Health Reform from a Surprising Source: CVS and the Latest Move Against Tobacco

October 27, 2014 by · Leave a Comment
Filed under: Health Reform, Public Health 

Marissa Mastroianni Photo Web page-1

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.

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Valuable Internet Resource Focused on Healthcare Cost Containment and Competition

tara-ragone

Cross-Posted at HealthLawProf Blog

 

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.

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Averting Mental Health and Fiscal Crises: Crisis Intervention Teams and Access to Meaningful Treatment for Mental Illness

August 26, 2014 by · Leave a Comment
Filed under: Health Reform, Mental Health 

Tara Ragone

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.

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Seton Hall Law Professor Angela Carmella on Hobby Lobby and Wheaton College

carmella_angela_lg3We 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.

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Health Reform à la Française: Making Class Actions Available for Health-Related Injuries

coleman_carl_lg2Proponents of tort reform in the United States often express particular ire at class action lawsuits, which they characterize as bonanzas for lawyers that unjustly penalize businesses while providing few benefits for consumers.  The enactment of legislation limiting class action lawsuits remains the tort reform movement’s primary achievement at the federal level, having succeeded while efforts to enact federal malpractice reform have consistently failed.

In France, by contrast, a key feature of the government’s recent health reform proposal is to expand the role of class actions by making them available to groups of patients harmed by medical interventions.  As explained by Health Minister Marisol Touraine, who announced a package of health law reforms in a press conference in late June,

to reach maturity in the field of health democracy, it is … necessary to strengthen the power given to patients when they are victims of damages. In light of the serial damages in the health sector, a law right could be contemplated: the introduction of class actions. This would represent major progress. Compensations would certainly be determined on a case-by-case basis but our fellow citizens would no longer be alone against the power of some industries.

At first glance, the proposal to introduce health-related class actions seems difficult to reconcile with France’s historic distaste for American-style litigation.  Indeed, American-style class actions were not available in any context in France until just a few months ago, when the Constitutional Court approved a new class action mechanism for financial injuries stemming from consumer and competition law violations.  The proposal to extend this new law to health-related claims by allowing recovery for bodily injuries and other non-pecuniary damages may strike some observers as a departure from other recent French malpractice reform efforts, which have sought to increase the role of no-fault compensation and to promote non-adversarial mechanisms for resolving disputes.

Yet, class actions à la française are not expected to look anything like their American counterparts.  For one thing, the new class action law allows only accredited consumer associations to represent plaintiffs in class action litigation, thereby precluding lawsuits brought by fee-seeking private attorneys.  Moreover, because French law does not allow no-fee contingency arrangements, the associations will be required to advance the costs of the litigation.  In addition, under the new class action law, plaintiffs must explicitly opt in to class action lawsuits, which may make it difficult to assemble classes of any substantial size.  If the class action law is extended to health-related lawsuits, similar limitations would undoubtedly be imposed.

Even with these limitations, the introduction of health-related class actions is likely to significantly shift the power dynamic between plaintiffs and defendants.  The impact would be the greatest in cases against pharmaceutical and medical device manufacturers, as product-related injuries are inherently more amenable to group litigation than claims of professional negligence.  As the proposal moves through the legislative process, it will be interesting to see how industry and other stakeholders respond.

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