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The Barbershop Study: How an Unorthodox Study on Black Men’s Health Brought Down the House and Where It Went Wrong

The study that changed everything was published last week.  An alien visiting the national cardiology meeting in Orlando may have thought that the trial of note was the one that featured the culmination of one hundred years of lipid research to develop an inhibitor of the enzyme PCSK9 (Proprotein convertase subtilisin/kexin type 9) that lowers lipids and reduces the risk of future heart attacks.

The Martian would be wrong.

The trial that has cardiologists across the land choking back tears is a hypertension study done in black barbershops.  The idea is fairly simple.  Black men have the highest rates of disability related to uncontrolled hypertension, in large part related to a difficulty in engaging black men with the health care system.  The end result of poorly controlled hypertension in this community was on full display where I did much of my medical training as a student and resident in the heart of North Philadelphia.  Ensconced in the walls of Temple we learned to manage the end organs ravaged by hypertension.  I have to say I never stopped to think what we could have done to interrupt this process even though we were located in the heart of an underserved black community.

Luckily, Ronald Victor has been thinking about this problem for some time.  A Cedars Sinai physician, his research focuses on community interventions to rectify health care disparities.  His first study in 2007 sought to examine the feasibility of blood pressure screenings in black barbershops because this was where black men congregated and may be susceptible to influence by important peer influencers: barbers.

The 2007 study by Victor proved that it was feasible to enlist barbers to measure blood pressures, correctly stage hypertension, and make a referral to a clinician for treatment.  This opened up funding for the next step in the process- actually affect blood pressure control in barbershops.  The trial was wildly positive.  In stark contrast to the multibillion dollars of research that lead to a $1000/month PCSK9 inhibitor that gives us a 15% relative risk reduction of a composite outcome of stroke/death/heart attack, the Victor barbershop protocol resulted in a staggering average 27mmHg blood pressure drop in 6 months.  The potential ramifications are large for a 20mmHg drop – a 30% reduction in risk of a heart attack or a 40% reduction in risk of a stroke.

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ACA Market Stabilization Push Is On But Success Is Uncertain

A critical test in Congress comes this week in year 2 of the ACA wars. Will lawmakers do the right thing?

It’s up in the air—again. Congress has until this Friday at midnight to pass a budget bill to fund the government through Sept. 30.   That bill is widely considered to be the last “must-pass” legislation before the mid-term elections.

As such, it’s probably the last chance lawmakers will have to enact measures aimed at stabilizing the ACA marketplaces for 2019.   Health plans start pulling their bids together in May and June and the deadline for final submissions is in September.

As of this writing, it’s unclear whether House Republican leaders will even include an ACA stabilization provision in their version of the budget bill. In the Senate Lamar Alexander (R-TN) and Susan Collins (R-ME) have submitted a proposal and are pressing hard for inclusion and a vote. (See details of the bill below.)

According to media reports, President Trump told the two Republicans on Saturday he would support their effort.   And Senate leader McConnell is also said to be supportive. But as drafted, the measure contains a poison pill: a provision that would forbid the use of federal dollars to help pay for insurance policies that provide abortions. Democrats say that’s a deal-breaker.

The renewed push now for ACA marketplace stabilization comes primarily because the repeal of the individual mandate penalty takes affect on Jan. 1, 2019.   That’s projected to trigger premium increases of between 7 and 15 percent, varying by state.   But, on top of that, the Trump administration has proposed policy changes that experts predict will spur additional premium increases—that, in turn will lead to coverage losses. Continue reading…

Why Do We Need ACOs and Insurance Companies? Part 3. The HMOs Strike Back!!!

This is the last installment in a three-part series that asks why we need both an insurance industry and an ACO industry. We are now stuck with the worst of all possible worlds – an inefficient insurance industry layered on top of an inefficient ACO industry.

I noted in Part I of this series that ACOs’ inability to cut costs explains why 90 percent of Medicare ACOs refuse to accept anything resembling insurance risk. In Part II I discussed ACO proponents’ expectation that many ACOs would accept full insurance risk, and I described the Medicare Payment Advisory Commission’s (MedPAC’s) reaction to ACOs’ inability to cut costs and their unwillingness to accept insurance risk. We saw that MedPAC attempted to design a plan called “premium support” that would generate competition between Medicare ACOs, Medicare Advantage plans, and the traditional Medicare fee-for-service program, and, after four years of trying (and even after dropping the FFS program from the project), gave up.

In this last installment I review a nearly identical attempt by Minnesota’s Medicaid program to set Medicaid ACOs and HMOs on a level playing field. I will close with a prediction of where the ACO industry is headed.

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After Right to Try Fails, Here’s How We Can Actually Bring Potentially Life-Saving Drugs to Patients in Need

Kenneth I. Moch
Arthur Caplan PhD
Andrew McFadyen

Last week, House Representatives failed to pass “Right to Try” (RTT) legislation, a bill that purported to help terminally ill patients access experimental medications. Opponents of this legislation, including these authors, have long argued that RTT does nothing to bring potentially life-saving medications to patients who are in dire need and, potentially, puts desperate individuals at risk. With the bill’s failure, Republican leaders should rewrite the draft legislation in a collaborative fashion, taking input from the FDA, the biopharmaceutical industry, patients, patient advocates, and bioethicists who are experts in the field of pre-approval access, working to craft legislation that will actually bring help to patients in need.

The failed RTT bill was fraught with errors, poorly written, and lacked any concrete action to give access to potentially life-saving treatments for terminally ill patients outside of clinical trials. Currently, thirty-eight states, representing 83% of the population in the USA, have already signed Right to Try bills into law. These bills align with the model legislation crafted by libertarian think tank, The Goldwater Institute. Promoted as providing “immediate access to the medical treatments” for terminally ill patients, the cruel reality with Right to Try legislation is that it will not grant patients the immediate access to treatments they desperately need – and it never has. Although over 270 million Americans are currently living within the boundaries governed with Right to Try laws, there continues to be no evidence of a patient ever receiving a life-saving medication under Right to Try legislations that they otherwise wouldn’t have received under the FDA’s current Expanded Access Program. The legislation simply doesn’t work, and it never will, for numerous reasons.

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Health in 2 point 00, Episode 10

Jessica DaMassa asks me about PBMs, Amazon Prime for Medicaid, Patents and more–all in 2 minutes — Oh, and if you want to sponsor this and reach a bunch of people here & on Linkedin, let us know! — Matthew Holt

On the Non-Effectiveness of Cost Effectiveness Analyses

Nortin Hadler MD
Robert McNutt MD

Take the example of a middle-aged woman undergoing chemotherapy for breast cancer. Month after month she receives a bill for $16,000. This purchases a monthly infusion of one chemotherapeutic agent.  Much of the bill is paid by her insurance, but her personal checking account will cough up about $1000 per month until she pays down her deductible.

The invoice, however, is an illusion. The amount is not the actual number of dollars required to pay for services and materials rendered. Most of the money is diverted in accordance with contractual agreements between the hospital and various agents, brokers, and insurers. The total transfer of those dollars is known but not readily accessible to any who was not privy to the negotiations. The $1000 co-pay is a tithe with totally obscure added value to be paid no matter how painfully.

Few of us know the direct cost of any medical intervention. The term “cost” is the money needed to produce a service. For example, the cost of a single chest-x-ray is amazingly cheap, just a few dollars. The materials are inexpensive, the x-ray machine can spit out exam after exam, and one person can service a multitude of patients, making the unit cost a bargain. The cost of many a test is so low that it could be given away without wobbling a hospital’s budget.

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Don’t Like Obamacare? Do We Have a Plan For You!

Struggling to break free from Obamacare oppression, Idaho is offering low-cost health plans that achieve this goal by avoiding covering anyone who’s been sick in the past and skimping on coverage for any diseases that might make you sick in the future. These strategies are, inconveniently, explicitly banned by the Affordable Care Act.

Fortunately, I have a solution perfect for Idaho and other GOPers eager to emulate Idaho’s example. My plan covers young and old, sick and healthy, fitness buff and couch potato, all for the same incredibly low price. No one, and no illness, is excluded.
Welcome to the Placebo HMO, dedicated to serving every American who fervently believes you don’t need real health insurance.

We’re a faith-based plan that offers empathetic, sincere and personalized advice from a broad range of highly skilled actors pretending to be doctors. Whether it’s a “seen everything” veteran like Tom Hanks or Meryl Streep in The Post or a bright-eyed idealist like Emma Stone and Ryan Gosling in La La Land, we provide unparalleled freedom of provider choice that plans dependent on actual doctors cannot match.

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On Theranos: It’s Time to Throw the Book at Healthcare Tech Frauds

Huge news hit today as Theranos, its Chairman and CEO Elizabeth Holmes and its former President and COO Ramesh “Sunny” Balwani were charged with “elaborate, years-long fraud” by the Securities and Exchange Commission. The litany of supposed violations of the Securities Act of 1933 and the Securities Exchange Act of 1934 are almost as dizzying as the detailed factual allegations of repeated, willful fraud perpetuated by Holmes and Balwani on investors who likely should have known better.

Reviewing the SEC complaint against Holmes, it’s stunning to see the extent to which Holmes and Balwani were able to pull the wool over investors’ eyes. The highlights of the SEC allegations include:

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The Conflicted-Disruption Complex

Elizabeth Holmes, the founder and chief executive of the controversial company Theranos, has been charged with an “elaborate, years-long fraud” by the Securities and Exchange Commission. The SEC alleges that Holmes and former company president Ramesh “Sunny” Balwani deceived investors into believing that its key product — a portable blood analyzer —was capable of using drops of blood to do the kinds of workups that now require much more blood—up to ten milliters per test.  Holmes fooled many people including the Theranos board of board of directors, high-powered investors and high ranking members of the military including General James Mattis, a huge fan, who left the Theranos board to become President Trump’s Secretary of Defense.

Things don’t look good for the Theranos leadership in terms of the SEC charges. The company already saw a three-year partnership with Walgreen’s collapse leaving many customers wondering if they had been deceived. The technology, which Holmes and her company touted as disruptive and revolutionary, never worked. So what happened to permit so much enthusiasm and money to be spent on a useless technology?

First, the company never published on its technology. The promise of small volume blood testing sounded great and indeed is great for many reasons not the least of which a lot less misery for patients who need to get a lot of painful blood drawn for tests. But no publication, no data driven presentations at professional society meetings, a lack of transparency turned Theranos into an 8 billion dollar Dutch tulip bubble.

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Dear CMS Administrator Verma

Stephen Soumerai ScD
Ross Koppel PhD, FACMI

Your address to HIMSS acknowledges many of the problems with Healthcare IT, highlighting lack of interoperability, lack of data exchange, and lack of cybersecurity, and suggesting some regulations that could be eliminated. This is a welcome realization of some of EHR’s more obvious limitations and problems.  However, most of your recommendations for improvement of health IT are insufficient, unproven, or have been repeatedly shown to fail.

We applaud your acknowledgement of: 1. The frustration (and often rage) of many clinicians when using the current EHRs’ clunky and inefficient user interfaces; 2. Patients’ frustration and alienation when doctors spend much time entering data into the EHRs rather than listening to them; 3. The need for better cybersecurity; 4. Benefits of increased patient access to their data; and 5.Healthcare systems’ refusal to share patient data with others clinicians (data hoarding).

We are also delighted for your strong support for the Sync for Science program.

However, your solutions to these problems are faulty or have already failed—and thus we are obliged to explain why and how they fail:

  • Belief in the magic of value-based care as a cure for excessive spending
  • Claim that “open APIs” (defined in next sentence) will solve the problems of lack of interoperability. Here, APIs refer to software programs that try to translate different forms and formats of information into a single commonly understood item.
  • Belief that a patient’s personal data store or personal EHR, called “MyHealthEData,” will help solve the problems of patient care. 
  • Confusing patients with customers. We train doctors to make diagnoses, order and interpret tests, and help patients make profoundly complex decisions. Healthcare decisions are not like buying a toaster. 
  • Attributing so many of the problems of EHRs to the regulations created in 2009, the “Meaningful Use” rules.   In fact, meta-analyses of EHRs—both before the Meaningful Use rules, and after–fail to find they reduce costs, mortality, or morbidity.

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