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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the upcoming academic year beginning in September 2013. Full-year availability is preferred, but single-term internships will be considered on an individual basis; please indicate your preference in your application materials. We are not currently accepting applications for Summer 2013, but may consider extension through Summer 2014 if there is mutual interest.
Who is eligible?
Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences. We are also interested in receiving applications from students interested in technology and communications, as we plan to substantially update and expand our Internet presence and social media strategy.
[Cross-Posted at PrawfsBlawg]
One of my favorite initiatives at Harvard Law School, where I teach, is that faculty members get to offer an optional 10-12 student not-for-credit “First-Year Reading Groups” on a topic of interest to them that is related to law in some way but not too law-class like. I’ve taught a reading group on bioethics and law through film that pairs films with papers/topics in bioethics (e.g., A.I. with readings on personhood, Minority Report and neuroscience and law and predicting criminality, Dirty Pretty Things and organ sale and exploitation, The Constant Gardener with clinical trials in the developing world, Eternal Sunshine for the Spotless Mind and therapeutic forgetting and “cosmetic neurology” and many others…)
Next year I will add The Sessions, a film I found very enjoyable starring John Hawkes, Helen Hunt, and William H. Macy from last year that I also found very bioethically interesting. The film is based on a true story and follows Mark O’Brien, a poet who lives in an Iron Lung due to complications from Polio. After unsuccessfully proposing to his caretaker, and believing the end of his life may be nearing, he decides he wants to lose his virginity. He hires Cheryl Cohen-Greene, a professional sex surrogate, who will offer him a maximum of six sessions but makes clear to him this is therapy not romance. I will stop there to avoid ruining the film, but on to the bioethics…
There are fairly clear issues raised about commodification, exploitation, the difference between sex therapy and prostitution, that I have written about in various forms in various places. These are certainly interesting issues but familiar enough. What the film newly prompted me to think about, though, is actually universal health care. In particular, as I have written about indirectly in a couple of papers, what would some of the most prominent theories explaining why we need universal health care say about whether the state should pay for sex therapy (or perhaps even prostitution) for people with disabilities like Mark who find themselves otherwise unable to have sex?
For example, in his wonderful book Just Health, my colleague Norman Daniels, coming from a more Rawlsian tradition (i.e., a liberal tradition focused on promoting liberty and distributive justice through giving priority to the worst-off), grounds the state’s role in promoting health in the obligation, as a matter of political justice, to ensure access to the “normal opportunity range” to pursue the “array of life plans reasonable persons are likely to develop for themselves.” Although Daniels’ focus is on health care, it seems to me that sexual satisfaction is also part of that normal opportunity range and part of a life plan most of us would like to pursue.
Similarly, Martha Nussbaum in her great book Frontiers of Justice, writing from a more aretaic (i.e., Aristotelian, focusing on character and virtue) perspective, has argued that the state’s role is to enable human flourishing by raising people above the threshold level on a number of “capabilities.” Among these she mentions “bodily integrity,” as including “having opportunities for sexual satisfaction and for choice in matters of reproduction.” I have previously discussed how this kind of approach may justify funding reproductive technologies, but it seems to me as though it also fairly directly establishes an argument for funding Mark’s attempts to lose his virginity.
Now this is meant to be provocative, of course. And for some this is no doubt a reductio ad absurdum against universal health care. Fair enough. But for those who believe there is a moral case for funding universal health care, does the argument also lead to funding these kinds of sex therapies? Health is important, of course, but let’s be frank (and my parents can stop reading at this point) so is sexual satisfaction, and both seem to me essential parts of the normal opportunity range and/or human flourishing.
I read an article recently which stated that the federal government is making a 51 billion dollar profit this year from student loan borrowers. That’s more annual profit than any private American business makes. Profit margins are up thanks to record interest rates and aggressive collection policies.
Having the government make money off of students like this strikes me as bad policy—particularly with regards to student health professionals. Medical school is an expensive proposition; the cost of attending medical school has been rising for the past 13 years, and the average medical school graduate leaves school with $166,750 in debt. That doesn’t take into account undergraduate or other debt, and a significant portion of graduates end up owing far in excess of that amount. Ben Bernake testified before Congress last year that his son was on track to leave med school with $400,000 in loans!
Systematically burdening medical school graduates with debt seems almost calculated to drive doctors away from primary care and into higher paying specialties. That’s unfortunate because research demonstrates that a greater availability of primary care physicians results in better public health outcomes. The U.S. already has a surplus of specialists but not primary care physicians. Continue reading
[this is a cross post from HealthLawProf]
Warning: some of this post is HIPAA-wonky. But read on: the punch line is that HIPAA does not protect the living or the dead from blanket release of medical records to their personal representatives—unless state law provides otherwise or patients have thought to specify in advance that they do not want anyone to see the record or parts of it and state law gives them this opportunity. This means that the default position is that personal representatives may see highly sensitive health information, including mental health records or sexual or reproductive histories: veritable skeletons in family medical closets.
In an important recent decision, the 11th Circuit has held that the federal Health Insurance Portability and Accountability Act (HIPAA) preempts a Florida statute that gave spouses and other enumerated parties the right to request the medical records of deceased nursing home residents. Opis Management Resources v. Secretary, Florida Agency for Health Care Administration, 2013 U.S. App. LEXIS 7194 (April 9, 2013). The nursing homes had refused to respond to requests for records made by spouses and attorneys-in-fact, arguing that these requesters were not “personal representatives” under Florida law. The requesters filed complaints with HHS’s Office for Civil Rights, which determined that the refusals were consistent with HIPAA. The Florida Agency for Health Care Administration issued citations against the homes for violating Florida law, and the homes went to court seeking a declaratory judgment that the Florida statute was preempted by HIPAA.
By Mary Ann Chirba and Alice A. Noble
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.
In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].
In April, the governor of Georgia signed H.B. 499 [link: http://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.
This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]
It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.
My guest blogging stint is drawing to a close. Thanks Glenn, Holly, and the rest of the Bill of Health family! Here’s a recap:
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The New England Journal of Medicine just published a new article by me (and my frequent co-author Dean Eli Adashi) entitled “Made-to-Order Embryos for Sale — A Brave New World?” As we note in the article:
The proliferation of commercial gamete sources (e.g., sperm and oocyte banks) has opened the door to a made-to-order embryo industry in which embryos are generated with a commercial transaction in mind. This prospect of a for-profit embryo bank is no longer theoretical. Indeed, as recently as November 2012, the Los Angeles Times reported on one such clinic that “sharply cuts costs by creating a single batch of embryos from one oocyte donor and one sperm donor, then divvying it up among several patients.” The report went on to state that “the clinic, not the customer, controls the embryos, typically making babies for three or four patients while paying just once for the donors and the laboratory work.
The paper then analyses the legal and ethical issues raised by the development of these kinds of banks. In so doing, a key question we ask is how this practice is similar or different from embryo donation (sometimes called “embryo adoption”), the sale of sperm and eggs for reproductive purposes, and the use of sperm and egg to produce stem cell lines that require embryo destruction.
This one is sure to be controversial, and while this short piece in the New England Journal is now published I would love to hear readers’ thoughts as I may write more on the subject.
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Working in private, the National Academy of Sciences’ panel on human-subjects regulations in social-behavioral sciences met this weekend to draft a final report. On Friday, the panel had wrapped up its public “Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences.” The workshop aimed to critique OHRP’s proposed revisions to federal human-subjects regulations (known as the Common Rule), rather to critique the regulations directly.
Here is what the National Academy panel members said they took to be a few take-points from the public workshop, which I attended:
By Hyeongsu Park and Kathy Wang
Nadia N. Sawicki
Two recent publications prompt me to ask this question.
The first, forthcoming in JAMA Internal Medicine, is a study by Jaime Rosenthal, a student at Washington University in St. Louis. Rosenthal and her colleagues set out to obtain pricing data for total hip arthroplasty from 20 top-ranked orthopedic hospitals and 102 representative general hospitals (two from each state and Washington DC). Rosenthal, posing as the granddaughter of a 62-year old woman without health insurance, contacted each hospital numerous times to inquire about the total cost of the procedure. Only 45% of the top-ranked hospitals and 10% of other hospitals were able to provide a complete bundled price; price estimates were obtained at 15% of ranked hospitals and 53% of other hospitals by contacting the hospital and physicians separately. And perhaps most startlingly, the prices quoted for the procedure ranged from $11,000 to $125,798. The authors’ conclusion is a modest one – that patients “may find considerable price savings through comparison shopping” – but I believe its impact is far greater. In part because of the way health care is financed in our country, the average American consumer has little awareness of how much any given medical procedure actually costs. But who can blame the consumer in this market, when those who provide the services themselves have no baseline against which to set costs?
This brings me to the second piece – Steven Brill’s excellent article in Time Magazine, “Bitter Pill: Why Medical Bills are Killing Us,” which my co-blogger Patrick O’Leary blogged about last week. ). Brill spent half a year trying to understand why some nonprofit hospitals seem to function like prosperous businesses – with brand-new facilities, impressive executive compensation, and high profit margins. He approached this problem by analyzing patients’ medical bills from hospitals, physicians, drug companies, “and every other player in the American health care ecosystem.” Brill offers a scathing commentary on a system where patients are billed $18 per diabetes testing strip that can be purchased in boxes of 50 on Amazon.com for about 55 cents per strip. Another example: one patient was billed $7,997.54 for a CT scan stress test that Medicare pays $554 for; and $3 for a reusable pen that marked where an incision would go. These prices, Brill explains, are based on the chargemaster, a master document of prices kept by every hospital that is the basis for insurance negotiation reductions. Nearly every executive he spoke with said that the chargemaster prices are irrelevant because “nobody gets charged those prices,” but Brill’s research suggests the contrary. Those without insurance, as we in the health law and policy community have long known, are charged more that those who are covered by insurance. Brill’s article also follows medical billing advocates who negotiate patient bills down dramatically for patients who are willing to pay their fees; however, not every patient is so lucky.
The findings in Rosenthal’s and Brill’s articles are startling. Few consumers, I would image, participate in the health care market with the understanding that the costs they might pay vary widely from institution to institution; that the prices they are asked to pay for a given procedure are far in excess of how much federal health programs believe the procedure is worth; or that they can “bargain down” their charges through skilled negotiation by someone with inside knowledge of the system. Readers of this blog might chafe at the comparison between the market for health care and the market for used cars, but perhaps it is the used car dealer who should feel offended. His customers, at least, can rely on the Kelley Blue Book.
About 10 days ago, the New York Times had two fascinating stories about reproduction (on back-to-back days) that I wanted to highlight and comment on. I discussed the first one here. In this post, I will take about the second story about “co-parenting” (though that term has a separate set of meanings related to divorce) through modamily.com. Modamily is a website (one among a series of such websites according to the story) that allows non-romantically affiliated people (i.e., strangers to start with) get together to produce a child and co-parent it, sort of match.com for parenting without any romantic relationship. The story centers on one couple, Ms. Hope and Mr. Williams and reports:
“Neither Ms. Hope nor Mr. Williams is interested in a romantic liaison. But they both want a child, and they’re in serious discussions about having, and raising, one together. Never mind that Mr. Williams is gay and that the two did not know of each other’s existence until last October, when they met on Modamily.com, a Web site for people looking to share parenting arrangements. Mr. Williams and Ms. Hope are among a new breed of online daters, looking not for love but rather a partner with whom to build a decidedly non-nuclear family.”
I find the convergence of assisted reproduction and web 2.0 fascinating. Here are a few thoughts: First, some sub-set of readers will say “well, what about the children” of these liasons? They will express a fear that the interests of these kids will have been set back. I have two responses: how different is this from single parent reproduction, or reproduction by couples likely to divorce? Further, as I have written about some countries’ attempts to limit the use of reproductive technologies as a single individual as well as a number of other kinds of restrictions on reproduction (see this and this and this and this). there are deep intellectual problems with these kinds of Best Interests of the Resulting Child arguments.
Second, there are some interesting, fairly subtle, eugenic impulses expressed (perhaps unintentionally) by the writer of the story in the Times. The story begins by describing “A 6-foot-2 former model who loves animals, Mr. Williams is athletic, easygoing, compassionate and organized.” If I can be slightly info-mercial/Sex and the City about it, the sub-text appears to be along the lines of “Gee, ladies, wouldn’t you like a piece of that for your kids!” This is of a piece with some of the other academic work I have discussed in earlier posts on the sperm ‘donors’ chosen in reproductive technology practices and their uber-mensch characteristics. That said, as I have written elsewhere, under what circumstances such eugenic impulses are wrong as opposed to being the reproductive technology equivalent of some of what many of us do in sexual mate selection remains very much contested ground.
Third, I think the article raises interesting questions about the unbundling of romance and reproduction. One might think that in the current world of “hook-ups” among our youth, that we have already begun to decouple sex and romantic relationships, and anonymous sperm donation uncouples romance and reproduction (through non-sex), but this takes it further still. One interesting wrinkle here is the non-commodified nature of the non-intimate form of reproduction. There are no arms-length doctor and bank mediated relations between the gamete providers, rather they are trying to become intimately involved in a non-sexual way without any money involved.
By Katie Booth
In the Supreme Court’s recent decision in Auburn Regional Medical Center, the Court held that a suit against HHS by eighteen hospitals alleging intentional underpayment of Medicare reimbursements was barred by a 180-day internal agency deadline for appeals of reimbursement decisions. The rub is that the hospitals only found out about the underpayments, which allegedly occurred from 1987 to 1994, in March of 2006. These underpayments affected thousands of hospitals and added up to billions of dollars. Yet under Auburn, since the hospitals did not sue within 180 days of the underpayment (or even within an extended three-year window for “good cause”), they cannot recover. The Court in Auburn rejected the hospitals’ argument that equitable tolling should apply, finding instead that “the presumption in favor of equitable tolling does not apply to administrative appeals of the kind here at issue.”
The Auburn decision raises important questions about the ability of the federal government to intentionally underpay healthcare providers. In oral argument, the lawyer for the hospitals characterized HHS’s actions as “intentional concealment . . . [and] misconduct by the Secretary, that caused the statute of limitations time to be missed.” While there are good reasons not to disturb decades-old reimbursement decisions, it is sobering that the federal government can intentionally conceal underpayments and—if it conceals the underpayment for only 180 days—never have to reimburse the injured party. This situation presents a striking contrast “to 42 CFR § 405.1885(b)(3) (2012), which permits reopening of an intermediary’s reimbursement determination ‘at any time if it is established that such determination . . . was procured by fraud or similar fault of any party to the determination.’” In other words, HHS can reopen reimbursement decisions if a provider intentionally conceals important information, but not vice versa.
Happy New Year billofhealthfans!!
As you all know Belgium legalized euthanasia in 2002 following the path of The Netherlands. The legalization came in the midst of a huge controversy. The influence of the Catholic Church is significant in Belgium. You might recall that in 1990 King Balduino refused to sign an Act legalizing abortion, something unseen in the history of Belgium. The solution could not be more ingenious: the King resigned for a couple of days, the Act was signed by the Prime Minister, and then Parliament restored Balduino in his throne.
According to a recent survey in Flanders, euthanasia and assisted suicide in Belgium follows a classical pattern: cancer patient between 65 and 79 years of age. The cases in which the individual is not in the terminal stage of his illness and requests assistance in dying are rare. Nothing significantly deviant from what is going on in other jurisdictions in which aid in dying (in its various forms) is permitted. At least that was the trend until last December 14th… Continue reading
The Supreme Court’s decision last week to grant cert in AID v. Alliance for Open Society International, demonstrates anew the importance of First Amendment jurisprudence to public health protection. In recent years, it has sometimes seemed as if the First Amendment has become the most significant legal obstacle to effective public health protection through law. In cases such as Lorillard Tobacco, Thompson v. Western States Medical Center (the compounding pharmacy case), and Sorrell v. IMS Health, Inc., the Supreme Court has found that First Amendment protections for commercial speech trump public health protection, a view that the D.C. Circuit seemed to endorse when it ruled last summer in R.J. Reynolds that the graphic warning labels required by the Tobacco Control Act violated the First Amendment Rights of cigarette companies.
Yet sometimes the First Amendment helps to advance the cause of public health, particularly by limiting the reach of laws that are designed to restrict an open and informed approach to sexual and reproductive. US AIDS offers one such example. In that case, plaintiff NGOs challenged a provision in the federal Leadership Act, 22 U.S.C. § 7631(f), that required them to adopt a policy explicitly opposing prostitution in order to receive federal funds available to fight HIV/AIDs, tuberculosis, and malaria. The plaintiffs argued that the Act constituted an unconstitutional condition and violated their First Amendment rights by compelling them to adopt the government’s viewpoint regarding prostitution. The Second Circuit, in an opinion by Judge Parker, concluded that the plaintiffs were likely to prevail on the merits and granted them a preliminary injunction.
Now the Supreme Court will reconsider the issue. Public health advocates are likely to weigh in and argue for the widest possible protection for their own advocacy. In doing so, they might want to keep in mind the threat that the First Amendment poses for public health in other contexts, especially in commercial speech cases. And they will certainly want to think about how they can convince courts to value public health when deciding First Amendment cases. Figuring out how to do that — how to develop a First Amendment jurisprudence that is respectful of public health – just may be the most pressing challenge facing public health lawyers today.
After the NFIB decision in June, Maine tried to expand Justice Roberts’ remedy to also make the “maintenance of effort” provision optional for states. Maine was unsuccessful in the First Circuit with the argument, for procedural reasons. Prior coverage here.
The Obama Administration is sticking to the letter of the law, and announced Tuesday that it is refusing to allow cuts for Medicaid beneficiaries at or below 133% (138% after the 5% income disregard) of FPL in Maine.
Maine has not yet announced whether it will take the case back to the First Circuit. With Huberfeld & Leonard, we’ve argued at length (see esp. pp. 75-83) that Maine does not have the winning argument, in an article to be published in the BU Law Review later this month. SSRN version here. The short version is that MOE is a common tool to lock-in states during transition to a new program, was discussed in the briefing, but was not part of the coercion analysis in Justice Roberts’ plurality. The key provision was 42 USC 1396c, the Secretary’s authority to reduce some or all of the funding to non-compliant states. But we will see if Maine wants to argue the substance of this point at the First Circuit.
@koutterson
By Scott Burris
Phil Coffin and Sean Sullivan have published a cost-effectiveness study of interventions that equip heroin users and others to administer naloxone in the event of a witnessed opioid overdose. Naloxone is the standard antidote, and can easily be administered by lay people with a minimum amount of training. Family members and friends of opioid users can quickly get the drug into an overdosing user via injection or a nasal spray. In an accompanying editorial, top brass at NIDA and FDA sum up the news like this: the study
“represents a significant step in the evolution of the science in this area: a detailed analysis of the cost-effectiveness of overdose intervention with naloxone administration for heroin abusers. The authors suggest that lay naloxone administration is likely to be highly cost-effective in this setting, a robust finding that holds up under various assumptions. Future analyses that extend their findings to the setting of prescription opioids would be welcome.”
The editorial flags one of the major legal issues that gets in the way of wider naloxone distribution – its status as a prescription drug approved for use by injection. Changing this is a torturous regulatory process. In the short term, though, lawmakers can do a lot to get distribution going where it is needed. As of July of 2012, eight states had passed laws to clearly authorize or otherwise reduce legal barriers to the prescription of naloxone to drug users and other potential good Samaritans. That leaves 42 states where programs may have trouble operating out of concerns related to prescribing a drug for a lay person to administer. LawAtlas covers the law and has examples of the legislative approaches these states have taken.
One more thing: evidence that naloxone distribution looks to be cost-effective ought to motivate lawmakers to consider these programs. Many places don’t have them at all: a study published last year in MMWR reported, among other things, that “Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.” In others, programs are operating but with little or no public funding to purchase naloxone, whose price has been rising precipitously (that’s another story about our creaking system for producing essential medicines).
