Early Warning on Heroin and Syringe Exchange?

By Scott Burris

It’s hard to believe that after all these years, all the evidence, and all the reductions in HIV among injection drug users, we still only have 15 states that explicitly authorize syringe exchange programs (SEPs). (See LawAtlas for an interactive map.)  CDC estimates we still have around 4,000 new cases a year by injection, so that’s reason enough to keep the SEPs we have open and start new ones where drug users are not now being reached.

Now another factor could be in play. Harm reductionists are reporting an upsurge in SEP users in places where efforts to crack down on illicit pill use have started to bite.  A lot of these users are reportedly young, under 25, and at serious risk of getting HIV or HCV.

So far we only have anecdotal reports. It could be coincidence, or overblown.  But we should be worried: there is nothing strange about pharmaceutical opioid users moving on to heroin when pills get scarce. It would be prudent as a matter of health policy to make sure that syringe access services are available in every community where opioid users are injecting, and to make sure these programs have surge capacity.  That’s prudent policy: here on planet earth we are cutting health budgets and, I fear, ignoring the effect of pill control on heroin use.

All this reminds us how important it is to be closely evaluating the consequences of new laws and policies that are intended to reduce illicit pill use.  Their success in reducing consumption is only part of the picture: the ultimate issue of concern is that we protect the health of people who are using until they can reach a safer place in their lives.

Quality Control on the Back-End via the ACA and on the Front-End via Tort Litigation

By Vickie J. Williams

I am back after a brief hiatus for the Jewish holidays. L’Shanah Tova to all my readers who have just celebrated the Jewish New Year.

The first Monday in October is, of course, a special day for all of us legal eagles–the Supreme Court is back in session. The other significant thing about October 1 for those interested in health law is that hospitals will now be fined if too many of their Medicare patients are readmitted within 30 days of discharge due to complications. As reported by the Associated Press, this is part of the Affordable Care Act’s push to incentivize quality improvement while trying to save taxpayers money. Right now, admissions for only three medical conditions are subject to the penalty: heart attacks, heart failure and pneumonia. Penalties are held to a maximum of 1% of the hospital’s Medicare payments for now, but will rise to a maximum of 3% of Medicare payments over several years. This attempt to control quality of care on the back-end constitutes a marked contrast with the way reimbursement policy has worked over the last several decades to discourage hospitals from keeping patients in beds for “social” reasons, such as having nobody to care for them at home if they are discharged. Many Medicare hospital readmissions are due to non-compliant behavior by fragile patients with few resources to help them once they leave the hospital, something that is not really subject to the hospital’s control, and says nothing about the hospital’s quality of care for the patient. For decades, Medicare payment policy, which generally pays hospitals the same amount for caring for a patient regardless of how long he or she is in the hospital, has encouraged speedy discharges. This is touted as a way to save costs. Apparently, the new policy on payments for readmission is an acknowledgement that there is both a financial and a human cost to treating medically and socially fragile people in the express lanes of health care. It remains to be seen whether the penalties result in better quality care, or significant savings, but surely they will result in increased work for hospital social workers and discharge planners. Read More

Al Roth – Nobel Prize Winner!

Congrats to our blogger, Al Roth, for his Nobel Prize in economics (alongside Lloyd S. Shapley of UCLA)!  Al built on Shapley’s theories about the best ways to match “agents” in markets — for example, students matched with schools or organ donors with patients needing organs — and conducted experiments to further illuminate Shapley’s work.  Al presented a really fascinating paper (with his colleague Judd Kessler) at one of last year’s Harvard Health Law Policy workshops on organ allocation policy and the decision to donate, and you can find lots more about his interesting work over at his Market Design blog.

Congrats again, Al! (Probably the best 4AM wake up call a person could get!)

Health Services Research Postdoctoral Fellowship and Research Scientist Positions

Liberty Mutual Research Institute/Harvard School of Public Health + Univ. of Massachusetts – Health Services Research Postdoctoral Fellowship and Research Scientist Positions

HEALTH SERVICES RESEARCH POSTDOCTORAL FELLOWSHIP: The Center for Disability Research (CDR) at the Liberty Mutual Research Institute in Hopkinton, MA and the Harvard School of Public Health (HSPH) are seeking applicants for a two-year postdoctoral position in health services/work disability research. This is a fully-funded, joint appointment based at the HSPH, involving faculty at both locations. We are also accepting applicants through a similar collaborative program based at the University of Massachusetts/Lowell.

The postdoctoral fellow will design and implement original studies at the CDR related to understanding and preventing work disability, conduct data analyses, and prepare first-authored scientific publications. The research focus is on the role of health care in work disability outcomes, through analysis of our extensive, longitudinal medical claims and disability data. After completion of the fellowship, transition to a full-time faculty-level position is quite possible.

For over a decade, this has been an excellent opportunity for postdoctoral fellows to develop expertise in health services research, build a strong publication track record, and begin a successful academic career. We have had considerable success in pursuing innovative analytic approaches to answer important research questions.

APPLICATIONS/FURTHER INFORMATION: Applications are due Nov. 15. More information is available at: http://www.mediafire.com/view/?7t8e7gaqaquoa4c. Interested persons should contact the Program Director, Glenn Pransky MD MOccH, at glenn.pransky@libertymutual.com

RESEARCH SCIENTIST: The Center for Disability Research is also recruiting a Research Scientist, to develop new studies on the return to work process, focusing on organizational and social aspects. Qualifications include a solid research background, and ability to implement innovative approaches to investigate the early phases of returning to work after injury or illness. This is an excellent opportunity – collaborative environment, all results are published in high-quality scientific journals, competitive salary and benefits, and a permanent fully-salaried position (not grant dependent). Although advanced training in a related, relevant field ­ such as economics or sociology – is required, experience in work disability is not necessary. A new perspective from outside the work disability field would be very welcome.

APPLICATIONS/FURTHER INFORMATION: A more detailed job description is at: http://www.mediafire.com/view/?13zys2knrg15y5j. The application deadline is Nov 30.

Soda Industry Sues to Block NYC Ban on Sugar-Sweetened Beverage Sales

By Rebecca Haffajee

Sure enough, last Friday the American Beverage Association and others, represented by Latham & Watkins, sued to block Mayor Bloomberg’s ban on the sale of sugar-sweetened beverages larger than 16 oz at certain NYC vendors. The suit, filed in the NY Supreme Court, asserts that the Mayor bypassed the proper legislative process for governing NYC, instead imposing the ban by executive fiat. The petition cites the many proposals considered and rejected by the NY City Council and NY State Legislature with respect to sugar-sweetened beverage (e.g., excise taxes, restrictions on the use of food stamps, warning labels, and product placement rules) as evidence that the legislature has chosen not to act to restrict sales in this sphere. The petition also claims that the scope of the Dept. of Health (DOH) action here is unprecedented, despite the fact that the DOH banned the use of trans fats in foods and required calorie postings at enumerated food service establishments.

Several specific causes of action are alleged by the soda industry, including:

  • that the New York City Charter, in it’s general language, does not delegate the necessary enumerated powers to the DOH to implement such a ban;
  • that even if authority to enact the ban has been delegated by the legislative branch to the executive branch, such delegation is unconstitutional as in violation of the separation-of-powers doctrine (i.e., the legislature cannot cede its fundamental policy-making responsibility to an administrative agency); and
  • that the ban fails to pass rational basis review given it’s arbitrary features that are unrelated to it’s stated purpose (e.g., cutoff at 16 oz size, exclusion of alcohol, and application to certain food establishments but not grocery or conveniences stores).

The plaintiffs request that the court enjoin and permanently restrain the ban.  They also want a decision by Dec. 15, 2012, so that affected businesses can avoid expending funds to comply with the law (set to take effect March 12, 2013). A response from the DOH will be forthcoming before an eagerly awaited court decision. A Cleveland Judge recently sided with the city when it sued the State of Ohio for trying to preempt its regulation of trans fats. Cleveland, the Judge ruled, was within its powers under the State constitution. But this most recent soda ban challenge applies to a different state’s legislative scheme, and a finding in favor of the plaintiffs could render Major Bloomberg’s “War on Fat” via other initiatives also susceptible to challenge.

Reality Check, Please!

by Suzanne M. Rivera, Ph.D.

By now, many people have seen a still photo or video footage of Rep. Paul Broun (R-Georgia), standing in front of a wall full of deer heads, proclaiming that evolution, embryology, and the Big Bang theory are “lies straight from the pit of hell.”  According to the Congressman, “it’s lies to try to keep me and all the folks who were taught that from understanding that they need a savior.”

Readers might shrug these statements off as merely absurd.  But Rep. Broun is a member of the U.S. House Committee on Science, Space, and Technology, and he’s running unopposed for re-election.

Broun is just one of the members of the House Committee on Science, Space, and Technology whose unusual views should give voters pause.  His colleagues on the Committee include Todd “Legitimate Rape” Akin (R-MO), and Randy Neugebauer (R-Texas), whose congressional record is most notable for introducing a resolution that “people in the United states should join together in prayer to humbly seek fair weather conditions.” Read More

Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA

By Leslie Francis

In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements.

A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles can be found here and are very much worth reading).

A posting Sept. 26 in the Federal Register indicates that the Secretary of HHS has delegated authority to to oversee the reporting process to the FDA.  Whether this signals improved monitoring of clinical trial data submissions remains to be seen.  One can only hope.

Filing a Complaint with HHS About a HIPAA Violation: A Warning About “How (Not) To”

By Leslie Francis

I posted in June about the fact that my social security number (and possibly other personal information) had been downloaded to an unknown site in Eastern Europe as part of a large security breach from the Utah state health department.  In connection with that breach, I have filed a complaint with the Office for Civil Rights at HHS (OCR).
I thought readers might like to know, however, that the process of complaining about a HIPAA violation to OCR is cumbersome indeed.  There are forms available on line, here.  You can open them, and fill in information, but you can’t save them.  If you close the form, you lose all the data. You also can’t file them online–you have to print them out and fax them off.  (You are helpfully told, however, to “print out a copy for your records.”)  I finally figured out that if you save the form to notepad before you fill it out, you can then email it to HHS–but this required a telephone call to the appropriate regional office of HHS.

When I pointed out to OCR that this process is not exactly user-friendly, they indicated that they are “working on it.” Imagine someone without a home computer, or a home fax machine, or a home printer, using public library computers in the effort to reach OCR about what they regard as a significant problem with their health information. Surely in a world of blue buttons and digital Medicare strategies, see Responsive Design and the New Medicare.gov, the ability to file a complaint about possible violations of health information security or confidentality should be an easier online process.

PCSBI: Privacy and Progress in Whole Genome Sequencing

Yesterday, President Obama’s Commission for the Study of Bioethical Issues released its fifth report: Privacy and Progress in Whole Genome Sequencing.  I haven’t had a chance to digest it yet, but for now, just wanted to call it to everyone’s attention.  The gist seems to be privacy, privacy, privacy.

Here are the major recommendations, straight from the Commission’s “mouth”:

Recommendation 1.1
Funders of whole genome sequencing research; managers of research, clinical, and commercial databases; and policy makers should maintain or establish clear policies defining acceptable access to and permissible uses of whole genome sequence data. These policies should promote opportunities for models of data sharing by individuals who want to share their whole genome sequence data with clinicians, researchers, or others.

Recommendation 1.2
The Commission urges federal and state governments to ensure a consistent floor of privacy protections covering whole genome sequence data regardless of how they were obtained. These policies should protect individual privacy by prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample came.

Read More