HIPAA and the Medical Records of Deceased Nursing Home Patients

By Leslie Francis

[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.

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Live Blogging from FDA in the 21st Century Conference, Panel 5: Major Issues in Drug Regulation

 [Live-blogging off-the-cuff, all errors, typos, etc, are my fault]

Geoffrey Levitt, Pfizer, Drug Safety Communication: The Evolving Environment

A drug by itself is just an object. Because of that fact it creates turf, governance. You must have effective processes for communicating accurate info.

Pharmacovigilance is the accuracy part. Spontaneous adverse event reports are flooding to companies. 600,000 of such reports go to Pfizer a year, with 2000 a day on avg. Each has to be classified, reported, and followed-up. If you mess up you get a warning letter. But it has limits: passive, haphazard, poor signal to noise value. Main value is generating safety signals to follow up on. But studies of that kind for follow-up are very expensive and competing with other possible safety studies and new drug development for funding.

For this reason there has been interest in active real-time drug safety monitoring, like Sentinel.

Once you have accurate and up to date info, how do you communicate it to the audiences that need it. It is not static info, dynamic and constantly changing, and often not fully baked. Timing is everything. That leads to governance. Who owns it? Which stakeholders get to drive it. In Wyeth v. Levine, S. Ct says drug sponsor owns the label, and is responsible at all times for content of the label, including safety info. In reality not that simple. Today there is a number of players outside health authority and drug sponsor who have emerged as powerful forces. Academic researchers, drug payers, detailers, and many others.  This is not by accident. One reason is emergence of vocal critics who have critiqued the sponsors ability to directly communicate. Claim that this is a form of collusion  of which Levitt does not agree.

Vioxx sparked a few important developments. IOM produced one of the most important recommendations that led to FDAAA especially as to post-market surveillance and power over the safety label. Balance of authority shifted from that authority towards FDA. FDA also began to be more proactive about communicating, even before fully confirmed and without participation of sponsor. Also put into place obligations to post clinical trial results on public website, so clinicaltrials.gov is born. In retrospect, that was the opening shot in a full barrage of FDA on clinical trial transparency. In Europe this had led to a drastic new policy of affirmatively publishing clinical study reports full-scale not just trial results.

Critics of the current model want to tear down the gate, and reinterpret data themselves by own standards. That may lead to different results and different conclusions. Will the erosion of the primacy of the sponsor and FDA lead to more truth or more confusion?

W. Nicholson Price II, Petrie-Flom Center, The Role of Innovation Policy in Pharmaceutical Manufacturing

M & M manufacturing is more precise than drug manufacturing. Poor innovation in drugs. 200 to 300 billion dollars a year are spent on drug manufacturing. This is very expensive and inefficient, contrary to the typical story that drug manufacturing is cheap. Drugs are way behind computers and electronics. Uses same processes as decades ago. A 20% reduction in manufacturing costs would lead to a gain annually 50 billion for consumers if paid back directly, or even more if invested in R & D. Connected also to drug shortages.

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Organ Donation Euthanasia

ELPAT (Ethical, Legal and Psycho-social aspects of Transplantation) is a division of the European Society of Organ Transplantation (ESOT). During the last weekend, the third ELPAT Conference has been held in Rotterdam. It has been a fascinating meeting that has gathered a group of prestigious scholars from many countries around the world to debate several ethical and legal topics involved in transplantation. Glenn Cohen has been one of the key speakers, along with Robert Truog, Alex Capron, Jennifer Radcliffe Richards and many others.

One of the issues which has been hotly debated is “organ donation euthanasia”, a practice that is currently being developed, albeit still marginally, in Belgium, where, as you know, euthanasia is legal since 2002. The issue which intrigued me more is the possibility of adding those organs to the common European pool for their eventual transplantation in a patient from a country in which euthanasia is still forbidden. In a way, our reluctance to such scenario seems to be analogous to the use of organs from executed prisoners. There are even more perplexing alternatives. As is well known, many British citizens travel abroad in order to get euthanasia (Switzerland is the main destination but also The Netherlands and Belgium). Should they also become eligible donors, would it be possible for British citizens to receive the organs? How can we handle that with the allegedly criminal behavior of the travel companions of the “suicide tourist”?

Euthanasia is not permitted in the US, although some States have enacted “aid in dying” statutes. I was wondering, first, if it might be possible in those States to be an “aided in dying organ donor”. What happens if the person who is prescribed the lethal dose requests it? Is it possible to arrange things in such a way that that request is feasible and honored (maybe the individual ingests the pills in an ICU)? Secondly, what about the organs? Should they remain in the State in which aid in dying has been legalized? What do you think?

Twitter Round-Up (3/31-4/6)

By Casey Thomson

This week’s slightly belated round-up concerns palliative care across cultures, the threat and problems of over-prescribing, and Big Pharma’s failure to create prices with the patient in mind. Read on for more from this week’s round-up.

  • Alex Smith (@AlexSmithMD) retweeted a piece on the lessons learned by Dr. Vvjeyanthi “V.J.” Periyakoil on how to approach palliative care for patients from a variety of backgrounds in ways that both extend life and fulfill the desires of the patient (in particular, reducing pain). (4/3)
  • Alex Smith (@AlexSmithMD) also retweeted an opinion piece in the NYT about the growing trend towards self- and over-medication, and the problems of overextending definitions of medical ‘conditions.’ As the piece’s author summarized: “The D.S.M. would do well to recognize that a broken heart is not a medical condition, and that medication is ill-suited to repair some tears.” (4/3)
  • Daniel Goldberg (@prof_goldberg) retweeted a link on two new wrongful death lawsuits against the NFL, which claim that the NFL withheld knowledge of the risks associated with concussions from players, that have been added to the string of other brain injury lawsuits filed against the league. (4/3)
  • Daniel Goldberg (@prof_goldberg) additionally retweeted a blog post on the striking results of a new study comparing male and female mortality amongst counties in the United States. While male mortality increased in only 34% of counties from 1992-1996 to 2002-2006, female mortality increased in 42.8%. This brings up questions concerning the cause of this demographic and largely geographic inequality, and what such a differential could mean on the health of dependents (children). (4/3)
  • Daniel Goldberg (@prof_goldberg) posted another article that put the recent New York “True Cost” campaign in historical context. The article called the campaign a “modern manifestation of…anxieties about the ‘contagion’ of working class and poor communities,” comparing it to the World War II-era venereal disease campaigns and the case of Typhoid Mary as all moralizing weapons aiming to instill shame rather than promote actual solutions to public health concerns. (4/4)
  • Arthur Caplan (@ArthurCaplan) linked to his own discussion of the problem with Novartis and India, noting that emphasis has been wrongly placed on patents when the concern should be on pharma’s hesitancy to create a pricing strategy that can provide medications for those who cannot afford huge prices. This unwillingness to do so, he claims, is violating a moral obligation. (4/4)

PERINATAL HOSPICE: NEW THEORIES ABOUT WHAT CHOICE MEANS

Guest Blogger: Allison M. Whelan*

So much of the political and legal debate about reproductive choice centers on abortion.  In doing so, these debates obscure so many other reproductive choices women must make.  And the choices are not easy—and the stakes are even greater in an era where any prenatal missteps might lead to aggressive state action, including criminal sanctions.  There are thorny situations that confront medicine and ethics.  For example, how should we think about families that choose to carry terminal fetuses to delivery only for the fetus to expire shortly after birth?  Should such pregnancies be terminated early given that doctors and even the intended parents know the fetus will not survive?  Where does the law stand on such issues?  What is morally permissible?

Thousands of women and families face lethal prenatal diagnoses and perinatal loss every year. In 2006, there were 25,972 reported fetal deaths at twenty weeks or later.  An additional 19,041 live-born infants died at less than twenty-eight days.  Birth defects such as congenital malformations and chromosomal abnormalities are the leading cause of fetal-infant deaths. Lethal anomalies (i.e., Trisomy 13; anencephaly; hypoplastic left heart syndrome) are a subset of birth defects characterized by a radically shortened lifespan. In 2005, there were 6,925 fetal and infant deaths attributable to lethal anomalies in the U.S.

Advancements in prenatal diagnosis coinciding with improved access to legal abortions create medical options for patients, but also spur challenging ethical questions.  For example, therapeutic abortions have become the “management of choice” for many women whose fetuses experience a “lethal condition”.  However, termination may not be the preferred choice for all women and families.  The concept of perinatal hospice fills this void and offers women valid options after a terminal fetal diagnosis. Although the concept is still relatively novel and unknown in much of the health profession and lay population, the development of perinatal hospice programs is growing.

Perinatal hospice is worth taking seriously.  For example, perinatal hospice programs are multidisciplinary and their services begin at the time of diagnosis (rather than death), in recognition of “anticipatory grief,” a term describing the grieving process that begins prior to death when a death is probable or imminent. Those who have used these services say that perinatal hospice provides a supportive environment for parents to grieve and appreciate any time they have with their infant.  Further, they say It affirms their role as parents and acknowledges that their loss is “as real” as the loss of any other loved one.  Maybe perinatal hospice is a safe place where parents can “be parents.”  It’s worth thinking about.

*Allison Whelan is a graduate student, University of Minnesota School of Law and Center for Bioethics

Twitter Round-Up (2/16-2/23)

By Casey Thomson

This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:

  • Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
  • Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
  • Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
  • Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
  • Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
  • Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
  • Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
  • Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)

R.I.P. Ronald Dworkin (Dec. 11, 1931–Feb. 14, 2013)

By Michelle Meyer

I woke this morning to the very sad news that legal philosopher and NYU law professor Ronald Dworkin died in London early this morning of leukemia, at the age of 81.

I’m not sure whether his illness was well known to those within the legal academy, but it came as news to me, so I confess I’m slightly shocked by news of his death. Others, of course, are much better positioned to give thoughts about his life and career, and no doubt will, here and elsewhere. I’ll share just one brief remembrance. I was the founding co-editor of the Harvard Law Review Forum, and for our very first issue, I solicited a response from Professor Dworkin to Fred Schauer’s (Re)Taking Hart. These were the days when online supplements to law reviews were new, and we didn’t really know how scholars would view these opportunities. When he readily agreed to provide a response, I recall emailing the news around Gannett, to much rejoicing. This was an especially meaningful “get” for me, as in addition to his work in legal philosophy, I had read and appreciated Life’s Dominion as an undergraduate studying bioethics. I was terribly nervous about interacting with him, but he was incredibly kind and gracious and unassuming throughout the process.

Professor Dworkin leaves behind his wife, two children, and two grandchildren. They and his friends and colleagues are in my thoughts.

Update: Brian Leiter is aggregating memorial notices here.

Slipping Euthanasia in Belgium

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… Read More

Twitter Round-Up 1/1-1/13

By Casey Thomson

Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:

  • Frank Pasquale (@FrankPasquale) posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
  • Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
  • Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
  • Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
  • Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
  • Michelle Meyer (@MichelleNMeyer) posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
  • Michelle Meyer (@MichelleNMeyer) also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
  • Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]”. (1/8)
  • Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
  • Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
  • Frank Pasquale (@FrankPasquale) posted an article discussing the recent move by  various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.