Medicare No Longer Excludes Coverage for Sex Change Surgery

Yesterday, Medicare’s Departmental Appeals Board set aside a thirty-year-old National Coverage Determination excluding Medicare coverage for sex change surgery.  As a result, Medicare beneficiaries may now seek coverage for sex change surgery, though the ruling does not make such coverage automatic; it only lifts the blanket national exclusion.  Regional and case-by-case determinations that such surgery is not “medically necessary” could still apply.  For news coverage, see here, here, and here.

The decision is not entirely surprising, Medicare had already in December reopened consideration of the National Coverage Determination precluding coverage.  One question to watch is whether this decision, and the changed Medicare policy that ultimately results from it, winds up furthering the case for coverage in private insurance.  There is an unmistakable trend in this area toward more coverage.  Connecticut recently mandated coverage for many plans, and California and Oregon expanded coverage last year.  And let’s not forget prison, in the First Circuit, at least, the refusal to provide sex change surgery to Michael Kosilek that doctors deemed to be medically necessary was ruled “cruel and unusual punishment.”  (Coverage in the Globe here.)

 

Not Just Any Week in Privacy

By Nicolas Terry

Privacy is never easy to think about. This week it became harder. Two pieces framed my week. First, Eben Moglen’s essay in The Guardian (based on his Columbia talks from late last year) took my breath away; glorious writing and stunning breadth combined to deliver a desperately sad (but not entirely hopeless) message about government and corporate overreaching in data collection and processing.

A wry speech posted by software developer Maciej Ceglowski also helped frame my thoughts. He wrote, “The Internet somehow contrives to remember too much and too little at the same time, and it maps poorly on our concepts of how memory should work.” There’s the problem in a nut. Ceglowski alludes to the divide between how human (offline) memory operates (it’s “fuzzy” and “memories tend to fade with time, and we remember only the more salient events”) and the online default of remembering everything. Government and Google and, for that matter, Big Data Brokers tell us that online rules now apply across the board and ‘that’s just peachy’ because we’ll have better national security, better searches, or more relevant advertising. But, that’s backwards. Continue reading

National Conference on HIV Criminalization

By Sterling Johnson, JD

Grinnell College in Iowa will host the first National Conference on HIV Criminalization next week, June 2-5 on its campus.

One of the stated goals of the conference will be to discuss the recent legislative changes in Iowa and how to apply the lessons to other states with laws that apply specifically to people with HIV.

Currently, 43 states criminalize actions by HIV-positive individuals. Check out our map at LawAtlas.org for more details.

US states with HIV criminalization laws

In 2009, Iowa became the center of this battle when Nick Rhoades, who is HIV-positive, had a one-time sexual encounter with another man, Adam Plendl. Three months after, Mr. Rhoades was arrested on suspicion of engaging in intimate contact without disclosing his HIV-positive status. At the time of the sexual encounter, he used a condom, had an undetectable viral load and his sexual partner did not contract HIV; however, Nick Rhoades was sentenced to 25 years in prison and classified as a sex offender. The case is now is now on appeal and being argued by Lambda Legal. The Iowa court of Appeals affirmed the conviction and the case is now under review by the Iowa Supreme Court. Mr. Rhoades’s case led to community organizers lobbying to reform the HIV criminalization law in Iowa. Continue reading

The Law & Economics of the VA Fiasco

By Alex Stein

Over at the CATO blog, Roger Pilon discusses the unfolding VA fiasco that involves hospitals covering up their failures to provide acutely needed services to veterans and doctors working in a slowdown mode (as illustrated by an eight-person cardiology department that “sees as many patients in a week as a single private practice cardiologist sees in two days”). He describes this fiasco as a paradigmatic example of government failure and proposes a remedy: the government should steer away from actually  providing medical care; instead, it should give veterans vouchers towards purchasing medical services on the competitive private market.

This proposal does not take into account the economies of scale and scope that the government can realize from centralizing the purchase of medical work, facilities and equipment, and from self-insuring against medical malpractice instead of buying expensive liability coverage. These economies dramatically reduce the cost of medical care and increase its affordability. Our market for medical care sets prices that many people, including veterans, cannot afford. The voucher system cannot bring those prices down.  Making this system work without shortchanging veterans would therefore cost the taxpayers a fortune. Continue reading

Worth Reading This Week

By Nicolas Terry

The U.S. Supreme Court vs. The American Psychological Association

by Dov Fox

The U.S. Supreme Court has not in recent years held the views of the American Psychological Association (APA) in so high regard as it did this week.

In 2012, the Court set aside the APA’s arguments for why due process requires the exclusion of eyewitness testimony obtained under suggestive circumstances that rendered it especially likely to be unreliable.

And in 2011, when the Court struck down on free speech grounds a state regulation on violent video games, it gave short shrift to the APA’s warnings about those games’ connection to violent behavior in young boys.

But in its recent death penalty decision, Florida v. Hall, the Court relied heavily on important APA insights in declaring it unconstitutional for states to set an IQ cutoff to determine whether a prisoner is eligible to receive capital punishment. Continue reading

The Law of Breast Cancer

By Alex Stein

During an annual mammogram screening for breast cancer, the radiologist detects a nodule in the patient’s breast. The nodule is large enough to require a biopsy, but the radiologist prefers to schedule a follow-up appointment with the patient for six months later. This appointment reveals that the nodule had grown and the radiologist refers the patient to a biopsy. The biopsy is carried out four days later by a surgeon. The surgeon determines that the nodule was malignant and diagnoses the patient with breast cancer. The patient consults two breast cancer specialists who unanimously recommend mastectomy and chemotherapy. These procedures and the ancillary treatments prove successful. They make the patient cancer free in one year. The chemotherapy caused the patient to experience hair loss, pain, nausea, headaches and fatigue, but all these symptoms are now gone as well.

The patient is happy with the result but is still upset. She believes that a timely discovery of her cancer would have given her a far less painful and less disfiguring treatment option: lumpectomy followed by radiation therapy.

Can the patient successfully sue the negligent radiologist? Continue reading

“That’s a Lot of Marijuana”

Nadia N. Sawicki

Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research. Continue reading

See and Share Job and Fellowship Opportunities on the Petrie-Flom Website

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Looking for new opportunities in the fields of health law, policy, and bioethics? Look no further!

This spring, we’ve added a new opportunities section to the resources on the new Petrie-Flom website. This page features opportunities in health law and bioethics including jobs, fellowships, graduate programs, seminars, calls for abstracts and submissions—and more! These opportunities are updated in real time, full posts remain active on the website until their deadline passes, and past posts are visible in our opportunities archive.

If you have opportunities that you would like to share with the Petrie-Flom community via our website and/or our biweekly e-newsletter, please contact us at petrie-flom@law.harvard.edu.

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Continue reading

Wait Times in the News in Canada

At the same time that wait times at VA hospitals have been in the news here in the U.S., a recent report has put healthcare queues in the news in Canada.  Specifically, a recent report from the Fraser Institute (a research institute that I’ve seen described as “conservative” and “pro-free market“) concluded that 44,723 women in Canada died between 1993 and 2009 due to increased wait times–or 2.5% of all female deaths during that period.  One week of delay was equated with 3 extra deaths per 100,000.  That surprising result led to a good bit of coverage, which is how it came across my desk (thanks to a google news search).  (See here, here, and here.)  But I have to admit I am a little bit skeptical.

Continue reading

Technology and The Horrors of Child Pornography

A recent spate of arrests in New York emphasizes the potentially dangerous connection between technology and sex crimes.  In a landmark police bust, authorities tracked down and arrested more than seventy people in the New York City area who were trading child pornography.  Among those arrested were a rabbi, police chief, nurse, architect, and nanny.  Police infiltrated chat rooms where traffickers made available images of children engaged in sex acts with each other and adults.

What is the role of technology in the arrests and distribution of these images?  While technology helped officers track down child pornography traffickers, the internet also facilitated the trading of those harmful, illegal images of children.  On line chat rooms and other social network spaces provide for the broad-spread, easy distribution of child pornography.

Importantly, the children whose images are trafficked are re-victimized each time their images are shared, bought, and sold.  The frequency at which this can occur is intensified over electronic media, opening a horrific floodgate as demonstrated in the New York arrests where thousands of obscene, pornographic images of children were collected from dozens of confiscated laptops. Clearly, solutions to this problem must necessarily emphasize examining technology’s  unwelcome dark side.

Boko Haram Kidnappings and the Victims’ Mental Health

In mid-April, Boko Haram, an extremist organization operating in the northern region of Nigeria, kidnapped nearly 300 girls from their boarding school in Borno.  Kidnappers threatened thatNigeria_Boko_Haram_Kidnapping the girls would be sold to sex trafficking rings in neighboring countries, causing international alarm.   In the weeks since that mass kidnapping, world leaders have issued collective demands for the return of the girls–and placed pressure on Nigeria’s president, Goodluck Jonathan to take aggressive action to achieve the girls’ return.  Some pundits believe hope may be around the corner, because in the last two days, Boko Haram leaders claimed that they will release some of the girls to safe houses.  Yet, it remains unclear whether this will happen. Continue reading

SAVE THE DATE: 9/18/14, Post-Trial Access to Medicines: Responsibilities and Implementation

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Please join us for a day-long conference at Harvard Law School on September 18, 2014, which will include presentations by leading experts and varied stakeholders as well as small group discussion and break out sessions that will work toward developing consensus in this difficult area.

Key questions include:

  • How should post-trial access be defined?
  • What type of interventions should be included in post-trial access obligations?
  • What are the responsibilities of various stakeholders?

More information, including the developing agenda, will be posted on the Petrie-Flom Center’s website as it becomes available.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

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Art Caplan on ‘Right to Try’ Law: More Cruel Than Compassionate

Art Caplan has a new opinion piece up at NBC News on Colorado’s new “right to try” law, which “expands access to experimental medications, making it legal for the terminally ill to seek access to drugs that have not yet received FDA approval.” From the article:

Colorado has become the first state to enact a so-called “right to try” law that expands access to experimental medications, making it legal for the terminally ill to seek access to drugs that have not yet received FDA approval. Many others are considering doing the same thing.

Politicians know a surefire winning issue when they see one. Sounds like a great idea? The truth is, such laws are utterly inadequate for helping the dying and the desperate. They would better be described as “right to beg” laws — a right which, sadly, the terminally ill already have and already use in social media campaigns.

Read the full article.

How Medicine Learns About the Law

Nadia N. Sawicki

Many medical providers learn about the law the way kids learn about sex – whispers with friends, internet message boards, and media depictions of the most dramatic and unrealistic kind. And while both medical schools and junior high schools offer some type of formal education, it is quite limited, especially as compared to the information these students collect through other, less reputable, sources. As a result, many medical providers go into practice with a dark cloud over their heads – the “scared straight” model of legal education, if you will.

We’ve heard a lot about the practice of defensive medicine – ordering more tests and procedures than are medically necessary in an effort to protect oneself from potential liability. But fear of liability manifests itself in other, less dramatic, ways as well – for example, in overly-restrictive interpretations of HIPAA requirements that make it difficult for patients and their care providers to access needed medical information. In reality, however, much of the fear of liability experienced by medical professionals is unfounded.

Continue reading

Doctors, Lethal Injection, and Firing Squads

Yesterday JAMA published a new perspective I co-wrote with Bob Truog and Mark Rockoff  “Physicians, Medical Ethics, and Execution by Lethal Injection“. In that article we make the case that the recommendations coming out of the Oklahoma botched lethal injection executions to require physician involvement would force physicians into an untenable medical ethical position. We also argue that it supports a kind of kabuki theater of medicalization, where execution becomes normalized.

Now comes a news report of a Utah lawmaker pushing to give those set to be executed the option of firing squad which he views as more humane than lethal injection. Many people will no doubt recoil at this notion. But here is my intentionally provocative question (and this is on my behalf not my co-authors): If you are in favor of capital punishment, wouldn’t a single close range shot to the head as a form of execution be, in some ways, more defensible than lethal injection? If you recoil at the notion of this being a way of doing execution, have you perhaps fallen for the kabuki theater of medicalization? Why not choose a method of execution that is more honest about the gravity (and perhaps the horror) of what we are doing rather than present something as somewhere on a continuum with sedation?