How En Banc Review Would Work in Halbig

This morning the D.C. Circuit ruled that the ACA “unambiguously restricts the section 36B subsidy to insurance purchased on Exchanges “established by the State.”  (See opinion here.)  In other words, the court ruled that the subsidies that make insurance on federally-operated exchanges affordable are illegal.

In the news and blog coverage this has already received, the possibility of this decision being reversed “en banc” has been mentioned.  (See here, here, and here for news, here and here for blogs.  For other blog reading on the opinion itself, see here and here.)  Having written a bit elsewhere about the logistics of the DC Circuit (see here), I thought I would chime in with specifics about exactly how the decision whether to rehear the case en banc, and en banc rehearing, would work.

Continue reading

Health Care Decisions in the New Era of Health Care Reform

The North Carolina Law Review has just released its symposium issue on Health Care Decisions in the New Era of Health Care Reform, featuring several Bill of Health contributors and friends of the Petrie-Flom Center.  Take a look at the description and contents below. [HT: Richard Saver, who served as faculty advisor for this issue, alongside Joan Krause.]

Optimal decision making in health care often proves challenging. Health care providers often confront multiple treatments for each condition with limited evidence as to which interventions work best; moreover, treatment decisions can implicate questions of ethics and personal values that may not be answerable by clinical expertise alone. Fragmented delivery systems lead to insufficient coordination among providers in managing patients’ overall care. Patients face significant informational disadvantage not only in dealing with clinical information, but also in making choices regarding health care insurance coverage. Payers must make reimbursement and coverage decisions with incomplete information about the value and cost effectiveness of many treatments. Governmental officials must make complex regulatory decisions in managing a health care system with seemingly endless demand, escalating costs, and limited resources.

According to some optimistic accounts, the new era of health care reform will radically improve health care decisions. The Patient Protection and Affordable Care Act includes many reform initiatives aimed at improving health care decision making. For example, the law encourages the formation of integrated delivery systems that share information and coordinate care, fosters the development of shared decision-making between providers and patients, develops a more comprehensive evidence base through comparative effectiveness research, and creates insurance exchanges where patients as consumers can choose between plans offering standardized benefits and compared in standardized formats. But there are also reasons for concern that, in the new era of health care reform, decision making will become all the more complex and daunting. This symposium will consider both the promise and limitations of recent reform efforts, highlighting the important issues that are likely to emerge as the health care system tries to improve decision making.

Contents:   Continue reading

Update and Thoughts on Lawsuit Over Medicare Hearing Backlog

Several months ago, I promised to post my thoughts on the viability of the American Hospital Association’s threatened lawsuit against the Secretary of Health and Human Services challenging the growing backlog of coverage appeals.  (See my post here).  That issue has become timely, because the AHA and several providers filed suit in May in the District of Columbia, and a few days ago filed a motion for summary judgment.   (See here).  There has been some coverage of the suit.  (See here and here.)  In short, their argument is that the statute says that a hearing must be held in 90 days and Medicare officials admit that the plaintiffs will not get a hearing for years, so therefore the court should order “mandamus,” forcing compliance with the 90 day deadline.

When I was in practice before moving to academia, I represented the Secretary in cases like this, so keep in mind my view might be biased.  But the government’s response to the complaint is due (by my calculation) Monday, July 28, so I wanted to offer my quick reactions about the case and what sort of response we might hear from the government.  I’ve just read over the AHA’s motion for summary judgment and I think that in a case like this, with an admitted violation of a statutory requirement, you have to start with the presumption that things could go bad for the government.  But with that said, I don’t think that the government’s case is as gloomy as it might at first appear, so this could be an interesting case to watch going forward.

Continue reading

Big Data, Predictive Analytics, Health Care, Law, and Ethics

Update: The Moore Foundation has generously paid to make my article available as open access on their website here. Today I am speaking at Health Affairs’ “Using Big Data to Transform Health Care” in DC, that will also launch its new issue devoted to the topic. I have a co-authored paper in the volume entitled “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care” that has just been released. Ironically the article is behind a paywall (while data wants to be free, I guess big data is different!) Here is the abstract.

Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.

I will also have a related paper on mobile health coming out later this summer that I will blog about when it comes out…

In the Aftermath of Hobby Lobby

By Gregory Curfman and Holly Fernandez Lynch

[A quick follow up to our recent NEJM Perspective on the case, with I. Glenn Cohen]

Immediately after Justice Samuel Alito’s announcement on June 30 of the majority opinion in Burwell v. Hobby Lobby, the Supreme Court took further actions on the contraceptive mandate, and both supporters and opponents of the opinion were furiously assessing the implications and impact of what has proved to be a wild week for women’s access to contraception.

A report from the IMS Institute last April found that 24 million more prescriptions for oral contraceptives without a copayment were written in 2013 (when the contraceptive mandate was in full effect) than in 2012 (when it was not). This translates into a savings of $483 million for women (on average $269 per person). The percentage of women with no out-of-pocket costs for contraceptives increased from 14% to 56%. What will be the impact of the Supreme Court’s decision in Hobby Lobby on these trends?

The Hobby Lobby opinion is quite clear that the contraceptive mandate, spawned by the Affordable Care Act, may not be enforced against closely held, for-profit companies with religious objections to paying for contraceptives coverage. In other words, such companies will not face the hefty fines for noncompliance that would otherwise be imposed by the Department of Health and Human Services.

Nonprofit Organizations

The opinion does not, however, apply to religious-affiliated, nonprofit organizations, such as Catholic schools or religious charities. For such organizations that object to paying for contraceptives coverage, the applicable regulation provided an accommodation by which the entities themselves were off the hook, but instead their insurers (or in the case of self-insured organizations, a third party administrator) would be required to provide free contraceptives coverage without cost to either the employee or the employer.  In order to be eligible for this accommodation, the nonprofit entity must complete a form designating its objection and provide a copy to its health insurance issuer or a third party administrator. A number of nonprofits filed lawsuits asking that they be exempt from even this requirement, on the grounds that they were still being required to violate their religious beliefs by deputizing someone else to provide the objectionable services. One such group, the Little Sisters of the Poor in Colorado, a group of nuns who perform charity work, was granted an injunction by the Supreme Court last January.

Continue reading

Religious Freedom and Access to Health Care

SCOTUSfrontCheck out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman.  We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space.  We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.

Take a look and let us know what you think!

On Agency Accommodations and Least Restrictive Alternatives

Nadia N. Sawicki

Did HHS shoot itself in the foot by providing an accommodation to religious non-profits?

In holding that the contraceptive mandate imposed by HHS on Hobby Lobby and Conestoga Wood was not the “least restrictive alternative” for providing no-cost contraceptive coverage to women, the Supreme Court pointed to the accommodation HHS recently provided to religiously-affiliated non-profit corporations. Under the accommodation, “eligible organizations” such as religiously-affiliated hospitals and universities can avoid funding insurance coverage for contraceptives if they certify that they have a religious objection to providing such coverage. In such cases, the eligible organization’s insurance issuer must exclude contraception from the organization’s group health insurance plan, and instead provide a separate issuer-funded contraceptive plan directly to employees. Given that such an accommodation is already in place for some employers, the Supreme Court noted, “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.”

One obvious problem with the Court’s assertion, noted in Justice Ginsburg’s dissent, is that the Court expressly declined to determine whether such an accommodation would in fact be permissible under RFRA. Given the challenges to the accommodation-by-certification requirement already brought by organizations like Little Sisters of the Poor, it is far from clear that the current composition of the Supreme Court would uphold this requirement if faced with a direct challenge.

A second, perhaps less obvious, concern about the Court’s proposal that the eligible employer accommodation be extended to for-profit corporations is that HHS may now regret providing it – and as a result, HHS may refrain from making similar accommodations in the future, which would be a significant loss to defenders of religious freedom.

Continue reading

What the EPA Case *Really* Has to Say About the ACA Subsidies Cases

By Abbe R. Gluck

Cross-posted at Balkinzation and Election Law Blog.

The proponents of the Affordable Care Act (ACA) tax subsidies law suits (currently pending in both the D.C. and Fourth Circuits and which I have discussed here, herehere, and here) have seized on the Court’s recent decision in Utility Air Regulatory Group v. EPA—going so far as to file letters of supplemental authority with both courts highlighting the case as additional relevant authority for the subsidies suits.   We should hope that the courts understand the ACA—and the specifics of the subsidies challenge—well enough to understand how different these cases are.  There is also much in Utility Air, not mentioned by the challengers, that supports the Government’s position in the ACA case, and that should resonate with even the most textualist of judges.

The ACA challengers’ filings and blog posts highlight the part of Utility Air in which the Court refused to let EPA “tailor” the Clean Air Act’s explicit pollution thresholds (raising them higher than the statutory allowance because greenhouse gas emissions are much greater than conventional pollutants).  They also highlight the Court’s invocation of the so-called “major questions” rule—the presumption that Congress does not delegate decisions to agencies of vast economic and political significance without making that delegation clear.

The subsidies challenges present completely different facts.  The issue in those cases is whether a line in the ACA that provides that the subsidies shall be available to individuals enrolled in insurance “through an Exchange established by the State under section 1311,” clearly also excludes individuals enrolled through federally-operated exchanges.  The challengers have made this argument because more than half of the states are using federal exchanges and denying the subsidies on those exchanges would be lethal to the ACA’s operation.   Both HHS and the IRS have interpreted the statute as providing the subsidies on the insurance exchanges operated by both the state and the federal governments.  Their interpretation is based on the fact that numerous other provisions of the statute, as elaborated in the government’s briefings, would be nonsense and superfluous under the challengers’ reading.  One of many possible examples is ACA §36B(f), which  provides that: Continue reading

An Autism Diagnosis: Still the Key to Unlocking Needed Services?

By Kate Greenwood

Cross-Posted at Health Reform Watch

In a recent, very moving, post about her son’s diagnosis with autism at age eight, blogger Amy Storch writes: “I guess I should mention the obvious — district services for Autism are much more comprehensive than ADHD.” An autism diagnosis should not, as a matter of law, be the key that unlocks needed special education services. Both autism and ADHD “count” as disabilities under the Individuals with Disabilities Education Act (the relevant regulation is here), and the Act provides that a child with either diagnosis who needs special education services is entitled to an educational program “designed to meet their unique needs.” As a matter of fact, though, an autism diagnosis may mean—as it apparently does in Storch’s school district—a more comprehensive program. An autism diagnosis can also be the key to getting necessary services outside of the school setting, through private health insurance.

According to the advocacy group Autism Speaks, 37 states plus the District of Columbia and the United States Virgin Islands have enacted laws requiring state-regulated private health insurance plans to pay for applied behavior analysis and other therapies children with autism often need. As I blogged about previously here, some of these state insurance mandates are relatively broad—New Jersey’s law requires private insurers to cover applied behavior analysis for children with autism, but also to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability.” Other states’ mandates, however, are strictly limited to children on the autism spectrum. Daniela Caruso of Boston University School of Law writes about Florida’s decision to limit its insurance mandate to children with autism here, attributing it at least in part to advocates’ success persuading legislators to view autism through a “dual frame of beauty and invasion.”

The Patient Protection and Affordable Care Act’s requirement that individual and small group health insurance plans cover ten essential health benefits, and in particular its requirement that plans cover “rehabilitative and habilitative services and devices,” promised to ease access to applied behavior analysis and other therapies often needed by children by autism. Habilitative care is left undefined in the statute, but it is defined at HealthCare.gov as “[h]ealth care services that help you keep, learn, or improve skills and functioning for daily living,” for example “therapy for a child who isn’t walking or talking at the expected age.”

There is a wrinkle, however. Continue reading

Waiting for Hobby Lobby–A brief refresher of the issues

Cross post from healthlawprof blog

Jennifer S. Bard

Since the likelihood is that many readers of this blog will be asked to comment when the Supreme Court, some time this week, announces its decision in Hobby Lobby and Conestoga Wood Specialty cases here’s a brief refresher and some links.  The cases are challenges to the Affordable Care Act’s requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception.  The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.

This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must include ten essential benefits, including contraception.  Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception.  They believe these contraceptives terminate rather than prevent pregnancy.  Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.

The cases raise three major issues:

  1. Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)
  2. Is providing insurance that covers birth control a “substantial burden?” on these two company’s’ religious beliefs?
  3. Does the government have a compelling reason for requiring companies that provide insurance to have it cover birth control?

Continue reading

“Isn’t Incarceration Better than Death?”

Katherine L. Record, JD, MPH, MA

Shortly after criticizing Massachusetts for incarcerating innocent individuals with substance use disorder (SUD) when drug rehab facilities are full, I received an email from a woman who lost her son to a heroin overdose just four months ago.

“Is preventing an overdose by detaining the SUD sufferer not a better alternative than leaving them to languish?” she asked.

She had found her 24 year-old son cold and blue, just hours after kissing him goodnight. He had been evicted from his sober living home for testing positive for drugs, but his mother did not know he had relapsed when he arrived at her front door. He was, in hindsight, a clear danger to himself – so why did his step-down house let him wander away? Why didn’t anyone call the authorities? Is jail not better than death?

Continue reading

Sunstein Keynote at Petrie-Flom Annual Conference featured in Harvard Law Today

sunstein-atlanticHarvard Law Today has posted a feature on Cass Sunstein’s keynote address at the 2014 Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy.” Sunstein, who is the Robert Walmsley University Professor at Harvard Law School and the co-author of Nudge: Improving Decisions About Health, Wealth, and Happiness, addressed the opening day of the conference on May 2, 2014, on the subject of “Choosing Not to Choose.”

Full video of the conference will be available soon via the Petrie-Flom Center’s website. In the meantime, you can read about and view Sunstein’s keynote address here.

A Drug Epidemic’s Silver Lining

By Katherine L. Record

Can there be a silver lining to a drug epidemic that is so extreme it is deemed a public health emergency? As prescription opioid (painkiller) addictions drive individuals to heroin, there just might be.

Heroin use has surged recently – seizures of supply increased by nearly 70% over the last few years in New York (the epicenter for imports into the United States). In Boston, overdoses increased by nearly 80% between 2010 and 2012. This has followed a rising trend in prescription opioid addictions – 4 out of 5 users are addicted to prescription painkillers when they first try heroin. Turning to the street opioid is often a move of desperation; prescription opioids are now harder to abuse, more expensive, and harder to obtain than heroin. In other words, heroin provides a cheaper, easier to score, and stronger high.

This surge in use is changing the face of heroin; the Office of National Drug Control Policy’s director recently described the drug as a former “inner city problem” that has become classless, affecting “all populations and all ages.” To be blunt, white people – many with high paying jobs and fancy apartments – are now doing 8 to 10 bags a day.

Continue reading

The Right to Health at the Public/Private Divide: A Global Comparative Study

In the U.S., the right to health is often held up as a utopian legal principle that other countries manage to embrace and that we shortsightedly spurn.  What I learned working on a new project is that the right to health does not always lend itself to admirable ends.  In some countries, a formal right to health is not used to advance equity but rather for the opposite.  In other words, having a right to health can lead to a less equitable distribution of health care resources because, for example, people who are better able to navigate the legal system can claim more resources for themselves.

This insight and others are featured in an excellent book that just came out from Cambridge Press, The Right to Health at the Public/Private Divide: A Global Comparative Study, edited by Colleen M. Flood, University of Toronto, Faculty of Law and Aeyal Gross, Tel-Aviv University, Faculty of Law.  This book is worth reading, in part, because it features chapters on countries that are not the usual suspects, including Hungary, Venezuela, Nigeria, New Zealand, and Taiwan.  Two of the chapters are by U.S. health care scholars: one I wrote on the U.S. system and the Affordable Care Act (A Vision of an Emerging Right to Health Care in the United States: Expanding Health Care Equity through Legislative Reform) and one Christina Ho wrote on China (Health Rights at the Juncture between State and Market: the People’s Republic of China).

In my chapter, I argue that while the U.S. does not have a formal right to health, the ACA could provide the vision and foundation for an evolving American conception of a right to health care.

Medicaid ACOs in New Jersey: At the Starting Line at Last

By Kate Greenwood

Cross-Posted at Health Reform Watch

Nearly three years ago, in July of 2011, Tara Adams Ragone wrote a blog post for Seton Hall Law’s Health Reform Watch blog entitled “Community Based Medicaid ACOs in New Jersey: A Signature Away”. As Professor Ragone explained, a month earlier the New Jersey legislature had passed Senate Bill 2443, which established a Medicaid accountable care organization (ACO) demonstration project, but Governor Chris Christie had not yet signed it. “It’s an exciting time for growth and innovation in the Garden State,” Professor Ragone wrote, “if we just get that signature.”

Governor Christie did go on to sign Senate Bill 2443 into law, in August of 2011, but the implementation process has been protracted. The act required the Department of Human Services to “adopt rules and regulations” that provided for oversight of the quality of care delivered to Medicaid recipients in the ACOs’ designated geographic areas and set standards for the gainsharing plans that participating ACOs must develop. The deadline for adopting the regulations was in June of 2012, but they were first issued, in draft form, in May of 2013. The final regulations were not adopted until earlier this week, one day before the proposed regulations were due to expire.

As Andrew Kitchenman reports here, with the regulations in place, the three community-based organizations that have been preparing to launch Medicaid ACOs, one in Camden, one in Trenton, and one in Newark, can finally get started. Unlike the State, they will have to move quickly; the deadline for applying to participate in the three-year demonstration is July 7th.

There is, in Kitchenman’s words, “a final piece to the puzzle”—the participation of managed care organizations (MCOs). Continue reading

Preventing Post-hospital Syndrome

By Michael Young

Recent Center for Medicare & Medicaid regulations incentivizing reductions in 30-day hospital readmission rates have prompted a flurry of research into how clinicians and administrators can optimize patient health following hospital discharge.  Preventable hospital readmissions in the U.S. are estimated to account for up to $15 billion in annual healthcare spending.  In considering this problem, many analysts and innovators have focused on deficiencies in transitional care as a root cause of many preventable readmissions.  While efforts to improve transitional care carry considerable promise, they tend to leave relatively underexplored a determinant of readmissions of equal if not paramount importance: the inpatient experience itself.

Writing in this week’s JAMA, Allan Detsky and Harlan Krumholz propose seven key interventions that can enhance patients’ hospital experiences and in so doing may portend improvements in patient health following discharge.

Continue reading

#BELHP2014 Panel 2, Potential Problems and Limits of Nudges in Health Care

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

By Matthew L Baum

In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.

The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.

Continue reading

#BELHP2014 Plenary 1, Provost Alan Garber

Provost Garber at the Conf

Provost Garber at the Conf

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is the first installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Alan M. Garber is Harvard’s provost, and both an economist and a physician by training.  He holds appointments in the medical school, the faculty of arts and sciences, the school of government, and the school of public health.   [Perhaps I should have just listed the colleges that haven't yet given him an appointment?]  I’ll mostly just paraphrase Garber’s talk, and sparsely add my own comments in brackets [as I just did].

Garber’s talk is focused on the Affordable Care Act, and says that it has two purposes:  expand access to care, and reduce the costs of care.  The latter is particularly important, given the way healthcare is impinging on the larger United States economy.

Continue reading

FRIDAY & SATURDAY: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, & Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

Continue reading

On Patents, Patients and the Public Interest

By Michael Young

Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent.  After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards' valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014).  Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.

While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.

Continue reading