Recommended Reading, “Regulating Conflicts of Interest in Research: The Paper Tiger Needs Real Teeth”

Jesse Goldner’s Regulating Conflicts of Interest in Research:  The Paper Tiger Needs Real Teeth, 53 St. Louis U. L.J. 1211 (2009), is a must-read for anyone who has anything to do with oversight of researchers’ conflicts of interest.  The article reflects an insider’s understanding of academic physicians’ perspectives on this still-contentious topic, provides a terrific survey of the literature, and proposes regulatory fixes by the feds that HHS will hopefully seriously consider.  The article’s timing is perfect, given that HHS is receiving comments until August 19, 2010 on proposed changes to its conflict of interest regulations.  See http://grants.nih.gov/grants/policy/coi/. Even in the short time since the publication of Goldner’s article, HHS OIG has issued yet another report on conflicts of interest management, entitled “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health,” (Nov. 2009), available at http://oig.hhs.gov/oei/reports/oei-03-07-00700.pdf.  Based upon an in-depth audit of 41 grantee institutions that reported conflicts in FY 2006, the OIG found that equity interests represent the most pervasive form of financial conflict of interest. The most popular tool employed by entities managing conflicts is disclosure to publications or at academic presentations; entities only rarely required the reduction or elimination of conflicts.  As important, and unsurprising based upon AAMC surveys, is the unreliability of the conflict reporting mechanisms used by most academic institutions.

The OIG report emphasizes the need for increased oversight of conflicts of interest.  Academic medical centers have had plenty of time and forewarning to address the issue but, as demonstrated by a vignette described by Goldner about his own efforts to accomplish this through the IRB which he chaired, faculty resistance is significant.  Consequently, Goldner is exactly right in calling upon HHS to issue aggressive regulations that accomplish the necessary reforms.  He would require the establishment of conflict of interest committees at every research institution, comprised primarily of independent members, to which faculty would report all financial relationships that create conflicts of interest. Resolution of such conflicts would be a condition precedent to proceeding with proposed research, and violations would result in significant penalties, including debarment from research.

As shall be discussed in a forthcoming Seton Hall White Paper entitled The Limits of Disclosure as a Response to Conflicts of Interest in Clinical Research, I do not have confidence in benefits accruing from requiring disclosure of conflicts to research participants in consent forms, although research participants do have a right to know of such conflicts.  This is a minor quibble.  Goldner’s article is a great contribution to the literature. 

Recommended Reading: Nonprofit & Tax Law

James J. Fishman’s Stealth Preemption:  The I.R.S.’s Nonprofit Corporate Governance Initiative, recently posted on SSRN, joins the growing chorus of critics of the IRS’s preemption of state nonprofit corporate law via the addition of an entire “governance section” to Forms 1023 and 990.  The underlying hypothesis is, of course, that by virtue of asking particularized questions regarding governance, the IRS will affect changes to facilitate the provision of the “right” answers on the respective forms; the IRS specifically acknowledges that no federal tax law addresses most of the issues about which it inquires.  The article is a great survey of the bases of criticism of the IRS foray into governance reform, particularly as it applies to the medium to small nonprofit.  It also catalogues examples of applicants being denied 501(c) (3) exemption as a result of concerns about, for example, conflicts of interest which, Fishman explains, the IRS appears to believe are per se bad, without an acknowledgement of why they may be necessary and appropriate for the small nonprofit, and can be managed, as is required by state law, to avoid foreseeable evils.  An important theme of Fishman’s article is the lack of empirical data showing that the IRS’s structural governance preferences actually have a positive substantive impact on the operation of nfps.

John D. Columbo’s The NCAA, Tax Exemption, and College Athletics, 2010 U.Ill. L. Rev. 109 is simply fun for those academics who enjoy complaining about the outrageous salaries of coaches, or who flinch at the reference to the “scholar athlete.”  More relevantly, however, Columbo’s article comprehensively outlines the doctrine relevant to analyzing the sparse legal guidance available regarding the assessment of the reasonableness of executive compensation, and whether it violates the prohibition on inurement or excess private benefit. This analysis is timely as well: the IRS may be on the verge of  delving into the salaries of coaches as part of its college audits. The article also makes incredibly accessible UBIT analysis, also of importance in teaching health law.  Like most of Columbo’s work, he makes hard concepts seem easy. As the IRS may be taking a closer look at coaches’ salaries.

Recommended Reading: Nonprofit & Tax Law

James R. Hines, Jill Horwitz & Austin Nichols’ The Attack on Nonprofit Status: A Charitable Assessment, just posted on SSRN, forthcoming in 108 Mich L. Rev. 1179 responds to the literature advocating for tax benefits to any entity, including the for-profit, that engages in charitable activity, regardless of organizational status.  Ultimately, the authors argue for the exclusive retention of tax exemption for the nonprofit firm, employing economic analysis and extant though limited empirical data to suggest the superior efficiency, higher quality and lower costs of nonprofits for at least some charitable activities.  The article is rich with empirical data about the demographic differences between the for-profit and non-profit employee, from which it suggests employees of the two sectors may be differently motivated –  by altruism as opposed to monetary incentives — thereby reducing costs and arguably increasing efficiency and quality.  Professor Horwitz’s work always makes an important contribution to the literature, and she doesn’t disappoint in this article either.

Lloyd Hitoshi Mayer and Brendan M. Wilson’s Regulating Charities in the 21^st Century: An Institutional Choice Analysis, available on SSRN, forthcoming in Chicago-Kent Law Review, invokes institutional choice theory to determine the best locus for the regulation of the charitable sector.  The article concludes that charity governance, comprising rulemaking and enforcement, best resides in a state agency independent of but related to the attorney general.  This outcome respects the historic role of the state in regulating charities, takes advantage of the state’s expertise in nonprofit oversight, and enables the state to be nimble in its regulatory approach.  The provision of sufficient funding remains a concern with this choice. Also of concern is inter-state consistency in regulating the multi-state nonprofit charity; inconsistency can foster regulatory arbitrage.

Recommended Reading: Nonprofit & Tax Law

Miranda Perry Fleischer’s Theorizing the Charitable Tax Subsidies:  The Role of Distributive Justice, just published at 877 Wash. U.L. Rev. 505 is a must-read for anyone asking what justifies hospitals’ tax-exemption in a post-reform world.  The least that can be said for this incredibly thoughtful article, which is apparently the first in a series on the topic, is that it provides a superb overview of tax-exemption theory for those who do not regularly read this literature.  It is perfect background reading for the non-tax teacher who introduces students to the topic in her health survey class, or the person who just wants a quick overview of the extant theoretical justifications for the charitable tax exemption.  Fleischer makes two primary points.  First, she chides tax theorists for their failure to acknowledge that tax exemptions for charities, and the attendant deductibility of charitable contributions, are redistributive. Second, she seeks a clearer justification for the determination for the charitable exemption, and convincingly enumerates disparate examples that prove the lack of coherence of current IRS policy, particularly with respect to the question as to whether charities are expected to serve the poor.  Unsurprisingly, hospitals are but one example.  She urges the adoption of a moral theory to facilitate the development of a coherent system of tax exemption, and starts the process of describing potential outcomes if we subscribed to a utilitarian, maximin, egalitarian or capabilities approach to defining charity.  Apparently, this project will be further developed in future articles, which is just in time, at least for the health care sector.

Jessica  Berg’s Putting the Community  Back into the “Community Benefit” Standard, just published at 44 Ga. L. Rev. 375, represents one of the first articles of what can be expected to be a flurry of post-PPACA proposals to reform the criteria for hospitals’ tax-exempt status when  charity care begins to decrease, at least in some markets (undocumented aliens will continue to be a significant burden in several states).  Professor Berg seeks to shift the focus from the provision of individual charity care as a means to satisfy the community benefit standard, to the provision of population health care benefits, which can be measured by local, state and federal authorities to justify their respective tax exemptions.  Berg seeks to avoid adopting a method for quantifying the value of the hospital’s community benefit that encourages hospitals to expend resources for the purpose of earning the tax exemption, rather than promotion of population health.  Consequently, she proposes that tax authorities measure the value of the effect or outcome of the hospital’s population health programs, by analyzing participation, mind states, behavior, health status, sickness care utilization, sickness care expenditures, and community value, which can be accomplished by looking at statistical lives saved, lack of pain and suffering, gains in productivity, and risk reductions.  Berg also proposes the administrative mechanism, which would include community participation, for identifying appropriate programs for hospitals’ implementation.  As is generally the case with Professor Berg’s scholarship, this article proposes on-the-ground solutions to pressing problems of the day worthy of serious consideration.

New Requirements for Tax-Exempt Hospitals in Health Reform Law

I. New Requirements for Tax-Exempt Hospitals Embedded in PPACA

Sen. Grassley’s fingerprints are evident in the Patient Protection and Affordable Care Act (H.R. 3950).  The Act includes in Section 9007 requirements to appear in new IRC §501(r), which applies to § 501(c)(3) charitable hospitals.  Every hospital facility, including each hospital in a multi-hospital system must meet these requirements, which fall within the following categories:

Community Health Needs Assessment and Implementation Strategy.  Hospitals must work with community representatives and experts in public health to develop community needs assessment made available to the public, as well as an implementation strategy.  This section takes effect in tax years that begin after March 23, 2012.  The hospital must include a description of how it is meeting the requirements of this section in its 990 filing. The Secretary of the Treasury is mandated to review a hospital’s community-benefit activities at least once every three years. IRC Section 4959 is amended to provide for a $50,000 fine for failure to meet the community health needs assessment provision of §501(r)(3).

Financial Assistance Policy.  Hospitals must develop a financial assistance policy which enumerates a) eligibility criteria, b) an explanation of how hospital charges are calculated, c) the process for applying for financial assistance, and d) whether such assistance includes free or discounted care.  If the hospital does not have a separate collections policy, the financial assistance policy must explain what happens if a hospital bill is not paid, including collections actions and reports to credit agencies.  The financial assistance policy must be widely publicized throughout the entity’s service area.

Limitations on Patient Charges. Hospital charges for emergency or other medically necessary care provided to patients eligible for financial assistance may not exceed the lowest amounts charged to insured patients, and may not be based upon gross charges.

Limitations on Collections Policies. Collection actions may not be undertaken until the hospital has undertaken reasonable efforts to determine if the patient is eligible for financial assistance.

Finally, the PPACA requires hospitals for the first time to include their audited financial statements with the 990 filings.

II. IRS 990 Version 2.0

The new Informational Return 990 for tax exempt organizations continues to raise philosophical questions about the “federalization of nonprofit law,” particularly with its many questions about governance. As presumably intended by the IRS, its questions about the existence of particular policies such as whistle-blower, document retention, etc., inspired many tax-exempt organizations to create these policies.  Many tax-exempt boards are actually seeing their entity’s 990 for the first time, again inspired by a question on the 990 itself.

The 990 for fiscal year 2009 reflects several changes, such as:

• Whether the entity follows the rebuttable-presumption-of-reasonableness procedure described in Reg. 53.4958-6(c);
• Whether the entity has made any significant changes to its program services or organizational documents.

Most important to hospitals is that the completion of Schedule H is mandatory for fiscal year 2009 (completion was optional last year).  Questions include:

• Whether the organization uses Federal Poverty Guidelines (FPG) to determine eligibility for providing free or discounted care to low-income individuals;
• Whether the organization budgets for free or discounted care, and whether actual expenditures exceeded the budgeted amount;
• The amount of unreimbursed costs from government programs;
• Whether the organization has a written debt collection policy, and how patients are advised of financial-assistance programs for which they might be eligible;
• Whether the organization creates an annual community-benefit report which it provides to the public.

“You see then that a man is justified by works, and not by faith alone.” James 2:24

When I heard these words at mass a few weeks ago, my heart soared, because it was the perfect lead-in for a sermon about the urgency of health care reform, based upon Christian notions of distributive justice and social solidarity seeking our collective good.  The punch line won’t surprise you — Not a mention of health care.   Why aren’t  progressives of faith, whether in the pulpit or in the well of Congress, not employing every persuasive tool to advance healthcare reform as an imperative not only for the least among us but for us all?

Evoking religious values has long been effective in achieving social transformation.  This tradition of social reformers, clergy and politicians joining together, and invoking faith to obtain fundamental change experienced its apex during the abolition, anti-Vietnam, and civil rights movements.  Progressives abandoned the device of transcendent vision almost simultaneous with Conservatives adopting this successful script of shared values and worldview based upon God’s will.  The religious right employs Christianity to resist protections against anti-discrimination laws — the Christian Coalition is currently mobilizing on a bill that would give gays and transsexuals federal protection in the workplace — and to support war — President George Bush famously explained to foreign leaders that God told him to invade Iraq and Afghanistan.

Televangelists employ prophetic language to preach against social evils, which are, in their view, largely perpetrated by, well, Democrats.  But the prophetic vision also embraces “a vision of a more equitable society characterized by the virtues of solidarity and compassion and of justice inspired by the love of God and neighbor.” (Lisa Sowle Cahill)  Why don’t we hear our elected representatives cry that “respect for life” and “human dignity” compel universal access to healthcare?

The left has ceded public policy grounded in faith to the right.  It can’t be because nobody on the left prays.  A Pew Survey reports that 84% of respondents self-identify affiliation with a specific religious denomination. I interpret that as meaning that progressives go to church and temple too. A Census Bureau 2001 American Religious Identification Study concluded that 76.7% of the U.S. adult population of 208 million is Christian.  Democratic presidential candidates emphasize their faith (Obama, Hillary Clinton, Bill Clinton, Jimmy Carter)  when they run, but as soon as they take office they revert to dry policy arguments for social goals that meet with passionately poetical threats of sin and damnation from the right.  Are Democrats unable to invoke a competing interpretation of faith to inspire outrage that 50 million people living in the United States are uninsured?  Such a position could find more persuasive biblical support than the position that “government takeover” of healthcare is unchristian.  Progressives were likewise paralyzed in the “death panel” debate, with no politician effectively arguing that the over-medicalization of death seemed an ironic position for people of faith who aspire to an after-life with God.

Many Progressives of faith are organizing to support health care, but Democratic politicians have left behind the rich tradition of invoking faith to achieve social reform.   Nobody even has to use the word God — like Susan Dentzer of Health Affairs, we can simply demand a debate about whether our system is ethical and just.

Sometimes It’s Better Not to be Ranked #1

The Chronicle of Philanthropy lead off its annual executive compensation story with the headline that “Nearly three in 10 of the leaders of the nation’s biggest charities and foundations have taken pay cuts in the past year as the recession causes donations to drop and batters endowments”.

USA Today interpreted the annual survey results differently, with yesterday’s headline: “Non-profit execs make millions: Big organizations have highly paid leaders,” coupled with the usual USA Today chart, this one listing the leaders of the pack, compensation-wise.  The accompanying article questioned why nonprofit compensation is so high.

How much is too much is a fair question, and one readers of this blog will recall that Attorney General Ann Milgram is asking about Stevens Institute’s President.  The ubiquitous Senator Grassley thinks non-profit salaries are too high, and is using health care reform as an opportunity for reforming more than the health sector — one of the 500+ amendments to the Baucus healthcare reform bill comes from Grassley, who wants to eliminate the presumption of reasonableness afforded federally tax exempt organization salaries as long as boards obtain inter alia a comparability study (which unsurprisingly, most do).

According to a recent IRS hospital study, “Although high compensation amounts were found in many cases, generally they were substantiated based on appropriate comparability data”.  The IRS is currently focusing on salaries at colleges and universities.   Somewhat unclear is whether the comparability study may include salaries from the business sector — the IRS has waffled so far, but then-New York Attorney General Spitzer was pretty clear in his mind that it was improper for Richard Grasso’s friends on the compensation committee to have relied on for-profit numbers when it came to setting Grasso’s $187 million compensation package as head of the then-nonprofit NYSE.

Some are outraged by non-profits’ salaries, which are, after all, subsidized by donors and the tax-payer, while others think that politicians should let nonprofit boards run their own show.  The argument is that nonprofits have to compete with the business-world for the best talent.

Is there any law on the subject?  Yes, but it’s rarely enforced.  State nonprofit corporate law contains a non-distribution constraint–that is, nonprofits can’t pay out dividends or excessively pay its employees or those with whom they do business — the money is supposed to be used to further the entity’s mission.  On the tax side, federal law prohibits private inurement and excess benefit, which essentially seeks to accomplish the same goals.  So, on the one hand, critics of excessive compensation do have a legal leg to stand on. On the other, all anyone seems to do about the issue is complain - neither the IRS nor state AG’s have boards particularly concerned about their compensation decisions.  In fact, all boards have to do is follow the right procedure, and their CEO salaries are presumptively reasonable.  So, if all non-profits essentially use the same small group of compensation consultants, and set salaries coincidentally high, then it’s a self-reinforcing system and nobody gets in trouble.

I have little hope that the real questions will be seriously considered, which include what the role of the nonprofit is in our society, and what we expect of nonprofits in exchange for their not having to pay taxes, and for their donors getting tax deductions.  The IRS has begun collecting information on the revised 990 about hospital “community benefit”, but the real question is whether any real change will come out of the whole thing, and whether it will go further than health care.  Nudge would suggest that merely by asking the right questions behavior will change!  I’m more in the Grassley camp of being a noodge….

Alternative Revenue Stream for Private Practice Physicians – Research Investigator

Clinical research is the only way [for a physician in the managed care era] to make a boat payment, quips David Stark, M.D.

With increasing frequency, pharmaceutical and medical device companies are turning to physicians in private practice, rather than academic medical centers, to serve as investigators overseeing the 60,000-odd clinical trials each year, between 80 and 90% of which are funded by industry as opposed to, say, NIH. Academic medical centers are losing the “business,” having fallen from 63% to 26% as the site for clinical research between 1994 and 2004. While it might be argued that trials in the private practice setting produce superior results because they occur under circumstances that more closely resemble how the drug or device will actually be used if approved by the FDA, there are significant risks attendant to this phenomenon that have received too little attention.

The ultimate question is whether physicians can compartmentalize the competing incentives that exist in advising patients about whether to pursue conventional therapy or participate in a clinical trial. This is especially true if the physician is being handsomely compensated for each patient she recruits into a trial, and is exacerbated when the physician also has other financial relationships with the trial sponsor (the drug or device company) for, say, speaking and consulting gigs. Clinical Research in the Private Office Setting — Ethical Issues The recruitment process for clinical trials is the longest and most costly part of the process - prospective participants have to undergo testing to see if they qualify for the study, and federal law requires that they receive significant amounts of information and have ample opportunity to have their questions answered pre-enrollment. A per capita payment contingent upon successful enrollment of the patient will tempt a physician to fudge on this process and enroll unqualified subjects. This not only may put them at risk because they are too sick, but also skew the research results because they’re not sick enough. Bonuses for meeting enrollment goals only make it worse.

Without impugning physician integrity, how realistic it is for physicians to serve in the dual capacity of treating physician and researcher? Studies have repeatedly confirmed “therapeutic misconception” whereby study participants believe, no matter how clearly told to the contrary, that they are “patients” receiving treatment, rather than “subjects” of research who may be receiving a placebo or an experimental drug. This phenomenon is certainly exacerbated when the patient’s treating physician is doubling as the investigator of the clinical trial. Most patients continue to believe that their own personal physician would be driven solely by their best interests. Ironically, some people have more faith in an experimental intervention when they learn that the investigator has a “piece of the action.”

Obviously, significant policy and legal questions arise from this practice, and a more holistic approach to the question of the best way to encourage clinical trials while safeguarding the interests of trial subjects is beyond what I can attempt here. But one possible approach could be drawn from informed consent law — whether statutory or common law, which should require physician disclosure of conflicts of interest to patients. Imagine the beginning of a conversation between doctor and patient/potential research subject:

Doctor: “Just so you know, if you agree to participate in this clinical trial, I get paid $1000 by the manufacturer of the product being tested, but if you don’t, and you just want regular treatment, I’ll only get paid $60 by your insurance company. But, in fairness, that’s because a clinical trial is a lot more work for me….”

But to be honest, I don’t really believe in this solution either. Most recipients of this information either don’t understand it, or have no idea what to do with it, or both. Some fear that too much confusing information might kill trials altogether, which would be a terrible outcome. And there are certainly reasons to fear that such trials are becoming harder to run, to the point where they’re not worth the money. Ultimately, I guess, I want to control how physicians get paid to serve as investigators — the Goldilocks Solution — not too much, and not too little. I want them to be paid just right, so that they are willing to conduct clinical trials, but aren’t tempted to act other than in the patient’s best interest. Of course, what is just right and how to enforce it poses its own problems.

Seton Hall Law School, the author’s employer, is the recipient of grants, donations and endowments from the pharmaceutical industry. No part of the author’s compensation is funded by these gifts.

x-posted at Concurring Opinions

American Health Lawyers Association on the Stark Law and its Revision: a Good Step Towards Holistic & Ethical Reform

Health reform that focuses exclusively on health care finance — that is, how we pay for universal access to insurance coverage — will not produce successful reform.  Reform must be holistic, with a focus on the entire system, as well as its component parts, including whether the system is structured to deliver the right kind of health care services in the most appropriate setting, whether we have sufficient quantity and kind of health care professionals and technology geographically dispersed to provide the health care services that people will presumably have insurance to access, and whether the system properly incentivizes health care professionals to make decisions that are efficient, effective, and in patients’ best interests.  This is a massive undertaking, with a tremendous risk that important components will be overlooked precisely because of the size of the undertaking.  The Stark Law represents the kind of on-the-ground healthcare delivery problems that healthcare reform must tackle.

The American Health Lawyers Association’s Public Interest Committee today released a Whitepaper entitled: “A Public Policy Discussion: Taking Measure of the Stark Law” analyzing the ” Ethics in Patient Referrals Act” (and its progeny), more commonly known collectively as the “Stark Law“, after its primary sponsor, Congressman Pete Stark, who now counts himself among the many who believe that while the problem the law aimed to address is real, the statute and its multitudinous exceptions have become a nightmare.

Stark was enacted in response to empirical studies showing that physicians who hold an equity interest in an entity that provides ancillary health care services, such as a clinical laboratory or MRI, more frequently order those services for their patients, referring them, unsurprisingly, to the entity they own (the Whitepaper notes that no studies indicated that this higher use equated to over-utilization).  The implication, then, is that the opportunity for additional profit causes excessive referrals, whether consciously or unconsciously.  Thus, Stark sought to establish a bright line test regarding the propriety of physician referrals.  Stark prohibits a physician from referring patients to entities in which the physician (or a family member) holds an equity interest.  Congress seeks to ensure that patients are referred only for tests and other health care services that are medically necessary and appropriate.  The law also prohibits the entity actually providing the services to the patient (the recipient of the referral) from billing Medicare if the patient care resulted from an impermissible referral (even if the patient needed the service).

But a basic prohibition proved too broad to be practicable.  For example, how should the law treat rural areas where the only potential investors in an MRI for the community are all of the local physicians?   While many of situations crying for exceptions have been legitimate, virtually every single business relationship that seems justified requires the adoption of a new exception — which, the Whitepaper points out, stymies innovation in a dynamic health care market.  I would add that simultaneous with the continuous recognition of new exceptions, Congress and CMS keep adopting new prohibitions in response to physicians (with the aid of their lawyers) who take advantage of loopholes by engaging in business practices that violate the philosophical goals of the law, but are not specifically banned.

And so now we simply have a mess on our hands.  According to the Whitepaper, on the positive side, Stark has encouraged health care institutions to adopt corporate compliance programs and contract management systems; hospitals are more careful about their relationships with physicians.  Repeating a recurring theme of this blog about physicians’ conflicts of interest, the AHLA Whitepaper suggests that Stark has had less effect on physicians’ awareness and avoidance of conflicts of interest — my observation is that they continue to engage in business arrangements and practices that increase healthcare expenditures and cause patients to receive unnecessary medical services.  This is likely because physicians don’t understand Stark, which is rarely enforced against them.  The Whitepaper conveys the observations of some of its participants that Stark has caused a restructuring of healthcare delivery (some would argue that physicians have simply re-packaged their business relationships, rather than eliminated their “pernicious” conduct).  Even more problematic is that Stark precludes the experimental implementation of some creative ideas to reduce health care costs and improve quality, such as pay-for-performance, shared savings, and bundled payments.  Essential to a reform of how we deliver health care is an alignment of physician and institutional financial incentives - Stark (as well as some other laws) makes difficult that effort.

The AHLA Whitepaper seeks statutory reforms and increased CMS discretion as part of overall healthcare reform.  It suggests reimbursement modifications as a mechanism that would more directly accomplish the government’s goals of reducing costs and controlling utilization, including: decreasing reimbursement for ancillary services provided through a physician group practice; decreasing payments for high margin services; implementing more stringent credentialing requirements for the provision of certain services; bundling the payment for a physician office visit and ancillary services;  and payments for episodes of care, rather than delivery of specific services.

While AHLA addressed an important problem that begs for resolution, the ultimate challenges for health care reform that the Stark problem points up are significant:

• First is the question of whether reform will restructure health care delivery so that patients receive quality care that they actually need, in a timely cost-effective and convenient way.
• Second is how to identify the most effective means of adjusting physicians’ norms of behavior so that they recognize and avoid or ameliorate conflicts of interest that adversely affect their care of patients.
• Third, since the HHS OIG began issuing its Guidances, the relationship between government and provider has been like one of cat and mouse — the government articulates a philosophy about its interpretation of fraud, waste and abuse and the attendant practices that violate the law, and providers adjust their behavior to discontinue the specifically enumerated offensive practices, and then adopt new behaviors that government then addresses and it goes on and on and on.
• All of the above points result from the fact that politicians have created a huge perception divide — physicians believe that they are professionals operating in a market who should be guided by their ethical code and the business practices that make America great - government regulators and prosecutors believe that taxpayers foot 40-60% of the healthcare bill, and should expect very stringent oversight of the behavior of health care providers to make sure taxpayer money isn’t being wasted. Whatever our health care system looks like this time next year, everyone — provider, supplier, and patient needs to acknowledge that irrespective of what descriptors we use, it is a system significantly underwritten by the government, which means that it necessarily operates by different rules….

In the meantime, the AHLA Whitepaper is a terrific description of all that is right and wrong with the Stark Law. Let’s hope Congress takes notice.  More important, it exemplifies the important contributions professional organizations can make to productively convey to policy-makers the on-the-ground effects of their laws.  The AHLA process also models an exemplary collaboration between the private sector and government to their mutual education and, hopefully, benefit.

While the author is an AHLA board member, this post solely represents the author’s interpretation of and opinions about the AHLA Whitepaper, and has not been reviewed by any director, officer or member of AHLA.  The author had no involvement in the production of the Whitepaper.

Medical Repatriation: Montejo v. Martin Memorial Medical Center

[Ed. note: Today's post comes from Dean Kathleen M. Boozang and Erika M. Lopes.  Erika is a Seton Hall Law student and a graduate of Trinity College, Connecticut, where she majored in Political Science. Ms. Lopes is a research assistant to Kathleen M. Boozang, and formerly worked as a litigation paralegal specializing in both Class Action and Foreign Corrupt Practices Act matters for Skadden, Arps, Slate, Meagher & Flom, LLP.]

A Florida jury won’t resolve the issue of how to provide health care to severely injured undocumented aliens, but it may signal to hospitals that engage in “medical repatriation” whether there are any legal risks attendant to the practice.  The case, Montejo v. Martin Memorial Medical Center, involves a claim of false imprisonment brought by the legal guardian of a patient transported by private plane in 2003 to Guatemala for rehabilitative care following severe brain injuries sustained in a car accident involving a drunken driver and two deaths.

Mr. Jimenez remained a patient in Martin Memorial Hospital for almost three years following the accident, incurring $1.5 million in medical bills, of which only $80,000 was reimbursed by Medicaid. As reported by local newspapers (here and here) the hospital CEO testified last week that the transfer to Guatemala was motivated by the fact that Mr. Jimenez missed his family and country — the medical staff came up with the idea to return the patient to “his own culture” where he would “be around his language . . . and [] be in a situation that was more relaxed than an acute care hospital.”  According to the hospital executive, the transport to Guatemala had nothing to do with the financial burden to the hospital of Mr. Jimenez’s care.  While the Guatemalan health ministry agreed to assume Mr. Jimenez’s care, a Guatemalan physician who testified for the plaintiff claimed that Guatemala does not have the kind of rehabilitation facility required by Mr. Jimenez’s condition.  In addition, the jury was presented with a 2003 affidavit from the vice consul for the Consulate General of Guatemala, in Miami stating that she had no authority to place Jimenez in a facility, no doctor to care for him and no way to pay for medical care he needed.  Mr. Jimenez, 37, currently lives in a remote village where he is largely cared for by his elderly mother.

The guardianship plan prepared for Jimenez, filed short of two years after his accident, recommended twenty-four hour skilled care.  The hospital intervened in the guardianship proceeding claiming that it was not the appropriate facility for the long-term rehabilitative care required.  Responding to the guardian’s objection to the hospital’s planned repatriation, a trial court directed the guardian to stop frustrating the hospital’s plan for relocation, and directed the hospital to provide a suitable escort and medical support.  On the day that the hospital was due to respond to a motion to stay, Jimenez was transported to Guatemala via private plane.  An appellate court later reversed the trial court order, citing the insufficient evidence that the patient would receive adequate care in Guatemala, a requirement of federal law directing hospitals to prepare appropriate discharge plans for patients.  42 C.F.R. § 482.43.

The guardian’s false imprisonment suit against the hospital was initially dismissed after the hospital argued that Montejo could not demonstrate that the detention was unreasonable and unwarranted — a necessary element of a false imprisonment claim.  The hospital contended that its actions were executed pursuant to a then-valid court order, and were therefore entitled to qualified or quasi-immunity. The appellate court disagreed on the grounds that the actions were not taken during the course of a judicial proceeding nor in an effort to prosecute or defend a lawsuit, but were carried out in the vindication or enforcement of a purely private right.  The court concluded that affording absolute immunity from tort liability would be an unwarranted and improper extension of the litigation privilege.  Accordingly, the appellate court reversed the trial court’s dismissal of the false imprisonment claim, and remanded to the lower court for a determination of whether the hospital’s actions were unwarranted and unreasonable under the circumstances.

The guardian is seeking the cost of Mr. Jimenez’s care and punitive damages from the hospital.

Health Care Reform & Undocumented Aliens

Several commentators have already observed the absence of any discussion of undocumented aliens in the discussion about health care reform.  And yet, the issue is huge, particularly for those ten or so states in which these individuals disproportionately live and work.  The June 2009 issue of American Journal of Kidney Disease includes an article on a survey of nephrologists^[1] who report an increasing number of undocumented aliens with End Stage Renal Disease (ESRD).  Unsurprisingly, access to care for these individuals is inadequate and shrinking, with about one third of physicians reporting undocumented patients to be wholly reliant on emergency dialysis, which carries with it higher cost and morbidity; 67%, however, reported availability of long-term dialysis care.

A significant minority of physicians reported advising their undocumented patients to move to another state or country to access care, even though accessing appropriate renal care is difficult due to scarcity in Mexico, the native country of the majority of undocumented aliens in the United States.^[2] On the other hand, undocumented aliens present much younger (40’s) with ESRD, which causes many nephrologists to argue that provision of kidney transplants would be a much less costly care approach, long-term.  Federal law prohibits use of Medicaid funds for transplants for this population.^[3]

Many hospitals find themselves “stuck” with chronically ill patients who no longer require acute care, but require discharge to nursing homes or rehabilitation facilities because their debilitation is so severe.  These include victims of car accidents and crimes, for example.  These patients originally appear in hospital emergency rooms in acute distress, thereby requiring the hospital to treat and stabilize pursuant to their EMTALA obligations.  Medicaid has in the past made some monies available to reimburse hospitals for this episode of care (although it was never enough, according to the hospitals, and while the most recent authorization law expired in 2008, funds remained for distribution into 2009).  Further, hospitals are required by Medicare Conditions of Participation to prepare and implement an appropriate discharge plan.  This becomes impossible to accomplish if there is no hope of reimbursement for the subsequent care facility.

Assuming there are Medicaid monies to be had for the emergency care of this population, courts have been split over the question of whether the Medicaid emergency services coverage provision covers the long-term and chronic aftermath of an acute situation.  Specifically, the question is whether the reimbursement is limited to the treatment required to stabilize the patient with leukemia, ESRD, or brain injury, or whether it extends to the post-stabilization care required to prevent a future emergency condition.   Greenery Rehabilitation Group v. New York City Human Resources Administration, 150 F.3d 226 (1998), concluded that if the patients’ post-emergency injuries were properly classified as chronic rather than acute, they do not qualify for Medicaid coverage.  Scottsdale Healthcare Inc., v. Arizona Health Care Cost Containment Syst. Admin., 75 P.3d 91 (D.C. Ariz. 2003), rejected the Second Circuit’s focus on stabilization as too narrow, holding instead that the “focus must be on whether the patient’s current medical condition–whether it is the initial injury that led to admission, a condition directly resulting from that injury, or a wholly separate condition–is a non-chronic condition presently manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical treatment could result” in an emergency condition. Id. at 98.  The issue has also been taken up in the last few years by the Connecticut and North Carolina Supreme Courts, in which both plaintiffs’ received emergency room diagnoses of leukemia and sought coverage of their subsequent chemotherapy treatments — these Courts also split on the issue.

These cases are merely a snapshot of a much larger issue.  A health care reform bill that doesn’t address the health care of both legal and illegal aliens will be inadequate, and adversely and disproportionately affect the several states where large numbers of immigrants live, work, and school their children.  The solution must address access to primary and emergency care as well as treatment for chronic conditions.  Those states whose workers compensation systems are inadequate in their coverage of immigrants disabled in the course of their employment might also ameliorate the crisis presented by this population by reform in this area as well.

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[1] Hurley & Kemp, et al., Care of Undocumented Individuals with ESRD: A National Survey of U.S. Nephrologists, 53 Am. J. Kidney Disease 940 (2009).

[2] Id. at 947.

[3] CMS Uniform Policy Manual § 3000.01

Dr. Collins and the Pope

President Obama’s nomination of Dr. Francis Collins as the new head of the NIH should be unsurprising, given his extraordinary accomplishments in leading the sequencing of the human genome, and fighting for its general accessibility to facilitate research.  Nonetheless, according to the New York Times some apparently object to his appointment due to his public religiosity — these critics demean the merits of his appointment by referring to it as a bone for the religious right.  To the contrary, it should be affirming that the leader of the nation’s research agenda should so publicly value ethical decision-making, especially in a time when we possess the power to accomplish so much that is both extraordinary and potentially destructive of our intrinsic nature as humans.   Whether a public intellectual’s ethical grounding is in religion or a secular philosophy should not become the basis of opposing his leadership; rather, we should celebrate the leader with a firm ethical grounding.

More specifically, religious perspective still has much to contribute to public debate, even when we disagree with that perspective.   Pope Benedict XVI’s June 29, 2009 encyclical, Caritas in Veritate, advocates the Church’s social doctrine, which the Pope presents as being interdisciplinary:

It allows faith, theology, metaphysics and science to come together in a collaborative effort in the service of humanity. It is here above all that the Church’s social doctrine displays its dimension of wisdom. Paul VI had seen clearly that among the causes of underdevelopment there is a lack of wisdom and reflection, a lack of thinking capable of formulating a guiding synthesis, for which “a clear vision of all economic, social, cultural and spiritual aspects” is required. The excessive segmentation of knowledge, the rejection of metaphysics by the human sciences, the difficulties encountered by dialogue between science and theology are damaging not only to the development of knowledge, but also to the development of peoples, because these things make it harder to see the integral good of man in its various dimensions.

Erasmus, Hans Holbein the Younger, 1523

While the Church may not always advance solutions that precisely befit our culture and time, the over-arching philosophy is one that but might provide a useful template for emulation in our own society.  This is particularly relevant as we contemplate whether to create a health care system that would provide universal access to health care in the United States.

Again, the guideposts demarked in Caritas in Veritate speak to the choices that confront us in this perennial public policy debate.  While embracing the value of the market, the Pope suggests that economic activity cannot solve all social problems, thereby requiring that it act in concert with the political community, whose focus should be on achieving the common good.  Driven by commitment to charity and justice, the Pope suggests that “Solidarity is first and foremost a sense of responsibility on the part of everyone with regard to everyone, and it cannot therefore be merely delegated to the State.”  And so I suggest that religiously-grounded social teaching remains relevant to our contemporary debates. We must pursue a system in which each of us has access to health care, which necessarily requires that, in solidarity for our fellow being, those of greater fortune accept the responsibility for those who do not, giving the gift of an opportunity for the basic good of health.

Medical Education & Health Reform

[Ed. note: As noted in the post above, we are very pleased to welcome Associate Dean & Professor of Law Kathleen M. Boozang, J.D., LL.M., to Health Reform Watch today.]

The news has been much absorbed by the “scandals” associated with physician conflicts of interest arising out of their relationships with the pharmaceutical and medical device industries. Concerns include the potential biases created by industry funding of continuing medical education, the impact on patient care of physician activities as paid industry consultants and promotional speakers, as well as the impact on the integrity and patient safety of industry-funded research.  Analogous issues emerge from industry funding of medical schools themselves.

A pervasive conception of systemic health care reform would provide the opportunity to address many of these problems.  Academic medicine’s drive for money arises not only from the amount of uncompensated care they provide to the under- and uninsured, but from the structural flaws of the funding mechanisms for medical education and research in the United States.  According to the June MedPac Report on medical education,  it is unclear how much it actually costs to train new physicians, partly because of the multiplicity of funding sources.  While it could be that the funding is sufficient, medical school faculty and deans nonetheless find themselves under tremendous pressure to raise money from government grants, industry relationships, and clinical practice to support themselves. This pressure increases as constrained state budgets contribute less to public universities. Income from physician practice plans is leveling off as academic medical centers become unappealing participants in managed care plans — they too frequently focus insufficiently on primary care, and managed care increasingly balks at contributing to the costs of medical education which are built into academic hospital rates. Further, many academic medical centers are less nimble and efficient than the multi-practice plans and surgi-centers pervasive in many communities.

While greed and poor judgment are certainly factors driving some physicians’ relationships with industry, academic medicine’s over-reliance on “alternative revenue” streams can also be explained by the irrationality of the extraordinarily complex mechanisms for funding medical education and research. More frustrating is Medicare is spending $9 Billion annually to new train physicians to function in a health care system that is hopefully short-lived in its current form.  Meaningful healthcare reform will rest on reform of the delivery and finance systems — new health care professionals must be educated to perform in this reformed environment, which should involve increased collaboration between physicians and allied healthcare professionals; treatment of patients outside of the hospital; and knowledge of comparative effectiveness of alternative therapeutic options.

Health care reform should condition future financing of medical education on the absence of collaborations that create conflicts of interest that threaten the integrity of the medical profession.  It should also jumpstart radical reform of the content, methodology and quality of educating medical students, residents, and physicians, who are the linchpin to changing how we deliver healthcare.  The plan for systemic reform should compel a reconceptualization and expansion of allied health care professionals’ roles in health care delivery to address cost, access, quality, and error avoidance.  Finally, the vision for the future should commit to resolving the inequities in the health care status of all who live in the United States, an issue whose solution is inextricably linked to producing a sufficient number and variety of health care providers available in every part of the country who have a broader conception of health care, with the knowledge and skills to achieve the goals of health for all.