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.
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.
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.
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.
Food, Drug and Cosmetic Act
Plastics are commonplace in modern society, despite increasing awareness of their negative environmental impacts. It is evident that plastic pollution litters our oceans and greenery, with devastating effects on natural ecosystems. Yet, the poor disposal of plastics is only part of the story—the production and management of plastics are incredible climate change contributors. Governmental action, however, has primarily focused on regulating the consumer and mitigating the impacts of plastics after use. Given the increasing urgency of climate change, it is time for the government to take the harm of plastics more seriously and regulate its production as the serious climate contributor it is.
The Plastic Problem
Every year, between five hundred billion and one trillion plastic bags are used worldwide. (Jennie Reilly Romer, Comment: The Evolution of San Francisco’s Plastic-Bag Ban, 1 Golden Gate Univ. Envtl. L. J. 439, 439 (2007).) The average lifespan of a plastic bag is only twelve minutes. (Travis P. Wagner, Reducing single-use plastic shopping bags in the USA, Waste Management 70, 3, 4 (Sept. 2017).) This short lifecycle comes from a mix of user apathy and the fact that recycling plastics costs more than creating new plastics. (CIEL Report).
Thus, the plastic or fossil fuel industry continues to produce new plastic, adding to greenhouse gas emissions with each item produced. “At current levels, greenhouse gas emissions from the plastic lifecycle threaten the ability of the global community to keep global temperature rise below 1.5°C degrees. By 2050, the greenhouse gas emissions from plastic could reach over 56 gigatons—10-13 percent of the entire remaining carbon budget.” (CIEL Report at 1.)
The Plastic Lifecycle
There are numerous reasons that plastics are considered to be major climate contributors. First, the substances used to make plastic, like ethylene and propylene, are derived from oil, gas, and coal, which must be extracted from the ground. (CIEL Report, at 21.) The combustion of these fuels and conversion of the petrochemicals each directly emit greenhouse gasses. (CIEL Report, at 44.)
Next, plastic production contributes indirectly to greenhouse gas emissions because the refining and manufacturing machines are powered by fossil fuels. (Id.). Currently, plastic production accounts for four to eight percent of global oil consumption every year and is projected to increase to about twenty percent by the year 2050. (CIEL Report, at 24). Studies have shown that for some plastics, the production process contributes up to sixty-three percent of the emissions in the plastic lifecycle. (Spyros Foteinis, How small daily choices play a huge role in climate change: The disposable paper cup environmental bane, 255 J. of Cleaner Production 1, 5 (Jan. 27, 2020)).
Further, some studies have attributed 37% of greenhouse gas emissions from plastics to management, or disposal processes. (Id.). Most plastic waste is put in a landfill. (CIEL Report, at 6). This is again because the cost of managing waste can often exceed the value of the materials that would be recovered from the recycling. (Wagner, at 5.) Additionally, plastic can only be “downcycled,” so single-use plastic can be of too poor quality to recycle. (Romer, at 446). As of 2017, only nine percent of all plastic discarded since 1950 has been recycled, and twelve percent incinerated. (CIEL Report, at 55).
Finally, some plastic is simply not managed. A portion of plastic is therefore just pollution. Such plastic often ends up in oceans and waterways, where it degrades slowly, releasing greenhouse gases and interfering with carbon sequestration. (Id.).
Most current regulation deals with pollutant plastic, or plastic which has been used and discarded, causing obvious environmental blight. Some cities and states have attempted to reduce plastic consumption by regulating the use of plastic bags. (Muhammad S. Khan et. al., Consumer green behaviour: An approach towards environmental sustainability, 28 Sustainable Development 5, 1019, 1168 (Oct. 8, 2020).). Local governments have also attempted to require the industry to invest in MSW management—thirty-three states have enacted extended producer responsibility (“EPR”) laws, which require producers to internalize some of the end-of-life costs of their products. (Wagner, at 3). Finally, localities often used unit-based pricing when picking up trash—but allow free recycling to incentivize residents to sort their own waste. (Id.).
However, these regulations generally focus only on regulating consumers rather than the plastics industry. Plastic bans incentivize a reduction in use, but only for a selection of plastics, at cost of the individual user. EPRs do regulate the plastic industry, but mainly forces the companies to internalize the economic cost, since the climate damage has already occurred by the time of disposal. Further, providing free recycling focuses solely on the consumer and does little to reduce the environmental cost given the lack of recycling that actually occurs and by again by focusing on only the end-of-life processes, after much of the climate damage has occurred.
It is therefore time for the government to take the greenhouse gas emissions over the plastic lifecycle more seriously, and work to reduce the production of plastics by directly regulating the plastics and fossil fuel industries—because they are the same thing.
Recommendations for the Future
The ideal environmental solution would be to reduce plastic manufacturing by setting limits on production; banning single-use plastic production and use; and stopping new oil, gas, and petrochemical infrastructure. (CIEL Report, at 82-83). Higher taxation on production could additionally achieve these reduction goals and incentivize the recycling of existing plastics. The federal and state governments could also adopt more stringent greenhouse gas emission targets and rigorously enforce them, including plastics in their calculations of emissions. (Id.)
Any of these solutions will be a political battle, however. The regulation of plastic has historically been impeded by the fossil fuel industry, which makes over four hundred billion dollars a year making plastic. Years of misinformation and court challenges by the fossil fuel industry have led to politicians shying away from plastics regulation. (See Jennie R. Romer & Shanna Foley, A Wolf in Sheep’s Clothing: The Plastics Industry’s “Public Interest” Role in Legislation and Litigation of Plastic Bag Laws in California, 5 Golden Gate University Environmental Law J. 377, 381 (2012).).
Perhaps, then, the first step is simply to acknowledge the climate impact of plastics and increase public support of greater regulation to provide the political incentive. The lack of attention to this issue is evidenced by the fact that Biden’s “Executive Order on Tackling the Climate Crisis at Home and Abroad” does not even include the word plastic. This is an unacceptable reality if we ever hope to truly make climate progress. It is time for the government to take plastic regulation more seriously—we simply cannot afford not to.
On January 1, 2021, Massachusetts Governor Charlie Baker signed into law an omnibus healthcare law called “An Act Promoting A Resilient Health Care System That Puts Patients First.” This multi-faceted healthcare law addresses various healthcare issues that have come to light or been worsened by the COVID-19 pandemic. This includes the codification of some emergency orders from the early days of the COVID-19 pandemic that helped loosen restrictions in order to provide easier access to healthcare. Thematically, the main provisions of the bill include: (1) surprise billing; (2) practitioner scope of practice; (3) telehealth; and (4) healthcare accessibility. First, each of these provisions will be discussed. Then, possible shortcomings of the law will be considered. To conclude, we must question why it took a pandemic to bring commonsense change to Massachusetts healthcare.
The act addresses so-called surprise medical bills, where the charges are higher than the insured individual expected, likely because they inadvertently received care from an out-of-network provider. This can happen if: (1) the insured patient receives care from an out-of-network provider in an emergency situation where the patient has no ability to select the care; or (2) the insured patient receives pre-planned care from an in-network facility, but the services are provided by an out-of-network provider.
Surprise medical billing has been in the spotlight at both state and federal levels. In late 2020, President Trump signed the No Surprises Act which holds consumers harmless from the cost of unanticipated out-of-network medical bills. The act applies to nearly all private health plans offered by employers, as well as insurance policies offered through the federal marketplace, but does not take effect until January 1, 2022. In addition, the federal law does not preempt state law, but instead defers to state requirements around surprise billing. To date, at the state level, 27 states have passed consumer protection laws against surprise medical bills and, in 2020, 5 additional states have passed and will enact or have enacted surprise billing legislation.
The Massachusetts law: (1) requires providers to disclose if they are out-of-network prior to the patient’s admission; (2) requires providers, upon request, to share the amount that the patient will be charged for admission, a procedure, or a service, including costs for services done by an out-of-network provider; (3) requires providers to notify patients if the patient is being referred to an out-of-network provider; (4) prohibits providers from billing insured patients in excess of the typical, applicable coinsurance, copayment, or deductible that would have been charged if services were provided by an in-network provider; and (5) directs the Secretary of the Executive Office of Health and Human Services, the Health Policy Commission, Center for Health Information and Analytics, and Division of Insurance to recommend a default rate for out-of-network billing by September 2021.
However, even after the expanded protections against surprise medical billing, Massachusetts is still categorized as a state with partial balance billing protections from The Commonwealth Fund and as a state with a limited approach to surprise billing from The Kaiser Family Foundation. Both organizations have found that to be considered comprehensive, a state must additionally: (1) hold patients harmless, (2) create a dispute resolution process between the insurer and provider; (3) provide a formula that the insurer must apply when determining how much to pay an out-of-network provider; and (4) apply in specific care settings, like emergency departments. The current Massachusetts law’s direction to recommend a default rate for billing is a step in the right direction towards a comprehensive approach to surprise medical billing, but will need to be taken further.
Practitioner Scope of Practice
The Massachusetts act also makes statutory changes to the scope of practice for several categories of health care practitioners. The act codified previous Department of Public Health emergency administrative orders allowing advanced practice registered nurses (“APRNs”), including nurse anesthetists, nurse practitioners, and psychiatric nurse mental health clinical specialists to have: (1) expanded practice at mental health facilities; and (2) independent prescriptive practice. To qualify for the expanded scope of practice provision, the APRNs must meet specific qualifications, including at least two previous years of supervised practice under a physician. The emergency orders were in response to the onset of the COVID-19 pandemic, but will now extend past the pandemic due to the act.
The act also expands scope of practice for optometrists. Optometrists now have prescriptive authority and can treat glaucoma. The act also creates an option for reciprocity for optometrists with licensure in other states. Additionally, psychiatric nurse mental health clinical specialists have expanded authority for determinations on psychiatric evaluations, restraints, and hospitalizations. Finally, the act recognizes the role of pharmacists, who are now able to integrate with coordinated care teams to review medications and identify areas of clinical improvement.
The act also codifies earlier COVID-19-related emergency changes to telemedicine. At the federal level, the Department of Health and Human Services made access to telehealth easier through guidance on HIPAA flexibility, allowing entities to file waivers with the Centers for Medicare & Medicaid Services related to originating sites, cross-state telemedicine, provision of care to new patients through telehealth, and billing for telehealth services as though they were in-person. At the state level, a Massachusetts emergency order required insurers to cover all medically necessary telehealth services and required that these services be reimbursed at the same rate as in-person services, creating pay parity between telehealth and in-person visits.
The new Massachusetts act: (1) updates the definition of “telehealth” to include audio-only services; (2) eliminates the requirement for providers to show barriers to in-person care or limitations on location settings in order to access telehealth services; (3) prohibits insurers from declining coverage of healthcare services solely because the services were provided through telehealth as long as the healthcare service would otherwise have been covered in-person and it may be appropriately provided through telehealth; (4) requires pay parity for copays and deductibles for in-person and telehealth services, plus extends the temporary emergency order for pay parity for 90 days after the expiration of the COVID-19 state of emergency in Massachusetts; and (5) requires licensed hospitals, insurers, health maintenance organizations (“HMOs”), and the Executive Office of Health and Human Services to ensure that the pay rate for in-network providers of behavioral health services and chronic disease management services provided via telehealth be no less than the rate of payment for the same services when provided in person.
The act’s provisions related to healthcare accessibility are wide and varied. The act addresses broad healthcare issues that have posed problems for many years, but have been exacerbated due to the COVID-19 pandemic. Two relevant provisions include: (1) Massachusetts Medicaid or MassHealth patients no longer need to seek referrals from a primary care provider to an urgent care visit; and (2) all insurers, including MassHealth, must cover all COVID-19 related emergency, inpatient, and cognitive rehabilitation services, plus they must cover all medically necessary COVID-19 testing.
Though this bill tackles many issues that public health experts have promoted for years, there are always additional healthcare problems to be solved. Governor Baker notes that he hopes, in future years, to focus on addiction services, behavioral health, primary care and geriatric services, and prescription drug prices.
However, the law is not without its detractors. The Massachusetts Medical Society, for instance, while applauding many provisions, took issue with: (1) the added burden on physicians to notify patients about possible out-of-network care and billing; (2) the general increased scope of practice for nurse practitioners, psychiatric nurse mental health clinical specialists, and certified registered nurse anesthetists, arguing that a physician-led team is the best care team; and (3) the lack of permanent pay parity for all telehealth services. Thus, it is likely that the law will face some pushback from physicians. Additionally, as seen with the surprise billing provisions, there are ways that the state could have gone further to provide more patient protection and access to healthcare.
The question remains, however. Why did it take a pandemic to bring about common-sense healthcare changes to Massachusetts? The answer, I think, lies in the shared experience of the COVID-19 pandemic. Governor Charlie Baker, while signing the bill into law, said that the “silver lining” of the pandemic has been that healthcare reforms were tested and proved effective, generating momentum to create long-lasting change for the future. There’s more to it than that. Even before the pandemic, we’ve all seen and heard from friends and family that the healthcare system is broken and now we’ve all seen how the pandemic has only exacerbated that. Massachusetts residents and members of the legislature have seen how barriers to care - like difficulties paying off a surprise medical bill and having to go into medical debt, difficulties getting an appointment with your physician because they’re busy with the pandemic but also then being unable to see an APRN for care, or an inability to access telehealth when you’re scared of going for in-person care in the midst of a pandemic - has affected our loved ones throughout the pandemic. It’s this shared experience and now shared understanding of the hardships of our existing healthcare system that drove the healthcare reforms and success of this bill.