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Running an RCT – A Conversation With the Investigators of the REGAIN Trial

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By SAURABH JHA MD SAURABH JHA

It is easy for armchair activists to bash randomized controlled trials (RCTs) with clever methodological critiques. However, it takes a lot of effort and coordination to pull off an RCT successfully. In this episode of Radiology Firing Line, I speak with Dr. Mark Neuman and Lakisha Gaskins, principal investigator and research project manager of the REGAIN trial, respectively, about the logic, challenges and intricacies of conducting an RCT. The Regional versus General Anesthesia for Promoting Independence After Hip Surgery (REGAIN) trial is an ongoing pragmatic, multi-center RCT, funded by PCORI, which randomizes patients with hip fractures to regional or general anesthesia.

Guests: Mark Neuman MD MSc, is an Associate Professor of Anesthesiology and Critical Care at the University of Pennsylvania. He is a senior fellow at the Leonard Davis Institute of Health Economics. He’s a former RWJ Scholar. Lakisha Gaskins is a research coordinator with extensive experience recruiting patients for RCTs.

Listen to our conversation on Radiology Firing Line Podcast here.

Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner.

For Your Radar — Huge Implications for Healthcare in Pending Privacy Legislation

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By VINCE KURAITIS and DEVEN McGRAW

Two years ago we wouldn’t have believed it — the U.S. Congress is considering broad privacy and data protection legislation in 2019. There is some bipartisan support and a strong possibility that legislation will be passed. Two recent articles in The Washington Post and AP News will help you get up to speed.

Federal privacy legislation would have a huge impact on all healthcare stakeholders, including patients.  Here’s an overview of the ground we’ll cover in this post:

  • Why Now?
  • Six Key Issues for Healthcare
  • What’s Next?

We are aware of at least 5 proposed Congressional bills and 16 Privacy Frameworks/Principles. These are listed in the Appendix below; please feel free to update these lists in your comments.  In this post we’ll focus on providing background and describing issues. In a future post we will compare and contrast specific legislative proposals.

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Failing Healthcare’s ‘Free Market’ Experiment in US: Single Payer to the Rescue?

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By KHURRAM NASIR MD, MPH, MSc 

In the industrialized world and especially in United States, health care expenditures per capita has has significantly outgrown per capita income in the last few decades. The projected national expenditures growth at 6.2%/year from 2015 onwards with an estimated in 20% of entire national spending in 2022 on healthcare, has resulted in passionate deliberation on the enormous consequences in US political and policy circles. In US, the ongoing public healthcare reform discussions have gained traction especially with the recent efforts by the Senate to repeal national government intervention with Affordable Care Act (ACA).

In this never ending debate the role of government interventions has been vehemently opposed by conservative stakeholders who strongly favor the neoclassical economic tradition of allowing “invisible hands” of the free market without minimal (or any) government regulations to achieve the desired economic efficiency (Pareto optimality).

A central tenet of this argument is that perfect competition will weed out inefficiency by permitting only competent producers to survive in the market as well as benefit consumer to gain more “value for their money” through lower prices and wider choices.

Restrained by limited societal resources, in US to make our health market ‘efficient’ we need to aim for enhancing production of health services provision at optimal per unit cost that can match consumers maximum utility (satisfaction) given income/budget restraints.

Keeping asides the discussion on whether a competitive market solution for healthcare is even desirable as adversely impact the policy objective of ‘equity”, however from a pure ‘efficiency’ perspective it is worthwhile to focus on the core issue whether conditions in healthcare market align with the prototypical, traditional competitive model for efficient allocation of resources.

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HIPAA RFI Comments: Patient Privacy Rights

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By ADRIAN GROPPER and DEBORAH C. PEEL

Adrian Gropper

Deborah C. Peele

Among other rich nations, US healthcare stands out as both exceptionally privatized and exceptionally expensive. And taken overall, we have the worst health outcomes among the Western Democracies.

On one hand, regulators are reluctant to limit private corporate action lest we reduce innovation and patient choice and promote moral hazards. On the other hand, a privatized marketplace for services requires transparency of costs and quality and a minimum of economic externalities that privatize profit and socialize costs.

For over two decades, the HIPAA law and regulations have dominated the way personal health data is used and abused to manipulate physician practice and increase costs. During these decades, digital technology has brought marvels of innovation and competition to markets as diverse as travel and publishing while healthcare technology is burning out physicians and driving patients to bankruptcy.

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Watch This Space: 3 Phenomena That Will Drive Health Care Innovation in 2019

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By REBECCA FOGG Rebecca Fogg

Back at their desks after the holidays, health care payers, providers and policymakers across the country are staring down their list of 2019 priorities, wondering which they can actually accomplish. Innovation to improve care quality and reduce costs will top many lists, and progress on this front depends, in no small part, on conditions for such innovation in the health care marketplace. Here are three phenomena unfolding there that I’ll be following closely this year to understand what innovators are up against, and how they’re responding.

  1. The legal battle over the Affordable Care Act (ACA). Over 20 million previously uninsured Americans acquired health insurance between 2010 and 2017, many due to the ACA’s premium subsidies, ban on pre-existing condition restrictions, and Medicaid expansion. At the most fundamental level, this coverage expansion has vastly improved one of the most important conditions for a healthy population—access to health care. But it also supports innovation toward better, more affordable care.Coverage expansion means providers get reimbursed for more of the care they deliver to patients who are unable to pay, which strengthens their financial position. It also enables some patients to maintain more continuous health insurance coverage, hence see a doctor more regularly over time. This, in turn, facilitates providers’ development of more effective approaches to management of long-term, chronic disease, which causes untold suffering and costs the U.S. hundreds of billions in direct medical costs.
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Overprescribing Is a Key Component of the Opioid Crisis — Here’s How to Stop It

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By DAVE CHASE 

Today’s opioid crisis is one of the most dire side effects driven by our dysfunctional U.S. healthcare system. A recent JAMA Surgery report found that many surgeons prescribe four times more opioids than their patients use. This opens the door for misuse and abuse later on. In fact, the total combined cost of misuse, abuse, dependence and overdose is about $78.5 billion.

Unfortunately, there’s a direct connection between the low-quality care many patients receive, and the astounding rates of opioid addiction. Often, insurance plans offer access to high-cost, volume-centric physicians and include high deductibles — creating an expensive cycle that doesn’t focus on patient outcomes. Instead of taking the time to figure out what is actually ailing a patient, these overworked and nearly burnt-out doctors get them in and out the door with a referral and a prescription for more pills than they could ever need.

What may surprise you is that employers play a large part in setting the stage for addiction. Millions of Americans get their health insurance from their employer, and a majority of those plans are fully-insured. To determine what insurance plan they offer, employers work with a benefits broker to purchase one from a carrier like Aetna or Cigna. Each year, employers and their broker join together for an annual dance — the broker tells them that healthcare costs are rising so their insurance rates have gone up, usually by 5-20 percent. The employers don’t know better than to accept these increases, filtering them down to employees in the form of higher premiums. Despite costs constantly going up, the quality of care does not follow.
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AHA’s FutureScan Publication Available Now

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Out this week is the AHA (or more precisely their SHSMD division’s) Futurescan publication. This year it’s edited by futurist Ian Morrison @seccurve and it features a bevvy of forecasting articles including one called “Flipping the Stack: Can New Technology Drive Health Care’s Future?” by Indu Subaiya and Matthew Holt (i.e. me)

To take a look at the listing and perhaps even buy a PDF or hard copy (yes, it’s not free, remember that whole capitalism thing, but it’s the cheapest thing you’ll ever get from a hospital!) follow this link  — Matthew Holt

 

The Future of the Affordable Care Act: Unscathed by Attacks from the Right, Overtaken on its Left?

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By ETIENNE DEFFARGES Etienne_Deffarges

Having survived years of attacks from Republicans at the federal level, will the surviving ACA be rendered obsolete by Democrats’ local and state efforts towards universal health care? This could be an ironic twist of fate for Obamacare. Conceived out of the conservative Heritage Foundation’s ideas and an early experiment in Massachusetts under a Republican governor, President Obama’s signature legislative achievement could very well survive its most recent judiciary challenge. But over time the ACA is susceptible to obsolescence, because of the many universal health care solutions being pushed at the state level.

Let’s start this brief outlook for Obamacare by reviewing how it has played defense, quite successfully thus far: During most of 2017 and 2018, the future of the ACA was always discussed in the context of Republican efforts to repeal it. After all, the GOP controlled the White House and both Chambers of Congress. Hadn’t Republicans spent the last four years of the Obama administration promising to repeal Obamacare the instant they could? And so they went after the ACA in 2017 with all the levers of Washington power. But repealing is one thing, legislating another: We know what happened in July 2017, when the last “repeal and replace” effort was defeated in the U.S. Senate by the narrowest of margins, because three Republican Senators, Susan Collins, Lisa Murkowski, and the late and much regretted John McCain, voted against the repeal. With their December 22 tax law, Republicans did succeed in eliminating the ACA’s individual mandate tax penalty owed by individuals failing to maintain “minimum essential coverage.” Most medical plans qualify for this, as long as they meet a number of requirements, such as not charging more for pre-existing conditions. For good measure, the Trump administration used executive orders in 2018 to allow low-cost plans not meeting these ACA guidelines to be offered by employers. Twenty state attorney generals from Republican states, led by Texas and Wisconsin, also initiated litigation against the ACA, arguing that without the tax penalty the law had become unconstitutional.

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Has U.S. Health Care Spending Finally Stabilized? An Outlook for 2019

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By ETIENNE DEFFARGES Etienne_Deffarges

The official 2017 statistics from the U.S. Department of Health and Human Services (DHHS) are out, and there are some good news: The annual growth rate of health care spending is slowing down, and is the lowest since 2013 at 3.9%—it was 4.3% for 2016 and 5.8% for 2015. The bad news is that our health care cost increases are still well above inflation, and that we spent $3.5 trillion in this area, or 17.9% of GDP. Americans spent $10,739 on health care in 2017, more than twice as much as of our direct economic competitors: This per capita health care spending was $4,700 in Japan; $5,700 in Germany; $4,900 in France; $4,200 in the U.K.; $4,800 in Canada; and an average of $5,300 for a dozen such wealthy countries, according to the Peterson -Kaiser health system tracker from the Kaiser Family Foundation, and OECD data. Spending almost a fifth of our GDP on health care, compared to 9-11% for other large developed economies (and much less in China), is like having a chain tied to our ankles when it comes to our economic competitiveness.

Could 2019 be the year when our health care spending actually decreases, or at least grows at a slower pace than inflation? Or will we see instead an uptick in costs for health care consumers?

To answer these questions, we need to look in more detail at the largest areas of health care spending in America, and at the recent but also longer term spending trends in these areas. Using the annual statistics from the DHHS, we can compare the growth in spending in half a dozen critical health care categories with the growth in total spending, and this for the last three years as well as the last decade. Over the last decade, since 2007, these costs grew 52% in aggregate (from $2.3T to $3.5T) and 41% per capita (from $7,630 to $10,740).

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A Bizarre Claim of Right to Try

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By ARTHUR CAPLAN, KELLY MCBRIDE FOLKERS, and ANDREW MCFADYEN DONALD TRUMP, RIGHT TO TRY

A patient with glioblastoma recently received an experimental cancer vaccine at the University of California, Irvine. Notably, this is being hailed as the first case of someone utilizing the Right to Try Act of 2017. ERC-USA, a U.S. subsidiary of the Brussels-based pharmaceutical company Epitopoietic Research Corporation, says it provided its product, Gliovac, to the patient at no cost. The vaccine is currently undergoing Phase II clinical trials. A handful of people in Europe have received access to it through “compassionate use.” This patient did not qualify for ongoing clinical trials in the U.S. The patient, who remains anonymous, is the first known individual to receive an experimental medicine that has not been approved by the FDA, as permitted under the federal right to try law.

Glioblastoma is a nasty cancer – John McCain and Ted Kennedy passed away after battling the disease for just over a year. We believe that patients with terminal illnesses, like those with glioblastoma, should have every reasonable tool at their disposal to treat their disease.

That being said, we’ve argued before that right to try laws are not the best way to help desperate patients. They still aren’t. The number of cases claimed to date is exactly one. And, further examination of what we know about this case does not make a strong argument for the widespread usage of the right to try pathway.

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