Of Mosquitoes and “Moral Convictions”: How Rolling Back the Affordable Care Act’s Contraceptive Mandate Jeopardizes Women’s and Children’s Health

By Linda C. Fentiman

December 5 is the deadline to submit comments on the Trump Administration's recent action to gut the Affordable Care Act’s contraceptive mandate, which requires employer-sponsored health plans to ensure women's access to free, effective contraception.  This decision, announced in October in two Interim Final Rules, threatens serious harm to American children, because of the risk that women who lack access to contraception will become pregnant, contract Zika, and unwittingly transmit the virus to their developing fetus.  Since 2015, as an exponentially expanding Zika epidemic swept across Latin America, the United States, and its territories, thousands of children around the globe have been born with microcephaly.  On the U.S. mainland alone, almost 100 children have been diagnosed with microcephaly or other Zika-associated birth defects.   In Florida, the Department of Health has recently reported a new, sexually transmitted, case of Zika in Miami-Dade County.  In 2017 alone, 225 cases of Zika infection were confirmed in Florida; 119 are pregnant women, and three infants have been born with congenital Zika syndrome.  New York City, more than 400 pregnant women have been diagnosed with Zika since January 2016 and at least 20 infants have been born with microcephaly or other Zika-associated birth defects.

             The World Health Organization, Centers for Disease Control (CDC), and other health agencies have scrambled to reduce Zika’s threat by controlling the mosquito population and minimizing the risk of sexual transmission of Zika.  The CDC have been particularly outspoken, urging women of reproductive age to consider Zika’s risks to a developing fetus when deciding whether to travel to a Zika-affected area and, indeed, whether to become pregnant at all.

    In the face of such a dangerous disease, the Trump Administration’s drastic action to limit contraceptive access is both short-sighted and flawed legally.  The Administration announced two new regulations in October authorizing expanded exemptions and accommodations for employers, universities, and other health plan sponsors who wished to deny women free access to FDA-approved contraception, based on the plan sponsor’s religious beliefs or “moral convictions” (82 Fed. Reg.47658 and 82 Fed. Reg. 47838).   No exemption or accommodation was provided for plan sponsors seeking to opt out of any other health care service.  These new rules make it quite likely that many, especially poor and middle-income, women, will be denied access to effective contraception.  While the Fact Sheet accompanying the regulations states that low-income women whose employers opt out may seek contraceptive care through community health centers it conveniently ignores the fact that pending Republican legislation seeks to dramatically reduce federal funding for family planning services, including contraception, and that Republican efforts to repeal the Affordable Care Act would have authorized states to deny Medicaid recipients coverage for such services.

            With infectious diseases like Zika, citizens expect government to take direct steps to minimize the chance of disease transmission and to advise them about how to protect themselves.  Those most at risk for contracting the Zika virus are, as usual, the poor, who live in substandard housing that fails to protect them from mosquitoes and lack financial and other resources to access effective healthcare, including contraception and abortion.  Further, in states like Florida and Texas, even women and girls with financial means are frequently prevented from obtaining the full range of reproductive health care by restrictive federal and state laws governing access to contraception and abortion.

Recent natural disasters compound the problem. Puerto Rico provides a striking example of the intersection of legal and economic barriers; similar problems exist in Florida and Texas.  In Puerto Rico, two-thirds of all pregnancies are unintended; recent rates in Florida and Texas were 58% and 56%, respectively. Like their counterparts on the mainland, many Puerto Rican women, both married and single, want effective contraception, especially long-acting reversible contraception (LARC), such as IUDS and hormonal implants, which prevent pregnancy most effectively.  However, until the ACA contraceptive mandate became law, LARC was out of reach for almost all middle-class and poor women because of its higher upfront costs. 

Today, Puerto Rican women of all economic strata face significant hurdles in controlling mosquitoes and accessing healthcare, due to Hurricane Maria’s massive destruction of island infrastructure.  Yet even before the hurricane struck, women living in Puerto Rico were at high risk of contracting Zika and of being unable to plan for the birth of a healthy child.  Since December 2015 more than 34,000 people have been infected with Zika in Puerto Rico, more than 3,300 of them pregnant women. Nearly 150 infants have been diagnosed with serious Zika-associated birth defects.

  Officials from the CDC and Puerto Rico's Department of Health have worked over the last two years to increase public awareness of the risks posed by Zika, expand access to effective contraception, and minimize Zika transmission to pregnant women.  However, since Hurricane Maria, efforts to combat Zika have largely stalled, as both federal and Puerto Rican government officials have focused on other pressing needs - food, safe drinking water, electricity, and other infrastructure repair.

In the face of recent natural disasters, the Trump Administration’s decision to gut access to contraceptive coverage threatens a public health emergency of immense proportion, risking the health of vulnerable women and children. At the very moment that women in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands are in the greatest need of government assistance due to devastating hurricanes, the Administration has erected major barriers to contraception and effective family planning, limiting the ability of women and their families to make informed decisions about the risks of bringing a potentially disabled child into the world.  This directly contravenes the Affordable Care Act’s command that “the Secretary of Health and Human Services shall not promulgate any regulation that-- (1) creates any unreasonable barriers to the ability of individuals to obtain appropriate medical care; or (2) impedes timely access to health care services….” (42 U.S.C.A. § 18114).

While the Administration asserts that its new contraceptive coverage policy is necessary to preserve the religious freedom and moral convictions of employers and other health plan sponsors, its promulgation of two Interim Final Rules that limit only women’s healthcare access displays an utter disregard for the constitutional guarantees of equal protection, due process, and personal privacy.  Finally, the decision to publish these controversial regulations as Interim Final Rules, with no opportunity for public notice and comment before they go into effect, contravenes the essential requirements of agency rule-making in a democracy. 

Everyone committed to gender equity, access to preventative health care, and protecting the public from infectious diseases should consider commenting on the Interim Final Rules before the December 5 deadline.  Here is the link:  https://www.regulations.gov/comment?D=CMS-2014-0115-13773

Briefly: Some Interesting Public Health Law Moves in Massachusetts

As you enjoy a very nutritious helping or two of Thanksgiving dinner this week, here's some interesting happenings in Massachusetts public health law for you to chew on (haaa).  

By Elisabeth J. Ryan

This week, the Commonwealth of Massachusetts became the first state in the nation to ensure that most health insurance plans cover birth control without cost-sharing to patients.  Technically, this provision already exists federally in the still-good-law Affordable Care Act.  However, in October, the federal government issued rules to roll back that requirement by allowing any employer to avoid such coverage by invoking religious or moral objections to contraception. The Massachusetts law still contains religious exceptions, including for churches and "qualified church-controlled organizations" as employers; it also does not cover any employers who insure themselves and are thus subject solely to federal, rather than state, regulations.  This law was intended as a direct rebuke to Trump and his Cabinet; the fact that it was drafted, passed, and signed within a matter of weeks is actually quite a remarkable feat for the Massachusetts state government.  Both the health insurance industry and the reproductive rights community supported the bill and helped to negotiate the resulting language.  In addition to the birth control access without cost-sharing, the bill also expands coverage by allowing a one-year supply of birth control pills, by increasing the types of birth control covered, and by covering the so-called “morning after” pill without a prescription. 

Massachusetts also took a significant step toward criminal justice reform recently when both branches of the legislature passed comprehensive bills addressing issues like repealing mandatory minimum sentences for drug crimes and considering 18-year-olds juveniles rather than adults.  While now in reconciliation talks, one provision that went mostly unnoticed in both bills would require prisons and jails to offer approved substance use disorder medication to inmates.  Currently, the only medication-based treatment available to inmates is Vivitrol, a monthly shot that “blocks” opioid receptors in the brain.  And even that shot (provided for free from a drug company accused of questionable tactics), is given to inmates only immediately pre-release.  Though a recent study suggests that Vivitrol is an effective treatment for opioid use disorder, the corrections system currently prohibits use of established medications like buprenorphine (Suboxone) and methadone, even for inmates who have valid prescriptions upon incarceration.  Corrections officials object to changing that status quo, claiming that such medications are simply contraband that would “caus[e] people to be assaulted. It’s causing people to have hits put on them.”  Yet knowingly withholding effective treatment from inmates in a state with one of the highest opioid-related death rates in the country because unauthorized use of medicine could cause security issues not only ignores the public health implications, but it assumes a controlled medical approach to such treatment would fail without actually trying it. The Commonwealth’s neighbors in Rhode Island instituted medication-assisted therapy in their correctional institutions last year and, at least anecdotally, have actually seen a reduction in contraband. 

GOP Tax Bill Would Inflict Real Pain on Nonprofit Hospitals [From Philly.com]

By Robert I. Field

Nonprofit hospitals have had much to fear from Congress recently. The Senate came within one vote of repealing much of the Affordable Care Act, which would have left millions of patients uninsured and unable to pay for hospital care. And Congress may soon consider major cuts to Medicare and Medicaid, which could slash reimbursement for many hospital services.

Now, nonprofit hospitals face a new threat in the tax reform plan unveiled recently by House Republicans. Nonprofit hospitals include most of the largest and most prestigious ones in the Philadelphia area.

Like all major tax changes, the Republican proposal would create winners and losers.  Some of those winners and losers had been expected, but the changes that put nonprofit hospitals in the loser’s column came as a surprise. They would be in for significant hits in at least two ways.

First, they would lose an important source of financing for expansion. Nonprofit hospitals raise money for construction projects by issuing tax-exempt bonds that allow investors to avoid paying tax on the interest. This reduces the interest rates they have to pay to attract investors, which saves them large amounts in project costs. The tax plan would eliminate the exemption for interest on many of these bonds, which would force the hospitals to pay prevailing market rates. For many of them, major new construction could become unaffordable.

Second, they stand to lose many of their donations. Donors to nonprofit hospitals receive a tax deduction for their contributions but only if they itemize deductions on their tax returns. Itemization is worthwhile only if deductible expenses add up to more than a standardized amount. The tax plan would raise that amount to almost double its present size —  $12,200 for individuals and $24,400 for couples — which would take away the benefit of itemizing for many. Without itemizing, the tax incentive for making smaller donations would disappear.

Tax-exemptions for bonds and donations are benefits that for-profit hospitals do not enjoy. In that regard, the changes would put nonprofits and for-profit facilities on a more equal footing. But for-profit hospitals can raise money by issuing stock to private investors, a funding source they rely on extensively. Nonprofits have no stock to sell, so the proposed changes would put them at a significant disadvantage.

On top of these threats, some in Congress, as well as President Trump, would like to add a provision to the tax plan repealing the individual mandate under the Affordable Care Act. The Congressional Budget Office estimates that this would cause 13 million Americans to lose coverage over the next 10 years. Without insurance, these people would lack the means to pay for hospital care.

And if a tax bill were followed by cuts to Medicare and Medicaid, the financial losses for many hospitals would be substantial.

Tax reform has been billed as a way to stimulate economic growth. But for one major industry that serves as a major source of employment, not to mention its role as a guardian of our lives and health, it would do just the opposite.

Generic Drugs and the PTAB

By Gregory Curfman, MD

When the Hatch-Waxman Act was passed into law in 1984, it established the generic drug industry and thereby forever changed the marketplace for prescription drugs. Today 80% or more of all prescriptions are filled with generic drugs, which has resulted in a savings of $1.67 trillion from 2007 to 2016. To incentivize generic drug entry into the market, the Hatch-Waxman Act provides that the first generic company to submit an Abbreviated New Drug Application (ANDA) will have the exclusive right to market its drug for 180 days. This provision, referred to as “first to file,” provides a strong financial inducement to file an ANDA early.

Generic drug manufacturers may seek FDA approval before expiration of patents protecting the brand-name product if they can establish that one or more of the patents is invalid, which may be done by filing a lawsuit in federal court. To provide a second pathway for challenging patent viability, and thereby effect the withdrawal of patents that fail tests of novelty or non-obviousness, in 2011 Congress passed the Leahy-Smith America Invents Act (AIA), which first established the process of inter partes review (IPR), an administrative procedure whereby the United States Patent and Trademark Office (USPTO) may reconsider the validity of a patent it previously granted. To conduct IPRs, the USPTO created the Patent Trial and Appeal Board (PTAB), an administrative board within the USPTO comprising administrative patent judges who, without involving juries, make determinations about patent viability. To expedite the review process, the PTAB is expected to make a judgment within one year of hearing a case. As of July 2017, more than 7000 petitions for inter partes review were filed, and the PTAB issued final decisions invalidating more than 1300 patents. Consequently, this second pathway of review, which involves administrative and not judicial review, may significantly accelerate entry of a generic drug into the market when it is successfully used to invalidate a patent on a brand-name product. 

On November 27, the Supreme Court will hear oral arguments in Oil States Energy Services v. Greene’s Energy Group, a case in which the constitutionality of the PTAB is being challenged. The petitioner argues first that Article III does not authorize the PTAB, as established by the USPTO, to reconsider the validity of patents that have been previously issued by the agency. The petitioner further argues that PTAB inter partes review violates the Seventh Amendment because patents are tantamount to private property and juries are not involved in the PTAB review process as, the petitioner argues, would be required under the Seventh Amendment.

The respondent argues that reassessment of a previously granted patent by the USPTO is consistent with the principle that patent rights are privileges bestowed by the government and that they may be revoked by administrative review (without the involvement of an Article III body). In short, the respondent claims that issuance of patents is a matter of public rights that reconsideration of previously issued patents may be properly performed by an administrative agency without the requirement of juries.

The outcome of this case will be quite important for the regulation of prescription drugs. Should the Court find that PTAB was unconstitutionally established, this would remove an important pathway by which generic drugs currently move efficiently to the marketplace. The remaining pathway, the federal court system, is a slower route to generic market entry, which could have the important result of raising prescription drug costs for consumers, which are already especially difficult to afford by lower-income citizens.

For the purpose of keeping this post concise, I have intentionally omitted many important details relevant to the arguments in this case, but I hope the general concepts are clear. Though I tend to believe that the respondent will prevail in this case, I would be interested in hearing from others who are more expert in intellectual property law and are following this interesting case.

CT Court Rules that State Cannot Vaccinate Children in its Temporary Care Without Parental Consent

By Elisabeth Ryan

The Supreme Court of Connecticut has, for the second time in three months, ruled that the state Department of Children and Families cannot vaccinate children in its custody without explicit parental consent.  News outlets have proclaimed in alarmist headlines that “State Can’t Vaccinate Kids in Temporary Custody,” but that’s untrue – Connecticut can continue to vaccinate children in its temporary custody, as long as the parents agree.  The state is not actually prohibited from vaccinating any and all children in its custody, but the decision is still concerning from a public health perspective.

In April of 2016, the Connecticut Department of Children and Families took temporary custody of two young children - ages one and two years - after their parents were arrested.  After a judicial finding of neglect, the trial court authorized an agreement between DCF and the parents that would keep the children in state custody temporarily, with an ultimate goal of reunification with the parents.  But the parties differed on one issue: whether DCF could vaccinate the young children according to its usual practice.  The parents objected to vaccinations, citing unspecified religious beliefs.  After an evidentiary hearing, the trial court ruled that DCF could vaccinate the children and that the state’s statutory vaccination requirement exemption for religious beliefs did not apply while the children were in the state's custody.

On appeal, the parents argued that DCF only has statutory authority to provide "medical treatment" to children in its custody and that vaccinations are not "medical treatment" because they are preventive, not curative.  The Supreme Court of Connecticut agreed, holding that the statutory phrase “medical treatment, including surgery, to insure the continued good health or life of the child…” was ambiguous, but that its legislative history referred to emergency medical care, which therefore excluded vaccinations. 

DCF petitioned for the court to re-consider its ruling, which it did.  On re-hearing, DCF argued that the statute it had originally – and apparently mistakenly - relied on (General Statutes § 17a-10 (c)) was not proper because it applied to minors in juvenile detention,  Rather, DCF argued that it should have should have based its case on General Statutes §§ 17a-93 and 17a-98, which “confer broader guardianship authority.”  The court last week quite bluntly rejected this request, calling it “simply…a means for giving the losing party a second chance to try a new argument.”

The concurring opinion – written by the Chief Justice and joined by 4 of her 6 colleagues – went beyond the procedural denial of relief and added that the statutes DCF urged the court to consider would likely be unconstitutional in this context, as DCF’s custody was explicitly temporary and the parents still have the right to make decisions for their children.  Further, by enacting a law allowing a religious exemption to vaccinations, the Connecticut legislature has indicated such a choice is an important public policy interest.

So even though this was a clear case of statutory interpretation, the Supreme Court of Connecticut has indicated that the case to vaccinate the children in temporary state custody would also fail on constitutional grounds, at least based on existing statutes.  The decision as it stands likely does not affect many cases and the legislature is, of course, free to strengthen public health by changing the statutory language.  The court’s indication that such a statute would be unconstitutional is much more concerning and could have larger implications, but it remains an issue that is not yet a reality.

Smart Gun Technology and the Potential to Save Lives

By Elisabeth J. Ryan

In the 1970s, a California man designed a magnetic lock that could be installed in the revolvers used by law enforcement, rendering the gun inoperable unless the user was wearing a special ring with an opposing magnet.  This device, designed so that someone who grabbed a police officer’s gun would not be able to turn that gun back on the officer, represented the first “smart gun” technology (and can still be purchased today for a mere $420). Beginning in the 1990s, technology entrepreneurs and even gun manufacturers began to develop more sophisticated firearm technology designed to “prevent shootings, both intentional and unintentional, by children, thieves, and other unauthorized users.” But developers faced vehement opposition, not from anti-gun activists pursuing a once-vocal push for individual disarmament but from very loud and very angry gun rights activists. Technology development withered.  Both Colt and Smith & Wesson abandoned federal grants for such projects after suffering a “revenue-crushing boycott” from their customers because of the research. Of course, the mere fact that the federal government administered such grants led some to question whether the money for public safety technology improvement was really “a smoke screen to eventually take all handguns that are not smart guns out of the hands of law-abiding U.S. citizens...”  

Fifteen years and more than half a million American gun deaths later, the owner of Maryland gun shop “Engage Armament” planned to offer the Armatix iP1 for sale in 2014. This particular model looks a little sleek and futuristic, but otherwise seems like any other basic .22 LR caliber handgun with a 10 round magazine. But unlike all the other handguns on the Engage Armament shelves in May of 2014, the Armatix iP1 comes with a wristwatch. And unless the person who handles that firearm also wears the accompanying wristwatch, the weapon will not fire. The Armatix iP1 represents the first retail-ready “smart gun,” a term used to describe “firearms equipped with small embedded computers that are supposed to enhance safety by preventing anyone other than authorized parties from firing the weapons and, in some cases, by ensuring that the guns only fire when aimed at inanimate targets.” Engage Armament’s owner, Andy Raymond, thought that selling the Armatix “smart gun” would expand the firearms market to people otherwise unwilling to own or handle conventional guns.  He called the ideal new customer “a lawyer in Georgetown with a high income and young children who has been on the fence about getting a gun because of safety fears.” But before he could even stock the German pistol for sale, protesters bombarded his shop with complaints and even death threats. A California shop also endured a “furious backlash” when it (briefly) put Armatix models on its shelves. Both shops quickly reneged on their initial plans to sell Armatix guns.  

The fear that “smart guns” will replace all conventional handguns is actually somewhat based in reality.  In 2002, New Jersey passed the “Childproof Handgun Law,” which required that the state Attorney General determine annually whether “personalized handguns” are available for retail sales purposes… [meaning that] at least one manufacturer has delivered at least one production model of a personalized handgun to a registered or licensed wholesale or retail dealer in New Jersey or any other state.” And 2.5 years after that determination, New Jersey must prohibit the sale or transfer of any handgun other than a “personalized handgun or an antique handgun.” Originally, lawmakers intended to further “the development of personalized handgun technology and reduce[] preventable gun deaths.” But in 2002, “smart guns” were merely a conception, the niche of a small number of tech companies; in 2014, they were a reality.  And with that reality has come the heightened intense criticism.  Suddenly, this obscure state law was being viewed as an apparent “gun control push.” Curiously, the New Jersey AG has declared that the Armatix iP1 does not fit the law’s definition of a “personalized gun,” so its sale would not trigger the prohibitive law. 

Loretta Weinberg, the New Jersey state senator who sponsored the Childproof Handgun Law, now concedes that it has hindered rather than encouraged the development of “smart gun” technology. In 2014, Senator Weinberg offered to repeal the mandate if the National Rifle Association publicly agreed “not to stand in the way of the technology.” And though it didn’t happen immediately, the NRA has officially stated that it “doesn’t oppose the development of ‘smart’ guns...[but] opposes any law prohibiting Americans from acquiring or possessing firearms that don’t possess ‘smart’ gun technology.” True to her word, now-State Senate Majority Leader Weinberg filed a bill that removed the provision mandating “smart gun” sales only and instead mandated every dealer in the state to stock smart guns (once available) as part of their inventory. And though the bill passed both houses of the state legislature, Governor Chris Christie issued a “pocket veto” in January of 2016 by refusing to sign it. Though not unexpected because Christie was still in the midst of a failing presidential campaign, Weinberg nonetheless called the pocket veto “a little mystifying, because…he keeps the current law on the books, which is much more stringent.”  

In December 2015, a Johns Hopkins survey showed that 60% of Americans would be willing to buy a smart gun if they were in the market for a new handgun. One former San Francisco police chief declared that he wanted his officers to be able to carry smart guns and even offered up his department as a potential pilot site for using the technology. Some estimate that the market for smart guns could be worth $1 billion. Yet despite these potentially very lucrative new markets and the New Jersey AG’s declaration that the Armatix model will not trigger the maligned law, the opposition to (or fear of) selling smart guns seems to persist.  In March 2016, I enlisted the help of friends and family across the country to contact 35 (mostly randomly selected) gun shops in California, Connecticut, Florida, Kansas, Massachusetts, Missouri, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Virginia, and Washington state. Not a single shop reported carrying Armatix models. One shop in Oregon offered to special order it, but warned that the price was “prohibitive.” A Connecticut gun shop passionately declared that it would “NEVER carry that type of gun… [and] that there are no smart guns.” A Washington state store “basically laughed [the caller] off the phone [and] made it clear she would not be carrying anything ‘like that’ in her store.” Another major national retailer in Connecticut stated flatly that it “won’t carry smart guns.” One retailer in Virginia told the caller that Armatix fires correctly “only 3 out of ten tries” and a Pennsylvania shop called the brand a “failed pipe dream.” Yet the Massachusetts Gun Control Advisory Board* certified the Armatix iP1 as meeting the state’s stringent statutory requirements, after an approved testing lab showed that the gun fired “the first 20 rounds without a malfunction [and] fire[d]…600 rounds with not more than six malfunctions.” Massachusetts has approved the model for sale in the Commonwealth, though apparently no dealers sell it.  Most retailers contacted indicated they had never heard of Armatix.

As of April 2015, only one person in the United States seemed to be selling Armatix: Doug, located somewhere in Nebraska, proprietor of “smartgunz.com.”  He wanted to keep his website, through which he legally sold Armatix models to other federally-licensed firearms dealers in other states, separate from his “brick and mortar business” and therefore declined to disclose his last name in the press.  But within hours, the pro-gun website “The Truth About Guns” outed Doug’s real identity and the name of his small shop, while simultaneously alluding to the “negative feedback” that the prior publicly-known Armatix sellers endured.  Smartgunz.com is now defunct.

Arizona, in April 2017, passed a law intended to preemptively ban a potential (albeit non-existent) “smart gun” mandate.  The state law prohibits requiring a person to use or be subject to “electronic firearm tracking technology,” defined as a device that uses “block chain” or a similar form of technology.  The sponsor of the bill explained that “he heard at a presentation at a conference that…the best way to regulate who can own and fire a gun is ‘block chain technology,’” so he wanted to ban it.  He claims the technology can “send out notifications if an unauthorized person tries to fire the weapon…’And that’s what I’m concerned about.’” While some have speculated that block chain technology – a sort of decentralized transactional system used primarily by digital currency companies like Bitcoin – could be utilized in smart guns, there is no evidence that any such product is even in development.  The fear that “smart guns” will one day mean the death of conventional firearms is so potent that Arizona enacted a law protecting itself against a non-existent mandate to use a non-existent technology.

Smart gun technology has not yet been perfected, due no doubt in part to the almost total lack of investment in the technology.  Recently, a hacker calling himself “Plore” succeeded in exposing security vulnerabilities of the Armatix model iP1 by extending the range of the watch’s radio signal and even disabling the locking mechanism with $15 worth of magnets. He went so far as to demonstrate exactly how to disable the safety features on a YouTube video, claiming that he isn’t opposed to smart gun technology, but that “If you buy one of these weapons thinking it’ll be safer, it should be… [The Armatix gun] really failed to live up to its side of the bargain.” 

Armatix has recently developed a prototype 9mm pistol – the iP9 – that can be activated with both the wristwatch and with an app, which would work at an unspecified “longer range” than the watch.  The model also provides an alternative unlocking model: the pistol grip acts as a sort of PIN pad. An authorized user “can unlock the gun by squeezing their fingers in sequences, which will enable the weapon to be fired until the same code is re-entered to turn it off.”  The company hopes that this model, more similar to what most law enforcement agencies already carry, will convince police and consumers who may have been skeptical of reliability to try the firearm. The company recognizes that getting law enforcement on board with using smart gun technology would likely lead the way to more widespread trust and interest. The company has also learned to emphasize that its products are “not here to replace other guns.” The Armatix iP9 was expected to be on the market sometime in 2017 but has not yet appeared.

The market does have some other “smart gun” technology available.  Kodiak Industries sells the “Intelligun,” which is not an independent firearm, but “a fingerprint-based locking system” that installs on any model 1911 handgun and will “unlock the firearm for operation immediately for authorized users.” iGun Technology Corporation has developed (though does not yet sell) a shotgun that operates only in the presence of a specially-equipped ring. Yet investment in these and other smart gun technology has remained virtually non-existent, even as the rest of technology has advanced exponentially since the 1990s.  The pro-gun lobby often espouses that smart gun technology is unproven yet it also opposes investment in research that could improve the technology.

In January 2016, President Barack Obama quipped that guns should have fingerprint recognition capability if his cell phone does and ordered federal government agencies to “conduct or sponsor research on digital devices that would reduce gun accidents and unauthorized use.” Three months later, the Departments of Justice, Homeland Security, and Defense announced a partnership with numerous law enforcement agencies at all levels of government to create “baseline specifications” to “outline…a clear description of what law enforcement expects from smart gun technology, particularly with regards to reliability, durability, and accuracy.”  By recognizing that buy-in to smart gun technology from the law enforcement community was vital to its continued existence and development, the Obama administration made a bold step towards encouraging investment in safer gun technology.  In November 2016, the National Institute of Justice released the “Baseline Specifications for Law Enforcement Service Pistols with Security Technology,” which reflected law enforcement concerns about allowing security access by more than one person, not increasing the time required to draw and fire, and defaulting to a “fireable” state if the security device malfunctions.  Undoubtedly due in large part to releasing the report at the time when the Obama administration was giving way to the Trump administration, no action has come of the reports. Some technology innovators initially expressed skepticism about whether Obama’s directive would lead to a viable market, partly because their presumptive consumer base remained so vocally hostile to the idea. Now almost two years later, their skepticism seems justified.

Despite the current dearth of financial support for the “smart gun” industry, this advancing technology could hold promise in reducing the number of gun deaths – more than 33,000 in 2014 – in the United States.  As some critics are quick to point out, smart guns obviously are not a panacea for America’s grossly disproportionate gun deaths. But with improved technology, clarified laws, and an adjusted attitude that no longer treats smart guns as a potential “Trojan horse for gun grabbers,” “smart guns” could hold the potential to reduce at least some of these appallingly high rates of gun deaths in the U.S. 

*In the interest of full disclosure, I served as counsel to the Massachusetts Gun Control Advisory Board at the time the Armatix model was approved.  I was not a voting member and have never had any financial interest in Armatix or any other related entity.

Navigating Minor Consent Laws Toward Confidential PrEP Access for Adolescents

By Jason Potter

According to the CDC, as of 2015, youth ages 13-24 comprised a staggering 22% of all new HIV infections in the United States. Given this alarming incidence rate, developing new and effective HIV prevention modalities for adolescents and young adults, and eliminating major delivery barriers, has become a priority. In the sphere area of biomedical HIV prevention for at-risk adolescents, one legal barrier looms large. The issue of caregiver consent (or the less inclusive “parental consent”) forms an oppressive threshold barrier to operationalizing biomedical HIV prevention among at-risk adolescents under the age of majority.   

Pursuant to laws in every U.S. jurisdiction, the majority of youth in the United States from ages thirteen to eighteen (“minors” or “adolescent minors”), a critical population in the fight against HIV, are unable to operate independently of their parents, guardians, and other adult caregivers in most healthcare decisions. The general rule, typically established by state statute, is that minors cannot legally consent to decisions about health and welfare that require an understanding and weighing of risks and benefits. State laws shift that responsibility to a third-party caregiver (which may include a parent, blood and non-blood relative, foster parent, conservator, or the state). Caregiver consent, although desirable in many contexts, can have devastating consequences in matters of sexual healthcare. The California Supreme Court has noted that “there is a considerable risk that minors will postpone or avoid seeking needed medical care if they are required to obtain parental consent before receiving medical care for such conditions”. One vexing legal issue in HIV-related care for adolescents is ensuring their medical privacy. The necessary foundation of confidential care for adolescents is access without caregiver involvement.

In an effort to protect the health of minors in situations where they would sooner forgo treatment than secure the consent of a parent or guardian, lawmakers have passed laws acting as exceptions to the general rule that minors may not make their own healthcare decisions. These exceptions (“minor consent laws”) permit sensitive healthcare decisions without adult consent and, in some instances, further secure the privacy of minors by permitting providers to forgo parental notification.  On the state level, minor consent laws are a major basis for a minor’s confidential receipt of necessary medical care that would otherwise be obfuscated by parental involvement.  

“HIV pre-exposure prophylaxis” (“PrEP”) is necessary a necessary tool in the fight against HIV among at-risk minors. PrEP is a multidimensional prevention therapy involving periodic diagnostic testing, counseling, and the prophylactic use of an antiretroviral (“ARV,” traditionally used to treat HIV infection) as a means to prevent it. Truvada (a well-established ARV manufactured by Gilead Sciences) was the first ARV to receive FDA approval for a PrEP application. Truvada as PrEP has an efficacy in adults of over ninety percent when used as prescribed. In light of its preventive potential, oral PrEP has been embraced by the public health community, and implementation is under way across the United States among at-risk adults. Although the therapy is currently indicated for adult use only and only one published study of the safety and efficacy of PrEP for adolescents currently exists, clinicians may prescribe Truvada as PrEP to at-risk minors off-label. However, confusion about the patchwork of consent laws abounds, and there is very little guidance available to clinicians and advocates about the legal and policy dimensions of PrEP access.

In this webinar for NASTAD, part of the 2017 NASTAD PrEP Financing and Access Series, I explore the consent dimension of PrEP access for adolescent minors. Toward the end goal of facilitating confidential PrEP for at-risk minors, I develop a framework for navigating variations among the patchwork of minor consent laws in the 50 U.S. jurisdictions (and the District of Columbia) and identify inroads to confidential PrEP access in them.

The power to consent to PrEP, and other future HIV prevention modalities, has remarkable potential to change the course of HIV incidence among youth. Giving at-risk adolescents the power to consent to PrEP helps embolden them to take charge of their health, safeguard their future, and protect each other.

Making America Healthy Again: Analyzing Trump's Take on the Social Determinants of Health [from Health Affairs Blog]

George Consortium member and Northeastern University professor Patricia Illingworth concludes on the Health Affairs Blog that the Trump administration shows "little interest in addressing the social determinants" of health, such as "education, socioeconomic status, poverty, the physical and social environment, employment, and discrimination, among others..."  

___________________________________________________________

Access to health care is critical for the health of individuals and for the well-being of the community, but health depends on more than medical care. Studies show that the social determinants of health, including education, socioeconomic status, poverty, the physical and social environment, employment, and discrimination, among others, are at least as important for health as is medical care. It is worth considering where the new administration stands with respect to the social determinants of health. President Trump’s budget, perhaps the best indication we have of his administration’s priorities, unfortunately appears to show little interest in addressing the social determinants.

The President’s Fiscal Year 2018 budget request, proposed back in May, targeted many of the social factors that impact health, slashing funding for education, energy, the environment, housing and urban development, among other social sectors. If the social determinants of health are underfunded, however, people’s need for health care will increase. As a result, these cuts would hurt the health and well-being of people living in the United States and would drive up the cost of health care. Take, for instance, the connection between education and health. According to economists David Cutler and Adriana Lleras-Muney, four extra years of education reduces the risk of heart disease by 2.16 percentage points and the risk of diabetes by 1.3 percentage points. People with more education are also less likely to smoke, drink excessively, use illegal drugs, or be overweight.

In a recent study published by the Brookings Institution, Princeton University economists Anne Case and Sir Angus Deaton show that “deaths of despair”—those associated with drugs, alcohol, and suicide—have risen significantly among middle-aged white non-Hispanic Americans without a college degree. In this respect, the United States is unique among the affluent nations Case and Deaton compare. They largely attribute this rise to a decrease in work opportunities for people with lower levels of education. Trump’s proposed budget, rather than boosting education and training, cuts funding for the Department of Education by 13 percent and for the Department of Labor by 21 percent. It also reduces funding for before-school, after-school, and summer programs by over $1.2 billion.

Living conditions also impact health. Asthma has been found to be the leading cause of children’s visits to emergency rooms, hospitalizations, and school absenteeism. Exposure to parasites and infectious agents, air pollution from vehicles, and the construction of buildings with poor circulation and little fresh air are among the causes of asthma in children. Not surprisingly, asthma is more prevalent in poor and minority communities. There is also evidence that public housing is itself a risk factor for asthma. Instead of increasing support for housing, Trump’s budget proposes a 15.2 percent reduction to housing assistance over a 10-year period.

The burden of the proposed budget’s assault on the social determinants of health will be borne primarily by the poor, but not only by them. Because people are social, the health of one person can impact the health of many people in a community. Health has some of the qualities of a public good. People are social; they flourish in the company of others. Their health is affected by the health of others and it affects the health of others. Contagious diseases are one example of how the poor health of one person can affect the health of others. Herd immunity demonstrates how the good health of some confers health benefits on others. To put it differently, health has a spillover effect.

Studies show that people are healthier when incomes are relatively equal, when early education is high-quality and accessible, and when poverty is low. For better or for worse, our health depends upon the health of other people, and their health upon ours. Unless we are prepared to live solitary lives, policy that affects the social determinants of health must contend with the inextricable connection between our health and the health of others.

Given the social dimensions of health, failure to ensure the health of all people with, for example, enriched educational opportunities and adequate housing and social programs, puts everyone’s health at risk. There are important social justice reasons for promoting the social determinants of health. But one need not care about justice and ethics to want to provide for the health of others. Self-interest speaks for itself. In this case, the message is loud and clear: ignore the health of others at your peril.

American Beverage Association v. San Francisco: When the First Amendment Jeopardizes Public Health

By Micah Berman, Wendy E. Parmet, and Jason A. Smith

Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public.  This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.

American Beverage Association concerned a challenge to a 2015 San Francisco ordinance requiring certain advertisements of sugar-sweetened beverages (SSBs) to display over at least 20% of the area of the advertisement a warning stating: “Warning: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”  

In support of the mandate, the city cited recommendations by the World Health Organization, the American Dental Association, and the American Heart Association that people limit their intake of added sugar, and noted that “sugar-sweetened sodas and fruit drinks containing less than 100% juice by volume, are major sources of added sugars in American diets…” The city further noted that the USDA had concluded in 2015 that consumption of added sugars was associated with obesity, type 2 diabetes, cardiovascular disease and dental caries.

Before the ordinance could take effect, the American Beverage Association (ABA), the California Retailers Association and the California State Outdoor Advertising Association, brought a First Amendment challenge in federal court. In May 2016, Judge Edward Chen rejected the plaintiffs’ request for a preliminary injunction, finding that they were not likely to succeed on the merits. As the district court noted, under the Supreme Court’s decision Zauderer v. Office of Disciplinary Counsel of Supreme Court, laws that compel commercial speakers to disclose factually accurate information are subject only to rational basis review. Responding to the plaintiff’s argument that Zauderer as well as Ninth Circuit precedent permitted rational basis review only when regulations were not controversial, the district court explained that “the ‘uncontroversial’ requirement should not be read expansively to mean something beyond accuracy. …” The court then went on to review the extensive evidence establishing the health dangers of SSBs, and determined that the warning was factually accurate and rationally related to protecting public health.

On appeal, the plaintiffs argued that the district court misinterpreted the Zauderer test and that under the correct approach, the court must consider whether warnings are controversial, non-factual, and unduly burdensome. Plaintiffs further argued that the lower court read the requirement that warnings not be controversial too narrowly. The Ninth Circuit agreed with the ABA on all three points – all of which are deeply problematic for public health.  To briefly summarize:

Controversial:  At the outset, the court (correctly) recognized that “‘uncontroversial’ in this context ‘refers to the factual accuracy of the disclosure…’”—i.e., whether or not the facts are reasonably in dispute.  There is no real scientifically valid dispute that sugary beverages do indeed “contribute to obesity, diabetes, and tooth decay.”  Thus, this issue should have been easily resolved in the City’s favor.  But, the court instead concluded that the City’s message was “controversial” because added sugars do not contribute to obesity or diabetes in all cases.  It accepted the ABA’s argument that only “overconsumption” is problematic.  Such nitpicking is perhaps explained by a failure to understand basic epidemiology (what “contributes to” means).  More broadly, though, the decision seems to accept the argument that the warning was “controversial” merely because beverage companies objected to having to carry it.  Thus the “uncontroversial” requirement is no longer limited to inaccurate statements, but rather applies as long as there is any objection to a warning. If this were the standard, of course, every warning or disclosure that a manufacturer did not want to convey would be “controversial.” 

Factual:  The court next concluded that the required warning was not “factual” because it implicitly suggested that “sugar-sweetened beverages are less healthy that other sources of added sugars … and are more likely to contribute to obesity, diabetes, and tooth decay than other foods.”  Thus, it concluded that the required warning was “misleading, and, in that sense, untrue.”  It used this example, supplied by the ABA:

If car dealers were required to post a warning only on Toyota vehicles that said: “WARNING: Toyotas contribute to roll-over crashes,” the common-sense conclusion would be that Toyotas are more likely to cause rollovers than other vehicles.

Putting aside the issue that added sugars in beverages may well be less healthy than other sources of added sugars, this is an inapposite example.  The City’s warning does not apply to a particular brand; it applies to all sugar-sweetened beverages.  A better analogy would have been a warning on cars that says “WARNING: Operating the audio system while driving increases the risk of an accident.”  Such a warning would not suggest that doing other things—like texting while driving—do not also pose a risk of distraction, or that engaging in other dangerous actions while driving would not also increase the risk of an accident. The First Amendment certainly surely does not require that compelled warnings be carefully contextualized and compared to all other hazards.   

Undue Burden:  Finally, the court ruled that the ordinance was “unduly burdensome” because the warnings would “overwhelm[] other visual elements in the advertisement.”  This decision is troublesome for public health, since other required warnings—such as those on smokeless tobacco products—are even larger.  The court went on to note that some beverage companies had suggested that they would stop advertising in San Francisco if the warnings went into effect, and that this “supports the [plaintiffs’] position that position that the disclosure requirement is unduly burdensome because it effectively rules out advertising in a particular medium.”  But the cases cited by the Ninth Circuit involved instances where it would have been literally impossible to comply with a warning required and still advertise in a particular medium.  Choosing not to advertise because one would rather not carry a warning is something entirely different, and—like the court’s reading of “controversial”—such a rule would effectively give regulated entities a veto over warning requirements. 

We have argued elsewhere that courts must consider the health impact of laws that regulate commercial speech in the name of public health. In making that assessment, professional expertise and scientific evidence should play an important role. Experts are often uniquely positioned to identify whether or not a law regulating speech may benefit or protect public health. As result, as the Third Circuit explained in a professional speech cases, legislatures “are entitled to rely on the empirical judgments of independent professional organizations that possess specialized knowledge and experience concerning the professional practice under review”.

American Beverage Association underscores the importance of allowing legislatures to rely on expert opinion, as well as the need for a more robust approach by courts for handling expert opinions.  Courts must be able to distinguish between scientific debate and established consensus. In finding that San Francisco’s proposed warning was controversial and factually misleading, the Ninth Circuit relied on statements by the FDA that added sugars are “generally safe” and “no more likely to cause weight gain in adults than any other source of energy.” The court also cited technical comments issued by the American Dental Association which stated in part “the evidence is not yet sufficient to single out any one food or beverage product as a key driver of dental caries.”

In relying on these comments to conclude that the warning was misleading and controversial, the Ninth Circuit failed to give respect to the city’s own health officials. The court also failed to appreciate he broad scientific consensus that SSBs contribute to the diseases cited in the warning, as well as the function of evidence within the regulatory process.  Equally troubling is the role that the food industry has in influencing both scientific evidence and regulatory systems. The food and beverage industries have been working consistently to fund scientific research that shifts blame from their products and have also been tireless in their efforts to hinder the FDA.  Given the Ninth Circuit’s conclusion that mandated warnings are unconstitutional as long as they are controversial, industry has yet more reason to fund and produce evidence that exonerates their products. In effect, the mere production of such evidence, no matter how scientifically questionable, may now restrict the state’s right to compel warning labels.

Although the court in American Beverage Association recognized that the protection of public health is a substantial state interest that may warrant restricting commercial speech in appropriate cases, its analysis placed new and possibly insurmountable obstacles on the regulation of commercial speech. By describing well-established scientific facts as “disputed policy views” or as “one-sided [and] misleading messages”—the court offered industry a blueprint for producing false controversy and striking down public health laws that are based on the weight of the evidence. The decision may yet be reviewed and reversed by the full Ninth Circuit en banc. The state’s ability to regulate commercial speech to protect public health may depend on what the full court does.

"Graham-Cassidy" Provides Zero Funding to Address the "Opioid Crisis"

By Elisabeth J. Ryan

One of the few positive provisions of the summer’s Senate “health care” bills was the inclusion of funding to states to “support substance use disorder treatment and recovery support services.”  With more than 30,000 people dying from heroin and painkiller overdoses in the United States every year, sufficient funding to address and effectively treat this issue is crucial.  Yet the latest Republican version of the “health care” bill has omitted this funding entirely.

The original Better Care Reconciliation Act included a $2B fund to distribute grants to states for fighting the “opioid crisis” and other substance use disorder issues; the “Cruz amendment” version significantly increased that amount to nearly $45B over nine years.  While even that amount would likely not have been sufficient to cover needs, the increase was hailed as a key provision aimed specifically at some Republican Senators still wavering in their support.  Yet the latest iteration – “Graham-Cassidy” – includes absolutely no such funding.  This glaring omission has received little attention, but it contributes to the bill’s overall potential to actually harm public health.  The bill would also make alarming cuts to Medicaid (which is one of the top insurers for substance use disorder services) and would also allow states to waive the current requirements that insurance companies not only cover substance use disorder treatment but also that they cover it without charging people higher premiums.  One analysis estimates that a person with "drug dependence" could face a premium surcharge of $20,000 per year.  

Without any funding added to the bill to offset those potentially devastating losses, treatment for substance use disorder will become either financially or practically impossible for the millions of people who may need it.  This lack of adequate, evidence-based, available treatment already constitutes a public health crisis - Congress may be poised to make it even worse.