Government Regulation, Lawyers and the Opioid Crisis

Government Regulation, Lawyers and the Opioid Crisis

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.

I’m reminded of a sequence of events that occurred about a dozen years ago. In late 2004 there was another pain reliever crisis. Pain relievers from a class of selective cyclooxygenase-2 inhibitors known as COX-2 Inhibitors, were suspected of harming patients by boosting the risk of premature death.

Vioxx and Bextra were both anti-inflammatory drugs once used to treat arthritis and acute pain. Vioxx was withdrawn from the market in 2004 due to safety concerns when prescribed for long-term use or in high doses. Bextra — another COX-2 inhibitor — was withdrawn from the market in 2005 due to some claimed side-effects that included an elevated risk of heart attack and stroke.

Over the course of a multi-year study that followed nearly 2,600 people, 45 of the patients taking Vioxx experienced heart attacks or strokes, compared to 25 people taking a placebo. The number of people in each group who actually died was five. Even though the death rate was equal, Merck removed Vioxx from the market — probably to reduce its liability. The makers of both Vioxx and Bextra paid out huge sums to settle lawsuits for people who died while taking the drugs.

These two drugs were popular because they did not irritate the stomach like other non-steroidal anti-inflammatory drugs (NSAIDs). Another reason people paid more for Vioxx (10 to 15 times more) than less-expensive pain relievers was because they caused less post-operative bleeding and protected the stomach against ulcers cheaper medications often cause. An estimated 16,500 patients who die annually of bleeding ulcers.

The millions of people worldwide who benefitted from access to Vioxx and Bextra are the real losers in withdrawal of the once popular prescription pain relievers. Of course, it’s easier to count those few people whom statistics suggest may have died in greater numbers than expected, even if only from natural causes, than to count those whose lives might have been extended by access to drugs taken off the market. The latter have no right to sue. The family members of thousands of deaths likely caused by older pain relievers can hardly be expected to attribute the deaths of their loved ones to a drug they couldn’t take. Yet under current law, those who die of a heart attack while taking a drug have every right to sue — even if the drug did them far more good than harm. They also have a right to sue even if the death of a family member cannot be proven to have been caused by the drug itself. The less effective, less expensive generic and over-the-counter pain relievers are poor targets for lawsuits.

More than 100 million people took these drugs before they were removed from the market. The use of COX-2 pain relievers also precludes taking aspirin daily to prevent heart attacks. Maybe that explains the slightly elevated risk of heart attacks and strokes from these drugs.

How many of the people in chronic pain who became addicted to opioids could have safely taken Vioxx or Bextra? We will never know. The ones who suffer the consequences are the patients, and they should be allowed to decide whether drugs are worth the risk, rather than having the decision made for them by a risk-averse FDA and other people’s lawyers. There is little reason to deny patients access to drugs like Bextra and Vioxx if they know the risks and are willing to accept them.

Devon Herrick, PhD is a health economist and senior fellow with the National Center for Policy Analysis.

A Not Very Good Proposal to Reduce Emergency Room Visits

A Not Very Good Proposal to Reduce Emergency Room Visits

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.

A spokesperson for BCBSGA stated:

…the policy wouldn’t apply when the patient is 14 or younger, an urgent care clinic isn’t located within 15 miles, or the visit occurs on a Sunday or holiday. She said it’s aimed at manifestly minor ailments — “If you had cold symptoms; if you have a sore throat. Symptoms of potentially more serious conditions, such as chest pains, could be seen at the ER even if they turn out to be indigestion.

The policy uses the “prudent layperson” standard, namely, what an average person would consider an emergency, not on the ultimate diagnosis reached by doctors after examinations and tests at the ER.

I understand what BCBSGA is trying to do.  We don’t want people using ERs as their PCP.  And it might be one thing to put a $75 or $100 copay on an “unnecessary” ER visit.  But to saddle the subscriber with the entire bill?

Were I to think that I might be saddled with the entirety of an ER visit bill (perhaps $2,000) if my view of “emergency” were not consistent with the prudent layperson test, as interpreted by the insurer’s staff who surely are not laypersons, I’d sure shy away from an ER visit.  Is that good?  Maybe and maybe not.  It will reduce ER visits; but given the “stitch in time” adage, on cases truly needing ER care who go without, the down-the-road bill may be much higher.

There are two possible alternatives here:

 

  • Spell out in more detail what will and will not suffice;
  • Get hospital ERs to triage care in a very different way.

 

Perhaps the ERs of the future have an intake specialist that directs patients in one of three directions:

 

  • Full ER;
  • Urgi-center (co located);
  • Send home with note to see PCP.

 

Are there liability concerns?  For sure.  But those abound in every scenario.  The best defense is to establish a community standard of ER care and use that is the guideline for triage.  That at least gives one some defense against malpractice claims, which by definition require proof of a violation of the accepted community standard of care.

In summary, I think the proposed course by BCBSGA is not appropriate.  We need to have professionals deciding what is medically necessary and what is not.  To that end, ERs must engage in true triaging with appropriate levels of care at appropriate costs.

 

 

Would ACOs Work if They Were Turned into HMOs?

Would ACOs Work if They Were Turned into HMOs?

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.

In this last installment I ask what if anything can be done to reduce the patient churn rate, and whether reducing the churn rate would do anything to improve the performance of ACOs. I’ll first review the argument some ACO advocates make that the churn rate could be greatly reduced if “attributees” were induced to stay within “their” ACO. We will see that there is little reason to believe that. Then I’ll go on to ask whether ACOs would work even if “attributees” were forced to enroll with an ACO, a requirement that would effectively define ACOs as HMOs. I’ll answer that question in the negative on the ground that the cost-control tactics available to ACOs, namely those that have long been available to HMOs and other insurance companies, have not worked.

Finally, I’ll discuss the only feasible option I see for salvaging something from the entire ACO/HMO experiment: Requiring that CMS and Congress abandon the fantasy that ACOs/HMOs can do something positive for entire “populations” and instead require them to provide defined services to patients with specific diagnoses.

I would like to apologize in advance for the frequent use of quote marks around words like “attributee” and “attestation.” But I insist on using them to warn readers that when we attempt to understand the conversation about ACOs we enter a strange world where words don’t mean what they seem to mean.

Back-door enrollment

When it became clear that the ACO would be enshrined in the Affordable Care Act, many observers asked whether ACOs weren’t merely warmed over HMOs. Proponents replied that HMOs were different from ACOs in several respects, the most important of which was that Americans would not have to enroll with ACOs and use only ACO doctors and hospitals. [2]

But it wasn’t long before ACO advocates began to complain that this distinction was making it impossible for ACOs to lower costs. Pioneer ACO managers voiced this complaint to L&M Policy, the author of the final evaluation of the Pioneer ACO program. “Representatives from many of the Pioneer ACOs noted that it was more difficult than initially anticipated to manage beneficiary utilization and patient visits outside of the ACO because beneficiaries did not face financial incentives to use ACO providers,” L&M reported. “Some ACOs reported frustration with translating existing care management programs to the ACO population without the benefit of traditional managed care tools (e.g., enrolled population, utilization management, prior authorization)….” (p. 70)

ACO proponents have responded to this lament with two related proposals: (1) CMS should ask “attributees” to “attest” that an ACO doctor is “their” doctor and, if they say yes, CMS should count them as ACO patients; and (2) ACO “attributees” should be given financial incentives to sign the letter and stay within the ACO network. As is always the case with managed care proposals, advocates have proposed these “reforms” without a hint of evidence that they’ll work or what they might cost.

You can readily see these two proposals together recommend enrollment without using the “enrollment” word. So why don’t proponents of these “reforms” just admit they want Medicare recipients to enroll in ACOs and suffer financially if they go outside the ACO network? I submit they know there was a hellacious HMO backlash in the latter half of the 1990s, triggered primarily by American hostility to limitations on choice of doctor, and that many Medicare recipients in FFS Medicare are there because they don’t want to enroll in a Medicare Advantage plan, and they’re hoping Medicare beneficiaries will be too dumb to notice that they’re being offered a bribe to enroll in an HMO dressed up as an ACO.

Avid ACO proponent and former CMS administrator Mark McClellan, for example, offered the enrollment-by-another-name proposal in a list of “reforms”  of the MSSP program he sent to CMS Administrator Marilyn Tavenner in February 2015. He proposed CMS should mail an “attestation” form to “attributees” that “attributees” could sign and thereby “positively identify their primary care provider … and thus declare their active participation in an ACO.” (p. 6) Got that? “Active participation” would be “declared.” What does “active participation” in something as vague as an ACO mean? Would it mean signers agree to stay within the ACO’s network? McClellan didn’t say. That was for Tavenner to figure out.

But McClellan hinted that that’s exactly what he meant when he described an additional proposal to expose “attributees” to financial incentives: “We also recommend that CMS consider additional incentives for patient participation in the ACOs, including waiving or reducing copays and deductibles for patients when they receive care from their primary care physician or other providers in the ACO.”

McClellan offered no evidence that his back-door enrollment proposal – one which would eliminate one of the few distinctions between ACOs and HMOs – would work. And he offered no estimate of what it would cost. [3] Obviously, contacting patients and urging them to sign “attestation” documents would cost money, and so would paying patients to stay within ACOs/HMOs.

Explaining Groupthink to Doctors

Let’s focus first on the “attestation” nostrum. Let’s set aside the cost issue for now, and ask the question that McClellan and other ACO advocates never address or address only with happy talk, namely: Even if CMS spends whatever it takes to contact every ACO “attributee” and urge them to sign a piece of paper that “declares their active participation” in an ACO, what good will that do? Remember, the message from CMS about the “attestation” form would be in addition to the notice CMS already sends out to Medicare beneficiaries indicating they have been assigned to an ACO.

Let me begin by reviewing evidence from the final Pioneer ACO evaluation on how poorly ACO doctors understand the vague “ACO” concept. Once you comprehend how confused the doctors are, you’ll shake your head and wonder how anyone could think patients will ever understand the flabby ACO concept. Remember, we’re discussing the crème-de-la-crème here – CMS selected the 32 hospital-clinic and clinic-clinic chains to participate in the Pioneer program because of their size and previous experience “managing care.” If doctors anywhere understand ACOs, you’d think it would be the doctors in the Pioneer ACOs.

Although ACO proponents claimed ACOs would be “run by doctors” and would therefore be kinder and gentler than HMOs [4], it turns out doctors not only didn’t run the Pioneer ACOs they had a poor understanding of what their ACOs were doing to and for them. According to L&M’s final evaluation of the Pioneer program, “The vast majority of providers participating in Pioneer ACOs were not directly part of the decision to participate, but rather were employed by or part of a medical group that joined the ACO.” (p. 23) The evaluation went on to say, “Survey results indicated that only 2 percent of Pioneer physicians had served on the ACO board of directors and only 9 percent had served on an ACO committee. Even for those reporting such involvement, only half of Pioneer physicians said they were satisfied with their participation….” (p. 43)

Because the vast majority of doctors weren’t involved in the decision to join an ACO, and because the ACO is so poorly defined [5], doctors had little comprehension of what their ACOs were doing. “In several respects, physicians were not particularly knowledgeable about the ACO,” reported L&M. “When asked if they knew which of their patients were aligned with the Medicare ACO, just over a third of Pioneer physicians reported knowing which beneficiaries were aligned and a similar proportion reported not knowing their aligned beneficiaries at all. When asked about the elements of their compensation, almost half of physicians participating in the Pioneer model reported not knowing whether they were eligible to receive shared savings from the ACO….” (p. 43)

Given their incomprehension of the ACO thing, Pioneer physicians understandably were unable to generate the evidence-free hype about ACOs that ACO advocates can generate in their sleep. For L&M and ACO management, physician confusion about ACOs reflected a defect in physicians, not in the wonderful ACO project. “Nearly all Pioneer ACOs reported interest in improving physician engagement,” L&M reported, “with many reporting frustrations in the perceived lack of engagement by physicians with the ACO.” (p. 41)

But maybe, just maybe, the problem wasn’t with the knuckle-dragging doctors. Maybe it was that ACOs were either doing so little that most doctors couldn’t detect anything that might be called an ACO intervention, or that doctors did perceive some ACO interventions but viewed them as not helpful. L&M did report that 70 percent of ACO physicians thought they were already practicing in a manner consistent with the goals trumpeted by ACO advocates, and for that reason, “they may have believed that they did not need the structure or strategies provided by the ACO to adapt to new approaches to care delivery.” (p. 42)

The one feature of ACOs the great majority of doctors understood clearly was that ACOs impose more paperwork on doctors. “Approximately three-quarters of Pioneer physicians indicated that participation had required them to increase time spent on administrative, documentation, and reporting tasks…, ” said L&M. (p. 45)

Explaining Groupthink to the Unwashed Masses

If doctors who have been roped into ACOs don’t understand ACOs, is there any hope that their patients will sign “attestations” with anything resembling informed consent? Informed consent, it should go without saying, will be necessary if “attestation” is to have any chance of influencing patient behavior.

In fact, the Pioneer program did make use of “attestations” (but not financial incentives). According to a December 2011 CMS press release, “beneficiaries may affirmatively attest that their primary provider is in a Pioneer ACO, and can then be aligned with the ACO and benefit from the enhanced care coordination that it offers.” (p. 2) Obviously “attestation” didn’t work. Why not? Because the ACO is so poorly defined ordinary mortals can’t understand it.

L&M discovered that “attributees” in Pioneer ACOs didn’t have the faintest idea what an ACO is. L&M concluded, “Despite the annual notification letter and Pioneer ACOs’ efforts to engage beneficiaries, in small group discussions with beneficiaries … we learned that beneficiaries were generally unaware of the ACO organization and the term ‘ACO.’ In the few cases where the beneficiaries reported hearing the term ACO, they were not able to describe what an ACO is….” (p. 51) Although L&M did a great job measuring and reporting high churn rates among Pioneer doctors and “attributees,” they made no attempt to ask why “attestation” didn’t work. [6]

If you were in charge of contacting “attributees” and urging them to sign ACO “attestations,” what would you say? Don’t bother asking ACO advocates like McClellan for help. Here’s all McClellan had to say on this topic in his letter to Tavenner: “CMS should also support better patient education around the goals and features of Medicare ACOs, and how patients can work with their providers to improve care.” (p. 6)

Would ACOs Work if “Attributees” Had to Enroll in Them?

For the sake of argument, let’s pretend that CMS could explain ACOs to Medicare recipients, that all recipients assigned to ACOs could be persuaded to “attest,” and that this back-door enrollment requirement reduced “attributee” churn. Would CMS’s ACO programs finally start cutting Medicare spending? (Note that I’m not asking whether the costs ACOs incur to do whatever ACOs do would exceed any savings for Medicare. I’m only asking whether Medicare costs might drop.)

To answer that question, we would need to know what interventions ACOs would apply to “their” patients. Sad to say, a decade after the phrase “accountable care organization” was invented, we don’t know what ACOs do. Again, that’s because the definition of the ACO is so vacuous. As L&M put it in their first evaluation  of the Pioneer program, “The ACO ‘treatment’ under investigation is not a prescribed set of activities or interventions. Rather, it is a financial arrangement….” Is it possible to be any more abstract? Have you ever seen a more useless definition of anything?

Even the managers of the Pioneer ACOs were in the dark. “The vast majority of Pioneer ACOs entered the model with care management experience,” L&M stated in the final evaluation. “However, there remained a decided lack of consensus on what makes care management effective.… Even through the third year of the [demonstration], Pioneer ACOs continued to report using trial and error to make incremental changes and improvements to their care management programs.” (p. 48)

So how does one rationally inquire why ACOs are failing when no one knows what they’re supposed to be doing? Lawton Burns and Mark Pauly, economists at Wharton, addressed this question in a 2012 paper in Health Affairs. They politely characterized the flabbiness of the ACO concept as a “lack of consensus … over what the new entities should do, or stop doing, to reduce spending and how they should control out-of-network utilization.” Then they attempted to do that which ACO advocates should have done before promulgating the ACO “arrangement”: They listed the tools or interventions available to ACOs and reviewed the evidence on each one.

Burns and Pauly made the reasonable assumption that ACOs had no choice but to use the same managed-care tools that HMOs and kindred insurers were using, such as utilization review, pay-for-performance, health information technology, and the ever-popular “care coordination.” After reviewing the literature on these tools they concluded, “The evidence … suggests that components of accountable care organizations have limited and uncertain impact, especially on cost savings, and thus provide little support for the [claim that] better care coordination will improve quality at any given cost, and … the organizations will lower Medicare’s rate of spending growth.” (p. 2412) [7]

If the tools available to ACOs can’t lower costs, then reducing churn among ACO “attributees” by forcing or bribing them to enroll in ACOs will do little to improve the ACOs’ ability to cut costs. To put it another way, the high rate of turnover among ACO “attributees” is not the most significant reason ACOs are failing. They’re failing because the cost-containment tools available to them are so ineffective. These same tools didn’t work for HMOs and other insurance companies, and of course enrollment is required for insurance.

Salvaging Something From the ACO Experiment

The taxpayer has now financed three ACO demonstrations – the PGP, Pioneer, and MSSP demos. [8] All of them have failed to cut Medicare spending; all of them are raising costs if ACO intervention costs are taken into account. The purpose of demonstrations is to learn something. Sad to say, we have learned nothing from the ACO demos. No one – not CMS, not MedPAC, not ACO buffs – can explain the chronic failure of Medicare ACOs (see my discussion of MedPAC’s bafflement here ).

The ACO demonstrations will not have been a total waste of money if CMS can determine whether any ACOs did anything that improved the quality of care of specific patients. It is possible that some of the managed care tools ACOs are expected to use would work (that is, they would at least improve quality and might lower costs as well) if they were applied to subsets of the chronically ill. It’s clear those tools are never going to work if they are applied to entire “populations.” Managed care proponents must stop thinking in terms of structures (ACOs, HMOs, “integrated systems,” “medical homes”) that apply managed care magic to entire populations, and start thinking in terms of specific services delivered to subsets of the chronically ill.

[1] According to the final report on the Physician Group Practice Demonstration, “[T]he demonstration saved Medicare .3 percent of the claims amounts, while performance payments were 1.5 percent of the claims amounts” over the five years the demo ran, for a net loss of 1.2 percent. (p. 64)

[2] Austin Frakt and other ACO proponents claimed that another difference between ACOs and HMOs is that ACOs bear less risk than HMOs. They argued that ACOs would not bear total insurance risk but would instead be subjected to a lower level of risk-sharing called “shared savings,” and this would give doctors and their ACO managers less incentive to deny necessary services to patients. But other ACO advocates claimed just the opposite – that ACOs were expected to move gradually from the limited risk of shared savings contracts to full blown insurance risk delivered via capitation aka premium payments. For, example, the final evaluation of the Pioneer ACO program stated, “CMS intended the model to allow these provider groups to move more rapidly from a shared savings payment model to a population-based payment model.” (p. xii)

Some ACO advocates also sought to distinguish ACOs from HMOs with the claim that ACOs would be more “accountable” than HMOs ever were because the spread of electronic medical records and alleged advancements in quality measurement since the “HMO backlash” of the 1990s would make it easier for unidentified third parties to monitor the quality of ACO medical care (see, for example, CMS’s brave promise to “routinely analyze data surrounding utilization of services” at p. 2 of this 2011 press release ). Thus, even if the shifting of some but not all insurance risk to ACOs induced ACOs to short-change their patients, all-seeing monitors would detect this behavior and correct it. Here are other examples of experts who claimed ACOs were not HMOs in drag: Ezekiel Emanuel in a 2012 comment  for the New York Times blog; two experts quoted in a 2015 article  by Kaiser Health News.

[3] Here is the totality of the “evidence” McClellan offered CMS administrator Tavenner in his February 2015 letter to her in support of his proposal that CMS allow ACOs to try to induce “attributees” to “attest” to their loyalty to an ACO doctor: “Results regarding the extent to which patients choose to join an ACO and the potential long-term impact are not yet available, but private-sector programs have had promising results, and increased beneficiary engagement is a fundamental objective for Medicare.” (p. 6)

[4] Obama adviser and ACO advocate David Cutler claimed ACOs would not “dictate to doctors and patients what they are allowed to do and what they cannot” as HMOs did (see Austin Frakt’s New York Times comment in footnote 2).

[5] For a discussion of the flabby, aspirational definition of “ACO,” see my comment here

[6] The problem ACOs face in inducing “attributees” to give a hoot about “engaging” with “their” ACO may go beyond the inability of mortals to comprehend what “ACO” means. According to L&M, many Pioneer ACO managers believe the problem is resistance to HMO-like interference in the doctor-patient relationship. I quote from the final Pioneer evaluation: “Pioneer ACOs highlighted difficulties managing FFS beneficiaries; these ACOs often contrasted ACO-aligned beneficiaries to beneficiaries in MA [Medicare Advantage] plans. … Some Pioneer ACOs asserted that beneficiaries often choose traditional Medicare FFS specifically because they do not want provider network limitations, and these patients may have construed efforts to engage them in the ACO as an effort to limit provider choice.” (p. 51)

[7] The conclusion by Burns and Pauly that none of the managed care tools work is consistent with other analyses using different methodologies. I reported in a literature review  published in Health Affairs in 2000 that insurance companies that use managed care tactics are not cutting costs. In a 2015 paper financed by the leading lights of the American health care establishment, Lawton Burns and Jeff Greenfield examined the evidence for “Kaiser-like entities,” aka “integrated delivery systems.” In a blog comment  about that paper, the authors stated, “We reviewed more than 30 years of academic literature on vertical integration and diversification in healthcare, and found virtually no measurable benefits – either to society or to the sponsoring healthcare enterprises themselves – of putting health insurance, hospitals and physician services under the same structure.”

[8] Strictly speaking, only the PGP and Pioneer experiments were “demonstrations.” The MSSP program was authorized by the Affordable Care Act and is a permanent program as long as the ACA remains law.

How Amazon Can Position Itself as the Pharmacy of the Future

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.

The principles of disruption

The Theory of Disruptive Innovation is widely acknowledged as a theory of competitive advantage brought forward by Clayton Christensen in his book The Innovator’s Dilemma. Its creation was in response to many well-run and successful companies faltering despite making, seemingly, all of the correct management decisions. After studying numerous cases Professor Christensen found that disruption stemmed from companies improving their offerings to an extent that they overshoot mainstream consumers’ demands for performance—often in pursuit of catering to their most demanding and profitable customers. Disruptive entrants capitalize upon this to reach less demanding and mainstream markets by bringing to market solutions that cost less and are more simple and convenient to use—often selling a product considered “inferior” in terms of traditional performance standards.

Amazon’s medication delivery program is not likely to be able to make an impact in the pharmacy industry on its own. Mail order pharmacies have been around for decades, and in many cases drug delivery may actually be less convenient than just picking up a prescription in person, as many pharmacies are co-located at the point of care. Amazon will instead have to find a way to reach less competitive markets, neglected by their existing competition, with its option of drug delivery. It can do this by hitching a ride with another disruptive technology that is already reaching previously neglected populations with convenient access to care.

Riding the coattails of telemedicine

Telemedicine (the use of telecommunications technology to evaluate, diagnose and/or treat patients in remote locations) holds promise for Amazon as an entrypoint into the pharmacy market, and as a vehicle to carry the company upmarket. Virtual visits have improved access to professional medical expertise in areas where the nearest doctor’s office may be over 40 minutes away, and in urban areas where the nearest appointment slot to see the doctor located down the road may be multiple days. For these reasons, along with the convenience of care at home, telemedicine is rapidly growing in use and is becoming more frequently turned to for acute and chronic care cases. In fact, Kaiser Permanente’s CEO Bernard J. Tyson recently revealed that, last year, over half of Kaiser’s patient visits were conducted via online portals, virtual visits, or the health system’s apps.

Amazon’s e-commerce platform can capitalize on the growth of telemedicine by finding ways to seamlessly integrate the process of ordering prescription drugs from its website into the virtual visit experience of major telemedicine vendors. By doing this, the common workaround of the physician having to find a pharmacy near the patient to send in the prescription can be overcome. Instead, the familiar Amazon checkout process can be used to approve the order sale and delivery of prescription medication directly to the patient. From the perspective of the sick patient, being allowed to opt-in to medication delivery prevents needing to leave the home to pick up the prescription, improving the patient experience for many illnesses.

Reach underserved markets with an innovative business model

Telemedicine is an attractive option for patients when they cannot see their provider in-person within a convenient timeframe. But, as the Theory of Disruptive Innovation would suggest, in order for patients to turn to telemedicine, they must still believe that virtual visit technology is “good and reliable enough” to meet their needs before they give in to the convenience. Right now, use of telemedicine technology is limited to only certain, routine and less demanding, patient care cases because of this performance-convenience tradeoff. As telemedicine technologies improve over time and become “good and reliable enough” for more complex and demanding patient cases, usage will increase beyond markets lacking adequate access to care and more patients will confidently opt for their convenience. Because of this, those pharmacies that are well equipped to integrate their online ordering process into the virtual visit processes of the major telemedicine vendors will hold an important advantage.

By integrating its medication delivery services into the virtual visit process of major telemedicine vendors, Amazon can first make its online pharmacy easily available in markets where patients lack convenient access to care or a pharmacy. In this way, Amazon can avoid direct competition with established pharmacy competitors who tend to concentrate in wealthy areas, and improve its odds for early success. Over time, as telemedicine capabilities improve and advance upmarket, Amazon’s medication delivery option will reach more patients, and become more and more attractive as the delivery speed of Amazon and affiliates improve.

Influencing care in the home

Healthcare is increasingly adopting new payment models that shift financial risk upon providers to manage the costs of patient care. This additional risk has compelled providers to find ways to improve medication and regimen compliance among patients. In many ways, Amazon is already building the capabilities that providers seek—to influence personal behavior and consumer habits outside the doctor’s office. Its new personal assistant technology Alexa, for example, may be able to remind patients to take their medication, send an order to refill a prescription, or assist in scheduling a telemedicine appointment all by voice command in the home (see Alexa diabetes challenge). These additional experiences could be included with an order from the online pharmacy, and hold potential to make monitoring and compliance easier for patients with chronic conditions. In this way, Amazon can keep patients healthier and providers happier, and improve the likelihood they turn to Amazon in the future.

Telemedicine has already made progress in reaching new and neglected markets with convenient care options. Amazon can stake its claim as the pharmacy of choice for providers and patients engaging in virtual healthcare at home, and grow alongside the booming technology that is disrupting in-person patient care as we speak. To do this, the e-commerce powerhouse will have to successfully integrate ordering and checkout from its pharmacy into as many telemedicine processes as possible, and continue its progress in influencing consumer behavior at home. If Amazon can accomplish this, it will be set to break into the pharmacy space in a big way, just as it has changed the face of numerous other industries.

Ryan Marling is a research associate at the Clayton Christensen Institute for Disruptive Innovation. 

HarvardX: Improving Global Health, Focusing on Quality & Safety

HarvardX: Improving Global Health, Focusing on Quality & Safety

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

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

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?

Well, let’s take the most basic first step and look at the evidence that the REMIND paper cited in its very first footnote to support its premise that patient “forgetfulness” is the problem. The paper cited is not, thank you very much, behind a paywall. Its very title should have been a tipoff: “Unintentional non-adherence to chronic prescription medications: How unintentional is it really?” This study concluded that “For our study sample, unintentional non-adherence does not appear to be random and is predicted by medication beliefs, chronic disease, and sociodemographics. The data suggests that the importance of unintentional non-adherence may lie in its potential prognostic significance for future intentional non-adherence. Health care providers may consider routinely inquiring about unintentional non-adherence in order to proactively address patients’ suboptimal medication beliefs before they choose to discontinue therapy all together [sic]” (emphasis added]

Reading further in the paper I’ve just linked to (which I highly recommend you do), “medication beliefs” include such things as “perceived need for medication”–statins, anyone?–and perceived medication affordability.

Let’s go a little further and consider something obvious about clinician-patient dynamics in an era of managed care. How many clinicians take the time, or have the time, to initiate a thoughtful discussion with a patient regarding the benefits and risks of a course of long-term medication being recommended? A statin, say, or low-dose aspirin for primary prevention, in someone who feels just fine? How many patients will push through the clinician’s subtle (or not-so-subtle) signals that s/he is pressed for time to initiate and then persist in a discussion, which might persuade a patient on the fence about the recommendation that there is an actual need for the medication? Or might even lead the patient and provider to jointly conclude that this long-term medication is not, after all, warranted?

Consider this: the more important you believe something to be, the easier it will be to remember to do it. “I forgot” is a convenient excuse we offer, after all, to our doctors. It is more polite, and less time-consuming, than initiating an uncomfortable conversation by saying, “I don’t see the point of this/I am experiencing unpleasant side effects/I cannot afford this/I am overwhelmed by the ‘treatment burden.’ ” Such comments can be taken as a direct challenge to the provider’s authority, although they might stem from the provider’s failure to communicate with/empathize with/educate the patient adequately in the first place.

A patient on insulin therapy is unlikely to forget to use insulin. It’s obvious that insulin is important. This suggests another possible flaw in the study design. It excluded patients taking more than three medications, apparently because their dosing regimes are just too complicated (math class is tough!). It would be interesting to learn if patients taking more medications might actually be more adherent because they feel that the stakes are higher. Alas! We will never know, at least from the authors of this study hellbent on reminding these silly patients who just cannot remember what is good for them. Although the study design notably did not include smartphone apps such as Mango Health that “gamify” taking medications and could use more investigation.

I feel compelled to point out as well that patients getting their meds mailed from their PBMs are by definition not in regular contact with an overlooked, underrated member of the patient’s care team: a flesh-and-blood pharmacist who reinforces dosing instructions, and provides that human touch. Yes, it is possible for a patient to make contact with an actual pharmacist at a PBM, but I wonder how many nonadherent patients are aware of that.

I should finally note that many patients view PBMs as an arm of their insurance company (which in fact they are) and may have viewed what appeared to be medical advice coming from their insurer as inexplicable and suspect. Indeed, “[b]ecause the study devices are currently available for commercial use and because participants received the devices by mail and could choose not to use them, patient-level consent was waived by Chesapeake Institutional Review Board.” Not obtaining consent may have made the study less useful, but I’m sure it was cheaper, amirite?

The writeup of the REMIND study grudgingly concedes towards the end that “because nonadherence is a multidimensional problem, addressing forgetfulness alone may have been insufficient to improve actual medication taking.” This spectacularly misses the boat. Because it’s not truly a problem of forgetfulness at all.

Is the Direct Primary Care Model Dead?

Is the Direct Primary Care Model Dead?

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.

Strictly defined, Direct Primary Care is a practice model centered on an arrangement wherein a patient and physician enter into a contract to provide unlimited primary care services for an affordable monthly fee (less than $100/month.) 80% of healthcare needs can be met in a DPC practice. The typical DPC practice has 1 or 2 physicians, 600 patients maximum per physician, and on average each physician sees 10 patients per day. Employees are minimal, usually including a receptionist and/or medical assistant. Only minimal office space is required to run such a lean operation, so overhead remains low. Supplies, medication, and equipment are purchased on an as needed basis and used only when necessary.

Qliance, founded in 2007 by Dr. Garrison Bliss and Dr. Erika Bliss, charged $64/month for adult members and $44/month for children. They had 13,000 patients in total including primary care and emergency care services, more than 20 times the number of patients compared to a traditional DPC clinic. They were trying to use a model embraced by direct primary care practices yet scale it into something entirely different. After 10 years, the experiment failed.

Iora Health, vying to become the “Starbucks” of healthcare, was in partnership with Turntable Health utilizing a “team based” concept. Each “team” included a physician, nurse, and a health coach. This model contracted with individuals, but also employers and unions already paying for healthcare by offering improved access to primary care services and pocketing a portion of the savings that materialized. In this model, physicians usually had 1000 patients and each health coach with a few hundred. Turntable charged $80/month for adults and $60/month for children to have access to their vision of a “wellness ecosystem”, which included yoga, meditation, and cooking classes.

An article in the New York Times quoted Duncan Reece, the VP of Business at Iora Health, “We wanted to do something radically different and show this isn’t your grandfathers’ doctor’s office.”

I get it. This is the kind of things that VP of Business say.

Let’s walk it back. Can someone please tell me what was wrong with that model? It was a quintessential small giant of the business world. My grandfather was an outstanding general practice physician with a small office and one nurse on staff. He made house calls. He did appendectomies, tonsillectomies, C-sections, vasectomies, and met most of his patients’ basic primary health care needs for 40 years. Why do we need something radically different?

The bottom line is healthcare requires two participants.

One physician and one patient. While it is a nice idea, we do not need yoga, massage, or smoothie bars in our clinics to improve patient outcomes. Adequate medical knowledge and time for meaningful conversations is essential; something the small giants of healthcare are experienced in providing. The vision of a “wellness ecosystem” should probably go the way of the “patient-centered medical home,” as there is little cost savings or difference in outcomes compared to the traditional fee-for-service system.

So what qualities make the best practices? According to a study conducted by The Peterson Center on Healthcare at Stanford, the very best primary care practices have either one location or a small handful of them. Stanford compiled a list of 10 distinguishing features of these top practices and many are commensurate with being a “small giant” of the business world. My favorite characteristic on the list is to invest in people, not space or equipment. By lowering overhead, physicians are not relying on patient volume to generate adequate income. These practices are consciously choosing to stay small by renting minimal space and investing in added services only when believing them to be more cost-effective.

The government and insurance companies cannot fix healthcare. It is up to physicians and patients– one micro-practice or DPC clinic at a time. Dr. Kimberly Legg Corba, owner of Green Hills Direct Family Care, said “The DPC model is growing and practices are converting all the time. Some are opening by transitioning an established practice, some are physicians starting clinics fresh out of residency from scratch, and others are leaving employed positions to return to practicing medicine in a way they love.”

While my practice is not DPC, it is a small, old-fashioned clinic serving families for as long as three generations. Our records are still on paper, a real human being answers the phone when it rings, and for occasional emergencies, patients stop by my house for a “reverse house call.” My belief in the DPC model is steadfast because any “care” model placing control directly into the hands of physicians and their patients is worth fighting to preserve and protect. The more small giants able to thrive in the constantly evolving healthcare landscape, the greater chance physicians have of inciting a large scale revolution to benefit patients everywhere.

Since the Affordable Care Act legislation went into effect, mergers and consolidations have increased by 70%, at the expense of care becoming less personalized and increasingly fragmented.   These large institutions are profit centers for CEO’s and business executives who have very little knowledge of what goes on between a physician and a patient. They need the independent practice model to fail so patient choice is no longer an option.

The small giants, micro-practices and DPC clinics, will continue to prosper and grow because a “care” model devoted to preservation of the physician-patient relationship cannot be defeated. Physicians must stop being afraid to take that leap of faith, leave employment, and go back to doing what we love most, caring for our patients and improving their lives. Physicians should be standing at the bedside, not in front of computer workstations. Direct Primary Care is a model for which we should all be rooting; it is transforming the physician-patient relationship and restoring the practice of medicine to its noble roots, allowing for the art, the science, and the wholly fulfilled physician.

My advice for patients everywhere: Whenever possible, find an independent practice, whether a solo doctor or direct primary care clinic, and patronize that physician. Your care will be more personalized, cost less in the long run, and your health will be better for the investment you made in yourself.

Marching For Skepticism

Marching For Skepticism

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.

When I think of scientists, I picture Archimedes running naked in the street shouting “Eureka.” Scientists no longer run naked in the streets. But the change in science begs a more primal question – what does science even mean these days?

The march organizers, @ScienceMarchDC, presumably to entice marchers, tweeted “colonization, racism, immigration, native rights, sexism, ableism, queer-, trans-, intersex phobia, & econ justice are scientific issues.” But do these, undoubtedly important, social issues belong to science particularly, as conspicuous by their absence from this tweet are physics, biochemistry, zoology, geology – i.e. science?

The science march seemed less about science and more about social injustice, and a lingering disbelief in a constituency that Mr. Trump, not Mrs. Clinton, is the president.

The fervor for the march suggests unprecedented scientific thinking in our society. However, the truth may be different. In enlightened circles, God is dead but faith is alive and kicking. New faiths are on the rise – faith in our ability to perfect man, faith in methods to engineer society and, above all, faith in technocracy.

The new science is a science for the people and of the people, but not by the people – few understand the language of technocrats. Still, science has been democratized. Science no longer is commissioned just to discover the mysteries of the multiverse, but to build a safer and fairer society. If philosophy begins where science ends, science now begins where religion ends. Science has taken over King Solomon and Raja Vikramaditya. The motto is not “govern justly,” but “govern scientifically.” We would now need data, not moral intuitions, to tell us that the Tibetans have faced injustice.

The new sciences need public funding. But Mr. Trump, to cut taxes and regulations to spur economic growth, has proposed substantial funding cuts for government scientific agencies. Even the Centers for Disease Control and Prevention (CDC) will get a haircut – a $1.2 billion cut, which its former director, Thomas Frieden, warned could lead to widespread deaths.

During the Ebola epidemic, the CDC played a more important role than the World Health Organization in containing the epidemic. But the CDC can lose its way by doing too much. The agency, under the capacious umbrella of “prevention,” has taken more than just infectious diseases on its plate, including issues such as workplace health, food safety, smoking and obesity, and has published “Preventing Chronic Disease.” If there’s an outbreak of a rogue virus, and statistically speaking this is a certainty, the fate of our species may depend on the CDC. Yes, I’ve watched Outbreak.

Why doesn’t the CDC stick to its most important mission – dealing with infectious diseases? Why the mission creep? A barber seldom says, “you don’t need a haircut.” A government agency never says, “we have enough funding, thank you.” For an agency, more work and more mission means more funding.

Similarly, Mr. Trump’s proposed cuts to the National Institutes of Health of $5 billion could be counterproductive. Publicly funded science drives private innovation and innovation drives growth. But, in so far as science is publicly funded, taxes are the mother of science, and people generate taxes, and many taxpayers are increasingly dubious of a science that’s increasingly politicized. Apocalyptic warnings of the dangers of defunding science will further tune out the proletariat from a class many believe are self-righteous and self-serving.

Science is at its weakest when scientists are most certain and the “science is settled.” Science’s biggest draw is that it embraces errors, eccentrics, and misfits. There is a discipline often applied in healthcare known as “Implementation Science” or the science of getting doctors to obey rules, which sounds like training some doctors to become a modern-day Moses to preach 10,000 Commandments (MACRA) to other doctors.

If science replaces religion, it’ll suffer the same fate as religion – people eventually lose faith in dogmatism. The challenge for scientists, a challenge singularly ignored in the March for Science, is in restoring in science its twin beauty of curiosity and skepticism. Instead of proclaiming “science is settled, you idiots,” scientists might celebrate the unsettling of settled science. We can have a unique Independence Day to celebrate emancipation from old facts and laud the scientific method which freed us, rather than vilify the original error.

Science is in gravest danger from believers, not skeptics. Science has been hijacked by puritans and needs rescuing by heretics. Science faces a crisis of purpose, a crisis of identity, a crisis of excessive dogmatism, not a crisis of funding.

 

Saurabh Jha is a contributing editor to THCB. This piece was originally published in Telegraph

Is eClinicalWorks the Next Volkswagen?

Is eClinicalWorks the Next Volkswagen?

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.

What this means for the industry

Some have argued that care providers are going to “go after” health IT developers and mimic the original plaintiff in hopes of “cashing in” or punishing these companies for “usability and design issues.”  But this is not the case.  This happened because of faked tests, not just bad design.  The industry is full of careful, thoughtful, passionate software designers and engineers who are working hard to deliver great products that improve health, and facilitate safe, efficient medical care.  Just as VW’s root problems were cultural, the root cause here is a “check the box” mindset that was pervasive at ECW.  Indeed, I had direct personal interactions with ECW staff when I was at ONC that confirmed ECW’s consistent lack of understanding of some facets of the certification program.  If one views EHR certification testing as an annoying hurdle that must be jumped, the program (and the policy goals it represents) wont’ be taken seriously, and cheating won’t seem unethical.   Would you want your EHR to be developed by someone with this mindset?

The culture that EHR developers need to maintain is one of integrity, transparency, collaboration, and humility.  This event is a great reminder for health IT companies to reinvest in the important (but sometimes forgotten) work that creates such a culture.

Purchasers of health IT who are unable access system capabilities for which their products are certified (check the certification status here) should first contact their EHR developer and insist that the capabilities be enabled.  (There may be additional cost for this – but the developer is required to publish the costs and limitations.  Here is the ECW disclosure as an example.  Find the link to disclosures on the certification status page.)  If you still can’t find a way to get the software to behave properly, contact ONC.

Parsing eCW’s $155 Payment to the Government

Parsing eCW’s $155 Payment to the Government

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.


After Health IT Certification

The program isn’t perfect.  I was on the developer side of this work from ~2006 – 2010 during the when CCHIT was the only certification path, and then for ONC’s first iteration of certification (2010 – 2011).  Indeed, the imperfection of the program was a motivating factor for me to join the government in 2011.  I wanted to help evolve the program toward perfection.  Certification criteria needed to be less prescriptive (more flexible) but still provide sufficient guidance/ structure so that they could be reliably tested and replicated.  This balance is hard to get right.  Sometimes we got it wrong.

Some have appropriately argued that there remains quite a bit of “check the box” busywork wherein health IT developers need to spend time building and configuring their software just to have it certified.  “Trust us and don’t make us do this busywork” was the persistent message from the developer community.  Recently, there have been renewed calls for scaling back the certification program and its many criteria, citing the maturation of the EHR incentive programs (meaningful use) and the fact that some of the certification criteria define capabilities that are not invoked by the incentive programs.  The argument is that ONC has no place creating certification criteria for capabilities that aren’t part of “meaningful use.”   I disagree.  The ECW case is a great example of why I disagree.

About the eClinicalWorks settlement

What happened?  You’ve read the press release from the Department of Justice by now.  Excerpts (my emphasis added):

In its complaint-in-intervention, the government contends that ECW falsely obtained that certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification.For example, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the company modified its software by “hardcoding” only the drug codes required for testing. In other words, rather than programming the capability to retrieve any drug code from a complete database, ECW simply typed the 16 codes necessary for certification testing directly into its software. ECW’s software also did not accurately record user actions in an audit log, and in certain situations did not reliably record diagnostic imaging orders or perform drug interaction checks.In addition, ECW’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW’s software to the software of other vendors. As a result of these and other deficiencies in its software, ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.As part of the settlement, ECW entered into a Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company’s EHR software.This innovative 5-year CIA requires, among other things, that ECW retain an Independent Software Quality Oversight Organization to assess ECW’s software quality control systems and provide written semi-annual reports to OIG and ECW documenting its reviews and recommendations. ECW must provide prompt notice to its customers of any safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks. The CIA also requires ECW to allow customers to obtain updated versions of their software free of charge and to give customers the option to have ECW transfer their data to another EHR software provider without penalties or service charges. ECW must also retain an Independent Review Organization to review ECW’s arrangements with health care providers to ensure compliance with the Anti-Kickback Statute.

Summary:

  1. ECW faked their certification testing.  The examples above are just examples.  There are other instances wherein ECW faked the testing and convinced the testing body that the software could do something that it could not do.
  2. Since the software was not certified, any physician or hospital who received incentive money and attested to the use of certified software was in fact fraudulently attesting to the meaningful use of certified software.
  3. The Corporate Integrity Agreement (CIA) commits ECW to:
    1. Oversight from an independent third party
    2. Notify customers of any safety risks (there are many)
    3. Provide software updates for free
    4. Support migration to other EHRs for free

So what?

Reminder:  The purpose of any certification program is to create a method for the purchasers of a product to confirm that the product safely and reliably does what it is supposed to do.

  • ECW is a big company, with ample resources.  Their software is used by tens of thousands of clinicians every day.  The lives of their patients (many of whom are Medicaid beneficiaries – as many federally qualified health centers use ECW) depend on the safety and reliability of this software.
  • ECW’s software doesn’t do what they claim.  Now that the government has investigated, and is holding them accountable, the message is clear:  the public’s interest is being protected.
  • ECW is not the only organization that cheated on certification.  They may have been the biggest, boldest violator, but they were not the only one.  Others have already started internal reviews of their own performance, and those who have not yet done so are very likely to do so tomorrow.  This case is a wake-up call for the CEOs of all EHR development organizations to dig deep, and have honest direct conversations with the small teams that prepared the software for certification testing, and performed certification testing with the test labs.  My advice to these CEOs:  look these teams in the eye and ask “is the software that was tested exactly the same as the software that is available to all of our customers?”  In many cases, the answer is no.  As Farzad tweeted today, a very common case is in the domain of interoperability:  can the system exchange data as it was certified to do?  All too often, the answer, when we speak with the EHR developers, is “yes, if you pay us $$$ to enable that capability for you.”

Today’s announcement is the culmination of several years of work – all focused on protecting the public and holding a company accountable.   As I’ve asserted both privately and publicly, the regulatory infrastructure of EHR certification is important because sometimes there will be bad actors.  While the “good actors” may be inconvenienced and annoyed by processes that seem unnecessary, for such important elements of our nation’s health infrastructure, we can’t have government abdicate this responsibility.  With or without the incentives programs, or MIPS, or 21st Century Cures, there is a set of capabilities that these systems need to have, and for which they must be certified.  The breadth of this set of requirements, and the depth of certification testing for any criterion are the needles that must be threaded.  I’m confident that Don Rucker and the team at ONC can navigate the balance well.