Category: Federal Legislation

Stop the Clock: Implications of Switching Time Zones

April 20th, 2019 in Analysis, Federal Legislation, State Legislation

The holiday season is joyous for many reasons; from family, friends, and food, there is ample joy and merriment to go around. There is one aspect of the season that doesn’t match these factors; especially in New England – darkness. At the outset of winter, on December 21st each year, the sun sets in Boston at 4:11pm. There are many negative effects of darkness setting in before the end of the workday – with increased crime, traffic accidents, and seasonal depression being one of the most paramount. Boston’s sunset is not the earliest in the area, with municipalities in Maine experiencing sunsets earlier than 4pm; but it is the earliest of the major cities, beating out Buffalo, NY despite being further south.

Early sunsets do not become apparent in New England until clocks fall back in line with the change from Daylight Savings Time. Daylight Savings is a federal program instituted during World War II that the country has become accustomed to; the federal legislation only permits states to opt out of the program, but it does not allow states to make the program permanent, which would keep the clocks from falling back an hour. Hawaii and Arizona have opted out of the program – made available through the US Energy Policy Act of 2005, allowing any state that lies entirely within one time zone to opt out.

New England states, primarily Massachusetts and Maine at this point, have been considering a change to the Atlantic Time Zone

The Sacred Cod and House Clock
Massachusetts House Chamber

in order to increase the number of waking hours with sunlight. With a change to Atlantic Time, and subsequent opting out daylight savings, New England would be out of sync with the rest of the Eastern Time Zone from November to March, or the period in which clocks “fall back” in line with daylight savings in the Eastern Time Zone. A transfer to Atlantic Standard Time – which includes Puerto Rico, the Virgin Islands and eastern Canada – would mean jumping an hour ahead of the Eastern time zone from November to February. The time zones would align from March to October.

While the benefits of having an extended amount of light in the evening hours are readily apparent, there are several drawbacks that accompany a change. Early risers in particular, who are likely accustomed to the sun being out while they start their days have reason to complain. School aged children may be leaving to their schools in darkness in the morning, and businesses that transact on financial markets may be put out of sync with the markets they depend on.

If New England were to change to Atlantic time, there would be a two-step process. First, the interested states would have to decide to leave. Second, the states would have to consult the US Department of Transportation, the cabinet agency that regulates time zones. States, municipalities, business interests, and others would have the opportunity to weigh in during both steps.

There could be major issues with “commerce, trade, interstate transportation and broadcasting” if one state moves ahead one hour while its neighboring states remain in the Eastern Time Zone. It seems to be a requirement of widespread support and agreement for any change in this area to take effect. Lawmakers in Maine might support the change – in May 2017, Maine’s Senate passed a bill that would move the state to the Atlantic Time Zone — if approved by residents in a state-wide referendum. Maine conditioned the change, subject to their approval, on Massachusetts and New Hampshire.

Some states seem to have considered the idea and decided against it, with the New Hampshire Senate voting against a bill that would move the state to the Atlantic Time Zone by a 16 to 7 vote; at the same time, the bill passed the house with a voice vote. While there has yet to be an affirmative move, the proponents of the change are enlivened by the action around the issue and are hopeful for the future.

Massachusetts established a commission to study the issue. In a neutral report neither supporting or disavowing the change, the commission stated its findings that “People tend to shop, dine out, and engage in other commercial activities more in after-work daylight,”. . . “Year-round DST could also increase the state’s (competitiveness) in attracting and retaining a talented workforce by mitigating the negative effects of Massachusetts’ dark winters and improving quality-of-life.” More daylight could also reduce street crime, on-the-job injuries and traffic fatalities, and boost overall public health, the commission found.

States in the Northeast seem intrigued by the change, but alterations of the particulars of their citizen’s days are deeply personal to their citizens may be a drastic change to take without widespread public support. In Arizona, the effects of their non-adherence to daylights savings time are apparent when the state is out of sync with the rest of the surrounding states – constant clarification of what time is in effect, setting different meeting times, etc. Results on an individual basis are a mixed bag, with businesses that are purely local and that thrive in the daylight being supporters of the longer day due to increased business, and those who constantly run up against timing differences by virtue of dealing with other regions.

It will be interesting to observe if public support for a time zone change increases as people in New England become aware that doing so is a possibility to increase their daylight hours in the depths of winter. In any case, it is clear that the states’ legislatures have identified it as a possible issue.

 

Drew Kohlmeier is a student in the Boston University School of Law Class of 2020 and is a native of Manhattan, KS, graduating with a degree in Biology from Kansas State University in 2016. Drew decided on Boston for law school due to his interest in health care and life sciences, and will be practicing in the emerging companies space focused on the life sciences industry following his graduation from BU.

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The US House Must Start Protecting Undocumented Minors

April 20th, 2019 in Analysis, Federal Legislation, Legislative Oversight

The 2018 midterm election should be considered less of a “blue wave” and more of a call to action made by the people of the United States to their House Representatives. The Trump administration has made many an egregious decision since 2017 and the Democrats of both the House and the Senate have unable to block such decisions due to their minority status. The Democrats must use their majority status in the House to actively combat the Trump administrations treatment of Latin American and other undocumented minors in detention.

Beginning in April 2018, Trump’s “zero tolerance” immigration policy led to the separation of infants from their mother’s arms, children from their father’s reach, and siblings from their brother’s or sister’s hands. Family separation shocked the conscience of the nation and the outcry against the policy’s ramifications drove President Trump to sign an executive order “ending” family separation. Thousands of children remained in detention, separated from their parents, for months after the executive order. In June 2018, a U.S. District Court Judge issued a preliminary injunction against the government, requiring that children be returned to their parents within 30 days. Come late October, the Department of Homeland Security still had hundreds of separated children in its custody. The government’s failure to comply with the injunction filled public discourse with calls to act to free the children. Some of the parents of these children who have been deported to the countries they fled have made the soul-churning decision to leave their children in the United States because returning the children to their country of origin could mean death. Despite the alleged “end” of the family separation policy, 81 children have been separated from their families since President Trump’s executive order.

Another source of turmoil within the United States’ immigration system is the lack of representation for these children. Children, who do not speak English and are as young as 3 years old, are representing themselves against the U.S. government in immigration courts. They are being led to make decisions that are not in their best interest. For example, a 5 year old girl named Helen was told to sign her name on a form that waived away her rights to a Flores bond hearing, which would have guaranteed her a hearing in front of an immigration judge in far less time than she spent at a shelter, separated from her family. While organizations like the American Civil Liberties Union, private firms, and law school institutions are providing legal services to help bring families back together, the number of children essentially being forced to represent themselves is too high.

The psychological toll on the detained children who were reunited with their families is immeasurable. There have been documented cases of young children, unable to understand why their parents suddenly disappeared from their lives, rejecting or distrusting their parents upon reunification. Other children live in fear of being taken again and anxiously cling to their parents. In December 2018, the nation took notice of the deaths of two undocumented children, one a 7 year old girl and the other an 8 year old boy, both from Guatemala, who died from medical complications while in Border Patrol custody.

More and more questions are being raised in Congress about how to address the turmoil of the Trump administration’s immigration landscape. Despite increased attention on this humanitarian crisis at the border, the problem has gotten worse over the past few months.  In fact, Boston University Law Professor Sarah Sherman-Stokes reports that a team of BU Law professors and students spent a week at the border in March.  They used sharpie markers to write parents' contact information on their children in case they were separated.  Despite this, the Trump White House seems to be now moving toward an even harder line toward migrants; complete with a purge of Homeland Security leadership.

At this point, there should be no compromise by Democrats regarding the treatment of undocumented children and their families. Now that Democrats have a deciding vote in the House, they must use that vote, the voice their constituents gave them--and especially their oversight powers--to protect the voiceless and vulnerable children in DHS custody.

This may be finally happening.  On April 17th, Elijah Cummings (D-Md.), chair of the House Oversight Committee, invited the architect of Trump's immigration policy Stephen Miller to appear before the Committee:

"I am offering you an opportunity to make your case to the Committee and the American people about why you -- and presumably President Trump -- believe it is good policy for the Trump Administration to take the actions it has, including intentionally separating immigrant children from their parents at the border to deter them from coming to the United States, transferring asylum seekers to sanctuary cities as a form of illegal retribution against your political adversaries, and firing top Administration officials who refuse orders to violate the law."

Miller is scheduled to appear before the Oversight Committee on May 1.

The safety of children should not be a partisan issue, but if anyone is going to act to ensure the safety of immigrant children, it should be the newly elected House of Representatives. The House should pressure the Senate and President to abide by the United Nation’s guidelines on the humane treatment of migrant children and their families and enforce their implementation. Any derogation leaves room for more horrifying tales of assault, abuse, trauma, and deaths of innocent children who were only trying to avoid such fates in their homelands. The House should also legislate to protect the Flores rights of unaccompanied minors and require that these minors be provided with representation in front of immigration courts.

The international community has condemned President Trump’s treatment of migrants, documented and undocumented, asylum-seeking and non-asylum-seeking, on several occasions, but some of the loudest condemnations fall upon the separation of families and treatment of children. Some governments and organizations have gone so far to call the family separation policy a humanitarian crisis and illegal. Let this moment in our nation’s history not go down as a complete humanitarian failure but as a showing of what the people can do to try and rectify the mistakes made by discriminatory policymaking.

 

Cassandra Castro will graduate from Boston University School of Law in 2020.

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The Future of Supervised Injection Sites in Massachusetts and Beyond

April 20th, 2019 in Analysis, Federal Legislation, State Legislation

With Massachusetts and the country facing a rising opioid overdose epidemic, lawmakers are looking to some controversial measures to curb overdose deaths. One of those measures being considered is supervised injection sites, also called safe injection sites or safe consumption spaces. Safe consumption spaces, of which there are 100 worldwide, are clean spaces where people can legally use pre-obtained drugs with supervision from healthcare professionals who aim to make injections as safe as possible while providing health care, counseling, and referral services to addicts. While safe injection sites have been successfully implemented in Canada, Australia, and Europe over the past 30 years, attempts to create such sites in San Francisco, Seattle, Boston, and more U.S. cities have not yet been successful. Beyond policy arguments as to whether these sites are effective, sites in the United States also face significant legal hurdles under federal law.

According to supporters of safe injection sites around the country and the world, the policy is an effective and relatively low-cost way to prevent overdose deaths and manage harm with no demonstrated consequences of increased drug use or increased crime. Opponents of safe injection sites, including Massachusetts Governor Charlie Baker, have pointed to increased opioid deaths in

The Massachusetts State House
Boston, 1787

recent years in Vancouver, which established its supervised consumption site Insite in 2003, to argue that safe injection sites are not actually effective in preventing overdose deaths. However, those arguments are misleading, as experts have stated that the increase in overdose deaths in Vancouver are due to the influx of fentanyl being added to drugs, and that Insite actually saw a 35% reduction in overdose deaths around the facility in the two years after it opened. While there are also studies questioning the efficacy of safe consumption sites—calling into question whether they have a significant impact on reducing deaths and reaching a significant amount of drug users—even the negative studies generally criticize safe consumption sites as being relatively ineffective as opposed to actively harmful. There are dozens of peer-reviewed scientific studies that have found that safe injection sites actually do significantly benefit those who are addicted to opioids and prevent opioid deaths. Notably, no death has ever been reported in an injection site, and a review of studies concluded that injection sites were associated with less outdoor drug use and did not appear to have any negative impacts on crime or drug use.

Despite the strong evidence backing the societal benefits of implementing and supporting safe injection sites, the policy faces significant legal and political obstacles in the United States. Perhaps the biggest hurdle that advocates of safe injection sites face is the potential legal liability of such sites under federal law and opposition from the Justice Department. The Controlled Substances Act makes it illegal to “knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance,” as well as to knowingly manage such a place. The plain language of that law may render implementation of safe injection sites impossible without some change or exception carved out in federal law.

However, advocates of safe injection sites do have a glimmer of hope that, once the first U.S. site is created, it will pass judicial muster through a creative legal argument proposed by law professor and drug policy expert Alex Kreit. In his paper, Kriet argues that a provision in the Controlled Substances Act providing immunity to state and local officials who commit drug crimes while enforcing local laws could protect safe injection sites from a crackdown by the federal government. Kreit has stated that the infrequently cited rule has previously been used in situations where authorities have seized marijuana and then returned it in states where marijuana has been legalized. Under this theory, those involved in safe injection sites would be protected so long as they were acting in accordance with a city ordinance or state law supporting safe injection sites. Other experts have expressed skepticism that such an argument would pass muster, however, with some stating that Kreit’s argument is a “stretch,” and that any path toward legality for safe injection sites lies in convincing the federal government not to target safe injection sites on public health grounds.

If cities and states cannot find a legal workaround protecting those involved with the safe injection sites, advocates likely face an uphill battle in convincing their communities and the Justice Department to accept injection sites. Attempts at establishing sites have not been politically palatable, as demonstrated by efforts in San Francisco and Boston. California Governor Jerry Brown vetoed a bill that would have allowed supervised drug consumption sites in the state and went so far as to describe it as “enabling illegal drug use.” In Massachusetts, in addition to Governor Baker’s opposition to the idea of safe injection sites, the Senate ultimately stripped a provision authorizing safe injection sites from its comprehensive opioid bill this past legislative session, instead replacing the pilot program with a commission to study the feasibility of establishing such sites. In addition to opposition from state Governors and a lack of strong state government support, it seems highly unlikely that the current federal administration would turn a blind eye to safe injection sites on public health grounds. In addition to a statement from the Vermont U.S. Attorney’s Office criticizing the policy and affirming that the United States Attorney would impose ramifications under federal law, there have been multiple other instances indicating the administration’s hostility towards safe injection sites and similar policies. In August, Deputy Attorney General Rod Rosenstein wrote an op-ed in the New York Times opposing safe injection sites and emphasizing the fact that they violate federal law. The Justice Department also “promise[d] [a] crackdown” on supervised injection facilities on an NPR radio show.

While there is scientific and global community support for safe injection sites, their future in the United States is still unclear, especially under the current federal administration. Until there are more assurances that sites could operate without intervention from federal law enforcement, it seems that most cities and states that have been at the forefront of the push for safe injection sites do not have the political will or capital to open the country’s first site and become the guinea pig of the movement. Philadelphia, however, may be the one city willing to go first. In August, Philadelphia Health Commissioner Dr. Thomas Farley said that Rosenstein’s opposition and warnings from the Justice Department would not prevent Philadelphia officials from further exploring the idea. Currently, Philadelphia seems to be going forward with its plan to allow, but not publicly fund, a non-profit site called Safehouse, which could serve as a jumping off point for litigation determining the legality of the sites and potentially creating more certainty for other interested cities and states. As for Massachusetts, it seems unlikely that the Commonwealth will be establishing any safe injection sites in the near future, though the members of the commission created in last session’s opioid bill will no doubt keep a close eye on Philadelphia as its safe injection site plan comes to fruition.

Chloe Aubuchon graduated from the University of Michigan with a B.A. in International Studies and Spanish in 2017 and anticipates graduating from Boston University School of Law in May 2020

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Curbing Medicare Drug Costs

April 17th, 2019 in Analysis, Federal Legislation

Prescription drug spend in the U.S. is the highest in the world. Americans pay up to three times the amount per capita of other countries. This is problematic for our growing aging population since their income becomes limited. While Medicare covers prescription drug costs, there are policy gaps that make it unaffordable. One major barrier to price controls is part D of title XVIII of the Social Security Act, in which explicitly prohibits the federal government “from negotiating directly with pharmaceutical companies to lower drug prices”. President Donald Trump proposed several policies to reduce the cost burden of prescription drugs on consumers through free-market competition approach, focusing mainly on cost transparency and promoting use of biosimilar or generic drugs. The policies are praised as a “small step in the right direction”. Yet, many Americans are dissatisfied since the proposals do not include direct Medicare negotiations with drug manufacturers. Pharmaceuticals argue that price controls would strain their investments in research and development (R&D) of new drugs. After taking a closer look, that is not fully the case. Greater price control measures can be taken, but there must be political will to support it. For now, the President’s policies are a small victory for seniors across America.

Medicare Coverage Today

Prescription drugs are covered under Medicare Part A, B, and C plans, but to a limited capacity. Part A is hospital insurance, part B is traditional medical insurance, and part C (Medicare Advantage) is like a health maintenance organization (HMO) or preferred provider organization (PPO) plan type. Only drugs administered within these respective settings are covered. Because of these limitations, the Medicare Modernization Act of 2003 was enacted, creating Medicare part D drug benefit.

Part D is an “optional” supplemental insurance that can be purchased with any of the other Medicare plans. It, however, is severely flawed. First, Congress did not commit any financing for part D, leaving costs falling on the recipient. Second, and most notoriously, is the “donut hole” coverage gap between initial enrollment and a “catastrophic coverage threshold”. The entry-point coverage limit is currently $3,750. Once this amount is reached, the patient is then responsible for fully paying for their medication until the maximum amount of the out-of-pocket (OOP) costs have been paid, or the annual time period lapsed. The OOP threshold now is $5,100, unaffordable for many seniors that suffer multiple chronic conditions.

Additionally, the plan disincentivizes patients from purchasing brand name drugs by increasing patient coinsurance payments. Provisions of the Affordable Care Act attempted to close this gap by 2020 by limiting patient payments to 25% of the gap. Under the Trump Administration, the Bipartisan Budget Act of 2018 advanced that date to 2019. Another caveat to Part D is that it is not really “optional”. If an individual fails to sign up once qualified and decides to enroll later, they will pay penalty fees for as long as they are on part D, with the exception of a few circumstances, such as having drug coverage from an employer.

The President’s Policies

To mitigate the Medicare drug coverage issues, the Trump Administration released his “blueprint” rules and policies, supplemental to the Bipartisan Budget Act. Provisions that went into effect include:

  • Step therapy” rule within the Medicare Advantage plans- clinicians are to prescribe cheaper drugs and monitor patient progress closely. If the drug is found to be ineffective, then a clinician can prescribe the next expensive drug. Clinicians in the Advantage plan get commission for the drugs they provide. The rationale is to curb physicians from “gaming” for greater profits. This rule is now in effect.
  • Taking harder action, the President recently signed legislation to ban “gag clauses” that prevented pharmacists from disclosing the best drug prices with customers. This is helpful for those who may be in the coverage gap of part D and would have to pay full price of the drug.

Other policies proposed and will likely be revisited for the upcoming session include:

  • Limiting doctor’s offices to charge consumer price index (CPI) of drugs administered in their office.
  • Shifting drugs from part B to D to promote greater market competition among drug makers to lower prices.
  • Allowing drug rebates to go to the consumer rather than the healthcare provider or health plan.
  • Promoting the use of biosimilars and generic biotechnology drugs.
  • Closing loopholes, such as the 180-day exclusivity that allow brand-name drug companies to “game” Food and Drug Administration (FDA) rules in ways that hinder generic competition.
  • Requiring drug manufacturers to disclose list prices in their advertisements.

These policies are a great step towards drug price controls. Yet, many argue that true price controls could only be achieved by allowing Medicare to directly negotiate drug prices. Perhaps that may be the case, as demonstrated by many other rich democracies. Pharmaceuticals, however, dispute this on the grounds that it would limit R&D investments.

In a recent study, Yu et al. evaluated the “top 15 drug companies in 2015” and found that the inflated prices are not justified by the R&D costs. Securities and Exchange Commission (SEC) laws and regulations require all public holding companies to publically disclose their financial statements. Knowing this, I reviewed the 2017 financial report of the largest pharmaceutical company in the world, Pfizer. Their R&D costs were $7.7 billion and accounted for 14.7% of their reported revenue of $52.5 billion. After discounting other expenses, their net income was $21.4 billion, allowing them to maintain 40.6% in profits. These figures are not uncommon. According to the International Trade Association, 15-20% of gross revenues is how much U.S. pharmaceutical companies spend on average on R&D (with the exception of the few that price gouged). In other countries, the R&D investments are much less, but drug costs are also lower.

Given these figures, it is of no surprise that advocates for better price controls are not convinced that R&Ds should be the main reason to maintain the inflated drug costs. Cost-effectiveness analysis (CEAs) may help determine the value of the drug, however it would likely, by default, favor biosimilars and generic drugs. In that case, the promotion of these drugs employed by the Federal government serve as a cost-effectiveness measure to some extent. For drugs that treat severe progressive conditions, such as Alzheimer’s disease or multiple sclerosis, it may be difficult to ascertain a value on new treatments since outcomes are unique to a patient’s condition. Moreover, measures involved in formal CEAs are derived from nationally administered quality/disability-adjusted life-year (Q/D-ALY) surveys of healthy people, thus not capturing the value of the treatment for those who are ill.

The President’s policies may not be perfect, but it is an experiment worth trying. Prior policies that attempted to “assist” our elderly population have failed, leaving those with chronic conditions and limited incomes forgoing treatment due to the high cost. For advocates of government price-fixing, it is important to keep in mind how much will prices be limited to, and it would likely require government to subsidize a portion of R&Ds. It is difficult to imagine that government would be willing to make such an investment if they are barely subsidizing part D costs.

Sarah Zahakos, MPH is working toward a PhD in Health Law, Policy & Management at the Boston University School of Public Health.
AHRQ T32 Research Fellow
Training in Health Services Research for Vulnerable Populations
Grant # 2T32HS022242

 

References

• Bartlett, B. (2013, November 13). Medicare Part D: Republican budget-busting. New York Times. Retrieved from https://economix.blogs.nytimes.com/2013/11/19/medicare-part-d-republican-budget-busting/

• Centers for Disease Control and Prevention (2018, November 15). Cost-effectiveness nalysis: Outcomes in natural units. Retrieved from

https://www.cdc.gov/dhdsp/evaluation_resources/economic_evaluation/docs/Economic-Evaluation-Part5.pdf

Cubanski, J., Koma, W., Damico, A., and Neuman, T. (November 19, 2018). Medicare: ow many seniors live in poverty? Henry J. Kaiser Family Foundation. Retrieved from https://www.kff.org/medicare/issue-brief/how-many-seniors-live-in-poverty/

 

eHealth (2018, November 16). HMO insurance plans. Retrieved from:

https://www.ehealthinsurance.com/health-plans/hmo

eHealth (2018, November 16). PPO insurance plans. Retrieved from

https://www.ehealthinsurance.com/health-plans/ppo

Food and Drug Administration (FDA) [2018, November 15]. Biosimilar and interchangeable products. Retrieved from

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm

Hederman, Jr., R.S. (2018, August 11). New Medicare drug pricing rule — a small 'step' in the right direction. The Hill. Retrieved from

https://thehill.com/opinion/healthcare/401404-new-medicare-drug-pricing-rule-a-small-step-in-the-right-direction

H.R.1 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

Retrieved from https://www.congress.gov/bill/108th-congress/house-bill/1

International Trade Association (2018, November 15). 2016 top markets report

pharmaceuticals. Retrieved from

https://www.trade.gov/topmarkets/pdf/Pharmaceuticals_Executive_Summary.pdf

Kaiser Family Foundation (2018, October 12). An overview of the Medicare Part D

prescription drug benefit. Retrieved from https://www.kff.org/medicare/fact-sheet/an-overview-of-the-medicare-part-d-prescription-drug-benefit/

Lagasse, J. (2018, September 13). Most Americans disapprove of how Trump, Congress

are addressing prescription drug costs, poll shows. Retrieved from

https://www.healthcarefinancenews.com/news/most-americans-disapprove-how-trump-congress-addressing-prescription-drug-costs-poll-shows

Medicare.gov (2018, November 15). How to get drug coverage. Retrieved from

https://www.medicare.gov/index.php/drug-coverage-part-d/how-to-get-drug-coverage

Moeller, P. (2018, February 14). President Trump signed these Medicare changes into

law. Here’s what to watch for. PBS. Retrieved from

https://www.pbs.org/newshour/economy/making-sense/president-trump-signed-these-medicare-changes-into-law-heres-what-to-watch-for

National Opinion Research Center (NORC) at the University of Chicago (2018, November

15). What should be done about the high cost of prescription drugs? Retrieved from

http://www.norc.org/Research/Projects/Pages/what-should-be-done-about-the-high-cost-of-prescription-drugs.aspx

Part D of title XVIII of the Social Security Act. Retrieved from

https://legcounsel.house.gov/Comps/Social%20Security%20Act-TITLE%20XVIII(Health%20Insurance%20for%20The%20Aged%20and%20Disabled).pdf

Pear, R. (2018, October 10). Trump signs new laws aimed at drug costs and battles

democrats on Medicare. New York Times. Retrieved from

https://www.nytimes.com/2018/10/10/us/politics/trump-health-insurance-drug-costs.html

Pearl, R. (2018, September 24). The immorality of prescription drug pricing in America.

Forbes. Retrieved from

https://www.forbes.com/sites/robertpearl/2018/09/24/nostrum/#614ba37a4fb1

Pfizer (2018, November 15). 2017 financial report. Retrieved from

https://s21.q4cdn.com/317678438/files/doc_financials/Annual/2017/Financial-Report-2017.pdf

Securities and Exchange Commission (2018, November 16). Rules and regulations for

the Securities and Exchange Commission and major securities laws. Retrieved from https://www.sec.gov/about/laws/secrulesregs.htm

Sarnak, D.O., Squires, D., & Bishop, S. (2017, October 5). Paying for prescription drugs

around the World: Why is the U.S. an outlier? Commonwealth Fund. Retrieved from

https://www.commonwealthfund.org/publications/issue-briefs/2017/oct/paying-prescription-drugs-around-world-why-us-outlier

Trump Administration (2018, May 30). American patients first: The Trump Administration

blueprint to lower drug prices and reduce out-of-pocket costs. Retrieved from https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf

Yu, N.L., Helms, Z., & Bach, P.B. (2017). R&D costs for pharmaceutical companies do

not explain elevated US drug prices. Health Affairs.

doi: 10.1377/hblog20170307.059036

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Raising the Blinds – Gaining Meaningful Insight into Pharmaceutical Pricing through Legislation

February 7th, 2019 in Analysis, Federal Legislation, Legislation in Court, Lobbying

Rising healthcare costs are a growing concern across the United States; in 2016 U.S. health care spending was $10,348 per person – or 17.9 % of the nation’s Gross Domestic Product (GDP). To counter this alarming rise in healthcare costs, states are addressing one of the largest factors in rising healthcare costs – high drug prices. 

Many factors contribute to the high price of healthcare in our country, some of which are natural to an aging populace due to the baby boom of the 1950’s as the proportion of the population that is 65 and over is projected to experience a large increase in the coming years. An increase in costs is natural with a larger number of consumers – addressing this change is an important, but avoidable, challenge to overcome.

One avoidable factor of increasing healthcare costs is rapidly increasing pharmaceutical prices. Variance in drug prices may be geographic; based on where the drug is sold , or whom the drug is being sold to (pharmacy v. government). Many factors contribute to price differences, but an important factor are Pharmacy Benefit Managers (PBMs) as an intermediate in the market. States have been working to roll back the PBM layer of the market for  the pharmaceutical industry.

Pharmaceutical pricing has long been the target of legislators, but with a lot of talk and a surprising lack of action. Drug pricing is  discussed in both major party’s campaign platforms of the major parties and has been featured prominently in speeches by President Trump, and has featured in initiatives by previous administrations. There has been an uptick of legislation passed in the past decade, at all levels of government, with state action against pharmacy benefit managers and President Trump’s signing the Know the Lowest Price Act and the Patient Right to Know Drug Prices Act.  A common thread in the legislation is increased transparency because a big factor in the high drug prices — and medical care generally—is the lack of information for consumers and purchasers. Since 2015, California, Oregon, Louisiana, Nevada, Vermont, Connecticut, and Maryland imposed reporting requirements on pharmaceutical manufacturers who increase prices over an established threshold in a set time period. For example, California requires reporting when a drug that costs more than $40 and its wholesale acquisition cost (WAC) increases by more than 16% over two calendar years.  The WAC is similar to a “list” price for pharmaceuticals to wholesalers and direct purchasers. The WAC, however, does not include discounts or rebates offered by pharmacy benefit managers.

The new transparency offers insight to price increases; if there are no legitimate reason for the increase other than higher profits due to market control, state officials, drug customers and the public can take action.

The states with transparency statutes have imposed different methodologies with manufacturers reporting to different government officials such as the Department of Health and Human Services, creation of new departments, or to the state’s Attorney General.

Oregon currently requires the most detailed reporting; manufacturers must report to the Department of Consumer and Business Services the following:

  1. Name, price of drug and net increase in price (in %) over previous calendar year
  2. Length of time on market
  3. Factors contributing to price increase
  4. Name(s) of any generic version(s) of the drug
  5. Research & Develop Costs from Public Funds
  6. Direct costs to Manufacturer
  7. Total sales revenue for drug over prev. calendar year
  8. Profit from drug over previous calendar year
  9. Drug's price at release and yearly increases over the past 5 years
  10. 10 highest prices paid for the drug during past year outside of the US
  11. Any other info relevant to price increase
  12. Supporting documentation

In contrast, California’s requirements provide for advance notice of price increases and unearthing the reasoning for the increase. The California law requires manufacturers to report (A) Date of increase, current WAC, and future increase in WAC (in dollar amounts); and (B) The change or improvement, if any, that necessitates the price increase. Purchasers then have notice of any forthcoming price changes and if the increase is warranted.  California also requires a report for new drugs if its price exceed $670—the 2017 Medicare Part D threshold.  California’s reporting scheme has been a model for other states.

Maryland’s approach was more severe, with a provision banning “price gouging” of generic drugs. An “unconscionable price increase” of any “essential off-patent or generic drug” is illegal and  Maryland can levy a fine and take action to reverse the price change. The state did not include any limitation of the law to drugs that have come into or passed through Maryland.

The generic drug lobby, the Association for Accessible Medicines, challenged the law and the Fourth Circuit Court of Appeals struck down the law as an unconstitutional regulation of interstate commerce. Maryland has petitioned the Supreme Court to revisit the case.

The Pharmaceutical Research and Manufacturers (PhRMA), one of the largest pharmaceutical lobbying groups, has sued California alleging the law, like Maryland’s, is unconstitutional. Because California’s law is informational—and does not allow forced price changes—it is likely constitutional. In fact, PhRMA’s initial complaint was dismissed, and subsequently filed an amended complaint on Sept. 18, 2018.

It will be imperative for states seeking to regulate pharmaceutical manufacturers to observe where courts determine the extent of reporting they may require when they go after a manufacturer for increasing the price of their drug. For the time being, it appears that information-gathering may be the easiest available avenue for states seeking to curtail increases in drug prices. Seeking justifications and reasoning for large increases in drug prices may create a barrier for pharmacuetical companies seeking to impose unsubstantiated increases in drugs. Going further towards affirmative control of pricing appears to be off limits to states going as far as Maryland, but more careful structuring of the controls to the specific state may be permissible.

 

Drew Kohlmeier is a student in the Boston University School of Law Class of 2020 and is a native of Manhattan, KS, graduating with a degree in Biology from Kansas State University in 2016. Drew decided on Boston for law school due to his interest in health care and life sciences, and will be practicing in the emerging companies space focused on the life sciences industry following his graduation from BU.

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Of Migration and Refugees: The Failure of Republican Deterrence Policy

February 7th, 2019 in Federal Legislation, Legislative Oversight

Despite two years of the Trump administration’s get-tough-on-refugees policy, the latest statistics continue to show record numbers of migrants crossing the U.S. border, with 16,658 family members in September, the highest one-month total on record and an 80 percent increase from July.This is just the latest in the periodic reports showing that Trumps immigration policy has failed, which should prompt questions both about why it has failed, as well as why Trump continues to insist on such a patently immoral approach to policy. Since at least 2014, Republicans have pushed for draconian treatment of border-crossers on the theory that such treatment will deter people from entering the United States. However, deterennce ignores the reasons why people are fleeing their home countries, and thus predictably fails, suggesting that the G.O.P. has adopted the policy in order to appeal to a segment of the voting public whose fear and hate have been amplified by right-wing propaganda.

Shortly after taking office, Trump quickly began to make good on his campaign promises to get tough on immigration, reversing what he termed Democrats’ soft approach. These policies included the end of Obama’s Deferred Action for Childhood Arrivals program, the end of Temporary Protected Status for hundreds of thousands of people, and the implementation of harsh treatment of immigration detainees at the border, including family separation, prolonged detention of asylum-seekers, the use of prisons as “detention” facilities, and a concentration of resources to increase prosecute border-crossers (and significant evidence of over-enforcement). The goal of such policies is apparently rooted in a belief that such policies will deter migrants from attempting to enter the United States, notwithstanding the lack of evidence that such deterrence is effective.

BBC.Com

These policies should be seen as derivative of the rhetoric of Republican critics of President Obama’s initial response to the so-called “surge” of children crossing the border in 2014. In early June, Obama originally declared the situation a humanitarian crisisand directed officials to apprehend and provide care, including housing and medical treatment, and legal aid. However, with right-wing propaganda outlets such as The Daily Caller whipping up fear of the children at the border, Republican politicians seized on the opportunity to make the humanitarian crisis into a political one. Claiming the crisis was due a failure of the Obama administration, politicians such as House Judiciary Chair Robert Goodlatte suggested that the solution was simply an end to “Obama’s lax immigration enforcement policies” and rigorous enforcement of the immigration laws. And, by the end of June, the Obama administration, feeling the pressure from the right, shifted gears and adopted a policy of deterrence. This crackdown included increased enforcement and wide-spread use of detention centers, as well as an information campaignto send a clear message to potential migrants so that they understand the significant dangers of this journey and what they will experience in the United States. This created little political traction for Democrats, as Republicans insisted that it was too little, too late, and that draconian deterrence measures were necessary.

The reality is that migration to the United States from Central America is largely driven by push factors forcing people out of their home countries, not pull factors luring them to the United States, which explains the lack of evidence for the efficacy of deterrence. As a worker at a migrant shelter in Tucson, Arizona is reported as explaining, Why would you undertake such a dangerous journey? When youve got a gun to your head, people threatening to rape your daughter, extort your business, force your son to work for the cartels. What would you do?While Trump insists on depicting migrants from Central America as gang-members, or even soldiers “sent” by their home countries in a mythical war on American interests, it is probably best to think of human beings fleeing their nations because of violence as asylum-seekers.

The Refugee Act of 1980 defines refugees and asylum-seekers to be those who are persecuted, or have a well-founded fear of persecution[,] on account of race, religion, nationality, membership in a particular social group, or political opinion.The law also provides a right to any alien within the United States to seek asylum, requiring those seeking such status to cross the border. Trump appears to see asylum, one of the basic pillars of human rights law, as a loophole to be exploited by evildoers, and is seeking to close that loophole,if not through legislation, then through deterring those seeking safe-harbor. Trump’s Justice Department, has moved to exclude domestic violence and gang targeting as bases for establishing persecution based on membership in a particular social group, overturning Board of Immigration Appeals precedent. On a moral level, there seems little reason to distinguish between the persecution faced by political dissidents in totalitarian regimes, and that faced by victims of the reign of terror perpetrated by gangs in Central America. Certainly, the pervasive fear of violence under both regimes is what drives people to seek safety in other countries. It is this push-factor, the pervasive violence faced by many Central Americans in their home nations, that is driving migration to the United States, and no amount of deterrence, short of recreating the violence of their home nations at the American border, will change the minds of those who feel forced to flee for their lives.

NBC News

That said, as Trump is able to feed on fear and hate in order to build political power with his Republican base, it is unlikely that evidence-based policy arguments about the efficacy of deterrence policy will make much headway towards a reconsideration of said policy. Perhaps a congressional re-imagination made possible by the new Democratic House majority will lead to legislative changes prompting a humane response to what is at base a humanitarian crisis. The House leadership’s recent refusal to appropriate money for what many consider a boondoggle border wall suggests that Democrats are eager to pass sensible border policy rather than acquiesce to Trump’s grandstanding. Congressional mandates that the executive branch again consider domestic violence and gang intimidation as possible bases in the determination of asylum would be a start. Shifting resources from detention centers to asylum officers and immigration judges, thereby treating asylum-seekers as asylees and not felons would help as well. And, in the long-run, Congress should consider how best to address the push factors causing people to flee for their lives in the first place.

 

Dan Ordorica anticipates earning his Juris Doctor from Boston University School of Law in May 2019.

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Examining the ERA’s Comeback: the Legal Debate Over a 38th Ratification

February 5th, 2019 in Analysis, Federal Legislation, State Legislation

At a time when the issues of gender and sexual harassment have come to a head, some activists are looking to a decades-old proposed constitutional amendment to secure gender equality. The Equal Rights Amendment (“ERA”), originally proposed by suffragist Alice Paul in 1923, would affirmatively state that no person’s rights under the law may be denied or abridged based on sex. This would raise the level of judicial scrutiny afforded to claims of gender discrimination from the “intermediate” and often uncertain level of scrutiny to the much more arduous level of strict scrutiny. Strict scrutiny would make gender a protected class and grant legal safeguards for gender discrimination claims on par with those of claims of racial discrimination. Despite renewed public support for the ERA, its complicated history and potential future passage raise contentious legal issues.

The ERA was introduced in every Congressional session from 1923 until its eventual passage in 1972. After passage, the landmark legislation went to the states for ratification; needing the ratification of at least 38 states—two thirds of the states—before the congressionally imposed deadline of March 22, 1979. While there was an initial surge in ratification, only 35 states ultimately ratified the ERA. Congress extended the deadline to June 30, 1982, however no other states ratified in that time.

After the deadline passed without the prerequisite ratification, the ERA largely disappeared from the national conversation and lay dormant until its contemporary resurgence. Millions participated in the Women’s Marches in response to President Trump’s election, and the #MeToo movement aimed at ending workplace sexual assault and harassment; both reflect a renewed push for gender equality. In light of those movements, the ERA, too, gained steam.  On March 22, 2017, exactly 45 years after Congress first passed the ERA, Nevada became the 36th state to ratify the amendment. A little over a year later, on March 30, 2018, Illinois followed suit, leaving the ERA needing only one more state to reach the required two-thirds of states. The final necessary ratification may come in the upcoming legislative session beginning in January, as Virginia lawmakers have recently wrapped up VAratifyERA, a 10-day, bipartisan bus tour of Virginia aiming to gather support for the bill across the state.

While activists pursue a 38th ratification, legal scholars debate the legitimacy of a passage of the amendment so far beyond Congress’ deadline. Does Congress have the power to simply extend the deadline again and certify the ERA’s passage if a 38th state passes it, or did the ERA expire in 1982, rendering a 38th ratification moot?

According to a 2018 Congressional Research Service (CRS) report on the ERA and ratification issues, ERA advocates argue that a contemporary ratification is valid given Congress’ broad authority over the constitutional amendment process, including the power to extend or limit the deadline for the ERA. ERA supporters point to Article V of the Constitution—giving Congress broad power to propose amendments “whenever two thirds of both houses shall deem it necessary” and stating that proposed amendments are “valid to all intents and purposes” when ratified by the legislatures of three fourths of states—to argue that Congress may extend ratification deadlines as it sees fit. Notably, Article V does include any specific time limits related to constitutional amendments, while other constitutional rules with time periods are explicitly specified. Proponents of the ERA, including Nevada’s ERA Ratification Organizer, point to the 27th Amendment’s ratification process to support an expanded—if not long—ratification process. The 27th Amendment, the most recent amendment to the Constitution imposing rules on increases or decreases to the salaries of members of Congress, was introduced in 1789, without a deadline, and was not fully ratified until 1992.  ERA supporters argue that Congress can extend deadlines where the time limits appear only in the original proposing clause, not the text of the amendment itself. Finally, the fact that Congress already extended the deadline once suggests that Congress has the power to do so again.

According to the CRS report, opponents argue that despite Congress’ plenary power over the constitutional amendment process, extending the ERA deadline to allow for contemporary ratification would be unconstitutional because of ratifying states’ potential reliance on the time period in their decision to ratify. However, since the deadline was only in the proposing clause and all of the states’ ERA ratifications prior to the first deadline extension raised no constitutional issues, this argument may lack merit.

Significantly, a 38th ratification of the ERA may raise the question of whether states’ rescinding of ratifications of constitutional amendments are valid, as five states—Idaho, Kentucky, Nebraska, South Dakota, and Tennessee—have withdrawn their ratifications. This is not a settled area of law, but ERA proponents argue that such rescissions are not legal, as Article V provides only for ratification procedures, not rescission. The passage of the Fourteenth Amendment in 1868 lends credence to this argument, at it was certified based on the ratification of a two-thirds majority of states including Ohio and New Jersey, despite the fact that they had previously attempted to withdraw ratification. Additionally, the Supreme Court has been reluctant to weigh in on the validity of states’ ratifications of recessions of constitutional amendments. In Coleman v. Miller (1939), the Court regarded the question of the “efficacy of ratifications by state legislatures…” as a political question and did not issue a ruling on the merits. Therefore, it is likely that Congress could certify the ERA in a similar vein to the Fourteenth Amendment—that is, including ratifications from states that have since attempted to withdrawal their ratifications—legally and without intervention from the courts.

While the legal status of a 38th state ratification may be murky, the importance of the ERA today is clear. United States Supreme Court Justice Ruth Bader Ginsburg has supported the ERA, arguing that while recent women’s rights advancements through legislation are positive, it could be repealed without an underlying principle of equality enshrined in the Constitution. For example, a 2012 Wisconsin Act rolled back protections for victims of wage discrimination. Practically, the ERA’s heightened scrutiny on gender discrimination cases would go a long way in preventing rollbacks of laws protecting gender equality as well as preventing the implementation of laws that actively discriminate based on gender. For example, the ERA would likely have prevented the rollback of the Wisconsin wage equality law. Experts also argue that a heightened level of scrutiny for gender discrimination claims likely would have changed the outcome of the famous 2014 Burwell v. Hobby Lobby case, which allowed for-profit companies to deny its employees health coverage of contraception based on religious objections. If the ERA can win its final state ratification and pass through the many legal hurdles it faces, it would represent the realization of an almost century-long ordeal to ensure a basic principle of equal protection and rights under the law regardless of gender.

 

Chloe Aubuchon graduated from the University of Michigan with a B.A. in International Studies and Spanish in 2017 and anticipates graduating from Boston University School of Law in May 2020.

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The U.S. Postal Service is Staying Alive (for now)

July 19th, 2018 in Analysis, Federal Legislation, Legislative Oversight

During the Spring, President Trump has brought to the spotlight a little-discussed, quite unsexy policy dilemma: how to save the U.S. Postal Service.

In a series of Tweets, the President accused Amazon of unfairly taking advantage of the U.S. Postal Service. The first of these Tweets appeared on his Twitter feed on March 29th, and seemingly accused Amazon of shirking its tax responsibilities and free-loading from the government delivery service:

“I have stated my concerns with Amazon long before the Election. Unlike others, they pay little or no taxes to state & local governments, use our Postal System as their Delivery Boy (causing tremendous loss to the U.S.), and are putting many thousands of retailers out of business!”

President Trump also seemingly accused the Washington Post, which is owned by progressive billionaire Jeff Bezos, of engaging in secret lobbying. Although it is not entirely clear to which type of lobbying President Trump was referring in his March 31st Tweets, he seems to imply that the Washington Post is Amazon’s lobbying arm or propaganda machine that is helping Amazon to rip off the post office:

“While we are on the subject, it is reported that the U.S. Post Office will lose $1.50 on average for each package it delivers for Amazon. That amounts to Billions of Dollars. The Failing N.Y. Times reports that “the size of the company’s lobbying staff has ballooned,” and that...

“…does not include the Fake Washington Post, which is used as a “lobbyist” and should so REGISTER. If the P.O. “increased its parcel rates, Amazon’s shipping costs would rise by $2.6 Billion.” This Post Office scam must stop. Amazon must pay real costs (and taxes) now!”

After several news outlets, including the New York Times, published articles rebutting his statement that Amazon is not paying taxes (Amazon paid $957 million in income taxes in 2017) and is costing the U.S. Post Office billions of dollars per year, President Trump again asserted that he was correct, tweeting in part, “Only fools, or worse, are saying that our money losing Post Office makes money with Amazon. THEY LOSE A FORTUNE, and this will be changed.”

A few days later, he again tweeted that, “Amazon should pay these costs (plus) and not have them bourne by the American Taxpayer. Many billions of dollars. P.O. leaders don’t have a clue (or do they?)!” However, if one thing is clear, it is that the U.S. Post Office is not funded through taxpayer dollars, but through its own revenue. Still, the President is correct that the post office is losing money every year, specifically $2.7 billion in fiscal year 2017. However, it is unlikely that the bulk of that loss was incurred by conducting business with Amazon.

According to the U.S. Postal Service’s annual report for fiscal year 2017, its biggest losses came from fluctuating forces outside of its control. “The controllable loss for the year was $814 million, a change of $1.4 billion, driven by the $775 million decline in operating revenue before the 2016 change in accounting estimate, along with the increases in compensation and benefits and transportation expenses of $667 million and $246 million, respectively.” Mail volumes declined by 3.6%, while employee benefits and transportation costs have increased. On the other hand, the report indicated that package mail is up by 11.4%, providing “some help to the financial picture of the Postal Service as revenue increased $2.1 billion.” However, that growth has not been able offset other losses.

In other words, package companies like Amazon may actually be helping the U.S. Postal Service, even if they are receiving discounted shipping rates. By law, the Postal Regulatory Commission ensures that all items sent through the U.S. mail are profitable. Therefore, even if the U.S. Postal Service gives a discount to Amazon, those shipments will still be profitable to some degree. Whether the U.S. Postal Service should charge higher rates is a separate issue.

Postmaster General and CEO Megan J. Brennan described the report’s findings as “serious though solvable.” So, how can the government hope to save an agency that has not had a net surplus since 2006? The U.S. Postal Service is hopeful that H.R. 756, which was introduced to the House of Representatives by Rep. Chaffetz in 2017, and is being sponsored by Rep. Garrett in 2018, will pass and provide some relief by reforming postal service benefits, operations, personnel, and contracting. In addition, the Postal Regulatory Commission must adopt a new pricing system to generate additional revenue.

U.S. Senator Bernie Sanders has also pitched some ideas in the past, which are now catching the public’s eye in light of the President’s recent Tweets. Senator Sanders recently told Vice News that the post office should expand its services to generate more revenue. For example, the U.S. Postal Service could offer gift-wrapping services to capitalize on package shipments around the holidays. Additionally, "[t]he postal service could make billions of dollars a year by establishing basic banking services so lower-income people have access not to these payday lenders but to someplace where they can be treated with respect."

This idea is not new. In fact, until 1966, many U.S. post offices did offer simple banking services. Moreover, other countries such as Japan, the United Kingdom, France, and Italy currently use similar systems of postal banking with success. Senator Sanders emphasized that the post office must survive or else Americans living in rural areas, where it is not profitable to deliver mail, will face a decrease or elimination of mail services.

One former postmaster added that “[a]bsent a public infrastructure like the postal service network, it’s likely that both of these private sector firms (Fedex and UPS) would either refuse to serve many areas of the country or they would use their powers as an oligopoly to control prices.” In other words, if the U.S. Postal Service goes out of business, other mail carriers may be unable to fill the gap, or may only do so at inflated rates.

With so much at stake, it is daunting to imagine America without the U.S. Postal Service. We can only hope that Congress will step in and make the necessary reforms before it is too late.

 

Caitlin Britos anticipates graduating from Boston Univeristy School of Law in May 2019.

 

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Mental Illness and Gun Violence:  What’s Really Responsible?

July 11th, 2018 in Analysis, Federal Legislation, Local Legislation, State Legislation

You’ve heard it all before.  In fact, you’ve heard the same arguments repeated back and forth so many times you have memorized them yourself. The cycle goes like this:  There’s a mass shooting, then in the tragic aftermath, the liberal and conservative pundits begin repeating their arguments left and right.  Usually, on the conservative right there are calls for mental health reform and on the left, liberals agree that we need to address mental health, but point to gun access as the key issue to prevent these tragedies from happening.  The rest of us, the general population, are left somewhere in between.  We point fingers like everyone’s to blame, but we take action like nobody is responsible.  That is to say, we take very little action at all.

Although this cycle has repeated itself to the point of feeling like a broken record, it’s important that we not get stuck like one.  After all, the definition of insanity is doing the same thing over-and-over again while expecting a different result.  Where some blame the mentally ill and some blame guns, it is important to step back and reframe our arguments to see the issue of gun violence in a different light.  Maybe the solution, as is often the case, lies somewhere in between.

The tragedy in Parkland has energized this debate to unprecedented levels, but has also brought with it many familiar arguments.  In particular, recent calls from President Trump to strengthen limitations on the ability of the mentally ill to access firearms gives us cause to reevaluate his premise that mental illness is associated with gun violence.  President Trump’s critique is founded on a commonly shared belief among the majority of Americans.  According to a Pew Research poll in 2017, 89% of people across the political spectrum favor placing increased restrictions on the ability of the mentally ill to purchase firearms.  This commonly held belief across the political spectrum forces us to ask ourselves: What is the real relationship between mental illness and gun violence?

What do the Numbers Say?

The evidence suggests that we may be biased when it comes to our perceptions of the mentally ill and the potential for persons dealing with mental illnesses or disorders to exhibit violent tendencies.  In fact, a 2013 national public opinion survey (p.367) found that 46% of Americans believe that persons with mental illness are “far more dangerous than the general population.”  However, the public perspective is vastly distinct from reality.  Another study (p.241) demonstrates that between 2001 and 2010, “fewer than 5% of the gun-related killings in the United States… were perpetuated by people diagnosed with mental illness.”  People are far more likely to be killed by a person with a gun that does not have a mental illness, than someone that does have a mental illness.

While mental illness is not strongly correlated with gun violence, there are other conduct measures that appear to be strong predictors of such violence.  Three conduct measures in particular that are powerful are past acts of violence/criminal history, a history of domestic violence, and substance abuse.

First, with regard to a history of violence, the American Psychology Association issued a report (see p.8) that concluded based on longitudinal studies, “The most consistent and powerful predictor of future violence is a history of violent behavior.”  One article from Wisconsin Public Radio affirms this trend in reporting that for gun homicides in Milwaukee about, “93 percent of our suspects have an arrest history.”  Although the Milwaukee sample is small and not entirely representative of the entire United States, such a high correlation is worthy of our attention in considering factors for reevaluating our gun policies.

Second, when it comes to the correlation between domestic violence and mass shootings or gun violence, the evidence is even stronger.  According to a study quoted in the New Yorker, “Of mass shootings between 2009 and 2013, 57 percent involved offenders who shot an intimate partner and/or family member.”  Further, a report from Everytown for Gun Safety shows that persons with a history of domestic violence account for “54 percent of mass shootings between 2009 and 2016.”

Third, with regard to substance abuse, a study (p.242) by Dr. Jonathan Metzl, an often quoted figure in studying the causes of gun violence in the United States, found that, “[A]lcohol and drug use increase the risk of violent crime by as much as 7-fold, even among persons with no history of mental illness.”  According to the same study, “serious mental illness without substance abuse is ‘statistically unrelated’ to community violence.”  In other words, substance abuse increases an individual risk of violence in general, including an increased risk of gun violence.

States Offer Pragmatic and Nuanced Solutions

However, correlation does not equal causation.  Many of the current studies on the causes of gun violence and mass shootings face limits (p.240) in this particular regard.  However, the low statistical correlation indicated in multiple studies between mental illness or disorders and gun violence are informative.  The fact that there are other risk factors that are strong predictors of violence generally and gun violence specifically point to where our attention is likely better directed in trying to rework gun laws in a manner that will work for everyone.

The Giffords Law Center to Prevent Gun Violence points to one such unique legal mechanism adopted in Oregon, Washington and California, which have adopted laws for Extreme Risk Protection Orders (“ERPOs”).  These laws allow family members or law enforcement officers to petition a court to keep guns away from someone going through a crisis.  The laws are geared toward the principle that family members are best able to gauge changes in an individual’s behavior that could pose a serious risk of harm.  Petitioners under these laws still have the burden of providing sufficient proof that the individual poses a risk of danger to themselves or others.  ERPOs are also only temporary, but may vary in length.  For longer protective orders, more compelling evidence must be offered that the person poses a risk of harm to themselves or others.

Oregon offers another pragmatic solution in its closing of the “domestic abuser loophole” through passage of a recent state law.  Under the 1996 Domestic Violence Offender Gun Ban, domestic abusers are banned from owning or possessing a gun.  However, the federal ban only applies to someone if they are married, living with, or have a child with the victim of the abuse.  The wording of the law creates the “domestic abuser loophole,” which means that someone who is not living with their significant other and does not meet any of the other mentioned criteria, but who abuses their significant other, can still buy a gun.  Oregon’s new law prohibits anyone convicted of a crime of domestic violence from owning or possessing a gun, regardless of whether or not that person lives with their significant other.

Oregon State Capitol
Salem, 1938

These new state laws are just examples of a number of other pragmatic and nuanced policy solutions that are geared toward preventing future gun violence while avoiding burdensome restrictions on the Second Amendment rights of the vast majority of Americans.  Such solutions demonstrate our capacity to tackle the problem of gun violence in new and creative ways, while still preserving individual freedoms.  Finally, these laws represent effective solutions that are based on empirical evidence about true risk factors for gun violence and not on ill-founded stigmas.  A path forward on fixing our gun laws exists, but to move forward we must set aside our preconceived notions and work together to promote innovative solutions that protect both our rights and our safety.

Nicholas Stone graduated from Boston University School of Law in May 2018 and plans to practice in Portland Oregon.

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Drive-By Legislation Will Not Solve Drive-By Lawsuits

July 10th, 2018 in Analysis, Federal Legislation, Legislation in Court, Legislative Oversight, Uncategorized

If you ask disability rights activists about the ADA Education and Reform Act of 2017 (the “Reform Act”), you may get a response that the Reform Act, which recently passed the House, is not nearly as benign or as amicable to the interests of persons with disabilities as its title suggests.  In fact, many activists claim that the Reform Act would be downright harmful to persons with disabilities.

Tension over the Reform Act arises over key provisions requiring individuals with disabilities to give notice to businesses before filing a noncompliance lawsuit under the Americans with Disabilities Act (“ADA”).  Currently, an individual can bring a lawsuit under Title III of the ADA immediately for a business’ failure to comply with the ADA. Under the proposed law, after receiving notice, the business would have 60 days to provide a written plan describing how the business will conform to the ADA’s requirements.  The business then could take another 120 days to remove or make “substantial progress” toward removing the accessibility barrier.   Individuals with disabilities would have to wait at least 180 days, if not longer, to enforce their civil rights under the ADA.

Although disability rights activists and many supporters of the disabled community oppose the proposed law, the Reform Act has some bipartisan support in Congress in an effort to stem the tide of excessive “drive-by” lawsuits.

Do we have a “Drive By” Lawsuit Problem in the United States?

“Drive-by” lawsuits are a practice where unscrupulous attorneys file hundreds of lawsuits alleging often minor, technical violations of the ADA.  Lawyers working with as little as one plaintiff file lawsuits with boilerplate complaints looking for quick settlement payouts.  These lawyers have often only visited the business they are suing one time and sometimes neither the lawyers nor their clients are patrons of the business.

Recent, more extreme versions of “drive-by” lawsuits are called “Google lawsuits;” where lawyers file lawsuits just by looking for ADA violations on Google Earth.  By some estimates, businesses pay an average of $16,000 to settle these lawsuits rather than paying significantly more in legal fees to challenge the lawsuits in court.  Under Title III of the ADA, a plaintiff cannot recover damages, but can recover attorneys’ fees along with injunctive relief (see p.378).  Proponents of the Reform Act argue that these remedies promote excessive litigation.

Unfortunately, these “drive-by” lawsuits often do not result in increased ADA compliance.  These settlements are often just shakedowns for cash, which may not actually lead to fixing the underlying ADA violation.  As a result, some in the disabled community feel that these “drive-by” lawsuits actually harm relations between businesses and persons with disabilities.  Still, could the Reform Act do more harm than good?

Could the ADA Education and Reform Act Damage the ADA?

Originally enacted in 1990, the ADA has improved the lives of countless individuals with disabilities.  The ADA passed with widespread bipartisan support and is considered one of the most comprehensive and progressive disability civil rights statutes in the world.  In fact, many other nations have modeled their disability rights laws after the ADA.

The ADA is effective, in part, because of two key areas: Title I and Title III, which allow private rights of action to enforce individual rights.  Title I protects persons with disabilities in the employment context, and Title III protects persons in public accommodations.  Under Title III, places of public accommodation must remove accessibility barriers, but only if this is “readily achievable” and not and where removing barriers would require a fundamental alteration or an undue burden.  Unfortunately, although employers and places of public accommodation must proactively comply with the ADA, persons with disabilities often have to bring lawsuits to enforce the provisions of the ADA.  Businesses comply with the ADA not only because it is the right thing to do, but also because of the threat of lawsuits.

Accordingly, disability rights activists decry the Reform Act as a thinly veiled threat to disability rights.  The proposed law would fundamentally shift the balance of power for ensuring compliance to favor businesses.  Instead of proactive compliance, businesses could sit on their hands and wait to be sued.  Then, businesses would only have to show “substantial progress” toward compliance, not even full compliance, over the course of months.  For those who are legitimate patrons of a business and who require accessibility, waiting six months or more for “substantial compliance” is simply not a realistic option.

A Path Forward:  Changing Our Perception

Disability rights attorney Robyn Powell argues changes can be made without the Reform Act.  First, Ms. Powell posits that attorneys are bound not to represent individuals in frivolous lawsuits; making this is an issue for state courts and bar associations to address, not Congress.  Second, Ms. Powell points out that the, “ADA does not require any action that would cause an ‘undue burden’ or that is not ‘readily achievable,’” for a business to accomplish.

Many of the issues that the Reform Act seeks to address are issues that can be resolved without curtailing the civil rights of persons with disabilities.  Both the business community and the disability community have mutual interests in ensuring that frivolous, “drive-by” lawsuits are prevented.  However, rather than place severe restrictions on the rights of persons with disabilities through an extensive period of notice and opportunity to cure, other options should be considered.

States and their respective state bar associations could opt to impose stricter penalties for attorneys filing frivolous lawsuits under the ADA.  Coupled with these stricter penalties, state bar associations could also adopt mechanisms like thresholds for the number of lawsuits that can be filed with one plaintiff under the ADA before an investigation is triggered.  Alternatively, we could adopt requirements that prioritize injunctive relief over attorney’s fees or damages.  Such requirements would force parties to engage with each other and would reduce the number of businesses that can be subject to “drive-by” lawsuits.  Further, injunctive relief under the ADA would be consistent with the goals of truly achieving accessibility.  At the very least, if the Reform Act moves forward, it should be amended so that the notice and opportunity to cure period is significantly shorter in order to lessen the burden that would be shifted to persons with disabilities.

Finally, when it comes to accessibility we would all do well to remember that accessibility is a universal issue, not just a disability issue.  For example, stairs are an accommodation to people who are capable of walking to move between floors.  Despite the frustration of these “drive-by” lawsuits, the fact that these lawsuits exist serve as a reminder that we must continue the push for improving accessibility for all people.  With increased accessibility, there will be less opportunity to take unfair advantage of laws like the ADA.

Nicholas Stone graduated from Boston University School of Law in May 2018.  He plans to practice in Portland Oregon.

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