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.
Recommended Reading: AHLA White Paper “Beneficiary Inducements in an Evolving Market: Assessing the Risks, Understanding the Benefits and Drawing the Lines”
This white paper reports on a convener session held by AHLA’s public interest committee in October 2013. The session brought together a diverse array of individuals from government, industry, providers, patient advocates, and academia, including Seton Hall Law Professor John V. Jacobi, to discuss the federal Anti-Kickback Statute and Civil Money Penalty Law’s prohibitions on inducements to beneficiaries and whether any changes to existing law or additional guidance may be appropriate. In particular, the session considered the applicability of the prohibitions on inducements to a variety of current industry practices that offer the promise of improving health care delivery and access, including wellness programs, patient assistance programs, transportation and lodging assistance, promotion of adherence to treatment regimens, incentives to remain in network, readmission reduction, and end of life–palliative care programs. Building on the new exception to the Beneficiary Inducement CMP Law in the ACA that protects remuneration that promotes access to care and poses a low risk of harm to patients and federal health care programs, the white paper identifies a number of benefits and safeguards that the government should balance when considering whether to permit beneficiary inducements in certain circumstances. It reports that “there was a strong sentiment that clearer guidance in this area will enable providers to implement beneficiary inducements that assist the Programs, improve patient care and promote the goals of health care reform.”
Recommended Reading: Houston Law Review Frankel Lecture and Commentaries Offer Valuable Analysis of the Affordable Care Act and Guideposts for Continued Reform
As the ACA’s first open enrollment period closes, a trio of articles in the recent Houston Law Review offers critical analyses of what health reform has accomplished and important reminders of what remains to be done:
1. Mark A. Hall’s Frankel Lecture, Evaluating the Affordable Care Act: The Eye of the Beholder, seeks to provide “a dispassionate analysis of the law’s actual effects . . . to inform those with open minds (however few they might be) about how this major piece of market and social engineering is actually performing.” To accomplish this analysis, Hall relies on available information to assess the ACA’s progress towards its primary goals “to increase coverage and preserve a decent range of choice in the private market.” He also evaluates whether the ACA created any unintended consequences, such as employment and insurer effects. The varied ways states are implementing the law has created a natural, albeit complex, experiment “that should reveal whether health care access and consumer protections improve or worsen in states that fully embrace the law as compared to states that actively oppose it” – so stay tuned.
2. In David Orentlicher’s Commentary, The Future of the Affordable Care Act: Protecting Economic Health More than Physical Health?, he seconds Hall’s data-driven approach to assessing the ACA’s impacts. But given evidence of a tenuous link between having insurance and being healthy, Orentlicher questions whether the ACA will improve health. Instead he discusses evidence that socieoeconomic status may bear more on health status than access to health care. He also faults the ACA for pouring too much money into treatment of disease and investing too little on effective public health interventions.
3. William M. Sage’s Commentary, Putting Insurance Reform in the ACA’s Rear-View Mirror, similarly examines “the pros and cons of connecting insurance reform to health care and health.” While Titles I and II of the ACA are about expanding health insurance coverage and improving affordability, Title III aims to improve health care delivery and Title IV focuses on improving underlying health. Like Orentlicher’s observation above, however, Sage notes that health insurance and healthcare are not coterminous and “health care is not the major determinant of health.” What he views as the ACA’s radical breakthrough — trying to make medical care better and more efficient and to improve public health – may also overreach, given the complexity of each goal. Sage urges us to move beyond insurance reform as swiftly as we can so we can focus on addressing delivery system reform and underlying health, and his conclusion offers some ideas.
In a similar vein to these articles, the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and New Jersey Appleseed Public Interest Law Center are collaborating on a two-year project funded by the Robert Wood Johnson Foundation to assess the ACA’s implementation in New Jersey. The Sentinel Project moves beyond questions of eligibility for insurance to focus on how effectively health insurers in New Jersey are delivering mandated essential health benefits to consumers under the ACA. In addition to providing legal advice to consumers who are having trouble securing the medical care they need, the Project also will collect and analyze information from consumers throughout the state to highlight implementation trouble spots and develop recommendations for improving access to essential health benefits. Consumers may contact the Sentinel Project by calling (973) 991-1190 or by sending an email to email@example.com.
Filed under: Antitrust, Litigation and Liability
Cross-Posted at Bill of Health
Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct? The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.
Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case. He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here. Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.
While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review). Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Read more