Quality Measures and Doctor Behaviors

by Vadim Shteyler

Efforts to improve health care quality under the ACA have been directed towards expanding EHR use and health IT, improving care delivery by promoting care coordination and population health, and laying incentives for providers to meet quality measures. The 33 ACO quality measures include 8 measures to evaluate preventive care, 12 measures to address goals of managing 4 common diseases, and 7 to assess patient satisfaction. Though quality improvements have not been consistently shown, studies have found modest Medicare spending reductions. In fiscal year 2013, CMS began reducing health care reimbursement rates to hospitals with excessive 30-day readmission rates, as generalized by their readmission rates for heart attacks, heart failure, and pneumonias. These were extended to include readmission rates for hip and knee surgeries in fiscal year 2015. And, as readmissions were estimated to account for $17.5 billion of Medicare costs in 2012 (in part attributable to insufficient discharge services, access to outpatient care, and follow-up), efforts to curb them are expected to continue.

The ACO quality measures have been criticized for being too process oriented (as opposed to outcomes oriented). And, undoubtedly, so few quality measures can’t encapsulate all of health care. Noted shortcomings of readmission rates as a valid indicator of quality include that they do not differentiate between planned and unplanned readmissions and they don’t adequately control for different case-mixes between hospitals. As psychiatric illness is often poorly recorded in medical records, it is a major confounder that may impact different hospitals differently. In this blog post, I add the speculative concerns of a medical student from limited experiences on the wards. Continue reading

Check out the latest news from the Petrie-Flom Center!

Check out the April 17th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

PFC Logo-RGB-Round-Otlns-NewApply Now!
2015-2016 Petrie-Flom Student Fellowships

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. More information on our current fellows and their work, is available on this website.

Eligibility: The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements.  Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.
Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).
Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015.

View the full requirements and application instructions on the call for applications.

 For more on news and events at Petrie-Flom, see the full newsletter.

The Rights of Donor-Conceived Offspring

Guest Post by Naomi Cahn
Harold H. Greene Professor of Law at The George Washington University Law School
[Cross-posted from the Concurring Opinions Blog]

Today’s Washington Post prints an interesting article on regulation and the fertility industry.   One issue that it addresses is the rights of donor-conceived offspring to learn the identity of their egg and sperm donors. As I’ve written in numerous articles and books, it is a fundamentally important right for all donor-conceived offspring to learn the identity of their donors (the strength of my advocacy on this issue may not be clear from the Post article).

Other academics disagree with this position, believing it important to protect the identity of gamete donors for a variety of reasons.  I disagree, and I think the  law has a critical role to play in ensuring respect for the rights of donor-conceived people.   Parents can make the legal choice never to find out the identity of their donor.  By contrast, donor-conceived offspring have no such legal right in the United States: unless their parents opted into a known donor program, they are unable to learn the identity of their donors.  While their parents’ choices affect them as children, donor-conceived children grow up, and many become curious about their origins. Yet the law’s tight focus on the parent-child relationship excludes legal questions relating to donor-conceived adults. Continue reading

How to Fix Our Hospital Pricing Problem (and How Not To)

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Last month, Slate columnist Reihan Salam wrote a provocative article about outrageous hospital prices that are driven, according to Salam, by greed, avarice, and market power. Salam gets a few things dead right, namely his diagnosis that we have a massive hospital pricing problem that is bleeding us dry and that the problem is largely caused by growing hospital market power. However, he misses the mark when laying out policy recommendations to curb monopoly-driven hospital prices.

The solutions

Antitrust:  Salam favors using antitrust enforcement to prevent health care consolidation and to reduce barriers to entry for competition. The biggest problem with antitrust enforcement is that it can do little to reverse or break up existing monopolies. Antitrust laws will be unable to help the vast majority of hospital markets that are already concentrated. Second, even with its improving success rate in court, the FTC simply cannot prevent or police the ongoing wave of hospital mergers, resulting in price increases up to 40% price increases in some areas. To be sure, increased antitrust enforcement is a necessary element of the strategy to control hospital prices to stem the tide of consolidation that is driving prices upward. But antitrust is no silver bullet, especially for hospital markets that have already become noncompetitive. Continue reading

My Plan to Avoid the Ravages of Extreme Dementia

Guest Post by Norman L. Cantor
Professor of Law and Justice Nathan L. Jacobs Scholar Emeritus
Rutgers School of Law – Newark

The first signs of my friend Gertie’s descent into dementia were mild — confusion about days of the week and memory loss about recent events. These were troubling but understandable phenomena in my then 84 year-old friend. Aging inevitably entails some cognitive decline. Over time, though, her symptoms of mental deterioration worsened — disinterest in pursuits like reading and listening to music that had once occupied and entertained her, forgetting not just long-time friends, but even her devoted husband who had died years earlier, and obsessive repetition of certain thoughts and phrases. Now 89, Gertie barely recognizes the devoted caregivers around her. She cannot recall her distant or recent past, she no longer knows who or where she is. Gertie remains physically tenacious, with no life-threatening maladies. While dependent on assistance for dressing, eating, ambulating, bathing, and toileting, Gertie may continue in her mentally detached and dysfunctional limbo for years more.

I am determined to avoid Gertie’s fate. So I am now contemplating how to respond if and when I am diagnosed with early Alzheimer’s. My prime object is to avoid the precipitous mental deterioration accompanying advanced Alzheimer’s or similar dementia. My aversion is not based on prospective emotional distress and suffering. While some people in sharp mental decline may experience anxiety, frustration, embarrassment, confusion, or agitation, some, like Gertie, seem placid and indifferent to their debilitation. My aversion is grounded rather in my abhorrence of reduced mental function to a degree I deem intolerably demeaning. Such a status is unacceptable to me whether or not I would experience distress in a future demented state.

Keep in mind that I spent my work career as an academic. My personal satisfaction and self-image have flowed largely from intellectual functions like observation, reflection, and analysis. Inability to understand and process information is, for me, an intolerably undignified status. This preoccupation with future mental dysfunction reflects unwillingness to soil the lifetime image to be left with my survivors. I care mightily about posthumous recollections of my personality and I seek to shape my life trajectory (including a dying process) in a way that preserves a modicum of dignity. Continue reading

Mainstreaming Medical Legal Partnerships (MLPs)

Last week, I had the opportunity to speak at the 10th Annual Summit of the National Center for Medical Legal Partnership in McLean, Virginia. The summit brought together more than 400 people working to “mainstream” medical legal partnerships (MLPs). The theory of change is that through these partnerships, the health care sector can begin to more systematically address social, behavioral and environmental determinants of health. Particularly on behalf of patients who are low-income, legal professionals address root causes of illness by working with utilities companies, landlords, social service agencies and the court system.

Concretely, MLPs are programs in which civil legal aid agencies, health care organizations and public health departments cooperate to train their staffs, treat individuals and identify population level problems. Most often, it is civil legal aid agencies that provide expertise in the laws around housing and public benefits, and spend their resources to ensure access to housing subsidies, food benefits, health insurance and employment. Some law firms also contribute pro bono time to the cause, as do some law schools in the form of clinics.

Continue reading

Ending Institutional Corruption Conference, May 1 & 2

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in the Edmond J. Safra Center for Ethics at Harvard University conference “Ending Institutional Corruption,” held in the Milstein Rooms in Wasserstein Hall at Harvard Law School. Participants include:

  • Christopher T. Robertson, Academic Fellow alumnus, speaking on “The Institutional Advantages of Courts, and the Potential of Litigation, as a Solution to Institutional Corruption”
  • Christine Baugh, 2014-2015 Student Fellow, conference co-organizer
  • Aaron S. Kesselheim, affiliated faculty member, speaking on “Trends in the Use of Expedited Drug Review and Approval Designations at the FDA”
  • Judge Nancy Gertner, affiliated faculty member, speaking on “The Limits of the Criminal Sanction”

For a full description of the conference, a complete agenda, and registration information, click here!

Highlights from the Consortium of Universities for Global Health Conference: Part III

By Guest Blogger Dan Traficonte 

In this third blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some research from the conference focused on the importance of considering local social practices and belief systems into health policies and interventions.

Faduma Gure, a Master’s student in Interdisciplinary Health Sciences at the University of Ottowa, conducted fieldwork in Somalia to explore awareness of and attitudes to emergency contraception and their implications for health interventions. Somalia’s high fertility rate, high maternal mortality ratio, and low contraceptive prevalence rate coupled with restrictive abortion laws make addressing the lack of family planning services an extreme challenge. In conflict or post-conflict settings like Somalia, emergency contraception can be critical for pregnancy prevention, yet Somalia remains one of the few countries in the world without a registered progestin-only emergency contraceptive pill.

Ms. Gure conducted a qualitative, multi-methods study comprised of structured interviews with key informants, including physicians, non-governmental officials, government officials, local Somali pharmacists, and married and unmarried Somali women. Most participants showed little knowledge of existing family planning methods or emergency contraception, however, once contraception was described, all participants expressed tremendous enthusiasm for expanding access to post-coital contraceptive methods in Somalia. All participants expressed that an available emergency contraceptive would fill a major gap in reproductive health service delivery, and all government officials interviewed indicated that emergency contraception could easily be incorporated into the existing health system.

It is a common belief—and often a misconception—that people in conflict-torn and impoverished countries like Somalia reject modern medical technologies due to conflicting local practices and beliefs. Ms. Gure’s preliminary research indicates that the lack of emergency contraception in Somalia does not result from local beliefs, but from lack of knowledge and access to the technology.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we are joined by Thad Pope, one of the country’s leading scholars on end-of-life issues. Thad is professor of law and director of the Health Law Institute at Hamline Law. He curates a particularly useful web site, Medical Futility & Non-Beneficial Treatment Cases, at ThaddeusPope.com and authors the Medical Futility Blog. He joins us to discuss VSED (some background here) and Assisted Suicide. His scholarship on the topic includes papers here and here. The British Columbia case he discusses is here. In addition we discuss regulation of dietary supplements and the problem of agency capture and the HHS-ONC Report on HIT Information Blocking and a recent FTC letter to ONC.

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 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

Bioethicist Art Caplan: German Mom Expecting Quads at 65 is ‘Irresponsible’

A new piece by contributor Art Caplan on NBC News:

Berlin school teacher Annegret Raunigk is proudly prolific and, at age 65, not done making babies — pregnant with quadruplets that would enlarge her family from 13 to 17 children. Why?

Raunigk said she became pregnant again because her 9-year-old daughter asked for a younger sibling. (Her first 12 children — by five men — are ages 22 to 44). She told German tabloid Bild that donated eggs were fertilized and implanted at a clinic in Ukraine. Multiple attempts were required to get the eggs to fertilize. She did not say whose sperm was used or if the egg donor was paid.

Some media outlets have trotted out the usual fluffy descriptions of “miracle” and “gift” while trying to figure out if she is the oldest woman ever to have a child (she isn’t) or to have quadruplets (almost certainly she is). But this line of reporting completely misses the mark.

What she is doing is unethical. […]

Read the full article here.

TOMORROW (4/14): The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

Limiting D&E Abortions:  The Kansas Maneuver

Anti-abortion groups have found another way to limit previously legal abortions.  Building on the analysis in Gonzales v. Carhart, the 2007 case upholding the federal partial birth abortion law, Kansas has now prohibited “dismemberment” of fetuses.  This law would ban dilatation and evacuation (D&E) of the uterus by banning piecemeal removal of fetal parts, which is the standard way of performing second trimester abortions.  Several other states have similar legislation in the pipeline.

While 90% of abortions occur in the first trimester when suction aspiration or medication abortions are available, most later abortions occur by D&E, which involves several passes into the uterus with forceps or other instruments to remove the fetus.  The fetus is ripped apart and removed piecemeal.  The Kansas law would require that the fetus first be killed in utero by a KCL injection, and then removed piecemeal.  Alternatively, labor could be induced so that a very early nonviable fetus is delivered whole and dead.  If it is breathing, it is then not resuscitated because it is too immature to survive. Continue reading

Highlights from the Consortium of Universities for Global Health Conference: Part II

By Guest Blogger Dan Traficonte 

In this second blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some fascinating new research on the relationship between global poverty and population health.

Dr. Joseph Dieleman from the Institute for Health Metrics and Evaluation at the University of Washington presented his research on national poverty rates of 129 countries and their effect on mortality. Typically in the global health literature, a country’s wealth serves as a predictor of population health outcomes—that is, wealth means health. However, the relationship between poverty and health outcomes has not been systematically evaluated in cross-country studies because of insufficient data. Dr. Dieleman sought to address this relationship and show how poverty can explain variation in health using 22 complete poverty and health data series.

Building on the World Bank’s International Comparison Program dataset of 800+ household surveys, Dr. Dieleman used covariates and intertemporal trends to generate a complete data series for 129 countries for 1990-2013. To predict national poverty rates at 51 different income thresholds, 20 variants of three models were supported by out-of-sample validation to choose the best model. Finally, Dr. Dieleman incorporated health data into his model using fixed-effects linear regression techniques to test how national poverty rates are associated with changes in adult and child mortality. Continue reading

Arizona Enacts “Abortion Reversal” Law

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

On Wednesday, March 25, Arizona legislators passed a bill prohibiting women from buying insurance plans that cover abortions on the federal health exchange.  Senate Bill 1318 also includes a provision on medical abortions, which are typically used during the first nine weeks of gestation. Medical abortions involve taking two pills within a few days of each other.  The law requires doctors performing such abortions to tell their patients that if they reconsider their abortion after taking their first pill, they should return to the doctor for a procedure that can allegedly “reverse” the abortion.  The law amends Arizona Statute § 36-2153 to add that at least twenty-four hours before an abortion is performed, the physician must orally and in person inform the woman that “it may be possible to reverse the effects of a medication abortion if the woman changes her mind but that time is of the essence.” The law also requires the Department of Health Services to update its website to include information about the potential ability to reverse a medical abortion.  Republican Governor Doug Ducey, who opposes abortion rights, signed the law on March 30, 2015.

Like any law addressing abortion, the law is controversial. Abortion opponents lauded the bill, stating that Wednesday, March 25th was a “great day for women in Arizona who are considering getting an abortion to get all the facts they need.” On the other hand, women’s rights and health care providers’ groups oppose the coverage exclusion and vehemently oppose the abortion “reversal” provisions.  Senate Minority Leader Katie Hobbs called it “junk science” and “quack medicine.”  Arizona-based gynecologist Ilana Addis stated that there is no evidence to support this provision and women would essentially be “unknowing and unwilling guinea pigs.” Continue reading

Fraudulent Concealment and the Statute of Repose

By Alex Stein

Anyone interested in the tobacco litigation and/or medical malpractice must read Hess v. Philip Morris USA, Inc., — So.3d —- (Fla. 2015). Stemming from the Engle class action, this decision of the Florida Supreme Court advances the understanding of statutes of repose and how they apply, inter alia, in medical malpractice cases. Continue reading

The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests

A new post by Rachel Sachs on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Last fall, the Food and Drug Administration (FDA) finally took steps toward an action that it had been publicly considering for over four years: the regulation of laboratory-developed tests (LDTs). The FDA defines LDTs as tests which are “designed, manufactured, and used within a single laboratory.”

This definition encompasses a wide range of diagnostics, including complex multigene panels that are performed in just a single laboratory in the United States, and basic diagnostic tests like a complete blood count, which are performed in thousands of laboratories nationwide.

As long as a manufacturer does not make and sell a kit for use in other laboratories, its test can be provided as an LDT. Estimates suggest that tens of thousands of diagnostic tests, including the majority of genetic tests, are currently available as LDTs.

Yet at present, the FDA exercises essentially no regulatory authority over LDTs. As such, they can be performed without any of the safeguards that typically apply to other medical technologies, including pre-market review and adverse event reporting. This is not to say that these tests are entirely unregulated. […]

See the full post here.

Building on 20 Years of Success: The Future Role of Law

By Scott Burris, JD

On this, the last day of National Public Health Week 2015, we’re looking forward by looking backward. There is nothing new about using law and policy to promote healthier environments, products and behavior. There is no good future for public health that does not include even more, and more effective, legal interventions.

Evan Anderson and I wrote in 2012 about the legal regulation of health-related behavior over the past half-century. The story we told offered several reasons for unabashed optimism about what law can do for health. The record is clear that law works, and works across a wide range of different health threats. We pointed to CDC lists of Great Public Health Achievements from the last century and the first decade of the 21st.   Every one of them — from high levels of vaccination, through motor vehicle safety and cancer prevention to maternal and child health – could not have been successful without law and policy. Continue reading

Monday 4/13 HLS Health Law Workshop with Rachel Sachs

HLS Health Law Workshop: Rachel Sachs

April 13, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Presentation Title: “Rethinking the Incentives/Access Dichotomy: Prescription Drug Reimbursement as Innovation Incentive.” This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Rachel E. Sachs is an Academic Fellow at the Petrie-Flom Center. She earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. She holds an A.B. in Bioethics from Princeton University. After law school Rachel clerked for the Honorable Richard A. Posner of the United States Court of Appeals for the Seventh Circuit. Rachel’s primary research interests lie at the intersection of patent law and public health, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems. Her past scholarship has examined the interactions between patent law and FDA regulation in the area of diagnostic tests, and explored the mechanisms behind the passage of patent-related legislation. Her current scholarship applies this focus on innovation and access to the intersection of patent law and drug reimbursement policies.