Archive for the ‘Health Law’ Category
The inter-branch turmoil continues
posted by Nicole Huberfeld
After the Supreme Court heard oral arguments in Douglas v. ILC, the Secretary of HHS approved some of California’s deep cuts in Medicaid reimbursement. The Court requested additional briefing regarding the impact of the rate reduction approval, and the United States responded that the case was not moot because the grant of certiorari was based upon the Supremacy Clause question, not a determination as to the actual sufficiency of the state’s Medicaid payment rates. As soon as the rate reductions were approved by HHS, the California Hospital Association, the California Medical Association, and other Medi-Cal providers filed additional claims for injunctive relief.
Yesterday, U.S. District Court Judge Christina Snyder issued an injunction against California preventing the implementation of the HHS-approved rate reductions because they would cause irreparable harm to hospitals’ skilled nursing units (among other problems). The new injunction keeps the issues in Douglas alive, whether as a matter of payment rate adequacy or as a matter of private enforcement of state violations of the Supremacy Clause. Thus, even though HHS approved Medi-Cal rate reductions, the conflicts in Douglas have not been resolved.
There is also a fascinating real-time separation of powers quandry in this case, which is highlighted by the injunction that was just issued. Federal courts perceive states’ failure to abide by the mandate of the Equal Access provision, but HHS, whose job it is to ensure state compliance, turns a blind eye to state decisions that will limit access to medical care. In the meantime, Congress does not modify the Equal Access provision to contain stronger language or a clearer private right of action, it merely relies on implied private enforcement actions (see the amicus brief of Members of Congress). And HHS has issued paltry draft regulations to facilitate enforcement of the Equal Access provision, but the draft regulations do not guide CMS’s enforcement efforts so much as they provide some standards for states to self-report with little federal oversight. It seems that federal courts are acting because the legislative branch either can’t or won’t, and because the executive branch either can’t or won’t ensure that this federal law is followed. This makes the Obama Adminstration’s deference to state decisions all the stranger in Douglas, and courts’ patience with Equal Access litigation a bit more understandable. It also helps to explain the sort of underlying tone of confusion at oral arguments. The Court is left with the unenviable task of cutting this Gordian knot of inter-branch disfunction.
December 30, 2011 at 3:11 pm
Tags: Constitutional Law, health care, Supreme Court
Posted in: Constitutional Law, Health Law, Supreme Court
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The other healthcare case with constitutional implications
posted by Nicole Huberfeld
Another Medicaid case this term also involves constitutional challenges – Douglas v. Independent Living Center of Southern California. That certiorari was granted is notable unto itself, as no circuit split existed, the Acting Solicitor General had recommended that the Court deny the petition, and the Court does not seem to relish hearing healthcare cases. The conflict in Douglas is whether California violated the Medicaid Act by enacting 10% reimbursement rate reductions, but this is not the question before the Court. The Court will consider whether the plaintiffs (a group of Medicaid providers and enrollees) may privately enforce the Medicaid Act against the state by claiming the state has violated the Supremacy Clause. Depending upon the timing of the opinion, Douglas may give us hints as to how the Court will decide Florida v. HHS, even though the United States has taken notably different positions in the two cases (about which I have written more here.)
Medicaid was intended to mainstream the poor into American medicine. The Medicaid Act thus informs states that they must pay healthcare providers “sufficient[ly]” to ensure the same access to medicine for Medicaid enrollees as others in the geographic region enjoy. This “Equal Access” provision is a pillar of Medicaid, and it has been a source of litigation against states that pay providers too little. In fact, before Gonzaga, lower federal courts were in agreement that the Equal Access provision was enforceable via section 1983. Through this litigation, the circuits developed varying methods for deciding sufficiency of payment, as the Centers for Medicare and Medicaid Services (CMS) has not enforced the Equal Access provision vigorously against the states. Despite the lack of agency action, ”sufficiency” is key to Medicaid’s success; if states do not pay enough for the medical services they buy, Medicaid enrollees will be forced into substandard care or will not be able to find caregivers at all, and the program would be undermined. Due to Gonzaga, and because CMS infamously does not monitor the states, Medicaid providers and enrollees have sought to enjoin states from violating the Medicaid Act under the Supremacy Clause.
California argued that the Medicaid Act does not include private actions, thus the plaintiffs could not seek an injunction because the statute fails to meet the “unambiguous conditions” element of the Dole test for conditional spending. This argument speaks to clear statement advocates on the Court (such as Justices Alito, Scalia, and Thomas), because it claims that states do not have clear notice of Medicaid enforcement actions in federal court. To the surprise of many, the United States’ amicus brief not only supported California but also urged that no private right of action exists for beneficiaries of federal spending programs (generally) to enforce federal standards against states. The Acting Solicitor General’s brief thus took a much bolder position than was expected. Remarkably, members of Congress and ex-administrators of the Department of Health and Human Services strongly disagreed with the SG’s position. In fact, the ex-administrators, which represent both sides of the aisle, insist that CMS relies heavily on private enforcement to police the states.
Douglas may lead the Court to articulate a default rule that ends implied private rights of action under the Supremacy Clause, but Medicaid is a flawed vehicle for such a sweeping, federalism-based decision. [More after the jump.]
December 21, 2011 at 12:15 pm
Tags: Constitutional Law, federalism, health care, Supreme Court
Posted in: Constitutional Law, Health Law, Supreme Court
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An additional thought on coercion
posted by Nicole Huberfeld
Recently I wrote about the coercion question posed by Florida et al. in the PPACA litigation. I have a quick follow up thought: I wonder if those advocating a more robust read of coercion recognize that their position could backfire if the goal is broadening federalism protections. An expanded coercion doctrine ostensibly would introduce the possibility of judicially enforcing states’ rights against the congressional power to spend. But the states should not assume that they are the only parties that could enforce federalism principles. Just last term in Bond v. United States, Justice Kennedy wrote that individuals can have standing to enforce the principles of the Tenth Amendment against the federal government because federalism protects not just the states but also individuals. In Bond, the conclusion was foreseeable, as a criminal defendant should be able to challenge the constitutionality of the statute under which she is charged. But the idea is muddied in a conditional spending program, wherein individual beneficiaries are often at odds with the state and contest its compliance with the federal government’s statutory conditions.
States have sought to prevent private enforcement of conditional spending statutes, and they have been more and more successful in closing the courthouse doors. For example, the Court has limited implied rights of action as well as actions under civil rights law 42 U.S.C. § 1983, decisions that narrow state exposure in federal court. In fact, this type of question is before the Court now in Douglas v. ILC, which confronts private enforcement of the Medicaid Act against states via the Supremacy Clause.
If the coercion theory is expanded, then private plaintiffs could be reintroduced into the federal courts, the very thing that states have been trying to prevent. And, individuals engaging in coercion analysis may have different goals than states. Further, it is possible that coercion could inaugurate a new theory by which those conditions, and the ways in which they are or are not executed by states, can be challenged by private plaintiffs. So, not only is state coercion by the federal government an inherently sticky question, but it also may not produce results that states desire.
December 14, 2011 at 4:17 pm
Tags: Constitutional Law, federalism, health care
Posted in: Constitutional Law, Health Law, Supreme Court
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A Union’s Integrated Delivery System
posted by Frank Pasquale
Robert Kuttner has an excellent article on the Local 6 Union’s health plan in the American Prospect. The plan’s success at reducing costs and improving quality may make it a good model for those who claim we need to go beyond ACO’s to integrate delivery. A few quotes from the piece:
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December 12, 2011 at 1:37 pm
Posted in: Health Law
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Secret Prices: Free Market Triumph or Tragedy?
posted by Frank Pasquale
Can a market work when buyers are kept in the dark about the prices they’ll pay? That’s an increasingly urgent question for fans of consumer directed health care. In vogue during the administration of Bush fils, CDHC is reemerging as Obamacare’s opponents seek a standard to rally around (other than “laissez mourir”). In theory, consumers could force doctors and hospitals to compete by shopping around for services. But when the rubber hits the road, informed consumption is easier said than done, as Josh Barro describes:
Recently, my employer switched to a high-deductible health insurance plan, which means I’m paying at the margin for most of my health care. As a result, I have become more aware of the true cost of the care I receive—and more aware of how difficult it is to figure out that cost. . . . if you ask doctors how much a service costs, they tend not to know. I once had an argument with my doctor, who did not want to give me a blood test for fear that my insurer would deny the claim for the expensive test. I later found out that this test costs all of $9.48 at my insurer’s negotiated rates, despite a list price of $169. When I got orthotics, my podiatrist told me they would cost nearly $600. But that was the list price; the actual insured price was less than $250. . . .
It doesn’t have to be this way. We could legally obligate hospitals and medical practices to disclose their full price lists—both the inflated list prices and the rates negotiated with each insurer that the practice accepts.
A commenter on Barro’s blog retorts:
I’m a little surprised to see a blogger at the [National Review Online] suggest that the government “require” price disclosure from private market participants. This goes well beyond the market interference that some other odious “mandates” require. Why don’t we mandate that everyone disclose exactly what they pay each employee? . . . If you have an HSA or High-deductible policy, I would suggest it’s incumbent on the insurance provider to help you figure it out. If consumers want it enough the system should respond, right? Why not switch to an HDP that is more transparent?
The problem, of course, is that lots of parties have to agree to provide transparency, and there is a great deal of inertia. If all the other insurers aren’t transparent, there’s little reason for one of them to try to distinguish itself if it already has a steady customer base. And when it stirs itself to do so, it will find a wall of resistance from providers, who say “why should we give all this information to you—no one else is demanding it?” (Moreover, the “prices” don’t really exist except on paper on a “chargemaster,” and they’re practically meaningless (except as opportunities to gouge the unlucky). The real price is the negotiated price, and that’s generated out of iterative interactions.) Moreover, many interventions involve multiple providers, as a reader of Andrew Sullivan’s blog explains:
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December 12, 2011 at 9:37 am
Posted in: Health Law
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Jumping ahead to Coercion
posted by Nicole Huberfeld
I had intended to address Douglas next, as it is a nice gateway for discussing Florida v. HHS, but a defense of the coercion argument just published in the New England Journal of Medicine Online inspired me to address the latter first. I will begin by discussing why I think the Court granted the petition for certiorari then turn to the Medicaid coercion question.
The Rehnquist Court excluded the Spending Clause from its federalism revolution inasmuch as that would have meant limiting the power to spend by the Tenth Amendment. When Chief Justice Rehnquist authored South Dakota v. Dole, the evidence is that he believed it was an easy and relatively inconsequential case. For those sane enough not to engage in the reading of tea leaves that is deciphering the spending power, a quick review. Dole articulates typical Rehnquist categories for evaluating the constitutionality of conditions placed on federal spending: the spending must be for the general welfare; the conditions must be clear and unambiguous (as modified by Arlington Central School District Board of Education v. Murphy); the conditions must have a nexus with the federal spending (“germaneness”); and the conditions cannot themselves be unconstitutional. After providing this test, Rehnquist noted that “in some circumstances the financial inducement offered by Congress might be so coercive as to pass the point at which ‘pressure turns into compulsion.’” No theory or constitutional provision was cited, but the opinion indicated that coercion would depend on the amount of money or percentage of money withheld if the state violates the conditions. It seems that the Court meant that coercion would be a Tenth Amendment, state sovereignty problem. But, Dole also explicitly stated that the Tenth Amendment was not implicated in the bar on unconstitutional conditions. So, while Dole provides the test for conditional spending, it is undertheorized and a bit self-contradictory. Nevertheless, the Rehnquist Court reiterated that the Spending Clause is not limited by the Tenth Amendment in New York v. U.S. and held to that position in subsequent cases, disappointing many who believed spending to be the next front in judicially-enforced federalism.
The Roberts Court has given hints now as to its approach to spending as well as federalism, and members of the Court have signaled interest in revisiting both topics. For example, Justice Kennedy’s concurrence in Comstock stated: “The limits upon the spending power have not been much discussed, but if the relevant standard is parallel to the Commerce Clause cases, then the limits and the analytic approach in those precedents should be respected.” Justice Kennedy also addressed broader federalism concerns in that concurrence, which were given free rein in his opinion for the Court in Bond v. U.S. as well. Likewise, Justice Alito’s opinion in Arlington was written as a spending power decision rather than a limited statutory interpretation, which I have written elsewhere resulted in a narrower clear statement rule for the second element of the Dole test.
Additionally, even though the Court seems to dislike hearing both spending and healthcare cases, it already has heard Douglas this term, so spending, federalism, and Medicaid are fresh in the justices’ minds. And, what could be a better vehicle for considering coercion than the largest grant-in-aid program that also constitutes the second largest portion of states’ budgets? (Education is first.) Further, numerous lower federal courts have attempted to construe coercion, but none have struck down federal legislation under the doctrine, making the issue ripe for the Court’s consideration.
Despite the idea of coercion arising repeatedly in federalism cases over the last thirty-ish years, its contours are unknown. At what point is the money being offered too much? And is the offer really the issue, or is the problem the amount or percent of money a state stands to lose if it does not comply with the conditions? (Dole indicated the latter, as South Dakota was not coerced because it would lose only 5% of its federal highway funding if it refused to comply with the minimum drinking age that the federal government sought to impose.) Can coercion only apply to an existing conditional spending program that a state could not leave because it has become dependent on the program? Or is there some federal program that would offer so much money that no state could turn it down, even at the outset, such that the new program would be coercive? If it is the former, then clear statement rules also need to be revisited, because they seem to assume some kind of regular restatement of the rules of the program to which a state actively agrees. That simply does not occur in a long-standing program like Medicaid, making me think that clear statement rules are almost meaningless in that context. Additionally, states inherently relinquish some sovereignty when they agree to the terms of a cooperative federalism program, highlighting tensions between dual sovereignty and cooperative federalism.
So, what is the upshot for the Medicaid expansion? [more after the jump]
December 9, 2011 at 1:26 pm
Tags: Constitutional Law, Current Events, federalism, health care
Posted in: Constitutional Law, Health Law, Supreme Court
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Today’s denial of cert. in Blackstone
posted by Nicole Huberfeld
Many were watching this morning’s conference to see if the petition for certiorari would be granted in Blackstone Medical, Inc. v. U.S. ex rel. Hutcheson, but it was not. The issue in Blackstone was whether a medical device company that paid illegal kickbacks to prescribing physicians could be liable under the False Claims Act (FCA) for causing false claims to be submitted to Medicare. The FCA is the rare statute that is what it sounds like – basically, if you submit claims for federal monies, the claims cannot be false or fraudulent. If they are, the federal government can recover large fines for each false claim as well as treble damages. The statute includes a qui tam relator provision that encourages whistleblowers to come forward with information about false claims; if they are successful, they share in the government’s bounty. The civil FCA has become the DOJ weapon of choice for fighting healthcare fraud, and circuit splits abound regarding the interpretive details of this statute. In part, this is because whistleblowers tend to push the envelope of false claims theory. To wit, in this case, the claim is not “factually false” (which would indicate that the services were not actually provided), it is “legally false,” which means the services are provided as claimed, but another law for which the filer has certified compliance is being violated.
A grant in Blackstone would have been notable, as the Roberts Court has decided five False Claims Act cases in five terms (October Term 2006-2010), as compared to four such decisions in the eleven years of the natural Rehnquist Court, making this potentially the sixth in seven terms. It is hard to say if the Court is hearing so many FCA cases organically, or if something more is afoot. But, the FCA decisions illustrate at least four big picture issues.
First, separation of powers. The Court is having a conversation with Congress that seems to further a clear statement rule project. The Court has consistently read the FCA narrowly, forcing Congress to include the language it wants to see in the statute. Twice Congress has responded, and quickly, by re-expanding the scope of the FCA, and in a third case, PPACA had already addressed the issue. (Seems fraud is one of the few things Congress can agree on these days…) The problem is that such rules are lost on whistleblowers, who dominate FCA prosecutions. Second, the cases seem to support the theory that the Roberts Court is business-friendly, as a glance at the amicus briefs reveals. The problem is that “business friendly” does not necessarily inform meaningfully or even predict outcomes. For instance, the Chamber of Commerce often sides with healthcare providers, and it advocated for narrowing the scope of the FCA in the cases before the Court, which keeps whistleblowers out of court. But in Douglas v. ILC (to which I’ll return in my next post) the Chamber advocated for hospitals, which would keep the courthouse doors open. Third, the five cases reveal a docket clearing exercise that is consistent with the theory that the courthouse doors are being closed by the Roberts Court, irrespective of the business-friendly question. Fourth, the Court’s interpretation of the FCA, and Congress’s response to the Court, will likely facilitate an increase rather than a decrease in the number of whistleblower actions brought under the FCA. PPACA will increase the number of claims flowing through federal healthcare programs, and federal money flowing into the state insurance exchanges will be subject to the FCA too.
So, even if the Court does not grant the petition in the other FCA case on the docket (Amgen, Inc. v. New York), it’s a safe bet the Roberts Court will be telling us more about the FCA soon.
December 5, 2011 at 10:24 pm
Posted in: Constitutional Law, Health Law, Supreme Court
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The Jungle Comes to Minnesota
posted by Frank Pasquale
I highly recommend Ted Genoways’s shocking investigative report on the impact of a leading factory meat processor. The piece focuses on Quality Pork Processors Inc. (QPP), in Austin, Minnesota. One worker alleged that the workers in the plant felt nearly as disposable as the animals:
“I feel thrown away,” Miriam Angeles says. “Before, I worked hard and willingly for QPP, but after I got sick and needed restrictions, they threw me away like trash.”
Rest assured, many other employers may be planning to emulate that example. Sickness and exhaustion are apparently a common problem at the plant. As the article notes, “The line speed at QPP had increased from 750 heads per hour in 1989 to 1,350 per hour in 2006, while the workforce barely grew.” It’s the “They Shoot Horses, Don’t They” model of management. Few parts of the production process, from cutting and slicing legs and other parts to vaporizing swine brains, are easy. Health effects are dramatic:
December 1, 2011 at 12:47 pm
Posted in: Agricultural Law, Health Law, Law and Inequality
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The Court, Spending, Federalism, Medicaid, and Other Minor Stuff
posted by Nicole Huberfeld
My thanks to Angel, Dan, and the rest of the regulars at CoOp for the invitation and the introduction. I am delighted to be guest blogging, especially at a time when my fields of interest are overflowing with developments. Everyone has been talking about the Commerce Clause questions raised by the minimum coverage provision of the Patient Protection and Affordable Care Act (“PPACA”). I too have been avidly following this litigation, but because I study (among other things) Medicaid as a vehicle for constitutional change – and that phenomenon is happening right now. The Court will decide two high-profile Medicaid cases this term, each of which has the potential to facilitate major movement in structural constitutional law. Oral arguments were heard in the first case, Douglas v. Independent Living Center of Southern California, on October 3d. The second case, Florida v. HHS, will be heard in the spring.
I try not to assume that folks know a lot about federal healthcare programs with their layer cakes of complexity; to wit, a justice said during oral argument, “Suppose there were a provision in the Medicaid or Medicare Act… I get the two of them confused.” (Ahem.) So, I will begin with a bit of background that I hope will help to illuminate the two cases before the Court. Later posts will explore Douglas and Florida v. HHS and their implications for conditional spending jurisprudence, federalism, and Medicaid itself more directly.
Medicaid is a forty-six year old spending program that provides federal money to the states in exchange for states agreeing to provide particular medical services to the “deserving poor.” Medicaid has been described as a classic example of cooperative federalism, but the program is structured this way for historic rather than philosophical reasons (which I detail in Federalizing Medicaid). States were responsible for welfare programs since our founding, and when they could no longer afford to provide welfare medicine, they asked the federal government for money to help care for the deserving poor. The federal government responded with almost conditionless grants to the states through the Social Security Act of 1935. Over time, the states asked for more money, and the federal government provided it, but each amendment to the SSA included more and broader rules for the federal funds to ensure they were being used properly. Fast forward to 1965 and the passage of Medicare, with Medicaid in tow. While Medicare was grounded philosophically in social insurance (but only for people 65 and older), Medicaid continued the old patterns. Indeed, the elderly convinced Congress not to allow Medicare to be a joint program between the federal government and the states. So, Medicaid is a cooperative federalism partnership between the federal government and the states, but not because it was thoughtfully constructed that way. And, this partnership seems to have fostered more disagreement than cooperation between the federal government and the states.
Why does this matter? A number of reasons. PPACA’s expansion of Medicaid is a major philosophical change in the program because it eliminates the idea of the deserving poor for the first time in our history. But, the tensions between the federal government and the states are very much alive and on display before the Court. Douglas involves a challenge to California’s Medicaid reimbursement rate reductions under the Supremacy Clause, and it raises questions regarding the nature of spending legislation, access to federal courts, private rights of action against the states, and Medicaid’s very aspirations. Florida v. HHS challenges the institutional structure of Medicaid (the federal-state partnership) and thus raises major spending questions and federalism questions, including the ever-elusive idea of “coercion.” The kicker: it has been clear for some time that certain justices were eager to decide these questions.
December 1, 2011 at 12:06 pm
Tags: Constitutional Law, Current Events, health care
Posted in: Constitutional Law, Current Events, Health Law, Supreme Court
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Neuroscience at Trial: Society for Neuroethics Convenes Panel of Front-Line Practitioners
posted by Amanda Pustilnik
Is psychopathy a birth defect that should exclude a convicted serial killer and rapist from the death penalty? Are the results of fMRI lie-detection tests reliable enough to be admitted in court? And if a giant brain tumor suddenly turns a law-abiding professional into a hypersexual who indiscriminately solicits females from ages 8 to 80, is he criminally responsible for his conduct? These were the questions on the table when the International Neuroethics Society convened a fascinating panel last week at the Carnegie Institution for Science last week on the uses of neuroscience evidence in criminal and civil trials.
Moderated and organized by Hank Greely of Stanford Law School, the panel brought together:
- Steven Greenberg, whose efforts to introduce neuroscience on psychopathic disorder (psychopathy) in capital sentencing in Illinois of Brian Dugan has garnered attention from Nature to The Chicago Tribune;
- Houston Gordon (an old-school trial attorney successful enough not to need his own website, hence no hyperlink), who has made the most assertive arguments so far to admit fMRI lie-detection evidence in a civil case, United States v. Semrau, and
- Russell Swerdlow, a research and clinical professor of neurology (and three other sciences!). Swerdlow’s brilliant diagnostic work detected the tumor in the newly-hypersexual patient, whom others had dismissed as a creep and a criminal.
In three upcoming short posts, I will feature the comments of each of these panelists and present for you, dear reader, some of the thornier issues raised by their talks. These cases have been reported on in publications ranging from the Archives of Neurology to USA Today, but Concurring Opinions brings to you, direct and uncensored, the statements of the lawyers and scientists who made these cases happen … Can I say “stay tuned” on a blog?
November 20, 2011 at 12:39 pm
Tags: law & neuroscience, neuroethics
Posted in: Bioethics, Capital Punishment, Criminal Law, Evidence Law, Health Law, Psychology and Behavior, Uncategorized
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The Yale Law Journal Online: Bad News for Professor Koppelman: The Incidental Unconstitutionality of the Individual Mandate
posted by Yale Law Journal
The Yale Law Journal Online recently published Bad News for Professor Koppelman: The Incidental Unconstitutionality of the Individual Mandate, in which Gary Lawson and David B. Kopel respond to Andrew Koppelman’s Bad News for Mail Robbers: The Obvious Constitutionality of Health Care Reform. Koppelman’s essay argued that the constitutionality of the individual mandate in the Patient Protection and Affordable Care Act could be derived from the Commerce Clause and the Necessary and Proper Clause by the same logic that renders federal laws against mail robbery constitutional. Lawson and Kopel argue that contrary to Koppelman’s belief, the Necessary and Proper Clause cannot be used to validate the constitutionality of the individual mandate. To arrive at this conclusion, Lawson and Kopel rely on principles of eighteenth-century agency law, administrative law, and corporate law embedded in the Necessary and Proper Clause.
Preferred citation: Gary Lawson & David B. Kopel, Bad News for Professor Koppelman: The Incidental Unconstitutionality of the Individual Mandate, 121 YALE L.J. ONLINE 267 (2011), http://yalelawjournal.org/2011/11/08/lawson&kopel.html.
November 14, 2011 at 11:10 am
Posted in: Constitutional Law, Health Law, Law Rev (Yale)
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Perfect Timing for a Conference on Accountable Care Organizations
posted by Frank Pasquale
The biggest news in health care last week was the release of the ACO Final Rule, governing accountable care organizations. With a great sense of timing (and some good luck), our law review at Seton Hall is sponsoring a conference this Friday that will bring together some of the leading legal, academic, and medical experts on ACOs. (We’ve even invited an information technology expert who can address the vital role of electronic medical records in promoting quality and efficiency.)
Why care about ACOs? Here’s Jenny Gold from Kaiser Health News:
Accountable care organizations take up only seven pages of the massive new health law yet have become one of the most talked about provisions. This latest model for delivering services offers doctors and hospitals financial incentives to provide good quality care to Medicare beneficiaries while keeping down costs. A cottage industry of consultants has sprung up to help even ordinary hospitals become the first ACOs on the block.
When the draft ACO regulation was released, there were many naysayers. But as Sarah Kliff reports, the concept is now “getting a much more positive reception.” In a familiar Obama Administration pattern, the rule now “marks a victory for hospitals, clinics and large doctors’ practices that have lobbied to alter draft regulations they viewed as too burdensome and financially risky.”
The Seton Hall Law Review symposium will bring together those who are implementing and studying ACOs. For a good run down of presentation topics, check out our posts on the speakers at the Health Reform Watch blog.
October 23, 2011 at 11:26 pm
Posted in: Health Law
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Implementing the Affordable Care Act: What Role for Accountable Care Organizations?
posted by Frank Pasquale
As Kevin Outterson has noted, even if the individual mandate is ultimately declared unconstitutional, the rest of health care reform is very likely to survive judicial challenge. Political plans to defund critical aspects of US health finance are likely a bigger threat to the success of the ACA than the Supreme Court.
Nevertheless, even if the mandate is struck down, and those defunding decisions are made, there will still be some lasting legacies of health reform. One of them–innovation in the health care delivery system–will be the subject of Seton Hall Law Review’s annual symposium conference. We have a stellar lineup of attorneys, academics, and physicians to address the thorny legal issues raised by Accountable Care Organizations (ACOs), a critical feature of the ACA designed to improve quality and reduce waste.
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September 29, 2011 at 12:38 am
Posted in: Health Law
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Inspirational Healthcare In(ter)ventions
posted by Frank Pasquale
The New York Times has an excellent section on “low-cost innovations that can save thousands of lives.” A conversation today focuses on Dr. Paul Polak, a 78-year-old former psychiatrist.
[Dr. Polak] has focused on creating devices that will improve the lives of 2.6 billion people living on less than $2 a day. But, he insists, they must be so cheap and effective that the poor will actually buy them, since charity disappears when donors find new causes.
His greatest success has been a treadle pump that lets farmers raise groundwater in the dry season, when crops fetch more money. He has sold more than two million, he said. He also helped develop a $25 artificial knee and a $400 hospital lamp to save newborns with life-threatening jaundice.
Dr. Polak’s work reminded me of an inspirational conference in Boston, organized by Kevin Outterson, the Ewing Marion Kauffman Foundation, the Rhode Island College of Pharmacy, Universities Allied for Essential Medicines & Mind the Health Gap. Una Ryan, President & Chief Executive Officer of Diagnostics for All, gave a powerful presentation on her company’s quest to bring tests to individuals for pennies. Developments like these indicate that conditions for the world’s poorest can actually improve.
September 27, 2011 at 10:46 pm
Posted in: Health Law, Law and Inequality
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Jost on a Drafting Error in the Affordable Care Act
posted by Frank Pasquale
A few days ago, Timothy Jost offered insights on the Fourth Circuit’s jurisdictional rulings on constitutional challenges to the Affordable Care Act. (That post was part of a terrific series he has done for the Health Affairs Blog.) Today, Jost offers a fascinating perspective on “an ACA drafting error that would seem to deprive millions of uninsured Americans of tax credits to purchase health insurance and invalidate regulations recently proposed by HHS and the Treasury Department:”
The mistake is found in section 1401 of the ACA, which creates a new section 36B of the IRC. Two subsections of 36B ((b)(2)(A) and (c)(2)(A)(i)) suggest that premium tax credit eligibility under the ACA depends on the applicant being enrolled in a qualified health plan “through an Exchange established by the State under section 1311.” This would in turn suggest that individuals enrolled in a qualified health plan through a federal exchange established under section 1321(c) would not be eligible for premium tax credits, contrary to the recent proposed regulations.
That this is a drafting error is obvious to anyone who understands the ACA. Section 1311 of the ACA requests the states to establish American Health Benefit Exchanges and sets out the duties of the exchanges. Section 1321 of the ACA, however, provides that if a state elects not to establish and exchange or fails to do so, HHS must “establish and operate” an exchange in such a state and “take such actions as are necessary to implement” the other requirements of title I of the ACA, which includes section 1401. There is no coherent policy reason why Congress would have refused premium tax credits to the citizens of states that ended up with a federal exchange. None of the CBO reports scoring the ACA suggest that premium tax credits would only be available though 1311 state exchanges and not through 1321 federal exchanges. It is, finally, highly unlikely that the House, whose bill included only a federal exchange, would have approved a bill that only provided tax credits through state exchanges but not through the federal exchange.
For the full argument, check out his post at the Health Reform Watch blog.
September 11, 2011 at 10:04 am
Posted in: Administrative Law, Health Law, Tax
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Assessing Medicaid Managed Care
posted by Frank Pasquale
The Washington Post has featured two interesting pieces recently on Medicaid managed care. Christopher Weaver reported on a battle between providers and insurers in Texas. Noting that “federal health law calls for a huge expansion of the Medicaid program in 2014,” Weaver shows how eager insurers are to enroll poor individuals in their plans. Each enrollee would “yield on average $7 a month profit,” according to recent calculations. Cost-cutting legislators see potential fiscal gains, too, once the market starts working its magic.
There’s only one problem with those projections: it turns out that “moving Medicaid recipients into managed care ‘did not lead to lower Medicaid spending during the 1991 to 2003 period,’” according to a report published by the National Bureau of Economic Research this month. Sarah Kliff is surprised to find that this is “the first national look at whether Medicaid managed care has actually done a key thing that states want it to do.”
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August 29, 2011 at 3:31 pm
Posted in: Empirical Analysis of Law, Health Law, Law and Inequality
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New Profit Opportunities in American Health Care
posted by Frank Pasquale
I notice there is a lot of handwringing over the Affordable Care Act’s “government takeover” of the health care system. So let’s take a look at some exciting new markets that are still thriving.
1) At the beginning of the summer, I noted some problematic drug shortages (bottom half of post). The problem keeps getting worse. There is a steady stream of heartrending stories about care being compromised. Reform measures to assure an adequate supply are moving at a snail’s pace, thanks both to truculent manufacturers and the bipartisan drumbeat to “cut health care costs.” But at least some folks are thriving: as the NY Times notes, ”Unscrupulous wholesalers have made matters worse by scooping up scarce drugs and offering them to hospitals at markups that often reach 20 times the normal price or more.”
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August 26, 2011 at 10:14 am
Posted in: Health Law
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Announcement: Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics’ 2012-2014 Academic Fellowship Program
posted by Frank Pasquale
At the request of the Petrie-Flom Center, I am posting this announcement:
The Petrie-Flom Center is an interdisciplinary research program at Harvard Law School dedicated to scholarly research at the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research and bioethics. The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy or bioethics. Our prior fellows have found employment as law professors at Harvard, UC Berkeley, BU, UCLA, Cornell and the University of Arizona. More information on the Center can be found here. Read the rest of this post »
August 18, 2011 at 9:32 pm
Posted in: Health Law
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Auditing Studies of Anti-Depressants
posted by Frank Pasquale
Marcia Angell has kicked off another set of controversies for the pharmaceutical sector in two recent review essays in the New York Review of Books. She favorably reviews meta-research that calls into question the effectiveness of many antidepressant drugs:
Kirsch and his colleagues used the Freedom of Information Act to obtain FDA reviews of all placebo-controlled clinical trials, whether positive or negative, submitted for the initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. . . .Altogether, there were forty-two trials of the six drugs. Most of them were negative. Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.
Angell discusses other research that indicates that placebos can often be nearly as effective as drugs for conditions like depression. Psychiatrist Peter Kramer, a long-time advocate of anti-depressant therapy, responded to her last Sunday. He admits that “placebo responses . . . have been steadily on the rise” in FDA data; “in some studies, 40 percent of subjects not receiving medication get better.” But he believes that is only because the studies focus on the mildly depressed:
The problem is so big that entrepreneurs have founded businesses promising to identify genuinely ill research subjects. The companies use video links to screen patients at central locations where (contrary to the practice at centers where trials are run) reviewers have no incentives for enrolling subjects. In early comparisons, off-site raters rejected about 40 percent of subjects who had been accepted locally — on the ground that those subjects did not have severe enough symptoms to qualify for treatment. If this result is typical, many subjects labeled mildly depressed in the F.D.A. data don’t have depression and might well respond to placebos as readily as to antidepressants.
Yves Smith finds Kramer’s response unconvincing:
The research is clear: the efficacy of antidepressants is (contrary to what [Kramer's] article suggests) lower than most drugs (70% is a typical efficacy rate; for antidepressants, it’s about 50%. The placebo rate is 20% to 30% for antidepressants). And since most antidepressants produce side effects, patients in trials can often guess successfully as to whether they are getting real drugs. If a placebo is chosen that produces a symptom, say dry mouth, the efficacy of antidepressants v. placebos is almost indistinguishable. The argument made in [Kramer's] article to try to deal with this inconvenient fact, that many of the people chosen for clinical trials really weren’t depressed (thus contending that the placebo effect was simply bad sampling) is utter[ly wrong]. You’d see the mildly/short-term depressed people getting both placebos and real drugs. You would therefore expect to see the efficacy rate of both the placebo and the real drug boosted by the inclusion of people who just happened to get better anyhow.
Felix Salmon also challenges Kramer’s logic:
[Kramer's view is that] lots of people were diagnosed with depression and put onto a trial of antidepressant drugs, even when they were perfectly healthy. Which sounds very much like the kind of thing that Angell is complaining about: the way in which, for instance, the number of children so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) was 35 times higher in 2007 than it was in 1987. And it’s getting worse: the editors of DSM-V, to be published in 2013, have written that “in primary care settings, approximately 30 percent to 50 percent of patients have prominent mental health symptoms or identifiable mental disorders, which have significant adverse consequences if left untreated.”
Those who would defend psychopharmacology, then, seem to want to have their cake and eat it: on the one hand it seems that serious mental health disorders have reached pandemic proportions, but on the other hand we’re told that a lot of people diagnosed with those disorders never really had them in the first place.
That is a very challenging point for the industry to consider as it responds to concerns like Angell’s. The diagnosis of mental illness will always have ineradicably economic dimensions and politically contestable aims. But doctors and researchers should insulate professional expertise and the interpretation of maladies as much as possible from inappropriate pressures.
How can they maintain that kind of independent clinical judgment? I think one key is to assure that data from all trials is open to all researchers. Consider, for instance, these findings from a NEJM study on “selective publication:”
We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. . . . Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall. (emphasis added).
Melander, et al. also worried (in 2003) that, since “The degree of multiple publication, selective publication, and selective reporting differed between products,” “any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.” Without clearer “best practices” for data publication, clinical judgment may be impaired.
Full disclosure of study funding should also be mandatory and conspicuous, wherever results are published. Ernest R. House has reported that, “In a study of 370 ‘randomized’ drug trials, studies recommended the experimental drug as the ‘treatment of choice’ in 51% of trials sponsored by for-profit organizations compared to 16% sponsored by nonprofits.” The commodification of research has made it too easy to manipulate results, as Bartlett & Steele have argued:
One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004 . . . the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.
The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. . . . As the months ticked by, and the number of people taking the drug climbed steadily, the F.D.A. began to get reports of adverse reactions, including serious liver damage that sometimes led to death. . . . [C]ritics were especially concerned about an ongoing trial in which 4,000 infants and children, some as young as six months, were recruited in more than a dozen countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis. The trial had been sanctioned over the objections of the F.D.A.’s own reviewers. . . . In 2006, after inquiries from Congress, the F.D.A. asked Sanofi-Aventis to halt the trial. Less than a year later, one day before the start of a congressional hearing on the F.D.A.’s approval of the drug, the agency suddenly slapped a so-called black-box warning on the label of Ketek, restricting its use. (A black-box warning is the most serious step the F.D.A. can take short of removing a drug from the market.) By then the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths.
The great anti-depressant debate is part of a much larger “re-think” of the validity of data. Medical claims can spread virally without much evidence. According to a notable meta-researcher, “much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong.” The “decline effect” dogs science generally. Statisticians are also debunking ballyhooed efforts to target cancer treatments.
Max Weber once said that “radical doubt is the father of knowledge.” Perhaps DSM-VI will include a diagnosis for such debilitating skepticism. But I think there’s much to be learned from an insistence that true science is open, inspectable, and replicable. Harvard’s program on “Digital Scholarship” and the Yale Roundtable on Data and Code Sharing* have taken up this cause, as has the work of Victoria Stodden.
We often hear that the academic sector has to become more “corporate” if it is to survive and thrive. At least when it comes to health data, the reverse is true: corporations must become much more open about the sources and limits of the studies they conduct. We can’t resolve the “great anti-depressant debate,” or prevent future questioning of pharma’s bona fides, without such commitments.
*In the spirit of full disclosure: I did participate in this roundtable.
X-Posted: Health Law Profs Blog.
July 14, 2011 at 3:56 pm
Posted in: Bioethics, Culture, Health Law, Law and Psychology, Philosophy of Social Science, Technology
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Some of My Health Law Posts
posted by Frank Pasquale
I blog each Thursday at Health Reform Watch, a blog sponsored by Seton Hall’s Center for Health & Pharmaceutical Law & Policy, and at Health Law Profs. I haven’t re-posted all of those items here. Here are some from 2011 that might be interesting:
Health Information Technology
On personal health records (this later became a presentation titled “From Medical Record to Medical Reputation”)
On online data and health reputation.
On patient control over medical records.
On physician resistance to new health IT
(Mis)Allocation of Health Spending
On the immortality-industrial complex.
On “surge capacity” and public health.
On mini-med exemptions from the ACA.
I hope readers interested in health law & policy enjoy the posts.
Photo Credit: Anolobb.
July 10, 2011 at 9:40 pm
Posted in: Health Law
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