Cross-Posted at HealthLawProf Blog
Nurse Kaci Hickox is a powerful reminder that states must carefully balance patient’s liberty interests when crafting appropriate, reasonable responses to potential threats to public safety.
Beginning with New York and New Jersey last Friday and now continuing with Illinois, Florida, Maine, and Virginia, states are issuing quarantine orders that exceed the CDC’s federal response. New York and New Jersey initially announced that individuals who had direct contact with a person infected with Ebola while in Liberia, Guinea, or Sierra Leone would be subject to a mandatory 21-day quarantine even if they showed no signs of infection.
Under this policy, New Jersey quarantined Maine nurse Kaci Hickox in a tent at University Hospital in Newark after she returned from caring for Ebola patients in Sierra Leone, even though reportedly she did not initially display any symptoms and subsequently tested negative for the disease. The American Civil Liberties Union demanded that Governor Chris Christie disclose how the state had determined that mandatory quarantine of healthcare workers was medically necessary and expressed its “serious constitutional concerns” regarding the policy. New Jersey quickly changed course, announcing that Ms. Hickox would be permitted to return home, subject to Maine’s home quarantine requirement.
Each state enjoys broad police powers to protect the health, safety, and welfare of those within its borders, which powers may include the authority to order quarantines to limit the spread of infectious diseases like Ebola. But individuals also have a constitutionally protected right not to have their liberty infringed without due process of law. Imposing a quarantine affects an individual’s freedom of movement. How can a state fulfill its duty to protect the health and well-being of its residents without violating individuals’ Fifth Amendment rights?
A state must carefully balance its legitimate public health concerns with the rights of individuals. Balance is the simple answer, though, and in practice, the answer is far more nuanced and difficult to identify.
In upholding a mandatory vaccination law against a substantive due process challenge in 1905, the United States Supreme Court in Jacobson v. Massachusetts recognized that courts may need to intervene to protect an individual where the state exercises its police power “in . . . an arbitrary, unreasonable manner, or . . . [goes] so far beyond what was reasonably required for the safety of the public.” A state must exercise its police powers reasonably and may not act arbitrarily.
Building on this concept of reasonableness, Professors David Fidler, Lawrence Gostin, and Howard Markel (abstract) have discerned four limits that courts have imposed on quarantine authority: The individual must be -
- Actually infectious or have been actually exposed to an infectious disease;
- Placed in safe and habitable conditions;
- Treated in a non-discriminatory manner; and
- Afforded procedural due process.
As explained by the United States Supreme Court in Mathews v. Eldridge, what procedural due process must be afforded individuals before they are quarantined is a fact-specific inquiry that generally requires the balancing of three factors: “First, the private interest that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute procedural safeguards; and finally, the Government’s interest, including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirement would entail.”
Some lower courts have analogized quarantines to involuntary confinement of mentally ill patients and adopted similar procedural due process protections. In Greene v. Edwards, for example, a 1980 per curiam decision, the Supreme Court of Appeals of West Virginia reasoned that because “involuntary commitment for having communicable tuberculosis impinges on the right to ‘liberty, full and complete liberty’ no less than involuntary commitment for being mentally ill,” the state must provide the same procedural due process protections in both situations, namely:
(1) an adequate written notice detailing the grounds and underlying facts on which commitment is sought; (2) the right to counsel and, if indigent, the right to appointed counsel; (3) the right to be present, to cross-examine, to confront and to present witnesses; (4) the standard of proof to be by clear, cogent and convincing evidence; and (5) the right to a verbatim transcript of the proceedings for purposes of appeal.
Similarly, in City of Newark v. J.S., a New Jersey Superior Court Judge held that the standards and procedures required by the New Jersey Supreme Court in involuntary civil commitment proceedings must also be followed when the state seeks to involuntarily commit a patient to a hospital pursuant to the state’s TB control statute.
The states vary considerably in how they exercise their authority to institute quarantines. As a recent Congressional Research Service Report notes, some states like Louisiana require a court order to quarantine individuals against their will (with exceptions for some diseases), while many others permit health officers to make the call without judicial oversight. In some states, the state health department has authority to identify the diseases subject to quarantine, but in others, statutes specify eligible diseases.
One commonality among state quarantine laws that the CRS Report points out is “their ‘overall antiquity,’ with many being between 40 and 100 years old.” States should review their laws and procedures to ensure they comply with due process commands and reflect contemporary scientific knowledge about disease. The Network for Public Health Law published an issue brief in June 2012 that collected some useful model tools that states may consider, including bench books from Washington, Oregon, and Texas.
Ensuring due process does not mean that individuals will not be quarantined. Newark satisfied its due process burden in J.S., and thus the patient was quarantined. Although the Supreme Court of West Virginia in Greene granted the writ of habeas corpus, it delayed release of the patient for thirty days to permit the state to comply with the due process requirements.
Individual liberty interests may need to yield to the state’s interest in protecting public safety. But states must acknowledge and validate the fundamental value of these liberty interests by complying with due process. Remembering less restrictive alternatives, forced quarantine of an asymptomatic healthcare worker in a makeshift hospital tent with a portable toilet and no shower, hundreds of miles from her home, where she is willing to comply with home monitoring restrictions, may not be constitutional, even if the state provides wi-fi.
By Marissa A. Mastroianni
The war on tobacco took an interesting turn when CVS announced its latest move to improve public health. As of last month, CVS banned the sale of all tobacco products in 7,700 CVS locations. The decision cost CVS an estimated $2 billion annually. This choice came as a shock to many as it is not often a multi-billion dollar company voluntarily foregoes substantial profits for the public good. The plot thickened on October 20, 2014 when CVS announced the second phase of the fight against tobacco: bringing Caremark into the mix and effectively making tobacco much less profitable for its competitors. In the midst of heated public debate over the Affordable Care Act and health reform, CVS exemplifies what big business could accomplish without needing any consensus from Washington, D.C.
In February 2014, CVS vowed to stop selling tobacco products in an effort to support customer health. The decision to stop selling tobacco stunned many regarding CVS’s willingness to forego large profits in a competitive market. However, CVS deemed its new policy “simply the right thing to do ….” CVS has fostered something often more challenging to attain than pure profits—a positive public image—which is always good for business. In fact, CVS’s name (formerly CVS Caremark) recently underwent a makeover as it became the newly dubbed CVS Health.
CVS’s decision to include Caremark in the war on tobacco is strategic. Caremark, CVS’s pharmacy benefits manager (PBM), is one of the largest PBM service providers in the United States. Caremark manages drug coverage for health plans and employers with a national network of about 68,000 retail pharmacies. As a result of CVS’s big move, Caremark will soon require customers to make additional co-payments of up to $15 for prescriptions filled at pharmacies selling tobacco products. The increased co-payment will deter customers from using such pharmacies and will instead lead them straight through CVS pharmacy doors. Caremark and CVS, owned by the same parent company, can now both share the goodwill created by the fight against tobacco.
CVS completed a study showing that eliminating tobacco products at retail pharmacies in Boston and San Francisco yielded up to a 13.3% decrease in buyers of such products. In an article published in the Journal of the American Medical Association, CVS’s Chief Medical Officer Troyen Brennan explained that pharmacies have been heavily criticized by public health advocates for selling tobacco products in light of efforts taken by the pharmacy industry to become integral to the health care system.
The conditions proved to be just right in persuading CVS executives to commit to tobacco-free pharmacies. Helena Foulkes, President of CVS/pharmacy, noted the decision was consistent with the company’s purpose in helping people attain better health. Including Caremark in this plan is just plain business savvy.
CVS is currently in the process of identifying pharmacies within its network that are tobacco-free to implement the new increased co-payment plan. A list will be provided to Caremark plan members before any changes are instituted that will include CVS pharmacies and all other local or regional pharmacies that have already begun the war on tobacco. In fact, Philadelphia is the first city to join CVS by creating the Preferred Health Network. The network will identify all tobacco-free pharmacies in the city and any non-union city employee who fills prescriptions outside of the network will face a $15 surcharge.
The new plan to integrate Caremark into the fold has left some disillusioned with the original seemingly selfless decision to eliminate tobacco products in all CVS pharmacy locations. For example, the President of the Independent Pharmacy Alliance of America, Inc. recently asserted the strategy represented “unfair competitive practice.”
Irrespective of the criticism, the events reflect integration of the health care system into big corporations with the power to effectuate big changes. CVS’s willingness to give up $2 billion annually shows potential for more health reform in the coming years from what some might consider an unlikely source—big business. In a time where Congress and State legislatures cannot agree on health reform, CVS’s war on tobacco demonstrates the potential for the private sector to pick up the mantle.
We are very pleased to welcome Marissa A. Mastroianni to Health Reform Watch today. Marissa is in her third year at Seton Hall University School of Law where she is a member of the Seton Hall Law Review.
Filed under: Compliance, Elder Issues, Litigation and Liability, New Jersey, Public Health, Quality Improvement, Whistleblowers
New Jersey has perhaps the most employee-friendly whistleblower law in the nation, and the NJ Supreme Court is one of the most employee-friendly courts. It was, therefore, more than a little surprising to read the court’s most recent Conscientious Employee Protection Act decision, Hitesman v. Bridgeway, Inc.
A quick summary of the law and the facts make it even more surprising.
Law-wise, CEPA protects employees from retaliation for opposing any activity “the employee reasonably believes . . . is incompatible with a clear mandate of public policy concerning the public health.” Further, and seemingly tailor-made for Mr. Hitesman, CEPA also bars retaliation “in the case of an employee who is a licensed or certified health care professional, [for opposing conduct he] reasonably believes constitutes improper quality of patient care.”
As for the facts, plaintiff, a registered nurse who was shift supervisor for the defendant, believed that there was an upswing in respiratory and gastrointestinal infections at the nursing home. He reported his concerns first to management, then to local and state health agencies, and, not getting much of a reaction, went to a local television station. Perhaps needless to say he was fired.
In this kind of scenario, if the whistleblower loses, it’s usually because (1) he can’t prove that he was reasonable in his belief as to a violation of public policy or (2) he can’t prove that the adverse employment action he suffered was causally linked to his protected conduct. But neither was the problem for plaintiff since a jury had found both that Hitesman’s beliefs about improper patient care were “objectively reasonable” and that Hitesman’s reporting his concerns to the government was a “determinative motivating factor” in his discharge.
So why did he lose before the Supreme Court? Apparently, because his attorney never put in evidence that inadequate infection control was a threat to patient health. Really. And in a nursing home at that, which necessarily serves a more vulnerable population. Although it would seemingly have been easy to prove medical standards of care in dealing with potential infection, for example, citing to Center for Disease Control publications, the only evidence put in of the relevant policies was an American Nursing Association Code of Ethics and two internal policies of the nursing home, none of which focused directly on infections.
The court wrote:
[A] pivotal component of a CEPA claim is the plaintiff’s identification of authority in one or more of the categories enumerated in the statute that bears a substantial nexus to his or her claim. . . . [T]he plaintiff must identify the authority that provides a standard against which the conduct of the defendant may be measured.
While CEPA recognizes “a range of standards that may support a claim,” including professional codes, a claim “cannot proceed unless the plaintiff demonstrates a reasonable belief that the defendant’s patient care is ‘improper,’ measured against an authority recognized by CEPA,” which requires plaintiff to “identify a law, rule, regulation, declaratory ruling adopted pursuant to law or professional code of ethics that applies to and governs the employer in its delivery of patient care.”
That plaintiff hadn’t done, or at least so said the majority. The dissent of Justice Albin disagreed on several counts, but one of which was that the plaintiff had testified about the CDC Guidelines on infection control. The majority dismissed this on the ground that “Neither the trial court’s prior references to CDC standards in its summary judgment decision, nor plaintiff’s vague references to CDC-recommended precautions in his testimony” provide the detail of what CEPA requires.
Especially given the court that handed it down, Hitesman is a head-scratcher. Arguably, it’s a sport opinion, whose major impact will be a cautionary tale to attorneys to introduce exhibits citing chapter and verse rather than relying on plaintiff’s testimony and common-sense conclusions. But it’s possible the case may have more significance, signaling to the lower courts that CEPA has been applied too broadly in the past.
Filed under: Drugs & Devices, Health Insurance, Health Law, Health Reform, Litigation and Liability, Patient Protection and Affordable Care Act, Public Health, Seton Hall Law, Women's Health Issues
We are very pleased to welcome Angela Carmella, a Professor here at Seton Hall Law, to the blog today. Professor Carmella’s intellectual focus is the intersection of law and religion, specifically the First Amendment’s religion clauses, religious land use, and Catholic social thought.
By Angela Carmella
On Monday, June 30, the U.S. Supreme Court issued its path-breaking decision in Burwell v. Hobby Lobby Stores, Inc. In a 5-4 ruling, the Court held that HHS’s contraception mandate violates the rights under the Religious Freedom Restoration Act (RFRA) of closely-held, for-profit corporations that object to providing this coverage. The mandate requires employers to provide their female employees with insurance coverage for all twenty FDA-approved contraceptives without cost-sharing. Justice Alito, writing for the majority, repeatedly notes the decision’s narrow applicability to the mandate alone; Justice Ginsburg, in dissent, criticizes the decision for its “startling breadth,” fearing that for-profits will now seek exemptions from other requirements of the Affordable Care Act and from other federal laws, to the detriment of employees and customers.
Critical to the Court’s decision is the “accommodation” currently available to religious nonprofits—charities, colleges, hospitals and the like—that object to providing contraceptive coverage to their female employees (and students). In contrast to the targeted exemption given specifically to churches and their close affiliates, which leaves employees without this coverage, the accommodation requires the nonprofit’s insurer (or third party administrator for self-insured plans) to provide coverage directly and separately to employees. Thus, the accommodation attempts to respect the twin goals of religious liberty and women’s health.
Justice Alito and Justice Kennedy (who joined the majority opinion but also wrote a separate concurrence) regarded the accommodation as evidence that the government had already devised a mechanism to address the religious objections of employers while advancing its public health goals. For the Court, extending this accommodation to for-profits was an obvious and straightforward way for the government to satisfy RFRA’s requirement that it use the least restrictive means to advance its objectives.
Hobby Lobby consolidated two challenges to the mandate, one brought by the Green family, evangelical Christian owners of the Hobby Lobby arts and crafts stores and Mardel religious book stores, and the other brought by the Hahn family, Mennonite owners of cabinet manufacturer Conestoga Wood Specialties. They refuse to provide their employees with coverage for four (out of twenty) contraceptives that might interfere with implantation of a fertilized ovum, because to do so would involve them in facilitating abortions. (Some of the other businesses that have brought similar challenges oppose providing coverage for all contraceptives.)
RFRA prohibits government from “substantially burden[ing] a person’s exercise of religion even if the burden results from a rule of general applicability” unless it “demonstrates that application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.” 42 U.S.C. Secs.2000bb-1(a), (b). RFRA applies to “any exercise of religion, whether or not compelled by, or central to, a system of religious belief.” Sec.2000cc-5(7)(A).
The opinion takes a pragmatic approach, but its driving vision is RFRA’s overarching purpose in this context: to prevent government from excluding religious people “from full participation in the economic life of the Nation” (Alito 46) and to protect the right “to establish one’s religious (or nonreligious) self-definition in the political, civic, and economic life of our larger community.” (Kennedy 2). The Court first determines that for-profit corporations are “persons” capable of “exercising religion” under RFRA. “[A]llowing Hobby Lobby, Conestoga and Mardel to assert RFRA claims protects the religious liberty of the Greens and the Hahns,” (Alito 21). Their religious liberty here consists in being able to “run their businesses as for-profit corporations in the manner required by their religious beliefs” (Alito 2, emphasis supplied).
Next, rejecting HHS’s argument that the connection between the mandate and any immoral act is too “attenuated,” the Court finds that the “mandate imposes a substantial burden on the ability of the objecting parties to conduct business in accordance with their religious beliefs.” (Alito 36, emphasis in original) Given the prospect of fines against Hobby Lobby of up to $475 million per year, the answer for the majority is clear. The Court refused to scrutinize the claimants’ arguments regarding complicity in immoral conduct, noting that “it is not for us to say that their religious beliefs are mistaken or insubstantial.” (Alito 37)
The majority opinion assumes that the mandate fulfills a compelling governmental interest, while Justice Kennedy’s concurrence makes clear that the government has demonstrated it. But both opinions focus on the accommodation as the least restrictive alternative to further the government’s compelling interest. Although government provision of contraceptives might be an alternative, the Court concludes that “we need not rely on the option of a new, government-funded program in order to conclude that the HHS regulations fail the least-restrictive means test. HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.” (Alito 43) The Court notes that under such an accommodation, female employees of Hobby Lobby, Mardel and Conestoga would receive the contraceptive coverage to which they are entitled under the regulations.
Because the Court does not decide whether the accommodation “complies with RFRA for purposes of all religious claims,” (Alito 44) Justice Ginsburg’s dissent largely ignores the majority’s solution and focuses instead on what she views as a radical interpretation of RFRA that allows businesses to “opt out of any law (saving only tax laws) they judge incompatible” with their beliefs (Ginsburg 1) without regard to the impacts on third parties (like the female employees of objecting businesses). Her dissent emphasizes the significance of contraception to women’s health, the expenses associated with contraception, and the compelling nature of the government’s interest in an employer-based insurance system that provides it. She draws a sharp distinction between religious nonprofits, which are accommodated because they “exist to serve a community of believers,” (Ginsburg 29) and commercial entities with diverse workforces. Justice Ginsburg concludes that not only is the claim of burden on religious exercise too attenuated, but “[i]n view of what Congress sought to accomplish, i.e., comprehensive preventive care for women furnished through employer-based health plans, none of the proffered alternatives would satisfactorily serve the compelling interests to which Congress responded.” (Ginsburg 30-31)
In other pending cases many religious nonprofits are challenging the accommodation itself as insufficiently protective of their religious liberty. The Court’s praise for this mechanism as meeting the twin goals of religious liberty and women’s health in the for-profit context might be read as a sign that the nonprofits currently in litigation may be sorely disappointed. But predicting the impact of Hobby Lobby in the nonprofit context became more complicated on July 3, just four days after Hobby Lobby came down, when the Court issued an interim order in Wheaton College v. Burwell.
Wheaton College is a religious nonprofit that is unquestionably eligible for HHS’s accommodation for religiously affiliated institutions. It has challenged the accommodation itself as a violation of RFRA on the grounds that the school will be morally complicit in providing abortifacient coverage when it files the required “self-certification” form; this form, it argues, triggers the third party administrator’s obligations to provide the objectionable coverage. Without deciding the merits, the Court decided 6-3 that the college need not use the government’s form; since the government is already on notice of its objection, HHS (and its third party administrator) can proceed as though the form had been filed.
One can view this as consistent with Hobby Lobby: as in that case, the Wheaton Court finds a solution that both respects the college’s religious exercise (it does not have to sign) and meets the government’s interest (the third party provides the contraceptive coverage). But in her dissent to Wheaton, Justice Sotomayor voiced her frustration: since the Court already found that the accommodation was the least restrictive means of furthering the mandate’s goals—indeed, it “served as the premise” for the decision—the “grant of injunctive relief [in Wheaton] simply does not square with the Court’s reasoning in Hobby Lobby.” (Sotomayor 16, 13)
Although it may be impossible to predict Hobby Lobby’s specific impacts in both commercial and nonprofit contexts, two thing are certain: first, the notion that religious liberty and government interests can be reconciled to avoid harms to third parties is now on the table for further consideration; and second, the Court’s broad reading of RFRA marks a new chapter in free exercise jurisprudence.
Filed under: Drugs & Devices, Food and Drug Administration (FDA), Information Technology, Public Health, Transparency
On June 2, 2014, the Office of Informatics and Technology Innovation (OITI) within the Food and Drug Administration (FDA) announced the launch of OpenFDA, a searchable, online public health database containing drug adverse event information compiled between October 2004 and June 2013. The FDA press release reports that OpenFDA employs
a search-based Application Program Interface (API) to collect large amounts of existing publicly available data, offering developers the ability to search through text within that data, ranking results much like a search using Google would do. This method then allows them to build their own applications on top of OpenFDA, giving them a large amount of flexibility to determine what types of data they would like to search and how they would like to present that data to end-users.
Currently, OpenFDA consists of approximately three million drug adverse events, though the FDA plans to expand the amount of adverse events, along with product recalls and labeling information, as they increase their capacity.
For various reasons, U.S. governmental agencies have developed open data initiatives in a number of contexts. Perhaps the most long-standing database relevant to the FDA approval process is the clinical trials database maintained by the National Institutes of Health (NIH). NIH has maintained the clinical trials reports and results database since 2000 as directed by Congress in legislation. Recent amendments in 2007 imposed additional requirements on NIH and clinical trial sponsors. Several other governmental initiatives to provide open data across such topics as health, agriculture, climate, and education, can be found here.
The move by FDA follows President Obama’s Executive Order in May 2013, entitled Making Open and Machine Readable the New Default for Government Information. That Executive Order directs executive departments and agencies to implement measures to support an open data policy in their operations and missions. The memorandum detailing this policy “requires agencies to collect or create information in a way that supports downstream information processing and dissemination activities. This includes using machine readable and open formats, data standards, and common core and extensible metadata for all new information creation and collection efforts.” In addition, “it involves agencies building or modernizing information systems in a way that maximizes interoperability and information accessibility, maintains internal and external data asset inventories, enhances information safeguards, and clarifies information management responsibilities.” President Obama has touted an Open Government Directive focusing on transparency, participation, and collaboration since taking office in 2009.
Researchers, web developers, and members of the public praise OpenFDA, citing numerous challenges to access and interpretation of adverse event information in the past. These challenges include lengthy Freedom of Information Act request turnaround times, a lack of uniformity in quarterly bulk reports distributed by the FDA making them difficult to decipher, and no ability to search across data in the FDA adverse event reporting system. A GCN article notes that with OpenFDA “users can find what they’re looking for by typing drug names, QR or UPC codes or even reaction symptoms. Misspellings will likely still return an accurate result because each query is given a score that is similar to how search engines operate.” TechRepublic provides a helpful overview of the technical features of OpenFDA here.
Many sources urge that the new database will maximize the return on the adverse event data and enable the private sector to innovate in an area where the FDA has limited resources. In fact, one application resulting from OpenFDA has already sprung up. ResearchAE, developed by Social Health Insights, is a query interface allowing users to search adverse drug effects by multiple classifications, such as date, location, patient age, drug name, manufacturer, and reaction. HealthCare IT highlights this new application here.
While OpenFDA has been met with widespread enthusiasm, a few concerns have arisen about the availability and use of the information. Some have questioned the security of the information on OpenFDA. However, the FDA assures that all identifying information has been removed from the adverse event data available in the online database. The Chief Health Informatics Officer within OITI, Dr. Taha Kass-Hout, stated “we will not release any data that could be used to identify individuals or reveal other private information.” Others, including pharmaceutical manufacturers, have questioned whether the public and other entities will be able to comprehend the data without causing undue turmoil in the market. To that criticism, Kass-Hout responds that the FDA “will be correcting misinterpretations” of the data.