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 contact@njsentinelproject.org.

Monday Morning Recap: The Week (4.14.14-4.20.14) in Drug & Device Law & Policy

What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. An article by Ariana Eunjung Cha in this past week’s Washington Post describes a Patient-Centered Outcomes Research Institute-funded project of unprecedented scale that “may be one of the most radical projects in health care ever attempted.” Cha describes “government-funded scientists” “[i]nside an otherwise ordinary office building in lower Manhattan” gathering “data — from every patient treated at one of New York’s major hospital centers over the past few years[.]” “The effort,” she explains, “is being duplicated at 10 other sites across the country using data from hospitals, academic research centers, community health clinics, insurers and other sources. If all goes well, by September 2015 they will be linked together to create a giant repository of medical information from 26 million to 30 million Americans.” Cha also explains that although “researchers say the potential of the network to speed up research efforts and to answer questions that have long vexed scientists cannot be overstated,” the project raises ethical and other questions, including “critically important to the multibillion-dollar pharmaceutical industry, how will the Food and Drug Administration view this type of research when considering applications for new drugs or in recalling old ones?”

2. At the New England Journal of Medicine, Ameet Sarpatwari, Jerry Avorn, and Aaron Kesselheim, comment on the use of Risk Evaluation and Mitigation Strategies (REMS) by branded drug manufacturers as a tool to forestall or prevent generic competition. They write: “We think that a single, shared REMS system for a given drug would be the best way of seamlessly and consistently providing guidance to prescribers, pharmacists, and patients; preventing adverse events; eliminating unnecessary confusion; and reducing administrative burdens on all participants. . . . The importance of protecting patients’ health demands that an efficient and effective risk-management approach be available to both brand-name and generic drug companies.”

3. From Christine Vestal at USA Today comes a very interesting article about a new telemedicine pilot project in Mississippi, supported by a newly-passed law requiring “private insurers, Medicaid and state employee health plans to reimburse medical providers for services dispensed via computer screens and telecommunications at the same rate they would pay for in-person medical care. . . .  Starting in June, 200 people with diabetes in one of the state’s poorest regions, the Mississippi Delta, will be given Internet-capable computer tablets loaded with software provided by Intel-GE Care Innovations and GE Healthcare. The software will enable medical professionals at the University of Mississippi and a hospital in the region, North Sunflower Medical Center, to remotely monitor patients’ test results and symptoms.”

4. The new hepatitis C drugs continued to make news this week.  At The KHN Blog, Jay Hancock reports that “UnitedHealth Group spent $100 million on hepatitis C drugs in the first three months of the year, much more than expected, the company said Thursday. The news helped drive down the biggest insurance company’s stock and underscores the challenge for all health care payers in covering Sovaldi, an expensive new pill for hepatitis C.” And at Kaiser Health News, Julie Appleby writes that both the California Technology Assessment Forum and a Department of Veterans Affairs expert panel issued recommendations urging doctors to limit Solvadi and other new treatments for hepatitis C to those with advanced liver disease.

5. Finally, of interest to many as states begin to experiment with legalizing marijuana, Aaron Carroll offers this Healthcare Triage: Is Marijuana Harmful to Health?

Direct to Consumer Genetic Testing and the Over-Production of Genetic Information

Cross Posted at HealthLawProf Blog

23andMe, the Internet genetic testing company, which offered genetic testing for health conditions and ancestry, has received extensive publicity in recent months. In November 2013, the FDA ordered 23andMe to stop marketing its health-related genetic test results to customers because their product is a “device”, which requires FDA approval. In its letter to 23andMe the FDA focused on the harms of consumers’ interpretation of genetic test results without the appropriate medical guidance.

And for sure, consumers’ independent interpretation of genetic results is potentially harmful. But, another important concern not addressed by the FDA is the need to regulate and constrain the production of genetic information in the first place – at the time that a consumer decides which tests to take. Direct to consumer genetic testing companies, like 23andMe, usually offers a battery of multiple tests that the consumer purchases without careful selection of what information is desirable to her. And, although genetic information can help improve and control health outcomes, not all genetic information is made equal and not all tests results are similarly desirable for all people. In my essay Direct to Consumer Genetic Testing: Gatekeeping the Production of Genetic Information, I discuss the problem of indiscriminate production of genetic information and argue for the need for a medical gatekeeper not just for the interpretation of genetic test results but earlier on to guide consumers through the selection of tests.

The guidance of a medical practitioner (particularly a genetic counselor) at the test selection stage is important to avoid the production of genetic information that is unsuitable for the specific person who wants to undergo testing. First, some people may prefer not to know certain genetic information about themselves because there are no effective preventive measures, and they do not want to live with the knowledge that they are likely to incur a certain genetic disease. For example, currently, the most effective prevention for breast cancer is a mastectomy. Some women would welcome the information and the ability to prevent the disease. But, others may not view this as a preventive measure they can endure and would prefer not to undergo a genetic test for the breast cancer genetic mutations. Second, some genetic tests convey little information. Certain positive genetic test results indicate only a slightly higher probability of incurring the disease than the likelihood in the general population. Finally, some genetic tests may lack solid scientific validity, whether due to the state of the science or the effect of many mutations and environment factors that act in conjunction. For all these reasons, catering the selection of genetic information to the person testing can be as important as regulating the interpretation of the results stage.

Health Law Outlook: Ending Philosophical Exemptions for Mandatory Vaccinations

By Adino Barbarito

Adino (“A.J.”) Barbarito is a first year student at Seton Hall University School of Law who is interested in public health policy and litigation, as well as skeptical analysis and philosophy.  He plans to participate in the Ronald Riccio Moot Court Competition and to pursue studies in health law and litigation. This post is part of Volume VII, Issue 2 of Health Law Outlook, which is written and edited by student members of Seton Hall Law’s Health Law Forum.  Previous Health Law Outlook issues can be found here.

Mandatory vaccination, as a matter of public policy, is overwhelmingly accepted within the United States as a prerequisite for children seeking a public education. Vaccination continues to be upheld by the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts,1 and is considered established law. Unfortunately, exemptions to mandatory vaccination remain in effect in 48 states, based upon religious—and in some cases, philosophical—objections. While medical exemptions serve a legitimate interest, other opinion-based exemptions threaten the policy on which mandatory vaccinations are based. States that allow such exemptions should cease the practice. Furthermore, parents should pursue the possibility of tort liability against other parents who subject children to harmful diseases with their decision not to immunize their own children.

The Jacobson court recognized that the majority of the medical community, the citizens of the State, and the Massachusetts legislature all accepted that vaccines provide a necessary benefit. Since the state had a duty to protect its citizens’ welfare, it was within its rights to pass a law compelling them to be immunized, even if immunization was unattractive to a few:

. . . In every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.2

While no municipalities are currently under the threat of smallpox, they should still consider diseases like pertussis, polio, and measles—diseases that stand to threaten communities—as “great dangers.”3 Jacobson ruled that Massachusetts could compel its citizens to receive smallpox vaccinations, and that such compulsion was constitutionally justified under the police power afforded the states.4 In so ruling, the Supreme Court stated:

We are not prepared to hold that a minority, residing or remaining in any city or town where smallpox is prevalent, and enjoying the general protection afforded by an organized local government, may thus defy the will of its constituted authorities, acting in good faith for all, under the legislative sanction of the state.5

The Court was not prepared to let the whims of a minority refute laws that were designed for the protection of the people in good faith. The Court recognized that the mandatory smallpox vaccinations were for the benefit of the entire community, including those who may oppose them. Had the immunizations been designed to oppress the opposing minority, the Court may have decided differently.

What the Supreme Court did not do in Jacobson was prevent states from enacting statutes exempting certain individuals from vaccination. Forty-eight states have enacted statutes exempting individuals from vaccination for religious reasons. In addition, nineteen states have statutes which also exempt individuals from vaccination for “philosophical” reasons. While philosophical reasons vary by state, the most common exemptions allow a very broad array of reasons that can be deemed “philosophical.” As a result, a parent in most of these states can simply choose a “philosophical exemption” without stating any actual reason.6 Obviously no child should be compelled to receive vaccinations if she or she is predisposed to health risks as a result. It is recklessly irresponsible, however, for states to allow exemptions for any reason aside from health risks, when those exemptions create a public health danger and subject all unvaccinated children to easily preventable diseases.

It is well established that a parent may not forego lifesaving medical treatment while substituting prayer or other religious means of treatment.7 Courts have time and again recognized the fact that religion is no substitute for proper medical care, and that even a fervent belief in the power of prayer to heal does not excuse the parents and caretakers of children from their proper duty of care. Parents and guardians are required to submit to the expertise of medical professionals when a child is in imminent danger. It follows that, since we do not allow parents to substitute prayer for medicine, we should likewise not allow parents to substitute their religious beliefs for the proven vaccines that would prevent their child’s death.

In a series of cases leading directly back to the Jacobson holding, courts have established that there is no constitutional guarantee of religious exemption, and the Supreme Court, through their refusal to hear cases challenging compulsory vaccination, seems to believe the matter settled with Jacobson. The most current cases in vaccination address, and dismiss, free exercise claims when it comes to mandatory immunizations for children entering public school.8 With no constitutional hurdle, then, religious and philosophical exemptions rely solely on the discretion of the states, only two of which have refused to allow them.

The matter then becomes one of state policy. Unfortunately, states presently have little reason to compel vaccination against religious or philosophical arguments when the will of its voters does not reflect a desire for such compulsion. No state wants to enact a statute that defies most citizens’ expectations of free speech and free exercise without a particularly persuasive argument. Almost certainly, religious and anti-vaccination groups will oppose such a statute. It is a politically risky endeavor, which politicians would be loath to pursue without a strong public push in that direction. So how do concerned parents achieve such a push? Read more

Monday Morning Recap: The Week (4.7.14-4.13.14) in Drug & Device Law & Policy

What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. First up, the Washington Post analyzed data released this week on Medicare payments to doctors and  found “that the cost of drugs administered by doctors accounts for a growing piece of Medicare’s spending and varies widely from region to region in the United States, raising questions about whether some physicians may be misusing the pharmaceuticals. Most of the 4,000 doctors who received at least $1 million from Medicare in 2012 billed mainly for giving patients injections, infusions and other drug treatments, those records show.”

2. Eric Palmer at Fierce Pharma writes: “In case anyone missed the latest forecast, drug prices were up last year and are going to continue to grow, perhaps at double-digit rates in some cases. The outlook comes from the second pharmacy benefits management report to be released in three days, this one from CVS Caremark ($CVS) following Express Scripts’ ($ESRX) missive on Tuesday.” Palmer notes that although specialty drugs accounted for 1% of prescriptions in the United States, they “accounted for more than a quarter of total drug spending.”

3. Also making the news this week, new findings from a study by the Cochrane Collaboration that anti-influenza drugs Tamiflu and Relenza may not work as well as previously believed and may even do more harm than good.  In an article at Bloomberg News, Oliver Staley quotes one of the authors of the study who said: “’There’s no credible way these drugs could prevent a pandemic’ . . . Money spent on stockpiling ‘has been thrown down the drain.’”

4. Emily Cook and David Ivill of McDermott, Will & Emery reported on recent developments related to the 340B drug pricing program which requires pharmaceutical companies to give a discount to safety net health care providers. They write: “Entities participating in or contemplating participating in the 340B Program should remain alert to 340B Program developments in the coming months and should be prepared to implement changes to 340B Program operations as necessary to remain compliant with changing requirements.  All 340B stakeholders should carefully monitor the status of forthcoming proposed rules related to the 340B Program and be prepared to provide substantive comments to OPA during open comment periods.”

5. Finally, Ben Comer at the PharmExecBlog wrote a fascinating post (that quotes Seton Hall Law’s Dana Darst) on “Project DataSphere, the newest data transparency and collaboration project with buy-in from several top pharmas and academic medical institutions,” which currently contains data sets from the comparator arms of a number of late-stage oncology trials.  Among other things, Comer touches on the intriguing possibility that Project DataSphere will enable researchers to use “‘in silico’” comparator arms for new active trials”. He also discussed challenges associated with de-identification (a consultant to Project DataSphere has written “an informative de-identification strategy paper for organizations grappling with the legal implications of de-identification.”).  Comer concludes with a quote from Professor Peter Doshi who “says what’s often overlooked in the charge on pharma’s data vaults is the data that’s housed at FDA. ‘They singularly hold the most data across companies, across therapeutic areas, across time. EMA is releasing data, but why is FDA not similarly opening up its archives to the public?’ asks Doshi. ‘I think the status quo for them is a more comfortable place to be than a revolution in access to data.’”

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