Author: Ann Marie Marciarille

I think of a surprise as something unexpected. Was the pandemic expansion of Zika truly unexpected?  

Kevin Outterson has had me thinking about this since Saturday when, in opening remarks at  the American Journal of Law and Medicine sponsored "Global Infectious Diseases: New Challenges and Solutions" conference he pointed out that the December 3, 2015 special supplement in Nature, predicting the next possible pandemics, did not mention Zika.  

This is true. This is notable. But the very last entry on Nature's list was the idea of the predictably unpredictable rise of a formerly known virus to pandemic levels through  a combination of possible mutation and certain increasing human travel and disturbance.  

As Anthony Fauci and David Forens have noted in the NEJM, "[Zika] has already reinforced one important lesson: in our human-dominated world, urban crowding, constant international travel, and other human behaviors combined with human-caused microperturbations in ecological balance can cause innumerable slumbering infectious agents to emerge unexpectedly."

We should, in short, expect the unexpected.  That a disease first identified in 1947 in Uganda,  then  lived in relative obscurity, primarily in wild primates and arboreal mosquitoes,  until its spectacular expansion beyond a relatively narrow geographic niche is a compelling story.  It is, in part,  a story about 5,000 years of adaptation by the  mosquito to life with humans using domestic water storage containers. And it is also a story about the rise of large scale domestic water storage in and near dwellings in water-starved parts of  Brazil.  That this evolutionary cascade would yield this kind of surprise, seen from this perspective, may not be entirely surprising. 

The real shock will be if we continue, in light of this, with our one bug one drug approach to treatment, rather than developing vaccine platforms for varied virus groups that can be quickly modified to attack newly emerging viruses.

I guess it all depends on how you feel about surprises. 

 

x-posted  at prawfsblawg

Goodbye to Vincent  Albert "Buddy"  Cianci, Jr. — a man who, whatever you think of him, certainly left his mark on the City of Providence. I would say that he was a Providence original if I didn't recall that though he was born in Providence he was a true son of Cranston and then, only later, the Mayor of Providence.

My absolute favorite excerpts from the eventual trial transcripts of "Operation Plunder Dome" (essentially, a RICO tapes case) were the parts discussing the selling points of various "no-show" or "low-show" jobs distributed by then Mayor Cianci. Steven Antonson, a Cianci-appointed City of Providence Building Board member, wasn't quite lucky enough to get that no-show or low-show appointment, however. Apparently, then Mayor Cianci really wanted him to show at Building Board meetings involving Providence's University Club and to wholeheartedly oppose all University Club petitions for building variances necessary for a pending re-model unless and until Mayor Cianci was offered a free lifetime membership in the University Club. What made it pure Buddy Cianci was not the apparent extortion but the ironic twist that the chief value of free lifetime membership in Providence's University Club appears to have been as payback for a rejected Buddy Cianci membership application to the Providence University Club in the early 1970's, decades earlier.

My favorite part of Buddy Cianci's sell of the Building Board appointment was Mayor Cianci's schooling of Steven Antonson on why it would be a smart move to accept it: "Remember, I appoint people to this board. You get Blue Cross. You get a check. You always said safety was important. Well, this is it."

Yes, Steven Antonson was among several would be appointees who chased the Mayor of Providence relentlessly for health insurance. Even wiseguys need health insurance. Go figure.  Or, as they say on South Coast, "Go Figah."

Steven Antonson eventually wore a wire and proved to be a fertile source of Buddy Cianci stories, many more of which you might glean from Mike Stanton's 2003 book,  The Prince of Providence: The True Story of Buddy Cianci, America's Most Notorious Mayor, Some Wiseguys, and the Feds.

x-posted at Prawfsblawg

Last week, the New York Times reported a tuberculosis outbreak in Marion Alabama so severe that TB incidence in Marion is now at a rate that exceeds TB incidence in much of the developing world. Marion is the county seat of Perry County and it is saying something when a city of roughly 3,600 people has had 20 cases of active TB diagnosed in the last two years alone, producing two TB related deaths.  Those who count TB infections do not typically  count latent infections — relatively easily if time-consumingly treated — though these have been documented in a further two dozen people.

Now, if there have been 20 active cases, the latent infection rate is likely much higher than that, but no one knows how much higher since screening for latent TB infection in the general population is not standard procedure in the United States. Why such screening for latent TB has not been pursued earlier in Alabama is a more difficult question. Long before the New York Times arrived on the scene, TB cases have been unusually high in Alabama. The number of tuberculosis cases increased in 2014 in  Alabama, but decreased nationwide. Across the nation, the number of new infections decreased by more than 2 percent. In 2014, there were 133 cases of tuberculosis in Alabama, compared to 108 the year before. The TB trajectory in Alabama has not been good for some time. 

The reasons for this are hard to parse. As the New York Times points out, there is a tradition of limited access to health care in this low income rural community where lack of reliable transportation to health care venues looms as one of the chief causes of limited health care  access. Since the data shows that those with transportation — disproportionately the insured — use that transportation to leave the community for health care, leaving the uninsured lacking transportation to seek care locally,  it is no wonder 54 of Alabama's 55 rural counties have official shortages of primary care providers. After all, good payor mix in your patient panel is one of the ingredients to successful sustainable  practice.

A people who lack the resources and opportunity to access care have a limited culture of care. The disincentives to leave the community, even when able to do so, are complicated by a general distrust of health care providers, particularly among African American residents.  Ironically, a provider-patient relationship built on trust may be the scarcest health care resource of all in Marion. 

But the situation is more complicated than this even, since the conversion rate between latent TB infection and active (or manifest) TB infection is not evenly distributed among the TB exposed population.Drug users, alcoholics, and, in particular, those who are HIV positive are particularly at risk of TB exposure converting into active TB. Drug use, particularly use of   injectables like heroin, appears to havemore than a toe hold in Marion. The Marion refrain "I don't want nobody knowing my business" in response to public health attempts at contact tracing for those with active TB may make more sense evaluated in light of access or lack thereof to drug treatment programs in Marion.

On the international stage, public health authorities struggle with the prevalence of active TB infection in injectable drug using and HIV positive  populations.  In the developing world, there is some evidence that financial incentives to promote screening and successful treatment, if required, have begun to make a dent in promoting the completion of TB treatment.  Interestingly, TB screening incentives are reported as now being offered to the entire Marion community and not exclusively to relatively high risk sub-populations such as the homeless or self-disclosed injectable drug users.

Is it that the United States Public Health Service and the Alabama State Department of Public Health as well as county public health officials  are unaware that broad screening incentives are not the norm?  Or, is it that in a community of a few thousand, the only way to screen at significant levels is to create an incentive for all to be screened in a de-stigmatized way? Whether it is folly or it is genius, only time will tell.  But if it is the syndemic of injectable drug use and TB or HIV and TB masquerading as an outbreak of TB alone that ails Marion, it will take far more than screening incentive payments and TB treatment incentive payments to right what is wrong with Marion — emblematic of so much that is amiss in rural low income America.

 

x-posted at prawfsblawg

 

For the past several months, a series of announced hospital settlements with the U.S. Department of Justice  under the Federal False Claims Act has been gathering momentum and interest.   Reported to be the product of years of investigative work, the 450 plus hospitals that have settled with the government for more than$250 million dollars are rumored to yet be only the tip of the iceberg of a nationwide investigation into the suspected overuse of implantable cardiac devices. These ICDs are spendy, costing about $25,000 each in comparison to a more conventional pacemaker that might cost less than 50 percent as much. It has been noted elsewhere that, "[c]ardiovascular disease remains one of the largest cost drivers in medicine."

Anything involving more than 450 American hospitals ought to be of interest and an investigation involving a rumored twice that number of American hospitals out to be riveting.  The fact that HCA has 42 hospitals, to date, involved in these settlements (though scores more, reportedly, involved in the investigation) also ought to be of interest. HCA's troubled history with overuse of lucrative cardiac treatments is the stuff of legend. HCA is a hospital behemoth, particularly in the disproportionately Medicare enrolled population of Florida.  An estimated two thirds of the entrants on this 2014 list of the most profitable hospitals in the United States are HCA facilities.  A full five percent of all U.S. hospital services take place at an HCA facility. 

In addition, the subterranean dispute beneath all this concerning  the role of Medicare National Coverage Determinations in the area of cardiac rhythm management also matters.  None of the three biggest hospital systems involved in the settlement agreements, to date, have conceded liability. Community Health Systems (31 settling facilities to date) delicately noted, in an October 2015 statement, that "[t]he issue involved a highly technical interpretation of a Medicare national coverage determination that was the subject of strong disagreement in the medical community."  But that is the rub, the Medicare National Coverage Determination on cardiac rhythm management and ICDs was not highly technical or particularly highly technical for a technical field.

It was controversial, however. It is worth thinking about why it was controversial. A Medicare National Coverage Determination is arguably one of the few restraints the Medicare system explicitly places on  provider discretion to determine the scope of Medicare coverage for a certain diagnosis. Medicare's general mandate to provide to its beneficiaries what is reasonable and necessary for the diagnosis or treatment of an illness or injury sets scant limit, in and of itself, on what may be covered. Medicare National Coverage Determinations are infrequently made and, to the extent they cluster in areas of high-cost arguably low-value care, they are always controversial.  They are, surprisingly,  non-transparent to  those, arguably, most interested in the scope of what Medicare might cover: Medicare beneficiaries. 

So, just what happened at these facilities? ICDs, apparently,  were implanted in many cardiac rhythm management patient Medicare beneficiaries that were not Medicare coverage reimbursable, falsely representing to the U.S. Government that they were (by billing for them and their implantation costs  through the Medicare program) and by representing to the individual Medicare beneficiary patient/implantee that they were within the Medicare scope of coverage for each of them.   

Was this the product of  dismal provider ignorance of the revised Medicare National Coverage Determination in this area? Was it confidence that the Medicare National Coverage Determination in this area would not be enforced so long as any conflicting practice protocol could be cited? Was it awareness that Medicare Coverage Determinations have, historically, been difficult to audit for compliance combined with a telling  lack of awareness that new Medicare data and data search capabilities would make it possible for whistle blowers — including two cardiac healthcare reimbursement consultants — to search out those hospitals and those individual providers implanting ICDs before the 40-day post heart attack milestone, for example, where a significant percentage of cardiac patients may no longer need something like an ICD?  Perhaps it was all of these things and more.

One thing we do know:  physicians billed for 70,969 of these devices under Medicare in 2008 and 51,052 in 2013, so somebody's reading the Medicare National Coverage Determinations now, at any rate. Now, that's a shock to the system. 

 

x-posted at Prawfsblawg

I have been following Vermont's all-payer claims database litigation, Gobeille v. Liberty Mutual Insurance Co. — argued at the U.S. Supreme Court on December 2, 2015. Perhaps you have as well. There is absolutely nothing like a good ERISA preemption dispute to to remind me of the force of Bill Sage's observation that is a case like this that reminds you why  you must explain "to every class of Health Law students… that ERISA [is] the most important law affecting private health insurance in the United States."

Strictly as an ERISA preemption case, Gobeille is interesting for how it may force the Court to parse yet again and yet further whether the collection of health care data by a state interferes with a core ERISA function belonging to the U.S. Secretary of Labor or whether state by state variable all-payer claims database reporting requirements are arguably unduly burdensome on the reporting entities and firms.   If you've read this far, I know you are fascinated by preemption, but even more importantly, such a decision would test whether or not the gradual movement of the states to mandating reporting of all-payer claims data has legs.

It is early days, but there is some evidence that the all-payer claims data has begun to influence health care cost to consumers and health care consumer decision making in New Hampshire (under its Comprehensive Healthcare Information System established by state law in 2007). The claim of price transparency triumphant, of course, is also balanced by arguments about adverse affects of health care  price transparency because limited research may also indicate that it causes rates to narrow and average costs to rise.

All of this is based on fairly little experimentation with health care cost transparency in the U.S. of the sort that may be developed from  all payer claim databases.  So just what is it that we would rather not know, rather not test empirically, about the competitive effects of the disclosure of this kind of information?

 

x-posted at Prawfs Blawg

I have written previously about Missouri's attempts to create a new category of health care practitioner: assistant physician.  You may recall, Missouri's goal is to re-direct non-matching medical school graduates to work as assistant physicians in medically underserved areas in the state.  

Who's idea is that, you say?  Why, an orthopedic surgeon's, though the bill was supported by the Missouri Medical Association, an organization tilted — as are all classic licensed health care provider organizations — toward non-rural providers.   And there's the rub: the rural provider community does not seem to be in love with the idea. Not surprisingly, the AMA and the licensed Physicians Assistant organization hate it.

It is reported that several other states with significant rural populations and chronically underserved areas are watching Missouri's roll out.  This is where it gets tricky. Gov. Nixon's signing message included warnings about consumer protection. The new legislation will require significant scope of practice, licensing, and regulatory work to even approach implementation. This all might help explain why, at about 18 months out, Missouri has not seen one assistant physician.

The larger issue is whether sidestepping medical residency (a multi-year experience for the typical practicing physician and at least a one year experience under traditional Missouri standards) is the way to ease the shortage of primary care providers in medically underserved areas.  

Why not also expand scope of practice under very restrictive Missouri standards to allow every licensed health care practitioner to work to the limits of their training? Ah, because the fight over collaborative practice requirements for groups like advance practice nurses is a fierce one in Missouri.  The assistant physicians hew to the old collaborative practice standards and break no new Missouri ground on independent practice.  I suspect that is the tail wagging the dog here.

 

 

 

 

Yesterday, Kaiser announced its intention to open a medical school in Southern California.  Fresh from the press release, I mentioned the announcement to a friend. His reaction: "Would they actually  name that school: Kaiser Permanente Medical School?'  

I've been thinking about that question ever since. In the moment, my response was "why not?" or "why not Henry J. Kaiser Medical School?" but, afterwards, I thought he may have been tapping into some reserve over a "branded" medical school, one conspicuously designed to take the Kaiser care model to the source of physician training. But if a particular team primary care based approach is associated with the name, why not use it?  After all, Kaiser Permanente's Allied School of Health Sciences  in Richmond, California is named just that.

What of the idea that a medical school could be too closely aligned with one service delivery model and so tarnish its academic reputation in some way by taking that model as part of its name? Or, does it reek too much of grow your own talent in its explicit anticipation that Kaiser expects many of the students at its medical school to focus on primary care and go on to work with Kaiser?

The tricky part is that I am not certain existing medical school education does not involve the close alignment of a branded medical school with a particular care-delivery  model associated with that school that then brings it back to the source: physician training. Does anyone really imagine that medical school training at, say Stanford Medical School, models health care delivered in a multi-site high-tech care-delivery system like Kaiser or is what is going on there more like the high-tech academic medical center ("AMC") model of care (though some of Stanford's medical students do seem interested in PC)? 

Many have observed that the AMC model is probably not the ideal environment in which to cultivate community based primary care medical practitioners. Now, Kaiser appears poised to take this observation and turn it on its head: what would be the ideal environment in which to cultivate and train community based primary care physicians organized in a team delivery model serving one of the most diverse populations in the entire United States look like?  

I can hardly wait to see what they propose. 

Just in case it crossed your mind while reading my two previous posts, it is probably important to know up front that the incarcerated may not use the exchanges to purchase health insurance. For this purpose, however,"incarcerated" has a fairly narrow meaning: excluding probation, parole, or home confinement. In addition, you are not incarcerated if you are in jail or prison pending disposition of charges. Still, the interpretation of ACA Section 1312's language stating that a prisoner "shall not be treated as a  qualified individual, if at the time of enrollment, the individual is incarcerated, other than incarceration pending disposition of charges" has generated a fair amount of confusion.

Many of the imprisoned, on the county jail level, are essentially transitory in that status. The relatively long fuse on applying for health insurance through the exchanges or Medicaid, for that matter,  and then the wait for actual enrollment, probably made this seem mostly a theoretical concern from the perspective of an entity seeking to lower its own correctional health care costs  Of course, if the emphasis were on preparing the incarcerated individual for re-entry, jails would be a clear point of contact for newly eligible individuals for both exchange purchased and government funded health insurance.

As the National Association of Counties points out,  it might be difficult to identify a population more in need of behavioral health services, for example, than the currently imprisoned. For that reason alone, county jails and all correctional authorities ought to be priority locations for assistance in applying for health insurance coverage, whatever the source.  An estimated fifty percent of prison or jail inmates have a mental health problem. Not surprisingly, an untreated mental health problem marks a prison or jail inmate as more likely to have been involved in a fight inside the facility since incarceration. As one group of authors so poignantly asked: When Did Prisons Become Acceptable Mental Healthcare Facilities?  Or, for that matter, when did prisons become unacceptable mental healthcare facilities?  Are they really healthcare facilities at all?

Post-incarceration, the same individuals may be eligible for subsidized exchange purchase. The recently released have a sixty day special enrollment period. After that, it is necessary to wait for the next exchange open enrollment. 

Originally, Medicaid was interpreted to mean a loss of eligibility status upon imprisonment. Section 1905(a)(A) of the Social Security Act prohibits Federal Financial Participation in funding medical care provided to inmates of a public institution, unless the inmate is a patient in a medical institution. As far back as December 12, 1997, DHS clarified that an inmate may not  be funded by FFP unless the inmate becomes a patient in a medical institution on an inpatient basis (now defined as an inpatient stay of at least 24 hours).  This exception was also extended to those on probation, parole, or home detention. The thinking was that the Eighth Amendment obligation of the correctional facility to provide care should not be shifted to other funding sources under ordinary circumstances. From this perspective, each state or county or other political unit would bear the Constitutional cost of its incarceration policies as well as its Medicaid plan design. 

All of this did not excite too much attention until the passage of the ACA.  Once the dust settled on theNFIB v. Sebelius  reinterpretation of Medicaid expansion under the ACA, it became apparent that now-optional Medicaid expansion states had opened Medicaid eligibility to populations beyond infants, children, pregnant women, people with disabilities, and some seniors.  Many of the incarcerated were, in fact,  newly eligible under expansion Medicaid. The fact that expansion Medicaid offers a FMAP of 100 percent through 2017, probably also helped to catch the attention of some states. The enhanced Medicaid match rules found in the ACA were, after all, meant to be attention getting.

Delaware, Louisiana, and Oklahoma were reported to be the first states to access Medicaid dollars for inmate hospitalization.  Other states have been slower to adapt or slower to broker the necessary cooperation between corrections, Medicaid, and the local social services agency.

Even non-Medicaid expansion states, like North Carolina, appear to have become motivated to identify their Medicaid eligible inmates receiving Medicaid eligible services.  In 2013, for example, roughly three percent of North Carolina's inmates had recorded inpatient stays but only one percent of these were Medicaid allowable inpatient stays. Similarly, in 2013, roughly six percent of California's inmates had inpatient stays with just over two percent of those stays deemed allowable inpatient stays. This means that, in 2013, California drew down $38.5 million dollars for these allowable inpatient services for inmates and North Carolina $2.5 million dollars.

Interestingly, North Carolina found these federal funds so attractive, the state reported hiring or training state prison staff to assist in enrolling inmates — this in a a non-expansion state not historically terribly focused on assisting the rest of its citizens in applying for Medicaid. You can now apply for Medicaid in North Carolina online, however, and this may partly account for the post-ACA North Carolina Medicaid enrollment surge.  North Carolina, instead, has decided to focus on turning Medicaid toward Medicaid managed care, reforming but not expanding Medicaid. But, if you're a hospitalized inmate, apparently they might want to really help you.

Your ability to timely apply for Medicaid as you approach release depends upon your ability to navigate the Medicaid application alone or, if you require assistance,  the quality of the negotiated agreement between your correctional facility and the and the local social services agency. Then, in a sense, you're just like everyone else in North Carolina.

Does all of this make sense?  Ought California be able to shift some of the financial cost of its Three Strikes Sentencing  Law approach to incarceration to the federal fisc —  really other states? Is it defensible as part of a grand bargain to expand Medicaid to much larger populations under the ACA?  And what's North Carolina's narrative?