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By Jonathan Kahn

In a recent article in Wired, science journalist Angela Saini discusses “the disturbing return of scientific racism.” The piece is drawn from her new book, “Superior: The Return of Race Science.” Scientific racism per se might be succinctly characterized as (mis)using science to assert essential biological bases for differences among socially defined racial groups. It has been used over 200 years to justify, and indeed promote, the subordination of certain racial groups as purportedly inferior to others.

Saini does an admirable job of tracing the roots of modern scientific racism and identifying its resurgence. Her story in the Wired piece, however, focuses primarily on the more obviously pernicious manifestations of scientific racism exemplified by Bruce Lahn’s work at the University of Chicago asserting a genetic basis for cognitive differences across socially defined racial groups. Saini effectively shows how other geneticists and socially scientists dismantled these claims but frames its appeal in the widely held mistaken belief that “races have natural genetic propensities.”

The dangers of scientific racism, however, manifest not only in pernicious attempts to show superiority of inferiority among races. It also emerges more subtly and complexly in the well-meaning work of biomedical professional seeking to explore broader racial differences, particularly in the field of health disparities.

The differences that cause race-based health disparities are not genetic, but they do emerge from a complex interplay of social and biological factors. It is in this interplay that the temptation arises to attribute disparities to genetics, which might seem more manageable and less politically fraught than attributing them to the messy realities of historical and ongoing social forms of discrimination.

As many of the grander promises of the genomics revolution have failed to materialize (curing cancer, diabetes, and so on) attention has increasingly turned to using genomics as a tool to redress racial injustice in health. A driving mantra in this enterprise has been “diversity.” Diversity is an organizing tenet of the NIH’s grand “All of Us” precision medicine program, seeking to enroll over one million Americans into a vast genomics database to propel health innovation to the next level (there is always a next level).

The tricky thing about diversity, however, it that, like health disparities, it is both a social and a biological concept. And so, when we talk about diversity in relation to health disparities, the door is opened to conflating and confusing social aspects of diversity (race) with biological aspects of diversity (genetic variation). Indeed, under the guise of “diversity,” the All of Us program is literally building race into its genetic data bank.

This is dangerous.

Unfortunately, this is exactly what we see happening in otherwise well-meaning initiatives such as the All of Us program. In seeking to “diversify” its research cohort, All of Us is appealing to groups primarily based on their racial identities. Specifically, it argues that a genetically diversified research cohort may contribute to alleviating the health disparities that afflict the socially defined racial groups from which they are trying to recruit.

It is well-know that while humans are 99.5% genetically the same, some variation does occur clinally, that is, through graduals changes across geographic distance and or environmental shifts, such as altitude or coal dust in the air.

The idea behind the All of Us diversity initiative seems to go something like this: in order to discover meaningful genetic variants that contribute to disease, we need to have a research cohort that is genetically diverse; one way to increase genetic diversity of a cohort is to recruit from populations that have historically been geographically distant from each other; the way we think about geographic distance today is largely in terms of continents, so let’s recruit diverse continental ancestries. A big problem comes with the next step where programs such as All of Us move on to conflate socially identified racial groups with diverse continental ancestry.  Someone who “looks” Black comes to represent all of Africa genetically; someone who “looks” East Asian comes to represent all of Asia, someone who “looks” White comes to represent all of Europe, and so on.

This thinking is not without a certain scientific logic, but it sacrifices scientific rigor to social convenience. There is, for example, more genetic diversity across populations within the African continent than there is in the entire rest of the world. Moreover, assuming that people who socially code as “Black” or “Asian” are somehow genetically distinct erases more contemporary contributions to an individual’s genetic make-up. Also, this assumption implies a notion of some sort of underlying genetically “pure” African or Asian genetic prototype in a manner that directly reinforces the sort of genetic essentialism found in the work of researchers like Lahn.

Make no mistake, race-based health disparities are real and persistent. They matter. But they are overwhelmingly due to social, economic, political and historical forces. Genetics can only take us so far, and it can take us in the wrong direction if we use it as a substitute for or distraction from the legal, political, and economic initiatives that are needed to address the long, tangled history of racial oppression in this country.

Jonathan Kahn is a Professor of Law at Biology at Northeastern University School of Law.

The post Why Race-Based Health Disparities Have Little to do With Genetics appeared first on Bill of Health.

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There does not seem to be a week that goes by without an NHS (National Health Service) patient safety crisis hitting the headlines and this has been the case for many years. Major public inquiry reports into patient safety and health quality failings are published. Recommendations are made, and then another crisis event follows soon afterwards spawning yet other reports, broadly saying the same thing.

The NHS has built up a huge back catalogue of inquiry reports into patient safety crisis’s, spanning decades containing a lot of deep thinking, useful analysis and valuable recommendations. Analysing present and past patient safety crisis inquiry reports is a very useful educational exercise and can help inform future policy development in the area. Some of the seemingly intractable, stubbornly persistent patient safety problems that beset the NHS, both past and present are identified and discussed. Revisiting reports and analysis can also refresh our perspective on patient safety issues and provides an information bedrock on which we can base change.

Patient safety inquiry reports also provide a momentum for change through their recommendations which the government of the day can accept or reject.

New Patient Safety Public Inquiry

The Department of Health and Social Care (DHSC) announced on 6th June 2019, a new independent inquiry, investigation into the serious incidents at Liverpool Community Health NHS Trust between 2010-2014. The Guardian newspaper report of the announcement contains some very worrying figures:

“Ministers have ordered an inquiry into evidence that an NHS trust failed to properly investigate 150 patient deaths and 17,000 incidents in which patient safety was put at risk. The investigation is the latest in a series of inquiries into the care provided by Liverpool Community Health (LCH) NHS Trust. They all found serious problems including shoddy treatment, bullying and failures of leadership.”

The investigation will be conducted through three stages which are described in the DHSC announcement. The inquiry will seek to identify individual serious patient safety incidents that were not reported or adequately investigated. Undertake a series of historical mortality reviews. At stage 3 the inquiry will fully investigate incidents identified in stages 1 and 2. The inquiry will determine the scale of patient harm and identify local and national lessons to be learnt from the events.

This will be the second into Liverpool Community Health conducted by Dr Bill Kirkup.The first Kirkup report published in 2018 found serious dysfunctionality in the trust (health care organisation):

“Demoralised staff were badly treated and sometimes bullied, and there was a failure of nursing management and HR procedures. Serious incidents causing patient harm were not reported, not investigated and lessons not learned. The result was unnecessary harm to patients. (p7)”.

Recurrent learning points

Recurrent learning points found will no doubt be the need to maintain safe staffing levels, good leadership and staff management practices. No bullying, good patient caring and not focusing inordinately on financing. Putting patients first, reflective and safe practice, improve communication skills at all levels, avoiding defensive attitudes when things go wrong and so on.

Reviewing patient safety crisis inquiry reports

We do need to develop much more of a sense of NHS patient safety history and to not always follow the seemingly innate and intractable NHS tendency to reinvent the wheel when there are already existing intelligence and solutions existing in current and past patient safety inquiry reports. Reading reports of patient safety inquiries is a practice to be encouraged and can help advance both national and global patient safety agendas.

The post The Latest in the Continuing Cycle of NHS Patient Safety Inquiries appeared first on Bill of Health.

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Millions of Americans rely on the likes of birth control, IVF, and genetic testing to make plans as intimate and far-reaching as any they ever make. This is no less than the medicine of miracles. It fills empty cradles, frees families from terrible disease, and empowers them to fashion their lives on their own terms. But every year, thousands of accidents happen: Pharmacists mix up pills. Lab techs misread tests. Obstetricians tell women their healthy fetuses would be stillborn. These mistakes can’t be chalked up to reasonable slips of hand or lapses in judgment as often as human failures and flawed quality controls.

But political and economic forces conspire against meaningful regulation. And however egregious the offense, no statute or doctrine says that these injuries matter, legally speaking. The American legal system treats reproductive negligence less like mischief than misfortune. Some courts insist that thwarted plans are too easy to contrive and too hard to verify. Others wonder why victims didn’t just turn to abortion or adoption instead. Most are unwilling to risk characterizing any child’s birth as a legal injury. So judges throw up their hands when professional misconduct leaves patients with no baby, when they undertook reliable efforts to have one; any baby, when they set out to avoid pregnancy and parenthood; or a baby with different genetic traits than the health, sex, race, or resemblance they’d carefully selected.

This isn’t the first time that technological advances have outpaced the slow churn of the legislative process and existing tools of the common law. It was exactly one century ago, the legal scholar Roscoe Pound, then dean of Harvard Law School, published the new edition of his treatise, On the Law of Torts. What made the textbook remarkable was its inclusion of a prescient chapter that set forth an emerging right for the “Interference with Privacy.” That right is well-established today. But American law wasn’t much concerned with the exposure of secrets until advances in picture-taking made natural bedfellows with professional muckraking.

This post originally appeared on OUPblog. Read the rest of it there.

The post How Technology is Changing Reproduction and the Law appeared first on Bill of Health.

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Last summer, a group of cancer survivors and others struggling to have children held a memorial service for their “hopes and dreams lost.” That’s the message they had engraved on a bench in the Ohio cemetery where these would-be-parents-who-won’t mourned.

More than 4,000 of their frozen embryos and eggs were destroyed when a high-capacity freezer tank failed at University Hospitals Fertility Center in Cleveland one Saturday in early March 2018. Another thousand were lost the same weekend, after a similar malfunction at an unrelated clinic across the country, Pacific Fertility Center in San Francisco.

Some of those affected had made appointments to try to initiate pregnancies the very next week. All had undergone painful procedures and paid, in some cases, thousands of dollars to keep their materials suspended in liquid nitrogen at a constant −196°C. But that weekend in March, tank temperatures began rising, and by the time the Ohio lab technicians returned for their next shift, everything inside had thawed beyond rescue or repair. It’s not clear why remote alarms were turned off; investigations are ongoing. So far, only coordinated cyberattacks have been ruled out.

Similar steel tanks are used by almost 500 fertility clinics nationwide to store millions of reproductive tissues, including eggs, embryos, and sperm. Developed in the 1960s to store livestock semen for breeding, the cryopreservation containers aren’t regulated any better than kitchen appliances or farm tools. In lawsuits, some blame clinic staff for neglecting to refill the nitrogen chambers in these “ever-dependable vessels,” and clinics for failing to adopt more reliable monitoring systems that measure nitrogen levels with a super-sensitive scale that identifies signs of dangerous warming much earlier than the thermometer-based sensors that can only warn hours before it’s too late.

This post originally appeared on Vox.com. Read the rest of it there. 

The post The Legal Limbo of Lost Embryos appeared first on Bill of Health.

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The rather esoteric issue of a national patient identifier has come to light as a difference between two major heath care bills making their way through the House and the Senate.

The bills are linked to outrage over surprise medical bills but they have major implications over how the underlying health care costs will be controlled through competitive insurance and regulatory price-setting schemes. This Brookings comment to the Senate HELP Committee bill summarizes some of the issues.

Who Cares?

Those in favor of a national patient identifier are mostly hospitals and data brokers, along with their suppliers. More support is discussed here. The opposition is mostly on the basis of privacy and libertarian perspective. A more general opposition discussion of the Senate bill is here.

Although obscure, national patient identifier standards can help clarify the role of government in the debate over how to reduce the unusual health care costs and disparities in the U.S. system. What follows is a brief analysis of the complexities of patient identifiers and their role relative to health records and health policy.

Patient Matching

Patient matching enables surveillance of patient activity across service providers and time. It can be done either coercively or voluntarily. We’re familiar with voluntary matching like using a driver’s license number to get a controlled substance prescription. People are not aware of the coercive matching that goes on without our consent.

Voluntary matching is cheap and reliable. Coercive surveillance for patient matching is quite expensive and prone to errors. Why would so many businesses promote the coercive alternative? It’s mostly about money. The relationship between health surveillance and money in the U.S. healthcare system is relatively unique in the world. The issue of a national patient identifier is also pretty specific to the U.S. The reasons, as all things in U.S. healthcare, are complicated. But, fundamentally, they boil down to two things:

  • Patients have a right to be treated without identification — what HIPAA calls “known to the practice” — but paying for that treatment clearly requires some identification.
  • The byzantine financial incentives in the U.S. system mean that thousands of data brokers have a financial interest in the hidden surveillance. Otherwise, they would just ask patients for consent.
Insurance

Payers already have a patient identifier. The impact of adding a surveillance component, either voluntary or coercive, is hard to estimate. Would patients have a choice of plans with or without coercive surveillance? Would we need regulations, similar to GINA, to reduce the risk of biased interpretation? I’m not aware of any insurance industry comments on the House national patient identifier amendment.

All Payer Claims Databases

Pretty much everyone in the health care “system” is working as hard as they can to avoid transparency. Transparency of quality, of cost, of data uses, of directories, of “black box” and artificial intelligence algorithms, and more. The principal strategy for both the House and Senate versions of the cost reduction bills is to increase transparency, but that could be achieved with either coercive or voluntary identifiers.

Prescriptions

Coercive patient surveillance is already in place on a massive scale. Surescripts tracks over 200 million U.S. patients and sells that information for all sorts of purposes without patient consent or obvious oversight. In theory, one can opt-out of Surescripts. In practice, it’s practically impossible. (I tried it.) I did find errors in my file. Even fixing those errors was more trouble than it was worth. Would Surescripts’ coercive surveillance be mitigated by a national patient identifier? Quite possibly, if the final legislation introduces privacy protections, such as opt-in and real-time patient notification by Surescripts or anyone else that is making use of the identifier.

Known to the Practice

HIPAA encourages a trusting physician-patient relationship by allowing confidential and even anonymous consultation. This promotes public health. The implementation of a national patient identifier must preserve this option.

TEFCA

The federal government has been trying to create a national network for health records for over a decade. The current state is the Trusted Exchange Framework and Common Agreement (TEFCA) Draft 2. TEFCA is still far from obvious with major detractors from the incumbents and no clear solution to the very hard problems of regulatory capture of standards, security, consent, and patient matching. Three address these issues.

Aside from moving patient data from here to there, TEFCA aims to provide a surveillance mechanism that will track the locations where patients receive health services. This can be quite useful for maintaining a longitudinal patient record, measuring outcomes, and informing research, as well as policy.

But a national surveillance system can also spook patients and increase public health risks if populations concerned about bias and loss of opportunity hide or actively game the system. It’s therefore essential to design TEFCA with the highest level of privacy and transparency, similar to what we have in finance. A national patient identifier will help TEFCA, but only if it is voluntary (linked to consent), transparent (to mitigate security risks), and most importantly, if it replaces the current design based on coercive surveillance.

Privacy

People already have any number of national-scale identifiers. Mobile phone numbers and the unique device identifiers that phones broadcast just by being on, email addresses, driver’s license numbers, Medicare and private insurance IDs, a Social Security Number, and credit cards. What matters for privacy is not the existence of personal identifiers but how they are used. Is the usage regulated? Does use in one domain, e.g. purchasing, cross over into another domain such as taxation? Is the use of the identifier voluntary like when you sign to allow your credit surveillance history to be accessed by an auto dealer or a landlord? Are you notified whenever an identifier is used? Are there usage logs and statements conveniently available to you? A national patient identifier will need to answer all of these questions and more.

Errors, bias, and ethics

Every large system is subject to errors, bias, and ethical issues. The proponents of a national patient identifier make self-serving arguments about reducing errors, such as assigning data to the wrong patient, without a critical analysis of how errors might be intentionally or accidentally introduced into the system. Other questions include how patients can catch errors or omissions and how access to a national identifier might bias relationships with employers or a new generation dating sites. The ethics of health care are mostly about the unintended consequences of what superficially seems like a good idea.

Coerced, Voluntary, or Self-sovereign

Self-Sovereign Identity (SSI) that is cryptographically secure and controlled by the individual person. If we introduce a national identifier, for patients or any other large-scale use, in 2020, should that identifier be compatible with SSI?

Independent Patient-Controlled Longitudinal Health Record

A new national patient identifier is not an end in itself, it must serve or enable something new. That new thing could be universal healthcare coverage, which exists in almost every other developed economy. Another new thing would be a longitudinal health record that is independent of any particular public or private institution. An independent health record would promote competition, enable greater transparency of outcomes and costs, and it would significantly reduce the costs of research and innovation. It’s important to design TEFCA and other federal programs around the outcome rather than a tweak of the process.

Non-HIPAA Components

What would be the scope of a new national patient identifier? Should it be used to add non-HIPAA components like exercise or diet to a patient’s record? Should it apply to over-the-counter purchases in pharmacies or telemedicine from outside the US? Will the new identifier expand the scope of surveillance by Facebook, Google, and other hard-to-avoid platforms?

Should you care?

Yes. The uniquely high U.S. health care costs are now driving politics directly and indirectly. Universal coverage could be the top issue in 2020. But health costs also impact immigration discussions, as well how we deal with technology-driven shifts in employment and employer-based insurance.

Bi-partisan efforts such as the “surprise medical bills” legislation now before the House and Senate are aimed at health care cost outcomes and the balance of power between hospitals, payers, patients, physicians, and regulators. That balance of power was swept under the political rug in previous efforts. With health care waste and fraud running at about $1.5 trillion or 6 percent of GDP, the debate over a national patient identifier should not be about the process of patient matching but over the path to increased transparency, competition and innovation.

The post A National Patient Identifier: Should You Care? appeared first on Bill of Health.

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Recent headlines highlighted a $40 million investment by a range of Blue Cross Blue Shield companies in Solera Health, a start-up focused on improving chronic disease management. Solera Health will use the investment to scale up its wellness programs, which seek to improve social determinants of health for patients.

One of Solera’s initiatives focuses on providing medically tailored meals to beneficiaries. The concept behind medically tailored meals is simple. Patients with diabetes, congestive heart failure, and other chronic illnesses can be treated only to a limited extent in doctor’s offices. By extending services like meal provision to beneficiaries—thus improving their long-term health—insurers can potentially avoid paying for more costly interventions down the line.

A variety of pilot programs, including several prominent Medicaid demonstration projects, have eased the path towards Solera’s initiative. One of the first of these pilots took place in Philadelphia, where researchers conducted a comparative study of Medicaid patients and clients enrolled in the city’s Metropolitan Area Neighborhood Nutrition Alliance. The study found that the average cost of health care services for clients in the Alliance were 31% lower than those of the comparison group.

In response to the success of city-scaled pilots, a handful of states have successfully applied for demonstration waivers seeking to provide coverage for medically tailored meals under Medicaid. A medically tailored meals pilot was launched in eight California counties in April 2018. The program is collecting data on the costs and health effects of medically tailored meal-provision for a population of 1,000 Medicaid patients, and the results of the study are expected to be published in 2020.  North Carolina is seeking to pilot delivery of medically tailored food boxes to Medicaid recipients as part of its recently approved demonstration project.

Similarly, Harvard’s Center for Health Law & Policy Innovation partnered with Boston-based non-profit Community Servings to implement a range of “Food is Medicine” initiatives in Massachusetts. The program seeks to treat and prevent chronic disease by offering clients with chronic disease medically tailored meals and providing clients who are food insecure with access to fruit and vegetables, among other programs. In studying these interventions, the “Food is Medicine” partnership has found that provision of medically tailored meals is associated with fewer inpatient and emergency department admissions.

It is meaningful that large, private companies have begun taking an interest in treating social determinants of health like access to food as a worthy investment. As Solera’s initiative moves forward, it is also noteworthy that the work and research done by public programs and non-profit organizations has laid the groundwork for this new venture. Recent headlines about the investment in Solera expose the role of Medicaid demonstration projects and non-profit entities in improving and re-shaping our health system as a whole.

Alexandra Slessarev is a 2018-2019 Petrie-Flom Center Student Fellow.

The post Medically Tailored Meals and the Reverberating Impact of Public Demonstration Projects appeared first on Bill of Health.

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By Elizabeth Sepper and John Aloysius Cogan, Jr.

Known for his national injunctions of federal legislation, district court judge Reed O’Connor is at it again. In DeOtte v. Azar [PDF], he issued a permanent injunction granting religious exemptions to two nationwide classes that object to the Affordable Care Act’s contraception mandate. Judge O’Connor’s decision is notable for both its expansion of religious exemptions—in contradiction of eight out of nine appellate courts to consider the issue—and its casual disregard for the realities of health insurance markets.

DeOtte is the latest in a series of lawsuits pitting the Religious Freedom Restoration Act, which bars the federal government from substantially burdening a person’s exercise of religion, against the ACA’s mandate that insurance plans cover FDA-approved contraceptives.

Initially, under the mandate, churches were exempt and religious non-profit employers—like hospitals and universities—received an accommodation. So long as non-profits gave notice of their objection, their plans could exclude contraception. Their employees then would receive contraception coverage through the insurance company or health plan administrator. In 2014, the Supreme Court extended the accommodation to closely held for-profit corporations in Burwell v. Hobby Lobby, Inc.

Unsatisfied, Braidwood Management—the for-profit employer in DeOtte—sought a total exemption. It argued that the accommodation process itself imposes a substantial burden on its religious exercise in violation of RFRA. While sexist beliefs about women’s roles may have been submerged in previous cases, they were front and center in DeOtte. Braidwood argued that copay-free contraception encouraged women to engage in nonmarital sexual activity. The individual plaintiffs instead mounted a claim that the contraceptive mandate violates their RFRA rights “because it forces [them], and other religious believers, to choose between purchasing health insurance that makes them complicit in abortifacient contraception, or forgoing health insurance entirely.”

Judge O’Connor agreed, issuing summary judgment in favor—not only of the named plaintiffs—but “[e]very current and future employer in the United States that objects, based on its sincerely held religious beliefs” to covering contraception and “all current and future individuals in the United States” who object to coverage and “would be willing to purchase or obtain health insurance that excludes coverage.”

The decision mounts an end run around other federal courts and prior precedent in the Fifth Circuit and risks disrupting insurance markets.

Accommodation as Substantial Burden – An End Run Around Courts of Appeals?

RFRA requires that religious objectors establish a substantial burden on their free exercise. Faced with claims from religious non-profits identical to the employer in DeOtte, eight out of nine courts of appeals concluded that the accommodation process does not meet this threshold. One of those courts was the Fifth Circuit, which includes the Northern District of Texas where O’Connor presides. This would seem to be an insurmountable barrier for the employer plaintiffs.

But Judge O’Connor said a distinction exists. The religious non-profits before the Fifth Circuit held a religious objection to facilitating access to abortion, and the Fifth Circuit concluded that filling out a form giving notice of objection did not facilitate access given insurers’ independent legal obligations. For Braidwood, by contrast, “Refraining from executing the accommodation forms . . . *is* the religious exercise here.” In other words, filling out the form is a substantial burden. Assuming compelling interest, the opinion then breezes through the least restrictive means analysis. It says Hobby Lobby “held” that the government can provide free contraceptives (it didn’t) and “its reasoning controls.”

Because O’Connor certified a national class, the decision applies even in areas of the country where eight federal courts of appeal have ruled that the accommodation process does not violate RFRA. It also represents an end run around injunctions issued by federal courts in California and Pennsylvania against the Trump Administration’s 2017 regulations that would exempt any employer from the contraception mandate.

Everything and Nothing Is a Burden on Religion

The individual plaintiffs’ claim of a substantial burden on their free exercise seemed even thinner. After all, the ACA’s individual mandate penalty has been repealed. No individual faces a tax penalty for failing to carry insurance. Any objector to contraceptive coverage (which other people in the risk pool might use) could either buy non-ACA coverage without contraception coverage or go bare.

But Judge O’Connor found a burden. Although the penalty is gone, the mandate still exists in the federal code. According to O’Connor, the expressive function of law—in the absence of any enforcement mechanism—burdened individuals who wanted insurance but objected to contraception. If individual plaintiffs can find insurers willing to offer contracts without contraception coverage, Judge O’Connor ruled, those insurers may issue the policies without fear of federal penalties.

DeOtte flies in the face of a number of decisions rejecting substantially similar religious objections to contraception coverage. It also opens the door to more libertarian uses of RFRA. If a regulated industry won’t challenge laws that apply to it, potential consumers of their products now might.

Haphazard Deregulation of Health Insurance Markets

DeOtte’s aberrant application of RFRA isn’t its only problem. The decision also demonstrates a profound misunderstanding (or disregard) of U.S. health insurance markets. The order covers more employer groups that its analysis justifies, haphazardly attempts to regulate insurance markets, and opens the door to risk fragmentation in the self-insured market.

We’re about to get a little wonky, but stay with us.

Employer-based insurance falls into three categories: small group markets for small employers (fully insured), large employer plans from insurance companies (fully insured), and employers (mostly large, but some small) that essentially act as insurers and use an insurance company to administer their plans (self-insured). Judge O’Connor lumped these three together, but they differ in important ways.

Small employers with fewer than 50 employees (whether fully or self-insured) pay no penalty if they don’t provide health coverage. By O’Connor’s own reasoning, they face no burden. They are not forced to choose between paying a tax penalty or violating their beliefs by providing contraceptive coverage through a health plan (or filing for a religious accommodation). Yet these small employers are included in the order.

Fully insured plans in the small and large group markets may not find any relief from the religious burdens Judge O’Connor identifies. These plans remain subject to state insurance regulation, which in thirty states requires some form of contraceptive coverage. Judge O’Connor’s order doesn’t preempt those state requirements.

Self-insured employer plans, by contrast, are exempt from state insurance laws under the Employee Retirement Income Security Act of 1974 (ERISA). Judge O’Connor’s order thus frees them from any contraceptive coverage requirements. But these freedoms come at a cost. Self-insured employers can now shift medical costs onto women employees. Under DeOtte’s reasoning, a self-insured plan might equally seek religious exemptions from adult HPV vaccination, STI screening, prenatal care, and other medical services. Women would then have to bear their medical costs directly, seek coverage elsewhere (from a spouse’s plan or in the individual market), or find other employment.

The order’s treatment of individual plaintiffs is even more baffling from an insurance perspective. This class of individuals encompasses two distinct groups: people like the named plaintiffs who purchase insurance on healthcare exchanges and employees covered by a group plan. Their argument boils down to wanting to buy a product the market doesn’t offer, like a seatbelt-free car or a lead pacifier. Judge O’Connor’s order purports to allow them to do so, by permitting group plans and insurers offering individual coverage to offer separate insurance contracts without fear of federal penalties.

But health insurance does not work this way. Again, any fully insured plan is subject to coverage mandates under state insurance laws. And there is also the issue of price. In the individual and small group markets under the ACA and state law, insurance contracts remain subject to strict pricing and pooling restrictions. It is unclear how Judge O’Conner’s order would function in these markets. Group plans are even less likely to spin off individual policies for employees. The purpose of grouping individuals (usually employees of a single employer) within a single plan is to pool risks and price accordingly.

What’s Next?

Despite its strained extension of RFRA and its slapdash attempt at insurance regulation, Judge O’Connor’s order is binding on the federal government; it cannot enforce the contraception mandate against any insurers or employers that raise a religious objection. The central question now is procedural: What happens next? It’s unclear if anyone will appeal DeOtte. The defendant, the Trump administration, agreed that the contraception coverage requirement violates RFRA. The State of Nevada filed a motion to intervene in May, but Judge O’Connor has yet to rule on it. A notice of appeal must be filed by July 5th. Absent an appeal, the order will stand.

Elizabeth Sepper is a Professor of Law at the University of Texas at Austin School of Law. 

John Aloysius Cogan, Jr. is an Associate Professor of Law and Roger S. Baldwin Scholar at UCONN School of Law. 

The post The Contraceptive Mandate Takes Another Hit   appeared first on Bill of Health.

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By Adrienne R. Ghorashi

After what seemed like a barrage of legislative attacks on abortion rights last month, some states are hitting back by strengthening their laws to protect the right to an abortion. Illinois, Maine, Nevada, New Jersey, New York, Rhode Island, and Vermont have all passed legislation this year expanding access to abortion in various ways. In the current political climate, where some fear that Roe v. Wade is in danger of being gutted or overturned, state legislatures are a key battleground in the abortion fight. Legislatures and courts alike have been testing the very limits of the constitutional protections cemented in Roe. As deference to Roe wavers in the courts, enacting proactive legislation is a strategy that advocates of abortion access are paying close attention to.  

New York’s Reproductive Health Act, passed this January, is a sweeping measure that codifies the protections of Roe within state law. The NY law regulates abortion as healthcare, rather than a criminal act, and expands the types of qualified healthcare professionals that may provide abortion. It also extends post-24 week protections where a pregnant individual’s health or life is in danger, or the fetus is not viable. New laws in Rhode Island, Illinois, and Vermont were also signed into law earlier this month, providing broader protections for individuals seeking abortion care. For reproductive rights advocates, these are legislative victories that come on the heels of a decades-long battle.   

Before the most recent wave of proactive legislation, just eight states had statutes codifying the right to an abortion up to viability, according to data published by the Center for Public Health Law Research’s Abortion Law Project. The data, available on LawAtlas.org, also explore court opinions that interpret state constitutional provisions, such as the right to privacy, as protecting abortion rights. 

As of December 1, 2018, eight states (CA, CT, DE, HI, ME, MD, NV, WA) had a statute protecting the right to an abortion up to viability.

State law initiatives such as these are significant for a few reasons. Most obviously, they unequivocally guarantee the right to abortion by enshrining protections in statutory law, meaning that even if the courts fail to uphold the decision in Roe, citizens in states like New York would still have abortion access. Additionally, public support for these laws could work to remove the stigma surrounding abortion and frame it as healthcare, rather than continuing to criminalize abortion providers and their patients.    

Furthermore, there’s an increasing chance that states will feel encouraged to follow suit by passing similar legislative measures, as demonstrated this year. Though not always rooted in evidence-based practice, states have the ability to set an example for other lawmakers and lead the way for further innovation. We’ve seen instances of how legislation can catch on like wildfire at the state level, for better or worse. Fetal heartbeat bans and many other types of state abortion restrictions are proposed as a result of “model legislation” pushed out by special interest groups in a nationwide strategy. With abortion rights perceived to be under threat at the federal level, some advocates are taking a page out of their opponents’ playbook by enacting proactive state laws.  

As these battles unfold in state legislatures, it’s important to remember who will be most affected. Lawmakers in Illinois claimed to be “building a firewall around Illinois to protect access to reproductive healthcare for everyone.” While privileged women with the means to travel across state lines will continue to have access to the services they need, historically it was black and brown bodies who had their autonomy stripped away by oppressive political and social institutions. Today, women of color still seek abortions at a much higher rate than white women do, attributed to the lack of affordable healthcare and other manifestations of institutionalized racism. When 75 percent of women seeking abortion are low-income, barriers to safe abortion care hit hardest among those lacking resources.  

So while state-by-state initiatives are a crucial tool that finally seems to be paying off in the fight for reproductive justice, the larger challenge ahead is ensuring that access to healthcare is no longer dependent upon a person’s income level or zip code.  

Adrienne R. Ghorashi is a Program Manager at the Policy Surveillance Program at the Temple University Center for Public Health Law Research. 

For more data on state abortion regulations, please visit the Abortion Law Project. The Abortion Law Project was created through a collaboration between the Policy Surveillance Program at Temple University’s Center for Public Health Law Research, Guttmacher Institute, Resources for Abortion Delivery (RAD), American Civil Liberties Union, Center for Reproductive Rights, National Abortion Federation, and Planned Parenthood Federation of America. 

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The post When It Comes to Abortion Restrictions, State Legislatures Try Fighting Fire with Fire   appeared first on Bill of Health.

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In terms of transparency and accountability the National Health Service ( NHS) in England is excellent at producing insightful, well-produced reports on health quality and patient safety. It does this on a regular basis and one of the great difficulties faced by NHS nurses and doctors today is the sheer volume of reports published. It’s an impossible task for nurses and doctors to keep up to date with all the reports published and to maintain heavy workloads in resource constrained environments. It’s also hard for health care staff to know which reports to prioritize and which are authoritative.

There is an urgent need for the NHS to create a one stop, patient safety information hub which collects reports from all NHS sites and other important global sites, putting everything into one accessible place. Some recent reports on written patient complaints have been published which are helpful in assessing, testing patient safety and health quality in the NHS.

NHS complaints

Patient complaints are a good barometer of patient safety and health quality and should be analysed for trends, themes. Complaints should also be viewed as a valuable source of patient feedback. Many retailers view complaints from customers positively as constituting useful marketing feedback which can inform new products and services development. Unfortunately the NHS experience with complaints is not that positive and defensive attitudes prevail as the House of Commons Committee of Public Accounts in 2017 stated, “There seems to be a prevailing attitude of defensiveness in the NHS when things go wrong, and a reluctance to admit mistakes, which is likely to be leading to more clinical negligence claims.”

NHS Digital Complaints Reports

NHS digital produce regular data reports on written complaints in the NHS. NHS Digital in 2018 provided data in a report on written complaints in the NHS -2017-2018. “The total number of all reported written complaints in 2017-18 was 208,626. This is the equivalent to 4,012 written complaints a week or 572 complaints per day…The total number of all reported Primary Care written complaints has increased by 4,058 (4.5 per cent) from 90,579 in 2016-17 to 94,637 in 2017-18,” said the report.

An interesting takeaway point from the above quote is the figure of 572 written complaints a day.

More recent figures

More recent figures have been produced by NHS Digital in a 2019 report. This is quarterly collection count of written complaints made by or on behalf of patients about NHS Hospital and Community Health Services (HCHS) in England. The report states that for the period  1 January – 31 March 2019 (Q4) there were 29,507 new HCHS written complaints compared to 28,019 in Q3.  Over the period, the report states, 27,054 complaints were resolved, of these 8,684 (32.1 percent) were upheld, 8,453 (31.2 percent) were partially upheld and 9,917 (36.7 percent) were not upheld.

The report breaks down the 29,507 new complaints made into discrete areas, service, subject and profession. There were 38,417 complaints by service area, the largest proportion being attributable to inpatient services with 33.2 percent (12,748) followed by outpatient services at 22.0 percent (8,465). The report states that there were 48,886 complaints by subject area, of which 27.0 percent (13,210) were complaints about clinical treatment:

“The largest proportion by all subject areas were about communication with 15.6% (7,620) then patient care including nutrition/hydration at 12.5 percent (6,115).“

There were 42,648 complaints by profession, with the largest proportion being attributable to medical with 41.4% (17,651) followed by nursing at 23.3 percent (9,929).

The NHS does need to reappraise how it deals with complaints and must view them more positively and less defensively.

The post Testing the Temperature of Patient Safety in the NHS appeared first on Bill of Health.

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We had two excellent guests this week. Dr. Julie Cantor is an adjunct faculty member at the UCLA School of Law. She is a graduate of Stanford University, UC Berkeley School of Law, and the Yale University School of Medicine. Dr Cantor has two decades of public policy and advocacy experience focused on federal healthcare policy. She has published broadly including in the New England Journal, Annals of Internal Medicine, the Indiana Law Review, the ABA Human Rights Journal, the NYT Debate section, and has submitted amicus briefs in several Supreme Court cases.

Making a welcome return to the pod is Ross Silverman, Professor of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health at IUPUI, and holds a secondary appointment as Professor of Public Health Law at the Indiana University Robert H. McKinney School of Law. His research interests include legal, ethical and policy issues in public health and medicine, mobile health law and policy, interdisciplinary curriculum development, professional school admissions, medical humanities, human rights, and patient safety. Professor Silverman has published extensively on vaccination issues, for example here and here.

Our discussion topic rotates around the recent measles outbreaks and the public health and public health law issues they raise.

If you happened to pick up the June 5 issue of the New England Journal of Medicine you will have seen articles by both Julie and Ross (co-authored w/ Douglas Opel and Saad B. Omer) addressing aspects of the current law and policy debates. Other sources noted were this op-ed by Prof. Michael Willrich, Yiddish mistranslation, this New York Times risk-benefit analysis, and Angela Shen’s Measles Madness And Value post.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, Spotify, Tunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry @WeekInHealthLaw.

Subscribe to TWIHL here!

The post Julie Cantor and Ross Silverman on “The Week in Health Law” Podcast appeared first on Bill of Health.

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