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Category: Health Policy

Patient Privacy Rights: Comment on Regulatory Capture

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Deborah C. Peel
Adrian Gropper

By ADRIAN GROPPER, MD and DEBORAH C PEEL, MD

To ONC and CMS

We begin by commending HHS, CMS, and ONC for skillfully addressing the pro-competitive and innovative essentials in crafting this Rule and the related materials. However, regulatory capture threatens to derail effective implementation of the rule unless HHS takes further action on the standards.

Regulatory capture in Wikipedia begins:

“Regulatory capture is a form of government failure which occurs when a regulatory agency, created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating.  When regulatory capture occurs, the interests of firms, organizations, or political groups are prioritized over the interests of the public, leading to a net loss for society. Government agencies suffering regulatory capture are called “captured agencies.” (end of Wikipedia quotation.)

The extent to which HHS has allowed itself to be influenced by special interests is not the subject of this comment. This comment is just about how HHS and the Federal Health Architecture can act to more effectively implement the sense of Congress in the 21st Century Cures Act.

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One Physician’s Frustrations of Practicing Amidst the CHIPHIT Complex and Implications for the Future of the U.S. Healthcare System

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By HAYWARD ZWERLING, MD

The high cost, low quality and systemic inequities of the U.S. healthcare system have been the impetus for its redesign. Our healthcare system is now controlled by Consolidated Healthcare institutions, Insurance companies, Pharmaceutical companies and Health Information Technology companies (CHIPHIT complex). The CHIPHIT complex, along with the Federal Government, will create and control our future healthcare system. Ominously missing from this list are independent healthcare policy experts, independent healthcare providers and members of the general public.

Historical precedents have demonstrated that the CHIPHIT complex is incapable of creating the healthcare system we need.

Thus, if we hope to build a low cost, high quality, egalitarian healthcare system, physicians and their professional organizations must take an emphatic stand against the CHIPHIT complex today.

Consolidated Healthcare Institutions

There are innumerable mandates which make running a small medical practice very difficult. As a result, many younger physicians will no longer attempt to start a new medical practice and existing profitable practices, which are looking to off- load their regulatory burdens, are being acquired by large healthcare institutions and private equity firms.

While these consolidated healthcare institutions vocalize their desire to improve our healthcare system, many enforce a uniformity on the practice environment which belies the reality of patient care; that there is no “best” practice model, nor are there information technology tools which work well for all physicians. This imposed uniformity stifles physician innovation, which is a necessary precondition to improve our healthcare system.

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Private Health Insurance Organizations Shouldn’t Dictate Quality of Care

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By LYNLY JEANLOUIS

Health insurance companies are standing in the way of many patients receiving affordable, quality healthcare. Insurance companies have been denying patient claims for medical care, all while increasing monthly premiums for most Americans. Many of the nation’s largest healthcare payers are private “for-profit” companies that are focused on generating profits through the healthcare system. Through a rigorous approval/denial system, health insurance companies can dictate the type care patients receive. In some cases, this has resulted in patients foregoing life-saving treatments or procedures.  

In 2014, Aetna, one of the nation’s leading healthcare companies, denied coverage to Oklahoma native Orrana Cunningham, who had stage 4 nasopharyngeal cancer near her brain stem.  Her doctors suggested she undergo proton beam therapy, which is a targeted form of radiation that can pinpoint tumor cells, resulting in a decrease risk of potential blindness and other radiation side effects. Aetna found the study too experimental and denied coverage, which resulted in Orrana’s death. Aetna was forced to pay the Cunningham family $25.5 million.  

In December of 2007, Cigna Healthcare, the largest healthcare payer in Philadelphia, denied coverage for Nataline Sarkisyan’s liver transplant. Natalie was diagnosed with leukemia and had recently received a bone marrow transplant from her brother, which caused complications to her liver. A specialist at UCLA requested she undergo a liver transplant, which is an expensive procedure that would result in a lengthy inpatient hospital stay for recovery. Cigna denied the procedure as they felt it was “too experimental and outside the scope of coverage”. They later reversed the decision, but Nataline passed away hours later at the University of California, Los Angeles Medical Center.

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The “Back Story” of the JAMA Wellness Smackdown (Part 2)

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By AL LEWIS

Part 2 picks up where Part 1 left off, as coincidence would have it.

Soeren Mattke (as mentioned in the last installment) and I were quite relentless in trying, quixotically, to get Professor Baicker to explain her results. Its popularity could have landed her many profitable speaking and consulting gigs, but she evinced no interest in cashing in, or even in defending her position. Indeed, the four times she spoke publicly on the topic, she didn’t do herself, or her legions of sycophants in the wellness industry, any favors. In each interview, she distanced herself more and more from her previous conclusion. Here are her four takeaways from her own study “proving” wellness has precisely a 3.27-to-1 ROI:

  1. It’s too early to tell (um, after 30 years of workplace wellness?)
  2. She has no interest in wellness anymore
  3. People aren’t reading her paper right (Shame on us readers! We’re only reading the headline, the data, the findings and the conclusion, apparently)
  4. “There are few studies with reliable data on the costs and the benefits”(um, then how were you able to reach a conclusion with two significant digits?)

Individually or in total, these comments sounded an awful lot like retractions, but she (and her co-author and instigator, David Cutler) claimed those comments didn’t constitute retractions. Whatever they were, she wasn’t exactly doubling down on this 3.27-to-1 conclusion.

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The “Back Story” of the JAMA Wellness Smackdown (Part 1)

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By AL LEWIS

Let’s climb into the WABAC Machine (and, yes, that’s the way it’s spelled) and set the dial for 2008.

Then-candidate Barack Obama, campaigning on the promise of universal health coverage, enlisted Harvard professor David Cutler as his key adviser on that topic. Business lobbying associations were not thrilled about their members having to cover all their full-time employees and incorrectly assumed, then as now, that the major drivers of healthcare cost were employees smoking, overeating, and not exercising. Prof. Cutler suggested, quite correctly, that one way to assuage that concern would be to allow employers to spend less money covering employees with those three health habits.

Fast-forward to 2009, when it appeared that — with enough concessions to enough vested interests — the Affordable Care Act (ACA) could become a reality. Business lobbying groups were, then as now, powerful entities. Using Prof. Cutler’s suggestion, they were pacified by allowing businesses to tie up to 30% of total premium dollars to employee health (in practice, largely employee weight). Generally, the business lobbying groups engineered this withhold in the shadows. It wasn’t until 2015 that one of those business groups, the Business Roundtable, publicly admitted that the 30% withholdwas the main reason they bought into the ACA.

Since this 30% was basically a giveaway to corporations, the Obama Administration needed to justify it as a cost-savings measure. On the one hand, they had the Safeway experience “proving” that wellness could save money in practice. This alleged proof was met with open arms by both parties. Safeway’s CEO became a “rock star” on Capitol Hill.  (Of course, Safeway’s wellness program, like virtually every other great-sounding success in wellness, turned out to be a scam. In retrospect, just reading the Safeway CEO’s Wall Street Journal op-ed* announcing these results, it’s amazing how the mind-blowingly fallacious statistics didn’t get called out back then, by me or anyone else.)

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Economics Lessons from the Subcontinent: India’s Coronary Stent Policy

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By ANISH KOKA MD

It is commonly believed that deliberate, careful price regulation by enlightened technocrats trumps the haphazard and chaotic regulation of prices imposed by the free market—especially when the market is subject to greed and corruption.

A most interesting case study challenging that belief comes courtesy of the largest Democracy in the world: India.

In 2017, an arm of the Indian Government, the National Pharmaceutical Pricing Authority (NPPA) took action to control the price of coronary stents in India by capping their retail price.  The problem that stimulated this action was their exorbitant price that made them unaffordable to many Indians.

The retail prices of US made drug-eluting stents ranged from Rs 80,000 – 150,000 (~$1000 – ~$2000), while the price of Indian made drug-eluting stents ranged from Rs 45,000 – 90,000 (~$600 – ~$1200).  Considering that a good job for 90% of the Indian labor force pays about Rs 180,000 per year, these prices put most coronary stents out of the reach of a vast swath of the populace.

What regulators knew, however, was that the price point at which coronary stents were being imported into India was a fraction of the price being charged to Indians.  The up-charge had everything to do with what happened after the stent was brought onto Indian soil: The Indian subsidiary of the US stent manufacturer would sell its product to a domestic distributor that would then employ all means necessary to ensure their stent was chosen by cardiologists to be implanted.

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A Change in Tactics

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By ROBERT PRETZLAFF MD, MBA

Those that advocate for change in healthcare most often make their case based on the unsustainable cost or poor quality care that is sadly the norm. A 2018 article in Bloomberg highlights this fact by reporting on global healthcare efficiency, a composite marker of cost and life expectancy. Not remarkably, the United States ranks 54th globally, down four spots from 2017 and sandwiched neatly between Azerbaijan and Bulgaria. Unarguably, the US is a leader in medical education, technology, and research. Sadly, our leadership in these areas only makes our failure to provide cost-effective, quality care that much more shameful. For the well-off, the prospect of excellent accessible care is bright, but, as the Bloomberg article points out, as a nation our rank is rank. Anecdotally, I can report that as a physician I am called upon with some regularity to intervene on the behalf of family and friends to get a timely appointment or explain a test or study that their doctor was too busy to explain, and so even for the relatively well-off, care can be difficult and deficient.

The cost of care frequently takes center stage in arguments advocating change. The recognition that health care costs are driving unsupportable deficits and limiting expenditures in other vital areas is very compelling. Therefore, lowering the cost of care would seem to be an area in which there would be swift consensus. However, solutions to rein in costs fail to address the essential truth that most of us define cost subjectively. Arguments about the cost of care divide rather than unify as the discussion becomes more about cost shifting than controlling overall cost. Further, dollars spent on healthcare are spent somewhere, and there are many who profit handsomely from the system as it is and work aggressively sowing division to maintain the status quo.

Poor quality and access are additional lines of argument employed to win support for change. These arguments fail due to a lack of a commonly accepted definitions of quality and access to care. Remedies addressing quality and access issues are frequently presented as population level solutions. Unfortunately, these proposals do not engage a populace that cares first and foremost about their access to their doctor. The forces opposed to change readily employ counterarguments to population-based solutions by applying often false, but effective, narratives that population-based solutions are an infringement on a person’s fundamental freedoms. In that counterargument is the key to improving healthcare.

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Are Bipartisan Agreements on Health Care Possible?

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By KEN TERRY 

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.

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How Can Patients on Medicaid Possibly Be Worse Off than Those Who Don’t Have Insurance?

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By Saurabh Jha, MD

“Extraordinary claims require extraordinary evidence,” said Carl Sagan.

The claim that health insurance improves health outcomes is hardly ground breaking. Studying whether insurance affects health status is like wondering whether three meals a day lead to a higher muscle mass than total starvation.

Well that’s what I thought. Until I read the study on Oregon’s Medicaid program by Baicker and colleagues in the NEJM earlier this year and, more recently, Avik Roy’s short treatise “How Medicaid Fails the Poor”.

Baicker et al found that Medicaid enrollees fared no better in terms of health outcomes than those without insurance. That is, no insurance no difference.

The study is an exemplar of policy research laced with regression equations, control of known confounders and clear separation of variables. There is only so much rigor social science can achieve compared to the physical sciences. Yet this is about as good a study as is possible.

The one thing the study did not lack was sample size. It’s useful to bear in mind sample size. Large effects do not need a large sample size to show statistical significance. Conversely, if study with a large sample size does not show even a modest effect, it means that the effect probably does not exist.

There are several interpretations of the Medicaid study, interpretations inevitably shaped by one’s political inclination. The ever consistent Paul Krugman, consistent in his Samsonian defense of government programs against philistines and pagans, extolled critics of Medicaid as “nuts” and asked, presumably rhetorically, “Medicaid is cheaper than private insurance. So where is the downside?”

Unlike Krugman I am not a Nobel laureate and am about as likely to win a Nobel Prize as I am of playing the next James Bond, so it’s possible that I am missing something blatantly obvious.  Could the downside of a government program paying physicians, on average 52 cents, and as low as 29 cents, for every dollar paid by private insurance in a multiple payer system be access?

Indeed, it’s darn impossible for patients on Medicaid to see a new physician.  As Avik Roy explains “…massive fallacy at the heart of Medicaid….It’s the idea that health insurance equals healthcare”.

But wait. It gets better.

I am accustomed to US healthcare throwing more plot twisters than Hercule Poirot’s sleuth work. But one I least expected was that patients on Medicaid do worse than patients with no insurance (risk-adjusted, almost). I am not going to be that remorseless logician, which John Maynard Keynes warned us about, who starting with one mistake can end up in Bedlam, and argue that if you are for Medicaid that is morally equivalent to sanctioning mass murder. Rather, I ask how it is possible that possessing Medicaid makes you worse off than no insurance whatsoever.

To some extent this may artifactually appear so because poverty correlates with ill health, and studies that show Medicaid patients faring worse than uninsured, cannot totally control for social determinants of health.

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Return to McAllen: A Father-Son Interview

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By IAN ROBERTSON KIBBE


By now, Dr. Atul Gawande’s article on McAllen’s high cost of health care has been widely read.  The article spawned a number of responses and catalyzed a national discussion on cost controls and the business of medicine.  It even made it’s way into the President’s address to the AMA.

Almost overnight, McAllen and the Rio Grande Valley were thrust into the national health care spotlight – the once sleepy border town became, not a beacon on a hill, but a balefire in the valley, representing much of what is wrong with the current medical culture.

But, McAllen wasn’t always like something from an old Western, where doctors run wild and hospital CEO’s compete like town bosses.  I remember McAllen quite differently.  I remember it, because as it turns out, it was where I was born.Continue reading…

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