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.
Today the notion that health is a preferred state of being, rather than a set of disconnected functions or services, is increasingly being embraced. A recent JAMA article promoted a health measurement system called the “flourishing index” focused on 6 key domains: happiness and life satisfaction, physical and mental health, meaning and purpose, character and virtue, close social relationships, and financial and material security.
Gro Brundtland, former director-general of the World Health Organization, wrote
in the World Health Report 2000 that
“The objective of good health is twofold – goodness and fairness;
goodness being the best attainable average level; and fairness, the smallest
feasible differences among individuals and groups.”
the age of Trump, with forced separation of immigrant mothers and children,
criminalization of abortion, and purposeful obstruction of enhanced access to
health care for vulnerable populations, it becomes impossible to ignore a
significant modern-day truism. Health is profoundly political.
Health is a collection of resources unequally distributed in society. Health’s “social determinants” such as housing, income, and employment, are critical to the accomplishment of individual, family, and community well being and are themselves politically determined.
Introduction Every day and in every corner of the country, innovative health care leaders are conceiving of strategies and programs to manage their patients’ health, as an alternative to treating their sickness (see Figure 1).
The value-based contracts that have proliferated in this
country over the past decade and which now account for about half of the money
spent on healthcare allow these wellness investments to make good financial
sense in addition to benefiting patient health.
However, a phenomenon in health coverage in the US is
increasing costs, destabilizing care continuity and holding back the potential
of value-based care. It prevents us from making the long-term investments we
Churn refers to gaining, losing, or moving between sources of coverage. Every year, approximately a quarter of the US population switches out of their health plan. Reasons can be voluntary or involuntary from the perspective of the beneficiary (see Table 1) and vary from changes in job status, eligibility, insurance offerings, and preference, to non-payment of premiums, to unawareness of pending coverage termination.
A friend of mine told me the other day, “We’ve seen our insured patient population go from 15% to 70% in the few years since Obamacare.” As a primary care physician in the Midwest, he’s worked for years in an inner-city clinic that serves a poor community, many of whom also suffer from mental illness. Before the Affordable Care Act (ACA), the clinic constantly struggled to stay afloat financially. Too often patients would be sent to an emergency room because the clinic couldn’t afford to provide some of the simplest medical tests, like an x-ray. Now, with most of his patients insured through the Medicaid expansion program, the clinic has beefed up its staffing and ancillary services, allowing them to provide better preventive care, and in turn, reduce costly ER visits.
From the time Medicaid was established in 1965 as the country’s first federally-funded health insurance plan for low-income individuals, state governments have only been required to cover the poorest of their citizens. Before the ACA, some 47 million Americans were uninsured because their incomes exceeded state-determined benchmarks for Medicaid eligibility and they earned far too little to buy insurance through the private marketplace.
The ACA reduced the number of uninsured Americans by mandating that states increase their income requirement for Medicaid to 138% of the federal poverty line (about $1,330 per month for a single individual), and promising that the federal government would cover the cost to do so. However, in a 2012 decision, the Supreme Court left it to the states to decide if they wanted to increase their Medicaid eligibility. If they agreed to adopt Medicaid expansion, the federal government offered to cover 100% of the increased cost in 2014 and 90% by 2021.
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.
Within the ever-widening array of Democratic contenders for the Presidency, the “Medicare-for-all” debate continues to simmer. It was only six weeks ago that Kamala Harris’s vocal support drew fire from not one, but two billionaire political rivals. Michael Bloomberg, looking for support in New Hampshire declared, “I think we could never afford that. We are talking about trillions of dollars… [that] would bankrupt us for a long time.” Fellow billionaire candidate Howard Schultz added, “That’s not correct. That’s not American.”
Remarkably, neither man made the connection between large-scale health reform’s potential savings (pegged to save 15% of our $4 trillion annual spend according to health economists) and the thoughtful application of these newly captured resources to all U.S. citizens without discrimination. Bloomberg’s own 2017 Health System Efficiency Ratings listed the U.S. 50th out of 55, trailed only by Jordan, Columbia, Azerbaijan, Brazil, Russia. Yet he seemed unable to connect addressing waste with future affordability.
Schultz was similarly short sighted. While acknowledging that the
manmade opioid epidemic, mental health crises, and income inequality are
“systemic problems” and at levels “the likes of which we have not had in a long
time”, he failed to connect the cause (a remarkable dysfunctional and
inequitable health care system) with these effects.
As I outline in “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/ June 4, 2019), today’s greatest risk to continued progress and movement toward universal coverage and rational health planning is sloppy nomenclature. To avoid talking past each other, we need to define the terms of this debate while agreeing on common end points.
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.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.
This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications. Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.
Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.
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.
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.