PANDAS

PANDAS: An acronym for Pediatric Autoimmune Disorders Associated with Strep.

PANDAS is the sudden onset of symptoms like those of obsessive-compulsive disorder or Tourette syndrome following infection with streptococcus bacteria, caused by an autoimmune reaction that affects the basal ganglia in the brain. If tics are seen, they may or may not be choreaform like those of Sydenham chorea, a closely related condition that can follow a bout of rheumatic fever, which is caused by the streptococcus bacteria.

Diagnosis is primarily by observation, although a blood marker for the disorder has been identified. Treatment is by plasmapheresis or intravenous immunoglobulin, prophylactic antibiotics, and/or medication for specific symptoms.

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Modifying Hospital Community Benefit Tax Policy: Easing Regulation, Advancing Population Health

Editor's note: This post is part of a periodic series of Health Affairs Blog posts discussing the Culture of Health. In 2014 the Robert Wood Johnson Foundation announced its Culture of Health initiative, which promotes health, well-being, and equity. These blog posts are being run in conjunction with the November 2016 issue of Health Affairs, a thematic issue on the Culture of Health which explores roles for individuals, communities, commercial entities, and public policy that extend beyond the reach of medical care into sectors not traditionally associated with health. 

How might regulatory tax policy constraints be eased while promoting greater health equity? The Trump Administration could take steps-under existing legislative authority-to broaden the longstanding definition of “community benefit” spending to promote fuller community-wide health improvement partnerships between tax-exempt hospitals and the communities they serve. These steps, discussed below, are described at length in a new report issued by the Milken Institute School of Public Health at the George Washington University and funded by the Kresge Foundation and the Robert Wood Johnson Foundation.

Origins And Evolution Of Community Benefit Policy

Under policies first adopted by the Internal Revenue Service (IRS) in 1956 under Revenue Ruling 56-186, nonprofit hospitals could qualify as tax-exempt charities if they “operated to the extent of [their] financial ability for those not able to pay for the services rendered and not exclusively for those who are able and expected to pay.” In other words, charity care was the basic prerequisite to tax exemption.

In 1969, the Nixon Administration replaced this earlier standard with Revenue Ruling 69-545, which recognized the promotion of health for the benefit of communities as a whole as a charitable purpose. Under the ruling, hospitals could eliminate their charitable care activities altogether without losing their tax-exempt status as long as they could demonstrate a benefit to their communities as a whole.

In 2009, the IRS first issued a special reporting schedule (Schedule H) that must be completed annually by exempt hospitals as part of their Form 990 filings. This schedule provides guidance on what constitutes community benefit spending.

The Community Benefit/Community Building Conundrum

Part I of Schedule H contains a relatively detailed definition of community benefit spending. To a considerable degree, the Schedule H definition represents something of an evolution from the activities first classified as community benefit spending by the IRS in its 1969 revenue ruling: financial assistance (often termed charity care) for patients, with considerable hospital discretion to define the terms of assistance; hospital expenditures to offset losses in connection with participation in Medicaid and other means-tested government health insurance programs that pay less than the cost of care; community health improvement and community benefit operations; health professions education; community-wide subsidized health care such as regional trauma units; and research. The term “community health improvement” is defined as “activities or programs, subsidized by the health care organization, carried out or supported for the express purpose of improving community health. Such services do not generate inpatient or outpatient revenue, although there may be a nominal patient fee or sliding scale fee for these services.”

Separate and apart from community benefit spending activities, Part II of Schedule H permits hospitals to report expenditures for certain “community building” activities. Part II activities encompass physical improvements and housing, economic development, community support, environmental improvements, leadership development and training for community members, coalition building, community health improvement advocacy, workforce development, and other activities.

The IRS reporting instructions note that Part II expenditures may be reported as community health improvement spending under Part I. At the same time, however, the same instructions note that Part II expenditures are “not reportable” under Part I. Furthermore, the instructions fail to provide guidance regarding the circumstances under which Part II spending can be reported under Part I and therefore count as support for the hospital's tax-exempt status.

Hospital organizations have attempted to give examples to their members regarding the types of community building expenditures that might qualify as Part I community health improvement activities. Moreover, on occasion, and in response to specific queries (related to housing), the IRS has recognized community building as community health improvement. But the ambiguous IRS instructions create uncertainty regarding what community building activities qualify; indeed, the very existence of Part II effectively creates a presumption of exclusion of some or most community building activities. One might infer from the community benefit/community building distinction that activities focused on patient care (e.g., free lead tests for children) are reportable as community benefits, while activities that help community residents who are not patients (e.g., installing water filters in homes) amount to community building with a presumption of exclusion from Part I. This creates a disincentive for hospitals worried about maintaining their tax-exempt status to engage in the latter set of activities.

Hospitals As Community Health Actors: Eliminating The Community Benefit/Community Building Distinction

Health system transformation, spurred on by the Affordable Care Act (ACA), creates an opening for a different approach to defining community benefit, one that the IRS could adopt under its current legislative authority, just as it has done over the years in establishing the concept of community benefit itself. Using its authority, the agency could eliminate the community benefit/community building distinction, thereby incentivizing hospitals to move beyond patient care and assume a far more forceful role as full participants in efforts to improve the health of their communities.

Such a move would be consistent not only with the growing focus on underlying social conditions that affect health, but also with the “Triple Aim”-reducing the cost of health care while improving quality of care and population health-which has been part of the broader health policy landscape for years. This aim cannot be achieved by insurance alone. The Affordable Care Act has reduced the uninsured from 49 million to 29 million, from 16 percent to slightly more than 9 percent of the population, and its delivery reforms are structured to promote efficiency and incentivize hospitals and other health care providers to take a more holistic approach to patient health. While the ACA's insurance reforms face an uncertain future, to the extent that hospitals feel the effects of improved coverage, they can begin to focus on the broader community-wide health improvement role the Nixon Administration originally envisioned.

To be sure, the continued need for charity care remains great. This is particularly true in non-Medicaid expansion states for lower-income people who would be Medicaid-eligible in expansion states; it also holds true for privately insured patients, covered through individual and employer plans alike, who face steep, escalating cost sharing. But despite this continued need for financial assistance in connection with hospital care-which was established under the Internal Revenue Code as a basic condition for tax exemption (see page 1961)-the expansion of insurance can be expected to have a positive impact on hospital financing.

This positive effect can be seen in a 2015 study, which estimated a $6 billion decline in uncompensated care among hospitals in 2014. A separate study shows uncompensated care reductions as well, particularly in Medicaid expansion states. Added to potential gains from insurance expansion are payment incentives designed to reduce unnecessary readmissions and shorten the length of stay. These two developments, taken together, elevate the case for a hospital strategy that looks beyond the hospital door at the social conditions of health.

Tax Policy As Health Policy: Broadening The Meaning Of Community Benefit

The IRS possesses the power to broaden the definition of community benefit by eliminating the community building/community benefit distinction that the agency itself has created. Such a move-a recognition of hospitals' potential role in community-wide health improvement-would come at a time of transformation of hospital mission and practice and of growing awareness of the importance of the role of hospitals as community health anchors. We believe the IRS could take several actions to achieve this broad goal.

Eliminate The Separation Between Part I And Part II Of Schedule H

First, the IRS could eliminate the wall between Part I and Part II of Schedule H in terms of what the agency classifies as community benefits. This would encourage hospitals to contribute to clearly identified, high-priority health needs identified by hospitals themselves as part of their community health needs assessments (CHNAs), required by the tax code. The CHNA process emerges as a critical guide to such community-wide health improvement efforts. CHNAs must be conducted with input from the community served as well as public health experts and must be accompanied by annual implementation strategies that demonstrate how a hospital will respond to the needs that have been identified.

The George Washington University's (GW's) review of the most recently available CHNAs shows that, indeed, hospitals are themselves identifying population health conditions whose amelioration depends less on timely medical care and more on changing the conditions under which children grow and adults live, work, and age. By eliminating the Schedule H Part I/Part II distinction, the IRS could encourage hospitals to position themselves as full participants in community-wide health improvements that do not depend on a provider-patient relationship.

Identify Promising Community-Wide Health Improvement Activities

Second, the IRS could issue comprehensive guidance to help hospitals identify those community-wide health improvement activities that hold real promise. To do so, the agency clearly would need the help of public health experts, just as the agency turned to these experts to develop its CHNA rules. This expertise could be provided through a government-wide advisory group that could guide tax regulators on promising health improvement efforts, while also suggesting criteria that hospitals might apply as they seek to introduce additional community health improvement innovations.

Typically the IRS waits until it receives queries regarding the lawfulness of particular practices, such as supportive housing. A far better course would be for the agency to affirmatively engage with experts across the government-drawn from the Departments of Agriculture, Education, Health and Human Services, Education, Housing and Urban Development, Transportation, Veterans Affairs, Labor, Commerce, and other agencies-in developing community health improvement policy. The National Prevention Council, whose mission is to promote lifelong health, potentially offers such a starting point for the agency.

Establish Metrics To Guide Reallocation Of Hospital Community Benefit Spending

Third, the IRS could establish basic metrics to guide hospitals as they consider reallocation of community benefit spending. Federal law establishes no minimum community benefit spending floor, but hospital community benefit spending is considerable. According to a January 2015 IRS Report to Congress on Private Tax Exempt, Taxable, and Government-Owned Hospitals, in 2011, hospitals governed by the community benefit spending requirement spent $62.4 billion on community benefits. About half went to charity care and Medicaid shortfalls; only about 4 percent of this total (about $2.7 billion) was spent on Part I community health improvement activities, a figure that also includes expenditures on hospitals' own community benefit administration operations.

Moving forward, expenditures to support direct patient care undoubtedly will and should continue to play the major role in community benefit spending. But this leaves considerable room for spending on a far broader set of activities that can improve community health and that are undertaken in response to health priorities identified through the CHNA process. The IRS could set as a specific goal the greater alignment of community benefit spending and the priorities set through hospital CHNAs; the agency could offer suggested performance measures by which hospitals could, over time, slowly begin to reallocate their own community benefit spending toward these priority needs. Such actions could help ensure that as hospitals realize gains from broader insurance coverage, their contributions to community health improvement grow, and community benefit spending does not shrink.

In sum, eliminating the distinction between community building and community benefit is the essential first step. For maximum effect, however, this step should be coupled with broad guidance on community health improvement strategies that show promise, as well as guidance for hospitals that could, over time, help them reallocate spending toward CHNA-established priorities.

There are many efforts to improve the health of communities that will require new legislative authority coupled with increased spending. But the transformation of community benefit policy is not one of them. These reforms can be set in motion through executive action, led by the agency that oversees federal tax policy but deeply informed by the many sources of public health expertise within government. This approach to community benefit policy offers the potential for integrating tax and health policy in new ways, so that federal policy levers are not only being pulled, but pulled in the same direction.

Authors' Note

Funding from the Kresge Foundation and the Robert Wood Johnson Foundation support the report on which this blog is based.

Science in the Age of Trump

By DAVID SHAYWITZ, MD

As Donald Trump seeks to build his administration, he will likely struggle with creating a science infrastructure, given his estrangement from the nation's scientific community.

The distance between Trump and scientists seems to reflect mutual disdain. Trump famously trusts his gut over more data-driven methods. Trump's success, against most expectations, can be read as a triumph of instinct over science, or at least to reveal the perils of data-driven overconfidence. Trump's apparent intention to appoint a climate-change skeptic to lead the environmental protection agency suggests to many a disregard for the vast weight of scientific data here, while his comments about vaccinations during one of the Republican debates were charitably described by Steven Salzberg as “wildly inaccurate” and “thoroughly discredited.”

For their part, most scientists take a very dim view of Trump: Science prides itself on being inclusive, international, objective and collaborative–not generally the first adjectives used to describe Trump. (Whether science in practice lives up to these ideals is another question.) Add to this Trump-specific distaste the left-leaning bias of universities (well documented by centrist academics like Jon Haidt, among others–see here and references therein), and the result is a community that seems solidly united against the President-elect. (That said, I'd note that I've met more than a few political independents within academia who chafe at current norms.)

The problem, of course, is that science matters to America and to Americans. The U.S. scientific ecosystem has advanced knowledge and powered a range of industries, from biotech to aerospace. America has a wonderfully robust tradition of supporting scientific exploration, and it's hardly surprising–but worth noting–how many great scientific advances, including many resulting in Nobel Prizes, were made by researchers originally from other countries attracted to the United States by the freedoms of our nation.

Many Trump critics argue passionately against participating in the Trump Administration, essentially suggesting that joining the team would help legitimize an unworthy (some would say execrable) regime. (In a small, informal and unscientific Twitter poll I did over the weekend, about a quarter of respondents were in this category.)

The alternative view is that in a Trump administration, it's especially important for rigorous scientists to participate and be heard–provided, of course, that their voices would be heard, rather than their prestige co-opted. Because so few scientific innovators seem to be drawn to the Trump team, those who participate may find themselves–like Silicon Valley VC Peter Thiel – with an opportunity for influence far greater than they would have had in a more traditional administration.

To this end, one name that immediately comes to mind as a potential biomedical advisor or potential appointee is Dr. Jeffrey Flier, who recently stepped down as Dean of Harvard Medical School, after nearly a decade in that role.

(Disclosure: I know Flier as an endocrinologist and colleague, but do not have a personal or business relationship; I do have a long history with the university, including a current adjunct/visiting scientist appointment.)

In addition to deep expertise in medicine and science, and a range of honors including elected membership in the National Academy of Medicine, Flier has three attributes that would presumably appeal to the Trump administration.

First, Flier has encouraged the university to embrace entrepreneurship while remaining true to its academic foundation–an incredibly difficult needle-threading challenge that he somehow seems to have pulled off, a testament to his vision, independent thinking and political aplomb.

Second, Flier's striver background is arguably similar to Trump's: on the way to becoming Dean at Harvard, Flier went to City College of New York, and received his MD and subsequent training at Mount Sinai School of Medicine. He rose through the ranks at Harvard's Beth Israel Hospital, which might be viewed as Boston medicine's version of coming from the Outer Boroughs (see this Samuel Shem classic for more detail).

Finally, Flier's love of medicine is clearly part of the family business; his wife is also a professor of medicine at Harvard, his brother as an internist in the Boston area, and his two daughters are physicians as well.

While Flier has suggested on Twitter he has no interest in being considered for a role in the new administration, Trump's team would do well to do whatever they could to bring him into the fold.

Our nation's continued leadership in biomedical science is vitally important for our collective future. The new administration must seek to recruit the best talent–even NeverTrumpers, like Flier; similarly those who are tagged–even NeverTrumpers–must consider serving, for the benefit of the country.

The Current 21st Century Cures Legislation Is Still A Bad Deal For Patients

A lot can happen in 18 months.

In July 2015, the House of Representatives passed the 21st Century Cures Act, which contained public science funding and numerous provisions aimed at adjusting how the Food and Drug Administration (FDA) evaluates new medical products and new indications for existing prescription drugs and devices. Early in 2016, a Senate committee approved several individual bills that addressed some of the issues targeted by the initial House bill, but did not consider the full package of changes.

Finally, on November 25, late Friday over a holiday weekend, Congressional leaders released an amended version of the 21st Century Cures Act. After some final tweaks, the legislation was expected to pass in the House on Wednesday, November 30th. It would then move on to the Senate for consideration. At 996 pages, the revised bill (without the final tweaks) is 90 pages longer than the Affordable Care Act (ACA) and over 600 pages longer than the original bill. More than 1,400 lobbyists have worked to shape the proposed legislation behind the scenes.

Uncertain Funding

Whereas the original bill was lauded for providing National Institutes of Health (NIH) funding for the discovery of new medical advances, the current bill provides significantly less certainty in its support for prevention, research, and regulatory science. In 2017 and 2018, $500 million would be placed in a fund to help states combat the opioid epidemic. Over a 10-year period, $2.8 billion and $430 million would be placed in funds to support NIH research and FDA innovation, respectively. However, this funding would not be guaranteed; Congress would have to vote each year to actually make the money available as part of the appropriations process.

Additionally, most of the proposed NIH funding would come at the expense of cuts to the Prevention and Public Health Fund, which might otherwise vanish if the new Congress repeals the ACA next year.

Easier Pathways, Greater Risk

The current bill also retains some controversial provisions affecting how regulators evaluate certain types of medical products. Despite the insertion of clauses that purport to keep the FDA's approval standards intact, these provisions could be interpreted to afford the Health and Human Services (HHS) Secretary considerable discretion in applying those standards. The Act, for example, would require the creation of a program to use “real-world evidence” in support of new indications for existing drugs. Defined as information on drug outcomes that are derived from sources other than clinical trials, real-world data are less likely to have been uniformly collected and therefore risk being less reliable. Attempted analysis of real world information is potentially further plagued by systematic differences between populations of interest that may not be captured and, thus, cannot be adequately controlled, which can distort the true benefits and risks of a drug.

Another concerning provision involves a new “limited population” approval pathway for antibiotics treating patients with unmet needs based on a sliding benefit-risk scale, factoring the severity, rarity, or prevalence of the infection to be treated and the availability of alternative therapies. Manufacturers would be required to affix disclaimers flagging this pathway in the drug's labeling and to submit promotional materials to the FDA for inspection. But research has shown that consumers rarely read, let alone heed, health disclaimers, and the FDA has been increasingly hampered in its ability to regulate pharmaceutical promotion for unapproved or off-label uses.

Numerous sections in the current bill relate specifically to medical device regulation. For example, one section would formalize and expand an ongoing pilot program that entitles “breakthrough” high-risk medical devices to priority review, in which approvals could be made despite greater risk-benefit uncertainty. Yet, as defined in the current legislation, a device could be classified as a breakthrough even if its possible advantages are not “clinically meaningful.” Therefore, many new, high-risk devices would qualify for this pathway, and faster reviews of high-risk medical devices are associated with increased reports of safety problems after approval.

Such provisions will inevitably lead to widespread use of new and costly treatments before they are shown to work or before their risks to patients are adequately known. In many cases, government payers like Medicaid and Medicare would have no choice but to cover these treatments, while private insurers would be forced to play a more pronounced gate-keeping role.

Is It Worth It?

Of course, there are some positive provisions in this 996-page piece of legislation. The bill retains sections from the original legislation that would strengthen the FDA's ability to hire, train, and retain experienced staff scientists needed to evaluate greater and increasingly complex data. It also adds a requirement for manufacturers to publicly disclose how, if at all, they may make experimental therapies accessible to patients with serious or life-threatening conditions who do not qualify for clinical trials. Such transparency could help physicians and patients learn about the all-too-rare cases in which manufacturers offer such expanded access programs.

Still, we believe the bill's potential benefits and modestly enhanced funding for scientific advancement are far outweighed by the increased risk of patient harm, and added pressure on the FDA to rush new products to market without adequate evidence. The current 21st Century Cures Act would not drive innovation. Instead, it represents a poor deal for patients.

People Post: Staff And Board Changes At Health Foundations

Mary Backley, vice president for finance and administration at Grantmakers In Health (GIH), departed from the organization at the end of September. According to an announcement from Faith Mitchell, president and CEO, “Mary has been a core member of GIH's staff since 1993, helping us grow from a small circle of Funding Partners to our current 250+.” Backley was well known for event coordination-particularly the GIH Annual Conference on Health Philanthropy.

Meredith Sullivan Benton is the new senior program officer at the Healing Trust, a foundation in Nashville, Tennessee. (The funder was formerly called the Baptist Healing Trust.) This philanthropy funds nonprofits in forty counties in Middle Tennessee. Benton was previously chief of staff and assistant commissioner for external affairs at the Tennessee Department of Environment and Conservation. According to her biography, “her career highlights include serving in the office of a U.S. senator, two Governor[s'] administrations and for a former President's international organization.”

Lisa M. Fasolo Frishman has joined the Syracuse, New York, office of the Health Foundation for Western and Central New York. She is senior program officer and directs the funder's work in community health capacity and policy, according to an October press release. She was previously executive director of the NY (New York) Funders Alliance. Her past positions include program coordinator at Syracuse University's Maxwell School of Citizenship and Public Affairs.

Jake Grindle has been promoted to program officer I at the Maine Health Access Foundation (MeHAF). According to his biography, he “administers the Discretionary Grant and Meeting Support Programs and is helping to lead MeHAF's efforts to deepen its focus on health equity.”

Kristen Keely-Dinger, executive vice president of the Healing Trust, has been promoted to be its new president and CEO. A licensed advanced practice social worker, she will succeed Catherine (“Cathy”) Self, who will retire. Keely-Dinger will become the trust's new leader in December.

Elizabeth (“Beth”) McGlynn was named chair of the ABIM Foundation's board, according to a July press release. She is director of Kaiser Permanente's Center for Effectiveness and Safety Research.

Diane Oyler has joined the Health Foundation for Western and Central New York as a program officer. She started there in July. Oyler was previously with the Erie County (New York) Department of Senior Services. At the foundation, Oyler will focus on vulnerable older adults and caregivers. She continues as a lecturer at Buffalo State College in its public administration department.

According to an October press release, Robert (“Bob”) K. Ross, president and CEO of the California Endowment, will join the Weingart Foundation's board of directors, effective January 1. The Weingart Foundation, located in Los Angeles, California, funds in six Southern California counties. Read its announcement about its “Fiscal Year 2017 Program Plan.”

Brandon Skidmore has joined Sunflower Foundation, located in Topeka, Kansas, as a program officer, according to an October e-alert. Skidmore most recently was director of the Bureau of Health Promotion at the Kansas Department of Health and Environment. According to the e-alert from Billie Hall, Sunflower president and CEO, Skidmore will manage the foundation's Health Care program area, including its Integrated Care Initiative. The program focuses on “attainable and sustainable integration of primary and behavioral health care at the community and statewide levels.” Skidmore also will work closely with Sunflower's Healthy Living and Active Communities and its Advocacy and Policy program areas.

Charlie Venti, executive director of the Nicholson Foundation, located in Newark, New Jersey, will retire at the end of December. He “has led the day-to-day operations” of the foundation since 2010, according to his biography. His successor will be named soon.

Pamela Browner White is now senior vice president of communications at ABIM and the ABIM Foundation, according to an August press release. On the foundation side, she is supporting its mission to advance medical professionalism. For example, she will strive “to expand conversations about avoiding inappropriate or unnecessary tests and treatments” through the foundation's Choosing Wisely campaign. White most recently was senior vice president of corporate communications and strategic development at Esperanza Inc., “the largest Hispanic faith-based nonprofit” in the United States. Before that, she was vice president, public affairs, for Cancer Treatment Centers of America.

Honors

Ralph Fuccillo, president of the DentaQuest Foundation, received the 2016 Albert Schweitzer Prize for Humanitarianism. He was “honored for his work as a servant leader in public health and his lifelong commitment to health equity,” according to an announcement from the foundation. He received the award on November 4. Read the original announcement from the Albert Schweitzer Fellowship organization and an article in the Somerville (Massachusetts) Times for more information.

Grantmakers In Health announced in September that eighteen foundation staffers were named to the 2016 class of fellows for the Terrance Keenan Institute for Emerging Leaders in Health Philanthropy. The Aetna, Blue Shield of California, Empire Health, and Robert Wood Johnson Foundations fund the institute this year. Two of the new fellows have written for GrantWatch in the past. Jennifer Chubinski of Interact for Health (formerly the Health Foundation of Greater Cincinnati) coauthored a GrantWatch article, “For Two Regional Health Foundations, Returns from the Kentucky Health Issues Poll Are Worth the Investments,” in the September 2014 issue of Health Affairs. Kimalon Meriwether of the Cleveland (Ohio) Foundation wrote a July 2015 Health Affairs Blog post titled “A Perfect Combination: The Cleveland Neighborhood Model for Urban Health Care Education.”

Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation (RWJF), was one of three people honored by the United Hospital Fund “for their work to improve health and health care,” according to a September press release. Lavizzo-Mourey “received the Health Care Leadership Award for her visionary work to build a national 'culture of health.'” She has announced plans to step down from her position at the RWJF. Read a GrantWatch blog post about this news.

Read Health Affairs' Editor-in-Chief Alan Weil's interview with Lavizzo-Mourey and Alonzo Plough, vice-president, research-evaluation-learning, and chief science officer at the RWJF, in the November issue of Health Affairs. The interview is titled “Building A Culture Of Health.”

Next Avenue's 2016 Influencers in Aging, who “continue to push beyond traditional boundaries and change our understanding of what it means to grow older,” included some names from philanthropy: Bruce Chernof of the SCAN Foundation, John Feather of Grantmakers In Aging, Terry Fulmer of The John A. Hartford Foundation, and Carol Levine of the United Hospital Fund.

What Does the Recent Election Mean For Predictive Analytics In Healthcare?

By ROBERT ROWLEY, MD

The outcome of the recent election caught many people, and many forecasters, by surprise. How could their predictions have missed the mark so significantly? Granted, there were a number of people who predicted the outcome more accurately, but many of those who used data models to analyze the likely outcome are left now with head-scratching and postmortem analysis in order to improve their methods.

In their book Superforecasting, The Art and Science of Prediction, authors Philip Telock and Dan Gardner describe a subset of people who, on average, are significantly more accurate in their ability to predict upcoming events. “What makes them so good is less what they are than what they do-the hard work of research, the careful thought and self-criticism, the gathering and synthesizing of other perspectives, the granular judgments and relentless updating.”

What does this mean for healthcare? I'm not talking about the impact of the new presidency on health policy and healthcare delivery (that's another discussion) – I'm talking about whether predictive analytics is really all that accurate in the first place. Where does it fail?

The strengths and weaknesses of predictive analytics

Predictive Analytics in healthcare, a buzzword in the industry for a couple of decades, is the science of determining which populations are likely to become ill, what the health and cost implications of that are, and what might be done by way of pre-illness intervention to change things. About 20% of the population consumes 80% of health care dollars. But those who are catastrophically ill this year are not necessarily the ones who will become catastrophically ill next year – the high-cost cohort, though a consistent finding year after year, will be comprised of different individuals each year. The goal of medical Predictive Analytics is to figure out who will likely drop into that high-cost bucket next year, and what can be done to reduce that risk.

Much of risk stratification (the core of medical Predictive Analytics) is focused on populations. Taking people with certain health risk parameters in aggregate, as a population, is something that is predictable, can be measured and studied, and is the basis of what we have now. But drilling that understanding down to an individual patient becomes much more uncertain. Should this diabetic patient, controlled with medications but not on a statin, and who has at-target LDL cholesterol levels for a diabetic – should this patient be prescribed statins anyway? Doctors will have differing opinions, will do different things, and will look to supporting data (which may be sparse in a more granular analysis) to justify their choices.

How can we get better at individualizing medical recommendations? How can we take the current state of Predictive Analytics, which concerns itself with population management, and move it forward to something more precise?

AI: the next step in prediction

This is where Artificial Intelligence (AI) in healthcare can be very powerful. AI is the intersection of Machine Learning (ML) – a set of self-teaching algorithms that can identify patterns in data without being pre-programmed on what to look for (therefore without “pre-analysis bias”) – and the application of that ML to very large data sets. The shortcoming of medical AI so far is not so much a shortcoming in ML algorithms, but is the lack of very large, normalized data sets on which it can work. Medical data (clinical data) is historically fragmented into institution-centered silos, and claims data is segmented into payer silos. Aggregating this data into huge data sets is the task at hand in order for AI to become meaningful.

From this effort, our Medical Knowledge Graph (MKG) can be extraordinarily useful. The Flow Health Medical Knowledge Graph is the organized result of AI insights built in a way that can be used on-the-fly by a variety of medical applications, such as Electronic Health Records, population management and reporting tools for value-based care, web tools, and patient-facing apps. For the patient described above, the individualized recommendation can be made for that given person, and take into account all the diagnoses, lab values, medications used and discontinued in the past, and genetic markers if known.

Does this technology, once it matures, make the doctor's role obsolete? No. It makes the doctor's role more precise, more accurate, more consistent. In clinical medicine, we use clinical judgement based on recognizing a pattern presenting in a given patient, and we try to match that against similar patterns from our learning and our experience. We then use that pattern-matching to make recommendations. In the case of AI and the MKG, the pattern can be described in more detail, and the comparison is done against the entire body of data available to the ML engine. It becomes a tool that can make clinical judgement much better informed.

Predictive analytics, and the AI tools now becoming available, predict the odds of success, or the odds of something occurring. They deal in probabilities. However, as noted by many forecasters, nothing is truly certain (until it happens). Failures of accurate prediction teach the learning engines. This is true in political outcome prediction, and it is true in medicine. Leaders, whether in government, in the military, in business, or in healthcare, need to be well-advised, but must make executive decisions. In healthcare we call that making a surgical decision (there are no erasers on the ends of scalpels). Clinicians need to be decision-makers, informed by the best analytics available. In health IT, we need to build the best analytics engines we can, so as to inform medical decision-making in the best way that technology allows.

Robert Rowley, MD is Chief Medical Officer at FlowHealth

Calculating Medicare Advantage/Fee-For-Service Price Differences Is Harder Than It Looks

Understanding whether fee-for-service (FFS) Medicare and Medicare Advantage (MA) plans pay different prices is important - but more difficult to determine than it seems. In “Medicare Advantage Plans Pay Hospitals Less Than Traditional Medicare Pays,” we reported that MA plans paid hospitals 8 percent less, on average, than did FFS for a standard basket of hospital services. Our colleagues at the Medicare Payment Advisory Commission (MedPAC) have since alerted us that we did not account for differences in the way that hospitals receive Indirect Medical Education (IME) payments for MA, as compared to FFS, beneficiaries. In this post, we investigate the extent to which these differences affect our key result.

The Problem

The fundamental problem is that payments to hospitals from FFS have IME included in them, but payments from MA plans do not. According to MedPAC, for each MA admission, CMS makes an IME payment directly to the hospital equal to what would have been included in the payment for the admission had it been for a FFS rather than an MA beneficiary. These IME payments for MA admissions are over and above whatever payments are made by the beneficiaries' MA plans and the beneficiaries themselves.

The Centers for Medicare and Medicaid Services (CMS) calculates the IME payments for MA admissions based on claims that hospitals are required to submit to CMS. These claims are sometimes called dummy or “no pay” claims, because they are separate from and in addition to the primary claims for payments that hospitals submit to MA plans. In our analysis, we did not include the IME payments made on behalf on MA beneficiaries through this separate channel. Thus, although we accurately calculated the difference in payments made by FFS and MA plans, we may have overstated the difference in payments received for FFS and MA admissions.

The Solution

The correct way to account for IME payments would be to obtain from CMS the IME payments made on behalf of MA beneficiaries and then match them, at the admission level, to the payments made by the beneficiaries' MA plans and the beneficiaries themselves. The sum of payments from these three sources should then be compared to the sum of payments from FFS (including the embedded IME) and FFS beneficiaries themselves for the common (standardized) basket of admissions.

Unfortunately, we were not able to make this calculation. However, we were able to stratify hospitals by whether they were “teaching” hospitals or not, and then calculate the MA/FFS payment gap for a fixed basket of admissions for non-teaching hospitals only. Because non-teaching hospitals have no (or low) IME payments, the MA/FFS gap in payments we calculate for them would provide an (approximately) unbiased estimate of the difference that we might expect (at least for non-teaching hospitals) if we were able to account for IME payments for MA admissions.

We found that in 2012, the MA/FFS price gap for non-teaching hospitals-analogous to the 8 percent gap we calculated for all hospitals-was 4.7 percent. The bottom line: the exclusion of IME payments from MA claims account for part, but not most, of the MA/FFS difference we originally calculated.

Looking Forward

More generally, our MedPAC colleagues are raising a crucial issue: What does it mean to compare claims payments made from two different systems when the systems may have different side payments not captured at the claims level? In particular, CMS is now giving bonuses to (and imposing penalties on) hospitals with certain FFS claims patterns, over and above (or under and below) regular FFS. According to recent work, these payments are on track to amount to almost 6 percent of all inpatient hospital FFS payments in 2016. By the same token, MA plans may also be exploring the use of bonuses and penalties to provide stronger performance incentives. Because the MA/FFS gap is of approximately the same magnitude as these side payments, accounting correctly for them needs to be a key part of future analyses.

Authors' Note

The authors thank our colleagues at MedPAC and Amanda Frost of the Health Care Cost Institute for helpful comments.

Laurence Baker and Daniel Kessler have received fees for speaking, consulting, or both from hospitals, insurers, or both.

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Why Trump Won? A Brief Tutorial for Harvard Medical Students

By ANISH KOKA, MD

Mike Milligan, a Harvard medical student, recently wrote in THCB about the shock felt throughout his medical school upon the election of Donald Trump.  Seeking to understand how it may be that 'equality, service and compassion' were defeated, Mike settles on the narrative that appears to have taken hold of the elites on the left – Trump did not really win, Hilary lost.  While he does not say so in explicit terms, clearly we are to understand that the recent election was lost, and that in order to assure a better outcome the next election, physicians should urge their patients, and particularly their 'poorer and less educated patients' to register to vote.   Hopefully, these voters can then ensure that access to 'affordable, high-quality medical care' through constructs like Obamacare and MACRA are nevermore placed in jeopardy.

What complete hogwash.

Let me start with the factually incorrect parts.

Mike writes that 'Mr. Trump received fewer votes in victory than the previous two republican nominees garnered in defeat.'  As of today Donald Trump has received 62.2 million votes out of a total of 126.6 million votes cast.  Mitt Romney received 60.9 million votes out of a total of 126.8 million votes, and John Mccain received 59.9 million votes out of a total of 129.4 million votes cast.  So despite the fact that his opponent raised and spent close to 1 billion dollars on ads promising the literal apocalypse if Trump was elected, no republican candidate in history garnered more popular votes than Donald Trump.  While it is true that nearly half of all Americans did not cast a ballot in this election, 3 million more votes were cast in 2016 than were cast in 2012.  The percentage of eligible voters casting their vote in 2012 was 55%.  The percentage of voters casting their vote in 2016?  Also 55%.  I realize the desire to deligitimize Trump by arguing this was a low turnout election that delivers no mandate is a very strong one among the millions on the losing side.  Unfortunately, wishes and reality sometimes find themselves in conflict.

The real story of the election is that the Donald Trump managed to flip the rust belt states of Michigan, Wisconsin and Pennsylvania by convincing blue-collar, mostly white voters that his party was now the “workers' party”.  Traditionally blue strongholds of towns like Erie, Luzerne, and Northampton counties in Pennsylvania turned red in 2016. A Republican hasn't won Erie County since 1984!  Obama won this county  by 16 percentage points in 2012 – Trump won this same county by 2 percentage points.  Statewide, Trump performed better than Romney in 58/67 counties while Clinton performed worse than Obama in 65 counties.  So it is absolutely true that Clinton performed worse than Obama, but not to focus on the story of the overperformance by Trump is to be willfully blind.

As to the implication that it was the least educated sitting at home that sunk Mrs. Clinton, data would argue the opposite.  The poorly educated did vote, and by a wide margin chose Trump.  Pre-election polling showed Trump with a 30-percentage point advantage among whites without a college degree – he ended up winning them by 40 points.  Indeed, one of the single best predictors identified in counties that swung to Trump is the percentage of non-college whites.  The greater the percentage of non-college educated whites in your county, the greater the chance of Trump emerging victorious.

The only metric found to be even more predictive than your race and education?  Poor health. You are reading that correctly.  In an analysis done by the Economist , a weighted index of obesity, diabetes, heavy drinking, physical exercise, and life expectancy performed even better than race and education level in predicting counties that moved to Trump.  The poorer your health, the more likely you were to vote for Trump.

A wonderful interactive version of the graph can be found here.

Apparently, those who stood the most to gain from affordable, high quality health care were also most likely to choose the candidate who called for repeal of Obamacare.  It is safe to say that this was a stunning repudiation.  To a great many who had voted for the promise of Obamacare, the reality of high premiums, penalties, and narrow networks left a bitter taste.  And so it came to be that those uneducated and in poor health – the losers in this economy – chose the candidate who promised change over the candidate whose campaign slogan was grabbed from the recent Lego movie – “Everything is Awesome”. What a complete shock.

There are many story lines that underlie Hilary Clinton's defeat.  She was clearly unable to animate and connect with her base in the way Barack Obama did – but if this is the major narrative rocking liberals to sleep in these cold dark times, I would advise the overworked mental health specialists dealing with the trauma of a Trump election on college campuses to pace themselves for eight years of inconsolable sobbing.

Anish Koka is a cardiologist in Pennsylvania.

Junk DNA

Junk DNA: Noncoding regions of DNA that have no apparent function. The term "junk DNA" is a disparaging one, expressing some of the disappointment felt by geneticists when they first gazed upon sizable segments of the genetic code and, instead of seeing one wonderful gene after another, they saw a few exons surrounded by vast stretches of "junk DNA."

Exons are the regions of DNA that contain the code for producing the polypeptide molecules that make up protein. Each exon codes for a specific portion of the complete protein. In humans and some other species, the exons are separated by long regions of junk DNA.

However, junk DNA has been found to be even more conserved than protein-coding regions of the DNA in humans and other mammalian species. The extent of conservation indicates that there is some function for junk DNA that remains to be determined. Junk DNA may prove not to be junk.

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
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The Uncertainty Bomb

By PAUL KECKLEY

I like certainty and routine. I like my daily Tall Dark Roast with no room for cream at 5 am at Starbucks. I like the same restaurants, the same suits and ties and the same TV shows. Holidays throw me off and I get bored quickly when I have down time.

For six years, the healthcare industry in the U.S. has been adjusting to its new normal based on the regulatory framework of the Affordable Care Act (ACA). It became routine to discuss the volume to value, accountable care organizations, bundled payments, Medicaid expansion and Healthcare.gov. We were certain they'd be around for years to come.

Then came the election. When 61 million voters elected Donald Trump to the White House and kept GOP majorities in both houses of Congress, it signaled our routines in healthcare would be disrupted. The campaign promised to repeal and replace the ACA: its repeal appears certain but it's replacement injects uncertainty into our routines around a number of meaty issues:

• Senate Composition: The mechanisms for replacing key elements of the law will require a super majority of 60 in the Senate: will the 52 GOP senators broker support from 8 Dems for weighty items like how Medicaid block grants could work, how consumers could buy insurance across state lines, how tax credits would work as individuals replace employers as the key insurance market, the potential for vouchering Medicare and much more. How the Senate advances the ACA's replacement will be a protracted process with many moving parts and considerable political deal making.
  
  


• Federal Budget: Healthcare spending by the federal government is 30% of its total spending. The tension between budget hawks in Congress who fear escalating deficits and the Trump team's promise to invest $550 billion in infrastructure including hospital improvements will require deft political craftsmanship. Funding for healthcare will compete against pressures to reduce federal spending pitting it against education, transportation, homeland security and defense for budget consideration. And GOP partisans vow cuts to healthcare spending which, in some cases, are at odds with Trump campaign promises.
  
  


• Health Insurance: Creating a new regulatory framework for private health insurance will be complex and time-consuming. Uncertainty about the individual insurance market is particular unsettling and the future of marketplaces unknown. Will the new administration ease restrictions on private insurers that result in higher premiums? Will the individual and employer mandates that are repealed be replaced by other mechanisms that induce coverage and spread risks? Will the shift of financial risk and affordability to providers from insurers accelerate the growth of integrated health systems that operate hospitals, sponsor health plans and networks of clinicians? There are 106 of these today: is integration of financing and delivery the future? And what's to become of the 21 million who gained insurance coverage through the ACA, including the 12 million who expect to get subsidies to pay their premiums (estimated at $43 billion this year).


• Consolidation: What's the future for industry consolidation? Will FTC recent constraints on health system consolidation in Pennsylvania and Chicago be sustained or revisited as appointments to key posts in the Department of Justice and FTC are made. What's the view of the new administration toward mega-mergers like CHI-Dignity Health, Aetna-Humana and Anthem-Cigna to name a few.  And will the Trump affinity for  free market competition lead to mega-players akin to other industries like banking where five organizations control 45% of assets nationally, airlines where 4 carriers control 80% of passenger miles flown?
  
  


• Veterans Health et al: And how will the new administration orchestrate pledged improvements in veteran's health, lower drug prices, protection of Medicare, trade agreements and tax reforms that impact U.S. drug and device manufacturers that operate globally and much more?

Answers to these are unknown. And they'll not be found overnight. That's the new, new normal. Uncertainty.

Most healthcare organizations put their 2017 Strategic Plans to bed before the election. Capital and operating budgets are already in place as by-products of their planning effort. Each is based on assumptions that carry a high level of certainty.  The election results changed things for many.

The new, new normal in U.S. healthcare is about navigating uncertainty.

For drug and device companies, the news is mostly good. Though the 12 nation Trans Pacific Partnership trade deal appears dead and the Trump campaign railed against drug prices, price controls appear unlikely.  The elimination of excise taxes on medical devices and mandated discounts for prescription drugs appear likely. The administration is likely to focus on streamlining the FDA's approval process to create more competition which could take years. That's the reason their stocks in these sectors have gained 10% since the election.

Ditto good news for the health insurance industry. Repeal of the ACA means onerous requirements like essential health benefits and premium increase constraints go away. They'll benefit from greater flexibility in setting premiums and benefits design. No doubt, they'll negotiate around guaranteed issue and risk-ratings to strengthen their bargaining position. The marketplaces will be auctioned off to the states, and commissions will be created to define a path forward for private coverage just in time for the 2018 elections. All in all, good news.

For health information technology companies, the news is mixed: there's no evidence meaningful use will be suspended at last through Stage Two since its funding is outside the ACA, but fear that hospitals and physicians might pull back investing in HIT given mounting uncertainties is evident. Digital health and telemedicine sectors are the exception as the healthiest hospital systems advance their care coordination and population health management efforts but solution providers in both sectors are plenteous and standards around privacy and security risks a work in process.

But for providers, especially hospitals, the election outcome is particularly unsettling. As insurers gain leverage and employers press for lower costs, they'll hammer physicians, hospitals and post-acute providers for steeper discounts. Medicare's path will be an unknown for a while: will the GOP successfully orchestrate its transition to a premium support model? Will its mandated bundled payment and value-based purchasing programs carry over as a new CMS team steps in? As Medicaid is transferred back to the states via block grants, will providers be commoditized by the private Medicaid managed care organizations currently used in 39 states to keep costs/beneficiary low? For physicians, MACRA isn't likely to go away: the election assures that at least 90% of eligible physicians will simply opt for its lower risk MIPS payment model until the dust settles around alternative payment programs like ACOs. Thus, for all providers, uncertainty is reality. And for hospitals, the uncertainty is precautionary.

In most hospitals, boards and management are meeting to revisit their 2017 plans in light of the election results. Like early-stage prostate cancer for men, watchful waiting is a reasonable response to the new, new normal. Uncertainty can be debilitating but a few things are clear:

The certainty of escalating cost pressure. Operating margins for hospitals will shrink faster than anticipated. The potential suspension of insurance coverage for 21 million newly insured means increased bad debt for hospitals. That's reality. Scale and scope need fresh attention: affiliations and partnerships make more sense now than ever. And cost reduction efforts will take center stage beyond the bread and butter punch list promoted by most consultancies– supply chain improvements, workforce productivity, capital costs for bricks, sticks and technology, and formulary design. Clinical process redesign will be first and foremost: a recent Truven analysis showed savings of $400 per admission in cardiology, gastroenterology and other key programs that are designed around efficiency and effectiveness-more than savings in formulary design and other staples in cost reduction. These expanded hospital cost reduction efforts will necessitate attention to medical practice operational performance since one in three physicians is now a hospital employee and compliance risk mitigation to avoid penalties for safety lapses, avoidable errors and suboptimal outcomes. Add cost effectiveness in data capture necessary to quality, safety and costs, rationalizing of health information technology investments, surgical precision in the design of health insurance benefits for hospital employees and openness to outsourcing virtually every function where efficiency and effectiveness gains can be realized-that's the widening domain of hospital cost reduction. And it's certain to be a priority.

The imperative of physician leadership. Physicians aren't happy. The majority in their ranks believe the health system is deteriorating as their clinical autonomy is challenged and incomes threatened. Being an employee of a large medical group or hospital is not a desired end-game for many but remaining independent seems a pipe dream to most. And the complexity of clinical practice-adherence to evidence, measuring and monitoring outcomes and patient experiences, engaging peers in care coordination, converging behavioral, physical and alternative health disciplines in diagnostics and treatment planning, and acclimating to person-centered care that's transparent-is daunting. Hospitals bear the brunt of these understandable feelings: they're intense. Effective physician leadership will be imperative in every sector of healthcare as the new, new normal unfolds. It requires business savvy that compliments clinical training: as financial pressures mount and regulatory expectations change, understanding creation of and access to capital, compliance risks, workforce performance, and day to day operations will be as important as acumen in understanding signs, symptoms, risk factors and co-morbidities. System-building is the future: that's certain. And those activities, programs, investments, relationships and business interests will revolve around capable physician leadership and financing and delivery are fully integrated.

The centrality of person-centered services. Individuals in every stage of health are the most important stakeholder in the new, new normal. Patient-centered care is limiting: it conveys a paternalistic demeanor toward individuals lending to widespread variability in access, costs and outcomes. It's limited to inpatient and outpatient services delivered by providers to patients. That's not the future. Employers are pushing away from conventional coverage forcing employees into high deductible plans. Social media and digital health are providing meaningful comparisons of providers, drugs and plans conveniently and credibly. Health is being defined more broadly around concepts of wellbeing in which social determinants and community programs matter. Alternative health, retail services, telemedicine and online services are as critical in the new, new normal as beds and clinics. Healthcare organizations that default to traditional views of individuals as patients and enrollees risk a growing opportunity for growth and innovation. Transparency in interacting with individuals will be more important than ever: the unintended consequence of Campaign 2016 is widespread public disillusion with established institutions and suspicion about “fake news”.  That's the reality of the new, new normal.

The election 12 days ago assures uncertainty in U.S. healthcare. Across our system, the unknowns outweigh the knowns. The new, new normal need not be paralyzing: it presents new opportunities for organizations that adapt.

Paul

P.S. The election surprised many. In this Thanksgiving season, we should celebrate a system where our periodic political campaigns are the basis for the governing of our Republic. Regardless of the outcome, we live in a system that's imperfect but still “of the people”.

Sanfilippo syndrome

Sanfilippo syndrome: The most common disorder of mucopolysaccharide metabolism, a syndrome in which the onset of clinical abnormalities occurs between ages 2 and 6, with mild coarsening of the facial features (but normal clear corneas), mild stiffening of the joints, slowing of growth, and intellectual deterioration that results in severe mental retardation. On a biochemical level, Sanfilippo syndrome is characterized by the excess excretion of heparan sulfate in the urine and the accumulation of mucopolysaccharides in the central nervous system and other tissues. On the genetic level, there are four types of Sanfilippo syndrome (types A, B, C, and D), each due to deficiency of a different enzyme. All four types are inherited in an autosomal recessive manner and result in identical clinical syndromes. Also known as mucopolysaccharidosis type III (MPS III).

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
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Two Nations Separated by 5.3 mm

By SAURABH JHA MD

A popular meme is that the U.S. spends more on healthcare than other developed nations but has nothing to show for that spending. This is different from saying that the U.S. spends more, but achieves something, but the something it achieves is so little that it isn't worth the public purse. The latter is difficult to assert because the asserter must then say how little is too little in regards to how much is spent, and why. It is easier believing the excess spending has no effect whatsoever, zilch in fact, because this absolves one from having to apply a value judgment on how much a life is worth. This meme, a convenient heuristic, like other convenient heuristics, is wrong.

A recent study looked at trends and outcomes in the management of abdominal aortic aneurysm (AAA) in the U.S. and the U.K. An aneurysm, dilation of the aorta, is more likely to burst the bigger it gets. Aneurysms should be repaired before they rupture because the mortality of ruptured aneurysms can be 50 %. The study, which analyzed several databases that recorded surgery, size of aneurysms, and cause of death, found that Americans repair twice as many aneurysms as the Brits, and the repaired AAAs are smaller, on average, in the U.S. Between 2005-2012 elective AAA repair (i.e. repair of non-ruptured aneurysms) increased from 27 to 32 per 100, 000 in the U.K, and from 58 to 64 per 100, 000 in the U.S.

Does the increased frequency of repair of AAA in the U.S. reap benefits? It seems so. In 2012, there were twice as many ruptured aneurysms in the U.K. as the U.S., and aneurysm-related deaths were 3.5 times higher in the U.K. Only trends, not absolute numbers, should be inferred from secondary databases. And the trend is clear: in both the U.K. and the U.S., the rates of ruptured AAA and aneurysm-related deaths have declined, while elective AAA repair has increased. The U.K. has reduced aneurysm-related deaths by 20 per 100, 000 by adding only 5 per 100, 000 cases of elective repair. It seems that U.K. has picked the low-lying fruits (large aneurysms) and the U.S. is approaching diminishing returns.

Roughly, for 32 excess electively repaired AAAs, there are 9 fewer ruptured AAAs and 25 fewer aneurysm-related deaths, per 100, 000. These figures aren't exact but show that repairing AAA before it ruptures has a good return-on-investment and, as far as life expectancy is concerned, more the merrier. Of note, electively-repaired AAAs have the same outcome – i.e. the same complications and therapeutic effect – in the U.S. and the U.K. Neither the skill of the surgeon, nor the attentiveness of the support staff, seems meaningfully different between the two countries.

The corollary of Americans repairing more AAAs is that the size-threshold for repair of AAA in the U.S. is smaller than the U.K. The average size of repaired AAA is 5.8 cm in the U.S. and 6.4 cm in the U.K. At the time of repair of the AAA, on average, is 5.3 mm smaller in the U.S. than U.K. 5.3 mm is a lot! Risk of aneurysm rupture is non-linear – the increased risk of rupture of 65-mm vs. 60-mm aneurysm is more than the increased risk of rupture of 45-mm vs. 40-mm aneurysm, even though the difference in size in the two pairs is the same. The non-linearity of rupture risk means that excess 7-cm AAAs floating around in the U.K, for example, will contribute disproportionately to aneurysm-related mortality.

Clearly, the Americans are repairing aneurysms sooner than the Brits and, in many instances, aneurysms smaller than the recommended size threshold. Further, AAA is more likely to be repaired endovascularly – i.e. by a stent – in the U.S. Stents have lower morbidity-mortality than open repair. In the U.S., there are more physicians available to stent AAAs, or more willingness in physicians to stent, or both. Why is this so?

Consider an analogy. Peter drinks more alcohol than Paul because he has more alcohol in his house than Paul. But the reason Peter has more alcohol in his house than Paul is because he drinks more alcohol than Paul – he drinks more because he has more and he has more because he drinks more. The process is recursive. Americans stent more because it pays more to stent than not to stent. But crucially, the “more stenting” is not for naught. Americans are more aggressive not only with stenting AAA, but surveillance of AAAs – I can attest to that as I read follow-up CT angiograms for AAA. The “Aneurysm Surveillance Program” puts the vigilance of the Central Intelligence Agency to shame.

The study suggests that the size-threshold for repair of AAA, presently 55/ 50 mm (men/ women), should be lower. Thresholds are derived from risk vs. benefit of an intervention – the safer an intervention, the lower the threshold for intervening. Threshold for repair of AAA was derived from a randomized controlled trial (RCT) when aneurysms were repaired by open surgery. Threshold should be revised because now stents, which are safer, are mostly used. The study is an excellent example of how analysis of a secondary database can question practice derived from an outdated RCT.

The study also hints that screening for AAAs may be beneficial. However, it won't be easy for an RCT to show a treatment effect of mass screening for AAA, even though, undoubtedly, some lives will be saved by screening. This is because the outcome, death from ruptured aneurysm, is still an uncommon occurrence, at a population level.

In summary, Americans stent more aneurysms and stent smaller aneurysms than the Brits, increasing the longevity of some people with aneurysms. There is another message in this paper. The Americans are repairing aneurysms smaller than the recommended threshold. To state this bluntly – they're saving lives by ignoring evidence-based medicine (EBM). This is, partly, how medicine progresses – someone ignores the status quo, i.e. guidelines. To advance science you must, occasionally, ignore EBM. This is a paradox until you think about it.

This is a good time to deliver my annual message to both countries. Brits: if you want American outcomes, put your money where your mouth is. Americans: if you want British healthcare spending, build more graveyards. Sometimes less is more. Sometimes more is more.

 

About the author

Saurabh Jha is a radiologist and contributing editor to Healthcare Blog. He makes his living measuring aneurysms. He can be reached on Twitter @RogueRad

American Healthcare Rackets: Monopolies, Oligopolies, Cartels and Kindred Plunderbunds

By NORTIN HADLER, MD

The Healthcare Dollar, the Healthcare Industry and the Healthcare System are shibboleths. All are parlance. All render terms such as Healthcare Profession, Service Profession, and Healthcare Professionals quaint. All drive linguistic determinism: if it's labeled so, it must be so. Furthermore, all have become jingoistic. This is our dollar, our industry, our system and don't dare tread on us.

These are shibboleths that engender considerable cognitive dissonance. If healthcare is no longer a service profession but an industry that transfers wealth in a systematic fashion, shouldn't it comply with the legal constraints that tightly govern other industries including others that serve essential needs of the population?

For many such industries the states have an important degree of control over productivity and pricing. Insurance Commissions provide governance over the cost and scope of companies purveying homeowner's, automobile and Workers' Compensation insurance. Utility Commissions regulate the rates and services of private sector public utilities. Boards of Education perform similarly whether education is public or private. Federal statutes complement the states' role in consumer protection. For example, attempts to construct monopolies are met with regulatory zeal.  Otherwise communication and energy monopolies would never have been “busted” and unconscionable pricing would be rampant. This form of check-and-balance relies on the consumers' political leverage when they realize they are being ripped off.

The track record is far from perfect. Take the “military-industrial complex” (please), an industry charged with supplying armaments and whatever else is needed to support the proclivity of our species to seek violent solutions to disputes and violent means to assuage insatiable greediness. Historically, this was a cottage industry populated by craftsmen, farmers, and all manner of factotums. This cottage industry, like nearly all others, did not survive the industrial revolution. Thanks to unbridled growth in demand and in ingenuity a behemoth has superseded.  In FY 2017, total US government spending for defense (including military defense, veterans' affairs, and foreign policy) is budgeted to be $853.6 billion, with ¾ for “defense.” This has represents about 5% of the GDP annually during the War on Terror. The expenditure was about 40% of the GDP during World War II and settles down near 1-2% between wars. The military-industrial complex is largely an oligopoly since very few companies are in the modern armaments business, or the business of providing supportive services for that matter. It is a peculiar empire with many an idiosyncrasy, including many that are tolerated despite ethical compromises. For example, the Pentagon typically contracts for goods and services on a “cost-plus” basis resulting in delays and overruns which may lead to penalties and subsequently to more costly contracts that factor in the penalties and promote recidivism. Many an advance in weaponry is initiated by the private sector in collaboration with government and military professionals. We are all aware of the notion of the “revolving door” which predisposes to bread buttering even if the butter must remain in cold storage for a regulated interval. We are all aware of abuses in pricing, such as the infamous air force ashtrays. We are all aware of “this dog won't hunt” disappointments moldering somewhere without penalty for the manufacturers. We are all aware that the denizens of K Street include a great number of lobbyists for the military-industrial complex. These lobbyists have many agendas, not the least of which is to participate in the debates that define allies who are an appropriate primary or secondary market for armaments. We are also aware of the lobbyists whose agenda is domestic sales. We are awash in claims of our military's ascendency based on incontrovertible outcome measures in the details of the violence that is wreaked and the intensity of the racket made by our rattling sabers. We are variously amazed and bemused by the mind-boggling transfer of wealth necessary to create corpses. It's all business as usual. It's all assumed or asserted to be a necessary evil. And it's so well-funded and established that cries for reform are largely lost in the din of routine.

It's so familiar a scenario that we can find it reasonable for the Healthcare Industry to operate on a similarly organized playing field. Before I detail the parallels, let me emphasize that I am not unleashing a diatribe against the players. I am targeting the playing field. I am also not writing a partisan screed. The playing field I decry is the home turf today for fee-for-service, ACA, single payer, block grant, and other reform advocates.

I do not excuse the players for the errors of their ways, but blaming them misses the forest for the trees. Many, if not most, of the leading players in the healthcare and military-industrial complexes are competent, well-meaning and doing the best they can. For example, most military leaders were the fine youngsters admitted to our service academies where they are imbued with traditions of honor and patriotism. The precedent for training leaders in medicine is more of a moving target. Unlike the military, healthcare survived the industrial revolution as a cottage industry and its practitioners as a guild well into the 20^th C before it transitioned to “industry” statues. Nonetheless, most students enter medical school today brimming with talent and with sincerely held goals regarding the betterment of mankind. American medical schools are less likely to foster these goals than the service academies. The goals of the industry insinuate earlier. The unanticipated consequences of this insinuation become apparent in postgraduate life. That's when the young doctor is disabused of any residual notion that the patient's care and the people's wellbeing are principle raisons d'être of the Healthcare Industry. These young practitioners have crossed the Rubicon and now their resilience is to be tested.

Connivance and Collusion

So much of what is reprehensible about American healthcare has been comprehensively documented by many authors – including me in the context of my writing to empower patients to ask telling questions. Here I will emphasize the enabling economic and organizational structures that would not be tolerated in a service profession but are well entrenched in the Healthcare System.

Foremost is rampant Regulatory Capture. The Nobel Prize winning economist, George Stigler, was one of the luminaries in the mid-century “Chicago School”. Stigler developed a theory of economic regulation by analyzing the positive and negative influences of public power on the economic status of industries and occupations. Regulatory capture recognizes the tendency for a regulatory agency, created to act in the public interest, to be dominated by the interests it was meant to regulate. In the Healthcare System captured agencies are seldom furtive; rather the capture is declared expedient if not necessary.

The FDA is our object lesson. The current director was appointed despite considerable misgivings relating to his career as a drug “trialist”, including his prior role as director of Duke's Clinical Research Institute (CRI), a Clinical Research Organization (CRO.) He denies being on the payroll of any pharmaceutical entity although his compensation at Duke was noteworthy and the CRI itself brought Duke a pretty penny (in a law firm he'd be called a “rainmaker”). His predecessor at the FDA departed under something of a cloud relating to conflictual relationships between her husband's financial firm and particular pharmaceutical firms. All this is innuendo at least, certainly unseemly, but it pales next to the institutionalized conflictual relationships that exist between the FDA and the pharmaceutical industry. Several are statutory or officially sanctioned. A substantial portion of the FDA's budget is derived from users' fees, income collected from the petitioning company as the price for determining whether any New Drug Application merits licensure. This tithe alone renders the relationship between the FDA and its clients unhealthy. The political climate keeps them in bed together; there are 6 healthcare lobbyists available to “help” each member of congress appreciate the value of the pharmaceutical industry and of its omnipresent advocacy organization, PHrMa. PHrMa is a behemoth on K Street shelling out far more largesse in 2012 than the lobbyists for the military-industrial complex and big oil combined. Of course, this budget is skimmed off the top of the cost of drugs, devices and potions.

There are other aspects of the licensure process for new drugs that should cause widespread discomfort and debate. Very few of the licensed new drugs are really “new” let alone major therapeutic triumphs. Most are either “me too” agents or afford very few patients more than very little benefit. On top of that, the rare drug that is really a breakthrough is a nearly always a triumph of academic investigators funded by federal dollars; the pharmaceutical firms co-opt the federally funded intellectual property, often gratis, and patent the therapeutic derivative. These are the hard realities of an industry that has largely overgrown its usefulness but not its avarice. And the avarice is facilitated by naiveté on the part of society and inadequacies of oversight. I can find little in the history of the pharmaceutical industry that speaks to originality in its business model, only exploitation. The industry backed onto its perch as an inviolate cash cow. One secret to this evolution is my friend and former colleague, the brilliant biostatistician Dennis Gillings. We were junior faculty together, co-authoring papers and co-editing a book in the 1970s, when Dennis discovered another personal skill and proclivity. Dennis was willing to consult with the pharmaceutical industry regarding the development of drug trials and the presentation of the forthcoming data in a fashion that satisfied the requirements for licensing new drugs or licensing old drugs for different indications. That proclivity became Quintiles Transnational and then the entire CRO industry. I have a great deal of respect and warmth for my Horatio Alger friend but no respect for the industry he spawned and the consequences of its success. Without CROs, I can't imagine that total prescription drug spending would have exceeded $450 billion (16.7 percent of health care spending) by 2015 or be estimated to increase annually by 6.7 percent through 2025.

Here's how the shell game works. CROs are the go-to for pharmaceutical firms when they are ready to subject a drug to a licensing trial. Since they anticipate that the drug will have little efficacy at best, affording slight benefit to most or more benefit to very few, the licensing trials are expensive, large, and sloppy (it's hard to find appropriate subjects, harder to recruit them, and hardest yet to maintain adherence to the trial's methodology.) CRO's are contracted at great cost to undertake this exercise. If this was elegant science, equipoise would dominate the methodology, i.e. no one would have any preconception regarding the outcome. However, this is a business arrangement that inherently lacks equipoise: the drug company anticipates success and the CRO has reason to see their client emerge pleased with their contracting. Large sloppy trials seeking small effects lend themselves to all sorts of data massaging and data torturing in the subliminal (or not) quest for success. No wonder these trials are far more likely to demonstrate a statistically significant degree of efficacy if undertaken by a CRO than when the same drug is studied by trialists with federal funding.

So, the applications for the licensure of new drugs that appear in the FDA's in-box, wrapped in user fees, are seldom overwhelmingly compelling. They tend to support the assertion that there is a statistically significant difference in efficacy between the active drug and the comparator although the magnitude of difference is debatable in terms of clinical meaningfulness. The FDA is not unaware of this “subtlety”. It convenes advisory panels of experts with relevant experience and often relevant conflictual relationships, which Congress deemed acceptable. Interestingly, when studied these experts are not predisposed to look kindly on drugs produced by companies for which they are paid consultants; rather, they are predisposed to disparage the competition. So me-too and small effect drugs are routinely licensed and heavily marketed with language often designed to mislead. For example, how often do we hear that some agent offers a 50% reduction in some outcome when we should have been told that if 400 patients took the drug for 6 months, only one would suffer an untoward outcome compared to 2 who didn't take the drug (e.g. AstraZeneca's Jupiter trial which turned Crestor into a “blockbuster” drug ). This is a ploy that plays out at great expense only in America. Direct-to-consumer advertising is not countenanced in any other country save New Zealand where the approach is, comparatively, very understated.

All this is business as usual, and I am not the sole critic. Recently, the FDA and CMS (Medicare Administration) have decided to collaborate regarding the clinical utility of the licensed interventions afforded the Medicare population, a collaboration offered with considerable sanctimony as if this is a novel agenda. It isn't; it ignores precedents such as PCORI in the ACA, the clinical guidelines kerfuffle, and the machinations of the National Quality Forum (NQF) and the Institute for Healthcare Improvement (IHI). The NQF and the IHI started as advocacy groups that have grown into sizable organizations that capture many millions of dollars to push their agenda. For example, the NQF receives over $10 million annually from CMS (Medicare) to provide the performance measures CMS uses to monitor the quality of the services it purchases. NQF is still reeling from scandals. The first caused the dismissal of its Chair, Dr. Charles Denham, after the Department of Justice accused him of profiteering from kickbacks to the tune of $11.6 million. He was replaced by Dr. Christine Cassel, recruited in 2012 from the American Board of Internal Medicine (ABIM) which she had chaired for a decade. Her appointment to NQF raised a cloud of dust when it was learned that she was paid nearly a quarter of a million dollars by Premier, Inc., a Charlotte, North Carolina company that offers group purchasing and performance improvement consulting for nearly 3000 hospitals and thousands of nursing facilities. Premier clearly has a stake in the work of the NQF and Cassel has since seen wisdom in discontinuing her relationship with this and other similar entities.

The FDA is the object lesson I've focused on. But there is a wealth of object lessons all with their distinctive acronym: ACGME, ABIM, AHA, ABMS, ACS, CMS (MIPS, MACRA), HIPAA and there are many more in the alphabet soup. Others are known by their full name like The Joint Commission, a non-governmental agency that wields accreditation with power and authority causing some 20,000 health organization, particularly hospitals, to cringe and comply.  Acronym or not, all these bearers of standards beg critical analysis. All have regulatory influence and all have fallen victim to regulatory capture to some degree. Too often it's to a degree that undermines benefits to be derived from adherence to standards and regulations. The overlapping of purview and the ubiquity of regulatory capture has created a regulatory establishment that requires ever more funding to support its unbridled reach. It has a life of its own which increasingly impedes the recognition of and response to the needs of the person who has turned to a physician for solace, support, wisdom and care. The American Healthcare Industry desperately needs to be healed of this affliction so that it can provide the infrastructure for America's Service Professionals to practice according to their conscience and for America's patients to be served with the uncompromised elegance that has finally become possible in the 21^st C. The promotion and growth of a Healthcare Industry is social iatrogenesis at its worst.

Nortin Hadler emeritus professor of medicine and microbiology/immunology at the University of North Carolina, is the author of Worried Sick, Rethinking Aging, Citizen Patient, and By the Bedside of the Patient.