Category: Uncategorized

Evidence-Based Satire

Dec 22, 2018• 1

By SAURABH JHA

Sequels generally disappoint. Jason couldn’t match the fear he generated in the original Friday the 13^th. The sequel to the Parachute, a satirical piece canvassing PubMed for randomized controlled trials (RCTs) comparing parachutes to placebo, matched its brilliance, and even exceeded it, though the margin can’t be confirmed with statistical significance. The Parachute, published in BMJ’s Christmas edition, will go down in history with Jonathan Swift’s Modest Proposal and Frederic Bastiat’s Candlemakers’ Petition as timeless satire in which pedagogy punched above, indeed depended on, their absurdity.

In the Parachute, researchers concluded, deadpan, that since no RCT has tested the efficacy of parachutes when jumping off a plane, there is insufficient evidence to recommend them. At first glance, the joke was on RCTs and those who have an unmoored zeal for them. But that’d be a satirical conclusion. Sure, some want RCTs for everything, for whom absence of evidence means no evidence. But that’s because of a bigger problem which is that we refuse to acknowledge that causality has degrees, shades of gray, yet causality can sometimes be black and white. Somethings are self-evident.

In medicine, causation, even when it’s not correlation, is often probabilistic. Even the dreaded cerebral malaria doesn’t kill everyone. If you jump from a plane at 10, 000 feet without a parachute death isn’t probabilistic, it is certain. And we know this despite the absence of rigorous empiricism. It’s common sense. We need sound science to tease apart probabilities, and grayer the causality the sounder the empiricism must be to accord the treatment its correct quantitative benefit, the apotheosis of this sound science being an RCT. When empiricism ventures into certainties, it’s no longer sound science. It is parody.

Health in 2 Point 00, Episode 63 Walgreens & Fedex partnership, Verily’s adherence program, & more!

Dec 21, 2018• 1

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

CMS Should Boost the Signal on Social Determinants of Health

Dec 21, 2018• 1

Herb Kuhn, Missouri Hospital Association, Social Determinants of Health

By HERB KUHN

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 21^st 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.

Increased Payer and Provider Support May Drive Billions of Dollars in Savings from Biosimilars

Dec 20, 2018• 1

By SHEILA FRAME

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.

Organizations such as the American College of Rheumatology and the American Society of Clinical Oncology have issued educational documents to help guide providers in incorporating biosimilars into treatment plans, where appropriate. Yet, many doctors remain hesitant to prescribe them due to concerns about safety, efficacy, immunogenicity, effects of switching to a new biosimilar and the economic value to patients.

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.

The Importance of Patient Engagement in Post-Acute Care

Dec 19, 2018• 5

Brian Holzer, patient engagement, post-acute care

By BRIAN HOLZER MD, MBA

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.

What Does Congressional Gridlock Mean for the Rest of the Country?

Dec 18, 2018• 2

Joe Molloy, health policy, Congressional gridlock

By JOE MOLLOY

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.”

Health in 2 Point 00, Episode 62- AHIP in Nashville!

Dec 17, 2018• 2

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

Last Month in Oncology with Dr. Bishal Gyawali: November 2018

Dec 17, 2018• 2

By BISHAL GYAWALI MD

Keynote speech

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.
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Hotlines Aren’t Enough to Help People at Risk of Suicide

Dec 14, 2018• 4

Cara Angelotta, suicide prevention, health policy

By CARA ANGELOTTA MD

Contrary to popular belief, the risk of suicide does not increase around the holidays. But, according to the Centers for Disease Control and Prevention, annual suicide rates in the U.S. have risen nearly 30 percent since 1999.

Much of the media coverage following the high-profile suicides of Kate Spade and Anthony Bourdain has followed recommended best practices to reduce risk of suicide contagion or “copycat” suicides by including warning signs a person may be at risk of suicide due to depression and contact information for the national hotline for suicide prevention. This overly simplistic approach implies that we can prevent all suicides by reaching out to loved ones in emotional distress and advertising the existence of mental health treatment.

As a psychiatrist who treats individuals hospitalized for acute suicide risk, I am concerned that much of the media coverage has belied the complexity of suicide. While we do not yet fully understand why suicide rates are rising, we do know that suicide is a complex public health problem that will require a multifaceted approach to reduce deaths. Increased awareness of depression as a treatable medical illness is an important but insufficient response to the suicide epidemic.

Win, Lose, or Draw: Not all ACA Enrollees Gain from Increased Competition

Dec 13, 2018• 3

By KATHERINE HEMPSTEAD PhD

The 2019 ACA plan year is notable for the increase in insurer participation in the marketplace. Expansion and entry have been substantial, and the percent of counties with one insurer has declined from more than 50 percent to approximately 35 percent. While urban areas in rural states have received much of the new participation, entire rural states have gained, along with more metropolitan urban areas.

Economic theory and common sense lead most to believe that increased competition is unquestionably good for consumers. Yet in the paradoxical world of the subsidized ACA marketplace, things are not so simple. In some markets, increased competition may result in a reduction in the purchasing power of subsidized consumers by narrowing the gap between the benchmark premium and plans that are cheaper than the benchmark. Even though the overall level of premiums may decline, potential losses to subsidized consumers in some markets will outweigh gains to the unsubsidized, suggesting that at the county level, the losers stand to lose more than the winners will win.

One way to illustrate this is to hypothetically subject 2018 marketplace enrollees to 2019 premiums in counties where new carriers have entered the market. Assuming that enrollees stay in the same metal plan in both 2018 and 2019, and that they continue to buy the cheapest plan in their metal, we can calculate how much their spending would change by income group.

Under these assumptions, in about one quarter of the counties with federally facilitated marketplaces (FFM) that received a new carrier in 2019, both subsidized and unsubsidized enrollees would be better off in 2019, meaning that they could spend less money and stay in the same metal level. In about thirty percent of these counties, all enrollees are worse off. In almost all of the rest, about forty percent, there are winners and losers, but in the aggregate, the subsidized lose more than the unsubsidized win. Overall, in about 70 percent of FFM counties with a new carrier, subsidized enrollees will lose purchasing power, while in about 66 percent of these counties, unsubsidized customers will see premium reductions. In population terms, about two-thirds of subsidized enrollees in counties with a new carrier will find plans to be less affordable, while a little more than half of unsubsidized enrollees will see lower premiums.