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John Irvine

The Case For Real World Evidence (RWE)

Randomized control trials – RCTs – rose to prominence in the twentieth century as physicians and regulators sought to evaluate rigorously the performance of new medical therapies; by century’s end, RCTs had become, as medical historian Laura Bothwell has noted, “the gold standard of medical knowledge,” occupying the top position of the “methodologic heirarch[y].”

The value of RCTs lies in the random, generally blinded, allocation of patients to treatment or control group, an approach that when properly executed minimizes confounders (based on the presumption that any significant confounder would be randomly allocated as well), and enables researchers to discern the efficacy of the intervention (does it work better – or worse – than controls) and begin to evaluate the safety and side-effects.

The power and value of RCTs can be seen with particular clarity in the case of proposed interventions that made so much intuitive sense (at the time) that it seemed questionable, perhaps even immoral, to conduct a study. Examples include use of a particular antiarrhythmic after heart attacks (seemed sensible, but actually caused harm); and use of bone marrow transplants for metastatic breast cancer (study viewed by many as unethical yet revealed no benefit to a procedure associated with significant morbidity).

In these and many other examples, a well-conducted RCT changed clinical practice by delivering a more robust assessment of an emerging technology than instinct and intuition could provide.

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Trump and Rx Drug Prices: Let the Games Begin

President Trump is scheduled to deliver a major speech on drug prices today.  This post is intended to start a dialogue on what he says and proposes.     

It’s unclear whether Trump will provide specifics or whether those will be rolled out in coming weeks.   As is always the case with Trump, there’s concern he’ll go off script despite apparent careful preparation of the speech.     

The speech is reportedly going to coincide with an RFI from HHS on ways to restrain drug prices, building on ideas proposed in the administration’s fiscal 2019 budget request.   That sounds like a delay tactic, but we’ll see.    

Notably, Alex Azar and Scott Gottlieb, health secretary and FDA Commissioner, respectively, have recently hinted at substantial policy proposals.  Azar, for example, has proposed shifting some of the drugs now paid for under Medicare Part B (such as chemotherapy drugs administered in doctors’ offices) to Part D, where private plans would have clout to push for lower prices. 

Azar and CMS administrator Seema Verma have also suggested requiring PBMs to share the savings from drug rebates with consumers. Continue reading…

Empowering Patients through Decentralized Information Governance

Seema Verma is right, US health care will be transformed if we empower patients and physicians through access to information. Don Rucker is right to focus attention on APIs to enable the transformation. A year and a half into the new administration and the massively bipartisan 21st Century Cures Act, the Department of Health and Human Services (HHS) is having to navigate between the shoals of highly unpopular Meaningful Use regulations and the apparent need for regulation to undo the damage of market consolidation that they caused. From my perspective, it looks like HHS is doing a good job.

Prediction is a dangerous game but it’s necessary for investments that depend on health information technology. Nowadays, pretty much everything in healthcare depends on information technology, particularly if we need effective quality measures to enable transition to value-based healthcare.

Based on Verma’s most recent remarks, it’s safe to predict that HHS will use the power of the $900 Billion purse as a way of avoiding regulation as it tries to break down the oligopoly of the consolidated “integrated delivery networks” and their even more consolidated EHR vendors. What’s more interesting is to anticipate how Rucker’s recent remarks about Persistent Access will be translated into decision support information for patients and physicians that will actually drive the practice innovation Verma is talking about.

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MedStar Franklin Center:  The Case Against Global Capitation

Baltimore County, Maryland is one hour north of Washington DC, where politicians appear impotent to contain runaway healthcare expenditures.  In January 2014, the Centers for Medicare and Medicaid Services (CMS) in partnership with the state of Maryland, piloted an “All Payer Model,” where every insurer, including Medicare and Medicaid, paid a fixed annual amount irrespective of inpatient or outpatient hospital utilization.  Maryland agreed to transition hospitals from fee-for-service arrangements to this global capitation model over five years. 

Capitation, in general, reimburses a fixed amount per patient, unrelated to service volume.  This sets an artificial fiscal ceiling and disincentivizes hospitals, physicians, and other healthcare personnel to provide healthcare. The philosophy is if hospitals or physicians reduce their output and save money, the unused funds can be kept by the organization. The basic premise of capitation pays hospitals, physicians, and others to AVOID providing care, an unfortunate consequence. 

Maryland is experimenting with global capitation, which allots a fixed sum to an institution from each payer, making revenue predictable, while at the same time, encouraging stewardship by the hospital to allocate funds wisely.  When expenses are lower than the prearranged sum, that hospital retains the leftover funds as additional profit.  To ensure care is not withheld to increase revenue, quality measures are assessed and shared publicly.  A 2015 report in the New England Journal of Medicine showed expenditure reductions of 0.64% and inpatient admissions decreased by 5%.   However, with unproven payment arrangements, unintended consequences always occur. 

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Trump’s Docs

It’s now clear that two public assessments of President Trump’s health since 2015—the only ones we know about—were seriously compromised.   

The import of this has been eclipsed by other (more salacious) recent events—Stormy Daniels, etc.   But what has transpired raises troubling questions and should prompt a reassessment of how candidates for president and presidents are medically evaluated, and the public’s right to that information.     

I’ve written two pieces for THCB on Trump’s physical and mental health.  You can find them here and here. 

The first assessment of Trump’s health, conducted in 2015 by his personal physician of 35 years, Harold Bornstein, is now under a dark cloud.   Bornstein told CNN this month that Trump dictated the contents and language of a one-page letter signed by Bornstein and released publicly by the Trump campaign in the early months of the campaign.    

The letter aimed to assuage concerns about Trump’s age and health status.  Clinton and Trump were two of the oldest candidates ever to make a presidential bid and neither had shared much information about their health status up to that point; both were under pressure to do so.

“He dictated that whole letter. I didn’t write that letter,” Bornstein told CNN.  He had previously admitted (in August 2017) that he had typed the letter in his office in just five minutes while a limo sent by Trump waited outside.   

At the time, the four-paragraph letter seemed suspicious, to say the least.   It didn’t contain any details of test results or the like.   Instead, the letter made unusual and hyperbolic statements about the president’s health such as: “His [Trump’s] physical strength and stamina are extraordinary.”  And:  “If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency.”Continue reading…

Not Actually Fake News

Trump appointees cheered by both Republicans and Democrats. Venture capitalists venting about too much investment cash. Data nerds decrying the deification of artificial intelligence.

For two days, Health Datapalooza 2018 offered a glimpse of a Washington where all sides work in harmony “to improve Americans’ health through better data,” in the words of Eric Hargan, deputy secretary of Department of Health and Human Services (HHS).

Not to mention the goal of improving health care economics. Enable digital health entrepreneurs to earn millions of dollars in profits, goes the logic, and their innovations will help the feds and others avoid paying many more millions of dollars in health care bills.

Health Datapalooza began nine years ago as a showcase for public-private data partnership. The shining example back then was the way the release government meteorological data had paved the way for online apps like weather.com. What was significant at this year’s event was not so much the sweeping rhetoric as the signals sent by HHS that it will accelerate the push by previous administrations towards value-based payment.

So, for instance, Seema Verma, the administrator of the Centers for Medicare & Medicaid Services (CMS), said CMS will ask private insurers and state Medicaid programs to require hospitals to provide patients with their own data electronically. The Medicare program wants to make that requirement part of the “conditions of participation” for hospitals in Medicare; i.e., do this or you can’t participate in the program that’s your largest customer.

“The expectations of CMS have changed,” said Verma. “Patients can never again be kept in the dark with regard to their health care information.”

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Expanding Medicare Advantage Benefits to Address Social Determinants of Health

The Centers for Medicare and Medicaid Services (CMS) recently announced that Medicare Advantage (MA) plans could, in 2019, expand the health-related benefits they offer. In the announcement CMS wrote that it would

“allow supplemental benefits if they compensate for physical impairments, diminish the impact of injuries or health conditions, and/or reduce avoidable emergency room utilization.”

Such supplemental benefits could include things that are not normally thought of as “health care,” like, for example, groceries, air conditioners for beneficiaries with asthma, and even provider organized Lyft and Uber rides to and from and medical appointments.

While MA covers all Medicare services, MA plans are already permitted to offer extra coverage for supplemental benefits. Previously, MA supplemental benefits had to have a primary purpose of preventing, curing, or diminishing an illness. This ruled out those that might affect health outside the traditional health system, like groceries and non-ambulance transportation. CMS’s new regulation will permit such nontraditional MA benefits so long as they “increase health and improve quality of life.”

You may question why health care plans would include these types of benefits. The answer: If health is a puzzle, medical care is only one piece. The rest of the puzzle is filled in with pieces like environment, diet, and socio-economic status. CMS’s new regulation is intended to more directly address these social determinants of health.

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Seeing Value From the Patient’s Perspective

“Value” is the focus right now in American health care. Payers like Medicare and private insurers are placing great emphasis on it, as are hospitals and doctors’ offices needing to satisfy the demands of those payers to get paid. But the focus on value in the present system is centered on reforming payment and lowering costs almost exclusively, rather than enhancing the patient experience, and involves unproven approaches like “bundled payment” and “pay for performance”, in which doctors and hospitals are financially incented to fixate on efficiency in how they deliver care. In short, right now “value” means figuring out ways insurers can save money and providers cannot lose money.

The emphasis on value in terms of efficiency and payment reform isn’t trickling down in positive ways to individual patients. Insurance premiums continue to rise, taking more dollars out of patients’ paychecks to cover the care they need. Health insurance is covering less in that many of us pay higher deductibles and co-pays in our plans for services such as physical therapy, mental health care, and emergency care. Many people have annual deductibles of thousands of dollars that must be paid before having any specialty care covered.

Americans pay more and yet have serious access problems in primary care, long-term care, and much specialty care. Wait times to see all kinds of doctors are increasing in most areas of the country. To deal with this, in American primary care patients are guided into undifferentiated, highly transactional forms of service delivery that may be cheaper but are less comprehensive in the services offered and impersonal, involving fast-food care provided through web-based apps, big box stores, and urgent care centers. These sources of care often practice their medicine according to “cookbooks” of standardized clinical guidelines using high-turnover providers, giving us fewer moments of the relational excellence so important in high-quality health care.

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There Are Buoys: The Real Path to Lower cost in the Coming Catastrophic Deformation of Healthcare

There are buoys, far out in the ocean, that bob in the waves and signal, through satellites, when the surf will rise at Mavericks on the California coast, or when the tsunami will hit.

Here comes.

Healthcare in the U.S. is a hollow economy, inflated, impossible, all over patches and gimcracks and work-arounds puffed up on clouds of hot air generated by sweaty, dedicated crews of policy panjandrums and podium pundits burning forests of acronyms. True, that’s just looking at the bad side. But this bad side goes all the way around.

Will it pop? Will it undergo catastrophic exothermal deformation? Is it the Hindenburg nearing Lakehurst? This could be.

Look, this is the 21st Century. Whatever its name, catastrophic deformation, restructuring, “disruption,” or “creative destruction,” this is normal for businesses, industries, entire sectors. We have talked and whined and freaked out about massive change in healthcare since we had a peanut farmer in the Oval Office, and it hasn’t happened. Not really. Trust me, I was there, I watched it not happen. Nothing like the video stores, big-box malls, and Fotomats whose husks litter the landscape like the yonquerías of Baja. Nothing like Eastern Airlines, Western Airlines (“The only way to fly”), Northwest Airlines, Pacific Southwest with its dayglo go-go-booted stews, PanAm, and all the others whose logos adorn the Electras, L-1011s, 727s and Constellations parked wingtip to wingtip in the Mojave.

Healthcare has planetary inertia, gas giant inertia. It snacks on cost-cutting schemes like DRGs and Certificate of Need commissions and just gets bigger. It downs slices of GDP — 12 percent, 15, 18, 19 — and just gets bigger. Right through recessions, reforms, budget cuts. It’s Hungry Mungry. Its extraordinary resistance to deep transformation, compared to other industries and sectors, makes us ask why. What is holding it together? And makes us ask: What would do it? What would puncture this hollow, makeshift gas envelope? 

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State Employee Health Plans Key for Driving Value-Based Initiatives

2018 has brought renewed attention to high and rising employer health care costs, especially among employees. Teacher strikes across the country, motivated in part by rising health costs that have essentially canceled out small yearly raises, demonstrate the impact of these cost increases, which impact workers in all sectors of the economy. Over the last five years, the employer share of health care costs for family coverage increased by 32%, while employees’ share increased 14%. Average premiums have almost tripled since 2000.

Taking action is imperative. However, no single group can drive change of its own, not even giants like Amazon and JP Morgan. The total number of employees at most organizations represents a very small number of the commercially insured population. A critical mass of employers is needed to drive change, and should include an often overlooked and underused group: state employee health plans.

State employee health plans are frequently the largest commercial plans in the state; in 18 states, they cover more than 10% of the privately-insured population. Their members are often spread across the state, giving the plan a footprint in every major market. State employees have than double the median tenure of private sector employees and are often insured through retirement, making it more financially viable for the state to make long-term investments in employee health. States often have regulatory flexibility to try new initiatives, and their transparency requirements allow state employee health plans to signal to the market their future direction and leverage publicly shared information in negotiating reforms.

As state funded plans, they are also under pressure to run efficiently, with many succeeding. Nevada’s plan runs almost 10% leaner than comparable commercial plans while still reimbursing providers competitively. While running a lean plan limits some plan flexibility and management options, it offers an example for how plans can operate at the lowest possible cost.

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