Fueled by Americans’ urgent need for better chronic disease care and insurers’ march from fee-for-service to value-based payments, innovation in population health management is accelerating across the health care industry. But it’s hardly new, and CareMore Health, a recent acquisition of publicly-traded insurer Anthem, has been on the vanguard of the trend for over twenty years.
CareMore Health provides coordinated, interdisciplinary care to high-need patients referred by primary care physicians in nine states and Washington, D.C. The care encompasses individualized prevention and chronic disease management services and coaching, provided on an outpatient basis at CareMore’s Care Clinics. It also includes oversight of episodic acute care, via CareMore “extensivists” and case managers who ensure effective coordination across providers and care sites before, during and after patient hospitalizations.
The majority of CareMore patients are covered by Medicare Advantage or Medicaid, and company-reported results, as well as a Commonwealth Fund analysis, indicate that the patient-centered, relationship-based model leads to fewer emergency room visits, specialist visits and hospitalizations for segments of the covered population. They also suggest that it leads to cost efficiencies relative to comparable plans in its markets of operation.
The day after NBC releases a story on a ‘ground-breaking’ observational study demonstrating caramel macchiatas reduce the risk of death, everyone expects physicians to be experts on the subject. The truth is that most of us hope John Mandrola has written a smart blog on the topic so we know intelligent things to tell patients and family members.
A minority of physicians actually read the original study, and of those who read the study, even fewer have any real idea of the statistical ingredients used to make the study. Imagine not knowing whether the sausage you just ate contained rat droppings. At least there is some hope the tongue may provide some objective measure of the horror within.
Data that emerges from statistical black boxes typically have no neutral arbiter of truth. The process is designed to reveal from complex data sets, that which cannot be readily seen. The crisis created is self-evident: With no objective way of recognizing reality, it is entirely possible and inevitable for illusions to proliferate.
Republicans and Democrats are seen as poles apart on health policy, and the recent election campaign magnified those differences. But in one area—private-sector competition among healthcare providers—there seems to be a fair amount of overlap. This is evident from a close reading of recent remarks by Health and Human Services Secretary Alex Azar and a 2017 paper from the Brookings Institution.
Azar spoke on December 3 at the American Enterprise Institute (AEI), the conservative counterpart to the liberal-leaning Brookings think tank. Referring to a new Trump Administration report on how to reduce healthcare spending through “choice and competition,” Azar said that the government can’t just try to make insurance more affordable while neglecting the underlying costs of care. “Healthcare reform should rely, to the extent possible, on competition within the private sector,” he said.
This is pretty close to the view expressed in the Brookings paper, written by Martin Gaynor, Farzad Mostashari, and Paul B. Ginsburg. “Ensuring that markets function efficiently is central to an effective health system that provides high quality, accessible, and affordable care,” the authors stated. They then proposed a “competition policy” that would require a wide range of actions by the federal and state governments.
Today on Health in 2 Point 00, Jess and I get festive for the holidays. In this episode, Jess asks me about Walgreens and its new partnership with FedEx for next day prescription delivery and with Verily to help patients with prescription adherence. She also asks me about blockchain startup PokitDok getting its assets acquired by Change Healthcare. Lots of job changes are happening as well. Amy Abernethy, the chief medical officer at Flatiron Health, was named Deputy Commissioner of the FDA. Rasu Shrestha, who was previously at the University of Pittsburgh Medical Center, is the new chief strategy officer of Atrium Health. Finally, Zane Burke, who recently stepped down as president of Cerner, was just hired as Livongo’s new CEO, while Glen Tullman remains executive chairman of the company. Dr. Jennifer Schneider was also promoted from the company’s chief medical officer to president. We have one more episode of Health in 2 Point 00 for 2018, so be on the lookout for our year-end wrap-up. —Matthew Holt
Historically, the Centers for Medicare & Medicaid Services’ (CMS) stance on the influence that social determinants of health (SDOH) have on health outcomes has been equal parts signal and noise. In April 2016, the agency announced it would begin adjusting the Medicare Advantage star ratings for dual-eligibility and other social factors. This was amid calls for increased equity in the performance determinations from the managed care industry. At the same time, CMS continued to refuse risk-adjustment for SDOH in the Hospital Readmissions Reduction Program (HRRP) despite the research supporting the influence of these factors on the HRRP.
It wasn’t until Congress interceded with the 21st Century Cures Act that CMS conceded to adjusting for dual-eligibility under the new stratified approach to determining HRRP penalties beginning in fiscal year 2019. The new methodology compares hospital readmission performance to peers within the same quintile of dual-eligible payer mix. The debate surrounding the adjustment of incentive-based performance metrics for SDOH likely is to continue, as many feel stratification is a step in the right direction, albeit a small one. And importantly, the Cures Act includes the option of direct risk-adjustment for SDOH, as deemed necessary by the Secretary of Health and Humans Services.
SDOH are defined as “the conditions in which people are born, grow, live, work and age.” The multidimensional nature of SDOH reach far beyond poverty, requiring a systemic approach to effectively moderate their effects on health outcomes. The criteria used to identify SDOH include factors that have a defined association with health, exist before the delivery of care, are not determined by the quality of care received and are not readily modifiable by health care providers.
The question of modifiability is central to the debate. In the absence of reimbursement for treating SDOH, providers lack the resources to modify health outcomes attributable to social complexities. Therefore, statistical adjustments are needed to account for differences in these complexities to ensure risk-adjusted performance comparisons of hospitals are accurate.
FDA Commissioner Scott Gottlieb has said biosimilars are “key to promoting access and reducing health care costs. And it’s a key to advancing public health.” While the Administration works to reduce barriers to bringing biosimilars to market, payers and providers can help increase adoption of biosimilars in clinical practice and ensure cost savings.
Biosimilars are developed in a similar way as existing biologics and have the same safety, efficacy, and quality profiles, but are more competitively priced to ensure more patients have access to these important medicines and that the system can afford them. A ten-year growing body of real-world use in the EU shows biosimilar medicines increase usage of biologic medicines, while matching their reference biologics in terms of safety, efficacy and quality.
Leaders in hospitals and health systems as well as post-acute care providers such as skilled nursing facilities (SNFs) and Home Health Care (HHC) agencies operate in a complex environment. Currently, the health care reimbursement environment is largely dominated by fee-for-service models. However, acute and post-acute leaders must increasingly position their organizations to prepare for, and participate in, evolving value-based care programs—without losing sight of the current fee-for-service reimbursement structure.
With that said, the call to action for acute and post-acute providers working at both ends of the reimbursement spectrum is real. The time is now to innovate, test and adopt new post-acute care models to support each patient’s transition from hospital to post-acute settings, and eventually home to enable a better care experience for patients and their care teams.
This is especially relevant for Skilled Nursing Facilities (SNFs) and chains that meet the current Medicare requirements for Part A coverage. Increasingly, the SNF industry is under pressure from the Medicare program to improve coordination and outcomes. Medicare’s hospital readmission policy and value-based purchasing program (VBP), bundled payments, and ACOs encourage SNFs, and other post-acute settings, to avoid readmissions. In addition, earlier this year, the Centers for Medicare and Medicaid Services (CMS) finalized a new patient-driven payment model (PDPM) for SNFs, which will go into effect on October 1, 2019. The overhaul of the entire system will require significant staff focus and operational changes.
Often, a Congressional gridlock is essentially good. This is because the executive arm of government is forced to consider a bipartisan approach to issues if it’s to secure the approval of both Democrats and Republicans in Congress.
The outcome of the midterm elections indicates that the Republicans have managed to retain their control of the Senate, while Democrats have secured control of the House of Representatives.
Health a Central Issue During the Midterms
According to a survey by Health Research Incorporated, the three top issues of concern during the midterm elections were health, followed by Social Security and Medicare, with 59% of the respondents irrespective of age, race or geography citing health as the most significant.
Among Trump’s electoral promises was a complete repeal and replacement of Obamacare under the Affordable Care Act (ACA) with a policy that was apparently less expensive and more effective. On his first day of office, Trump signed an executive order instructing federal agencies “to take all reasonable measures that minimize the economic burden of the law, including actions to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act.”
On Episode 62 of Health in 2 Point 00, Jess and I are reporting from Nashville—while enjoying some delicious barbecue. We’re in town for AHIP’s Consumer Experience & Digital Health Forum, where Jess did an amazing job as a moderator and I was on a panel. In this episode, Jess asks me about my key takeaways from the forum, what the deal is with Tivity Health acquiring Nutrisystem, and how I managed to get into a fight on Twitter while at AHIP. —Matthew Holt
There was a very sobering piece in NEJM by the FDA last month in which the authors try to explore what went wrong with the Keynote-183, Keynote-185 and checkmate 602 trials testing PD-1 inhibitors combinations with pomalidomide or lenalidomide and dexamethasone in multiple myeloma. Interim analysis of Keynote 183 and 185 revealed detrimental effects on overall survival (OS) with hazard ratios of 1.61 and 2.06, not explained by differences in toxicities alone. The checkmate 602 trial was also halted in light of these findings and also showed higher mortality in the nivolumab combination arm.
In the thoughtful NEJM piece, the authors make at least three important points. First, they question why these PD-1 inhibitors were tested in combination despite their having limited single-agent activity. In fact, a couple of years ago, Vinay Prasad and I asked the same question: why are novel cancer drugs being tested in combination despite having limited activity as a single agent? We found that these drugs, even when ultimately approved, provide relatively low value and recommended that drugs with poor single agent activity not be tested in combinations unless there are specific reasons to expect synergy.
The second important point in the article is that many cancer drug approvals are lately based on durable response rates in single arm trials without a control group, a situation in which it is difficult to evaluate the safety and efficacy of drug combinations. Indeed, without an RCT, the oncology community would never have known these signals of detrimental effect. If the FDA had approved these PD-1 inhibitors in multiple myeloma on the basis of non-randomized trials, which it often does in other oncology contexts, who knows how long it would have taken to recognize the increased mortality in patients—and at what cost. This is another reason why we need RCTs more now than ever. Finally, the authors point out that these PD-1 inhibitors in multiple myeloma were directly advanced to phase 3 trials after phase 1 trials were completed, without phase 2 information. Indeed, in a recent paper, Alfredo Addeo and I showed that a substantial percentage of drugs that fail in phase 3 trials do not have supporting phase 2 data. Continue reading…