Author: Ann Marie Marciarille

As a Health Law professor, I probably observe the health care encounter a little bit more carefully than most. Today, I sat in the waiting room at the MRI clinic, watching the arrival of the closely stacked appointments — each patient efficiently but speedily ushered through eight pages of medical forms, co-pay and deductible calculations and payments, and one  pre-treatment, pre-disbute physician-patient arbitration agreement each. Some of the patients came fully "prepped" — having complied with elaborate physical preparations for their MRI.

California has a long tortured path to its current understanding of the legal enforceability of pre-treatment pre-dispute voluntary physician-patient arbitration agreements. Although MICRA's provision permitting such agreements was passed much earlier, it was not until Ruiz v. Podolsky in 2010 that some important aspects of the statutory language were clarified.  For those of you wondering, yes such an agreement is legally binding upon you and your heirs in California, so long as the agreement is truly voluntary.

How voluntary you say?  Would presenting the physician-patient arbitration agreement at the time of treatment give enough time for review?  Would presenting the agreement at the entrance to the treatment room door possibly undermine the notion of voluntariness, particularly if the treatment was difficult to schedule, hazardous to health to delay, or very challenging to re-schedule elsewhere in a plan with narrow networks?

This gets tricky.  The American College of Obstetricians and Gynecologists (in 2014) offered an opinion that a provider may not condition treatment on an obligation to sign such an agreement but this is a national perspective. Closer to home, the California Medical Association opines that a physician may decline to accept a new patient who refuses to sign a medical arbitration agreement, implying that the only time to confront this  issue is before the start of the patient-provider relationship.  But, this still begs the question of what kind of advance notice of such a contingent assent is required and how far in advance it must be solicited to meet the voluntariness requirement. As many insurers require that an MRI be provided only upon referral, ought the disclosure of the mandatory assent to the physician-patient arbitration agreement be made at the point of the referral itself?

From one perspective, arbitration agreements are an expression of freedom used to articulate a previously agreed upon mechanism for dispute resolution. From another, they fulfill the promise of MICRA in helping to contain costs associated with medical negligence claims.  How the provider-patient relationship became, in California, the best manifestation of the environment in which to express and experience such freedom of contract might bear re-thinking, especially  in light of significant  diversity of opinion about MICRA's accomplishment of its goals. 

I have been watching the battle over the interplay between the Affordable Care Act ("ACA") along with its implementing regulations and the Public Health Services Act ("PHSA") in the Central United Life litigation.  On July 1, 2016, the D.C. Circuit affirmed the federal district court determination  that HHS lacked proper administrative authority to promulgate a regulation applying the ACA's minimum essential coverage rules to indemnity health insurance.  HHS was found, in attempting to limit indemnity health insurance sales to those who were already covered in compliance with minimum essential coverage requirements, to have "colored outside the lines" of its authority in a display of "administrative overreach."

Indemnity health insurance has a few different variants on a motif, but the principle is health insurance coverage that may be capped at a fixed amount for a particular service or for a particular calendar period.  Indemnity health insurance, for example,  may insure an enrollee for $500 a day and no more for hospital services, whatever the actual expense of the hospital services provided. It is, in short, thin insurance and is often — though not always— sold with a more affordable premium than comprehensive or major medical insurance.

Do we know how many Americans are enrolled in such insurance with any certainty? No. One estimate of four million enrollees is probably most useful as the "low" in a "high-low" estimate. 

Do we know the demographics of American enrollees in indemnity health insurance products with any certainty? No.

There does seem to be some consensus that this kind of product might be attractive to a variety of demographic groups. Indemnity health insurance may be  health insurance of first choice for those who are invincible while also being  health insurance of last resort for those Americans in the coverage gap, excluded from  their state's health insurance exchanges because they do not earn 100 percent of the federal poverty level but ineligible for Medicaid in their state because their income and assets are too high. Remember, the indemnity health insurance purchasers of first resort are gambling that their indemnity insurance premiums plus their ACA non-minimum essential coverage fine or tax will be the rational economic choice for their annual health insurance needs. 

The knock on indemnity health insurance, historically, has been that many individuals do not know what they are buying (and what they are not buying) until it is too late. Certainly, the evidence that we are a health insurance illiterate people is strong. But it is also probably true that many low income individuals understand all too well that these indemnity health insurance products as stand alone health insurance are meant to be health insurance of last resort for them.  This group purchases it, in short, because it has no other feasible health insurance option.

Someone wise observed that these products, for this last resort population, represent the pay day loans of health insurance. Indeed, low wage earners are often both unbanked and uninsured.

Universal Health Services v. Escobar involves a allegation of the violation of the Federal False Claims Act by Universal Health Services (through its subsidiary Arbour Health System)  in its provision of mental health counseling services to teenager Yarushka Rivera of Lawrence, Massachusetts under that state's Medicaid program.  Yarushka died in 2009 at the age of 17 following multiple seizures after several years of treatment, including the prescription of strong prescription drugs to which she apparently had an adverse reaction, received at one of Universal's Lawrence clinics. 

Those interested in the Federal False Claims Act and the theory of implicit fraud or implied certification theory of FCA liability — including myself — have reviewed the Supreme Court's recent opinion with interest. After Yarushka's death, a clinic worker apparently came forward to her parents to advise that those who had been treating the teen were not qualified to do so under state licensing and Medicaid regulations.

The case hinges on whether the clinic's billing of the Massachusetts Medicaid program, without disclosure of the failure to comply with the relevant credentialing and supervisory regulations, was an implicitly false claim under the implied certification theory of FCA liability.  From one perspective, the filing of the claim for reimbursement implied that the relevant providers were appropriately credentialed for the services provided and the method in which they were provided. Alternatively, silence as to credentials and supervisory standards might be construed as just that: a non-representation and, had the state deemed the credentialing and supervisory standards absolutely critical to the payment of the claim — materially relevant — they would have been called out as such. This is, as a result, a case about the sounds of silence and about materiality.

Half truths are funny things. Benjamin Franklin reminds us that "Half a truth is often a great lie." The willful omission of information the reasonable consumer and/or payer would deem essential to acceptance of the services and payment for the services cannot serve to insulate the half truth teller or can it?  Here's Justice Thomas for the majority:

Accordingly, we hold that the implied certification theory can be a basis for liability, at least where two conditions are satisfied: first, the claim does not merely request payment, but also makes specific representations about the goods or services provided; and second, the defendant’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths.

There is another kind of half truth in this case.  This is the half truth we tell ourselves when we say this case is about bureaucratic regulations and health care fraud alone. This case encapsulates so much more. I have to ask myself how it could be that one of the largest mental and behavioral health providers of services to low income individuals in Massachusetts conducted themselves, for as long as decades at a time, in violation of credentialing and supervision requirements put in place out of concern over safety and quality.

It may be that "don't ask, don't tell" is another kind of half truth — also the kind that is often a great lie.  A reluctance to inquire too closely, until shamed into doing so, into the bona fides of one of the largest providers of mental health and behavioral health services in the entire state of Massachusetts may stem, in part, from the reality of the extreme shortage of mental and behavioral health providers available to the Medicaid population. This is  particularly  true in Lawrence, Massachusetts, the poorest city in Massachusetts and one of the poorest cities in the entire United States.

The fifth volume of Karl Ove Knausgaard's "My Struggle" is out in English translation.  I am almost through it and then will, once again, be bereft of Knausgaard's struggle until the final volume is available in English translation or until I teach myself to read Norwegian, whichever comes first. Don't think I haven't considered it.

There is a beauty to Knausgaard's careful examination of the events of his life, often repeatedly, from the vantage of different times in his life that seems Proustian to me. It is almost unspeakably touching to hear him reflect on his youth from the vantage of near youth, young adulthood, and even middle age. Each telling is the same and yet it is different, offering a meditation on the nature of memory, meaning, and the construction of a self. In Knausgaard's words: "Meaning requires content, content requires time, time requires resistance." (Book One, "My Struggle")

In Book Five, Knausgaard works in various health care facilities for a while, complete with harrowing stories of his work, but it is as visitor to his grandfather — a cardiac patient — that we encounter his meditation on the nature of objectification in health care. Struck by the highly compartmentalized nature of services in the hospital, Knausgaard visits his grandfather in the cardiac ward and reflects on how his grandfather is both objectified as a heart patient and reduced to his identity as a heart patient in the facility, becoming someone less than Knausgaard knows him to be in the process. Once we decide to "collect all physical suffering in one place" and categorize the suffering by organ, it is inevitable we would need to see the organ's host somewhat objectively.  "[F]or hospitals all hearts are the same." (Book Five, "My Struggle")

Apparently persuaded that you will know a non-profit hospital when you see one, the IRS has been busy developing some of the new conditions attached to federal tax exempt status for acute care facilities required by Section 9007 of the  Affordable Care Act. IRS Section 501(r)'s, new requirements applicable to charitable tax-exempt hospitals. These requirements include the obligation to perform a community health needs assessment every three years, the obligation to establish written policies on financial assistance and emergency care, and the imposition of certain limitations on billing and collection actions.

Now, charitable financial assistance at the acute care level has long been a thorny issue. California has required reporting of charity care by acute care facilities for some time, and that data has been fascinating. Since California's reporting didn't require any real standardization of the definition of charity care, merely a snapshot of a facility's own definition and provision of charity care, the first thing that became apparent was that definitions of charity care may often be in the eye of the beholder.  In particular, the decision to include written off bad debt as charity care can have a significant effect on the calculation of the charity care rate or percentage of operating income.  The second thing that became apparent was the fact that, in California, for-profit or investor owned facilities appeared to provide as much or more charity care than tax exempt charitable facilities. The third interesting insight gleaned from the California data was that the provision of charity care in acute care facilities was not evenly distributed between and among facilities, not by a long shot. Further, a study of institutional response to a Texas statutory requirement that acute care charity care be provided at a certain minimum level showed that the statutory threshold requirement served to level the provision of charity care, but reduced the total amount of charity care. This implies  that the acute care providers — left to their own devices — defined their fair share differently or that there is a natural tendency to see the regulatory threshold as both the floor and the ceiling in these kind of matters — a target to be hit but not overshot or undershot. Standardization has its risks, particularly if the standardization is to quantity but not as to quality.

The IRS, perhaps drawing lessons from both the California and Texas data, has not seen fit to define charity care for the acute care facilities.  They are to define it themselves and each is left, as at present, to design its own eligibility criteria for charity care. This means the new rules are all about disclosure. Of course, disclosure itself may produce the same leveling effect discussed earlier, perhaps with a loss of total charity care.  But, this would be hard to know as reporting has been so relatively sketchy to date.

I am interested in  just who this disclosure of widely variable definitions and eligibility criteria is supposed to help. Is it consumers who, once advised of the existence and terms of the programs, per the new regulations, will become wily analysts of the acute care institution charity care programs in their communities? 

More importantly, perhaps uncompensated care — in a culture of coverage — is more likely to tend to become a function of un-affordability rather than un-insurance. Preliminary data on hospital uncompensated care from several large acute care hospital chains may bear this out.  This is the situation where an insured person appears at the facility with ACA acquired high deductible health insurance or with Medicaid in an expansion state with co-insurance requirements. The hospital accepts the coverage, but struggles when the patient fails to pay their after-billed high deductible or co-insurance amount because of un-affordability.  

Interestingly, the Mosaic acute care system in Missouri  is reported to have recently announced its decision to allow those in arrears on acute care payment to still be evaluated for patient charity care assistance for ongoing services.  That is more than Indiana's expansion Medicaid offers its very low income non-payers of Medicaid premiums. For some low income individuals in some states, it might be better to approach an acute care facility without any insurance at all, rather than as an expansion Medicaid enrollee with un-affordable premiums and co-insurance. 

Sometimes a conversation overhead in a public place will be so powerful, so forceful, that I fail at the willed blocking out of its content.  If you sometimes work in coffee houses, you probably know what I mean.  Snatches of personal — even intimate — conversations must be studiedly ignored, both to get things done and for the good of your own sanity.

I could not turn it off, however, a few days ago when a middle aged man sat at the next table in a local coffee house, took a sip of coffee, pulled out his cell phone, and (apparently) called his doctor's office to report that he was calling for the fifth day in a row asking to see his doctor because his morning urine was bright red with blood — a new occurrence for him.   The man was calm, even analytical, in discussing the various shades of red produced on different days as compared with the color of his ordinary morning urine. But I could hear a tone of fear underneath his matter of fact request. The side of the call I heard indicated the man was fully insured with commercial insurance and had an ongoing relationship with his primary care physician. He left a message, indicating he had done the same for the previous four mornings to no effect.

I was just returning to my work when his cell phone rang. His primary care physician was on the telephone directing him for blood work and an MRI as well as a possible referral to a urologist. He seemed surprised that he had finally attracted enough attention to have gotten a response, politely thanking the provider (who called him two times in the next fifteen minutes with further updates on next steps), indicating he would proceed to the lab as soon as he finished his coffee.

Now, I am aware that many things can cause blood in your urine — everything from a simple infection to bladder cancer. I understand that different people have different tolerances for risk and different people also show different levels of persistence. But I was taken aback by the casual administrative cruelty of not either calling this man back to advise him of the wisdom of watchful waiting or on how and when to proceed until his fifth telephone message.

KCUR-Kansas City Reporter Dan Margolies and I had a pretty wide-ranging discussion on physician supply several weeks ago. Now he has produced an interesting radio segment on why so few providers of health care services focus on elders, though elders disproportionately consume health care resources.  

One thing Dan and I discussed that did not make it into his article was my speculation that, though there is evidence that current medical students have somewhat different values and perspectives than have formerly been attributed to those currently practicing medicine, it may be a reach to expect the overwhelmingly relatively young and the overwhelmingly relatively robust to have a powerful natural interest in the health and well-being of elders. One thing that has not changed all that much in the past several years is the average age of the person attending medical school.

I have noticed that an interest in Elder Law is often fostered by an attorney's lived experience with our health care system or our Social Security system, often developed while helping a relative or a friend. When I consider that, I wonder if geriatrician recruits ought not come from those who have lived a little bit more of life before starting medical school, perhaps even having been involved with elders in a health care or non-health care setting.

Of course, this would mean actively recruiting students for medical schools in some cases, a concept perhaps at odds with current medical school student admissions and that might require re-thinking the debt-financed nature of medical education. As medical residency is already funded by government funds, this may not be as unusual as it sounds. 

California's End of Life Option Act is scheduled to take effect June 9, 2016. The Act allows, but does not require, medical professionals in California to assist qualified terminally ill patients to end their lives by providing them with script for certain medications in life-ending doses, which the patients may then self-administer. The Act is quite similar to Oregon's Death With Dignity Act.

Huntington Hospital made the  news a week or so ago for reports of  a medical leadership vote to "opt-out" of the statute, a vote that would need to be ratified by the hospital's board of directors on May 26, 2016 in order to take effect.  This is a position that has garnered considerable attention from the press. Huntington Hospital is a large non-religiously affiliated hospital in Pasadena.  As the Los Angeles Times points out, Huntington has more than 800 active physicians serving residents of the greater San Gabriel Valley and beyond, noting that many local doctors with their own practices might be unwilling to jeopardize their access to Huntington by assisting terminally-ill patients under the terms of the law.

As Oregon DWDA policy analysts have noted:  "Institutional refusal may create conflicts for both patients and health care professionals. An attending physician may wish to provide a prescription for an eligible patient under the Oregon Act but be prohibited from doing so by the institution or system. In such an instance, his/her responsibility to the system conflicts with responsibility to the patient. The physician may also be limited in his/her ability to refer the patient to another physician for continuity of care if the patient’s health care system doesn’t participate in the Oregon Death with Dignity Act or restricts referrals (see Attending Physician and Consulting Physician)."

Health care provider participation in California's End of Life Option Act will also be optional.  Oregon's reported experience with its DWDA tells us that not all Oregon providers make this script writing service available to their patients. The latest statutorily-mandated report on Oregon's DWDA tells us more.  A total of 106  Oregon physicians wrote 218 of these prescriptions during 2015 (1‐27 prescriptions per physician). As even some of the fiercest opponents of Oregon's DWDA note, the Oregon data reveals  a significant number of Oregon's physicians decline this service to long time patients. Patients must then find a new provider if they wish to pursue this service. 

Perhaps the most important fact in all of this is that, in Oregon, no physician was present in 90 percent of the cases when the roughly 50 percent of script recipients actually used the script and died.

Why would  a huge non-religiously affiliated acute care facility feel the need to remove the opt-out decision on ELOA participation from its  individual medical staff entirely and decide the issue for them with an institutional/system-wide opt out?  It is hard to say. There is no press reportage on motive — perhaps the single most interesting aspect of all this.  In fairness, press reportage in Oregon and Washington on non-religiously affiliated systemwide opt out under those statutory schemes was also shallow.

This may be a principled position about the kinds of values required of physicians who practice in a particular institution or are hoping to be affiliated with a particular institution. Or, it may be something else. Acute care hospitals in California are places of dying and end-of-life care on a massive scale already and on a scale that considerably exceeds the American average: end stage fatal diagnosis cancer patients spend less time in hospice, more time in the ICU, and more time visiting physicians in the last six months of their lives than do  Americans with similar diagnoses outside California.  No doubt, a culture shift may also be involved in all of this.

Oregon's policy analysts advised: "Systems that choose not to participate in the Oregon Act should notify patients and health care professionals in advance."  This makes sense. But, just how many of us — in an era of narrow networks — choose our health care practitioners (who, data shows, in turn choose our acute care facility) with a single-minded focus on end of life care and aid-in-dying care?  Even the Consumer Reports-produced admirable guide on how to select a physician doesn't mention this one. I had no luck finding that information available on Physician Compare.  What does that mean for the unsophisticated consumer? 

 

The concern that making patient health information and health records highly portable or transferable would also make it harder to retain patients has stalked the the subject of electronic health records for some time.  Of course, patient health record portability or transferability limitations designed  to stem patient loss or transfer was an issue long before EHRs as well. This was part of  the story behind the contact lens and eyeglass prescription consumer access rule. The question of who owned patient health record data lurked in disputes between providers and insurers as well, long before the rise of EHRs on any scale.  

Yes, those patients with open access to their medical records and access to an interoperable EHR have one crucial ingredient necessary to becoming mobile. In reality, not everything important to the health care provider patient relationship is found in a medical record and patients often feel tied to long-time providers by bonds of trust and familiarity, but other encounters may not be shaped as much by this.

A few years ago, what is now known as health care data blocking began to be discussed in the EHR world.  Providers (institutional as well as individual or group) may not, in fact, have desired full interoperability of EHRs across medical systems if it meant free transfer of patients across medical systems. 

EHRs are hard to develop and hard to integrate with existing health care privacy rules but there was a dawning recognition that some of this complexity may have been exacerbated or even manufactured by providers concerned about the business implications of what I call "un-tethered patients."  It is also worth noting that a huge industry has grown up around interoperability challenges,  self-interested in emphasizing the complexity and the difficulty of interoperability and exquisitely attuned to the financial risks of full interoperability.

But, the cat is out of the bag. Late last month, CMS proposed a rule that would require physicians accepting Medicare assignment and being paid under the Merit-Based Incentive Payment System (MBIPS) and those participating in the meaningful use program (both designed to promote and reward the use of interoperable EHRs between and among providers) to attest that they do not engage in health information blocking and to run the risk of a Federal False Claims Act violation if they falsely attest as part of billing Medicare. The actual requirement is an attestation that the providers have not "knowingly and willfully taken action.. to limit or restrict the … interoperability." This also includes an obligation to implement for interoperability and to make timely interoperability a priority. This means, under the proposed rule, that health care providers may be investigated or audited for this as well. This supplements a warning from the OIG that Anti-Kickback Statute safe harbors designed to promote EHRs were not intended to shelter health information blocking EHRs.

The tricky part is that  it is  difficult to apply a knowing and willful standard in such a complex and evolving area. Perhaps this is no more than a CMS shot across providers' bows indicating that they are wise to something.

We might do well to consider what  health care provider information blocking practices tell us about the business case for  genuinely interoperable EHRs; it is not compelling. This is the real takeaway:  participation in the MBIPS or meaningful use programs may not offer sufficient financial rewards to health care providers (particularly health care systems, such as acute care hospitals, that rely on brand loyalty).

If un-tethered patients are more mobile between and among systems, this may be a good thing for the price sensitive health care consumers among us.

 

 

I don't know Amy Tuteur. I do know that someone who writes so authoritatively about relative risk in hospital and non-hospital births probably ought not wait until the last quarter of a New York Times Article to disclose "Personally, I would always opt for a hospital birth." If you have strong opinions, it seems to me, that you should  announce them at the start. That way, people can read what you say in comfort instead of wondering "who is this?"  And, then you will be better at avoiding sounding like you are making claims to either neutrality or expertise that you lack. Her recent New York Times article is powerful, though it does nothing to explain why C.P.M.'s flourish in a system where C.N.M.'s are available — much of the real story behind C.P.M. use by American women. And if you think that American women simply misunderstand relative risk, then the easy fix is better education of women about risk. What if choice of a C.P.M. isn't about genuine choice at all but rather where most women who want a home birth end up because licensed midwives often require, as a condition of licensing, obstetrician backup which many providers and their insurers will not allow to be provided in the home?  Ah, but then it would be so much more complicated, so much harder. 

Here is Amy Tuteur asserting that midwives ought be required to obtain and carry liability insurance because no insurer will cover them if they are not safe. If she's relying on the liability insurance industry to police the health professions for quality, she is going to be waiting for a while.  Malpractice insurance underwriting is not as simple as that — neither in the distinction between community rating and experience rating (or merit rating) nor in its time frame for responsiveness to both claims and payouts.