Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.
This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.
The event is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine, and co-sponsored by Health Affairs, The Hastings Center, and the Center for Bioethics at Harvard Medical School. Below, we will highlight a few themes that have emerged so far. The conference’s speakers will author a series of posts that follow on more specific topics.
The Affordable Care Act
In January 2013 at the First Annual Health Law Year in P/Review, we reviewed National Federation of Independent Business v. Sebelius, the first examination of the Affordable Care Act (ACA) by the Supreme Court. The opinion in that case, written by Chief Justice John Roberts, stunned many Supreme Court pundits and has greatly affected health insurance coverage in the U.S.
While the individual mandate was upheld under Congress’ taxation power, the requirement for states to expand Medicaid or lose their existing Medicaid funding was struck down, resulting in many fewer citizens benefiting from the safety-net program than the law intended.
Of course, NFIB v. Sebelius did not end the Supreme Court’s examination of the ACA. At this year’s conference, we will review the Act’s second trip to the Supreme Court, Hobby Lobby Stores, Inc. v. Burwell, and preview the third trip scheduled for March 2015, King v. Burwell (and other related cases pending in lower courts).
In Hobby Lobby, the Court held that as applied to closely-held, for-profit corporations, the contraceptive mandate derived from the ACA was an unacceptable violation of religious freedom, thereby allowing such employers to refuse to cover contraceptives without copayment in their employee health plans, as would otherwise be required. This legal result leaves many women without the sort of family planning coverage recommended by health care experts.
At issue in King v. Burwell are the subsidies provided for the purchase of health insurance on the exchange established by the federal government. The challengers claim the subsidies should only be available through exchanges established by the individual states. The fate of these subsidies will affect the health care coverage of millions of citizens who live in one of the 36 states that rely on the federal exchange.
Public Health Policy
As in years past, this year’s event will address some of the most pressing issues in public health law. In the First and Second Annual P/Review conferences, tobacco was an important topic of discussion, and we examined the constitutionality of federal regulations mandating graphic warning labels on cigarette packages. This year, tobacco is back raising different, but no less interesting, public health questions. Recently CVS Health, the second-largest pharmacy chain in the U.S., made the strategic decision to cease the sale of tobacco products in its retail stores.
We will explore the rationale for this business decision and assess the ramifications to date, both for the company and for the health of the public. Also, during the past year, the popularity of e-cigarettes has grown exponentially, raising questions of whether they represent a valuable tobacco-cessation product or actually promote the initiation of tobacco use. As the FDA considers whether and how to regulate these devices, we will preview the legal and public health dimensions of the proposed rule.
We will also analyze the most recent example raising foundational issues at the heart of public health law and ethics: the Ebola crisis of 2014-15. Among the many important questions the worst Ebola epidemic in history are the role of travel restrictions, quarantines for returning health care workers, and the way in which newly-developed vaccines will be studied in clinical trials.
Want whiter teeth but don’t want to pay the dentists’ prices of $400 to $1300 for the whitening procedure when non-dentists charge only $75 to $125? The Supreme Court’s decision in North Carolina Board of Dental Examiners v. Federal Trade Commission will determine your options. The North Carolina Board of Dental Examiners ruled that only dentists may offer teeth-whitening services. At issue in the case before the Court is whether the state-established board is immune from federal antitrust laws such that it may legally exclude non-dentists from offering teeth-whitening services.
We will also examine antitrust challenges directed against hospital mergers, which have become increasingly commonplace throughout the country. Defenders claim that through economies of scale, mergers may improve the efficiency and quality of care offered by the merged institutions, while opponents say they drive up health care costs by unduly expanding market share. The outcomes in multiple antitrust actions will affect the organization and function of many hospitals involved in such mergers throughout the nation.
Veterans Health Administration Scandal
2014 was a difficult year for the Veterans Health Administration (VHA), which came under attack for long waiting times for health care resulting in the death of 35 veterans in the Phoenix, Arizona, VHA hospitals. The Secretary of Veterans Affairs, Eric Shinseki, was forced to resign. We will provide an update on the problems within the VHA and potential solutions.
Other topics covered in the upcoming Third Annual Health Law Year in P/Review will include legal measures to stem antibiotic resistance, financial conflicts of interest and the Physicians Payment Sunshine Act, family law and medical child abuse, the role of health professionals in executions, the story of Brittany Maynard and its effect on the right-to-die movement, key life science intellectual property cases, FDA regulation of lab-developed tests, employee wellness programs, and regulatory oversight of learning health care systems.
Each year, our list of topics expands and develops, as new issues come to light and existing challenges percolate or reemerge. Without a doubt, the law plays an enormous role in shaping our health and health care system in myriad ways.