Whose Son?

When articles began to pop up about Neil Gorsuch's mother,  the late Anne Gorsuch Burford, I thought "that's interesting."  Stories about political families are always interesting.  Anne Gorsuch Burford's career at the EPA was interesting as was her her 1986 take-no-prisoners book on her experiences in D.C.  I am  not, however, among the group that thinks that the most telling thing about Neil Gorsuch's parentage is that Anne Gorsuch Burford was an extremely controversial EPA head.

Actually, the most interesting thing I wonder about Neil Gorsuch's experiences as his mother's son (one of two sons among three siblings) is whether the experience of his mother's death from cancer in 2004 helps to explain some differences  between the chapters in his 2009 book The Future of Assisted Suicide and Euthanasia that appear to have been written specifically for the volume and those  that were essentially reprints of earlier articles on  these topics. 

I know nothing about Ann Gorsuch Burford's death but that she died too young, at the age of 62, and that she died from cancer.  Although there are those who say that "dying of cancer is the best death, " there is another school of thought that notes many cancer patients die in "excruciating pain and fear." At any rate, we sequester the dying so successfully in our society that it may not be until a very close friend or family member dies from cancer that we  knowingly look a cancer death in the face. 

Ann Gorsuch Burford's obituary reports she died in Aurora, Colorado while her son Neil Gorsuch resided in Vienna, Virginia. I do not know if Neil Gorsuch was able to participate in caring for his mother at the end of her life when he himself was only 37 years old. What I do know is that the experience of hands  on caregiving and on-the-spot decision making for someone leaving this world in the face of great physical and/or psychic pain can be life transforming. Interestingly, we see this transformative experience studied more in the shifts in perspective  some hospice and palliative care providers make over a career of caring for the dying than in the re-working and re-thinking of beliefs related to death and dying in the  lives of lay people or even bio-ethicists who pass through this experience.

I am interested in whether and how  lay people and family caregivers who actively care for those approaching an untimely and painful death also have to square up their lived experience with their theoretical understanding on all sorts of issues, including assisted suicide or medically assisted death.  Some of those lay people are bio-ethicists,  which I find even more interesting.

How an earlier in life experience with death and dying  can draw a scholar or a practitioner first  close and then even closer to work in the area of death and dying might be seen as  a kind of  history of the present. From this perspective, we are all still re-considering, in our lives and in our work,  our earlier experiences with death and dying each time we confront the mortality of those close to us.

The work of  philosopher John Finnis appears to have been a powerful influence on our latest Supreme Court nominee. It might be argued that John Finnis is the intellectual parent to this son.  But I still have to wonder if Neil Gorsuch personally walked those last  hands-on miles with his mother.

X posted at Prawfsblawg 

Email, The Gift That Keeps on Giving

U.S. District Judge John D. Bates spilled a considerable amount of ink in yesterday's Memorandum Opinion enjoining the Aetna-Humana health insurance merger.  Even though antitrust opinions are not known for their brevity, the roughly thirteen pages devoted to discussing whether Aetna's announced  withdrawal from the complaint counties about three weeks after the date of the filing of the government complaint was  motivated by a desire to  improve its litigation position or as part of ordinary business decision making is pretty detailed.  Because the announcement of withdrawal implicated actions that might be interpreted as consistent with business interest (leaving the exchange market in Missouri, for example, where Aetna was  distressed over years of non-profitability) or might be interpreted as inconsistent with business interest (leaving the exchange market in Florida, for example,  where Aetna was apparently profitable).

Yes, it was the  internal documents of Aetna management discussing motivation for withdrawal from the profitable Florida exchange market or, even, in refusing to discuss the Florida decision while laying out the business case analysis behind withdrawal from the exchange markets in other locales that animated Judge Bates' opinion.  It is interesting to find internal Aetna management correspondence (from Steven Kelmar, Aetna's Executive VP and Chief of Government Affairs)  memorializing "Most of this is a business decision except where DOJ has been explicit about the exchange markets. There we have no choice." 

Still, my favorite part involved hints at what was sometimes unsaid in emails.  When Aetna's Florida Market President, Christopher Ciano, received word of the decision to exit the Florida exchange market (he was not part of the decision making group), his serial emails lamenting the decision, pointing out that Florida's exchange market was profitable for Aetna, and stating that he just couldn't make sense of the decision are powerful because of his apparent ignorance or because of what wasn't said.   Christopher Ciano was, eventually,  directed to stop discussing this matter in emails and to take the conversation to the telephone.

That's the thing about email correspondents — they often know, on some level, that the messages may be brought to light in some way but they can't always seem to stop.  I wonder if, because email can be so conversational in tone, they forget that they are creating a written record.

x-posted at Prawsblawg

 

Empathizing With Students

I spent some time last week in a twenty hour January mini-term experiment combining students and faculty from UMKC's School of Nursing, School of Pharmacy, School of Dentistry, School of Medicine and School of Law. Our focus was on considering how to use personal narrative interviewing techniques to try to understand healthy, happy aging. Inter-professional training and education can also be something of an education in how other professional students understand their own roles and responsibilities and on  how they propose to  interact with other licensed professions.   It can be incredibly revealing just to observe how students in the various licensed health professions think about wellness, aging, older people, people of modest means,  and lawyers as problem solvers.

So many interesting observations on professional training and identity were offered by the students that I thought I might share a few of them here. Here's to the  advanced medical student who, when asked to develop a few questions that might help him place an older individual in the context of a lifetime of health decisions, concerns and health successes, candidly observed "so, you're asking me to unlearn some of what I know."  I won't forget the advanced pharmacy student who described her professional responsibility to "remember that everything can be poison" and that much depends on precision and caution in dosing. I was struck by the observation of one advanced dental student that people often come to the school's dental clinic deeply discouraged "to have lost their smile." Striking observations all.

My own thinking on what motivates people to enter licensed professions has been  enriched by my time with these students and with all the generous with their time older individuals we interviewed this past week.

Empathy is a funny word, a slippery fish. I do not have an opinion on whether it can be taught but I do know it was revealed to me in unexpected moments last week.

 

x posted at Prawfs Blawg

What Vets Know That Physicians Don’t?

Barbara Natterson-Horowitz, M.D., is a cardiologist who has made a name for herself as a thoughtful observer of both veterinarians and the veterinary patients whose heart cases she occasionally consults on. It is not entirely surprising that an M.D. cardiologist (or, as another example,  a dental surgeon) might be asked to consult on a complex veterinary case, particularly one involving a mammal.  Those who ask her to consult believe that she  has something to add to the treatment team.

What makes her a bit more unusual is her observation that the veterinary treatment team may have something to offer the M.D.: insights often drawn from the close study of veterinary patients who demonstrate their physical or psychic pain or disease in ways that require keen observation across a breed and, even sometimes, between breeds. Wondering if certain symptoms or behaviors in humans, closely observed, might allow M.D.'s to tap into veterinary knowledge, Dr. Natterson-Horowitz has joined with a group of veterinarians and M.D.'s to pursue these interests.

You may have seen her TedMed talk or read her book.

Whether or not the "One Health" approach to clinical and veterinary medicine will lead us anywhere beyond the insight that vets and physicians might have somethings to talk about remains to be seen. But the entry of the Oncept canine oral melanoma vaccine into the animal health care market is thought provoking. Oncept is not a true  vaccine in that it is not a canine oral  melanoma preventive. Rather it is administered post-diagnosis in serial doses that appear to have some substantial success in prolonging canine lifespan post-diagnosis.  Interestingly, Oncept is reported to have been, at one point,  in joint clinical trials for possible human use. This joint canine-human drug development track is not a common story, though a number of drugs are tested on canines as a precursor to clinical drug trials involving humans. 

Oncept is not inexpensive.  The Los Angeles Times estimated in June of this past year that  a full series of four treatments cost approximately $2,800.  Clearly, many pet owners are likely priced out of this market. Pet health insurance is uncommon and, even when present, often excludes pre-existing  conditions and the coverage of older dogs.  It should be noted that these same pet owning individuals and households are likely also priced out of many of the other new cancer treatments now offered for pets (sometimes offered using medical equipment down-scaled from human cancer treatment clinics).

Just as you might imagine, households with higher incomes and greater wealth will often spend substantially more money  than low and moderate income households on a pet  nearing the end of life. A new paper by Liran Einav, Amy Finkelstein and Atul Gupta considers the expenditure differential in these situations.

Vets who deal with life-ending or gravely life-threatening illnesses like canine oral melanoma seem to have considerable experience with helping pet owners sort through the complicated issues of cost and benefit, both to pet and to household, in treatment decisions at or near the end of life.  Maybe this is what vets really know.

X-posted at PrawfsBlawg

The Blue Inhaler

PrawfsBlawg: The Blue Inhaler
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The Blue Inhaler

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I carry an albuterol inhaler as my  quick relief medication for asthma. I use it infrequently, which is good news for me and good news for my asthma. Known in many other countries as the blue inhaler or the blue puffer, albuterol/salbutemol is a tremendously popular and effective relief inhaler.  First brought to market in the 1980's, sales of the blue inhaler have grown as have rates of asthma diagnosis.  

Traveling recently in the E.U., my albuterol inhaler stopped working short of its full number of available measured doses. And so I was off to my neighborhood pharmacy in  Ponta Delgada, hoping that a licensed pharmacist might be able to prescribe inhaled albuterol over the counter and spare me the quest for the Centro de Saude on New Year's Day.  Frequent travelers are no doubt aware that certain prescription only medications in the United States may be sold over the counter in other countries or dispensed at the discretion of a licensed pharmacist, even in the absence of a prescription, in still  other countries.

One glance at the Pharmacia Moderna receipt found above will tell you I was successful. I was seen quickly by a licensed pharmacist who discussed my symptoms, examined my current inhaler (stunned, it seemed, that the United States would allow a relief inhaler to be packaged in bright red or anything other than the blue that is the color coded signal to asthmatics the world over that a rescue inhaler is at hand), and sold me a full size blue salbutemol inhaler for just under 3.75 Euros.   I paid for it with pocket coins.

Today, I will not discuss drug pricing in the Açores beyond mentioning that Portugal (the Açores are an Autonomous Region of Portugal) uses a reference drug pricing system to set prescription drug prices.  The reference involved is to drug pricing in several other countries (varying  yearly, but often including Spain).  Portugal, in short, is not interested in being an outlier in prescription drug acquisition cost nor an outlier in prescription drug cost to consumers. For some years, in fact, Portugal's citizens paid less than other reference countries for certain pharmaceuticals, something that has been increasingly altered by a Memorandum of Understanding relating to drug costs, promoted by the E.U. after the latest financial crisis. 

The price to me was a remarkable ten percent of my U.S.  commercially health insured co-pay cost for the differently-named albuterol inhaler. The contents, however, were the same, though the color of the casing on my damaged inhaler disturbed my Açorean pharmacist and the lack of a dose meter mechanism on the blue inhaler sold to me in Ponta Delgada disturbed me. I have written elsewhere about the problems of relief or rescue inhalers without dose meters.

What was equally stunning, however, was the ease of the entire encounter.  I had a new relief inhaler in hand inside of ten minutes. No visit to the the clinic, no transferral of the prescription from the clinic to the pharmacia, no complicated health insurance negotiations over whether a new inhaler would be covered (it was broken) or not covered (my request for a new inhaler was untimely by calendar standards).

This made me want to know if the blue inhaler is an over the counter drug in other countries.  Sure enough, the blue puffer can be bought in a U.K. supermarket, in a drug store without prescription in Australia and Spain, and elsewhere all for about the price I paid at Pharmacia Moderna.  Tracking backward to check if a push had ever been made to allow Albuterol inhalers to be sold over the counter in the U.S., I learned of a relatively recent effort by the FDA to generate discussion about the possible creation of a third class of medicines: over the counter, over the counter with conditions of safe use, and prescription.  

Last widely discussed in 2012, the FDA held hearings on the OTC/SCU category's appropriateness for formerly prescription only items like steroidal asthma inhalers. Multiple days of hearing on the idea produced varied positions, including  AMA opposition to the encroachment on physician scope of practice. One AMA spokesperson supported pharmacist supervision of OTC/SCU prescribing, as soon as the relevant pharmacist had gone to medical school. The FDA proposal went nowhere.

I know of no place in the U.S. where OTC/SCU prescribing involving steroid inhalers has gained any traction after the 2012 blowup at 
the FDA, though pharmacist prescribing is developing a bit of a track record in Canada and in the U.K. Our own state-based experiments with pharmacist prescribing authority are a mixed bag of programs based on  dependent authority (collaborative practice with licensed physicians) and independent authority (think Oregon, Washington,  and California's hormonal contraceptives statutes) but they have proven extremely limited in scope.

And the blue inhaler? Google it, if you like, and read all the apparently U.S. based articles and  chat board discussions on how to survive an asthma attack without a relief inhaler. 

 

x-posted at PrawfsBlawg

 

Jokes About Dentists

Having just returned from AALS, I have been thinking about all I saw and heard at the conference. I attended some outstanding panels and talks but it is Brad Smith's Plenary Program talk on Preparing a Diverse Profession to Serve a Diverse World that I can't get out of my head. Actually, Brad Smith, President and Chief Legal Officer of Microsoft Corporation, did not really speak on his assigned topic. His talk, though interesting, was really about how disruptive technologies have changed the world and will continue to change the world.  (If his remarks in the panel discussion following his formal  remarks were more focused on the announced topic, I cannot say as I regret I had to leave the Plenary Program just after the conclusion of his formal remarks.)

Brad Smith did briefly discuss the lack of diversity in the legal profession — noting that law is the least diverse profession, followed only by dentistry.  This last observation about the lack of diversity in the dental profession,  earned Mr. Smith his biggest laugh of the speech when he added "why, I have no idea."

Of course, it was funny in an offhand way. But it was also a marker of how uncurious we can all be about things, how uncurious we can all choose to be, and how even those of us who pride ourselves on promoting innovation can think in remarkably static ways.

That roughly three and a half percent of all American  dentists are African American  can tell us some things about the legacy of exclusion on the basis of race from dental education and the dental profession in the United States.   That African American dentists overwhelmingly serve the African American community (with a reported 62 percent same race patient panel) can also tell us some things about patterns of dental practice.

A story could also be told about how dentistry's move from an apprenticed trade to a profession arguably made the dental profession less diverse. The rise of the university-affiliated licensed dental school in the late nineteen century (first at the University of Maryland) made the roughly 120 apprentice-trained African American dentists anachronisms. Only slowly did African American enrollment in these new style dental schools grow.

Dentistry, for some time, has been a contracting profession. For a considerable period of time, few new dental schools opened and a number of dental schools closed.  The profession contracted but not uniformly as African Americans disproportionately disappeared from dental schools and from the ranks of practicing dentists.

Of course, many factors are at play. Dentistry has grayed during this period. Dental education is now overwhelmingly debt financed making the path more challenging for those who will not move into a family-owned or associated practice.  Dental services are often uninsured in the United States and more often paid out of pocket. Even Americans with the best known "dental insurance" plans often have a form of coverage that might more accurately be described as pre-paid dental for prophylactic care or limited "dental coverage" for actual low risk, high cost dental events. In short, it is not an easy time to launch a dental practice. 

The Bureau of Labor Statistics predicts the demand for dental services will continue to substantially outstrip supply.  As most dental students form the intention to enter dental school through exposure to family members and friends in the field, we should all give a thought to how technology and innovation might play a role in opening the world of possibility for a more diverse dental profession.

 

x posted at prawfsblawg

Dialysis Care’s Tangled Web

Christmas Day was the perfect day for the New York Times to publish its article on interesting goings on at The American Kidney Fund, one of the largest charities in the United States. Why? Well, Christmas Day is usually a slow news day and even trying to understand how dialysis care is funded for Americans is a slow read. It may be that all health insurance topics that span government-funded insurance as well as commercial insurance in the U.S. are a slow read. This is because our health insurance systems are complex but also because our health insurance systems are under-discussed.

Here, I am aiming for the fast read on the issues underlying  reports of recently issued subpoenas from the Justice Department to our two largest dialysis chains, Fresenius and DaVita. 

Renal failure patients have been  a special disease group under Medicare since 1972, when Congress extended Medicare coverage  to people of any age with kidney failure. The "kidney entitlement" (as it is sometimes known)  is distinctive in this regard. The story of the movement of dialysis from experimental to medical treatment, the rise of the dialysis industry,  and the sympathetic face of end stage renal failure patients all played a role in the dance of this legislation.  Indeed, a dialysis machine was reportedly brought to a Congressional hearing, though the account that a patient was actually dialyzed before members of Congress may be the stuff of urban legend. The early 1970's was also a time of  hope for comprehensive national health care reform, with the kidney entitlement seen by some as a stop-gap measure, not as an exercise in exceptionalism.   For all these reasons — and more — we saw the development of the extension of Medicare  coverage for dialysis to a disease group that included many who would formerly have been outside of the Medicare tent.

Dialysis evolved as did the dialysis industry. The nonprofit American Kidney Fund, from modest beginnings as a fundraising drive for a bankrupt dialysis patient, grew into a reportedly  majority dialysis industry funded charity whose premium support program allowed the American Kidney Fund, federal health care fraud and abuse law notwithstanding, to expand the relationship between the dialysis industry and the charity through collection and distribution of funds in the form of health insurance premium payment, including Medicare and commercial insurance premium payment for end renal failure patients. 

In health care delivery, payer mix is all. A health care delivery entity's business model necessarily revolves around a favorable payer mix. Fresnius and DaVita, for example,  were reported to receive $300,000 per patient per year from the Oregon state insurance pool for a year of dialysis treatment in 2011 as compared with the $82,000 they were reportedly able to bill Medicare in the same year. Now, allegations have been made that the American Kidney Fund excludes applicants from health care entities that do not contribute to the Fund, though this would be an apparent violation of the terms under which the premium support program was found not to violate health care fraud and abuse law.

In addition, litigation by United Health tips us off to the fact that the dialysis industry may  – in light of the extraordinary reimbursement differentials — have decided that the best use of premium support funds was to enroll  renal failure patients in commercial insurance. In addition, it has historically been the policy of the American Kidney Fund to terminate all premium support if a patient pursues transplant and dialysis terminates.

In this tangled story of dialysis treatment we have the larger American health care system's incentives written on a grain of sand: each insurer determined to push risk and cost on its competitors; each provider entity determined to retain its market share and maximize reimbursement rates; and a charity program perhaps operating as a demand-enhancement reimbursement maintenance control center.  

 

X-posted at Prawfsblawg

King Drug’s Significance: The Sounds of Silence

On November 4, 2016, the U.S. Supreme Court met for its fifth conference of the 2016 term and denied review of a Third Circuit opinion holding that a patentee's otherwise lawful grant of an exclusive license must undergo antitrust scrutiny. The Third Circuit, in King Drug, interpreted the Supreme Court's 2013 Actavis opinion to include antitrust scrutiny of exclusive license arrangements.  In Actavis, the Supreme Court looked a reverse-payment patent litigation settlements (often to resolve Hatch-Waxman litigation for alleged infringement by the generic company's filing of an Abbreviated New Drug Application or ANDA). 

Note that all the King Drug opinion tells us is that such exclusive license agreements as consideration for an agreement not to launch an authorized  generic are within the umbrella of Actavis scrutiny. This means the agreement must be scrutinized as follows:  1) Was there a reverse payment? 2 Was the reverse payment large and unjustified? and 3) Would the reverse payment survive scrutiny under Antitrust's rule of reason analysis?

So, now we know something but I'll be darned if we know exactly what.  The Third Circuit's opinion that a monetary payment is not the sine qua non of an Actavis antitrust scrutiny trigger is interesting.   A no- authorized generic agreement can be quite valuable and, so, meets the Actavis  antitrust scrutiny test.

Then, how far does the Actavis antitrust scrutiny trigger analysis extend, to anything that can be monetized?  

 

 

Scope of Practice Wars: The V.A. Weighs In (Kind Of)

The V.A. has put themselves out there with a new final rule allowing advanced practice nurses to practice to their full authority at V.A. facilities.  This is a big step toward increasing primary care  provider supply for V.A. patients. This rule was not promulgated without controversy.

Controversy appears to have taken down the part of the rule dealing with allowing certified nurse anesthetists (CRNAs) to also practice to their full  authority at V.A. facilities.  Here, the American Society of Anesthesiologists was quite vocal and, apparently, quite successful.  Full practice authority for CRNAs was just not as much of a priority for the V.A.

Make no mistake, even this limited new proposal should rock the world of many providers.  The V.A.'s role in treating 8 million veterans each year will make this the largest experiment in full authority practice for advanced practice nurses some jurisdictions have ever seen. 

 

 

 

Greetings from the Affordable Care Act Dead Zone

The New York Times' Inara Verzemnieks' article, In the Dead Zone,  featured Kansas City, MIssouri front and center in its discussion about those in the Affordable Care Act's coverage gap.  Those too rich for their state's Medicaid eligibility rules or outside of categorical eligibility but also too poor to purchase health insurance inside the exchanges are in a kind of "dead zone" where health care can be catch as catch can.  This is an article about how the ACA has helped many Americans living between 100 percent and 250 percent of the federal poverty level achieve insured status, and how the ACA — after the optionalizing of the Medicaid expansion at the Supreme Court — has also left many outside of health insurance.

There is a lot to like about this article, particularly its fact-based look at just who is in the coverage gap, including the under-discussed one in eight close to to 65 year olds and how the majority are workers. I have noted before that the average American still retires at 62 years of age (when a reduced benefit is first available) yet Medicare eligibility kicks in at age 65, producing a natural constituency in favor of some kind of health care reform that will cover these vulnerable folks before Medicare eligibility.  I often find that these "dead zone oldsters" are everywhere and everyone seems to know at least one.  

The fact that the ACA has been of tremendous benefit to low income, but not impoverished, near seniors is under-discussed and under-appreciated.  This is the group moving, statistically, toward significant health care needs and, as a result, a group tremendously vulnerable to the effects of medical underwriting for pre-existing conditions.  

Yes, I know, that it has been widely announced that pre-existing condition exclusions will be retained upon ACA repeal or revise.  Let's just say I'm  uncertain how this could be done without some kind of mandate or mass incentive to broaden and deepen the pool of insured with the relatively younger and relatively more robust.  In fact, the Paul Ryan proposal to allow age based  premium banding expansion to a 5:1 ratio, tells us that some health insurance for older low income, but not impoverished, seniors could get very spendy indeed.

Perhaps my favorite phrase in the entire article discusses the "highly improvisational" ways that those in the dead zone must seek out health care. That's one way to put it.  I think of improvisation as a way to accomplish something with the tools and materials at hand.  This looks a little more like desperation to me.