October 5, 2012
A Review of Failing Law Schools: Is Correlation the same as Causation?
It seems like many law professors spent part of their summer review Brian Tamanaha’s Failing Law Schools and I am no exception. Jennifer S. Bard, Book Review, 33 (3) Journal of Legal Medicine 417(reviewing Brian Tamanaha Failing Law Schools (2012))
The issues it raises are indeed so much discussed that our friends at Tax Prof Blog have created an entire section entitled “A Law School Crisis Reader” which compiles writings from a wide variety of sources.
My review can be summed up in a single phrase: “At root, this book is fatally ﬂawed because it mistakes correlation for causation.” Just because the global financial crisis has dramatically changed the market for lawyers does not necessarily mean that law schools have been engaging in fraud because they have not been doing a good job teaching legal skills. My review points out that the criticism this book makes of legal academe, legal scholarship, and the practice skills of law professors may be valid, but they are not the source of today’s employment crisis. And they certainly are not evidence of bad faith.
Of course law schools have to do a better job at teaching legal skills. I write about that often. But our students would not have an easier time finding jobs had we done this earlier and won’t have an easier time if we do it now. They will be better lawyers sooner, but I have seen no data to suggest that they will have better employment options on graduation.
No one can deny that the legal market, and with it legal education, is changing. Perhaps law will be a less popular career as salaries go down and jobs become scarcer. But to ascribe the current situation as one that legal academe brought on itself through pride and sloth is not particularly helpful and, yes I will go out on a limb on this, not true….”
Moreover, “the book’s core assertion is that law school never was, and certainly is not now, worth the money that students are asked to pay, and the conclusion drawn from that assertion is that this lack of value is the cause of the current lack of employment opportunities. Neither of these is true. To say law school was not worth what students were paying is like saying “a designer dress is not “worth” what it costs and that the designer who lives in luxury of its sale is a parasite.” But that doesn’t mean that “the current bleak job market is a result of long term efforts by “legal educators” to use “regulatory mechanisms. . . to further their own interests,” which he describes as teaching less and earning more.”
It is likely that the coming years will bring dramatic changes to all aspects of higher education. But to suggest that the current economic crisis was precipitated by law professors’ failure to produce useful scholarship or teach effective drafting skills is not to offer a productive formula for effectuating that change.
New "what ifs": Election questions; ongoing ACA litigation
Two vaguely related thoughts this week on the future of the ACA (and apologies for the delayed post, I was participating in the wonderful Health Law Grand Rounds at Indiana University McKinney School of Law - and many thanks to my co-bloggers for being excellent hosts!).
First, when I present my co-authored Medicaid post-mortem paper forthcoming in B.U. L. Rev., I find I am frequently asked "what could a President Romney do to dismantle the ACA if he can't repeal it?" An incisive answer to this question was posted recently by Tim Jost over at the Health Affairs Blog. While I generally agree with Tim that it is very hard for the President to change the law without some kind of joint action by Congress (because, of course, that's our grand design), I feel less confident that the President can't undermine a law by method of non-enforcement. The President guides the priorities of the agencies responsible for enforcement of the various aspects of the law, and it would be possible to have atrophy by non-enforcement, especially for the federal spending program changes (Medicare, Medicaid expansion, funding of federally qualified health centers, family planning, etc.). So, while I would be genuinely surprised if the law were repealed, that does not mean it could not be at least partially neutralized by other means.
Second, the big news in ongoing ACA litigation this week was the Court's request for the opinion of the Solicitor General as to whether Liberty University's challenge should be rendered moot by NFIB. Lyle Denniston at SCOTUSblog summarized the questions thus:
The Supreme Court opened its new Term on Monday by asking the federal government to offer its views on whether the way should be cleared for new constitutional challenges to the federal health care law — including a new protest against the individual mandate that the Court had upheld last June. The request for the government’s views came in response to a rehearing request by a religious-oriented institution, Liberty University in Lynchburg, Va. The university’s earlier petition was simply denied in June, so it asked the Court to reconsider and wipe out a lower court ruling in order to revive the university’s religious challenges to both the individual mandate and the separate insurance coverage mandate for employers.
The rest of the post does a nice job of explaining why this may be nothing or everything; what's most notable is that the Court held the petition for rehearing all summer rather than summarily disposing of it, which would be more usual. Also, Liberty University has raised the question of the employer insurance "mandate" (really another tax penalty), which of course was not addressed by NFIB. The Solicitor General has 30 days to respond.
October 3, 2012
Medicaid Denials of Coverage for Prosthetic Devices: A Successful (for now) Challenge
A Utah Court of Appeals decision last week is very much worth calling to the attention of those interested in access to health care and in disability rights. As financial pressures on Medicaid increase, and as Medicaid plays a increasingly important role in health reform, states are likely to consider ways of restricting services in order to manage costs. Alexander v. Choate, 469 U.S. 287 (1985), has long stood for the assumption that cutbacks in Medicaid funding are very difficult to challenge as disability discrimination. In the near future, it will be critical for advocates on behalf of people with disabilities both to challenge this assumption and to consider other ways of arguing that funding cutbacks under the Medicaid program are legally problematic.
Conley v. Department of Health, Division of Medicaid and Health Financing, 2012 Ut. App. 274 (Sept. 27, 2012), is a challenge to the denial of benefits for "speech augmentative communication devices (SACDs)" for non-pregnant Medicaid recipients over the age of 21. These are electronic speech aids used by people with conditions such as cerebral palsy who cannot make themselves heard due to motor difficulties. The ALJ hearing the case had concluded that it was reasonable for the Utah Medicaid Program to provide these devices to persons under the age of 21 and to pregnant women, but not to others qualifying for Medicaid. The ALJ's reasoning was that federal regulations and case law allow state Medicaid to use a "utilization control procedure" in deciding what benefits to provide.
In the appeal from final agency action denying the benefit, the state did not challenge whether the petitioners were eligible for Medicaid or whether SACDs are medically necessary devices. Instead, the state argued that the policy of denying coverage for SACDs was reasonable under the Medicaid statute, as SACDs are an optional service. The Utah Court of Appeals reviewed the agency's interpretation of the statute for correctness. Because the Utah legislature has granted discretion to interpret the Medicaid program to the agency, the court reviewed the agency's interpretation for abuse of discretion, which under Utah precedent is understood as "reasonableness and rationality."
Petitioners made two basic arguments that the coverage denial did not meet the reasonableness and rationality standard. The court agreed with both arguments. The first argument was that the denial of coverage for SCADs was unreasonable in light of the purposes of the Medicaid program. In response to this argument, the court examined the structure of the Medicaid Act and the placement of SACDs as a provided benefit. The court concluded that SACDs could be included as durable medical equipment for those receiving home health services, as supplies and equipment related to speech disorder services, or as prosthetic devices. Utah Medicaid has elected to provide home health, speech disorder services, and prosthetic devices. The court rejected Utah's argument that it could elect to cover SACDs only for the category of Medicaid recipients under the age of 21 and concluded that as Utah had elected to cover services such as prosthetic devices it was arbitrary to restrict SACDs. In the language of the court "it is unreasonable for the State to opt into the categories in which SACDs could be categorized for all categorically and medically needy individuals but then to limit coverage of certain services within those categories by the age of the recipient."
Petitioners' second argument was that the denial of coverage of SACDs to non-pregnant individuals over 21 violated the Medicaid Act's comparability of services requirement. In the judgment of the court, denying SACDs to people over 21, while providing them to people under 21 under the early diagnosis and treatment program was contrary to Medicaid's requirement that services be provided that are sufficient to achieve their purposes.
This decision clearly has implications more generally for limitations of types of benefits for some groups of Medicaid recipients. It was litigated on behalf of the petitioner by the Disability Law Center, Utah's Protection and Advocacy agency. I gather that it is highly likely that it will be appealed to the Utah Supreme Court.
October 2, 2012
Quality Control on the Back-End via the ACA and on the Front-End via Tort Litigation
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.
Yesterday was the first Monday in October, and of course, that is 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.
And as we look at incentivizing hospitals to provide good quality care through post-discharge financial penalties, a recent decision from the Washington State Supreme Court should give hospitals every incentive to ensure that they credential only well-qualified physicians and health care professionals on the front-end. In a case involving birth injuries, The Court unanimously held that the state's peer review and quality improvement privileges do not apply to records documenting a hospital's initial credentialing and privileging of a staff member. The Court also construed the quality improvement privilege narrowly, holding that in order to be privileged, documents must be created specifically for, collected, and maintained by, a quality improvement committee, as opposed to any other committee or hospital authority. Although this decision seems like it will encourage better quality care by incentivizing hospitals to be vigilant in credentialing, it could have a chilling effect on internal quality improvement efforts, based on the fear that candid assessments of care by peers will be discoverable in subsequent litigation. Hospitals need to ensure that they have clearly designated a quality improvement committee, and that all peer review activities are conducted through that committee, if they want to refrain from assisting the plaintiff's medical malpractice bar in its endeavors.
cross-posted on Healthy Interests
October 1, 2012
ACA Litigation Update
Last week, Health Affairs posted a nice summary of the different legal challenges that have survived the Supreme Court's decision in NFIB v. Sibelius, including one pending before the 6th Circuit in which plaintiffs argue that the individual mandate violates the Bill of Rights. Nicole Huberfeld also has provided some very helpful updates on the additional legal challenges to the Affordable Care Act, including one here.
"The most polarizing instance of judicial restraint on record"Interesting book chapter on NFIB v. Sebelius by political scientists Andrea Campbell and Nathaniel Persily, here, suggesting that the opinion simultaneously increased support for the ACA and decreased the court's own approval rating. The Times' summary story is here. Meanwhile good legal articles continue to appear on the case itself (particularly on the Medicaid expansion issue) by Mitchell Berman, here, and Nicole Huberfeld, Elizabeth Weeks Leonard, & Kevin Outterson, here. [NPT]
September 30, 2012
The Dangers of Uninformed Reporting: Clinical Trials in Russia
It’s way too easy to say “never believe what you read in the papers.” But on the occasions when I read or hear something about which I know more than the reporter—a recent general example being whether the individual mandate had been upheld or not, it’s disconcerting to see how much they get wrong because they lack any context. This is an especially serious issue when reporters without a background in science, medicine or law rely on too few sources. Here’s the most recent example. In an article in Friday’s New York Times entitled, “Russians Eagerly Participating in Medical Experiments Despite Risks.” The reporter, Andrew E. Kramer, who has been reporting on Russia for the Times since 2005, has written what amounts to a press release touting the wonderful advantages of bringing drug development overseas. The direct subjects of the article are Russian citizens delighted to have the opportunity to enroll in clinical trials to test drugs for which they would otherwise not have access. The testing of pharmaceuticals intended for use in the United States using patients in countries with less developed laws regarding quality, monitoring and human safety is a topic of intense discussion and concern in the popular press, legal, industry, human rights and bioethical communities. And by concern I mean in the sense of there being “concern” in Israel about the Iranian nuclear program” The article explains how the Russian government is encouraging pharmaceutical companies into the country to conduct these trials by requiring that drugs sold in Russia be tested in Russia. The reporter never considers how odd that is---we don’t have that requirement in the US nor does Japan, Switzerland, New Zealand, or the like.
JSB“The law” he reports “ has the effect of compelling investment in clinical testing on Russians, trade groups say.” And indeed the entire article is based on information from “trade groups.” The article’s primary source, is “John Lewis, the vice president for the Association of Clinical Research Organizations.” The reporter characterizes Russia’s laws, like those in Singapore, as having “benefits both for the local population and for the drug companies, although the association does not endorse that motive.” This last sentence seems to come from the industry representative who is then quoted as stating that “Clinical trials should be viewed as experiments, as investigations, not as treatment.” Apparently conditions in Russia are so good that “A host of pharmaceutical companies operate in Russia, including Bayer, Bristol-Myers Squibb, Eli Lilly, Novartis, Novo Nordisk and Pfizer.” Seemingly oblivious to the context of the story, the reporter gets to what he may not realize is the heart of his subject: notes that “The companies use the results of trials in Russia, as elsewhere, to help win approval from the United States Food and Drug Administration.”
The reporter continues, without apparent irony, that “Companies have turned to Russia in particular to test experimental psychiatric medicines, sometimes in the same mental health wards once used to confine Soviet dissidents.” The good news, however, is that “there is no indication political detainees are used today in drug testing.” As an afterthought, he does note that “there have been strange results. In 2007, an F.D.A. official wrote that the agency approved Eli Lilly’s top-selling antipsychotic drug Zyprexa for use by adolescents based on the results of a Russian test, even though trials in the United States showed the drug had no effect. Why tests differed in Russia and the United States was never explained. Doctors now routinely prescribe the drug for American adolescents.” Obviously Mr. Kramer was not aware that this, too, has been a matter of significant “concern” here in the U.S. In 2009 Eli Lilly plead guilty and paid a $515 million criminal fine and a total of $1.415 billion in civil penalties and fines for promoting the use of Zyprexa for adolescents without evidence that it was safe or effective. Does the New York Times still have an active Google account?
The article concludes as uncritically as it began by reporting that:
“In March, Domain Associates, an American venture capital firm, agreed to jointly invest with the Russian government about $760 million in 20 biotechnology start-up companies in the United States. The investment was intended to help Russia transfer drug development expertise to its own, nascent biotech industry.
As an incentive for the American drug companies it will invest in, the joint venture offered to help these start-ups conduct “advanced stage clinical trials in Russia of new pharmaceuticals,” according to a statement.
In another example, VitaPortal, a Russian Web site analogous to WebMD, plans to profit by helping pharmaceutical companies find test subjects among visitors to the Web site who have searched for information about particular ailments.”While perhaps we wouldn’t expect analysis and criticism from a reporting piece in the business section, it is interesting that the article does conclude that the practice is ethical. Although not directly attributed to Mr. Lewis, the industry spokesman, proximity makes clear that he is the source for the reporter’s sentence that “ethically, if a clinical trial will most likely improve a patient’s health — for whatever reason, including because the patient lacks access to standard, already accepted care — a doctor should admit the patient to the trial.” Although I am not advocating a “full employment act for health law commentators” it wouldn’t have been difficult to find someone who could have noted the existence of, at least a difference of opinion on the ethics of asking citizens of countries with far fewer resources than the United States to take risks that would not be allowed here and on the safety concerns these practices generate.