Author: Ann Marie Marciarille

Atul Gawande has a short observation in the November 21, 2016 issue of the New Yorker on the likely fallout of the recent election cycle.  Interestingly, he seems persuaded that health care professional ethics will redeem us from a  potential world where the undocumented are turned away at the emergency department door. This is because health care practitioners "have evolved their own ethics, in keeping with American ideals."  In light of recent studies on the political values of physicians, I have to wonder if that might better be phrased as "they have evolved multiple systems of ethics, in keeping with American ideals,"  but who am I to quibble?

What really caught my eye was his man-in-the-small-town interview with a man named Jim Young who, along with making some interesting observations about the election, noted that "[l]ast year, his son, who was born with spina bifida, died, at the age of thirty-three after his case was mismanaged in the local emergency room."  The single most striking observation in the entire article goes undiscussed: someone who believes a life was lost from medical error goes unquestioned as to whether this has caused him to doubt the value of all that Obamacare he, his extended family, and his fellow Americans have been receiving.

It is extraordinary to find the personal narrative of real or perceived medical error in the general press. I actually try to collect obituaries that note medical error, if any of you would like to contribute to my collection.

We act at our own peril when we  chew Obamacare to death but we let assertions of medical error  unto death slip by unremarked.

Here are some of the lyrics to Macklemore's new song: "Drug Dealer."  Anybody else catch the line "my drug dealer was a doctor." Not sure why the AMA's task force on opioid addiction is loving it but I am pretty sure that this is a brave stance. Or, did they not even listen to the song? You can listen to it here. 

Stay tuned for Pharma's endorsement next?

It was a pleasure to hear Rena Conti present yesterday on her work on the effect of physician and health system consolidation on the prices of outpatient prescription drug-based cancer care. She has developed some very interesting data on how steeply the cost of cancer care rises once consolidation occurs, with special attention to the price of the outpatient prescription drugs administered. Since outpatient prescription drug cancer care is a value center for a number of  acute care facilities, we should all be concerned about how the price of this care — predominantly from increasing the spread between the center's acquisition cost for these prescriptions  and and what these facilities may charge insurers for these prescriptions appear to contribute to the price run up.

Rena Conti is piecing together a compelling competitive effects story about vertical integration.  She has yet to test whether the end result of these price run ups is that access to care or cost to final consumer are involved, so the story must still unfold.  Still, the presumption that most vertical mergers do not raise competitive concerns and are likely pro-competitive (because of improved economic efficiency) is going to have a little test here.

It may be that in the context of fee for service out-patient health system-affiliated prescription drug cancer care, where providers have extraordinary influence on the type of treatment offered and the intensity of the treatment offered, that Rena Conti has found a exception to the general rule favoring vertical mergers.  Or, it may be that her searching analysis might well be turned elsewhere in our health care system where the profit is on the spread and the provider is a powerful influencer on treatment type and treatment intensity  

Time will tell if this is cancer care's version of unilateral  competitive and institutional incentives  to raise downstream prices after a vertical merger. I watch her work with interest. 

I am struck by poll data reporting that seven out of ten Americans supporting President Elect Donald Trump think that American culture and way of life have declined since the 1950's.  There is much to consider about this kind of deep nostalgia in Americans, famously known as being forward looking to a fault.  But I still have to wonder — even taking into account  the remarkable skew by age in the President Elect Trump supporter group — if many voters aren't experiencing nostalgia for something they did not actually experience directly.  After all, seven out of ten Americans were not alive during the 1950's. In 2013, The Atlantic calculated that less than a third of Americans then alive in 2013 were alive at the time of JFK's assassination. 

This makes me wonder if we are not more in the grips of saudade, rather than true nostalgia.  The famously untranslatable Portuguese word, saudade, refers to a kind of nostalgia or emptiness that can even be felt for or about something that was not personally experienced. So, it is not so much remembrance of things past as remembrance of someone else's remembrance of things past.

What was health care like in the 1950's?  Well, in the 1950's the price of hospital based care doubled, setting the stage for the substantial problems of access and cost that gave rise to the large government funded health insurance programs of the 1960's. 

Just what part of this equation are we longing for?

 

Richard Kaplan's recent paper on Religion and Advance Directives: Formulations and Enforcement Implications discusses a topic I often wish we had more time to discuss in my health law survey course: the overlay of declared religious principles on health-care proxy document templates.  Of course, the push-me-pull-you of this is that documents that are often conceived of  by some as the fullest legal expression of individual autonomy at the point of end-of-life decision making can also be understood by others as the fullest expression  of individual participation in a collective: religious belief and religious identity at the point of end of life decision making. 

And so I was perplexed to read Richard Kaplan write:  "[t]he inevitable result of such religious-doctrine-incorporation provisions is to limit the discretion of the designated proxy to make medically optimal decisions in any clinical situation" and that such directives "might further complicate the task of health-care professionals who must apply these directives in specific contexts."

Well, yes. It is probably harder to try to apply articulated guidelines of any kind rather than to focus end of life decision making priorities on choosing someone as the decision maker who has a world view, including a religious world view, consistent with the individual's. But, I don't think it is inherently more complicated because the guiding principles are explicitly religious. It is just more complicated because they are more specific and, perhaps, because such guidelines are morally freighted for some individuals. 

And, I have to wonder if Richard Kaplan doesn't see this too because he then goes on in his article to discuss, in much greater detail, how the undisclosed to patient religious beliefs of providers do, in fact, shape how treatment choice options concerning end of life decision making are presented.  We might call this the hidden religious screen on end of life decision making — the undisclosed religious screen of the provider. 

Are we better off with non-disclosed religious perspectives helping to shape end of life decision making or with completely up front declarations of preferences by some to adhere to religiously articulated principles that guide end of life decision making?

In light of information asymmetry and power differentials, the framing of the range of available choices on end of life decision making may actually be the far more significant act than the choosing among the limited choices presented. If this is true,  Richard Kaplan hasn't persuaded me that religious principles aren't already playing a significant role in end of life decision making but that, in fact, someone else's religious principles or religious affiliations are the ones that matter in many situations.   Somehow, I don't find this the more comforting scenario. 

I wonder if it isn't more important, then, to select a health care provider whose world view and religious sensibility is attuned to yours than it is to focus on these same characteristics when selecting the actual individual health care proxy. 

By now, you've probably heard of Mylan's long-term interest in getting the Epi-Pen listed as an A or B Category Preventive Medicine by the United States Preventive Services Task Force. It is a pretty exclusive club, but EpiPen's prevention of anaphlyaxis is the basis of its claim to this elevated status.  As this excellent article in MedPage Today makes clear, most curative prescriptions can also be seen as preventive in this sense — preventing the progress of disease and, even, preventing death. 

Surely it is the first dollar coverage aspect of the categorization, under Section 2713 of the Affordable Care Act and its implementing regulations, that is the tail wagging the dog here. The plea to make EpiPens available to those that need them seems to be based on a different idea of preventive coverage: that this potentially lifesaving drug delivery device ought to be available to all, so it ought to be an A or B category Preventive Pharmaceutical. It is, in short, the plea for a hidden cost shift.  First dollar coverage of an item billed at roughly $600 out of pocket cost for a two-pack doesn't necessarily  change the manufacturer's price, it just changes the cost to EpiPen consumer into  the cost to the public.

Of course all of this is complicated by Mylan's apparent other long-standing interest in keeping EpiPens from being listed on the generic drug list, except for its own $300 branded generic entry,  where reimbursement would be very different. And, Mylan's efforts to keep the EpiPens4Schools program exclusively tied to their branded EpiPen adds an additional dollop of strategy.

All of this has been seeping out for several weeks at just about the same time as a lively discussion about rethinking automatic insurance coverage for preventive health care under the Affordable Care Act. Turns out preventive care is expensive and, so the argument goes, first dollar preventive care coverage comes at the cost of possibly making treatment of illness itself prohibitively expensive. It is a sort of pitting those who would stay well against those who are already sick analysis.

As both debates — one on the proper role of first dollar coverage for preventive services and medications combined with significant co-insurance obligations for illness treatment and the other about whether preventing anaphlylaxis is truly a preventive service– continue, Mylan will have many strategic choices and counter-choices ahead if their plan is to continue to maximize profit.

It seems likely Mylan will lobby to move the EpiPen to A and B Category Preventive Medications status  unless and until first dollar treatment for those drug categories is removed, in which case Mylan will regroup and urge that the EpiPen remain out of the A and B Category of  Preventive Medicines and, instead, focus on keeping the cost shift alive and hidden  through the use of  end consumer targeted coupons, drug assistance programs, and branded EpiPen requirements for EpiPens4Schools programs. 

California's Drug Price Relief Act Initiative (Proposition 61) is on the ballot in November.  A "yes" vote essentially requires California's state agencies to pay only the U.S. Department of Veterans Affairs' acquisition cost  for prescription drugs. In short, it ties California state agency prescription drug acquisition cost to the prices paid by the V.A., the statutory low price pharmaceutical acquirer in the world of government funded insurance. The V.A. itself estimated, several years ago, that the  VA’s Pharmacy Benefits Management (PBM) program saved  the VA $1.5 billion between 1995 and 1999 (Sales, 2005) and reported that VA prices for 20 medications commonly used by seniors are lower even than those negotiated by private PBM companies for the Medicare Prescription Drug Plan (Families USA, 2005).

I have been thinking about preferred prescription drug pricing for the V.A. as one manifestation of favored group pharmaceutical pricing — a sort of "who's in and who's out" exercise.  I am mindful that V.A. pharmaceutical savings are only partly acquisition driven as the V.A. makes some of its savings through the use of narrower formularies that serve to help lower the cost by eliminating some choice in prescription coverage and by driving larger volumes through preferred medications. It is hard to know what to make of the "let's get the V.A.'s price but not the V.A.'s access constraints" argument in the abstract, though many Californians' experience of MediCal's formulary is of a considerably constrained benefit.

There is no denying the V.A., has long been a preferred program for subsidized health care. Seen in this light, the tradition of the Veteran’s Administration in—for example—leading the way as the low price leader, by custom and by statute, on domestic pharmaceutical acquisition cost, is the most recent iteration of Abraham Lincoln’s motivation in founding the Veteran’s Administration in 1865, “…to care for him who shall have borne the battle, and for his widow, and his orphan.”

By extension, all modern government programs that benefit favored groups with preferential cost and access to prescription drugs—whether it be veterans, or the “deserving poor” in non-Medicaid expansion states, or all lower income individuals in Medicaid expansion states—have a connection to this  history of favored pricing for their group.

Medicare's Part D prescription drug benefit prohibits collective government bargaining over pharmaceutical acquisition cost.  But, aren't seniors a sympathetic population? Not all seniors, apparently.

The public debate over Proposition 61, of course, is — depending upon your perspective — enhanced or devastated by the fact that no one can or will say, for certain, how the drug companies would respond to Propositions 61's passage.  We get a little hint from the current pharmaceutical industry sponsored ads saying it would harm veterans, both a rare admission of cross-subsidization in health care pricing from market players and a harkening back  a few decades to the last time V.A. prescription drug acquisition costs were factored into other forms of government funded health insurance, courtesy of OBRA '90. Then,  prescription drug acquisition costs are reported to have fallen by 15 percent. 

But it was not an enduring savings. This raises the interesting question of what mechanism can be found in Proposition 61 to keep it, in very short order, from being similarly gamed.

 

 

 

This one has been like the car wreck you see unfolding before you but feel helpless to stop.  By this, I mean this problem was identified soon after the ACA's passage as a likely problem with only complex fixes that demanded a well developed solution.  And, so far as I can tell, little heed was given by a number of the universities involved. It is ironic that large universities might not see themselves as large employers of graduate students who, either as conventionally defined employees or as common law employees, with an impermissible "premium reduction arrangement" for individual market health insurance baked right into their employment relationship with many of their graduate students. Or, maybe it was just wishful thinking that universities and graduate students would be seen as sufficiently distinctive or special, that push would never come to shove.  Well, it has — sort of.

The reason why most universities are struggling with subsidized  graduate student health insurance payments is that most student health insurance is not true employer sponsored insurance  ("ESI"). It is, for the most part, within the legal definition of  a special kind of insurance – student health insurance plans (SHIP).  And SHIP, as it is organized at most universities, is defined as part of the individual market. 

University employed students come in two flavors: conventionally defined employees and common law employees. The ACA brings many more employees (not just student employees, but all employees) inside of common law employee status for purposes of understanding who must be offered insurance, what kind of insurance must be offered, etc. Common law employee status does not map easily onto the definitions of employee found in the tax code, ERISA, and labor law. This gets tricky.

The insurance design of the  ACA wants and needs younger relatively healthy insured lives inside of group markets and not off by themselves in de facto age and fitness segregated risk pools.  Although, gradually, some of the provisions of the ACA have been brought to bear on SHIP, its very nature as a product—an individual market insurance product purchased in whole or in part by university subsidy marks it as an interesting anomaly to the general rule that the ACA is tone deaf to the pleas of younger insureds that they will, in fact, be subsidizing older insureds in the population (with small exceptions such as catastrophic coverage options available only to the youngest insureds).  This need for younger more robust insureds in the risk pools is, of course, arguably even greater in non-Medicaid expansion states who, arguably, have de-stabilized  all their insurance risk pools by their Medicaid expansion choice. And, the failure to expand Medicaid in a given state, removes Medicaid as backstop health insurance for some graduate students in those states as well. 

The orientation of the ACA is also to both drive as many people into group insurance markets as possible and to thwart any inclination of employers to want to subsidize their employee’s individual market health insurance purchases as a way to get out from under pay or play.

All of this comes to a head with the chorus of university announcements that university subsidized graduate student health insurance is coming to an end. This issue was identified by benefits and plan design consultants almost as soon as the ACA was enacted. But, since the gradual roll out of the ACA meant this would not be a problem for several years, it appears to have been a low priority for some universities.   By this, I mean that universities  could  have begun to make plans to work around the bite of these rules and regulations as applied to university student common law employees as soon as  it became apparent, barring a change in the regulations and their interpretation, these “premium reduction arrangements” would need to go away.  It takes time to develop a plan to bring common law student university employees inside of ESI, for example, or to establish a separate health plan to cover them or, even, to figure out what the compensation increase would need to be to replace a lost benefit.

Instead, the announcement is made that the premium subsidy is going away and that the ACA took it away. How anyone sees that probably depends on how they view causation. All of this is (yes!) further complicated of course,  by the fact that some universities are self-funded in their ESI and some are fully insured, for ERISA purposes.  Self-funded plans, of course, are exempt from many but not all of the ACA’s regulatory requirements.

There are a number of “fixes” possible.  And the recently announced one  year extension of time to allow universities to plan makes some of them more likely, I suppose.  But, as far as I can tell,  all of them will cost universities more and not be as generous actuarially to the relatively young and robust graduate student common law employee cohort. So, there is a political as well as insurance design angle to consider here.

I have been enjoying Siddhartha Mukherjee's The Gene: An Intimate History just as summer comes to a close. Mukherjee writes beautifully. Here he describes and summarizes the genetic hunt to explain sickle-cell anemia:

It was a Rube Goldberg disease. A change in the sequence of a gene caused the change in the sequence of a protein; that warped its shape; that shrank a cell; that clogged a vein; that jammed the flow; that racked the body (that genes built).  Gene, protein, function, and fate were strung in a chain: one chemical alteration in one base pair in DNA  was sufficient to "encode" a radical change in human fate.

Mukherjee tells us that "genetic diseases" may be a popular  misnomer as some of the disorders in this category may best be understood as the product of multiple genetic mutations. As Nathaniel Comfort reminds us, single gene disorders appear to pale in significance to genomic disorders."Ironically, the more we study the genome, the more 'the gene' recedes."

The history of  genetic and genomic science and research is fascinating. What a wonderful book. What a wonderful author. 

 

 

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.