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.
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.
The 2016 21st Century CURES Act is the law. It is built around two phrases: “information blocking” and “without special effort” that give the administration tremendous power to regulate anti-competitive behavior in the health information sector. The resulting draft regulation, February’s Notice of Proposed Rulemaking (NPRM) is a breakthrough attempt to bend the healthcare cost curve through patient empowerment and competition. It could be the last best chance to avoid a $6 Trillion, 20% of GDP future without introducing strict price controls.
This post highlights patient-directed access as the essential pro-competition aspect of the NPRM which allows the patient’s data to follow the patient to any service, any physician, any caregiver, anywhere in the country or in the world.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions.
When it comes to sharing health data, the intent of the 21st Century Cures Act is clear: patients and clinicians should have access to data without special effort or excessive cost. To make this a reality, the act addresses three major areas: technical architecture, data sets and behaviors. Part two of our series looked at how APIs address technical issues while part three covered the new data requirements. In this article, we delve into information blocking. A companion podcast interview with ONC expert Michael Lipinski provides an even deeper dive into this complex topic.
Blocking Comes in Many Forms
The Public Health Services Act (PHSA) broadly defines information blocking as a practice that is “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” The overarching assumption is information will be shared though the Act does authorize the Secretary to identify reasonable and necessary exceptions.
The proposed rules focus on “technical requirements as well as the actions and practices of health IT developers in implementing the certified API.” Information blocking can come in a variety of forms. It can be direct and obvious (“No you can’t have this data ever!”) or indirect and subtle (“Sure, you can have the data, but it will cost you $$$ and we won’t be able to get to your request for at least 12 months.”). The proposed rules are designed to address both. This passage illustrates some of the concerns:
“Health IT developers are in a
unique position to block the export and portability of data for use in
competing systems or applications, or to charge rents for access to the basic
technical information needed to facilitate the conversion or migration of data
for these purposes.”
According the 2019 Bloomberg Healthiest Country Index, the U.S. ranks 35th out of 169 countries. Even though we are the 11th wealthiest country in the world, we are behind pretty much all developed economies in terms of health. In the Americas, not just Canada (16th) but also Cuba (30th), Chile and Costa Rica (tied for 33rd) rank ahead of us in this Bloomberg study.
To answer this layered question, we need to look at the top ranked countries in the Bloomberg Index: From first to 12th, they are Spain; Italy; Iceland; Japan; Switzerland; Sweden; Australia; Singapore; Norway; Israel; Luxembourg; and France. What are they doing right that the U.S. isn’t? In a nutshell, they embrace half a dozen critical economic and societal traits that are absent in the U.S.:
· Universal health care
· Better diet: fresh ingredients and less packaged and processed food
When it comes to access to health care, the 34 countries that are ahead of the U.S. in the Bloomberg health rankings all offer universal health care to their people. This means that preventive, primary and acute care is available to 100% of the population. In contrast, 25 – 30 million Americans do not have health care insurance, and an equal number are under insured. For 15 – 18% of our population, financial concerns about how to pay for a visit to the doctor, how to meet high insurance deductibles, or cash payments after insurance take precedence over taking care of their health. Lack of preventive care leads to visits to the emergency rooms for ailments that could have been prevented through regular primary care follow-up, at a very high cost to our health system. Note: We spent $10,700 per capita in health care in 2017, more than three as much as Spain ($3,200) and Italy ($3,400). Many Americans postpone important medical operations for years, until they reach 65 years of age, when they finally qualify for universal health care or Medicare. Lack of prevention and primary care, health interventions postponed, and the constant worry that medical costs might bankrupt one’s family: none of this is conducive to healthy lives.
The $867 billion Farm Bill squeaked through our polarized Congress at the end of last year, though it was nearly derailed by arguments over work requirements for SNAP recipients. That debate was tabled after the USDA crafted a compromise, but it is sure to continue at the state level and in the next round of debates. While Republicans tend to favor work requirements and Democrats tend to oppose them, here’s something both sides can agree on: SNAP should help Americans eat healthy food.
The Supplemental Nutrition Assistance Program (SNAP)—formerly known as food stamps—provides financial resources to buy food and nutrition education to some 40 million low-income Americans. Costing taxpayers almost $80 billion per year, the program serves Americans across the spectrum of ages, ethnicities, and zip codes. Simultaneously, we reached a deficit of almost $800 billion in 2018. So how can we ensure this at-risk population of Americans can access nutritious food and better health outcomes within the confines of our current resources?
Studies have proven time and again how participation in SNAP reduces rates of poverty and food insecurity. And the program has improved substantially in recent years, with recipients now using debit-style cards to buy groceries and receiving increased benefits at thousands of farmers markets across the country.
Despite these clear benefits, SNAP dollars often don’t support healthy diets. In fact, a 2015 study determined that SNAP participants had poorer diets, with more empty calories and less fresh produce, than income-eligible non-participants. In 2017, another study found that participants have an increased risk of death due to diet-related disease than non-participants. The authors reported that the discrepancy might be partly caused by individuals who think they have high risk of poor health and/or struggle to pay medical bills are more likely to put in the effort to enroll in and redeem SNAP benefits. A recent survey of Americans across the country showed that foods purchased using SNAP benefits were higher in calories and unhealthy components, like processed meat and sweeteners, than those purchased by non-participants of the same income level.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities 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 and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions. In part three of this series, we look at how the new USCDI draft helps foster innovation.
The U.S. Core Data for Interoperability
(USCDI) draft is a step forward toward expanding the 21st Century
Cures Act. The Cures Act was helpful in moving the needle for interoperability
and defining data blocking. The latest draft of the USCDI is meant to further specify
what data should be shared freely.
In this article, we’ll look at the data added
to the Common Clinical Data Set (CCDS) used for ONC certification. We’ll walk
through the proposed plan to add more data over time. And we’ll explore why
this is a step in the right direction toward increased data sharing.
The bulk of the datasets in the USCDI comes
from the Common Clinical Data Set (CCDS), which was last updated in 2015. The
new USCDI draft adds two types of data:
Clinical notes: both structured
and unstructured. EHRs store these notes differently, but both are important
and helpful in data analysis.
Provenance: an audit trail of the data, showing where it
came from. It is metadata, or information about the data, that shows who
created it and when.
The Fast Healthcare Interoperability Resources (FHIR) have created standards around APIs used to access health care data. APIs developed under the FHIR standard aligns with the USCDI to meet the proposed certification rules. The USCDI draft recommends using a FHIR compliant API to access the data.
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.
Most will be surprised to learn that American Indians and Alaska Natives represent the only populations in the United States with a legal birthright to health care. Even though Article 25 of the UN’s Universal Declaration of Human Rights declares, “everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including…medical care and necessary social services,” U.S. federal policy only guarantees this human right to enrolled tribal members. The source of this juridical entitlement is what the United States Supreme Court has defined as the federal trust responsibility.
Between 1787 and 1871, the United States signed nearly 400 treaties with Indian tribes, in which, for the exchange of millions of acres of tribal land, the U.S. government promised in perpetuity to respect their sovereignty and provide benefits, including housing, education, and healthcare. Argued in March 1983, United States v. Mitchell is the most recent Supreme Court case establishing this principle as a matter of law. This week marks the 36-year-anniversary of that seminal case, providing us the opportunity to discuss the federal government’s failure to adequately fund the healthcare institutions that serve American Indians and Alaska Natives despite its legal responsibility to do so.
The current life expectancy for American Indians and Alaska Natives is 73 years, 5.5 years less than that of the general population. American Indians die at higher rates from heart disease, cancer, diabetes, stroke, and kidney disease. When we consider why Native communities suffer from preventable and treatable diseases at disproportionate frequencies, we must first evaluate the inequity in Congressional funding for Indian Health Services (IHS), the national agency within the Department of Health and Human Services that is responsible for providing comprehensive healthcare to the country’s enrolled American Indians and Alaska Natives.
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.