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Government Regulation, Lawyers and the Opioid Crisis

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A short letter to a medical journal nearly 40 years ago may have been the nudge that set the opioid crisis in motion. A letter to the New England Journal of Medicine asserted addiction to prescription opioids was rare, claiming only four addictions were documented out of thousands patients who were prescribed powerful opioid pain pills in a hospital setting. The article has been cited hundreds of times in the years since. Doctors and drug makers may have relied on the letter as evidence that it was safe to prescribed opioids to more patients with chronic pain in settings far removed from carefully supervised hospitals.

Nearly 40 years later it has become clear that opioids can be dangerous in the wrong hands. There is also significant risk of diversion to the illicit market. After states began closing down so-called “pill mills,” prescription opioids became less available. To fill the void, heroin and fentanyl began flooding the U.S. to take the place of the once plentiful prescription opioids. Whole regions of the country have been hard hit by prescription drug abuse. Worse yet: other diseases tend to accompany IV drug abuse, including hepatitis C and HIV.

A Not Very Good Proposal to Reduce Emergency Room Visits

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A recent article posits that an Anthem company, Blue Cross and Blue Shield of Georgia (BCBSGA), is poised to “punish” its members for “unnecessary” emergency room (ER) visits by charging subscribers the entire bill for unnecessary ER visits.  This is a variation on a theme which has been playing out in virtually every state and every insurer:  how do we reduce the number of unnecessary emergency room visits? 

Of course, expecting a lay person to be able to parse out what is medically necessary for ER care and what is not is probably expecting too much.  Example:  I’m playing softball, slide into third base (at my advanced age), and jam my leg.  I’m not sure if it is a bruise, sprain, tear, or a break.  But it hurts like hell.  It’s 7:30 PM on a Tuesday.  What are my options?

Option A:  I could limp home, medicate with ibuprofen and a few beers, and hope it gets better.  When it does not, or next morning when I awake and am unable to ambulate out of my bed, what do I do then?  But of course, the pain might subside over a few days also.  My mom’s healthcare advice of wait and see might work.

Option B:  Call my primary care physician (PCP), who is closed for the day with a message that “if this is a medical emergency, dial 911.”  That’s helpful.

Option C:  Seek a free standing urgi-center and go there.  They likely will order x-rays, etc.  Is BCBSGA saying you can’t go there?  Unclear.

Would ACOs Work if They Were Turned into HMOs?

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CMS has now conducted three demonstrations of the “accountable care organization,” and all of them have failed. The Physician Group Practice (PGP) Demonstration, which ran from 2005 to 2010, raised Medicare costs by 1.2 percent. [1] The Pioneer ACO program, which ran from 2012 through 2016, cut Medicare spending by three- or four-tenths of a percent on average over its first four years. And the Medicare Shared Savings Program (MSSP), which began in 2012 and may lumber on indefinitely, has raised Medicare costs by two-tenths of a percent on average over its first four years.

It is way past time for CMS and health policy researchers to determine why all three ACO demos failed. In the first two installments in this three-part series I laid out one of the reasons: CMS’s method of assigning patients to ACOs guarantees ACOs must apply their magic to a rapidly changing pool of patients and doctors. In the first essay , I demonstrated that this method, which assigns patients first to doctors based on where they get the plurality of their primary care visits and then to ACOs if their doctors are in ACOs, guarantees high churn rates among doctors and patients, shunts sicker patients away from the ACOs, and assigns few ACO patients to each ACO doctor. In the second essay I reviewed the series of evidence-free decisions that led to CMS’s plurality-of-visits method. I noted that the first of these decisions was one Congress made: They instructed CMS to figure out how to assign patients to ACOs without making patients enroll in ACOs.

How Amazon Can Position Itself as the Pharmacy of the Future

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How Amazon can position itself as the pharmacy of the future

We know Amazon has a knack for disruption—over the years it has upended countless brick and mortar bookstores and other major players in the retail industry. The e-commerce behemoth may be at it again, making headlines for its interest in breaking into the pharmacy market in the United States. But delivery of prescription medications to the home already exists for patients with chronic and even acute conditions, while patient portals already give patients online access to payments and prescription refills. So how might we expect Amazon to set itself apart from the competition and grow in the pharmacy space? If it stays true to the tenets of Disruptive Innovation, expect it to further expand its capabilities around healthcare in the home—just as it has kept book, grocery, and other retail shoppers at home over the years.

HarvardX: Improving Global Health, Focusing on Quality & Safety

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HarvardX is offering a free online course, Improving Global Health: Focusing on Quality and Safety, starting on June 27 on edX.org. Participants in this 8-week course will engage with top experts in the field of public health as they grapple with the nature of high-quality healthcare: What is quality? How do we define it? How is it measured? And most importantly, how can we make it better? Whether you’re a healthcare provider; student of medicine, public health, or health policy; or a patient who simply cares about getting good care—this course is for you. The course is taught by Ashish K. Jha, MD, MPH, director for the Harvard Global Health Institute.

To learn more and register for free, visit: http://bit.ly/2oMMsch

The Solution Never Works If You Haven’t Identified the Problem

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I have a bias, I admit it. I am sensitive to studies with a subtext of “those stupid patients, what are we going to do about them?” Read the following rant with that in mind.

A pharmacy benefits manager a/k/a PBM funds a study of patients nonadherent to chronic prescription medication. The premise of the study, Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial (hiding behind a paywall, by the way), is that “forgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.” Thus, the intervention consisted of sending a population which included folks taking meds for schizophrenia and bipolar disorder either “a pill bottle strip with toggles, digital timer cap or standard pillbox” along with their mail order meds. There was of course a control group who received neither notification or a device. Surprise, surprise! Getting a prize in your Crackerjack box from your PBM does not improve medication adherence. Those stupid patients! Why won’t they do what’s good for them?

Is the Direct Primary Care Model Dead?

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A recent Medical Economics article asked “Is the DPC model at risk of failing?”

The piece focuses on two large DPC-like organizations, Qliance Medical Management of Seattle, Washington and Turntable Health of Las Vegas, NV, working in partnership with Iora Health, which recently closed their doors. Qliance and Turntable were not actually DPC practices by strict definition; they were innovative large business operations providing healthcare services to patients and excluding third party payers. Their idea was commendable, but their closure indicates little cause for concern in regard to the growing Direct Primary Care movement.

Robert Berenson, MD, who admits to not being a fan of the DPC model, said “Qliance has been the poster child for DPC… If that one can’t make it… it suggests the business model (of DPC) is flawed.”  He is correct about one thing; the “business” model of medicine is certainly flawed.

What Dr Berenson fails to realize is that DPC is not a “business” model; it is a “care” model. Whether accepting insurance or DPC in structure, we already know solo and two-physician practices deliver the best care and have been doing so for the past 100 years. These intimate clinics know their customers better than anyone else in the industry, and can devote the time necessary to their clientele; these micro-practices should be known as the small giants of healthcare.

Marching For Skepticism

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In college, I once marched for the plight of Tibetans. Forty of us marched in Hyde Park, London – after an hour, half retreated to the nearest pub to discuss global injustices. Recently, over a million, including five penguins, marched for science. There were no penguins at our march for Tibetans but our goal, though naïve and unrealistic, was clear – we wanted Tibetan independence from Chinese rule. The goals of March for Science, a worldwide endeavor with marches as far south as Antarctica, were numerous and ambiguous.

If you attended the science march expecting to hear about the theory of ether, the nuances of the Special Theory of Relativity, or Galileo’s brush with the papacy, you’d be disappointed. While it was not clear what the march was about, it was patently evident what the march was not about. The march was not about scientific inquiry or an embracement of the scientific process. The marchers were not protesting their right to think freely without persecution.

Many marchers were protesting their right to the public purse particularly, as President Trump has threatened to slash the budgets of government agencies more mercilessly than parents slash the pocket money of an itinerant teenager. It was like Galileo protesting outside the Vatican, not so that he can experiment in peace, but that the Pope fund his activities.

How did scientists transform from demanding more freedom to demanding more funding? Science, particularly biomedical sciences, has changed, and is now an expensive enterprise with considerable oversight. It is no longer possible for curious clergymen with time on their hand to dabble in science. Science, like art, has become a profession. To be funded is to be free – with some restrictions. The scientist, once stubbornly curious, now curiously adheres to stubborn protocols.

Is eClinicalWorks the Next Volkswagen?

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Since the Department of Justice announced the ground-breaking $155 MM settlement with eClinicalWorks (ECW) on Wednesday, industry response has been dizzying.  Let’s collect the facts and review what it means.  I reviewed it all in greater detail yesterday here.

A short summary:  EHR developer eClinicalWorks settled a legal dispute with the Department of Justice that commits them to pay $155 Million, provide free services to customers, and undergo oversight for five years.  The government found that ECW faked certification testing: the EHR software was certified as having capabilities that it didn’t have. Tens of thousands of care providers collected millions of dollars when they attested to the meaningful use of a certified EHR. DOJ therefore states that “ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.”

Through social media and (gastp!) real-life conversations, we’ve heard:

  1. Too hot: This is evidence that ONC’s certification program isn’t working and should be rolled back
  2. Too cold:  This is evidence that ONC’s certification program is too easy and should be enhanced
  3. Just right:  This is evidence that ONC’s certification program is appropriate, and expects participants to have integrity

And we’ve heard the analogies:

  1. ECW is the health IT version of Volkswagen:  they faked a test, got caught, and have to pay the price.  Shame on them.
  2. ECW is the health IT version of Uber:  they developed shady software, used it to make millions of dollars, got caught, and have to pay the price.  Shame on them.
  3. ECW is Ray Stoller the car salesman, who sold cars that weren’t safe to unsuspecting purchasers and refused to make good on their commitments.  Shame on them.

Is this an indictment of the certification program?  Not at all.  While the program may not yet be “just right,” without certification, there would be no basis for any legal complaint against ECW, and this would all have remained hidden.  Despite the persistent calls for ONC to roll back the program, this case makes it clear that such a move would be a direct threat to public safety, and would invite more of these shenanigans.  ECW is indeed the VW/Ray Stoller of health IT (I don’t think the Uber metaphor sticks) but just as there are more car manufacturers than just VW who cheated on diesel emissions, there are more health IT developers who cheated too.  Perhaps not so boldly or carelessly as ECW, but I am 100% certain that there are other companies who have done this, and I’m confident that the government is investigating these others.

Parsing eCW’s $155 Million Payment to the Government

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UPDATE:  Here are the public records for the case.  More details there about the original complaint.  Excerpt:

What we’re talking about

The purpose of any certification program is to create a method for the purchasers of a product to have confidence that the product safely and reliably does what it is supposed to do.  One example from USDA:

Turning Point for Meat Inspection  In 1905, author Upton Sinclair published the novel titled The Jungle, taking aim at the poor working conditions in a Chicago meatpacking house. However, it was the filthy conditions, described in nauseating detail—and the threat they posed to meat consumers—that caused a public furor. Sinclair urged President Theodore Roosevelt to require federal inspectors in meat-packing houses.The Pure Food and Drug Act and the Federal Meat Inspection Act (FMIA) became law on the same day in 1906. The Pure Food and Drug Act prevented the manufacture, sale, or transportation of adulterated or misbranded foods, drugs, medicines, and liquors. The FMIA prohibited the sale of adulterated or misbranded meat and meat products for food, and ensured that meat and meat products were slaughtered and processed under sanitary conditions.

In this case, the government moved to protect the public because a subset of meat packers was putting profit above public health.  After The Jungle was published, public outcry caused the government to step in and regulate the industry.  Regulation is not, therefore, a four letter word.  It’s there to protect us from evildoers.

Before Health IT Certification

You may not remember this, but I do.  Before there was certification, Health IT development companies (some people call them “vendors”) created software and sold the software with claims of improved provider productivity, improved public health, and (yup) improved billing (among other impressive capabilities). Sometimes these claims were completely valid.  Sometimes they were not.  In the case where the developers’ functional claims were not quite valid, buyers had little recourse.  One might say “well, the markets will take care of that.  Bad actors will lose sales.”  But that’s not the case here for several reasons:

  1. The buyer may not be the one using the software.  A hospital buys software for clinicians.  Clinicians complain to hospital.  Hospital may or may not be a strong advocate with developer.
  2. It’s very hard to migrate from one system to another.  EHR purchase / deployment / optimization is a multi-year initiative.  If you bought a lemon, you may try to make lemonade as the though of migrating to something else will give you R11.0.
  3. Shame.  You don’t want your patients / competitors / peers to know that your EHR doesn’t work as expected.  You made a mistake.  Human nature is to hide our mistakes rather than treasure them as educational opportunities.