Recommended Reading: New Legal Scholarship from Ryan Abbott and Jennifer Herbst on Pharmacovigilance Topics

In his article Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, which is forthcoming in the Iowa Law Review, Ryan Abbott argues that third parties, including academics, insurance companies, and rival drug companies, should be incentivized via an “administrative bounty proceeding” to analyze the large and rich datasets that will be generated by health information exchanges.  Should a third party’s original statistical analysis reveal safety or efficacy concerns about a drug, Abbott suggests, it could submit the results to the Food and Drug Administration and be paid a taxpayer-funded bounty, the amount of which would be based on the value of the new information to the government in terms of health care dollars saved.  If a drug’s manufacturer knew or should have known about the concerns brought to light by the third party, Abbott proposes that the manufacturer fund the bounty, the amount of which would be based on the drug’s sales; depending on its degree of culpability, a manufacturer could even be liable to both the third party and the government for damages.

Abbott believes that the bounty system he proposes would level the pharmacovigilance playing field in a way that would redound to the benefit of consumers.  In his words: “The public deserves an advocate as equally committed to challenging the safety and efficacy of approved drugs as product sponsors are to maintaining these drugs on the market.”  Writing about Abbott’s proposal at the Bill of Health blog, Dov Fox distills it down to the following provocative question: Are we “better off evaluating medicines under an inquisitorial system or an adversarial system”?

I also recommend Jennifer Herbst’s article How Medicare Part D, Medicaid, Electronic Prescribing and ICD-10 Could Improve Public Health (but Only if CMS Lets Them), which is forthcoming in Health Matrix: Journal of Law-Medicine.  While the title might seem daunting, the article itself brings clarity to a murky, highly-technical area of the law with enormous significance for public policy.  As Herbst explains, although both Medicare Part D and Medicaid limit reimbursement to drugs prescribed for “medically accepted indications,” this limitation is not enforced, at least not at the time of payment.  And, while the government’s attempts to enforce it retroactively have led to headline-making settlements with pharmaceutical companies, they have not resulted in a significant dent in the rate of unscientifically-supported prescribing.

Herbst recommends that the government take advantage of the inroads made by electronic prescribing and require that patient diagnosis codes be made a condition of payment for outpatient prescription drugs.  Linking drugs to diagnoses in this way would allow pharmacists to do a more thorough safety review of the prescriptions they fill and it would give the government a powerful pharmacovigilance tool.  Of course, it would also allow the government to decline to provide reimbursement for drugs prescribed for indications that are not “medically accepted.”  Herbst argues that this would be a mistake because it could lead to widespread miscoding – there’s a disconnect between what the government deems medically accepted and what providers consider sound medical practice – which would undermine the value of the data being collected.  I wonder, however, whether it would be politically feasible for the Centers for Medicare & Medicaid Services “to continue its current policy of paying for all outpatient prescriptions not subject to prior authorization (contrary to the letter of the Medicare Part D and Medicaid statutes)” in the face of the data Herbst’s proposal would generate.

Recommended Reading: Recent Legal Scholarship on Workplace Wellness Programs

Since its release last month, Sheryl Sandberg’s bestseller Lean In has attracted seemingly continuous attention and controversy.  Critics charge that the book encourages women to “lean in” to their outside-of-the-home work without fully addressing the barriers that might be impeding women’s advancement.  They express concern that too intense a focus on what individual women can do to address the persistent achievement gap between women and men will only result in women blaming themselves for structural, societal problems.  Similar concerns underlie the controversy over workplace wellness programs.  While almost no one is against “wellness,” there is concern that emphasizing what individuals should do to achieve it, potentially on pain of losing their jobs, could be ineffective and even counterproductive.

Workplace wellness programs run the gamut from providing more nutritious food in the office cafeteria, to building an on-site gym, to providing counseling and other supportive services, to positive financial incentives keyed to achieving goals such as blood pressure control or smoking cessation, to negative incentives including hiring bans, health insurance surcharges, and, ultimately, termination.  With regard to variations in the price of health insurance, Tara Ragone has explained that “[a]lthough the [Patient Protection and Affordable Care Act] prohibits issuers in the individual and small group markets from basing premium variations on health status or claims experience, Federal law permits insurers to offer premium discounts to enrollees in the small and large group markets based on participation in certain wellness programs.”  The statute provides for wellness rewards of up to 30 percent of the cost of coverage, and the Secretaries of Labor, Health and Human Services, and the Treasury have discretion to increase the rewards to up to 50 percent.

In Jessica Roberts’ latest article, Healthism and The Law of Employment Discrimination, which is available on SSRN, she explains that while “issues of income, insurance, and health” seem discrete, in fact they are “intimately intertwined.”  Wellness programs could exacerbate existing health disparities by restricting relatively unhealthy individuals’ access to wages, wellness programs, and employer-provided health insurance.  Moreover, while “using tobacco and being overweight are conduct-based statuses”—and thus not fully protected under the federal statutes that outlaw trait-based employment discrimination—“the underlying choices are not simple ones.”  As Roberts notes, “[t]he lack of access to healthy foods and time to work out or a longstanding addiction to tobacco may be difficult obstacles to overcome without some help.”  Roberts recommends that Congress, or the substantial number of state legislatures that have not already done so, pass legislation shielding employees from discrimination not just on the basis of their health-related traits, but also on the basis of their health-related conduct.  She recommends that such legislation permit employers “to promote the healthy lifestyle choices of their employees through rewards programs that do not relate directly to employment status or compensation.”  I recommend Roberts’ article for its helpful (and thought-provoking) overview of the intersection between employment discrimination law, insurance regulation, and workplace wellness programs and for its nuanced legislative proposal.

I also recommend Wendy Mariner’s article, The Affordable Care Act and Health Promotion: The Role of Insurance in Defining Responsibility for Health Risks and Costs, published last year in the Duquesne Law Review.  In it, Mariner argues, pithily, that “wellness program incentive systems range from minor and marginally effective, to major and possibly coercive.”  She believes that the wellness rewards that PPACA permits “are likely to be too crude to significantly improve the population’s health or save money, and they pose an unnecessary threat to the [statute’s] underlying goals[.]”  By fostering the idea that the unhealthy are at fault for their condition, such rewards may increase resistance to the “public programs to provide preventive services, safer social and built environments, research and education” for which Mariner advocates.  She calls for the elimination of PPACA’s wellness program exception to the ban on basing the price of health insurance on health status or claims experience.  With the projected cost of premiums in the new health insurance exchanges widely-reported and much decried, elimination of the wellness program exception is unlikely.  Mariner’s article nonetheless offers a valuable note of caution as 2014 approaches.

Giving Patients a Piece of the Action: Appealing Proposals from Richard Frank and Christopher Robertson

In a recent edition of the New England Journal of Medicine, Richard Frank discussed recent efforts on the part of federal and state governments to enroll so-called “dual eligibles,” that is, individuals who qualify for both Medicare and Medicaid, into health plans that use “a strong care-management system under a unified budget.”  Many believe that such plans have the potential to both save the government money and provide better coordinated, higher quality health care.  (I discussed the need to better coordinate care for dually-eligible people here.)  Individual beneficiaries are not necessarily convinced, however.  Frank reports that it has been “very difficult to lure” them into “state-designed care coordination entities.”  Beneficiaries may be hesitant to leave their fee-for-service doctors and other providers; they may also be afraid of the incentive to restrict services that a capitated global payment creates.

To get beneficiaries to make the switch from fee-for-service to coordinated care, states are taking a page from Nudge and making enrollment in a coordinated care plan automatic.  The burden is then placed on the beneficiary to opt out if he or she so chooses.  The use of “passive enrollment” will no doubt “work” to increase the rolls of coordinated care plans, but Frank wants states to aim higher, to strive to “promote self-determination for vulnerable populations and offer them a reason to engage with a new care delivery system with coordinated-care arrangements[.]”

As Frank explains, “[c]oordinated care for dually eligible people is built on a financial structure known as shared savings, in which three of the parties involved –- the federal government and state governments and the [coordinated care plan] –- share any financial gains from coordinating care.”  Frank proposes that beneficiaries, too, be given a share of the expected savings– a share that they would be permitted to use to pay for “supplemental services and supports such as transportation, home modifications, and personal assistance with activities of daily living.”  The prospect of (limited) control over a share of the expected savings would serve as an incentive to beneficiaries to engage in care coordination, while also “promot[ing] self-determination and the exercise of real options.”

Frank’s very appealing idea brought to mind the proposal Christopher Robertson makes in The Split Benefit: The Painless Way to put Skin Back in the Healthcare Game, which is forthcoming in the Cornell Law Review.  While Frank would give beneficiaries an incentive to opt in to coordinated care, Robertson would give them an incentive to opt out of inefficient, high-cost care.  Specifically, Robertson proposes that when a physician “prescribes a high-cost treatment that the insurer reasonably believes is inefficient[,]” the insurer would “[p]ay a small but substantial part of the insurance benefit”—-what he terms the “split benefit”—-in cash directly to the patient beneficiary.  Then, “[i]f the patient chooses to proceed with the treatment, the patient takes the cash payment to the provider (along with any required cost share obligation), and the insurer matches it with the balance of the insurance benefit[.]”  Patients who choose not to proceed with treatment, however, could spend the cash differently, on a “treatment that is not covered by the insurer (whether it is acupuncture, an alternative diet regimen, a concierge doctor, or visiting nursing services), paying money to a member of the family to stay home and provide care to the dying patient, or purchasing disability insurance to help cope with the symptoms of the illness.”  They could even use the money to pay for non-health-related expenses.  As Robertson explains, the split benefit would save insurers (and, down the line, purchasers of insurance) money by giving beneficiaries a financial incentive to turn down high-cost, low-value treatments.  In Robertson’s words, the patient autonomy movement has been “cramped” by the fact that patients have been offered only “a walled garden of medical choices.”  His split benefit, by contrast, “embraces a value-pluralism, respecting the patient’s weighing of medical and non-medical values.”

I highly recommend both Frank’s and Robertson’s pieces to anyone who—-like me—-is interested in ways to give patients a piece of the action when it comes to the multiplicity of current efforts to coordinate and rationalize their care.

Recommended Reading: ‘Patients’ Racial Preferences and the Medical Culture of Accommodation’

I highly recommend Kimani Paul-Emile’s provocative article in the latest issue of the UCLA Law Review, Patients’ Racial Preferences and the Medical Culture of Accommodation, in which she “makes the counterintuitive claim … that the law does and should permit” physicians and hospitals to accommodate “patients’ racial preferences with respect to their choice of physician … in the hospital setting.”  Such accommodation is, Professor Paul-Emile reports, a quiet, but routine, occurrence, one that recent studies suggest “may not only alleviate race-based health disparities but also constitute a life-saving measure for many racial-minority patients.”

Professor Paul-Emile’s article begins with a concise and helpful summary of the relevant default legal rules, in particular the right of patients to refuse medical treatment and the obligation of hospitals to provide care in an emergency.  As Professor Paul-Emile explains, “[i]f a patient who desires treatment will not yield in his preference for a provider of a particular race and will not agree to a transfer, then the hospital is faced with the dilemma of choosing between (1) having a physician unwanted by the patient forcibly perform the [Emergency Medical Treatment and Active Labor Act]-mandated medical screening, thereby violating informed consent and battery laws, and (2) rejecting the patient in violation of EMTALA, thereby risking liability and the chance that this decision will cause the patient to suffer, experience grievous harm, or die.”

The article goes on to analyze hospitals’ decisions to accommodate a patient’s race-based request for a new doctor under Titles II, VI, and VII of the 1964 Civil Rights Act, and concludes that although “it is difficult to imagine preferences of this sort indulged in any other sector,” in the hospital setting such accommodation does not violate anti-discrimination laws.  Professor Paul-Emile goes further, arguing that accommodation “may be one of the best available means of enforcing Title VI’s mandate to enable individuals to enjoy the benefits of a covered entity or program, regardless of race, color, or national origin” to the extent that it “counter[s] the effects of implicit bias, discrimination, and stereotyping by physicians[.]”

Professor Paul-Emile concedes that “the notion of white patients rejecting minority physicians for bigoted reasons in emergency departments and other hospital settings is deeply troubling and uncomfortably reminiscent of the type of discrimination that the civil rights statutes were designed to eliminate[,]” but she counters with empirical evidence (1) that “requests for treatment by a physician of a particular race are more often accommodated when made by racial minority patients” and (2) that the benefits of racial concordance are many, including longer visits characterized by patient-centered participatory decision-making.

Reading Professor Paul-Emile’s article, it struck me that for every patient who insists on a change of doctor, there are likely many more who assume, rightly or wrongly, that they have no choice and so endure discriminatory treatment in the hospital setting.  Accommodating the demands of the few who speak up is at best a partial solution.  Professor Paul-Emile does not deny this.  She concludes her article with a call for an increase in the diversity of doctors and for an expansion of “cultural awareness at all levels of practice and training to enable providers to interact more effectively with various patient populations”—worthy, if daunting, goals.

Recommended Reading: Interoperability and Preemption

I highly recommend two recent articles that consider the intersection of HIPAA preemption doctrine, interoperability of electronic health record (“EHR”) databases, privacy, and confidentiality.

In her article, “Institutional Competence to Balance Privacy and Competing Values: The Forgotten Third Prong of HIPAA Preemption Analysis,” Barbara J. Evans takes on the well-settled belief — or “rumor,” as she calls it –  that the HIPAA “Privacy Rule merely sets a floor of privacy protection that leaves states free to set stricter privacy standards.”  (A draft of this article is available on SSRN, and it will be published in the University of California-Davis Law Review in 2013.)  Although this general rule of HIPAA preemption  is largely accurate, the article argues that it is wrong with respect to an enumerated “class of public health activities that Congress deemed to have high social value,” including “reporting of disease or injury, child abuse, birth, or death, public health surveillance, or public health investigation or intervention.”

Professor Evans begins with a textual argument, pointing out that HIPAA’s statutory text specifically includes a third prong, while HIPAA’s Privacy Rule, one of HIPAA’s key implementing regulations, collapses the statutory language into two prongs.  The article maintains that in doing so, the “Privacy Rule ignored a clear statutory instruction to preempt state privacy law in a specific circumstance where Congress determined that individual privacy interests should give way to competing public interests.”  In this specific public health context, she continues, “the HIPAA statute creates what might be called a ‘canopy,’ to shelter specific socially important data uses from more stringent privacy laws.”  The author buttresses her analysis with legislative and regulatory history as well as a comparison with the structure of ERISA preemption provisions.

Noting that the statute speaks directly to this issue, Professor Evans maintains that the public health portion of the Privacy Rule is not entitled to Chevron or Skidmore deference where its interpretation is contrary to the statute and the agency did not offer a persuasive account to justify its interpretations. Rather, “the HIPAA statute preempts state privacy laws — even ones that are more stringent than the HIPAA privacy Rule — in situations where state laws would interfere with public health surveillance and investigations.”

Professor Evans attributes the inconsistency between the Privacy Rule and HIPAA to politically savvy rather than incompetent agency drafting.  She asserts that HHS was aware that states were afraid that their privacy laws would be preempted, and thus the agency took a modest approach in the Privacy Rule, leaving unspoken the effect of the third prong on more stringent state laws in the limited context of enumerated public health activities.  The statutory text, however, reflects Congress’s choice to  ”trust[] no institution other than itself” to “strike the balance between privacy and competing public interests.”  There was a conscious choice not to permit a patchwork of varying state laws to frustrate the development of multi-state, interoperable databases needed for the enumerated public health activities.

This article breathes new life into statutory language that has been largely overlooked in the sixteen years since HIPAA’s enactment and is critical reading for anyone interested in public health surveillance, investigation, and privacy law.  Professor Evans argues that facilitating access to large-scale, multi-state, interoperable databases of health-related data for tens or even hundreds of millions of people could speed “the detection of drug safety risks, unmask[] ineffective or wasteful treatments, and understand[] disparities in health outcomes among various populations subgroups,” while “unduly restrict[ing] access to data and biospecimens can very literally kill people.”

The article closes with an invitation to scholars for further “dialogue about [HIPAA']s forgotten preemption provision,” an invitation the health law community would be wise to accept.  While she readily acknowledges that her conclusions are unorthodox,  they will undoubtedly generate substantial and serious academic discussion.

Another important article for interoperability policymaking is Leslie P. Francis‘s article, “Skeletons in the Family Medical Closet: Access of Personal Representatives to Interoperable Medical Records,” which recently was posted to SSRN and was published in volume 4, issue 2 of the 2011 Saint Louis University Journal of Health Law & Policy.

With HIPAA’s Privacy Rule and the HITECH Act, federal law now grants patients the right to access their own medical records, including EHRs, with some limitations for certain records, such as psychotherapy notes.  Importantly,  personal representatives now generally enjoy the same rights of access to medical records that patients themselves hold, consistent with state law.

In addition, although HIPAA preempts state laws that are inconsistent with federal law, HIPAA generally (see Professor Evan’s important caveat above) does not preempt state laws that protect privacy more stringently than federal law.  A state law is deemed more stringent when, for example, it provides individuals with greater access to their health information.  As a result, “states may expand the individual right of access to health information, but may not contract it.”

The article points out an unintended consequence of such an expansion, however, given federal law on access: states that provide equal rights of access to patients and their representatives would be expanding personal representative access in step with any increased rights for patients.

But given the breadth of interoperable EHRs, patients may not want or expect their personal representatives to have access equal in scope to their own.  Interoperable EHRs may very well  contain records of medical care that are not directly relevant to the patients’ current care and that patients may not want their personal representatives to see.  Professor Francis offers the example of an older patient being treated for a stroke who may not want her child to learn about her prior, unrelated pregnancy termination or psychiatric history – what Professor Francis calls “the metaphorical skeletons in her closet.”

The article thus explores the extent to which states may protect patient privacy and confidentiality in this legal framework by regulating personal representatives’ access to patient records.    For example, although states generally either grant or deny personal representatives access to patient records, Professor Francis details how some have been more nuanced.  For example, some permit patients to use advance directives to define the scope of access by personal representatives, such as on a need to know basis, while others restrict personal representative access to mental health or substance abuse treatment records.

Given the importance of respect for private autonomy, Professor Francis then makes four recommendations:

(1)    Advance directive statutes should permit competent patients to designate the scope of their personal representatives’ access to interoperable medical records, ideally with respect to specific types of information, such as mental health, substance abuse, and reproductive history, and options such as all information, information only as needed to make care decisions, or no information.

(2)    When patients do not have advance directives, there should be a presumption that personal representatives only have access to records needed for decision making about their care.

(3)    Interoperable medical records should be designed to permit special management of sensitive medical information, such as mental health or substance abuse treatment records, to which personal representatives would have access only when necessary for emergency care.

(4)    These recommendations generally should apply regardless if patients have mental illness or cognitive disabilities.

Recommended Reading: Recent Scholarship on Suits Brought by Plaintiffs Who Have Not (Yet) Been Harmed

In Not Sick Yet: Food-Safety-Impact Litigation and Barriers to Justiciability (forthcoming in the Brooklyn Law Review), Diana R.H. Winters focuses on a number of hurdles that must be cleared by plaintiffs challenging the “behemoth” that is America’s food safety regulatory apparatus.  Among these hurdles, “[p]laintiffs in food-safety-impact suits must find a way to show that they have suffered concrete and particularized injury from the challenged regulation although they have not contracted a foodborne illness.”

At least in certain circuits, plaintiffs can show the requisite concrete and particularized injury by “alleging an increased risk of contracting foodborne illness because of an established governmental policy.”  The Second Circuit, for example, held in Baur v. Veneman that “[a]lthough this type of injury has been most commonly recognized in environmental cases, the reasons for treating enhanced risk as sufficient injury-in-fact in the environmental context extend by analogy to consumer food and drug safety suits.  Like threatened environmental harm, the potential harm from exposure to dangerous food products or drugs ‘is by nature probabilistic,’ yet an unreasonable exposure to risk may itself cause cognizable injury.”

I recommend Professor Winters’ article for her cogent analysis of the litigation challenges that arise when a food-safety-impact plaintiff’s only harm is exposure to allegedly unreasonable risk (which, as the Second Circuit points out, has obvious implications for drug safety litigation).  However, her article is also well-worth reading for its overview of the “inefficiencies, inconsistencies, and even some absurdities” that characterize federal agency oversight of food safety and for its very interesting discussion of the significance of the lack of a well-organized food-safety-impact plaintiff movement.

I also recommend Against Liability for Private Risk-Exposure (forthcoming in the Harvard Journal of Law and Public Policy), in which Sheila B. Scheuerman focuses, like Professor Winters, on suits brought by plaintiffs whose only harm is exposure to allegedly unreasonable risk.  While Professor Winters’ article addresses Administrative Procedure Act suits brought against government agencies, Professor Scheuerman discusses tort and warranty suits brought against private companies.  Establishing a concrete and particularized injury is a hurdle confronting “no injury” plaintiffs in cases brought against corporations as it is in cases brought against the government.  Plaintiffs in tort and warranty cases do not typically allege that they suffered emotional harm as a result of their risk of exposure, or that they suffered economic harm because they sold the product at issue at a reduced value, because allegations such as these would raise “individual issues, thereby precluding class certification.”

In Cole v. General Motors, a Fifth Circuit case, the class representatives “brought claims for breach of the implied warranty of merchantability and breach of the express warranty against a car manufacturer based on alleged defects in the car’s air bag system.”  The Cole court allowed the case to proceed, on the grounds that while the plaintiffs had not sustained physical harm as a result of the air bag issue, they had sustained “‘actual economic harm … emanating from the loss of their benefit of the bargain.”  As one could guess from the title of her article, Professor Scheuerman believes that Cole and the other similar cases she discusses were wrongly decided and that “[a]llowing liability for private-risk exposure is not justified by any of the dominant rationales for the tort or warranty law.”  She quotes with approval a court that held that allowing such liability only benefits “‘the lawyers handling the case and perhaps the few consumers directly involved in the litigation,’” and notes that the class representatives in Cole consisted of a paralegal who worked for plaintiffs’ counsel, the paralegal’s cousin, and the mother of one of plaintiffs’ counsel.  Professor Scheuerman concludes that “the solution to encouraging risk reduction by manufacturers, without exposing companies to bankrupting litigation, lies with government regulation.”  Coming full circle, it is worth noting that none of the arguments Professor Scheuerman makes against no-injury tort and warranty suits would apply to preclude no-injury suits of the sort that Professor Winters discusses, brought to challenge-or enforce-such regulation.

Recommended Reading: Recent Legal Scholarship on the Affordable Care Act’s Medicaid Expansion

As Frank Pasquale noted recently at the Health Law Prof Blog and here at HRW, law review scholarship is starting to emerge on the Supreme Court’s holding in National Federation of Independent Business v. Sebelius that the Patient Protection and Affordable Care Act’s expansion of the Medicaid program was an unconstitutionally coercive exercise of Congress’ Spending Clause authority.  Professor Pasquale recommends Plunging into Endless Difficulties: Medicaid and Coercion in the Healthcare Cases, an article co-authored by Nicole Huberfeld, Elizabeth Weeks Leonard & Kevin Outterson, writing that it is “sure to make an impact.”

Also well worth reading is Samuel R. Bagenstos’ article, The Anti-Leveraging Principle and the Spending Clause after NFIB, which is forthcoming in the Georgetown Law Journal.  Professor Bagenstos contends that Chief Justice Roberts’ opinion in NFIB is best read narrowly as setting forth a three-part test–which Professor Bagenstos terms the “anti-leveraging principle”–for determining whether a condition Congress places on participation in a joint federal-state program unconstitutionally coerces the states to participate.  To apply the anti-leveraging principle, one must first ask whether a condition on federal spending “change[s] the terms of participation in [an] entrenched cooperative program[.]”  The second question is whether the condition leaves a state without a real choice to decline the funds at issue because, for example, there is a “very large amount of money at stake[,]” as there was with the Medicaid expansion.  The third and final question is whether “Congress was using a state’s desire to continue to participate in a lucrative program as leverage to force the states also to participate in a separate and independent program.”  Only if the answer to all three questions is yes, Professor Bagenstos contends, should a court find that a spending condition is unconstitutionally coercive.

The final section of Professor Bagenstos’ article, in which he applies the anti-leveraging principle, is particularly interesting.  Professor Bagenstos analyzes, among other things, the Affordable Care Act’s Medicaid maintenance-of-effort requirement, which Maine Governor Paul LePage has challenged, the Clean Air Act, the No Child Left Behind Act, Mitt Romney’s education reform proposal, and Section 504 of the Rehabilitation Act, and concludes that the Clean Air Act, which requires states to comply with certain provisions on pain of losing federal highway funding, is particularly vulnerable post-NFIB.

Stepping away from the constitutional questions addressed by the Supreme Court in NFIB, Jessica L. Roberts’ article Health Law as Disability Rights Law, which is forthcoming in the Minnesota Law Review, views the Medicaid expansion and other changes the ACA makes through the lens of “the historical division between the health and civil rights paradigms within disability law.”  As Professor Roberts explains, in the 1970s and beyond, disability rights activists actively rejected the health paradigm as grounded in an outdated, medical model of disability that failed to recognize that the barriers to access that people with disabilities faced had a strong social component.  The civil rights paradigm has its limits, though.  Courts have been reluctant to apply civil rights legislation such as the Rehabilitation Act and the Americans with Disabilities Act to Medicaid and other public programs “in a manner that ensures health-care services for people with disabilities.”  In the landmark Supreme Court case Alexander v. Choate, for example, the Court found that a state Medicaid program’s fourteen-day limit on in-patient hospital care did not discriminate against people with disabilities.  In so doing, the Court “construed the benefit at stake as a ‘package of health care services,’ not adequate, equitable, or accessible health care.”  Professor Roberts argues that “the ACA’s changes to public health insurance hold the promise to eliminate those barriers previously experienced by people with disabilities and, consequently, to reduce existing health disparities.”  Thus, while the Medicaid expansion and certain of the Act’s other changes “fall under the health law umbrella substantively, insofar as they promote access and equality for people with disabilities, they make a civil rights law impact.”  Professor Roberts’ article is thoroughgoing and thoughtful; I highly recommend it.

Recommended Reading (and a Lawsuit to Watch) on Prisoner Physical and Mental Health Issues

• In The Ninth Circle of Hell: An Eighth Amendment Analysis of Imposing Prolonged Supermax Solitary Confinement of Inmates with a Mental Illness (forthcoming in the Denver University Law Review), Thomas Hafemeister and Jeff George provide a fascinating history of prolonged solitary confinement and helpful reviews of the empirical research establishing that such confinement “is virtually guaranteed” to cause significant psychological harm and of the Eighth Amendment jurisprudence addressing the practice. Tragically, the limited extant empirical evidence indicates that our “supermax” facilities and units house not the worst of the worst but rather “a disproportionally large number of inmates suffering from a serious mental illness.” Hafemeister and George conclude that prolonged solitary confinement, without more, is not unconstitutional under the Supreme Court’s current standard. Inmates who are mentally ill or highly vulnerable to becoming so, however, “can readily establish the requisite deliberate indifference on the part of [prison] officials with regard to the impact of prolonged solitary confinement[.]“

• On May 31, 2012, the Center for Constitutional Rights filed an amended complaint in Ruiz v. Brown, a proposed class action lawsuit brought on behalf of prisoners at California’s Pelican Bay State Prison who claim “that prolonged solitary confinement violates Eight Amendment prohibitions against cruel and unusual punishment, and that the absence of meaningful review for [Security Housing Unit ("SHU")] placement violates the prisoners’ right to due process.” In its press release announcing the suit, CCR highlighted the following allegations: “SHU prisoners spent 22 ½ to 24 hours every day in a cramped, concrete, windowless cell. They are denied telephone calls, contact visits, and vocational, recreational or educational programming. Food is often rotten and barely edible, and medical care is frequently withheld. More than 500 Pelican Bay SHU prisoners have been isolated under these conditions for over 10 years, more than 200 of them for over 15 years; and 78 have been isolated in the SHU for more than 20 years. Today’s suit claims that prolonged confinement under these conditions has caused “harmful and predictable psychological deterioration” among SHU prisoners. Solitary confinement for as little as 15 days is now widely recognized to cause lasting psychological damage to human beings and is analyzed under international law as torture.”

• Priscilla Ocen’s article Punishing Pregnancy: Race, Incarceration and the Shackling of Pregnant Prisoners (forthcoming in the California Law Review) is also well worth reading. Ocen contends that because our Eighth Amendment jurisprudence is racially blind, the historical and ideological foundations of the practice of shackling pregnant prisoners during labor, childbirth, and recovery have been obscured. She argues, compellingly, for an “antisubordination” reading of the prohibition on cruel and unusual punishments, one that would take account of “the racial and gender stereotypes of women prisoners that render then vulnerable to shackling practices.”

• I also recommend Lisa Heinzerling’s searing blog post on the cost-benefit analysis which accompanied the Department of Justice’s recently-released final rule implementing the Prison Rape Elimination Act. Heinzerling describes the DOJ’s analysis as “a labored, distasteful, and gratuitous essay on the economics of rape and sexual abuse.” In it, she writes,  DOJ finds “itself in the remarkable position of asking how much money the victims of rape would be willing to pay to avoid rape and also asking how much money these victims would be willing to accept in exchange for being raped. … Never mind that rape is a serious crime, not a market transaction. Never mind that framing rape as a market transaction strips it of the coercion that defines it. Never mind that the law under which DOJ was acting is the Prison Rape Elimination Act, not the Prison Rape Optimization Act. In the topsy-turvy world of cost-benefit analysis, DOJ was compelled to treat rape as just another market exchange, coercion as a side note, and the elimination of prison rape as a good idea only if the economic numbers happened to come out that way.”

• Finally, Rick Hills’ response to Heinzerling’s post is also provocative and worth a read. Hills argues that the DOJ’s analysis should have gone further down the road of quantifying the benefits of prison rape regulation, in order to support additional, costly, reforms. Hills writes “that it is better to ‘feel violated’ by facing up to the need to choose between costly reforms and substantial benefits than to refrain from adopting any costly reforms at all in order to avoid the comparison. Put more generally, sometimes it is impossible to induce judges, legislators, and the voters at large to bear big burdens unless one makes explicit the benefits that such burdens will produce.”

Recommended Reading: “Breaking the Cycle of ‘Unequal Treatment’ with Health Care Reform: Acknowledging and Addressing the Continuation of Racial Bias”

Ruqaiijah A. Yearby, Professor of Law and Associate Director of the Law-Medicine Center at Case Western Reserve University School of Law, has written another important article focusing attention on persistent racial disparities in health care access and outcomes, “Breaking the Cycle of ‘Unequal Treatment’ with Health Care Reform: Acknowledging and Addressing the Continuation of Racial Bias.”  An abstract of the article is available on SSRN, and the full article is forthcoming in the next volume of the Connecticut Law Review.   Here’s a preview to whet your appetite.

The article begins by reviewing evidence of racial disparities in health care status and access to quality health care in the United States, such as the 1985 Heckler Report, 2002 Institute of Medicine Unequal Treatment Study, and 2007 National Healthcare Disparities Report.  It then identifies racial bias as the root cause of racial disparities and summarizes empirical studies demonstrating that racial bias creates a barrier to access to health care and causes poor health outcomes for African-Americans.  Professor Yearby describes three types of racial bias in health care, interpersonal, institutional, and structural:

Interpersonal bias is the conscious (explicit) and/or unconscious (implicit) use of prejudice in interactions between individuals.  Interpersonal bias is best illustrated by physicians’ treatment decisions based on racial prejudice, which results in the unequal treatment of African-Americans. . . . Institutional bias operates through organizational structures within institutions, which “establish separate and independent barriers” to health care services.  According to Brietta Clark, institutional bias is best demonstrated by hospital closures in African-American communities.  Finally, operating at a societal level, structural bias exists in the organizational structure of society, which “privile[ges] some groups . . . [while] denying others access to the resources of society,” including health care.  An example of structural bias is the provision of health care based primarily on ability to pay, rather than on the needs of the patient.

A particularly eye-opening section of the article describes the growing dominance of aversive interpersonal racial bias in which a physician “believes that everyone is equal but harbors contradicting, often unconscious, prejudice that minorities (such as African-Americans) are inferior.”  Studies show that when doctors rely on “conscious and unconscious prejudicial beliefs” instead of “on individual factors and scientific facts,” it can affect treatment decisions, leading to racial disparities in medical treatment and “inequities in mortality rates between African-Americans and Caucasians.”  In addition, patient perception of aversive racism by their medical provider increases stress levels, which also has a negative effect on health status.

Despite passage of Title VI of the Civil Rights Act, which “prohibits health care entities [but not physicians] receiving government funding from using racial bias to determine who receives quality health care,” and various government initiatives to eradicate racial disparities in health care, the article reports evidence showing that “unequal treatment of African-Americans because of their race is the main cause of the continuation of racial disparities in health care.”

Professor Yearby acknowledges that the Affordable Care Act (“ACA”) is an important first step to addressing these disparities. Importantly, several provisions, such as the mandate, Medicaid expansion, premium subsidies, and essential health benefits, should expand access to meaningful health insurance for many previously uninsured minorities.  The Act further attacks structural bias “by limiting a charitable hospital’s ability to charge uninsured patients more than the amount generally billed to insured patients for emergency and other medically necessary care.”  The ACA also standardizes racial data collection, makes the Office of Minority Health a part of the Office of the Secretary of Health and Human Services, creates offices of minority health in various other federal agencies to study health disparities, and applies civil rights laws, including Title VI, to its provisions.

Despite these strengths, Professor Yearby criticizes the ACA for not fully addressing structural racial biases and ignoring institutional and interpersonal racial biases, which will permit racial disparities to persist and possibly worsen:

If health care professionals continue to harbor implicit and explicit interpersonal bias against minority patients, which prevents them from providing quality health care to these patients, simply increasing minority patient access to health insurance and, thus access to health care services, is not going to improve overall care for minority patients.  Moreover, increasing access to insurance and preventative services means very little when patients do not have a health care facility located in their neighborhood — a result of institutional bias.

The article also criticizes the government’s continued failure to remedy significant flaws in its civil rights enforcement system in the health context.

After highlighting the ACA’s flaws, the article then makes a variety of recommendations, including:

• Educating physicians about the three levels of racial bias and how each impacts medical treatment and patients
• Having federal and state regulators review institutional plans to close or relocate quality health care facilities for disproportionate harm on African-American communities and, where appropriate, requiring the institution to take remedial steps to ameliorate any disparate impact
• Adding physicians to the definition of health care entities or defining payments to them as federal financial assistance under Title VI so that civil rights actions may be brought against health care professionals
• Linking regulations governing racial disparities with civil rights enforcement by, for example, requiring that racial disparities data collected under the ACA be provided to the Office for Civil Rights and integrating civil rights enforcement into regulations governing health care facilities

Regardless how the Supreme Court rules on the ACA in the coming weeks, Professor Yearby’s article provides a valuable blueprint for continued and needed reform to “begin to break the cycle of unequal treatment.”

Recommended Reading: The FDA on Its Post-2007 Safety Ramp-Up and Barbara Evans on the Ethics of FDA-Mandated Postmarketing Studies

The FDA has released a report — Advances in FDA’s Safety Program for Marketed Drugs — in which the agency declares that, as a result of reforms implemented following the passage of the Food and Drug Administration Amendments Act (FDAAA) in 2007, it “now oversees the safety of both innovator and generic marketed drugs with the same rigor and focus as for premarket drug review.”  The FDA is likely engaging in a bit of hyperbole, given the vast disparity in resources allocated to pre- and postmarket review and its previous representation to Congress that “postmarket surveillance will ultimately require a level of staffing and organizational structure similar to that used for premarket review.”  As Professor Barbara Evans points out in her most recent article, The Ethics of Postmarketing Observational Studies of Drug Safety under Section 505(o)(3) of the Food, Drug, and Cosmetic Act (forthcoming in the American Journal of Law & Medicine), the FDA spends upwards of $500 million a year on pre-market review while Congress authorized expenditures of just $25 million a year for the years 2008 to 2012 to implement FDAAA’s various provisions related to post-market safety.

Still, the FDA does marshal some impressive facts and figures in its report.  Among the changes the FDA highlights, the Office of Surveillance and Epidemiology, which is “primarily responsible for monitoring postmarket drug safety data[,]” grew in size from 123 employees in 2007 to 245 employees today.  New safety positions have also been established within each of the 18 divisions of the Office of New Drugs, to ensure that “postmarket safety issues that arise related to the drugs approved in their division are handled effectively[,]” and within the Office of Generic Drugs’ Division of Clinical Review, to “evaluate[] and track[] reports of potential inferior generic product quality, adverse events, and reports of different therapeutic effect compared to the relevant reference listed drug.”   In addition, the FDA now has “a team of biostatisticians dedicated exclusively to postmarket safety evaluation.”

Since 2008, the FDA has used its new powers under FDAAA to require manufacturers (1) to conduct more than 385 postmarket drug safety studies, (2) to adopt “new safety labeling 65 times … generally for whole classes of drugs,” and (3) to implement 64 risk evaluation and mitigation strategies (REMS).  The agency receives many more adverse event reports today than in the past — the number more than doubled between 2005 and 2010, from 323,384 to 673,259 reports — and it has developed new data mining algorithms to identify patterns that might indicate new or increased drug safety risks.  The FDA has also “carried through on its commitment to communicate early and often about new drug safety issues[,]” issuing 68 Drug Safety Communications (DSCs) in 2011, up from 39 DSCs in 2010.  The FDA notes that “[t]he DSC webpage has now become one of the most visited pages on the FDA’s website, receiving more than 8  million page views in 2011.”

On top of all of the above-described activity, the FDA has been working to develop the  FDAAA-authorized Sentinel System, which will be “a national electronic system for securely accessing health care data [such as insurance claims and clinical records] to monitor the safety of drugs and other FDA-regulated medical products.”  The FDA explains in its report that it has developed a “Mini-Sentinel” pilot program that provides the agency with access to the “electronic health information of more than 125 million patients, provided by 17 data partners nationwide.”  The agency has therefore met the target set in FDAAA that it have access to the information of 100 million patients by July 2012.

In her interesting and important article, Professor Evans addresses a potential intersection between the Sentinel System and the observational studies that FDAAA authorizes FDA to require manufacturers to conduct.  A key concern about these studies is that personal health information that is disclosed to a drug or device company that is unrelated to one of that company’s products “may be subject to no federal regulatory protections whatsoever: not HIPAA, not the Common Rule, and arguably not even FDA’s human subject protections.”  As a result, institutional review boards “understandably may conclude that privacy risks are not minimal and refuse to approve [a HIPAA] waiver” allowing the data to be disclosed.  If this data access problem is not solved, the FDA could be forced to order companies to conduct randomized controlled trials “to answer questions that could have been answered using observational approaches[,]” which “is troubling since, by their nature, postmarketing [randomized controlled trials] of drug safety are ethically dubious affairs that pose special risks for human subjects.”  Based on a careful analysis of the language of FDAAA, Professor Evans concludes that the data access problem is not insolvable, because the FDA can enter into collaborative agreements pursuant to which manufacturers cover the cost of performing studies using the Sentinel System.  She cautions, though, that protecting patient interests will require, in addition to “a strong set of contractual provisions[,]” “an open, transparent public process for deciding the content of those provisions and for ensuring their careful, ongoing enforcement.”

Recommended Reading

As proof that the only news in health law does not involve the Supreme Court’s consideration of the challenge to the Affordable Care Act, here are some interesting recent articles that are worth a read:

1.      Frank McClellan and others recently released the results of their study, “Do Poor People Sue Doctors More Frequently? Confronting Unconscious Bias and the Role of Cultural Competency.” Some doctors perceive that socioeconomically disadvantaged patients tend to sue their doctors more frequently, which has influenced them not to provide care or to provide care in different ways to this population. For example, 57 percent of physicians polled in California in 1995 cited this belief as important in their decision not to treat Medicaid patients.  Yet McClellan and his co-authors review studies showing that, to the contrary, poor patients tend to sue their physicians less often than other groups.   Indeed, there is evidence that patients in lower socioeconomic groups are also less likely to file nonmeritorious malpractice claims.  One possible explanation that the authors of this project offer to explain this disconnect between physician perception and fact is unconscious or implicit bias, which “describes thinking and decision making affected by stereotypes without one being aware of it” that “can explain why people may consciously believe in a truth, whereas their behavior, affected by subconscious prejudices, is contrary to that truth.”  For example, physicians unconsciously concerned that poor patients will not adequately compensate them for their care “might consciously or unconsciously presume poor patients are more likely to sue as an excuse or way of avoiding the presumed difficulty associated with collections from such patients.” The authors of this study make recommendations to confront unconscious bias and provide culturally competent care (“CCC”), including increasing diversity, educating providers about CCC, improving provider communication skills, and enhancing patient health literacy.  CCC educational efforts are especially valuable in specialties like orthopaedic surgery, where approximately 84 to 89 percent of providers are white males.   It is thought that these efforts will improve medical care to lower socioeconomic groups and reduce the risk of malpractice claims.

2.      In “Diversion of Offenders with Mental Health Disorders: Mental Health Courts,” Sarah Ryan and Dr. Darius Whelan review the use of mental health courts in the United States, Canada, England, and Wales and consider whether these courts should be established in Ireland.  The article first reviews Therapeutic Jurisprudence (“TJ”), a foundational theory underlying problem-solving courts like mental health and drug courts that “promotes the employment of a ‘problem-solving pro-active and results oriented posture that is responsive to the current emotional and social problems of legal consumers.’”  While advocating its strengths, the authors also warn of the danger that paternalistic applications of TJ can water down due process and rule of law values.  They then identify and compare features of mental health courts that have developed in the United States, Canada, England, and Wales since the pioneer court started operating in Broward County, Florida in 1987.   After evaluating the main merits (e.g., more appropriate treatment and potentially reduced recidivism and costs) and criticisms (e.g., concerns about coercion, waiver of due process rights, stigmatization and segregation of the mentally ill, diversion of resources, and lack of empirical data that they are effective) of these courts, the authors conclude that mental health courts could offer a partial solution to the challenges facing Ireland’s criminal justice system.  Not surprisingly, they urge policymakers to select the best features of the programs that have evolved to date and to apply TJ “in a careful manner, to avoid interference with defendants['] constitutional rights.”  For example, the authors recommend that a solicitor be appointed at the first indication an offender could be eligible to participate.  Further, they believe that Ireland should not require offenders to plead guilty as a pre-condition to participate in the program because such a requirement is “antithetical to the goal of decriminalising the mentally ill.”  They warn, however, that for the program to be viable, Ireland would have to allocate substantial funding to develop community mental health treatment facilities.

3.      Recent Harvard Law School graduate Maggie Francis has written, “Forty Years of ‘Testing, Testing’: The Past and Future Role of Policy Experimentation in Healthcare Reform,” which reviews the federal government’s use of pilot projects and demonstration projects over the past forty years to test innovative health reform ideas.   As Ms. Francis describes, her article is the “first . . . in the legal literature to analyze the use of systemic policy experimentation by the federal government to reform the healthcare system.”  She describes the number and types of problems facing the healthcare system and why policymakers have chosen pilots as a means of addressing these problems.   The article then evaluates whether pilot projects are a useful tool in healthcare reform.  Ms. Francis identifies numerous advantages to pilots, including that they provide some cover to controversial innovations from political pressures and permit government to try multiple theories in different pilots to assess what works better in different populations, locations, etc. and to make adjustments based on experience that should make large-scale implementation smoother.  She also warns of some possible roadblocks, including lack of adequate information and competence to select the right pilots and then to oversee their implementation and evaluation.  A common criticism of these programs is that they take too long to test new ideas and expand those that are successful.  Securing consistent funding has also been a challenge.  In addition, political interference and gamesmanship can undermine efforts to innovate.  Ms. Francis concludes that, despite their limitations, pilot projects satisfy policy makers’ need for information about reform ideas and their consequences and offer the most promise where “organizational challenges, rather than stakeholder opposition and distributional problems, are the primary obstacle to reform.”  As a result, she posits that pilots might be more successful at encouraging widespread adoption of less controversial innovations, such as medical homes, than with contributing “significantly to the goal of cost control, which necessarily raises contentious distributional issues among powerful stakeholders in the healthcare industry and is likely to trigger rent-seeking behavior by interest groups.”  Ms. Francis’s observations are not merely historically interesting but rather offer important insights given the variety of pilot projects included in the ACA to help identify a politically viable way to bend the healthcare cost curve while improving quality.  Ms. Francis reviews the diverse medley of pilots in the ACA, including, but far from limited to, the creation of the Center for Medicare and Medicaid Innovation, reminding us all how much more there is to the ACA than just the mandate and how much we will learn from its implementation.

Happy reading!

Recommended Reading: Russell Korobkin’s “Bounded Rationality, Moral Hazard, and the Case for Relative Value Health Insurance”

Earlier this week at The Incidental Economist, Austin Frakt asked the following question:

“Is it still the case that US and state laws make it impossible for insurers and hospitals to control the use of health technologies? If so, this is a substantial problem for translation of comparative effectiveness research (CER) into practice. It seems that physicians, as well as hospitals and insurers, would need some legal safe harbor to put CER to use. Who is thinking or talking about this? Anyone?”

In an interesting new article, Bounded Rationality, Moral Hazard, and the Case for Relative Value Health Insurance (posted last month to SSRN), Russell Korobkin identifies a way to incorporate learnings from comparative effectiveness research into insurance contracts without running afoul of the laws to which Dr. Frakt refers.  If a dispute arises over coverage of a medical treatment that is not clearly excluded under the terms of a health insurance policy, the law favors the insured individual over the insurance company. But, as Professor Korobkin explains, “there is no impediment, in theory, to insurers excluding from coverage treatments that fail to satisfy a cost-benefit analysis, as long as the exclusions can be adequately specified at the time of contracting.”

Professor Korobkin contends that an adequate level of specificity could be achieved if insurers sold policies that varied in just one way: the cost effectiveness of the treatments they cover.  “Under this framework,” he explains, “the function of government-sponsored CER would be to evaluate different treatments for medical conditions and rate them on a scale of 1 (low) to 10 (high) in terms of cost effectiveness.”  Insurers could then offer less expensive plans that cover only relatively cost effective interventions (e.g. those rated 7 or above) and more expensive plans that also cover less cost effective interventions (e.g. those rated 3 or above).

In choosing an insurance plan, consumers would be asked to “trad[e] off price against a general level of medical care coverage[.]“  Professor Korobkin argues that this is “a better approach to rationalizing the amount of resources allocated to medical care” than either (1) “consumer directed health care” — which is founded on the unrealistic assumption that consumers are able to make “complex cost-benefit tradeoffs at the point of treatment” — or (2) “proposals to pay physicians based on the efficient use of resources that rely on them to compromise their fiduciary duties and undermine professional norms[.]“  The (relative) simplicity of the 1 to 10 scale would enable consumers to make sound — and legally-binding — decisions about how much of their money to spend on health care and how much to allocate to other priorities.

Professor Korobkin acknowledges that there are impediments to putting his “relative value health insurance” proposal into practice — including the dearth of information on the effectiveness, never mind the comparative effectiveness, of many, if not most, medical interventions, the difficulty of making the value judgments inherent in “measuring the benefits side of the equation,” and the risk that the ratings process would be captured by industry — but suggests that they are not insurmountable.  He also reviews and responds to some of the issues that might arise in a “ratings-based market,”  including the effect of relative value health insurance on the Patient Protection and Affordable Care Act’s health insurance exchanges and premium subsidies.

I highly recommend Professor Korobkin’s thought-provoking article to everyone with an interest in our notorious health care cost curve and how to bend it.

Recommended Reading: Recent Scholarship on Drug and Device Regulation

In Patients Over Politics: Addressing Legislative Failure in the Regulation of Medical Products (forthcoming in the 2011 volume of the Wisconsin Law Review and available on SSRN), Efthimios Parasidis proposes a significant expansion of drug and device companies’ responsibility to engage in “active post-market analysis” of drugs and devices, to be coupled with a new rule that only companies that conducted such analysis would benefit from preemption of state tort claims.  Professor Parasidis’ article includes a nuanced and revealing analysis of the historical and other reasons for the Food and Drug Administration’s heavy focus on pre-market review of drugs at the expense of post-market surveillance, as well as useful updates on both the caselaw regarding the preemption of claims involving branded drugs, generic drugs, devices, and vaccines and the ongoing efforts to use health information technology to glean information about the safety and efficacy of marketed products.  Most notable, though, is the article’s thorough explication of Professor Parasidis’ interesting proposal that “preemption laws, which often are enacted pursuant to industry lobbying efforts [be linked to] protocols that further the public health.”

In Enforcing Integrity (forthcoming in the 2011 volume of the Indiana Law Journal and available on SSRN), Katrice Bridges Copeland makes a strong case for her conclusion that neither the exclusion of pharmaceutical manufacturers from Medicare and Medicaid — a punishment which the government is reluctant to impose because it would spell the end for the company — nor the use of corporate integrity agreements coupled with large fines — which manufacturers agree to in order to avoid exclusion — works to deter illegal marketing activities.  As Professor Copeland notes, numerous companies have learned that “the punishment for multiple offenses is simply another CIA and another fine.”  She recommends that the government consider a number of alternative penalties for repeat offenders, including (1) requiring that manufacturers fund clinical trials studying the off-label uses for which they promoted their products, (2) requiring that they license the product or products at issue to other manufacturers, (3) holding high-level individuals criminally liable under the responsible corporate officer doctrine, and (4) amending the Social Security Act to allow for the exclusion of particular drugs (as opposed to entire companies) from Medicare and Medicaid.

Finally, I recommend Seton Hall Law’s own Jordan Paradise’s fascinating article, Claiming Nanotechnology: Improving USPTO Efforts at Classification of Emerging Nano-Enabled Pharmaceutical Technologies (forthcoming in the 2011 volume of the Northwestern Journal of Technology and Intellectual Property and available on SSRN), in which she argues that the United States Patent and Trademark Office’s system for classifying patents on nanotechnology-related inventions, “[w]hile undoubtedly helpful for internal purposes,” cedes too much to the courts.  Reviewing the facts of the recent case Elan Pharma International v. Abraxis Bioscience, which involved a dispute over two patents describing nano or near-nano scale versions of the same existing cancer-fighting agent and was tried to a jury verdict, Professor Paradise points out several ways in which the patents’ claims potentially overlap.  She argues that the courts are “a clumsy forum” for sorting out the “complex patent law issues that arise based on scale, size, and interactions at the nanoscale that transcend previously envisioned physical and chemical boundaries[,]” and offers concrete recommendations for steps the USPTO can take to improve its classification efforts to reduce the number of patents with potentially overlapping claims thereby making court involvement less necessary.

Recent Comparative Studies of Health Systems

As America continues to wrestle with the thorny thicket of health care reform, there are a number of recent reports chronicling and comparing approaches to health care and health reform in different countries that are worth a read.  For example:

• The Organisation for Economic Co-operation and Development recently released Health at a Glance 2011: OECD Indicators, which provides “comparable data on different aspects of the performance of health systems in OECD countries.” The U.S. spends 2 ½ times more than the OECD average health expenditure per capita (which amounted to 17.4% of GDP in 2009). (OECD explores why in a separate addendum, “Why is Health Spending in the United States So High”.) Yet, with the exception of cancer care and acute care in hospitals, it is not clear Americans are getting improved quality for the greater expenditures. As reported by CQ HealthBeat and by the Commonwealth Fund, “hospital services cost much more in the United States and pharmaceutical prices are much higher compared to other countries;” “there are fewer practicing physicians per 1,000 population, fewer doctor consultations and shorter hospital stays;” “more CT scans, knee replacements, and Caesarean sections;” and “comparatively high hospital admission rates for preventable conditions like asthma, diabetes and hypertension.”

• Strengthening Primary Care: Recent Reforms and Achievements in Australia, England, and the Netherlands, a recent report by Sharon Willcox, Geraint Lewis, and Jako Burgers of the Commonwealth Fund, evaluates efforts to improve access to, and the quality of, primary care in these countries– and suggests what the U.S. can learn from these initiatives. These countries have been focusing on three primary care reform strategies: promoting coordination of care, reforming primary care payment, and improving quality and access. As the abstract summarizes, “[q]uality improvement strategies include postgraduate training programs for family physicians, accreditation of general practitioner (GP) practices, and efforts to modify professional behaviors–for example, through clinical guideline development. Strategies for improving access include national performance targets, greater use of practice nurses, assured after-hours care, and medical advice telephone lines. All three countries have established midlevel primary care organizations both to coordinate primary care health services and to serve other functions, such as purchasing and population health planning. Better coordination of primary health care services is also the objective driving the use of patient enrollment in a single general practice. Payment reform is also a key element of English and Australian reforms, with both countries having introduced payment-for-quality initiatives. Dutch payment reform has stressed financial incentives for better management of chronic disease.”

• Bradford H. Gray, Thomas Bowden, Ib Johansen, and Sabine Koch, also of the Commonwealth Fund, review the extent of adoption of “meaningful use” (as defined in federal regulations) in three countries with extensive experience with electronic health records, Denmark, New Zealand, and Sweden in Electronic Health Records: An International Perspective on “Meaningful Use.” Although these European countries have high levels of EHR adoption, they have not reached 100% meaningful use, with the greatest weakness being in information provided to patients. The authors suggest that the U.S. could learn from these experiences the value of “providing economic incentives to encourage adoption and designating an organization to take responsibility for standardization and interoperability.”

• International Profiles of Health Care Systems: Australia, Canada, Denmark, England, France, Germany, Italy, Japan, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States, edited by Sarah Thomson, Robin Osborn, David Squires, and Sarah Jane Reed and published by the Commonwealth Fund, provides an overview of the health systems in these countries– including “health insurance, public and private financing, health system organization, quality of care, health disparities, efficiency and integration, use of health information technology, use of evidence-based practice, cost containment, and recent reforms and innovations.”

• The Commonwealth Fund also recently released results of an international study of patients with complex care needs in eleven countries: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the U.S. Although it identified significant care coordination issues, it found that “patients who have a medical home reported better coordination of care, fewer medical errors, and greater satisfaction with care than those without one.” In addition, the study also found “that patients in the United States are much more likely than those in 10 other high-income countries to forgo needed care because of costs and to struggle with medical debt.” 27% “were unable to pay or encountered serious problems paying medical bills in the past year, compared with between 1 percent and 14 percent of adults in the other countries,” and 42% did not see a doctor, fill a prescription, or receive recommended care. The authors conclude that “[t]he United States in particular has opportunities to learn from abroad-including the use of purchasing power to lower prices, payment innovations, and the use of information systems and care system redesign efforts that are under way in several countries.”

Of course, there are a variety of reasons the experiences in other countries may not take root in the United States.  But we still should be aware of these efforts and critically evaluate whether we might transplant any of them as seeds of reform here.

Recommended Reading: Joan Krause’s “Skilling and the Pursuit of Healthcare Fraud”

In her latest article, Skilling and the Pursuit of Healthcare Fraud, which is forthcoming in the University of Miami Law Review, Joan Krause suggests that the Supreme Court’s decision in Skilling v. United States could have a paradoxical effect on health care fraud prosecutions.  In Skilling, the Supreme Court rejected Jeffrey Skilling’s argument that 18 U.S.C. §1346, which criminalizes frauds designed “to deprive another of the intangible right to honest services,” is unconstitutionally vague.  In so doing, the Court strictly cabined the scope of Section 1346, holding that it only applies to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.”  While the Skilling decision is expected to lead to fewer honest services prosecutions overall, Professor Krause believes that it may lead to an increase in honest services prosecutions founded on health care kickbacks.  Professor Krause notes that “bribery or kickback schemes” are activities that “have particular salience in health care.”  She also points out that there are strategic advantages to prosecuting healthcare fraud cases pursuant to Section 1346, including a “focus on the physician-patient relationship as the locus of the misbehavior” that may appeal to juries and the fact that violations of Section 1346 carry longer maximum prison terms than violations of the Anti-Kickback Statute.

In the conclusion to Professor Krause’s article, she acknowledges that “the broader use of the honest services theory in health care kickback cases would raise a host of analytical issues” and then provides a fascinating elaboration.  According to Professor Krause, “the characterization of the physician-patient relationship as a fiduciary one is, perhaps surprisingly, far more complex than first appears.”  The physician is not a typical fiduciary.  For one, the physician’s duty is not all-encompassing — his or her duty of honesty does not extend beyond the provision of medical diagnosis and treatment — and, for another, unlike a traditional fiduciary, a physician has no control over his or her patient’s money.  Moreover, and of central relevance for the prosecution of health care fraud as honest services fraud,  “the physician’s duty to disclose information to patients generally is handled through the state-based law of informed consent rather than through broad federalized notions of fiduciary duty, and few informed consent cases or statutes require the disclosure of financial rather than treatment-related information.”  (For an in-depth discussion of whether disclosure of financial information should be required, see Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy’s December 2010 white paper The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research and June 2011 Journal of Health & Life Sciences Law article An Argument Against Embedding Conflicts of Interest Disclosures in Informed Consent).

If physicians are not legally obligated to disclose financial information to their patients, in what sense do they deprive those patients of their honest services by accepting a kickback?  Professor Krause sets forth a number of possibilities, including (1) that kickbacks are per se deceptive, (2) that kickbacks are deceptive unless proved otherwise, and (3) that “in the absence of a clear duty to disclose a kickback under fiduciary law or informed consent” kickbacks are not deceptive and there can be no honest services prosecution without “additional evidence of harm to the patient — if not tangible harm, at least proof that the physician’s decisionmaking (i.e., the services owed), was in fact influenced in a way that could have affected the patient’s treatment.”  While the third option is arguably “a truer reading of the doctrine,” Professor Krause predicts that it “likely will be found wanting by jurists who believe the disclosure duties imposed under current health law are incomplete.”

I highly recommend Professor Krause’s article for its comprehensive and insightful analysis of the Skilling case’s potential paradoxical effect on health care fraud cases, but also for its thought-provoking concluding section and the numerous timely questions it raises about the relationship between physicians’ duties to their patients and the federal duty to provide honest services.

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