Four Key Issues In Health Law That Are As Relevant As Ever In 2016

2016-01-20 | Health Affairs Blog

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Spring may be the season of renewal and growth, but each year, January offers a chance for reflection and hope, learning from the past and taking on new challenges. The same is true in the world of health policy. As we embark on the new year, it’s the perfect time to take stock of which major issues remain outstanding from years past and which are coming down the pike.

Contraceptive Coverage Mandate

Any annual list of key issues in health law policy will be subjective, but it’s safe to say that the Affordable Care Act (ACA) would top any one of them. In the immediate wake of the law’s passage, the focus was on general implementation issues (including roll-out of the Exchanges), and of course constitutionality and attempts at repeal.

Attempts at repeal keep coming, but with the current balance of power in Washington, they seem to be more posturing than anything else. Although much of the litigation has finally died down, that has not been the case with regard to application of the contraceptive coverage mandate stemming from the ACA’s requirement to cover free preventive care.

Burwell v. Hobby Lobby Stores made a big splash in 2014 when the Supreme Court ruled that a secular, for-profit business owned by a religious family did not have to comply with regulations that would have required the company to cover free contraceptives on its employee insurance plans.

The Court left open the question of whether the accommodations that had been offered to religious non-profits would satisfy the legal standards protecting religious freedom, but will decide that question this term, in response to challenges brought by religious organizations claiming that they should be completely exempted from the coverage requirement. Litigation has also been brought by those with secular objections to contraceptive coverage, although those cases have not yet reached the Supreme Court.

Incremental Progress v. Total Reboot

Back to the ACA more generally, the real work continues with regard to Medicaid expansion, the ultimate fate of the “Cadillac tax” (which has already been delayed by two years), and most importantly, whether the required coverage is really affordable or adequate for consumers, and whether Exchanges will prove to be economically viable markets. With the presidential election on the horizon, the most important health policy question of 2016 is whether we’ll build on the reforms we have, or start again from scratch.

Controlling Costs

Relatedly, efforts to stem health care costs have been at the top of the list for some time, and will certainly remain there for the foreseeable future. Concerns are ever present about hospital system and insurance company mergers, resulting in restricted competition and raising serious antitrust issues.

Substantial attention is also increasingly being paid to common-sense efforts to link payment to the value of the care provided, rather than just the quantity of services, although there is debate about how and how quickly to push this approach. Since the ACA entrenched employers as a key provider of health insurance, more employers have begun to experiment with various incentives to encourage their employees to protect and improve their health through workplace wellness programs, thereby reducing employers’ costs overall.

Although these approaches may take advantage of certain “nudging” techniques, questions have been raised about their effectiveness and their legal permissibility in light of employer access to health information that may be used for discriminatory purposes.

Other attempts to stem costs focus on calibrating intellectual property rights in pharmaceutical products and medical devices, seeking the elusive balance between incentivizing appropriate innovation while promoting reasonable costs. This is not a new issue, of course, but it remains woefully unresolved, perhaps as best exemplified by Martin Shkreli’s controversial price hike of Daraprim, and other high profile cases in which companies have taken advantage of what some have called “loopholes” in FDA market exclusivity programs.

Regulatory Pathways

Beyond price issues, getting new products to patients who need them as quickly as possible is an ongoing theme in health law policy, but one that has increasingly picked up steam as the drug safety scandals of the 2000s appear to be fading from memory.

The 21st Century Cures Act is winding its way through Congress, with the goal of promoting the development and speeding the approval of new drugs and devices. As Jerry Avorn has explained, the proposal would provide a welcome and substantial increase in the National Institute of Health’s (NIH) budget, but could result in product approvals with substantially less data, putting patients at risk.

For their part, patients are increasingly clamoring for drugs even before they get approved, demanding a “right to try” experimental therapies when other options have run out. Several states have passed “right-to-try” laws (deemed dubious by some), and companies have responded by developing new policies to handle patient requests. At the same time, there are other patients who are ready to die and seek aid in doing so, prompting a 2015 legislative change in California, and new proposals in other states.

And More…

Other top issues at the moment include the extent of FDA’s ability to regulate off-label promotion in accordance with First Amendment principles, how best to stem the opioid-addiction epidemic, responses to attempts to defund Planned Parenthood and curtail abortion rights around the country, and the future of regulatory oversight of federally funded human subjects research in light of the recent Notice of Proposed Rule Making to amend the Common Rule. Less traditional issues that must nonetheless be key priorities for health policymakers in 2016 and beyond include whether and how to respond to gun control as a public health issue, as well as implications of the #blacklivesmatter movement for health and health care.

How these issues play out will be influenced in large part by the upcoming elections, and it is apparent that the parties could not be further apart on their desired approaches. As evidenced by the fact that the major themes have not changed dramatically over time—health care spending, the government’s role in health care markets, the proper purview of the FDA, and the like—these issues clearly are not easily resolved, but they are critical. One thing is for certain: health policy scholars will be busy again in 2016.

Author’s Note

We will be discussing these issues and more at the 4th Annual Health Law Year in P/Review conference, to be held on January 29, 2016, at Harvard Law School in Cambridge, MA. We invite you to join us: The event is free and open to the public, but registration is required. Conference presenters will participate in a blog series to follow here at the Health Affairs Blog. Stay tuned.

This year’s P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, The New England Journal of MedicineHealth Affairs, The Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

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