Thursday, January 24, 2019
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Last Month in Oncology with Dr. Bishal Gyawali: November 2018

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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.

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

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By CARA ANGELOTTA MDCara Angelotta, suicide prevention, health policy

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

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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.

Medicaid Expansion is Evidence the Health Policy Debate Defies Political Divides

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By AMY LONG and JOE MOLLOY Joe Molloy talking about health policy debate

Among all the talk of waves and tides of the close midterm races around the country, there were tremendous results on election day for Medicaid expansion. Three states – Idaho, Nebraska, and Utah – passed ballot initiatives approving the policy.

On top of that, in Kansas and Maine, governors who had vetoed the policy in the past were replaced with candidates promising to enact it.

This was obviously great news for supporters of Medicaid expansion with the total number of expansion states firmly at 36.

What were the issues?

In Idaho, the Expansion ballot initiative was designed to provide insurance covers for individuals under the age of sixty-five and whose income is below 138 percent of the federal poverty level and who are not eligible for any other state insurance cover.

Among the proponents of Medicaid in Idaho was State representative Christy Perry a Republican and staunch Trump supporter. She had over the years attempted to push for the expansion through the state legislature but faced resistance from statehouse leaders.

The scenario in Idaho applies to Utah and Nebraska, with the ballot initiative being necessitated by the strong opposition from the majority of Republicans and statehouse leaders. In Utah, opponents of the Expansion argued that the initiative would bankrupt the state treasury. In Nebraska caution was given against reliance on federal government financing for state programs noting that often the national government scale back or neglect supporting state programs without proper transitional mechanisms.

However, it was difficult to debate against the fact that Medicaid would free up resources invested by the state governments in local insurance programs and that the federal government is legally obliged to pay 90% of the cost of the policy.

The Disruptive Potential of Employer-Centered Care

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By LAWRENCE LEISURE 

When it comes to health care prices, the burden piled on payers can seem almost cartoonishly heavy. News stories on the state of the industry read as though some satirist decided to exaggerate real systemic flaws into cost-prohibitive fiction. A particularly painful example hit the presses earlier this year, when a writer for Reuters revealed that the cost of a full course of oncology treatment skyrocketed from $30,447 in 2006 to $161,141 in the last few years. The change was so unbelievable as to verge on dark comedy — but there isn’t much to find funny in the situation when lives and health outcomes are on the line.

For the average employee in my home of Silicon Valley, the price crunch is challenging regardless the size of your paycheck. For local employers, however, the dilemma can be even more pointed. Today, employees of companies, large and small, expect their employer to provide comprehensive health care benefits and are largely unaware of or insensitive to the factors exacerbating market problems today. Providing these benefits, however, is easier said than done.

Employers and insurers alike face a multitude of barriers to connecting employees with affordable care. Recent research suggests that prices will increase at an average clip of 5.8% annually between now and 2024, well above the expected rate of inflation. Even worse, the increased consolidation of healthcare providers has drastically undermined the negotiating power that payers would otherwise have in more competitive markets. In Northern California, for example, major health systems, including Sutter Health, sparked outrage and protest as they have managed to amass enough of the region’s hospitals, outpatient facilities, and primary care offices to diminish regional competitors and set what many view as unacceptably high rates — all the while knowing that the lack of local competition makes it challenging for the major health insurers to push back.

THCB Spotlight: Jesse Ehrenfeld, AMA

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By ZOYA KHAN

Today, we are featuring Dr. Jesse Ehrenfeld from the American Medical Association (AMA) on THCB Spotlight. Matthew Holt interviews Dr. Ehrenfeld, Chair-elect of the AMA Board of Trustees and an anesthesiologist with the Vanderbilt University School of Medicine. The AMA has recently released their Digital Health Implementation Playbook, which is a guide to adopting digital health solutions. They also launched a new online platform called the Physician Innovation Network to help connect physicians with entrepreneurs and developers. Watch the interview to find out more about how the AMA is supporting health innovation, as well as why the AMA thinks the CVS-Aetna merger is not a good idea and how the AMA views the role of AI in the future of health care.

Zoya Khan is the Editor-in-Chief of THCB as well as an Associate at SMACK.health, a health-tech advisory services for early-stage startups.

Where to Apply Artificial Intelligence in Health Care

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By HANS DUVEFELT MD Dr. Hans Duvefelt, A Country Doctor Writes, AI

I have seen the light. I now, finally, see a clear role for artificial intelligence in health care. And, no, I don’t want it to replace me. I want it to complement me.

I want AI to take over the mandated, mundane tasks of what I call Metamedicine, so I can concentrate on the healing.

In primary care visits in the U.S., doctors and clinics are buried in government mandates. We have to screen for depression and alcohol use, document weight counseling for every overweight patient (the vast majority of Americans), make sure we probe about gender at birth and current gender identification, offer screening and/or immunizations for a host of diseases, and on and on and on. All this in 15 minutes most of the time.

Never mind reconciling medications (or at least double checking the work of medical assistants without pharmacology training), connecting with the patient, taking a history, doing an examination, arriving at a diagnosis, and formulating and explaining a patient-focused treatment plan.

Part II | MedPAC’s Proposed “Reforms” Should Be Tested Before They’re Implemented: CMS’s Hospital Readmissions Reduction Program Is Exhibit A

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By KIP SULLIVAN JD Kip Sullivan, MedPAC, HRRP, hospital readmissions

The Hospital Readmissions Reduction Program (HRRP), one of numerous pay-for-performance (P4P) schemes authorized by the Affordable Care Act, was sprung on the Medicare fee-for-service population on October 1, 2012 without being pre-tested and with no other evidence indicating what it is hospitals are supposed to do to reduce readmissions. Research on the impact of the HRRP conducted since 2012 is limited even at this late date [1], but the research suggests the HRRP has harmed patients, especially those with congestive heart failure (CHF) (CHF, heart attack, and pneumonia were the first three conditions covered by the HRRP). The Medicare Payment Advisory Commission (MedPAC) disagrees. MedPAC would have us believe the HRRP has done what MedPAC hoped it would do when they recommended it in their June 2007 report to Congress (see discussion of that report in Part I of this two-part series). In Chapter 1 of their June 2018 report to Congress, MedPAC claimed the HRRP has reduced 30-day readmissions of targeted patients without raising the mortality rate.

MedPAC is almost certainly wrong about that. What is indisputable is that MedPAC’s defense of the HRRP in that report was inexcusably sloppy and, therefore, not credible. To illustrate what is wrong with the MedPAC study, I will compare it with an excellent study published by Ankur Gupta et al. in JAMA Cardiology in November 2017. Like MedPAC, Gupta et al. reported that 30-day CHF readmission rates dropped after the HRRP went into effect. Unlike MedPAC, Gupta et al. reported an increase in mortality rates among CHF patients. [2]

We will see that the study by Gupta et al. is more credible than MedPAC’s for several reasons, the most important of which are: (1) Gupta et al. separated in-patient from post-discharge mortality, while MedPAC collapsed those two measures into one, thus disguising any increase in mortality during the 30 days after discharge; (2) Gupta et al.’s method of controlling for differences in patient health was superior to MedPAC’s because they used medical records data plus claims data, while MedPAC used only claims data.

I will discuss as well research demonstrating that readmission rates have not fallen when the increase in observation stays and readmissions following observations stays are taken into account, and that some hospitals are more willing to substitute observation stays for admissions than others and thereby escape the HRRP penalties.

All this research taken together indicates the HRRP has given CHF patients the worst of all worlds: No reduction in readmissions but an increase in mortality, and possibly higher out-of-pocket costs for those who should have been admitted but were assigned to observation status instead.

Health in 2 Point 00, Episode 61

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On Episode 61 of Health in 2 Point 00, Jess and I are still in Tokyo—but this time we’re reporting from a famous whiskey bar. In this episode, Jess asks me about the most important takeaways from Health 2.0 Asia-Japan and the growing health tech market there. We also have two special guest stars today: Yuuri Ueda, the director of Health 2.0 Asia-Japan, tells us how loosening government regulations are opening up opportunities for more and more startups to break into telemedicine, and Fred Trotter explains how Japanese startups can learn from the U.S. in terms of data security and privacy. All this in (exactly) two minutes.

There’s so much more from Health 2.0 Asia-Japan that you all need to see, so keep an eye out on THCB for my three-point takeaway from the conference and be sure to watch Jess’s WTF Health interviews to hear from amazing people in the Asian health tech community —Matthew Holt. 

MedPAC’s Proposed “Reforms” Should Be Tested Before They’re Implemented: CMS’s Hospital Readmissions Reduction Program Is Exhibit A

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By KIP SULLIVAN JD Kip Sullivan about MedPAC’s Proposed Reforms

Egged on by the Medicare Payment Advisory Commission (MedPAC), Congress has imposed multiple pay-for-performance (P4P) schemes on the fee-for-service Medicare program. MedPAC recommended most of these schemes between 2003 and 2008, and Congress subsequently imposed them on Medicare, primarily via the Affordable Care Act (ACA) of 2010 and the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

MedPAC’s five-year P4P binge began with the endorsement of the general concept of P4P at all levels – hospital, clinic, and individual physician – in a series of reports to Congress in 2003, 2004, and 2005. This was followed by endorsements of vaguely described iterations of P4P, notably the “accountable care organization” in 2006 [1], punishment of hospitals for “excess” readmissions in 2007 [2], the “medical home” in 2008 and the “bundled payment” in 2008. None of these proposals were backed up by anything resembling evidence.

Congress endorsed all these schemes without asking for evidence or further details. Congress dealt with the vagueness of, and lack of evidence supporting, MedPAC’s proposals simply by ordering CMS to figure out how to make them work. CMS staff added a few more details to these proposals in the regulations they drafted, but the details were petty and arbitrarily adopted (how many primary doctors had to be in an ACO, how many patients had to sit on the advisory committee of a “patient-centered medical home,” how many days had to expire between a discharge and an admission to constitute a “readmission,” etc.).

New rule, new culture

This process – invention of nebulous P4P schemes by MedPAC, unquestioning endorsement by Congress, and clumsy implementation by CMS – is not working. Every one of the proposals listed above has failed to cut costs (with the possible exception of bundled payments for hip and knee replacements) and may be doing more harm than good to patients. These proposals are failing for an obvious reason – MedPAC and Congress subscribe to the belief that health policies do not need to be tested for effectiveness and safety before they are implemented. In their view, mere opinion suffices.

This has to stop. In this two-part essay I argue for a new rule:  MedPAC shall not propose, and Congress shall not authorize, any program that has not been shown by rigorously conducted experiments to be effective at lowering cost without harming patients, improving quality, or both. This will require a culture change at MedPAC. Since its formation in 1997, MedPAC has taken the attitude that it does not have to provide any evidence for its proposals, and it does not have think through its proposals in enough detail to be tested. Over the last two decades MedPAC has demonstrated repeatedly that it believes merely opining about a poorly described solution is sufficient to discharge its obligation to Congress, taxpayers, and Medicare enrollees.