What is the Meaning of Trump’s Day 1 Executive Order on the ACA?

Guest Post by Erin C. Fuse Brown

On the day of his inauguration, President Trump signed an executive order instructing the executive branch agencies to exercise their discretion and authority to  “waive, defer, grant exemptions from, or delay the implementation of” fees, taxes, or penalties under the Affordable Care Act (ACA).

The order does not specify which “fiscal burdens” it targets, but the individual mandate, the employer mandate, and the various industry and payroll taxes imposed by the law immediately jump to mind. These are all written into the law, and the President cannot unilaterally set them aside. The executive order says it is following the law, including the Administrative Procedure Act, which is good because it means the President is not instructing anyone to flout the law. Even existing ACA rules cannot be undone overnight and can only be changed or repealed through a lengthy notice-and-comment rulemaking process.

There is such a thing as “enforcement discretion,” which some suggest means that the individual mandate won’t be enforced anymore. I’m not so sure. If the President instructed the IRS to stop collecting taxes from billionaires under its enforcement discretion, that wouldn’t be legal. Continue reading

Digital Health @ Harvard Brown Bag Lunch Series: Free Independent Health Records, featuring Adrian Gropper, MD

January 26, 2017 12:00 PM
Berkman Klein Center for Internet and Society
23 Everett St., 2nd floor, Harvard Law School, Cambridge, MA

Register for this event

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology. The series is cosponsored by the Berkman Klein Center for Internet & Society at Harvard University and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The goal of the series is to discuss ongoing research in this research area, share new developments, identify opportunities for collaboration, and explore the digital health ecosystem more generally.

These lunches are free and open to the public, but RSVPs are required. RSVP now!

This Month

Dr. Adrian Gropper is working to put patients in charge of their health records, arguably the most valuable and most personal kinds of connected information about a person. They encompass elements of anonymous, pseudonymous, and verified identity and they interact with both regulated institutions and licensed professionals. Gropper’s research centers on self-sovereign technology for management of personal information both in control of the individual and as hosted or curated by others. The HIE of One project is a free software reference implementation and currently the only standards-based patient-centered record. The work implements a self-sovereign UMA Authorization Server and is adding blockchain identity as self-sovereign technology to enable licensed practitioners to authenticate and, for example, write a compliant prescription directly into the patient’s self-sovereign health record. Continue reading

Housing Equity Week in Review

Here’s the latest in housing equity and law for the week of January 16-22, 2017:

Did we miss anything? Let us know.

Visiting Health Law Position at Indiana University Robert H. McKinney School of Law

The Indiana University Robert H. McKinney School of Law invites applications for a visiting assistant professor position for 2017-18. The position would primarily involve teaching courses in the Health Law curricula and participation in the scholarly and student-centered activities organized by the law school’s Hall Center for Law and Health.

Applicants should indicate what Health Law courses they could offer and any additional courses they would be interested in teaching.

Please submit a letter of interest, a cv, and a list of three references to: Vice Dean Antony Page, Indiana University Robert H. McKinney School of Law at page@iu.edu  and Professor Nicolas Terry, terry@iupui.edu. The closing date for applications is Friday, February 24, 2017.

We are committed to achieving excellence through intellectual diversity and strongly encourage applications from persons of color, women, persons with disabilities, the LGBT community, veterans, and members of other groups that are under-represented on university faculties. The law school is an Equal Opportunity/Affirmative Action Institution and offers domestic partner benefits.

Can the Right to Stop Eating and Drinking be Exercised via a Surrogate Acting Pursuant to an Advance Instruction?

by Norman L. Cantor

The right of a grievously stricken, competent patient to hasten death by ceasing eating and drinking is increasingly recognized. In the typical scenario, a person afflicted with a serious degenerative disease reaches a point where the immediate or prospective ordeal has become personally intolerable.  The stricken person decides to shorten the ordeal by stopping eating and drinking, precipitating death by dehydration within 14 days.  The dying process is not too arduous so long as there is a modicum of palliative care available – emotional support, lip and mouth care, and provision of a sedative if patient agitation or disorientation ensues.

A further question is whether a person can dictate a similar fatal course for his or her post-competence self by advance instruction to an agent.  The instruction would be that — once a pre-defined point of dementia has been reached — either no food or drink should be offered to the incompetent patient or no manual assistance should be provided where the patient is not self-feeding.  This post-competence SED tactic appeals to persons who view the prospective demented status as intolerably demeaning and wish to hasten their demise upon reaching that state. The legal claim would be that if a competent patient has a right to SED, the right ought to subsist post-competence when exercised by clear advance instruction.  According to this claim, just as an advance instruction to reject a respirator would be upheld as an exercise of prospective autonomy, so an instruction for cessation of nutrition should be respected.

     A person who undertakes responsibility for a demented person normally has a fiduciary duty to promote the well-being, comfort, and dignity of the ward.  A guardian who forgoes available care measures such as shelter, warmth, hygiene, and food is chargeable with unlawful neglect.  Provision of food and assistance in eating are normally part of that fiduciary obligation.  A legal exemption might apply, though, if the guardian – in discontinuing hand feeding pursuant to an advance instruction — is simply respecting the right of the ward to exercise prospective autonomy. The question becomes: Is the acknowledged right to SED exercisable by means of an advance instruction?  Continue reading

MONDAY (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

Sam Halabi on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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We welcome University of Missouri-Columbia law professor Sam Halabi, who brings a wealth of academic and practical experience to the podcast. He is interested in corporate governance and regulation at both national and international levels. He has edited (with Lawrence O. Gostin and Jeffrey S. Crowley) Global Management of Infectious Disease after Ebola (Oxford University Press, 2017) and his book, Intellectual Property and the New International Economic Order: Knowledge, Exploitation, and Resistance is scheduled for publication by Cambridge University Press in 2018.

We discussed Sam’s article Selling Hospice (among others). Listeners may also be interested in a WaPo series on hospice care. The lightning round focused on past guest Allison Hoffman’s recent post on the seismic shift in the health policy landscape, the 21st Century Cures Act, new SAMHSA rules, and an OCR resolution agreement.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

The ACA’s Real Effect: Moving the Goalposts

By Christopher Robertson

“I believe and I look forward to working with you to make certain that every single American has access to the highest-quality care and coverage that is possible. … [W]e believe it’s appropriate to put in place a system that gives every person the financial feasibility to be able to purchase the coverage that they want for themselves and for their family.”

That quote is not from Barack Obama.  It’s from Trump HHS nominee Tom Price, and it shows just how successfully the ACA has shifted the American political landscape towards universal coverage. As I argued earlier this month in STAT, with Glenn Cohen and Holly Fernandez Lynch, the debate is now about how to get universal health insurance coverage, rather than whether to do so.

Republicans will of course favor market-oriented approaches, and they will find difficulty conceiving a plan that is farther to the right than the ACA itself while actually achieving the goals that Price promises.  But for now, even if the ACA is soon repealed, it has succeeded in moving the goalposts for health policy.

Well-rested versus well-trained doctors: New twist in debate over resident duty hours (Part II)

When people fall acutely ill, they deserve a non-sleep deprived doctor—but they also deserve an adequately-trained doctor. There are only so many hours to the day, and so in medical education a resident’s need for self-care must be balanced against the need for maximum clinical exposure. Since 2003, when restrictions to resident duty hours were first enacted, there has been disagreement about how to best navigate the tension. Recently, the debate resurfaced when the Accreditation Council for Graduate Medical Education (ACGME) proposed a change to the policy governing resident duty hour limits. Perhaps the most surprising part of the announcement was that their proposal increased the time limit that interns (first year residents) can care for patients without sleep. The policy ACGME enacted in 2011 had capped interns at 16 hours on-call, and the proposal increases the limit to 28 hours.

In my prior post I raised arguments for and against the proposed changes to duty hour limits. Here I will unpack the conclusions and limitations of the best empirical evidence available to ACGME: the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Published in the New England Journal of Medicine (NEJM) in 2016, the FIRST Trial randomized 117 surgical residency programs nationwide to have either “standard” duty hour policies, which included the current 16-hour cap on interns, or “flexible” policies, which reflect the recent ACGME proposal. Data were collected from July 2014 to June 2105. The sister-study involving medical residencies nationwide has regrettably not yet published.

The FIRST Trial warrant close attention because, like a Rorschach test, different people see different things in the data. For instance, take the finding that neither group caused significantly more or less harm to patients, though shorter duty hours were associated with more handoffs of patient responsibility. Taken at face value, these results neither clearly bolster nor contradict the proposed duty hour changes; yet they are used to both support and undermine the tentative changes to ACGME policy. The study’s first author told NPR that, “We believe the trial results say it’s safe to provide some flexibility in duty hours.” On the other hand, an editorial published in NEJM alongside the study argues that, “The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care.” Is there a right conclusion to draw from the study? Continue reading

Congressional Ignorance and the OTA

“Who is making all these decisions about science and technology that are going to determine what kind of future our children live in? Just some members of Congress? But there’s no more than a handful of them with any background in science at all! … This combustible mixture of ignorance and power is… going to blow up in our faces”.

– Carl Sagan, in interview with Charlie Rose

ota_sealThe Office of Technology Assessment (the “OTA”) was founded in 1972. It was charged by Congress with providing “competent, unbiased information concerning the physical, biological, economic, social and political effects” of new technologies. It made predictions and forecasts about what new developments were likely and distilled the entire assessment into impartial advice and actionable steps for Congress. It was a key source for the government’s development of public policy. It was also a pioneer in citizen engagement: it was among the first of the government agencies to publish its papers online.

During its existence, it published over 750 reports on everything from acid rain to medical waste management to bioterrorism. Despite its successes, it was defunded in 1995.  This move has been compared to “Congress giving itself a lobotomy” (Chris Mooney – Republican War on Science). Chris Mooney argues that defunding the OTA was not so much a budgetary decision as a political move designed to allow the reigning party to recruit partisan scientists who would “scientifically validate” their own policy goals. Readers can examine the reports of the various Presidents’ Councils on Bioethics and draw their own conclusions. Continue reading

Preventing a post-antibiotic world

Nick Bagley and I have an op-ed in today’s New York Times calling for serious economic incentives for antibiotics, delinking revenues from sales volumes with a $4 billion prize system.

From the piece:

On Friday, the Centers for Disease Control and Prevention released a disturbing report about the death of an elderly woman in Washoe County, Nev. What killed her wasn’t heart disease, cancer or pneumonia. What killed her were bacteria that were resistant to every antibiotic doctors could throw at them.

This anonymous woman is only the latest casualty in a war against antibiotic-resistant bacteria — a war that we are losing. Although most bacteria die when they encounter an antibiotic, a few hardy bugs survive. Through repeated exposure, those tough bacteria proliferate, spreading resistance genes through the bacterial population. That’s the curse of antibiotics: The more they’re used, the worse they get, especially when they’re used carelessly. […]

Read more here.

Over Before It Started: CMS Abandons New Payment Pilot

By Zack Buck

With little fanfare, last month, the Centers for Medicare and Medicaid Services (CMS) abandoned its proposal to begin a payment pilot in which Medicare Part B would change the way it pays for pharmaceutical drugs.  As I blogged about last March, under the proposed pilot, providers’ payments would be changed from the Average Sales Price (ASP) plus 6 percent of drugs’ costs (ASP+6), to ASP plus 2.5 percent of the drugs’ costs plus a flat fee per drug per day (of $16.80). This new proposed pilot would have been time-limited, and would have allowed officials to observe the effects of such a reimbursement change on prescribing patterns in an effort to cut Medicare’s substantial drug costs.

Following an outburst of negative reaction from Medicare’s providers, the pharmaceutical industry, and Congress (including the new nominee to be Secretary of Health and Human Services Tom Price), CMS announced in December that more than 1300 public comments were submitted in reaction to the proposal.  And following November’s election and the public comments shared with CMS, the agency announced that it had decided that “the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”

Continue reading

Final Common Rule Revisions Just Published

This morning, the Federal Register posted for public inspection the final rule revising the Federal Policy for the Protection of Human Subjects (AKA “The Common Rule”).  This has been a long, long road, beginning with an ANPRM in 2011 and a massive NPRM in 2015.  The agencies clearly wanted to slide this in before the administration change on Friday, but substantial uncertainty remains.

I’ve copied the preamble’s articulation of key changes – and key proposals that have been dropped – below the fold.  But I want to briefly address the “what now?” question.  The incoming Trump administration will have its hands full with ACA “repeal and something,” so it’s hard to imagine this regulatory change will be high on the priority list, especially with some of the most worrisome proposals having been nixed already.  But the Congressional Review Act provides Congress a streamlined process to eliminate new agency rules.  Under the Act, agencies must notify Congress of new regulations, triggering a 60 legislative day review period in which Congress can pass a resolution of disapproval for presidential signature (or veto).  So that’s a possibility here.

In addition, two bills have passed the House that could impact these regulations.  First, the Midnight Rules Relief Act would amend the Congressional Review Act to allow Congress to disapprove multiple rules at once.  In other words, Congress could pass a resolution of disapproval of ALL regulations that had been recently passed to get rid of them all in one fell swoop without individual consideration.  Second, the REINS (Regulations from the Executive in Need of Scrutiny) Act, if passed, would require that “major” rules get a joint resolution of Congressional approval within 70 session days to take effect – “major” is defined as having an annual impact of $100M or more, a major increase in costs, or significant adverse effects on innovation.

Point being, don’t get too comfortable with the new rule just yet.  Key changes – and things that are staying the same – are listed below (from the Fed. Reg. notice).  And I’ll be presenting on these matters at Petrie-Flom’s upcoming conference, Health Law Year in P/Review, on Monday 1/23/17.

Continue reading

The Unhealthy Return to Individual Responsibility in Health Policy

By Allison K. Hoffman, Professor, UCLA School of Law

[cross-posted from RegBlog. see original here]

It is still an open question—at least for a little while longer—what exactly the Republicans’ Affordable Care Act “repeal and replace” promise will entail.  However, the broad contours of the Republican strategy, which both Congress and President Trump have made clear they will pursue at all deliberate speed, are already visible.

Speaker of the House Paul Ryan (R-Wis.) foreshadowed the Republicans’ central approach in his Patient’s Choice Act, a health care plan he put forward in 2009. That plan emphasized a desire to empower individuals to make healthy decisions, asserting that a “large percentage of heart disease, stroke, and type 2 diabetes, as well as many cancers, could be prevented if Americans would stop smoking, start eating better, and start exercising.” According to Ryan, the aim of health reform should be to encourage “individuals to adopt healthy lifestyles and behaviors.”

Ryan’s assumption—a theme also echoed in the other major Republican proposals on the table—is that personal responsibility will serve as a salve to the wounds of the American healthcare system. Impliedly, if Americans would only jog more and eat more vegetables, then we could dramatically reduce cancer and strokes and save a fortune on medical care. Continue reading

Housing Equity Week in Review

We’ve rounded up the latest news from the past week, January 9-15, 2017, for housing law and equity. The HUD confirmation hearing was, of course, the biggest news, but a few other items of note:

Did we miss anything? Let us know!

Tim Jost on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week we are honored to have a conversation with Professor Tim Jost from Washington & Lee School of Law. Jost, one of our most prolific scholars and astute commentators, not to mention the rock around which the Health Affairs blog is built, looks back at the successes and failures of the ACA, speculates on some of the reasons for its rocky road, and looks ahead to repeal and replacement.

Jost’s posts at Health Affairs are more urgent than ever as the uncertainty around ACA repeal/replace/delay intensifies. While his work on consumer-directed health care is particularly relevant to today’s policy environment, he has also proposed reforms to strengthen the ACA.

For some notes on items we discussed: Frank mentioned an analysis of Tom Price’s plan to replace the ACA, focusing on the plan to “block grant $1 billion dollars a year for four years (or $2.2 million per Congressional District per year) to help states fund high risk pools.” Jost mentioned a Commonwealth Fund report suggesting that amount is not even within two orders of magnitude of the true cost of such pools (at least $100 billion). But at least some people will truly benefit from ACA repeal: the 400 highest-income households each “would get an average tax cut of about $7 million a year,” according to CBPP.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Maybe For-Profit Hospitals Aren’t So Bad

By Shailin Thomas

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

Continue reading

PFC Spotlight Series: Faculty Affiliate Ameet Sarpatwari

Learn more about the Petrie-Flom Center’s work through our Spotlight Series, which features interviews with Student and Academic Fellow alumni, as well as current Faculty Affiliates.

sarpatwari_peopleThis week’s post features Ameet Sarpatwari, J.D., Ph.D., who is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL). His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Read the article to learn more about his contributions to the Center and its mission!

Pharmacist Vaccination Laws, 1990-2016

Since the 1990s, there has been a growing movement to improve access to immunization services by giving pharmacists the authority to administer vaccines.

The newest map on LawAtlas.org explores state laws from 1990 to 2016 that give pharmacists authority to administer vaccines and establish requirements for third-party vaccination authorization, patient age restrictions, and specific vaccination practice requirements, such as training, reporting, record-keeping, notification, malpractice insurance, and emergency exceptions.

As of January 1, 2016:

  • Pharmacists were explicitly authorized to administer vaccines in 46 states and the District of Columbia.
  • Thirteen states and the District of Columbia permit exceptions to vaccination requirements for emergencies or epidemics.
  • Ten states grant pharmacists prescriptive authority to administer vaccines (i.e., pharmacists can vaccinate without a third-party authorization).
US map shows every sate except AL, MS, TN, WA have laws

As of January 1, 2016, every state except Alabama, Mississippi, Tennessee, and Washington had laws that authorized pharmacists to vaccinate.

The dataset was created by Cason Schmit, JD, Research Assistant Professor, Texas A&M University, and Allison Reddick, JD, MPH, Associate Attorney at Hill & Ponton, PA.

Check out the latest map and data at LawAtlas.org.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from the rising price of the opioid reversal agent naloxone, to the interpretation of surrogate endpoints in the era of the 21st Century Cures Act, to a comparative assessment of pharmaceutical licensing and reimbursement in the European Union, United States, and Japan. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, et al. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med. 2016;375(24):2395-2400.
  2. Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone – Risks to Efforts to Stem Overdose Deaths. N Engl J Med. 2016;375(23):2213-2215.
  3. Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clin Pharmacol Ther. 2016;100(6):626-632.
  4. Knopf K, Baum M, Shimp WS, Bennett CL, Faith D, Fishman ML, Hrushesky WJ. Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ. 2016;355:i6286.
  5. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016;375(24):2313-2315.
  6. Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016;24(24):6446-6451.
  7. Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016;31(12):1482-1489.