregnancy complications among men and women beyond childbearing age, and prostate cancers among women. RESULTS: Dispensed prescriptions generally increased steadily and consistently over time, suggesting that these claims may be complete. A commercially-available National Drug Code lookup database was able to identify the dispensed drug for 95.2-99.4% of these claims. Because of co-coverage by Medicare, Medicaid data appeared to miss a substantial number of hospitalizations among beneficiaries ≥ 45 years of age. Pregnancy complication diagnoses were rare in males and in females ≥ 60 years of age, and prostate cancer diagnoses were rare in females. CONCLUSIONS: CMS claims from five large states obtained directly from CMS and its contractors appeared to be of high quality. Researchers using Medicaid data to study hospital outcomes should obtain supplemental Medicare data on dual enrollees, even for non-elders. TRIAL REGISTRATION: Not applicable.

In-Hospital Cardiac Arrest Resuscitation Practices and Outcomes in Maintenance Dialysis Patients.

BACKGROUND AND OBJECTIVES: Patients on maintenance dialysis with in-hospital cardiac arrest have been reported to have worse outcomes relative to those not on dialysis; however, it is unknown if poor outcomes are related to the quality of resuscitation. Using the Get With The Guidelines-Resuscitation (GWTG-R) registry, we examined processes of care and outcomes of in-hospital cardiac arrest for patients on maintenance dialysis compared with nondialysis patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used GWTG-R data linked to Centers for Medicare and Medicaid data to identify patients with ESKD receiving maintenance dialysis from 2000 to 2012. We then case-matched adult patients on maintenance dialysis to nondialysis patients in a 1:3 ratio on the basis of age, sex, race, hospital, and year of arrest. Logistic regression models with generalized estimating equations were used to assess the association of in-hospital cardiac arrest and outcomes by dialysis status. RESULTS: After matching, there were a total of 31,144 GWTG-R patients from 372 sites, of which 8498 (27%) were on maintenance dialysis. Patients on maintenance dialysis were less likely to have a shockable initial rhythm (20% versus 21%) and less likely to be within the intensive care unit at the time of arrest (46% versus 47%) compared with nondialysis patients; they also had lower composite scores for resuscitation quality (89% versus 90%) and were less likely to have defibrillation within 2 minutes (54% versus 58%). After adjustment, patients on maintenance dialysis had similar adjusted odds of survival to discharge (odds ratio [OR], 1.05; 95% confidence interval [95% CI], 0.97 to 1.13), better acute survival (OR, 1.33; 95% CI, 1.26 to 1.40), and were more likely to have favorable neurologic status (OR, 1.12; 95% CI, 1.04 to 1.22) compared with nondialysis patients. CONCLUSIONS: Although there appears to be opportunities to improve the quality of in-hospital cardiac arrest care for among those on maintenance dialysis, survival to discharge was similar for these patients compared with nondialysis patients.

Accountable Care Organizations Serving Deprived Communities Are Less Likely to Share in Savings.

PURPOSE: Primary care physicians are increasingly participating in accountable care organizations (ACOs). While prior studies have identified ACO and patient characteristics associated with savings, none have examined characteristics of the communities served by ACOs. Our objective was to assess the relationship between an ACO's service area characteristics and its savings rate. METHODS: In this cross-sectional study, we used the Centers for Medicare and Medicaid Services 2014 Medicare Shared Savings Program ACO Provider and Beneficiary, and Public Use Files to identify ACO and beneficiary characteristics. We used the American Community Survey to measure community deprivation at the ACO service area-level by using the social deprivation index. The outcome of interest was the ACO savings rate. We conducted bivariate analyses and regressions, adjusting for ACO organization and beneficiary characteristics. RESULTS: Our sample consisted of 320 ACOs participating in the Shared Savings Plan. The savings rate for ACOs serving the most deprived communities was 1.19% compared with 1.14% for those serving the least deprived. Adjusting for ACO and beneficiary characteristics, however, ACOs serving the most deprived had a savings rate that was 2.3 percentage points lower than those serving the least deprived. CONCLUSIONS: ACOs serving deprived communities generate less savings. These findings are important to primary care practices, payers, and policy makers anticipating continued ACO expansion, if population health is to be achieved equitably.

Integrating Quality Improvement Education into the Nephrology Curricular Milestones Framework and the Clinical Learning Environment Review.

The Accreditation Council for Graduate Medical Education requires that trainees show progressive milestone attainment in the practice-based learning and systems-based practice competencies. As part of the Clinical Learning Environment Review, sponsoring hospitals must educate trainees in health care quality improvement, provide them with specialty-specific quality data, and ensure trainee participation in quality improvement activities and committees. Subspecialty-specific quality improvement curricula in nephrology training programs have not been reported, although considerable curricular and assessment material exists for specialty residencies, including tools for assessing trainee and faculty competence. Nephrology-specific didactic material exists to assist nephrology fellows and faculty mentors in designing and implementing quality improvement projects. Nephrology is notable among internal medicine subspecialties for the emphasis placed on adherence to quality thresholds-specifically for chronic RRT shown by the Centers for Medicare and Medicaid Services Quality Incentive Program. We have developed a nephrology-specific curriculum that meets Accreditation Council for Graduate Medical Education and Clinical Learning Environment Review requirements, acknowledges regulatory quality improvement requirements, integrates with ongoing divisional quality improvement activities, and has improved clinical care and the training program. In addition to didactic training in quality improvement, we track trainee compliance with Kidney Disease Improving Global Outcomes CKD and ESRD quality indicators (emphasizing Quality Improvement Program indicators), and fellows collaborate on a yearly multidisciplinary quality improvement project. Over the past 6 years, each fellowship class has, on the basis of a successful quality improvement project, shown milestone achievement in Systems-Based Practice and Practice-Based Learning. Fellow quality improvement projects have improved nephrology clinical care within the institution and introduced new educational and assessment tools to the training program. All have been opportunities for quality improvement scholarship. The curriculum prepares fellows to apply quality improvement principals in independent clinical practice-while showing milestone advancement and divisional compliance with Clinical Learning Environment Review requirements.

Facility Practice Variation to Help Understand the Effects of Public Policy: Insights from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

Recent Centers for Medicare & Medicaid Services policies have used dialysis facility practice variation to develop public ratings and adjust payments. In the Dialysis Facility Compare star rating system (DFC SRS), facility-relative rates of performance-based clinical measures varied nearly two-fold for mortality (standardized mortality ratio; 10th/90th percentiles: 0.71, 1.34) and hospitalization (standardized hospitalization ratio; 10th/90th percentiles: 0.64, 1.37), and nearly four-fold for transfusion (standardized transfusion ratio; 10th/90th percentiles: 0.43, 1.65). Medicare claims data (from July of 2014) demonstrate that facility variation for the proportions of patients on hemodialysis hospitalized (10th/90th percentiles: 27%, 50%) and transfused (10th/90th percentiles: 3%, 17%) within 6 months that far exceeds relatively modest recent overall longitudinal trends. DFC SRS-rated facility variation is also substantial for fistula (10th/90th percentiles: 50%, 78%) and catheter use >90 days (10th/90th percentiles: 3%, 19%). By contrast, DFC SRS-rated facility distributions for adult hemodialysis Kt/V>1.2 (10th/90th percentiles: 84%, 97%) and total serum calcium >10.2 mg/dl (median, 1%; 75th/90th percentiles: 3%, 5%) are quite narrow and may be of questionable value. Likewise, variation in the US Dialysis Outcomes and Practice Patterns Study is over two-fold for facility median serum parathyroid hormone (10th/90th percentiles: 290 pg/ml, 629 pg/ml) and ferritin (10th/90th percentiles: 469 ng/ml, 1143 ng/ml) levels, and facility mean treatment time varies by 30 minutes (10th/90th percentiles: 204 minutes, 234 minutes). Rising serum parathyroid hormone and ferritin levels, and generally short dialysis treatment time, represent areas unchecked by existing policy; both overall trends and facility variation in these values may reflect unintended consequences of policy or reimbursement pressures and therefore raise concern. Additionally, outcomes in the transition period from advanced CKD to dialysis remain poor, and policy initiatives and performance accountability in this area remain insufficient. Innovative models of comprehensive care in advanced CKD and the early dialysis period which are more amenable to policy oversight are needed. In summary, facility variation is typically larger than prevailing longitudinal trends, and should not be overlooked. The combination of nationally representative observational databases (e.g., the Dialysis Outcomes and Practice Patterns Study) and ESRD registries can provide policy makers with additional tools to evaluate facility variation, develop policies, and monitor unintended effects.

Delays in Prior Living Kidney Donors Receiving Priority on the Transplant Waiting List.

BACKGROUND AND OBJECTIVES: Prior living donors (PLDs) receive very high priority on the Organ Procurement and Transplantation Network (OPTN) kidney waiting list. Program delays in adding PLDs to the waiting list, setting their status to active, and submitting requests for PLD priority can affect timely access to transplantation. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used the OPTN and the Centers for Medicare and Medicaid Services data to examine timing of (1) listing relative to start of dialysis, (2) activation on the waiting list, and (3) requests for PLD priority relative to listing date. There were 210 PLDs (221 registrations) added to the OPTN kidney waiting list between January 1, 2010 and July 31, 2015. RESULTS: As of September 4, 2015, 167 of the 210 PLDs received deceased donor transplants, six received living donor transplants, two died, five were too sick to transplant, and 29 were still waiting. Median waiting time to deceased donor transplant for PLDs was 98 days. Only 40.7% of 221 PLD registrations (n=90) were listed before they began dialysis; 68.3% were in inactive status for <90 days, 17.6% were in inactive status for 90-365 days, 8.6% were in inactive status for 1-2 years, and 5.4% were in inactive status for >2 years. Median time of PLDs waiting in active status before receiving PLD priority was 2 days (range =0-1450); 67.4% of PLDs received PLD priority within 7 days after activation, but 15.4% waited 8-30 days, 8.1% waited 1-3 months, 4.1% waited 3-12 months, and 5.0% waited >1 year in active status for PLD priority. After receiving priority, most were transplanted quickly. Median time in active status with PLD priority before deceased donor transplant was 23 days. CONCLUSIONS: Fewer than one half of listed PLDs were listed before starting dialysis. Most listed PLDs are immediately set to active status and receive PLD priority quickly, but a substantial number spends time in active status without PLD priority or a large amount of time in inactive status, which affects access to timely transplants.

Insights from the early experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges.