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 →
“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
The 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 →
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. […]
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.
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.
Donald Trump’s pledge to repeal and replace the Affordable Care Act has looked much more like a plan for repeal than a plan to replace, especially in light of the kinds of reform proposals advanced by leading Republicans in Congress, including Trump’s designee for Secretary of HHS, U.S. Rep. Tom Price.
But Trump’s recent promise of “insurance for everybody,” suggests that he might actually have a serious replacement in mind. While we cannot automatically take Trump at his word, it may be the case that he is following the example of his Vice President-elect Mike Pence, who as Governor of Indiana defied Republican positioning in signing on to the Affordable Care Act’s Medicaid expansion. Continue reading →
Under Massachusetts law, suits alleging medical malpractice in a treatment of a minor patient must be filed “within three years from the date the cause of action accrues.” G.L.c. 231, § 60D. In a recent case, Parr v. Rosenthal, 57 N.E.3d 947 (Mass. 2016), the Supreme Judicial Court of Massachusetts decided that a patient’s continuous treatment by the same physician can toll this period under certain restrictive conditions. One of those conditions requires the plaintiff to show that the physician continued to treat the patient “for the same or related condition” after committing the alleged malpractice, and that “treatment” in that context includes supervision of, as well as consultation and advice to, other treating physicians. Another condition makes continuous treatment part of the discovery rule that moves the onset of the limitations period to the day on which the patient knew or could have reasonably suspected that her physician treated her negligently. According to the Court, continuous treatment instills in the patient “innocent reliance” that the physician treats her properly, which makes the physician’s malpractice not reasonably discoverable. Moreover, innocent reliance can even be present when the patient realizes that she sustained harm from the physician’s treatment. As the Court explained, “A patient who continues under the care of the same physician will still have the same challenges in learning whether the harm [she] suffered from the physician’s treatment arose from the physician’s negligence.” Based on these observations, the Court decided that the “continuous treatment” rule will not benefit patients who affirmatively suspected that they received negligent treatment from their physician. Such patients, the Court held, cannot show “innocent reliance.” Continue reading →
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.
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
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.
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.
This 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 thearticle to learn more about his contributions to the Center and its mission!
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).
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.
If every individual has millions of unique variants in their DNA, how can clinicians be expected to tease out a handful of disease causing mutations from a haystack of inconsequential variants? To aid their cause, public human genomic variant databases have sprung up to catalog variants that cause (or do not cause) disease. These databases aggregate, curate and share data from research publications and from clinical sequencing laboratories who have identified a “pathogenic”, “unknown” or “benign” variant when testing a patient.
International sharing of variant data is “crucial” to improving human health. To inform patient diagnosis or treatment, it is essential that data be accurate and up to date. If variants are collaboratively interpreted by laboratories, databases and treating physicians, who is ultimately responsible for the quality of data? If one actor in the chain does a shoddy job of interpreting variants, resulting in harm to patients, who could be liable? This is the question I pose with Professors Bartha Knoppers and Robert Cook-Deegan in a recent article in Genetics and Medicine: “Public Variant Databases: Liability?”. Continue reading →
“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. […]
Yesterday, a federal district judge made an important ruling in the ongoing patent dispute between Amgen’s cholesterol-lowering drug Repatha and Sanofi and Regeneron’s drug, Praluent. Early in 2016, Amgen’s patents covering the products had been found both valid and infringed, and now Judge Sue Robinson has granted Amgen’s request for an injunction against Sanofi and Regeneron, blocking the two companies from selling Praluent. (The injunction takes effect in 30 days, giving the companies time to appeal.)
This is very strange. Let’s be clear: Judge Robinson looked at a situation involving two competing, chemically distinct (though similar) drugs for the same condition and opted to kick one of them off the market, putting Amgen in a monopoly position and taking some number of patients off of the drug they’ve been taking. As far as Pharma Policy Twitter (h/t Forbes’ always-excellent Matthew Herper) can tell, an injunction of this type happens about once a decade – in 2008 with Amgen and Hoffman-LaRoche regarding an EPO product, and in 1996 with Novo Nordisk and Genentech over hGH products. (Please send along other examples, if you have them!)
A number of commentators have already weighed in on Judge Robinson’s order, with Professor Jake Sherkow providing a particularly thoughtful tweetstorm on the subject. I largely agree with Professor Sherkow’s analysis, but I want to emphasize two aspects of the case that have not yet received sufficient attention: the first is the decision to ask for the injunction, and the second is the practical effect the injunction will have on patients, on the market, and on the gathering of information about PCSK9 products going forward.
The American Psychiatric Association, in concert with the American Medical Association’s position on medical euthanasia, holds that a psychiatrist should not prescribe or administer any intervention to a non-terminally ill person for the purpose of causing death.
According to the APA Operations Manual, APA position statements “provide the basis for statements made on behalf of the APA before government bodies and agencies and communicated to the media and the general public.”
Together with the Centers for Disease Control and Prevention and Public Health Management Corporation, the Policy Surveillance Program recently released a new map addressing Emergency Powers laws.
Emergencies might involve dangers to public health, such as an outbreak of the flu; natural disasters, such as floods or earthquakes; or threats to security, such as acts of terror. In 41 states and the District of Columbia, governors are explicitly permitted to suspend laws that would interfere with an efficient, effective response to an emergency. Some states also permit governors to amend laws or create new ones during emergencies.
This new map covers laws granting broad powers to governors to manage emergencies in all 50 states and the District of Columbia.
PHLR spoke with the researchers, Kelly Thompson, JD, Law and Policy Manager at the National Nurse-Led Care Consortium, an affiliate of Public Health Management Corporation, and Nick Anderson, JD, ORISE Fellow at the Centers for Disease Control and Prevention, to discuss their work.
In today’s NYTimes, Jill Horwitz and I have an Op-Ed describing why Donald Trump’s selection of Tom Price for secretary of health and human services is a particular threat to women’s health. Read it here!
From the Op-Ed:
With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women.
It is regrettable, but not surprising, that Mr. Trump has nominated a strident opponent of abortion. It is also no surprise that Mr. Price, an orthopedic surgeon from Georgia, earned a zero rating from Planned Parenthood, an organization he’d like to defund, despite its role in providing preventive health services. […]
The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.
There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Continue reading →
Submit your questions to the panelists via Twitter @PetrieFlom.
Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will address the future of the Affordable Care Act under a “repeal and replace” strategy, alternative approaches to insurance coverage and access to care, the problem of high drug prices, innovation policy, support for scientific research, and other topics. The panel will discuss opportunities and obstacles relevant to President-elect Trump’s proposals, as well as hopes and concerns for health policy over the next four years. Webinar participants will have the opportunity to submit questions to the panelists for discussion.
Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
Lanhee J. Chen, David and Diane Steffy Research Fellow, Hoover Institution; Director of Domestic Policy Studies and Lecturer, Public Policy Program; affiliate, Freeman Spogli Institute for International Studies, Stanford University