Editor’s note: These issues and more will be discussed at the 5th Annual Health Law Year in P/Review conference, to be held on January 23, 2017, at Harvard Law School in Cambridge, MA. The event is free and open to the public, but registration is required. Conference presenters will participate in a blog series to follow here on Health Affairs Blog. Stay tuned. In the meantime, you can check out last year’s Health Law Year in P/Review blog series here.

“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title of a Steinbeck novella, may become the mantra for health policy in 2017.

The Affordable Care Act (ACA) was the largest and most ambitious alteration to American health policy in a generation. By the middle of 2016, it appeared to be largely “settling into place,” and the quartet of Supreme Court encounters with the law have by now been largely resolved. The Constitutional commerce and taxation clause challenges of NFIB v. Sebelius have been decided, with the Court weakening Medicaid expansion and causing other problems, albeit not ones that threatened the vitality of the overarching statutory scheme due to preservation of the individual mandate.

The decision in King v. Burwell left funding for the insurance Exchanges intact. Controversy over the contraceptive coverage requirements stemming from the Act remains, with the Court punting on the extent to which its analysis from Burwell v. Hobby Lobby ought to apply to challenges raised by other types of objectors in Zubik v. Burwell, leaving the litigants with a strange “Can’t you guys just work this out on remand?” sort of resolution.

Future litigation on this matter remains on the horizon for the lower courts, but this particular issue is not an existential threat to President Obama’s vision for 21st century health care on the magnitude of the other SCOTUS cases (without meaning to belittle the real needs of American women for contraceptive coverage). As we neared November 8, it looked like finally we were at a point where if we were nice before Christmas, we might receive the gift of a year at the U.S. Supreme Court in which the ACA was not on the docket.

The First 100 Days

But all of this changed with the election. After a campaign in which health policy was very much in the background (to be fair, this was also true of much domestic policy other than immigration during this election season), health care reform is now promised to be one of the signature goals of the Trump administration’s first 100 days. With a fierce Affordable Care Act critic nominated to head the Department of Health and Human Services (HHS), and the drumbeats of “Repeal and Replace” repeated in almost-bacchanalia fashion, one is expecting a major earthquake in this area. The health care markets seem to reflect that prediction, though reasonable minds differ on how much stock to put into those numbers. But, of course, “replace” is much harder than “repeal.”

Will Republicans be able to keep the exclusion of preexisting conditions, restrictions on annual and lifetime caps, and complete coverage of preventative care services, without an individual mandate? How will this goal interface with commitment to the deficit-reduction tax-aversion demanded by deficit hawks and anti-tax crusaders of the Grover Norquist type? What will be the effect on the cost-to-quality equation of a shift to Medicaid block grants for the states, if they go through, and what will happen to the existing Medicaid Expansion deal under a Trump health care reform? Tremendous uncertainty awaits as we enter the new year, though I expect that we will see a slowing down of the repeal and replace process, with even the individual mandate persisting for some time; unmaking the Affordable Care Act without leaving millions stranded will be harder than the campaign may have suggested.

The 21st Century Cures Act

But wait, there’s more… If the revolutions in health insurance and coverage were not enough to induce vertigo, there are several other major changes on the way for 2017. The first is the 21st Century Cures Act, signed into law on December 13, 2016. With broad bipartisan support (though a few notable holdouts including Elizabeth Warren and Bernie Sanders), it allocates a $4.8 billion to the National Institutes of Health (NIH) over 10 years for the Cancer Moonshot, the Brain Initiative, the Precision Medicine Initiative, and other research. It also increases much needed funding for opioid abuse. But the key question is whether Christmas came early only for the pharmaceutical industry or whether this is a boon for the American patient as well?

Are the new provisions relating to use of “real world evidence,” biomarker surrogate end points, novel trial design, and accelerated approval for stem cell therapies going to modernize the Food and Drug Administration (FDA) into a 21st Century drug regulator or chip away at the centrality of safety and efficacy in its review? How will President Trump’s choice to head the agency inflect these answers? How will all this interface with federal law governing human subjects research? A proposal to amend the Common Rule has been in uncertain status for some time, with lingering questions now as to whether it will come out in some form before Inauguration. If not, is there any prospect for adopting some of it during a Trump Administration, and should we cheer or jeer for that possibility?

What’s Next for Health Policy?

Of course, beyond health insurance and FDA policy, 2017 promises many more fascinating questions, including:

  • How will the U.S. approach cutting edge reproductive technologies and new genetic technologies such as mitochondrial replacement therapy, in vitro gametogenesis, gene editing, and gene drives?
  • How will the courts wrestle with new restrictions on abortion being passed at the state level, and what impact will the Supreme Court’s decision last term in Whole Woman’s Health v. Hellerstedt have?
  • Have we seen the last of Zika, and what does the public health community’s response to it and Ebola tell us about where this country is on outbreak preparedness and management?
  • Will we make headway on the crises at the center of poverty, public health, and local government, highlighted by the Flint water safety debacle? How will the Supreme Court’s latest patent cases and the follow-ups from the Federal Circuit affect the market for drugs, devices, and diagnostics?

There’s certainly no dearth of health policy issues ramping up for 2017. And like everything else in the new administration, we’re surely in for some surprises.

Author’s note

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.