The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

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FDA Releases Report Detailing Problematic Laboratory-Developed Tests

Last week, the FDA issued a report presenting 20 case studies of laboratory-developed tests (LDTs) that have or may have harmed patients, in support of its ongoing efforts to impose greater regulatory oversight on LDTs.  The report came just before yet another House Energy & Commerce Committee hearing on the issue, and the timing of its release may have been motivated in part by questions FDA officials faced at the last Congressional hearing, about the existing evidence of harm to patients.  The report categorizes the 20 case studies into seven groups, organized by the primary problem posed by the LDT: those with a high degree of false positives (the test yields a positive result when the disease is not present), those with a high degree of false negatives (the test yields a negative result when the disease is present), those which yield both false positives and false negatives, those which test for a factor seemingly unrelated to the disease in question, those linked to treatments based on disproven scientific concepts, those which affirmatively undermined the drug approval process, and of course, “other.”

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Should a patient have a right not to know genetic information about him or herself?

By Benjamin E. Berkman, JD, MPH

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual’s entire genome has not been without controversy.  Producing information on this scale seems to violate some of the accepted norms governing how to practice medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated.  One of these widely accepted norms was that an individual had a right not to know (“RNTK”) genetic information about him or herself.  Prompted by evolving professional practice guidelines, the RNTK has become a highly controversial topic.  The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned.

In a recent paper published in Genetics in Medicine, my coauthors and I provide some data that illuminates this and other issues. Our survey of 800 IRB members and staff about their views on incidental findings demonstrates how malleable views on the RNTK can be.  Respondents were first asked about the RNTK in the abstract: “Do research participants have a right not to know their own genetic information?  In other words, would it be acceptable for them to choose not to receive any GIFs?”  An overwhelming majority (96%) endorsed the right not-to-know.  But when asked about a case where a specific patient has chosen not to receive clinically beneficial incidental findings, only 35% indicated that the individual’s RNTK should definitely be respected, and 28% said that they would probably honor the request not to know.  Interestingly, the percentage of respondents who indicated that they do not support the RNTK increased from 2% at baseline to 26% when presented with the specific case.  The percentage of people who are unsure similarly jumps, from 1% to 11%.

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How broad can consent be?

By Nanibaa’ A. Garrison, Ellen Wright Clayton and Ingrid A. Holm

Based on today’s publication of the paper A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States in Genetics in Medicine. 

The recent Notice of Proposed Rule Making (NPRM) issued by the Office of Human Research Protections proposes to require researchers to obtain informed consent from virtually every patient and research participant for use of biospecimens for research. The proposed regulations also permit obtaining broad consent for future uses, without any IRB oversight unless individual results are going to be returned so long as an elaborate consent form is signed. The NIH Genomic Data Sharing Policy, which went into effect earlier this year, requires almost all investigators who receive NIH funding to seek broad consent from participants to allow their data to be shared with other investigators. Thus, in a short period of time, two major policies promoted broad consent for biobank research, changes in the practice of recruiting participants for research that make us take notice. They also raise new questions, including: What do research participants think about having their biospecimens and data shared, and about giving broad consent to do so?

Who is comfortable with Broad Consent?
The Electronic Medical Records and Genomics (eMERGE) Network’s Consent, Education, Regulation, and Consultation (CERC) working group set out to find some answers. As a part of this effort, we conducted a systematic review, which revealed that males, whites, older individuals, and more affluent individuals are generally pretty comfortable with broad consent that can be found here. By contrast, Asian and African American individuals are less comfortable with broad consent. Will these different levels of concern create a divide between those who will and will not participate? The consequences of lack of participation are clear – we will know less about how genetic variation in groups that do not take part affects health and less about how to provide optimal care. Continue reading

Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.

Texas, Self-Induced Abortion, and an Ode to Justice Powell

Flickr/Creative Commons—Edson Chilundo

Flickr/Creative Commons—Edson Chilundo

By Gregory M. Lipper

With the Supreme Court ready to review the constitutionality of restrictions on abortion providers in Texas, new research from the Texas Policy Evaluation Project suggests that between 100,000–240,000 Texas women age 18–49 have attempted to terminate a pregnancy on their own (that is, without help from a licensed medical professional). According to the authors, “the populations we found to be most familiar with abortion self-induction are among those that have been most directly affected by the closure of abortion clinics in the state.” As a result, the study predicts, “abortion self-induction will increase as clinic-based care becomes more difficult to access.”

This data reinforces that efforts to ban, restrict, or otherwise interfere with efforts to obtain legal abortion don’t stop abortion—they often push women to obtain abortion by other means that are far more dangerous.

Those consequences, as it turns out, are what led one conservative Supreme Court Justice, Lewis Powell, to support abortion rights. Justice Powell was no right-to-privacy diehard; he infamously cast the deciding vote upholding the Georgia sodomy ban in Bowers v. Hardwick. But when it came to reproductive freedom, Justice Powell joined the majority opinion in Roe v. Wade and continued to support abortion rights while sitting on the Court.

According to Justice Powell’s biographer, an incident from earlier in his career reinforced that if women lacked access to legal abortion, the result would be unsafe, off-the-books procedures:

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Abortion Derangement Syndrome, Missouri Edition

Flickr/Creative Commons—Nicola

Flickr/Creative Commons—Nicola

by Gregory M. Lipper

Although the biggest abortion-related news last week came from the U.S. Supreme Court, a Missouri state senator (turned Attorney General candidate) took the prize for most bizarre.

Senator Kurt Schaefer—chairman of the Missouri Senate’s interim “Committee on the Sanctity of Life”—wrote a stern letter to the University of Missouri; he suggested that state law prohibited a Ph.D student from researching the effects of Missouri’s mandatory 72-hour waiting period for women who want to have an abortion. The law he cited provides, “It shall be unlawful for any public funds to be expended for the purpose of performing or assisting an abortion, not necessary to save the life of the mother, or for the purpose of encouraging or counseling a woman to have an abortion not necessary to save her life.”

This farfetched attempt to censor academic research on the effects of government policy raises a pair of legal issues (and one psychological observation…).

First, Senator Schaefer’s interpretation of the statute is, to put it mildly, a stretch. The student isn’t going to be “performing or assisting an abortion”; she’s going to be studying abortion—more precisely, the 72 hours between when a woman seeks an abortion and is allowed to have an abortion.

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Identified versus Statistical Lives at the Movies

Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.

sq_martianFirst, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading

Actions for Sexual Assault Incidental to Medical Treatment Placed Outside the Scope of Medical Liability

By Alex Stein

Ex parte Vanderwall, — So.3d —- 2015 WL 5725153 (Ala. 2015), is a new important decision that defined “medical malpractice” to identify suits adjudicated under special defendant-friendly rules. As I explained hereherehereherehereherehere, and in a foundational article on the subject, categorizing a suit as sounding in “medical malpractice”—as opposed to “ordinary negligence,” “assault” or “battery”—determines whether the plaintiff must satisfy rigid limitations and repose provisions, comply with special requirements with regard to expert testimony, face the difficult burden of proving the defendant’s deviation from professional customs, and, in the end, suffice herself with the compensation amount limited by the statutory cap on damages.

In Vanderwall, this categorization determined whether a patient could use past instances of sexual misconduct incidental to medical treatment to prove that the therapist responsible for that misconduct sexually assaulted her as well. Continue reading

Premiums in Medicaid: The (not so) Recent Trend

By Emma Sandoe

Requiring Medicaid beneficiaries to pay premiums and other cost-sharing for medical services is not new to the Medicaid expansion debate. Premiums were introduced as part of the Tax Equity and Fiscal Responsibility Act of 1982. Previously, states were prohibited from imposing enrollment fees, premiums, or deductibles for any categorically eligible individual in the Medicaid program. This law allowed states to implement minimal cost-sharing for waiver demonstrations, but prohibited states from denying medical care due to an inability to pay.

Since this law was passed, the Centers for Medicare & Medicaid Services (CMS) has clarified that certain populations including pregnant women and children were exempt from most cost-sharing. Additionally, certain services are exempt from copayments and coinsurance entirely. The maximum amount that can be charged varies based on wage and type of service and where the beneficiary seeks treatment.

Prior to Indiana’s 1115, approved in 2014, CMS did not allow state waivers to charge premiums to individuals making under 50% of the federal poverty line (FPL). Indiana’s expansion plan is unlike any other state’s waiver plans. It requires individuals to pay a “monthly contribution” of $1 a month or 2% of a family’s income which ever is greater. When a beneficiary that has been paying these monthly contributions uses medical services, they are not required to pay co-payments. Previously, Indiana lowered the income eligibility for premiums during its 2013 waiver when it required premiums for individuals making between 50-100% of FPL. Arkansas and Iowa saw that precedent set by Indiana and lowered their cost sharing levels from 100% of FPL to 50%. Continue reading

The ACA’s Nondiscrimination Rule: Hobby Lobby 2.0?

Should healthcare providers, researchers, and insurers be able to engage in sex discrimination for religious reasons? HHS asked the public to weigh in on this question with regard to the ACA’s nondiscrimination provision.

The answer is no for three important reasons. First, the statute doesn’t allow additional exemptions. Not only is the text clear, but Congress also considered and rejected broader religious exemptions. Second, authorizing sex discrimination for religious reasons is bad health policy with damaging effects for women and LGBT people. Third (as I argued in separate comments with a group of law and religion scholars), granting religious exemptions here runs into constitutional limits set by the Establishment Clause.

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The ACA’s Nondiscrimination Rule: Kudos and Critiques

More than five years ago, Section 1557—a little known provision in the Affordable Care Act—promised to protect individuals from race, sex, age, and disability discrimination in health programs and activities that receive federal financial assistance. But until this fall, the Department of Health and Human Services (HHS) hadn’t offered any interpretation of what the nondiscrimination provision requires. Today, the comment period for the proposed rule closes, and HHS will set to work finalizing the Nondiscrimination Rule. Together with professors Jessica Roberts and Jessica Clarke and Yale Law students Elizabeth Dervan and Elizabeth Deutsch, I drafted lengthy comments on the proposed rule.  In a series of blog posts this week, we’ll explain what HHS got right, where its interpretation went wrong, and how it can provide clarity to healthcare programs and the public.

The ACA broke new ground in prohibiting sex discrimination in healthcare for the first time. Women and LGBT people face persistent and systemic discrimination at the hands of insurers, hospitals, and doctors. Women’s pain goes undertreated, and their heart attacks undiagnosed. Due in part to their capacity to become pregnant, women have largely been excluded from studies. More than half of LGBT people report facing discrimination in healthcare settings. Transgender men and women have encountered ridicule, refusals of treatment, and hostility in emergencies with fatal and near-fatal consequences.

The Affordable Care Act aims to change this. The Nondiscrimination Rule presents a historic opportunity for HHS to interpret sex discrimination broadly. In its proposed rule, HHS seems poised to take advantage of this opportunity by reaching pregnancy, sex stereotyping, and gender identity discrimination. To meet HHS’s goal of ensuring the most robust set of protections in current law, the final rule should also make clear that sexual orientation discrimination is sex discrimination.

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Nevada’s $350,000 Cap on Noneconomic Damages Held Constitutional and Applicable Per Incident

By Alex Stein

Bad news for Nevada’s victims of medical malpractice. This state’s Supreme Court upheld the constitutionality of the $350,000 cap on noneconomic damages as limiting recovery for all kinds of victims and injuries. Tam v. Eighth Jud. Dist. Ct., — P.3d —- , 2015 WL 5771245 (Nev. 2015).  Moreover, the Court held that the cap applies per incident, which encompasses all mistakes that the doctor may have made in delivering a single treatment to a patient and all the victims of those mistakes (such as twins born with birth defects as a result of negligent prenatal care or delivery). For my discussion of the “per incident” and alternative approaches to caps, see here. Continue reading

CMS Issues Notice Regarding Barriers to HCV Treatment

By Dalia Deak

Yesterday, the Centers for Medicare & Medicaid Services (CMS) issued a notice that affirmed CMS’s commitment to provide prescription drugs to beneficiaries, specifically highlighting beneficiaries suffering from hepatitis C virus (HCV). The notice comes at a moment of heightened interest in the cost of prescription drugs (particularly on the federal level as an inquiry in the Senate has been initiated regarding rising drug prices).

In the statement, CMS:

  • Reminded the states of their obligation, under the terms of the Social Security Act, that Medicaid programs must cover prescription drugs for medically accepted indications if the manufacturer of the drug is a manufacturer with whom they have rebate agreements with;
  • Discussed the concern regarding costs of direct-acting antiviral (DAA) HCV drugs, emphasizing the role of competition and negotiation in bringing down the drugs’ prices;
  • Expressed concern regarding some states’ policies to restrict access to the DAA HCV drugs that may be contrary to their obligations under the Social Security Act;
  • Encouraged states to ensure that their policies do not unreasonably restrict coverage of effective treatment;
  • Reminded states that drugs available under the states’ fee-for-service programs must also be available to beneficiaries of Medicaid managed care organizations; and
  • Indicated that CMS will monitor state Medicaid policies for DAA HCV drug coverage to ensure that they are compliant with approved state plans, statutes, and regulations.

CMS also followed up its notice with a letter to the CEO of AbbVie asking for additional information regarding the types of value-based purchasing arrangements offered to payers and to state Medicaid agencies by December 31, 2015.

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The Supreme Court and Contraceptive Coverage—Take 2

Supreme Court

Flickr/Creative Commons – Andrew Raff

by Gregory M. Lipper

Today the Supreme Court granted review in seven challenges to the accommodation offered to those with religious objections to the Affordable Care Act’s contraceptive coverage regulations. I won’t rehash my earlier posts about why I (and seven of eight federal appeals courts) think that these challenges, brought under the Religious Freedom Restoration Act, are bunk. For now, a few observations about the cases and today’s cert grants:

1. These cases involve challenges to a religious accommodation, not the coverage requirement itself. In Burwell v. Hobby Lobby Stores, the Supreme Court said that the government couldn’t enforce the contraceptive coverage regulations against for-profit corporations with religious objections. The Court pointed to a less-restrictive alternative: the accommodation, offered to nonprofit organizations, through which the organization submits a written objection and government arranges for the objector’s insurance company or plan administrator to provide the coverage at no cost to either the objector or its employees. The plaintiffs in these cases are challenging the accommodation itself. By analogy, this is like a conscientious objector challenging the process for opting out of the draft.

2. Oddly enough, Hobby Lobby didn’t officially resolve RFRA challenges to the accommodation. You might think that since the Supreme Court’s decision in Hobby Lobby pointed to the accommodation as the less-restrictive alternative, then the Court must have also made clear that the accommodation itself complied with RFRA. But the majority opinion did not do so. Instead, after pointing to the accommodation as a less-restrictive alternative, the majority said, “We do not decide today whether an approach of this type complies with RFRA for purposes of all religious claims.”

3. And/But: Justice Kennedy, the deciding vote in Hobby Lobby, suggested more clearly that the accommodation complies with RFRA. Although he joined the majority opinion, Justice Kennedy also wrote separately and appeared to bless the accommodation. Here’s what he said:

  • “That accommodation equally furthers the Government’s interest but does not impinge on the plaintiffs’ religious beliefs.”
  • “Yet neither may that same [free exercise] unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling. In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here.”

If Justice Kennedy holds to his view in Hobby Lobby, then the plaintiffs in these cases will probably lose.

4. Although the plaintiffs in these cases are nonprofit organizations, the result will affect employees of for-profit corporations. As instructed by the Supreme Court in Hobby Lobby, the government extended the accommodation to closely held for-profit corporations such as Hobby Lobby. But neither Hobby Lobby nor the other for-profit plaintiffs have said that they will accept the accommodation, and most of them are represented by the same organizations representing the nonprofit challengers to the accommodation. So if the Supreme Court doesn’t uphold the accommodation as applied to nonprofit organizations, employees of objecting for-profit corporations will almost certainly go entirely without contraceptive coverage as well.

5. “[Y]ou are not entitled to your own facts….” Today the Becket Fund, which represents Little Sisters of the Poor and several other plaintiffs, issued a press release entitled “High Court to decide if Government can force nuns to provide contraceptives.” This is false—full stop. Under the accommodation, contraceptives are provided by the employer’s insurance company or plan administrator; employers aren’t paying for the insurance coverage, let alone handing out the insurance coverage, let alone handing out contraceptives themselves. Whether or not you think that the accommodation resolves employers’ religious objections, it is simply not true that—as a matter of fact—objecting nuns are required “to provide contraceptives.” (This is not, I should add, the first time that the Becket Fund has made this claim in a press release.) I will be curious to see whether Becket Fund repeats this claim in its briefs to the Court.

Greg Lipper is Senior Litigation Counsel at Americans United for Separation of Church and State. You can follow him on Twitter at @theglipper.

The Ongoing Push for E-Cigarette Regulations

By Katherine Kwong

Last week, the American Academy of Pediatrics publicly joined the group of advocates for federal regulations on e-cigarettes. The AAP urged the government to ban the sale of e-cigarettes to everyone under age 21 and prohibit advertising to minors, and advocated for high taxes on e-cigarette products similar to those on other tobacco products. In its announcement, the AAP cited developing brains’ vulnerability to nicotine and the potential harms to long-term health as reasons for its recommendations to keep e-cigarettes away from youths. It also recommended that smoke-free laws governing secondhand smoke explicitly include e-cigarettes, saying, “[t]he aerosol emitted from e-cigarettes is not harmless; it contains a variety of toxic chemicals, including some carcinogens and significant amounts of nicotine.”

A recently released poll found that a majority of Americans (57%) believe e-cigarettes should be regulated like tobacco products, while less than 25% of respondents felt they should not be. The Food and Drug Administration proposed e-cigarette regulations in 2014, and recently sent the regulations to the Office of Management and Budget for review. While the final form of the regulations is still unknown, the proposal banned the sale of e-cigarettes to minors and required e-cigarette labels include a list of ingredients and a disclosure that they contain nicotine.

There is growing concern about the potential health risks posed by e-cigarettes. Advocates for restrictions on e-cigarettes have long warned that unregulated e-cigarettes frequently expose users to the harmful effects of nicotine, as well as toxic chemicals such as formaldehyde, benzene, and other carcinogens. There have also been warnings about the risk that e-cigarette use may lead to greater social acceptance of smoking and higher rates of tobacco use. (Despite frequent claims that e-cigarettes may help with smoking cessation, longitudinal studies consistently find no evidence that e-cigarette use increases quitting rates.) Anecdotal evidence has linked e-cigarette use to pneumonia and other lung problems. Forty percent of e-cigarette users reported having health concerns about their use.

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The Good, the Bad, and the Ugly: Physician Coverage under the ACA

By Elizabeth Guo

A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.

Here’s where it gets ugly.

Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.

The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Continue reading

Understanding “Lost Chances to Recover” (and Looney v. Moore)

By Alex Stein

My colleague, Professor Tony Sebok, drew my attention to an important recent decision, Looney v. Moore, 2015 WL 4773747 (N.Dist.Ala. 2015, by Chief United States District Judge Karon O. Bowdre). This decision adjudicated a textbook lost-chance case that involved the effects of oxygen saturation levels (SpO2) in premature infants with extremely low birth weights (ELBW). For any such infant, high SpO2 levels involved (among other complications) the risk of blindness caused by retinopathy of prematurity (ROP). On the other hand, low levels of SpO2 could lead to life-threatening neurodevelopmental impairments (NDI). The neonatologists’ customary practice was to maintain SpO2 levels in ELBWs between 85% and 95%. The effects of variations within that nationally accepted range were hitherto unknown.

To find out what those effects are, the defendants conducted a clinical trial. They divided the nationally accepted range of SpO2 levels into a high range (90%- 95%) and a low range (85%-90%). Infants whose parents agreed to participate in that trial—all having an extremely low birth weight—were randomly placed in either of the two groups. By making that division, the defendants tracked the infants’ rates of NDI, on one side, and ROP, on the other side.

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House of Reps v. Burwell: A Case Worth Following

By Matthew Ryan, Harvard Health Law Society

With the final judgment in King v. Burwell this summer upholding federal subsidies for health insurance, many legal analysts believed that lawsuits against the Affordable Care Act had ended. But the House of Representatives had other plans. In July of 2014, the House of Representatives voted on partisan lines to sue President Obama for overstepping his constitutional bounds. The House alleged that the President did not faithfully execute the Affordable Care Act with regard to two executive actions. First, the Obama Administration authorized payments to insurance companies to assist with cost sharing. The House argued Congress never appropriated these funds. Second, the House alleged that the Obama Administration unlawfully delayed the employer mandate at a $12 billion cost to taxpayers.

In September, the United States District Court for the District of Columbia cleared a major hurdle for the House: the court granted standing to the plaintiffs for their challenge to the Administration authorizing cost sharing funds without Congressional appropriation. The court did not grant standing with regards to the employer mandate implementation. Continue reading