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.
Filed under: Health Reform, Patient Protection and Affordable Care Act
Jaime King and colleagues at UCSF/UC Hastings Consortium on Law, Science & Health Policy have been busy building a rich web resource devoted to promoting cost control and competition in health care. The Source for Competitive Healthcare seeks to create a one-stop shop for academics, journalists, state attorneys general, and potential litigants by “posting news articles, policy papers, academic articles, litigation documents, and legislative/regulatory materials, as well as legal and policy-based analysis of those materials,” focused on “market issues, such as provider leverage and reform efforts, including the promotion of price transparency in healthcare.”
The site is relatively new and actively seeking content and feedback, but it already is a valuable treasure trove of information. The Litigation/Enforcement and Legislation/Regulation tabs immediately caught my eye. Each offers an interactive map of the United States highlighting states that are active in this space with links to pleadings, proposed statutory and regulatory language, and other primary sources in addition to analyses. I am exploring ways to weave these resources into simulations in my health law skills class this spring.
There are some limits to the site design that hamper usability. The Academic Articles and Reports sections of the site seem to provide all articles and reports with only temporal and not substantive sorting capacity.
The Stakeholder Perspectives section of the site lets users sort opinion pieces, reports, and other information from different points of view, including consumers/patient, government, providers, society, payers, and employers. But it does not let you also sort these perspectives by issue area.
The Key Issues area of the site is more sophisticated, permitting users to aggregate scholarly and journalistic articles by a number of topics — healthcare markets, healthcare costs, ACA impact, quality, and price transparency. Although an improvement over the Academic Articles and Reports sections, this sorting feature may be a bit rudimentary. When I selected the ACA impact category, for example, the sort included a rather broad range of topics, including preparing for open enrollment, Medicaid costs, accountable care organizations, narrow networks, emergency room crowding, and insurance rates, leaving users to do a fair amount of digging to find articles relevant to their work. It also does not permit sorting both by perspectives and issue areas.
The Source actively is seeking feedback from its users, so there is good reason to believe improvements will come, if people share feedback. Perhaps the site will add additional tags and sorting capacity as the site grows. Until those developments are implemented, users may need to do some digging to find what they need. But undoubtedly it will be more fruitful to begin with the Source’s vetted resources than to initiate a virgin search of the behemoth internet using a generic search engine.
Although the Source is “not aligned with any advocacy-based organizations or parties to litigation,” it acknowledges that it seeks to “serve as a catalyst for change within the U.S. healthcare system . . . [and] empower individuals and groups seeking to bring rationality to healthcare markets.” It certainly is empowering users with information. It will be interesting to see what we do with these sources to advance policy reform.
Filed under: Health Insurance, Patient Protection and Affordable Care Act
Cross-Posted at HealthLawProf Blog
As we prepare for the second open enrollment period for the health insurance marketplaces to begin in just over one month, transparency offers a potential means of empowering consumers to make better decisions regarding the health plans they choose.
Some states are making strides in this area. The New Hampshire Insurance Department was an early leader on the transparency front, creating a website called NH HealthCost in 2005 to provide information on the costs of medical services based on claims data collected from the state’s insurers and stored as part of the Comprehensive Health Care Information System. Although the site was down for months earlier this year because of problems encountered when it changed vendors, it is back up and running and promises that “significant changes” are in store. Currently, however, it only offers data on the costs of a few dozen medical services, such as MRIs, CT scans, ultrasounds, X-rays, colonoscopies, and emergency room visits.
Beginning October 1, 2014, insurers in Massachusetts must provide information about the full-range of costs for medical care on their websites. As Martha Bebinger reported earlier this week, there are some limitations to the disclosures. For one, the prices are not standardized among carriers, and thus some reported prices include all charges related to a particular medical service whereas others exclude related costs, such as charges to read the test or facility fees. In addition, carriers sometimes use different terminology to refer to the same procedure. Such differences make it difficult for consumers to make meaningful comparisons. There also are few prices available for inpatient care, and there is limited information about the quality of care provided at different costs. Consumers will need to log into their account, and the program will calculate each consumer’s particular deductible, co-pay, and co-insurance amounts based on what claims they already submitted in a plan year.
Although these efforts to make the cost of healthcare more transparent are important, consumers already tend to over-focus on cost when choosing health insurance. A Kaiser Family Foundation survey, for example, found that twenty-seven percent of consumers who purchased non-group coverage for 2014 identified cost as the most important factor in choosing a plan. In contrast, only eleven percent identified choice of doctors or providers as the most important factor.
Recent articles about out of network bills by Elisabeth Rosenthal and others are important reminders of how important it is for consumers to balance cost with access to needed providers, among other salient factors. Yet surveys by McKinsey & Co. and the Commonwealth Fund similarly found that roughly a quarter of consumers who enrolled in exchange plans did not know whether they had chosen a broad or narrow network plan, and McKinsey found that this number increased to forty-two percent for consumers who previously were not insured. The Commonwealth Fund survey further found that thirty-nine percent of adults who enrolled in an exchange plan or Medicaid through the marketplace did not know which doctors were included in their plan.
An August 2014 report of physician network transparency by the Urban Institute highlighted Massachusetts’ Health Connector as a model of transparency in many respects. For one, it includes a dedicated “provider network disclosure” section for each plan that makes plain whether the plan has a general or limited provider network and identifies in red lettering under each plan name if the plan includes a narrow network of providers. It also embeds provider directories for all plans in its state marketplace with full search functionality, which helps “alleviate the complexity and confusion around network-based plan choice.”
Although Healthcare.gov received praise in the report for displaying plan type directly beneath each plan’s name and including a hover definition, it was criticized for not embedding provider directories. And as Margot Sanger-Katz reported earlier this week, Healthcare.gov still will not have the capacity to permit consumers to identify which doctors and hospitals are participating with particular plans or to compare networks among different plan options in the fall 2014 open enrollment period. Consumers in the twenty-seven FFM states instead must navigate insurers’ external websites, which have varied greatly in terms of content and user-friendliness. For example, as the Urban Institute report noted, “[m]ost Marketplace websites link to carrier pages where it is difficult to associate a directory with a particular Marketplace plan because network names do not always match Marketplace plan names, and a single insurer can have different networks that apply to different plans.”
Although an FFM state cannot change Healthcare.gov, it can make information available to consumers to aid consumer choice, either by directly providing this information to consumers or by regulating carriers offering plans in its state.
The Pacific Business Group on Health’s Helping Vulnerable Consumers in the Exchange Project offers a number of transparency resources for states with and without exchanges to use as they build, or require insurers to build, consumer choice decision support. It is important to proceed thoughtfully because behavioral economists have found that too much information is not necessarily good. The jackpot question is how to improve transparency on multiple fronts without overwhelming consumers with too much information.
Alternatively, states may look to use decision support resources developed by others. A team of business, law, health care management, and technology professors at the University of Pennsylvania partnered with a veteran insurance company executive to launch Picwell in September 2014, which uses predictive analytics to offer personalized recommendation and decision-support technology to healthcare consumers. As its site explains:
The first technology of its kind, Picwell marries Big Data, predictive analytics, behavioral economics, and machine learning with consumer friendly user interfaces and engagement tools that integrate directly into healthcare exchanges and benefits platforms. The end result enables exchanges to quickly and seamlessly organize and analyze more than 900,000 variables that affect plan selection and present the highest recommended plans to participants based on their individual needs.
It was announced this week that Picwell will use its predictive recommendation engine to analyze the plan choices consumers made during the 2014 open enrollment period using deidentified data from state exchanges, beginning with Minnesota’s insurance exchange, MNsure.
The Robert Wood Johnson Foundation also is sponsoring the Plan Choice Challenge, which offers cash prizes to developers who design an “an app that will help consumers compare health plan cost sharing features and choose the best plan.” RWJF narrowed the field to six finalists in late September 2014 and plans to announce a winner in February 2015, following submission of Phase II plans in January 2015.
Many questions remain, including how to standardize available information so that consumers may make apples to apples comparisons, how to educate consumers about how to use these resources, and how to monitor these tools for accuracy and to ensure they are not subject to manipulation or industry capture. There is much work to be done, but I hope the experimentation continues.
Averting Mental Health and Fiscal Crises: Crisis Intervention Teams and Access to Meaningful Treatment for Mental Illness
Cross-Posted at Bill of Health
Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for increased training of law enforcement in crisis intervention as well as the need for improved access to treatment for people with mental illness.
The first is a video of the fatal police shooting of Kajieme Powell in St. Louis, Missouri earlier this month. Mr. Powell was twenty-five years old and suspected of shoplifting junk food from a convenience store. The first eighty seconds of the video show Mr. Powell pacing and muttering on the sidewalk — with four pedestrians passing by without incident — before the police arrive. The police then exited their vehicles with their guns drawn, shouted at Mr. Powell to drop his weapon, and fired about twelve shots fewer than twenty seconds after they arrived on the scene.
The second is an NPR story that included an audio recording of law enforcement officials in San Antonio, Texas responding to a 911 call about a twenty-four year old group home resident named Mason, who was off of his medications, had set his blanket on fire, and was a danger to himself and others. When they arrived at the scene, the officers acknowledged that they did not use the “tough guy command voice” that they typically would in responding to a 911 call reporting suspected criminal activity. Instead, in plain clothes and without their weapons drawn, they spoke calmly with Mason, reassuring him that they wanted to get him help. They astutely noticed signs suggesting that Mason was experiencing tactile, auditory, and visual hallucinations, and with patience and skilled questioning, got him to acknowledge the hallucinations and seek psychiatric treatment.
The San Antonio officers were members of a six-person mental health squad that the city created to confront severe prison overcrowding. As NPR correspondent Jenny Gold reported, the city and county have saved $5 million and eliminated prison overcrowding over the past five years by diverting people with mental illness out of prisons and overcrowded emergency rooms and into appropriate mental health treatment. Officers must take forty hours of crisis intervention team (“CIT”) training to help them learn how to handle mental health crises.
By juxtaposing the St. Louis and San Antonio incidents, I am not suggesting that they necessarily can be fairly compared. The facts that were available to the officers in each situation may have justified different law enforcement responses. The San Antonio officers were warned in advance that Mason may have been experiencing increased symptoms of mental illness and, when they arrived, Mason was sitting by himself without any suspected weapon. In contrast, the St. Louis 911 call reportedly did not raise any concerns that Mr. Powell was suffering from a mental illness. In addition, the police claim that Mr. Powell was brandishing a knife as he approached the officers, and a knife reportedly was recovered at the scene. Michael Woody, a CIT expert and former police trainer in Akron, Ohio, has opined that the St. Louis scene was not stable enough for the CIT protocol to be appropriate. (But query whether other tactics short of lethal force could have controlled the situation and spared Mr. Powell’s life.)
The starkly different outcomes in these cases shine a spotlight on the potential for CIT training to arm officers with effective tools to help de-escalate mental health crises in appropriate cases. In a December 2012 article in the Community Mental Health Journal, Kelli E. Canada, Beth Angell, and Amy C. Watson summarized some of the preliminary findings of CIT effectiveness, including:
- “improved officer preparedness and improved disposition of mental health calls”
- “improved attitudes, increased knowledge and patience, and an increase in support of local treatment programs”
- “the potential to reduce stigma and alter beliefs about mental illness”
- “increases in the number of identified mental health calls[,] . . . transports to treatment by CIT officers[,] . . ., and voluntary transports”
- “increasing access to mental health services through linking individuals with community providers”
An analysis of interviews these researchers conducted of CIT and non-CIT trained officers in Chicago “uncovered three specific areas that CIT trained officers demonstrated specialized procedures in comparison to non-CIT trained officers: assessment, response tactics, and disposition.”
Here in New Jersey, Camden was the first city to use CIT training back in 2008, and eleven New Jersey counties currently have CIT programs. A Union County officer reported that the training caused him to think twice before curtly shuffling a homeless man along. Instead by talking with the man, the officer learned that he was suicidal and convinced him to seek treatment for his previously undiagnosed schizophrenia. New Jersey should continue to expand CIT programs in law enforcement agencies throughout the state.
But, as the St. Louis incident reminds us, CIT training alone is not enough. (Indeed, reportedly one of the officers involved in the shooting of Mr. Powell was CIT-trained.) New Jersey also needs to invest in treatment services for patients with mental illness, both to help them avoid a crisis and to have appropriate and available treatment options when they reach a crisis. Officers need places to bring or refer individuals in need of mental health treatment. Yet patients often report difficulty trying to access appropriate mental health services in New Jersey as in other states. We need to be sure there are adequate networks of providers to meet the needs of people with mental illness.
Given current fiscal realities, it is unclear how New Jersey will fund efforts to improve mental health access. Gold reports that jails, hospitals, courts, police, and the mental health department in San Antonio banded together to build the Restoration Center, which offers an array of mental and physical health services, including “a 48-hour inpatient psychiatric unit; outpatient services for psychiatric and primary care; centers for drug or alcohol detox; a 90-day recovery program for substance abuse; plus housing for people with mental illnesses, and even job training.”
New Jersey agencies similarly should explore ways to coordinate. Given the cost savings San Antonio has realized, perhaps New Jersey should revisit the role for social impact financing to improve mental health network adequacy.
In a letter to counsel dated June 6, 2014, the Food and Drug Administration (FDA) granted citizen petitions that asked the agency to clarify its regulations and policies regarding truthful, non-misleading scientific communications and activities related to investigational new drugs and devices.
In particular, as part of a general commitment to “engage in a comprehensive review of the regulatory regime governing communications about medical products,” FDA agreed to provide greater regulatory clarity in four specific areas:
- Manufacturer responses to unsolicited requests;
- Scientific exchange;
- Interactions with formulary committees, payors, and similar entities; and
- Dissemination of third-party clinical practice guidelines.
It is not clear why FDA decided to release this letter now. 21 C.F.R. 10.30(e)(2)(i) generally requires FDA to respond to citizen petitions within 180 days, and when it approves a petition, “the Commissioner shall concurrently take appropriate action (e.g., publication of a Federal Register notice) implementing the approval.” The petitions were initially filed on behalf of members of the Medical Information Working Group (MIWG) on July 5, 2011 and then supplemented on September 23, 2013 – far longer than 180 days ago. And although the agency has approved the petitions, it is not concurrently taking appropriate action to resolve all of the issues raised by them.
In fairness, FDA already has taken steps to address some of the issues raised in the petitions. In December 2011, the agency issued a draft guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (Unsolicited Requests Draft Guidance). Later that same month, the agency published a request for information and comments regarding its policy regarding “scientific exchange about both unapproved new uses of products already legally marketed (‘off-label’ use) and use of products not yet legally marketed for any use.”
Then in February 2014, the agency released a revised draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices,” which proposes to revise the agency’s 2009 Good Reprint Practices Guidance. Pertinent to the citizens petitions, this draft guidance revises FDA’s recommendations for distributing scientific and medical reference texts and adds recommendations regarding distributing third-party clinical practice guidelines. (See summary prepared by McDermott Will & Emery here.)
At the same time that it granted the citizens petitions, FDA also issued “Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products–Recommended Practices,” which addresses the dissemination of risk information for approved prescription drugs and biological products. (See summary prepared by Ropes & Gray, one of the outside counsel to the MIWG, and early commentary here.)
But the agency acknowledges in its June 6, 2014 letter that several issues raised in the petitions remain unresolved. A considerable chunk of the letter reviews the background of the regulatory framework created by the Federal Food, Drug, and Cosmetic Act and the agency’s general goal to harmonize its “fundamental interest” in protecting public health with “First Amendment interests in the dissemination of truthful, accurate, and non-misleading information regarding medical products.” But there is minimal substantive discussion in the letter of how the agency is resolving the questions raised by the petitions and recent First Amendment case law developments, such as United States v. Caronia.
It is clear the agency is continuing to wrestle with how to balance its regulatory goals with constitutional principles. For sure, there are indications that the agency is retreating somewhat from its prior stance that manufacturer dissemination of off-label information is almost always off-label promotion and, therefore, impermissible. Indeed, FDA expressly acknowledges in its letter that “there can be utility in the dissemination of truthful and non-misleading scientific or medical information regarding off-label uses under appropriate circumstances.”
The agency’s response, however, leaves many questions unanswered, including the contours of these “appropriate circumstances.” FDA continues to consider comments submitted in response to the draft guidance documents described above, and the public will have 75 days from publication in the Federal Register of the most recent draft guidance to comment. The agency commits in the letter to release guidance by the end of 2014 addressing “unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally.” It also intends to issue a draft guidance by the end of the year in response to the MIWG’s requests concerning health care economic information, which industry has been anxious to receive.
Without question, FDA’s letter piques the interest of the regulated community and academics, but it also leaves many open issues. As Ropes & Gray, one of the counsel for the citizens petitions, observed:
It remains to be seen whether any regulatory changes made by FDA will result in additional flexibility or additional scrutiny over manufacturer communications regarding truthful, non-misleading information for approved or cleared products. It also remains to be seen whether FDA can square its current regulatory approach with constitutional requirements.
We will be waiting with bated breath for the promised regulatory guidance.