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The human mind knows almost no limit to its attraction to opioids and opioid-like substances. They reduce the perception of pain and, for some, induce a euphoric response, as  these drugs affect the brain regions involved in reward. Pharma has long experimented with developing synthetic opioids. Some synthetic opioids are developed in the lab and shelved after development, but their identities as research drugs live on, sometimes accessible through scientific research channels.

Synthetic opioid U-47700, popularly known as U4, comes from the research drug world to the land of street drug via this path.  Widely available, U4 is perhaps  the most recent synthetic opioid to make its mark in drug overdose and drug abuse statistics but it has its peers.  Originally invented by Upjohn in the 1970's, U4 is pharmacologically untested on humans, though widely reported to induce a heroin-like euphoria. Reportedly eight times more potent than morphine, U4 is attracting attention on the street.

U4 is not legally sold as a pharmaceutical.  It lives on as a research chemical sold over the internet under questionable circumstances, often from what is believed to be foreign lab manufacture, specifically labeled as "not for human consumption." Of course, its purchase is often for human consumption. Sadly, U4 is reported to have been part of the deadly drug cocktail implicated in Prince's death. U4's combination with Fentanyl can depress respiration to the point of death.

Both state and local governments can track some estimate of its internet-based purchase and use through drug overdose reports. Ohio, Wyoming, and Georgia were among the earliest states to ban U4's sale and consumption, raising fascinating federalism questions about the push and shove of power in drug control policy. Other countries have already categorized U4 as a controlled substance or as a narcotic.

The DEA has now announced its intent to add U4 to the Schedule One list on a temporary emergency basis after submitting findings of public safety concerns related to an increasing implication of U4 in overdose deaths nationwide. This functions as a two year temporary placement of U4 onto the Schedule One list of controlled substances, those controlled substances considered to be most dangerous to human consumption and deemed to have "no currently acceptable medical use." 

As the Notice of Intent states:

    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into     schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary     to avoid imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated     under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

    Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under     section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the     Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated scheduling     authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Other members of the Schedule One club include: Heroin, LSD, Ecstasy, and Marijuana. Marijuana has been a Schedule One controlled substance since the 1970's.  History tells us that its placement on Schedule One was itself complicated by the understanding that Marijuana's therapeutic potential needed more study before its possible re-classification. The rest, as they say, is history. Marijuana has been continuously listed as a Schedule One controlled substance ever since that time. 

What we know now is that this Schedule One designation has proven remarkably sticky. There are two ways to reschedule or de-schedule a pharmaceutical: administrative action or Congressional action. Both have proven unlikely to accomplish the rescheduling or de-scheduling of Marijuana.   As recently as last month, the DEA declined to re-schedule (or even de-schedule) Marijuana as a Schedule One drug, though it did indicate an intention to  loosen the tight restrictions on scientific research into Marijuana's medical therapeutic potential by making legally grown and supplied Marijuana for medical research purposes somewhat easier to obtain.  The August 2016 decision to maintain Marijuana's status as a Schedule One drug was a surprise to some but not to all. One expert noted, nothing happens fast on Marijuana policy.  It does highlight the risks of substantially constraining medical research into the therapeutic uses of a controlled substance and the significance of loosening the sole approved source requirement.

U4 is a dangerous recreational drug, at least as it is apparently being used on the street by a certain number of Americans.    But, given U4's therapeutic medical lineage, there is fear the temporary serious public risk categorization of it as a Schedule One controlled substance will effectively shut down research into a promising synthetic opioid. We are governed by our fears — in this case, the misuse of opioid medication and opioid research chemicals —  when we take the best science we have, memorialize it in law and regulation in a moment in time, and  then refuse to exercise the leeway built into the system  to revisit our best understandings of years or even decades old science.

The FDA's advisory panel on diabetes was divided this past summer on whether to recommend approval of a point of care diabetes testing diagnostic assay. Interestingly, the product at issue – by Avere – was not being scrutinized for problems with less accurate (than traditional lab based testing)  results.  Avere's point of care results were found to be as accurate as those produced by a lab.  It is unclear to me whether this is because Avere offers superior training to its clinical users or because the quality of American lab work has been compromised by severe lab staffing shortages. The larger concern appears to have been mostly with false positives on a diabetes diagnosis.  Yet, other countries that routinely use point of care diabetes testing do not report an epidemic of false positives from that testing. Indeed, in the U.K. there is some evidence that point of care diabetes testing is considered the norm for in-patient settings and of interest in out-patient if the business case can be made for the equipment's use.   

In fact, the larger issue is cost. Because it is administered by those clinically trained and not laboratory trained, point of care diabetes testing (depending upon the venue) can be considerably more expensive than lab based testing. But do these cost calculations factor in the cost of those suspected of diabetes, given a lab slip, pointed in the direction of the lab, and who never follow through?  Does the cost to their health factor in here?  What about the cost to patient health of doctors who never follow up on lab work that is ordered and completed, either through oversight or through lab reporting error?

I have to wonder if the utility and cost of point of care diagnostic diabetes testing is being measured against laboratory testing conducted in some perfect alternative universe none of us actually inhabit.

In July, the Missouri Health Insurance Rate Transparency Act (SB 865) was signed into law, making MIssouri the most recent state to establish (as of its 2018 implementation) a review process for health insurance rates advance filed with the MIssouri Department of Insurance. Yes, we have gone from being the "Surprise Me State" to being the "Show Me State." Only Oklahoma, Texas, and Wyoming continue on without health insurance rate review on the state level as Alabama has also only recently come into the fold. 

Missouri's rate review focuses on whether or not the proposed increases are reasonable. This will require significant data testing and analysis before producing a determination of reasonableness or unreasonableness. Then, the state will have the authority to ask the insurers to revise their submitted rates. Note that there will be no authority for MIssouri to force revision of the filed rates,  just the leverage of public scrutiny.  In this, Missouri's rate review is much like that of California's and a number of other states: the power of sunshine as a disinfectant is the true mechanism for rate review.

Let the rate filing and rate reviewing begin, complete with opportunities for public notice and comment. Those health insurers who sell into the Missouri market will need to change gears here as they were long accustomed to operation in a state that not only lacked adequate rate review, it required absolutely no advance filing of health insurance rates at all.  Time will tell if Missouri is prepared to be proactive on health insurance rate increases and not only, at best, reactive. 

 

 

Today is International Overdose Awareness Day. I know of no formal events acknowledging this in KCMO (though there are, apparently, events  scheduled elsewhere in Missouri). Nevertheless,  the incredible swath of death and destruction drug overdoses have cut in America’s young adult population is on my mind today.

Missouri has only recently made Naloxone (a/k/a Narcan, popularly known as  the drug overdose reversal drug) available in pharmacies via prescription or physician order. This law took effect only three days ago.

Some Missouri law enforcement and fire control agencies have chosen to supply Naloxone to their first responders and some have not. Of those who have, I have to wonder how long Naloxone will remain affordable for this purpose. The idea that even generic competition has not driven the price down because it is liability concerns that keep it rising so high — reported at $375 a shot in one locale — is surely something that is amenable to a legislative fix, if there is political will. 

Dan Margolies has put together an interesting and thought provoking article  on price variation in health care services. Yes, that knee replacement might be cheaper in St. Louis, in some absolute sense to that individual paying out of pocket for the service, than the knee replacement might be in Kansas City, though in-network and out-of network co-insurance obligations might hide that from the insured consumer. David Slusky, from K.U., explains this well in the article.

So, just how big a deal would it be for the uninsured to travel to St. Louis  for that knee replacement?  First, Missouri is a state with its most populous areas — St. Louis and Kansas City —  serving as border cities at two ends of the state separated by a several hour drive across the state.  Second, services like joint replacement are often followed by rehab stays. It can be uncomfortable, though not impossible, to travel to rehab in your city of origin when the actual surgery was several hours away.  And there is a good reason people want, whenever possible, to be near friends and relatives when in rehab.  It keeps morale up and good morale can contribute to better outcomes. Finally, the arrival of bundled payments for things like hip and knee replacement are probably going to make it harder, even for the out of pocket payment patient,  to cherry pick surgical services in one location and rehab services in another.  I predict it will not be long before it will not be possible to detach the surgery from the rehab, no matter the payment source.  

Though a majority of Americans still obtain health insurance through their employment, the trend is clear: health insurance is increasingly detached from employment.  For those still in the land of employer sponsored health insurance, the ritual is as familiar as it is confusing: march down to HR, get a whole lot of paper and online information pushed at you, and be prepared to choose (if, indeed, you have a choice) fairly quickly.  The selection process can be even more disorienting if only two options are offered: the first a reasonably comprehensive health insurance program and the second a high deductible plan twinned with a health savings account.  The latter is the darling of large employers, of late, and it is easy to see why using the offering as a mechanism to induce some cost-consciousness into enrollees may appeal to employers.

I  recently met a new faculty member at the university where I teach. This person is a licensed health professional in addition to being a professor.  This person volunteered that they had just completed their HR experience and I was curious to listen to them describe how bewildering the health insurance options were, this person having had limited personal exposure to high deductible health insurance in previous employment  And, yet, had this senior hire been practicing a health profession for the several decades that seemed likely, surely that person's patients had during that time had considerable exposure to high deductible health insurance.

This summer, when I queried a provider about her sense of the likelihood that a recommended scan would actually be authorized by my provider or whether we should also develop a Plan B for diagnosis and treatment, she replied "That is between you and your insurer."  How very odd.  I had just advised that if insurance would not authorize, I would likely not pay out of pocket for the scan, so it was her issue insofar as she would have to develop another recommended treatment plan. I kept quiet. But the world is changing. Yes, the relative thinness or richness of my insurance cannot help but be relevant to the treatment options presented.

For a product that has only been widely available to the public since the late 1990's, we sure have taken to hand sanitizers. Invented by Lupe Hernandez of Bakersfield, California in 1966, when she was studying to become an RN, the product has become ubiquitous of late. I don't remember a single "back to school" classroom supplies list where my children were not either reminded to pack their own hand sanitizer for daily use or asked to bring some as a classroom supplies contribution.  This week, I have noticed alcohol-based hand sanitizers of all sorts prominently displayed in advertising flyers for back to school supplies, so I suspect the trend continues.

Industry analysts track the rise of interest in and use of hand sanitizers to increased consumer awareness of the need for good hand hygiene in containing some communicable diseases and in increased media coverage of infectious disease outbreaks.  The problem with this is that even alcohol-based hand sanitizers are a poor second to good thorough hand washing. Hand washing, done right, means water, soap, and a good multi-directional scrubbing of sufficient duration. Anyone who has spent more than a moment in a public restroom knows how little hand washing, done right, occurs there. Perhaps it is this knowledge that the producers of alcohol based hand sanitizers tap into when promoting the product.

The problem with this is that there are risks and costs as well as benefits associated with significant alcohol based sanitizer use.  These I would describe as  two fold, raising two kinds of  questions about alcohol-based hand sanitizers.  First, what if they don't work as believed or hoped? And, second, what if they do more than believed?  The latter concerns both the fear that overuse (yet to be defined in the literature,  though it is easy to imagine exceeding usage of more than four or five times a day in many settings) of alcohol based sanitizers may harm the user, a particular concern for children or women who are pregnant and the concern that overuse of hand sanitizers may connect in some way to antibiotic resistance.  The former concerns the idea that use of these products is a substitute for hand washing, done right. 

As if all of this isn't troubling enough, there is the sense of false safety plentiful displays of alcohol-based hand sanitizer seems to imply. And complacency, particularly concerning the diseases alcohol based hand sanitizer cannot address as nearly as well as they might be addressed by hand washing, done right — such as c difficile — may be the greatest health threat of all.

With only a little dryness, I note in my now-published  paper: "Managing Our Microbial Mark: What We Can Learn About Pay for Performance From Ebola's Arrival At Our Shores" that how we became persuaded that alcohol-based hand sanitizer would save us from all communicable diseases in an increasingly small world, may be the greatest misperception aggressive marketing of the product has promoted.

As of late June of this year, the FDA has asked the antiseptic gels manufacturers to submit studies and data on the efficacy of these products as well as data and studies on risks to children and pregnant women.  

Let the hand wringing — I mean, hand washing — begin.

Austin Frakt's Upshot column in today's New York Times offers an interesting summary of some research looking at an important Calpers experiment with what he, elsewhere, calls horizontal reference pricing.  Reference pricing — what used to be called steering — has managed to make California's Calpers enrollees more price sensitive in provider selection for certain non-emergent procedures: knee and hip replacements, colonoscopy, arthroscopy, cataracts, etc.  Prices fell relatively quickly in response to this exercise of buyer power. Essentially, Calpers will fund a capped amount for certain procedures and no more.  The excess is then the elective responsibility of the patient.  Given the incredible variability in pricing for health services, this is a bold experiment. Sure enough,  the Calpers enrollees moved away from the high out of pocket cost providers and toward those clustered at or below the reference prices. That the prices providers charged were so responsive and so non-sticky tells us that price sensitivity can be induced in consumers relatively quickly and can be induced in providers by consumers relatively quickly, provided the services required are non-emergent and price transparency is both available to and comprehensible by by those patients involved.

In fact, the most common non-emergent services studied, it would appear, overwhelmingly target consumption by older Calpers enrollees. Some young people face joint replacement but many more older retirees do.  Similarly, colonoscopies are sometimes required by the young or youthful, but real turnout hits at the age of 50 in the United States.  So, it should be noted we are likely examining — at least in these studies — the price sensitivity of older Calpers enrollees, perhaps predominantly Calpers retirees.

As anyone who has ever spent time in communities with lots of  middle class retirees knows: many  middle class retirees have lots of time. In light of this, the fact that I have heard real estate agents code super-prepped for showing residential properties as "retiree owned" should come as no surprise.  

What about the rest of us?  Other insureds may lack the time, interest, and savvy to engage in the cost-quality tradeoff. This makes reference pricing the  retired middle class alternative to narrow networks, I suppose. 

 

KFF.org has an interesting article about a Morgan Hill, California hospital administrator retiree's quest for a non-surgical treatment for her osteoarthiritis.  She enters the land of stem cell research by locating a patient-funded stem cell treatment option on clinicaltrials.gov.  The rest of the article discusses the problem with non-disclosure of the significant patient costs, the phenomenon of funding health care needs on go fund me, and the general wide open nature of what can be posted as a clinical trial. These are all good points.

The part that caught my eye was when this  former retired hospital administrator was reported to be surprised that the research program she located was consumer-funded after reading this:

The company, which describes itself as “the premiere leader in the United States for regenerative medicine,” says it offers a “a    concierge approach to treatment,” which includes covering the cost of its patients’ hotel accommodations and a car service that   “will be waiting for you at the airport baggage claim when you arrive.”

A retired hospital administrator who thinks a car service and baggage assistance as well as coverage for hotel accommodations are standard operating procedure for a clinical trial strains credulity. I understand that certain clinical trials involve incentives to participants but surely anyone from within hospital-land knows what a money maker it can be to treat osteoarthritis in well off populations. And that treatment, even when surgical, increasingly moves to out-patient settings, every hospital knows a significant adjustment to balance sheets lies ahead.

 

 

 

 

 

 

Slowly and partially, we see information begin to appear in the press about the different enrollment procedures for traditional Medicare and Medicare Advantage.  These differences are important for product market definition in merger analysis, as I discussed in an earlier post on the difficulty in moving between Medicare Advantage and traditional Medicare augmented with Medicare Supplemental Insurance, but they are also significant for Medicare beneficiaries.  As the default option in a "seamless enrollment" exception to Medicare's general rule that a Medicare beneficiary must opt-in to Medicare Advantage, it turns out it is possible to be enrolled in Medicare Advantage without knowing you are (because you didn't read or understand your mail about Medicare Advantage), without having affirmatively chosen to be, and while believing that Medicare Advantage is irrelevant to you after believing you have affirmatively elected enrollment in traditional Medicare. The latter is most intriguing because, I suspect, it documents a Medicare beneficiary attempting to navigate the system of election and enrollment, as they broadly understand it, to enroll it without understanding that Medicare election and enrollment rules are malleable and can be distinctive to time and place.

One of the things about changes to choice architecture or defaults is the difficulty in addressing the  time lag  during which people's expectations of how the system will work as it is has previously clash with a very different new default rule.  This may be of particular concern when an older, more vulnerable population is involved, though there is ample evidence that Americans of all ages do not understand Medicare.  Lurking here, also, is the huge problem with the complexity of Medicare that leads many elders to rely on what I call Medicare "urban legends." Some of these urban legends — take, for example, the idea that Medicare funds long term care beyond a very limited benefit — have proven very sticky indeed.

Here, we have commercial insurers Medicare-authorized to seamlessly transition some of their enrollees, at the point of Medicare eligibility, to the Medicare plan that most closely matches their current insurance enrollment, presumably because their choices in commercial insurance will likely mimic their preferences in Medicare enrollment and to save any of those involved from missing Medicare enrollment timelines and deadlines.

What is interesting about this is the premise, that a choice in a certain kind of commercial insurance product signals an interest in a particular kind of managed care Medicare insurance product, appears to be based on a fascinating understanding of consumer choice in health insurance products. Most insureds do not choose their own health insurance, in the purest sense, but rather choose among a very limited range (or no range) of options actually chosen for them by their employer. If the purchase is through one of the state health insurance exchanges, choice is among the plans open for enrollment in their geographic area within the exchange, often a quite limited slate of plans.  

Very few Americans are exposed to the kind of choice between traditional Medicare (with or without Medicare Supplemental Insurance) and a Medicare Advantage product — the difference between, for example, broad choice of provider and a plan based on narrow networks.  Very little commercial insurance offers the kind of wide open provider options that are found in traditional Medicare.  Whether this is Medicare's glory or its bane, those over 65 years of age and those approaching 65 years of age are well aware that their health care access and choice may well improve upon enrollment in traditional Medicare, provided they have the funds to take advantage of it.  This may be why the evidence shows that those with higher incomes and assets naturally gravitate to traditional Medicare with Medicare Advantage the choice of the lower income, specifically those who cannot afford the Medicare Supplemental Insurance needed to wraparound traditional Medicare's limited coverage. 

I have to wonder if the surfacing of changed enrollment defaults for Medicare Advantage isn't because of these mis-matched assumptions about consumer choice and who really elects what in Medicare. After all, Medicaid beneficiaries, overwhelmingly low income individuals, have long had little choice about Medicaid managed care.