HRW Welcomes Amy Catapano, Esq.

We are pleased to welcome Amy Catapano, Esq., to HRW. She is a health care attorney who recently completed her Masters of Law (LL.M.) in Health Law at Seton Hall Law. She received her Juris Doctor degree, graduating cum laude, from Seton Hall Law in 2007 and thereafter completed a clerkship in the Superior Court of New Jersey with the Honorable Barbara A. Curran in Hudson County. During law school, she was a member of the Journal of Sports & Entertainment Law, the St. Thomas More Society, and held an externship with the U.S. Securities and Exchange Commission. She is a graduate of the University of Michigan where she received a Bachelor of Arts in Spanish.

Ms. Catapano wrote her LL.M. thesis on the HITECH Act and data breach insurance. She is interested in health information technology, HIPAA and privacy law, and health care reform. She is licensed to practice in New Jersey and New York, and is a member of the NJSBA Health and Hospital Law Section and the NYSBA Health Law Section.  She has significant experience in medical malpractice litigation, as well as insurance defense and health law matters, having worked at a boutique defense firm in Milburn, New Jersey and in New York, New York.  She can be reached at amycatapano@gmail.com.

(Slow) Progress Towards Uncovering Sex-Linked Differences in Drug and Device Safety and Efficacy

In 2000, the General Accounting Office (since re-named the Government Accountability Office) reported that more women than ever were being included in clinical trials funded by the National Institutes of Health.  In fact, the GAO noted, over 50% of the participants in the trials that NIH funded in fiscal year 1997 were women.  At the same time, the NIH had made much less progress implementing the requirement that certain clinical trials it funds be designed to reveal sex-linked differences in a treatment’s safety and efficacy.  In 2012, sex-linked differences in responses to treatments are still not being studied in research funded by the government or by the private sector.  In a summary released last month of an Institute of Medicine workshop on the problem, Theresa Wizemann reports that “[e]ven when women are included in clinical trials, the results are often not analyzed by sex” despite “growing acknowledgement that men and women have substantial and widespread biologic differences.”

As its title — “Sex-Specific Reporting of Scientific Research” — suggests, a focus of the IOM Workshop was whether medical journals could drive reform in this area by requiring that authors report sex-specific data.  Wizemann writes that because “[r]esearchers are eager to have their papers published in high-profile journals[,]” “editorial policies implemented by those journals can be effective in modifying behavior.”  But several participants in the IOM Workshop noted that studying population subgroups poses “methodologic and analytic” challenges.  In many cases, Wizemann reports, “achieving statistical significance for subgroup analyses would require unattainable or unjustifiable numbers of participants.”  Workshop participant Gregory Curfman, who is the Executive Editor of the New England Journal of Medicine, “cautioned against editorial policies that require trials to be designed to reach valid statistical conclusions for males and females separately[,]” because “[s]uch editorial policies would create a ’steep mountain to climb for investigators and for funding agencies[.]‘”

The participants in the Workshop seemed to be largely in agreement that journals could not, acting alone, re-shape “research culture to embrace consideration of sex differences as part of sound study design.”  There are steps that journals could (and should, I think) take short of dictating study design, though, including requiring study authors to tabulate and make available raw sex-specific data to facilitate future studies that draw on data from multiple trials.

Government agencies and other funders have a role to play too.  The NIH should more stringently enforce the statutory requirement that certain later-stage trials it funds be designed to evaluate sex-linked differences, and the FDA should take similar action with regard to trials funded by drug and device companies.

A study published last year by Sanket Dhruva, Lisa Bero, and Rita Redberg in the journal Circulation highlighted how little progress the FDA made on the device side over the last decade.  In 1994, the FDA issued a directive requiring that every time it makes a decision on an application for approval to market a new device, it issue a Summary of Safety and Effectiveness Data (SSED) that includes, among other things, a “gender bias” statement addressing the following two questions: (1) Did the proportion of men and women in the clinical trial reflect the distribution of the disease? and (2) Were there any sex-linked differences in safety or effectiveness?  Dhruva and colleagues reviewed all of the of the SSEDs for all of the cardiovascular premarket approval applications submitted and approved between 2000 to 2007 and found (1) that women were underrepresented in the underlying clinical trials and (2) that less than half (41%) of the SSEDs included the required “gender bias comment or analysis.”  Nearly a third (28%) did not even report the percentages of men and women enrolled in the studies supporting the application.  And, there was no improvement over time; “[t]here was no change in the presence of gender bias comments or analyses over the 8-year period” studied.

The FDA has been working for several years to address the problem and in December of 2011 it released a draft guidance in which it “strongly recommends” that device companies work closely with the agency to “investigate and report differences in study outcomes of treatment by sex.”

The Guidance provides clear direction for companies regarding (1) increasing the percentage of enrollees in device trials who are women, (2) designing studies to allow for the “consideration of sex and associated covariates” such as body size, (3) analyzing study data for sex-linked differences, and (4) “reporting sex-specific information in summaries and labeling for approved devices.”  Whether these strong recommendations translate into strong and consistent agency action remains to be seen, but the Guidance is an excellent start.  As Carolyn Clancy, the Director of the Agency for Healthcare Research and Quality, who participated in the IOM Workshop, emphasized, “[b]etter data on women would be better data for everyone,” allowing for more specific clinical practice guidelines and better-tailored care of individual patients.

The Hippocratic Math

Navigating the New Field of International Health Law, Featuring Gian Luca Burci, Legal Counsel for WHO

This lecture, “Navigating the New Field of International Health Law,” will explore the intersection of health and international law and the emergence of International Health Law as a practice area. Featuring Gian Luca Burci, Legal Counsel for the World Health Organization, this program will focus on the growing interactions between health policy and various areas of international law, including international business transactions, intellectual property, international security, and human rights law. The program is sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

The event will take place at Seton Hall Law, Newark, NJ, on Wednesday, February 22, 6 to 7 p.m.  There is no charge. 1 New Jersey CLE credit will be available. Click here to make your reservation or for more information, please contact Sara Simon, Director, Healthcare Compliance Certification Program, at sara.simon@shu.edu or call 973-642-8190.

AALS Panel on Teaching Health Law: A Tour de Force

The first speaker was Prof. Charity Scott,  Catherine C. Henson Professor of Law and Director of the Center for Law, Health & Society at Georgia State University College of Law.  Her presentation, “Collaborating with the Real World: Opportunities for Developing Skills and Values in Health Law,” was a terrific mix of high level observation, on-the-ground experiences, practical examples from her own health law program, and articles she edited as editor of the Teaching Health Law column of the JLME.  Scott noted that experiential learning can happen in time slots ranging from an hour to a day to a semester or year, so any committed professional can fit some opportunities into their schedule at some point.  She particularly focused on how students could help attorneys, doctors, and community members solve pressing problems.  In coming weeks, I’ll blog on some of the particular programs she mentioned.

The Nirvana Fallacy Among Health Care Cost Cutters

One of my fun little Christmas presents was the Gruber/Newquist/Schreiber comic book guide Health Care Reform: What It Is, Why It’s Necessary, How It Works.   It’s wonderfully illustrated and has a lot of good information.  It offers a very hopeful vision of what health reform can do.  It patiently explains the politics and policy that led to the ACA, portraying it as a compromise that both “left and right” should be able to support.

Unfortunately, the authors have chosen to portray virtually anyone who opposes the ACA, on both left and right, as either angry, exasperated, selfish, or unreasonable.  (This animated penguin reminds me of several of the characters in the book.) There are also some questionable implications in various parts of the book.  For example, on p. 21, it’s suggested that if employers didn’t have to pay so much for health care, they’d just pay that in higher wages to employees.  But in an economy where corporate profits are capturing “88% of the growth in real national income while aggregate wages and salaries accounted for only slightly more than 1% of the growth in real national income,” why should we assume that will happen? Workers’ share of national income is declining; they have little bargaining power.  We can’t extrapolate the economic projections of the “Great Moderation” era to today’s Great Recession, where employers are exploiting the desperation caused by high unemployment to hold the line on wages and benefits.

One other objection: check out this graphic (my apologies for the poor camera-work), which suggests the deep problem in the US economy is that we’re spending too little on military or homeland security expenditures, and too much on health care:

Read more

Health Affairs on Community Development

ACO Symposium: Professor Jessica Mantel to Present, ACOs: Can we have our cake and eat it too?

In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Jessica Mantel, Co-Director of the Health Law & Policy Institute, University of Houston, Law Center and  Assistant Professor of Law. Professor Mantel will take part in the panel concerned with “ACOs in Theory: Issues Raised by Integrated Delivery,” and will be presenting ACOs: Can we have our cake and eat it too?

Professor Jessica Mantel joined the University of Houston Health Law & Policy Institute as co-director after eight years of service with two government agencies in Washington, D.C. She worked most recently as a senior attorney in the Office of the General Counsel for the Department of Health and Human Services. In that position she advised Centers for Medicare and Medicaid Services on legal issues dealing with Medicare matters, including implementation of the prescription drug benefit, hospital payments, incentive payments for the adoption of electronic health records, and health care reform. She previously worked as a health policy analyst in the Government Accountability Office evaluating Medicare payment issues. Prior to her service with government agencies, she practiced as an associate in the Health Care Department of the firm of Ropes & Gray in Boston and clerked for the Honorable Karen Nelson Moore of the U.S. Court of Appeals for the Sixth Circuit in Cleveland. Her research interests include the impact of various legislative and regulatory schemes on emerging trends in the health care delivery system and the allocation of limited health care resources. In 1997, Mantel received both her J.D. from the University of Michigan Law School and an M.P.P. from the University of Michigan School of Public Policy. She also holds a B.A. in psychology from the University of Pennsylvania.

Congratulations Jordan Cohen ‘11 and Katherine Freed Matos ‘11

Tonight just a fond farewell and congratulations to two of our finest student bloggers: Jordan Cohen and Katherine Freed Matos, both of whom have graduated from Seton Hall Law, with each receiving  the much vaunted  Health Law Award. They are both now hard at work studying for that fiendish quiz they offer each year at the end of July to see if would be lawyers were paying attention (it is a horrible exercise, I assure you, and if someone you know is studying for the Bar– bring them some food, and leave them alone– they’ll reemerge into the land of the living soon enough). As such, it will be awhile until we hear from them (at least on this blog) again.

After the Bar Exam, Jordan Cohen will be off to employ in the law offices of Brach Eichler, LLC., a preeminent law firm in the New Jersey metro area and a recognized leader in the field of healthcare law.

Katherine Matos has been named to the Office of the Inspector General at the U.S. Department of Health and Human Services, where she will work in the Office of Counsel to the Inspector General, Administrative and Civil Remedies Branch.

You will both be missed. It was a pleasure to work with you, and this blog is better for your having been here. Can’t thank you enough, or wish you enough luck– I expect great things– as it is simply the usual for you both.

The Demographics of Illness and Cost: or, An Old Story About Chronic Conditions

We’ve reported on the distribution of health care costs among populations on numerous occasions here at Health Reform Watch. Over the last decades, our own Professor John V. Jacobi has been espousing reform, at times as almost a voice in the wilderness, as a matter of dealing in caring and cost conscious ways with chronic conditions.

In January of 2009 I noted, quoting HHS reports:

Twenty-five percent of the U.S. community population were reported to have one or more of five major chronic conditions:

• Mood disorders
• Diabetes
• Heart disease
• Asthma
• Hypertension

Spending to treat these five conditions alone amounted to $62.3 billion in 1996. Moreover, people with chronic conditions tend to have other conditions and illnesses. , according to 1996 MEPS data. On an individual level, treatment for the average patient with asthma was $663 per year in 1996, but when the full cost of care for asthma and other coexistent illnesses is taken into account, the average cost was $2,779.

When the other illnesses are added in, total expenses for people with these five major chronic conditions rise to $270 billion, or 49 percent of total health care costs.

Expenses for people with one chronic condition were twice as great as for those without any chronic conditions. Spending for those with five or more chronic conditions was about 14 times greater than spending for those without any chronic conditions. Persons with five or more conditions also have high hospital expenditures. In New York State during 2002, of the 1.3 million different persons admitted to the hospital, the 27 percent with five or more chronic conditions accounted for 47 percent of all inpatient costs.

I have also noted in July of 2009 that

…32% of Medicare costs are attributable to diabetes. It is no stretch to say that if we have a Medicare cost problem in this country (we do), what we really have is a diabetes problem (and, considering Halvorsen’s “we only get it right 8% of the time” figure, a diabetes treatment problem as well).

But first things first. 32% is a mere scooch (yes, that’s the technical term) away from ONE THIRD. That’s an enormous number. If one were to relate this portion of Medicare expense to houesehold expenditures, it occupies a place similar to a mortgage– but an expensive mortgage in a house that no one wants to live in.

And now a further health cost demographic from NPR’s Marketplace in conjunction with WHYY’s Health Desk, Gregory Warner. And yes, it’s about chronic conditions:

Tess Vigeland: Take everything this country spends on health care — the government, employers, patients — and it rounds out to a little over $8,000 per person on average.

But averages don’t really tell the whole story. A study by the National Institute for Healthcare Management found that in 2009, 15 percent of us had no health care costs at all. While at the other end, 5 percent accounted for almost half of all health care costs: $1.2 trillion.

….

Gregory Warner: Maybe you picture this high-cost patient as someone at the end of life, confined to a hospital bed and hooked up to expensive medical devices. But more likely, you’ll find this person at home or in a nursing home, living with five or more chronic conditions.

Recommended Reading: Recent Legal Scholarship on “Risk Classification by Design”

Tom Baker’s Health Insurance, Risk, and Responsibility after the Patient Protection and Affordable Care Act (forthcoming in the University of Pennsylvania Law Review) is short (it would seem a theme is beginning to emerge in my Recommended Reading posts), tightly-reasoned, and instructive.  I highly recommend it.

Professor Baker’s essay “explores the contours of the solidarity and individual responsibility” embodied in [the Patient Protection and Affordable Care Act].”  He identifies a number of challenges to the Act’s vision of “achieving … solidarity through individual responsibility[,]” including what he terms “risk classification by design.”   With the passage of the Act, health insurance companies will no longer be able to evaluate each prospective policyholder to determine the risk that he or she will need medical care and then charge him or her a premium that accounts for his or her individual level of risk.  Risk classification by design could still occur, however, “as individuals’ self select into different health care products according to their self-assessed health risk status.”  For example, ["h]igh health risk people tend to prefer more complete health insurance coverage, fewer restrictions on their choice of doctors, and other plan features that make it easier to consume more health care.”  If a plan offering with those features attracts a disproportionate number of high risk individuals, the health care costs associated with that plan would rise and premiums would increase accordingly.  The end result would be high risk individuals paying more than low risk individuals for their health insurance, “challenging the core non-discrimination value embodied in the Act.”

Professor Baker points to a number of regulatory tools that the Act gives the states, the health insurance exchanges that states have begun to create, and the Department of Health and Human Services, to address the challenges posed by risk classification by design.  These include (1) the minimum coverage requirements, which allow “less room for variation in plans that can be used to segment people into separate risk groups,” (2) the exchange certification requirement, pursuant to which an exchange can decline to certify a plan that uses “marketing practices or benefit designs that have the effect of discouraging” enrollment by high risk individuals, (3) the medical loss ratio requirements, which work by “requiring a successful cream skimming insurer to return to its policyholders all or most of the benefits of the cream skimming,” and (4) the risk adjustment procedure, the goal of which is premiums that reflect the entire exchange pool as opposed to the  pool that has self-selected into a particular plan.  These tools, Professor Baker argues, will only be partially successful, but that “will simply mean that more actuarial fairness survives than the Act’s drafters may have intended.”  And actuarial fairness, he notes, has “many supporters, not all of whom are insurance industry apparatchiks.”

I also highly recommend two other recent articles addressing the post-reform potential for risk classification by design, Will Employers Undermine Health Care Reform by Dumping Sick Employees? (published in the March 2011 issue of the Virginia Law Review) by Amy Monahan and Daniel Schwarcz, and PPACA in Theory and Practice: The Perils of Parallelism (forthcoming in the Virginia Law Review), in which David Hyman responds to the arguments made by Professors Monahan and Schwarcz.  Professors Monahan and Schwarcz warn of a “substantial prospect that [the Act] will lead some, and perhaps many, employers to implement a targeted dumping strategy designed to induce low-risk employees to retain [their employer-sponsored health insurance (ESI)] but incentivize high-risk employees to voluntarily opt out of ESI and instead purchase insurance through the exchanges[.]“  This dynamic, they fear, “could render insurance exchanges unsustainable and thereby jeopardize health insurance reform writ large.”  Professor Hyman counters that what Monahan and Schwarcz consider a “bug” might in fact be a “feature” of health reform, particularly since for “dumping/[risk classification by design] to ‘work,’ Monahan & Schwarcz are clear that it has to make employers and employees better off-both individually and collectively.”

Health Reform Watch Welcomes Tara Adams Ragone

Health Reform Watch is pleased to welcome Tara Adams Ragone, Research Fellow and Lecturer in Law here at The Center for Health & Pharmaceutical Law & Policy at Seton Hall Law. Ms. Ragone’s research and writing for the Center will focus on implementation of health care reform, accountable care organizations, health care access, and issues related to the representation of health care professionals. Ms. Ragone comes to us from the State of New Jersey, Office of the Attorney General, Division of Law, where she served as Deputy Attorney General. She handled the prosecution of licensing actions before the State’s professional boards and the Office of Administrative Law. Prior to her work with the Attorney General of New Jersey, Ms. Ragone served as clerk to The Honorable Robert A. Katzmann, United States Court of Appeals for the Second Circuit.

Her first post for HRW can be found immediately below.

A Biography of Cancer and Other Interesting Interviews

As I’m sure the great majority of our readers don’t get the regular joy of hearing Leonard Lopate at NPR’s WNYC, I thought I’d offer up these recent archive interviews for your pleasure and/or edification. Lopate’s interviews are generally extraordinary– and these are no different, except perhaps even better than the norm.

This is how they describe the show– recent favorite interviews– on the WNYC website:

Oncologist Siddhartha Mukherjee discusses his deeply personal biography of what he calls “the emperor of all maladies:” cancer. Yvonne Thornton talks about her long road to become the first African American woman board certified in the obstetrical sub-specialty of maternal-fetal medicine. Douglas Starr tells the true crime story that led to the birth of forensic medicine. And Anand Giridharadas gives us an intimate portrait of India’s remaking.

Enjoy.

Hastings Center Releases Special Report on Psychiatric Illness in Children

Earlier this month, The Hastings Center released a special report “Troubled Children: Diagnosing, Treating, and Attending to Context” that is well-worth reading.  Co-authored by Erik Parens and Josephine Johnston, the report carefully and thoroughly addresses the “intense debates” about the increasing number of children in the United States who receive psychiatric diagnoses and psychotropic medications.

The first section of “Troubled Children” discusses the complexities involved in both defining psychiatric disorders and matching individual children to diagnostic categories; the second section discusses available treatments and the evidence base that supports their use.  The third and final section of the report, in which the authors suggest reasons “why many children do not receive careful diagnoses, why evidence-based treatments are often not available, and why promising changes to children’s environments are not made,” is the most directly relevant to students and teachers of health law.

Among the reasons discussed are the “imbalance between investments in the development of new pharmacological compared with psychosocial treatments,” that physician visits are brief and often “less frequent than is necessary for optimal treatment management,” that insurance “coverage for psychosocial treatments is often more limited than for medication treatments,” and that “the system is fragmented among primary care physicians, hospitals, and various other mental health providers, with little cross-communication or coordination following referrals and limited interaction with other systems that care for children, including child protective services, juvenile justice, and schools.” Expanding on the fragmentation concern, the authors tell an all-too-familiar story, explaining that “payers are not willing to reimburse professionals for consulting with one another or developing systems that streamline communication and coordinate care. … This leaves families who are committed to psychosocial treatments to identify, access, and navigate them alone.”

In addition to its central text, which is neutral and scholarly in tone, “Troubled Children” includes ten “sidebars,” each written by a different author with an overt advocacy position.  One sidebar raises the possibility of “overmedicalization,” a negative consequence of which is that “everything becomes pathologized, turning all human difference into medical problems.”  The author of another sidebar objects that “[t]he theory of ‘medicalization’ … makes parents into scapegoats instead of grasping the real problem.”  This author notes that she “can’t imagine anyone seriously discussing the role that ‘values’ play in diagnosing cancer or suggesting that medications that shrink cancers are just tools to force people who are different to be like everyone else.”

A third sidebar discusses the correlation between adverse childhood experiences–such as parental mental illness, substance abuse, or criminality, family violence, physical abuse, sexual abuse, and neglect–and adult mental health and function and suggests that “the question whether medications are overused can actually distract us from the other important question: how do we alleviate stress in families?”  (Also recommended, this fascinating article from this week’s issue of The New Yorker profiling a pediatrician in San Francisco who hopes to use insights about the relationship between poverty, child development, and health to transform the treatment of survivors of childhood trauma.)  The authors of “Troubled Children” make reference to the “other important question” in the conclusion to their report.  They write that “[o]ur ethical obligations to children require that we–including policy-makers, educators, medical professionals, and parents–remember that in addition to changing children (by pharmacological or psychosocial means), we have the power to change the contexts in which children are embedded, which can be key to lasting improvements in their mental health.”

Health Care and You.org, Simply Well Done

There’s a new resource in town– and it’s both informative and refreshingly easy to use. It’s called healthcareandyou.org and it allows a user to click on their state, and find out what the health reform law means to them– personally. By clicking on New Jersey, I got this:

What You Need to Know About Health Care in New Jersey

• In 2011, those in the Medicare Part D “doughnut hole” will automatically receive a 50 percent discount on certain name-brand drugs and a 7 percent discount on generic drugs.
• Young adults up to age 26 can now stay on their parent’s health plan.
• NJ Protect is available for adults who have been uninsured for at least 6 months and have been denied coverage because of a pre-existing condition. Also, children up to age 19 can’t be denied coverage because of pre-existing conditions. (By 2014, insurance companies will not be able to deny coverage to anyone with pre-existing conditions.)
• Some small businesses can get tax credits to help pay for the cost of covering their employees.
• Insurance companies can’t put dollar limits on the care that is covered in your lifetime.

It will also allow further refinement by under/over 65 years old and small business owner– tailoring the pertinent information accordingly. Beyond that, the glossary is a major league help.There’s also an implementation timeline.

In case you were wondering, the site is the result of a partnership among AARP, American Academy of Family Physicians, American Cancer Society, American College of Physicians, The American Medical Association (AMA), American Nurses Association, Catholic Health Association of the United States, and the National Community Pharmacists Association.

In addition to the link in this post, the site will be listed on this blog going forward in Resources. It simply is.

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