The Growing Role of Big Data in Pandemics

In early April 2020, the New York Times published an article showing the tracked movement of Americans in the midst of the COVID-19 pandemic by analyzing cellphone location data across the entire country. Similarly, Tectonix, a data analytics firm who used locations of anonymized mobile devices, tweeted an analysis of the movement and spread of 5.6 thousand individuals identified on a Ft. Lauderdale beach on a specific day. While this near-real time analysis highlights the usefulness and practicality of Big Data in the fight against the pandemic, it also raises consumer privacy concerns in a largely unregulated sector.

As previously discussed, the U.S. relies on a patchwork of regulations to govern the collection and use of Big Data and to protect consumer privacy; this patchwork creates large gaps in regulation for Big Data usage. On April 9, 2020, the U.S. Senate Committee on Commerce, Science, & Transportation held a paper hearing entitled, “Enlisting Big Data in the Fight Against Coronavirus,” in order to address these concerns. The primary goal of the Committee’s hearing was to find the best way to maximize potential benefits of Big Data while minimizing the privacy risks to consumers.

Leading privacy experts submitted written testimony to the Committee recognizing the crucial impact of Big Data in the fight against the current pandemic, and the need for legislation that can protect consumer privacy while not diminishing its effectiveness. From identifying where social distancing is failing and understanding future transmission hotspots, to identifying environmental and geographic factors affecting the rate of disease transmission, Big Data provides actionable insight that other sectors are unable to provide. Still, enabling such unregulated use of Big Data during this outbreak may be risky; history has shown that practices enacted during emergencies are hard to undo.

The Future of Privacy Forum, a leader in privacy standards and principled data practices in support of emerging technologies, recommends four components to a “comprehensive federal privacy legislation that [is] flexible enough to support data-driven public health initiatives under the right safeguards and within limits consistent with privacy and civil liberties.” These components are: legal protections for sensitive data that includes not just health information but also geo-location data; mandatory privacy risk assessments for corporations involved in high-risk data processing; mandatory independent ethical review boards overseeing research that utilizes sensitive data—especially in sectors that are currently unregulated in their Big Data usage; and strict purpose limitation policies, which would require scientific research utilizing personal data to be “compatible” with the initial purpose for which the personal data was processed—pursuant to the European model.

Additionally, a consistent theme across proposals for increased regulation is the necessity for transparency. The mounting number of non-HIPAA-covered entities that are regularly collecting, using, and sharing sensitive consumer information, makes it increasingly more difficult for individuals to know who has access to their information and how that information is being used. However, increased transparency, in coordination with other privacy regulations, may encourage individuals to participate in data-related studies and ease concerns about how private information may be used.

The COVID-19 pandemic continues to test countless aspects of our societal norms, economy, and legal system. Big Data pulls together many of these issues by calling into question how much, and under what circumstances, individual privacy should be exchanged for public health and safety. The Senate’s paper hearing on April 9 confirmed the importance of Big Data in responding to the current pandemic and also signaled potential legislative action to protect consumer privacy in the modern digital world. While Big Data is playing a critical role in fighting the pandemic, this crisis has nonetheless exposed legislative gaps in protecting consumer privacy.

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The ACA meets COVID-19: Now What?

Before the Affordable Healthcare Act (ACA), 44 million Americans were uninsured. While the Affordable Care Act (ACA), passed in 2010, improved the provision and delivery of healthcare to over 16 million Americans, there are still gaps in coverage. Since its rollout, the ACA has faced several legal challenges including a lawsuit filed in 2016 against Sylvia Burwell, the HHS Secretary during the Obama Administration. This initial challenge sparked a nationwide injunction against certain ACA provisions. In what has been known as the landmark ACA case, U.S. v. Texas, 20 states sought to strike down the entire Act after challenging the individual mandate to maintain health coverage each tax year that was enacted following the passage of the Tax Cuts and Jobs Act of 2018 ( under the Trump Administration). The Supreme Court is expected to make its final ruling later this year as to whether ACA, in its entirety, will be upheld.

The COVID-19 crisis further complicates the ACA issues. A vaccine is likely not going to be available for the next year or so, meaning it will be available only after the Supreme Court will make its decision. Experts suspect that overturning the ACA will cost many Americans their insurance benefits, which limits their access to vaccines (when available), leaving Americans vulnerable to the continued spread of the virus. High-ranking elected officials view the continued pursuit of some courts to strike down the ACA as  “unconscionable” during a public health emergency such as this. 

Lawmakers are split on their views of the ACA in the wake of the 2020 Pandemic. Democratic lawmakers have expressed concerns over the problems that gaps in coverage will have on the spread of COVID-19, while Republican lawmakers have upheld their contention that Americans’ previously demonstrated intent to seek alternatives to ACA health plans, negates arguments that ACA should re-open enrollment. A House Republican further noted that coronavirus testing is free and the Administration reports that many states continue to expand Medicare to cover those experiencing loss of jobs and health coverage. 

In contrast to what Republican lawmakers presented in the ACA debate, nine states (Colorado, Connecticut, Maryland, Massachusetts, Nevada, New York, Rhode Island, and Washington) have made it possible for its citizens to obtain some form of medical coverage during the COVID-19 crisis. Typical of most insurance plans, individuals and families can only elect coverage during open enrollment once a year without a qualifying status change. Nonetheless, these nine states have created a special enrollment for citizens or extending the current open enrollment period. Insurers are supportive of these states and are looking for ways to mitigate any risks associated with new enrollees during the Pandemic.

Kaiser Family Foundation describes the use of ACA health plans as a safety net during the Pandemic that can be used by Americans who have lost wages due to reduced hours or business closings. Subsequent limits on health coverage may cause some to delay care which harms the health of the community. KFF further reports substantial out-of-pocket expenses for those hospitalized. The report insists that gaps in coverage will cause some people to delay treatment which could have serious consequences as the country tries to reduce the number of new or undiagnosed COVID-19 infections. As the ACA moves closer to its final day in court and the COVID-19 continues as a pandemic lawmakers are now asked to consider whether the health of the nation should suffer as a result of political turmoil.

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“Elective” Medical Services: Abortion during a Pandemic

Since the COVID-19 outbreak emerged in the U.S., federal guidance and state orders have been released in waves over the last several months having an especially drastic effect on healthcare that extends beyond the care of patients infected with the virus. Many states have now mandated the suspension of elective medical services. When response efforts are locally executed and state managed, however, disparities emerge over what governments consider to be “elective”. As a result, while many healthcare services have remained uninterrupted, surgical abortions are being called into question as to whether they should be considered “elective,” and therefore suspended during this time.

What is an essential business?

On March 16, 2020, the President and the Coronavirus Task Force recommended that civilians work from home while calling for those who work in critical infrastructure industries to remain in operation. The “Essential Critical Infrastructure Workforce” advisory list was developed to help state officials determine which businesses and services should remain operational during this period.

State interpretations

To create capacity and meet the increases in resource demands, many states have chosen to follow CDC guidelines stating that “healthcare facilities and clinicians should prioritize urgent and emergency visits and procedures…”

In states where surgical abortion procedures were previously facing challenges, the term “elective” in these materials has given states significant latitude in determining what patients need, under what terms, and when. The argument for restricting elective or non-urgent medical procedures is not without merit. The U.S. is experiencing a shortage of personal protective equipment and medical supplies leaving states to ration existing provisions. Most states have required providers to suspend non-urgent services such as annual physicals, dental check-ups, cosmetic procedures, and routine screenings such as colonoscopies and mammograms.

Although a patient may choose to receive an abortion, relying on this choice to classify surgical abortions as elective results in unique issues unfaced by other elective-designated medical procedures. Abortions are time sensitive. Most acutely in states that have reduced the window of time a patient may obtain an abortion, requiring a patient to wait until after the outbreak jeopardizes the opportunity they have to access this service. This is especially challenging when states are consistently moving back the date upon which elective or nonessential medical services can be resumed as new information emerges on the severity of state outbreaks. Historically, we know that restricting access to surgical abortions does not decrease the need for their services. Women who are unable to obtain an abortion will either require complex surgical procedures for later-term abortions, remain pregnant and require prenatal care and delivery services, or may use dangerous methods to induce an abortion on their own (UCSF Bixby Center). The side effects of suspending surgical abortions would result in more frequent clinical visits (i.e. prenatal care) or longer admissions (i.e. later-term abortions, self-induction, delivery) in the hardest hit clinical settings these restrictions are trying to protect. If suspending elective medical procedures is also a tactic to reduce social contact among patients and with medical providers, restricting abortions will likely result in women traveling to other states where the service is preserved, increasing the chance for viral mobility and exposure.

Below is a summary of the states that have classified abortions as “elective” during the pandemic and states that are facing challenges to these determinations in court.

Additional information on state-specific mandates/guidance can be found here. Challenges to these designations in court have been summarized here.

Post-pandemic

The COVID-19 outbreak has illuminated many vulnerabilities in our healthcare system. Prior to the pandemic, abortion services were facing renewed challenges in courts. Classifying abortions as “elective”, however, perpetuates the rhetoric that abortions are chosen luxuries when women often face little choice in the nonmedical reasons they have to obtain an abortion. It is difficult to see through the thicket of disparate recommendations and orders made by state and local governments, but it is clear that the end of the pandemic will not eliminate the challenges raised by these regulations nor the discretion states may take in the future in deeming what is and is not essential medical care.

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Stopping the Biological (Tax) Clock: ART & Generational Tax Assignments

Medical innovation in Assisted Reproductive Technology (ART) has rapidly outpaced the statutory Estate and Tax guidance that governs the inheritance rights of children conceived by such technology. The use of cryopreserved reproductive material and embryos poses a significant challenge for estate planning: how must we draft and administer multi-generational trusts to protect the wealth of families created by such technology?

            According to the 1992 Fertility Clinic Success Rate and Certification Act, ART is defined as fertility treatments in which both eggs and embryos are handled, specifically, medical procedures that surgically remove eggs from a woman’s ovaries, combine them with sperm, and return them to a woman’s uterus. The most common types of ART include in vitro fertilization-embryo transfer (IVF-ET), gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), and frozen embryo transfer (FET).

            The advancement of reproductive technology has enabled reproductive material to remain viable decades later. In fact, embryos can be preserved and used to conceive a child years after both of the genetic parents are deceased. While this may seem like an exceedingly rare circumstance, as of 2011, “the Social Security Administration reported receiving more than 100 applications for Social Security survivor benefits on behalf of posthumously conceived children.” It is unsurprising that this type of medical innovation has prompted innumerable estate planning questions to which applicable statutory guidance is yet to exist. Thus, courts are tasked with interpreting the wills and trusts of decedents who would have likely considered ART to be the subject of science fiction at the time of executing their wills or trusts.

            A core task of estate planning is to create documents that secure the future transfers of a family’s wealth, while protecting the inheritance from unfriendly or uncertain tax environments. An estate planning tool that seeks to accomplish such a task is called a multi-generational trust, which allows a grandparent to transfer money or property to his or her grandchild without transferring it to the grandchild’s parent first, thus skipping a generation of estate tax liability. However, such transfers will incur an astronomical generation-skipping tax (GST) rate of 40% on the value of the transferred money or property that exceeds the $11.8 million exemption, per the Tax Cuts and Jobs Act (TCJA) of 2018. Put simply, an individual’s generational assignment has remarkable tax implications.

            The collision between traditional estate law notions and current tax code begets the question: what is the generational assignment for children born posthumously by ART? The Internal Revenue Code offers rudimentary guidance:

  • 26 U.S. Code § 2651(f)(2) provides that if an estate or trust has an interest in property, each individual having a beneficial interest in such entity shall be assigned to a generation.
  • § 2651(f)(1) provides that when an individual is assigned to more than one generation, he or she is assigned to the youngest such generation.
  • § 2651(d)(2) states that the GST applies to gifts or transfers made to individuals at least 37.5 years younger than the donor, meaning that the individual need not be a lineal descendant.
  • § 2651(e) creates an exception for persons with a deceased parent, stating that if an individual’s parent who is a lineal descendant of the donor is dead at the time of the transfer, such individual shall be treated as if she was a member of the generation which is 1 generation below the lower of the transferor’s generation (i.e., a grandchild).

            Consider a parent who seeks to use the cryopreserved eggs, sperm or embryos of a deceased child to give life to his or her own grandchildren. To what generation does that conceived child belong? Would the child be the child of the parent or would the child be the grandchild? Would the predeceased parent exception apply? Would § 2651(f)(1) treat such a child as a grandchild? If the reproductive material was preserved for enough time, perhaps the 37.5-year threshold would trigger a generational shift regardless.

             The staggering legal uncertainty surrounding ART signals courts and legislatures to adopt reliable methods of administering the inheritance rights of children conceived by evolving technology. Without sophisticated models, fiduciaries are left stretching age-old principles of estate law to fit the needs of unimaginable and ever-changing family structures.

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Drug Pricing Draws Increased Attention in Election Season

As the 2020 presidential election draws closer, the conversation of health care spending has continued to intensify, particularly when it comes to the price of prescription drugs. A recent poll found that the #1 and #2 domestic concerns for Democrats and Republicans were to lower the cost of health care and reduce the price of prescription drugs, respectively.

            There are several competing proposals in Congress to lower the cost of prescription drugs, as both Democrats and Republicans attempt to craft competing strategies. Last summer, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), the Chairman and Ranking Member of the Senate Finance Committee, introduced S. 2543, the Prescription Drug Pricing Reduction Act (PDPRA). This bill would impose a yearly cap on how much manufacturers raise their list prices and establish a 100 percent rebate on any increases that rise above that level. In December, House Democrats passed H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, that would permit the Department of Health and Human Services (HHS) to negotiate the price of certain prescription drugs offered under the Medicare Part D program. The bill also integrates provisions in S. 2543 on inflation caps but adds an additional provision that retroactively penalizes price increases above the rate of inflation going back to 2016. In December, House Republicans introduced competing legislation to House Democrat proposals, H.R. 19, the Lower Costs, More Cures Act. This bill stripped out proposals related to drug negotiation and inflation caps and integrated several provisions from previously introduced previous draft drug pricing legislation, such as increasing generic drug entry to market and modernizing the benefit structure under Part D to lower annual out-of-pocket costs for eligible seniors. Five Senate Republicans, including the current chairman of the Senate Budget Committee and likely future chairs of the Senate Finance Committee and Senate Committee on Health, Education, Labor & Pensions (HELP), introduced companion legislation to H.R. 19 for consideration in the Senate.

            It is unlikely that any of the proposed drug pricing proposals will become law in 2020, as Senate Majority Leader McConnell has declared H.R. 3 “dead on arrival.” The Trump Administration has expressed a preference for S. 2543, but the bill has run into difficulties among Senate Republicans, who have raised concerns about the proposed inflation caps on price increases. Signaling some concern about the influence of prescription drug pricing on the 2020 presidential election, Senator Martha McSally (R-AZ), who is in a contentious reelection bid, recently introduced the Lowering Prescription Drug Prices for America’s Seniors and Families Act. If passed, the legislation would permit HHS to negotiate the price of prescription drugs covered under Part D, but only after those drugs lose their patent exclusivity and do not have any market competition. Congress has had some recent bipartisan success in drug pricing legislation, including the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act in the FY20 spending bill. The CREATES Act requires brand-name manufacturers to provide samples to generic drug manufacturers, which could increase competition among products. The last vehicle for any drug pricing proposals to be signed into law would be as part of a health care extender package, whose funding is set to expire on May 22nd. There are some bipartisan proposals that may be included in this package, particularly a redesign of the Part D benefit structure, which all competing drug pricing bills reform to some degree.

            President Trump has been under significant pressure to counter Democrat claims that his administration has failed to make meaningful steps to lower the price of prescription drugs. Many of his regulatory proposals have faced challenges in the courts or the administration has chosen not to finalize those initiatives. Proposals by presidential candidates Senator Bernie Sanders (I-VT) and former Vice President Joe Biden support greater government intervention in prescription drug pricing, with both candidates supporting direct negotiations with manufacturers on pricing. Given the Supreme Court’s decision to hear a new challenge to the validity of the Affordable Care Act (ACA), health care will likely continue to be a pressing issue to voters in upcoming elections.

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