Category: Administrative Law

Should Foster Parents Unionize?

June 29th, 2021 in Administrative Law, Analysis, Health Law, State Legislation

Foster care reform rarely makes it into dinner-table discussions of hot political happenings, but Massachusetts State Representative Tricia Farley-Bouvier of the Berkshires may change that with two bills she introduced this session: one creates a Foster Parent Bill of Rights, and the other allows foster parents to collectively bargain– raising the specter of a foster parent union.

The legislation addresses widespread problems in how the Department of Children and Families (DCF) deals with foster parents. “If there was a totem pole of regard and respect, when in the child welfare agency, [foster parents] are at the very bottom of that totem pole,” explained Representative Farley-Bouvier. The most egregious area of concern is DCF’s failure to communicate essential information like reimbursement rates, court dates, behavioral issues and even a child’s allergies and medications, a potentially dangerous omission that Farley-Bouvier says “happens more often than you would imagine.” Consider the alarming experience of one parent, Rachel, who told DCF she could not manage a child with severe behavioral problems. DCF nevertheless placed a child with her who had a history of a “violent temper,” including throwing chairs at school and threatening other children. DCF had concealed these behavioral issues from Rachel, flagging only that the child had hygiene issues. While “it’s true that in the months [the child] lived in Rachel’s home she smeared feces on the wall, that was one of the less frightening incidents.” In another troubling case, DCF failed to share with a parent that a twelve-year-old boy placed with her had a history of sexual predation; he abused her four-year-old daughter.

The Foster Parent Bill of Rights aims to address communication failures and other issues, and while DCF did not publicly comment on the legislation it “collaborated with the legislature on and supports” it. Under the bill DCF must:

  • Not discriminate on the basis of sexual orientation, gender identity, gender expression, age or physical ability
  • Keep foster parent information confidential
  • Develop a standardized training, as the current thirty-hour course parents are given is criticized for leaving them “ill-prepared to handle the complexity and severity” of emotional, physical, and psychological they see
  • Share information to “the greatest extent possible” on the physical and behavioral health of the child, their educational needs, and daily routine
  • Inform foster parents of all payments and sources of financial suport they may be entitled to, to address the common issue of families not being told what expenses they will be reimbursed for
  • Consult with foster parents in planning visitation
  • Provide no less than ten days of paid respite care per year
  • Establish a 24 hour emergency hotline
  • Not retaliate against parents who file complaints against DCF, and
  • Provide foster parents the opportunity to leave helpful notes for the next parent (for example “She’s afraid of the dark, but a night light comforts her. Her brother loves chicken nuggets.”).

What the bill does not do is set specific standards or allow for foster parent input on critical items like training or reimbursement rates. Foster parents would still need to advocate for their needs on an individual basis with DCF.

Farley-Bouvier’s other bill addresses this power imbalance by giving foster parents the right to collective bargaining. The bill classifies foster parents as public employees, but solely for this purpose—they would not receive a salary, be eligible for benefits, retirement contributions, or worker’s comp, and would not be permitted to strike. The bill directs DCF and a foster parent union to bargain on:

  • The responsibilities of DCF to foster parents
  • Education and training opportunities
  • Recruitment and retention of foster parents
  • Payment rates and other reimbursement issues, including for property losses caused by children, and extracurricular or social costs
  • Access to special education, respite care, and behavioral health services (which are sorely needed but currently take months to access)
  • Inclusion of foster parents in developing service plans for children

Retention of qualified foster parents is especially important, as too many children are placed in unsafe, abusive foster homes. In 2016, thirty-five foster children in Massachusetts died, and hundreds were neglected or abused. Two thousand families stopped participating in the foster system in the last five years, which is almost as many as the number currently participating. DCF does not track why parents stop participating, but research shows that lack of respect, insufficient training, and reimbursement rates that are far below actual costs contribute to a national turnover rate of fifty percent.

The Massachusetts State House
Boston, 1787

Unsurprisingly, the bill faces pushback. Dispute within the foster care advocacy group Massachusetts Alliance for Families (MAFF) illustrates both sides of the debate: former president Cheryl Haddad supports a union because it is “very unreasonable to ask these volunteers who help take care of children to go to the legislature to ask them for services. It’s crazy,” while current president Catherine Twiraga says “I didn’t become a foster parent to get a job, I became a foster parent to help children. So I don’t see how it can be one in the same. I’ve had jobs where I was an employee and that’s not how I approach being a foster parent.”

Conservative groups traditionally opposed to unions have seized on Twiraga’s argument, as demonstrated in a WSJ opinion cleverly titled “Clean Your Room or I’ll Call my Union Rep”.  Twiraga is quoted within, saying a union “will only reinforce the stereotype that we are doing it for money,” and that she is “baffled by the idea that the union will be negotiating for more vacation time for foster parents,” asking whether that means she can take Christmas off. Her comparison of respite care to vacation is disingenuous. Foster care is not a 9-5 job but a 24/7 endeavor replete with stresses not found in an office job, and parents are reimbursed only for costs, not paid a wage for their work. As a foster parent herself, Twiraga must know that respite care is a critical service that allows foster parents to deal with family emergencies, their own illness, or the emotional burnout that contributes to high turnover rates. But Twiraga’s arguments display a belief deeply held by many: foster parents should be selfless volunteers motivated only by altruism, and negotiating for better conditions means they are money-grubbers.

Even—perhaps especially—foster parents motivated by altruism should be fairly reimbursed for costs incurred, given plentiful training, and be able to hold DCF accountable for its responsibilities. While a desire to help children may be necessary to succeed as a foster parent, on its own, “altruism is no longer enough to recruit and retain foster parents.” Unions and care work are not mutually exclusive—helping professions like home health aides and childcare workers have successfully unionized. Improving conditions for care workers, paid or volunteer, can only result in benefits for the people in their charge. Those foster parents with good motives are precisely the ones the system needs most to retain. A union could equalize the power imbalance between foster parents and DCF to bargain for much-needed changes that could keep parents from leaving the system. If foster parents are given the resources they need to succeed in the system, children in foster care in Massachusetts stand to benefit a great deal.

Brianna Isaacson graduated from Boston University School of Law in May 2021.

Wearables and the FDA: Lessons from the COVID-19 Pandemic

June 28th, 2021 in Administrative Law, Analysis, Federal Legislation, Health Law

When the COVID-19 pandemic upended the entire world in March 2020, many industries were thrown in chaos. With the limitations on capacity in gyms across many states, technologies such as the Apple Watch or Fitbit (collectively called “Wearables”) became increasingly popular. Wearables are devices that track activities and record information about the person’s movements using sensors. Early models had simple uses like counting a user’s steps throughout the day. As the devices became more sophisticated, wearables quickly transformed into powerful tools that could monitor physical activity, sleep patterns, calories burned, and even blood pressure.

FDA Regulation of Medical Devices

In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act that provided the Food and Drug Administration (“FDA”) the authority to regulate medical devices. According to the Medical Device Regulation Act, the FDA regulates devices based on the potential risk of harm from the device, classifying devices as Class I, Class II, and Class III. Class I devices have a low risk of harm to patients while Class III devices are high risk. As the class of device increases, the FDA imposes more regulatory controls to ensure the device is safe and effective. In 2016, the 21st Century Cures Act (the “Cures Act”) clarified that certain digital software intended for low-risk general wellness purposes should be excluded from the statutory definition of a device. Low-risk general wellness software is defined as software features intended to help consumers maintain or encourage a healthy lifestyle and is not related to the diagnosis or treatment of a disease or condition.

However, a device’s intended use can be hard to define. Intended use refers to the objective aim for the purpose of device. The FDA has a longstanding policy that all relevant evidence can be used to determine intended use including labeling, advertisements, and oral and written statements. However, companies use different marketing tactics, including both general and very specific messaging, to make their devices standout which can leave the intended use of a device up to interpretation.

Wearables and FDA regulation

As the capabilities of wearables increased, the FDA has grappled with how to regulate the new technology. Originally, wearables were not considered medical devices unless they made claims about treating specific diseases or conditions. However, as the technology of wearables advanced, the FDA regulated some new features. For instance, Apple released an EKG feature on its watch to detect Atrial Fibrillation. Since it was meant to detect Atrial Fibrillation (an irregular heartbeat), Apple could not classify the feature as a general wellness device and the feature needed to be FDA cleared.

Wearables and the COVID-19 pandemic

In the early days of the COVID-19 pandemic, a N.Y. Times Op-Ed advocated for the general public to use pulse oximeters to monitor their blood oxygen levels in hopes of detecting potential COVID-19 cases earlier. In September, Apple released a new pulse oximeter feature for its watch to allow people to monitor their blood oxygen levels. However, unlike the EKG feature, Apple marketed the new feature as a general wellness device. This allowed Apple to avoid FDA regulation. Any mention by Apple of the device’s ability to detect, diagnose or treat a specific condition or disease would mean that the device is subject to FDA regulation. To avoid being subject to FDA regulation, during the launch video, Apple executives discussed the general importance of pulse oximeters in detecting COVID-19, failing to mention the new feature was not FDA cleared for the purpose of detecting COVID-19.

The FDA should regulate these new wearable features because these new functions are not general wellness low-risk devices. Although Apple did not directly promote the pulse oximeter feature to detect COVID-19, Apple hints that the device can do this despite the lack of FDA clearance or approval.  If the FDA lets this type of marketing go unchecked, they risk a “regulatory arbitrage” where companies design their devices to avoid costly clinical trials to prove safety and efficacy and instead promote devices as purely general wellness devices. Not only is this dangerous to consumers because the devices may not be effective for those purposes, but society may suffer as companies settle for simple devices rather than pushing to invent new technology.

In terms of risk level, the pulse oximeter is not low risk for two reasons. First, the FDA has released guidance documents stating that stand alone pulse oximeters should be classified as a Class II device. As a Class II device, the FDA considers pulse oximeters as medium to moderate risk devices. A feature in the Apple Watch (or other wearables) should not be subject to less regulation simply because it is part of a larger device. Second, the device could affect people’s decision to seek care despite the device’s documented inaccuracy. If the pulse oximeter feature shows normal blood oxygen levels, but in reality, a person has low blood oxygen levels, they might delay seeking care. This delay could have deadly consequences. Additionally, the device could mistakenly show low blood oxygen levels causing additional anxiety and emotional anguish during a period that has been incredibly hard for many people’s mental health.

The FDA’s role is to ensure medical devices on the market are safe and effective. However, some people argue that the FDA unnecessarily slows down products’ ability to enter the market stifling innovation. In this situation, some argue that a potentially helpful device, like the pulse oximeter on the Apple Watch, should reach the market as soon as possible and that market forces are sufficient to regulate new devices. The FDA is exploring this option through the launch of the Digital Health Software Precertification Program. Unlike the current system, the program would certify companies based on their comprehensive development and validation processes rather than focusing on specific products. Although this program would allow the products to get to market quicker, the program is still being evaluated. Until this program is proven effective, the FDA should not cede regulatory power to companies especially during a global pandemic.

Moving Forward

Although the FDA could exercise its regulatory power over the wearable industry, a more permanent solution is to update the Food, Drug and Cosmetic Act. Many products on the market, especially in the wearable industry, include different software features that could qualify as medical devices. Our laws regulating medical devices should be updated to reflect this possibility. Congress should clarify that any software feature, whether included in a larger device or not, will be regulated based on its intended uses and risk level to consumers.  Additionally, Congress should codify the FDA’s longstanding policy of using all available evidence and define intended use. This will keep manufacturers of products honest about the capabilities of a feature so they do not market a type of software generally for a specific purpose that it may not be FDA approved or cleared for.

 

Alex Maulden anticipates graduating from Boston University School of Law in May 2022.

Food, Drug and Cosmetic Act

Fighting the Federal Government: California’s Mission to Stop Environmental Rollbacks

January 29th, 2021 in Administrative Law, Analysis, Environmental Law, Federal Legislation, State Legislation

In July of 2020, California passed the historic Clean Trucking Rule, the first of its kind in the world. The rule requires manufacturers to sell increasing percentages of zero-emission trucks in the state. While many have applauded the action, the Trump administration was not a fan of the rule. California and the Trump administration have been at odds for years, as California has attempted to make up for the lack of climate action at the federal level. Over just four years, President Trump’s administration reversed over 100 environmental rules and regulations. To make up for the loss, California has passed numerous regulations and initiated at least twenty-four lawsuits to halt the Environmental Protection Agency’s (“EPA”) rollbacks. California, given its unique legal status on environmental issues, has proven itself to be a clear leader on climate action and emission reduction.

The Clean Air Act

When it comes to the climate, California is not restricted by Constitutional provisions such as the Commerce and Preemption Causes.   The Clean Air Act (“CAA”), first passed in 1970, gives the federal government the ability to regulate pollutants that are emitted into the ambient air and prohibits states from adopting or attempting to enforce any of their own motor vehicle emission controls. However, section 209(b) of the CAA allows states that had adopted standards prior to 1966 could apply for a waiver to that prohibition; and only California qualified. California was the first state to attempt controlling auto pollution and needed the ability to adopt more stringent controls to address the state’s extreme smog problem. To set new motor vehicle emissions standards, California must apply for a waiver from the EPA. The EPA administrator shall grant the waiver unless the standard is (1) arbitrary and capricious, (2)is not needed for compelling and extraordinary conditions, or (3) is not consistent with the CAA. Since 1970, administrators have consistently granted California its waivers. One exception was a waiver for new emissions restrictions on vehicles starting in 2009 that was initially denied in 2008, but President Obama later reversed the denial. This waiver program has created numerous California programs that differ from federal standards, including the Zero Emissions Vehicles (“ZEV”) Program, The Advanced Clean Cars program, and Low Emission Vehicles (“LEV”) Standards.

Under section 177 of the CAA, other states can choose to adopt either the current federal regulations or the California regulations if that will help the state achieve the CAA requirements more efficiently.  As of August 2019, fourteen states have adopted portions of California’s ZEV and LEV programs.

California’s New Rule

The California Air Resources Board (“CARB”) established the Advanced Clean Truck Program.  The program requires that

California State Capitol
Sacramento
By: Wingsdomain Art & Photography

beginning in 2024 manufacturers sell zero-emission trucks— that is electric and fuel cell powered trucks—as an increasing percentage of their annual California sales. Zero emission trucks need to make up 55% of Class 2b – 3 truck sales, 75% of class 4 – 8 straight truck sales, and 40% of truck tractor sales by 2035.  Massachusetts and seven other states have pledged to follow California’s lead for medium and heavy duty trucks. Additionally, fifteen states and Washington D.C. have signed a memorandum of understanding pledging to each develop an action plan to support widespread electrification of medium and heavy duty vehicles.

With these monumental steps forward, the federal government started to push back. The Trump EPA and National Highway Traffic Safety Administration (“NHTSA”) issued a final rule titled the “One National Rule Program,” which finalized parts of the Safer, Affordable, Fuel-Efficient (“SAFE”) Vehicles Rule that was first proposed in August 2018. The action makes clear that federal law preempts state and local tailpipe greenhouse gas emissions standards as well as ZEV mandates.  As soon as President Biden took office, however, he ordered federal agencies to reexamine these changes.

The EPA and California’s Rule

The California rule is set to take effect in 2024, but a waiver must be approved by the EPA beforehand. The EPA has never gone through a denial of a California waiver before, but that has not stopped the Trump Administration from trying to revoke previously granted waivers for zero emission passenger vehicle standards. The EPA is pursuing the revocation of California’s 2013 preemption waiver for greenhouse gas emissions and ZEV programs. This revocation is currently being challenged in court. If former President Trump won the  2020 election, the EPA may have tried to deny California’s zero emission truck regulations waiver. The EPA, however, would have faced an uphill battle because there is clear evidence that reducing emissions is necessary to help California achieve its CAA goals.  California’s argument would have been bolstered by the recent wildfires that destroyed large swaths of the state. It was unlikely the EPA could have offered enough solid evidence to uphold their waiver denial. In addition, most legal experts agree that California, and the states that follow their regulations, had a strong case that the Trump Administration’s efforts were unlawful. Still, the changing balance on federal appeals courts and the Supreme Court could undermine California’s waiver process and spell the demise of the original purpose and intent of the CAA. For the time being, however, California and allied states continue to have a valuable tool to fight climate change and reduce emissions across the entire nation regardless of who controls the EPA.

Conner Kingsley anticipates graduating from Boston University School of Law in May 2021.

What Never Was: The Indigenous American Cultural Heritage Repatriation Problem

August 19th, 2020 in Administrative Law, Analysis, Federal Legislation

The unfortunate beginnings of the fetishization of Indigenous American cultural heritage occurred concurrently with the systematic disenfranchisement of Native Americans throughout the United States. These events led to the amassing of millions of Indigenous American cultural heritage objects in federal repositories, museums, and private collections by the early twentieth century. Concurrently, archaeologists and anthropologists, largely funded by public research institutions like museums and universities, thoroughly destroyed prehistoric and historic sites in the hunt of the next ancient relic. The culmination of these events as well as forced assimilation created the idea that Indigenous Americans vanished and further justified the amassing of their cultural heritage. Unfortunately, today’s global society still believes in the vanishing Indian

The Native American Graves Protection and Repatriation Act (“NAGPRA”) was supposed to protect the heritage of the Indigenous Americans, but it is deeply flawed and needs to be either amended or replaced.

CONGRESS’S RUSHED RESPONSE TO CONTROVERSY

The Supreme Court ruled in Lyng v. Northwest Indian Cemetery Protection Association that the American Indian Religious Freedom Act (“AIRFA”), 42 U.S.C. § 1996, merely reiterates the First Amendment. Thus, the U.S. Forest Service (“USFS”) continued with road construction after minimizing the immediate impacts to the Yurok’s, Karok’s, and Tolowa’s religious practices. After the decision, the Indigenous American community knew they needed heightened protections, and the Senate Select Committee on Indian Affairs concluded that  federal legislation was necessary. On the heels of the committee findings, federal legislation was drafted and enacted. NAGPRA was supposed to positively affect the acquisition and repatriation of Indigenous American ancestral remains and cultural heritage.

(Image: Jacob Boomsma/Shutterstock)

Congress enacted NAGPRA to protect Indigenous American graves and repatriate remains, providing for proper tribal burials and religious rites. Although the legislative history suggests good intentions, the federal legislation provides a façade for museums, galleries, and collectors to continue acquiring and exhibiting Indigenous American cultural heritage. NAGPRA, enacted in November of 1990 and effective a year later, requires federal agencies and institutions benefiting from federal funding that have “possession or control over holdings or collections of Native American human remains and associated funerary objects [to] compile an inventory of such items and, to the extent possible based on information possessed by [the agencies and institutions, to] identify the geographical and cultural affiliation of such items.” From here, institutions and federal agencies inventory their collections “in consultation with tribal government [officials]. . . and traditional religious leaders” and supply records for better determining “the geographical origin, cultural affiliation, and basic facts surrounding [the] acquisition and accession of Native American human remains and associated funerary objects . . . .” “If a ‘cultural affiliation of Native American human remains and associated funerary objects’ is established with a particular tribe, then ‘upon the request of a known lineal descendant of the Native American or of the tribe[,]’ the museum must ‘expeditiously return such remains and associated funerary objects.’”

WHY NAGPRA FAILS

NAGPRA is but one illustrious example of the federal government fostering conflict between Indigenous American religion and Eurocentric ideals of science. While religion and science both concern themselves with “the human identity and defining our place in the universe,” their methods employed to achieve these goals often conflict. Science utilizes deductive methodology emphasizing quantifiable information and discernible facts and leads to evidence-based conclusions. Region supports discovery through “faith, complex belief systems, and longstanding traditions supported by cultural awareness.” The answer is not and never has been one practice over the other, and America’s past placed Congress in an important decision-making role to efficiently incorporate both viewpoints. What Congress enacted is neither effective nor efficient legislation, but an all show, no substance process.

NAGPRA leans heavily in favor of Eurocentric ideals of science over Indigenous American religious freedoms and oral history. Nevertheless, Congress failed at greatly considering the issue’s greatest stakeholder—Indigenous Americans. While Congress heard the religious perspective from tribal government representatives, lineal descendants, and various other support groups, the followed in-practice NAGPRA guidelines suggest their perspective fell on deaf ears.

Indigenous Americans view funerary, sacred, and cultural patrimony objects as the extensions of once-living ancestors, and therefore deserving of the same protections afforded to ancestral remains. Treating these objects as anything less offends Indigenous American cultural practices, and disturbances “force the spirits of those individuals to wander without rest.” The scientific viewpoint sees historical and scientific value in ancestral remains and their associated objects. Bioanthropologists premise their work around these objects and remains, hoping to learn more about past and present populations as well as information about the individual ancestral remains. Bioanthropologists swayed Congress with their wishes to retain ancestral remains for future study, supporting their argument by suggesting future technologies might provide unknown answers. Of course, Indigenous Americans’ oral histories provide the answers, but the judiciary and bioanthropologists brushed those claims aside. Thus, scientists and Indigenous Americans remain on polar extremes—“either believing in continued possession for research purposes or insisting on immediate burial without study.” Congress enacted NAGPRA with a focus on the repatriation of ancestral remains and associated objects. Yet, the rushed and sloppy NAGPRA legislation contains loopholes and lacks enforcement mechanisms.

Existing Loopholes

NAGPRA falls flat when repatriating cultural heritage not culturally identifiable and not traceable to a contemporary and federally-recognized tribe. These limitations result in 73% of remains remaining in museum collections because they were deemed non-affiliable and not repatriable. “[T]he unaffiliated remains of more than 115,000 individuals and nearly one million associated funerary objects have sat on museum shelves in legal purgatory.” A March 2010 amendment, Disposition of Cultural Unidentifiable Human Remains, attempted to redress these limitations. Before the amendment’s enactment, a majority of ancestral remains were classified as non-affiliable and outside NAGPRA’s initial scope.

NAGPRA, in its current state, fails on multiple fronts. First, the amendment addresses unaffiliated ancestral remains, but does

(© President and Fellows of Harvard College, Peabody Museum of Archaeology and Ethnology, [24-15-10/94603 + 60740377])
Mimbres bowls, produced by people living in the Southwest from the late 10th to early 12th century A.D., are renowned for the unique imagery found on their interiors. The black-on-white ceramics were often decorated with geometric patterns.

not resolve the issue with funerary and sacred objects such as Mimbres bowls. Second, NAGPRA requires museums, federal agencies, and public institutions to consult with tribal governments in determining affiliation and recommendations of repatriation, yet this important step rarely occurs. Third, cultural affiliation rests upon the interpretation of a preponderance of evidence determined by the same collection of museums, federal agencies, and public institutions retaining the Indigenous American cultural heritage. Fourth, only federally-recognized tribes may bring repatriation claims, thus eliminating hundreds of tribes awaiting or denied federal recognition. Fifth, NAGPRA only applies to federally-funded institution and federal agency collections. Consequently, federally-funded institutions receiving promised gifts and loans from private collections circumvent NAGPRA responsibilities. Finally, NAGPRA established the Committee, made up of seven members, which reviews repatriation claims when requested by any of the involved parties. However, the Committee merely publishes non-binding advisory findings. Language not clearly explained by Congress can be reasonably interpreted by federal agencies provided they give adequate explanations, and thus provides major deference to agency decisions. Therefore, the current loopholes allow federal agencies and federally-funded institutions to act as the decision makers for repatriation claims, and leads to biased outcomes against the marginalized Indigenous American tribal communities.

Lacking Enforcement Mechanisms

Congress limited NAGPRA’s effectiveness by omitting dissuasive penalties for federal agencies and federally-funded institutions. In fact, the legislation is completely silent on penalties towards federal agencies. Subsequently, most federal agencies have not completed collection inventories, a process required to place tribes on notice of NAGPRA-protected cultural heritage and ancestral remains. NAGPRA required completed inventories no later than November 16, 1995, yet the Department of the Interior’s (“DOI”) agencies have failed at cataloging over 78 million cultural heritage objects and ancestral remains. Thus, tribal governments cannot place repatriation claims and have no course of action for dispute settlements.

The DOI’s Secretary assesses civil penalties to federally-funded institutions who fail to comply with NAGPRA. Nevertheless, federally-funded institutions frequently circumvent any penalties if they reasonably explain their decisions not to repatriate based on a preponderance of the evidence, regardless of the Committee’s recommendations. Legislation without adequate enforcement measures leaves agencies and institutions with too much power and tribal governments incapable of obtaining the just and fair outcomes sought.

For Indigenous Americans, NAGPRA continues to fail and fall flat on Congress’s goals thirty years later. Improper interpretation of NAGPRA and unfair results will continue without reconsidering the current legislation and elaborating upon the ambiguities. Next session, Congress should, at the very least, take action to close the NAGPRA's loopholes and add meaningful penalties.  Even better, it should take this opportunity to completely rethink its approach to restoring and protecting the sacred objects of Indigenous Americans.

Tyler Heneghan anticipates graduating from Boston University School of Law in May 2021.

Telehealth in the Era of COVID-19 and Beyond

June 1st, 2020 in Administrative Law, Federal Legislation, State Legislation

Governor Charlie Baker of Massachusetts has recently issued an Order Expanding Access to Telehealth Services and to Protect Health Care Providers. The order, issued in March, is a public health response to the state’s state of emergency due to the Coronavirus or COVID-19 outbreak. Under the order, the Group Insurance Commission, all Commercial Health Insurers, Blue Cross and Blue Shield of Massachusetts, Inc. and health maintenance organizations regulated by the Division of Insurance are required to let all in-network providers deliver clinically appropriate, medically necessary covered services to their members via telehealth, and to mandate reimbursement for these services. The purpose behind the Order is to encourage the use of telehealth in the mainstream of health care provision, as a “legitimate way for clinicians to support and provide services to their patients.”

Gov. Charlie Baker (R-MA)
John Tlumacki / Boston Globe

Blue Cross and Blue Shield of Massachusetts has recorded over half a million patient telehealth visits over a six-week span and that number is only increasing with time. In comparison, the average number of telehealth visits before the COVID-19 pandemic was 5,000. The demand for health care and medical advice without the requirement of an in-person appointment has soared in light of the outbreak that prevents or prohibits people from attending one due to social distancing guidelines. Prior to the crisis posed by the pandemic and before Governor Baker’s order, hospitals and doctors were disincentivized from offering telehealth visits because health insurers did not cover them or would offer a smaller pay as compared to in-person visits. By introducing payment parity between in-person visits and virtual ones, the order expands access to care as current Massachusetts law allows insurers to limit coverage of telehealth services to insurer-approved health care providers in a telemedicine network.

The arrival of the pandemic and state of emergency has pushed for a rapid expansion of the use of technology in the practice of health care. Many of the barriers to access of health care via telemedicine have shifted in a relatively short period of time. In addition to Governor Baker’s order for payment parity, for example, the Governor allowed health care providers outside Massachusetts to obtain emergency licenses to practice within the Commonwealth. Before this and other similar licensure waivers, licensure requirements usually demand that providers be licensed within the state that their patients reside. By waiving this requirement, providers can expand the network of care they are able to provide, and telehealth serves to eliminate the only other barrier--distance.

An additional movement towards lifting barriers to the implementation of telehealth services is the relaxation of Health Insurance Portability and Accountability Act of 1996 (HIPAA) noncompliance enforcements by Health and Human Services, with the caveat that providers engage in good faith provision of telehealth during the national health emergency posed by the COVID-19 pandemic. HIPAA rules require the protection of privacy and security of health information. The discretionary enforcement order allows health care providers to use any non-public facing audio or video communication products during the COVID-19 public health emergency. This movement attempts to strike a balance between providing access to care during a national health emergency and the privacy protections against the risk of information exposure that are expected by patients in their interactions with their health care providers.

Another response to the public health crisis has been issued by the United States Drug Enforcement Agency, notifying that practitioners can, in light of the state of emergency, prescribe controlled substances in the absence of an in-person patient encounter. Prior, the prescription of controlled substances via telehealth evaluation was prohibited entirely. Now, prescribers are allowed to write prescriptions so long as: (1) the prescription is issued for a legitimate medical purpose in the course of the practitioner’s usual professional practice; (2) the telemedicine communication is conducted in a real-time, two-way, audio-visual communication system; and (3) the practitioner is acting in accordance to state and federal law.

As of May 2020, the Commonwealth of Massachusetts has initiated a four-phase reopening plan, beginning with hospitals and community health centers. The East Boston Neighborhood Health Center, for example, has indicated that they have an extensive screening process for patients who head over for in-person appointments, including the use of phone-tracking technology to notify staff when the patient has entered the building in an attempt to streamline entrance to examination rooms. The continued need to introduce methods of facilitating social distancing within the hospitals and community health centers indicates that there will be a continued incentive for the provision of telehealth services. The East Boston Neighborhood Health Center reports that, in the first phase of reopening, they expect 25% of visits to be in-person, with 75% of visits to continue to be via telehealth services such as video chat or over the phone.

While some find telehealth services to be inconvenient, due to technological challenges and care that requires more physical examination than can be completed over the phone or by video calling, it seems likely that we will see a blended version of care into the future. Health care practitioners have indicated that, while telemedicine is not a complete substitution of physically seeing and examining patients, being able to speak with a patient in combination with access to the patient’s medical history goes a long way in being able to diagnose and treat health problems. There is a growing sense of certainty that the use of a technology-based health care experience will “become the new normal.”

The natural question is how the legal landscape will have to adjust in response to the shift as society reopens and the balance of the role of technology in a “new normal” becomes more urgent to strike. Many of the barriers to the expansion of telehealth have been rapidly eliminated as a temporary alleviation in direct response to the public health crisis posed by COVID-19. This indicates that the changes are ephemeral; however, with the uncertainty posed by the length of the pandemic and the resulting impact this will have on the use of technology in health care, it seems likely that some of these legal shifts will need to be modified, rather than entirely eliminated, moving forward.

 

Zahraa Badat anticipates graduating from Boston University School of Law in May 2021.

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The Waiting Game: Supreme Court’s Decision on the Lawfulness of the Deferred Action for Childhood Arrivals (DACA) Program

June 1st, 2020 in Administrative Law, Analysis, Federal Legislation

As May 2020 comes to an end, many eagerly await a Supreme Court decision that could affect the futures of thousands of DACA recipients and shape immigration policy as we know it. The Deferred Action for Childhood Arrivals (DACA) is the program that is currently under scrutiny; in particular the Supreme Court will be deciding on the following two issues: (1) “Whether or not the Trump administration’s decision to end DACA can be reviewed by the courts at all?” and (2) “Whether or not the Trump administration’s termination of DACA was lawful?” This program was first instituted under the Obama Administration as an executive action to do the following for qualified Dreamers who completed the process of a first-time or renewal application: (1) protection from deportation for a time period, and (2) work authorization for a set period of time.

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During the Obama Administration, the DREAM Act of 2010 (H.R. 6497) was proposed and passed in the House but did not pass the Senate. The purpose, like its other variations, was intended to aid undocumented individuals by providing them a way to eventually reach legal status, because they were brought to the United States when they were children and have to live with a continued sense of uncertainty that attaches to being undocumented. In its stead, the Obama Administration designed a temporary solution, which came to be known as DACA, in which an individual could qualify by meeting a series of requirements (i.e. arriving in the United States before they turned sixteen years old).

 This policy gave a lot of individuals hope, but everything changed with the arrival of the Trump Administration. The Trump Administration’s policies quickly took on an anti-immigration rhetoric, and his Administration rescinded the policy on the basis that it was illegal. Thereafter, lawsuits followed with Department of Homeland Security, et al., v. Regents of the University of California, et al. reaching the Supreme Court level.

Regarding the two issues laid out above, there are many ways the decision could go, but the one that would have the worst effect on DACA recipients would be the court siding on the Trump Administration’s side in saying that “DACA was an unconstitutional use of presidential power to begin with.” This could have a devastating impact on DACA recipients especially at a time when they find themselves in the midst of the COVID-19 global pandemic alongside the rest of the world.

For example, ABC News quotes a college student saying “As a DACA recipient, and everything going on with COVID-19 and as well with the Supreme Court ruling coming at any time -- It's been very stressful.” On top of college, she works with authorization under DACA, but COVID-19 has added other stressors as she finds herself as the only provider at home. Ending DACA at a time like this would end up being very challenging and harmful for individuals like these who are trying to stay afloat during this pandemic.

Nevertheless, as this country struggles to recover from this pandemic, the most interesting development has happened to this Supreme Court case showing how vital Dreamers and immigrants have been to making this country function smoothly despite the havoc wreaked by the virus. A CNN report discusses how: “A letter sent to the Supreme Court states approximately 27,000 Dreamers are health care workers -- including 200 medical students, physician assistants, and doctors -- some of whom are now on the front lines in hospitals across the country.” The Supreme Court agreed to take this brief into consideration, and it makes one wonder whether the timing of the decision during a pandemic and the supplemental brief will have any impact at all?

Despite the positive contributions of these and other essential individuals, there have been a lot of issues that have also surfaced reflecting further difficulties that Dreamers are enduring. An example of this is federal funding under CARES Act. The pandemic has had even more disastrous effects on particular communities, and though the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 was passed with a part of it designed to provide aid and federal dollars to help students, and yet the benefits are not available to everyone. DACA students could not qualify to receive money under this Act, and it was one of the reasons the Democrats reached out to Secretary DeVos to change the language but to no avail. The House has brought another bill to the forefront, the Heroes Act, which proposes many changes; one aspect of which directly seeks to overturn “Secretary DeVos’s decision to exclude DACA students from the emergency aid.”

 This is a hopeful change, but the culmination of issues including the Supreme Court decision yet to be released, the uncertainty of COVID-19 on employment, health, and education, and a delay in passing the House bill paints a bleak picture.

Yet, at the end of the day, it is as Antonio Alarcon described it on CNN: “We’re hopeful that the Supreme Court will see the humanity of our stories and see the humanity of our families, because at the end of the day, this is a nation of immigrants.”

 

Nabaa Khan anticipates graduating from Boston University School of Law in May 2021. 

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