Thursday, June 30, 2011
Last week, Nic Terry compiled a list of current threats to Medicaid funding. As he noted then, Medicaid coverage is increasingly becoming meaningless for those seeking specialist care. Though more people are slated to enter the program, policymakers are unlikely to fix these flaws before they arrive. To the contrary, “physician reimbursement will decrease, and hospitals are looking to cross-subsidize some of their Medicaid patient expenditures from the privately insured.” Something to remember next time we here about how imperative it is to cut public health expenditures: there is an inevitable pressure to “rob Peter to pay Paul.”
The budget drama narrative has so far focused on Republican efforts to further slash (orend) Medicaid, and Democratic resistance. But now even the Obama Administration is showing signs of reverting to form and endorsing a patina of Medicaid coverage without its substance. It is now too scared to even try to assess the full extent of the access problem. Like “death panels” before, the buzzword “spying on doctors” ended a promising program to measure the relative difficulty of getting access to care using different forms of insurance.
Obama officials are also engaged in more troubling substantive capitulations. Consider this CBPP report:
An Obama Administration proposal that’s on the table for budget negotiators would reduce federal Medicaid expenditures by reducing the federal share of Medicaid and CHIP costs, shifting costs to states and likely prompting states to cut payments to health care providers and to scale back the health services that Medicaid covers for low-income children, parents, people with disabilities, and/or senior citizens (including those in nursing homes). . . . The proposal would replace the various matching rates at which the federal government reimburses states for their costs in insuring people through Medicaid and CHIP with a single “blended rate” for each state. A state’s blended rate would be set at a level that provided the state with less federal funding than under current law, thereby saving the federal government money.
Abigail Moncrief has noted that states “are statutorily required—and should be judicially required—to pay a reasonable price for the services they buy” by the Medicaid Act’s equal access provision (42 U.S.C. 1396a(a)(30)(A)). But the Obama Justice Department is apparently complementing the budget team cost cutters by arguing that the Supremacy Clause does not “provide a cause of action for an injunction to enforce” the equal access provision. As Steve Vladeck observes, this is “a shift in policy that, if endorsed by the Supreme Court, would make it all-but-impossible to enforce the equal access mandate–one of the most important statutory requirements of the Medicaid program.”
Providers don't like having comparative ratings (such as HACs) published, here. Neither do they relish visits from data-rich detailers, here. And, some of them seem prone to overreacting to patients posting their opinions on web sites, here. Now, we discover, they are opposed to "secret shoppers."
Access to care isn't getting any easier, as the recent research on attempts to make appointments for Medicaid-covered children, here, made clear. So, back in April, HHS slipped a notice into the Federal Register, here, outlining a plan to "collect data from physician offices in order to accurately gauge availability of Primary Care Physicians (PCPs) accepting new patients, assess the timeliness of services from PCPs, and gain insight into the precise reasons that PCP availability is lacking." It seemed innocuous enough and was designed to probe the same private-public vector as the Illinois Medicaid audit. However, the proposal was perhaps a little too explicit in describing its preferred methodology, using "mystery shoppers."
The HHS plan (including some of its scripted survey questions) was detailed in the New York Times earlier this week, here. It probably only took one quote from a doctor to scupper the plan, “I don’t like the idea of the government snooping… It’s a pernicious practice — Big Brother tactics, which should be opposed.”
Soon, according to Politico, here, a senator was circulating a draft letter to the Secretary and the critical headlines multiplied. By Tuesday the program was put on "indefinite hold," here, although an HHS spokesman tried hard to convince us that “Politics did not play a role in the decision”
And to think, we were under the impression that a new world of transparency had arrived as outcomes and effectiveness research were poised to mend the healthcare system! [NPT]
Wednesday, June 29, 2011
By a 2-1 vote, the Sixth Circuit upheld the individual mandate as a valid exercise of the Commerce Clause power. For those keeping score of political affiliation, one of the two majority judges was appointed by President Carter, the other by the second President Bush. The dissenting judge was appointed by President Reagan. (Thanks to Marty Lederman for reporting the decision on the con law professors list-serv.)
Tuesday, June 28, 2011
Yesterday, the White House Office of Management and Budget (OMB) released the final 2011 Report to Congress on the Benefits and Costs of Federal Regulations and Unfunded Mandates on State, Local, and Tribal Entities, available here.
In stark contrast to the claims being from some House members that regulations are costing too much, the report concludes that the benefits of federal regulations promulgated between 2000 and 2010 far exceed their costs. For pollution regulations, the benefits were mainly realized in the area of public health. One of the notable environmental regulations assessed was the joint greenhouse gas emission/fuel economy standards for light-duty vehicles, where costs were valued at 3.3 billion dollars, compared to 11.9 billion dollars in benefits. This comes at the same time that the House has passed a bill (H.R. 910) that removes EPA’s authority to regulate emissions of Greenhouse gases.
The Supreme Court’s 8-0 decision last week in American Electric Power v. Connecticut certainly has implications for environmental health. The Court ruled that the federal common law public nuisance claim that the Second Circuit would have allowed to proceed was displaced by the Clean Air Act. But AEP is more than just a climate change case. Similar nuisance claims have been brought against the tobacco industry, firearms manufacturers and distributors, lead paint and pigment manufacturers, and other industries that are alleged to substantially and unreasonably interfere with public health and welfare. It’s certainly possible that the Court’s reasoning in AEP could also apply to other public health threats. As Lyle Denniston wrote for SCOTUS Blog, to the extent that “targeted activities are covered by a broad federal regulatory law like the Clean Air Act, the new decision would appear to close them down.” In any case, the great majority of innovative public nuisance suits have been dismissed on a wide range of procedural and substantive grounds.
There’s a growing body of legal literature surrounding public nuisance. As the cases appear to be winding down, the literature is taking a turn from practical, advocacy-oriented pieces toward more theoretical examinations of how courts have handled these challenging cases. Tom Merrill recently put up a paper on SSRN asking Is Public Nuisance a Tort? He argues that “legislatures rather than courts are the proper institution to identify the circumstances in which public nuisance liability exists, as well as who has authority to institute a public nuisance action.” Much of the scholarship surrounding nuisance has similarly focused on procedural issues grounded in separation of powers.
I’m currently wrapping up a project that situates the doctrinal debate over the substantive scope of public nuisance within a broader debate over the legitimate scope of public health law. As Wendy Parmet and others have argued, public health provides a unique and valuable lens for examining a wide range of legal problems. But it provides a particularly appropriate theoretical framework for understanding public nuisance law. Public nuisance law and public health law share a common heritage in the police power of the state. It is widely agreed that the defining trait of a public nuisance is a substantial and unreasonable interference with a right held in common by the general public, including interference with public health, safety, welfare, morals and convenience. But the unique characteristics of public health have been misunderstood and misrepresented in the adjudication of public nuisance claims and in some of the academic commentary on nuisance. At the same time, public health law scholars have failed to fully appreciate the richness of the ties between nuisance and public health.
I argue that the current trend toward rejection of industrial public nuisance liability is part of a broader tension over the proper scope of public health law. In particular, the debate over the meaning of a “public right” in the context of public nuisance law and the debate over the meaning of the “public” in public health law are in many ways one and the same. In both disputes, the stakes are high. Designating a problem as “public” changes the rules of the game. If a state or municipality suing in parens patriae successfully pleads substantial and unreasonable interference with a public right, the door is opened to flexible doctrines of causation and fault that make liability more likely. If a concern is designated as a public health threat, legal doctrines that privilege state intervention over private interests come into play.
Both of these debates arise out of a mounting tension between the science and politics of public health. On one hand, evolving scientific understanding suggests that addressing social and environmental determinants of health is crucial to protecting the public’s health. On the other, there are deeply held political and philosophical beliefs about where the boundary between public and private responsibility for health legitimately lies. This tension will continue to play out in contexts ranging from sin taxes on sugared beverages to workplace wellness programs that incentivize employees to lower their body mass index. Situating public nuisance liability within public health jurisprudence sheds new light on the doctrinal controversy over nuisance. But at this point, the legal battle over nuisance seems to be nearly lost. The project’s more significant contribution may be its suggestion that the controversy over public nuisance is indicative of what the future holds for public health law.
Monday, June 27, 2011
According to Google's official blog, here, "Google Health" will be "retired" in January. Google Health was the first major company's entry into the personal health records (PHR) space (Microsoft's Health Vault is a different animal). It was announced in 2008 around the time the Bush Administration must have realized that market failures were going to derail its EHR project. A PHR model must have seemed a perfect substitute. It lacked the first mover, “misaligned incentives,” and network effects market failure problems associated with the Administration's national EHR model. Because PHRs operated in an essentially unregulated zone little touched by the HIPAA Code, jumping on the PHR bandwagon was nicely consistent with the Administrations' position that over protective privacy regimes were responsible for slowing EHR implementation. And, the PHR narrative could be conveniently interwoven with the then popular push for Consumer Directed Health Care (CDHC). As I suggested, here, a few months later, "PHRs are dangerously flawed adjuncts to or substitutes for provider-centric records, and, while lacking many of the touted quality or cost-reduction benefits of the of- ten-criticized EHRs, they pose substantially higher levels of risk regarding security, privacy, and confidentiality."
I stand by those comments and do not mourn the passing of the most visible PHR system. But, I do regret failing to appreciate the importance of Google Health being built on the universal language of the web. A few months ago the President’s Council of Advisors on Science and Technology (PCAST), available here, recommended that the, now government-stimulated, national EMR project should refocus its efforts on records interoperability and achieve that by concentrating less on records databases and more on segmented data expressed in a universal exchange language (likely an XML variant). This markup language would provide the metadata that could provide patient identifying information, privacy protocols, and provenance relating to those data elements. That data could then be accessed by providers through specialized and secure search engines that would crawl the meta-data. PCAST was pretty flawed as far as any short term implementation and rightly set off a lot of privacy and security alarms. But, longterm its concept of how to achieve efficient data interoperability may prove to be correct. After all, the closest to any PHR that most of us will see near term is a patient portal tacked on to the end of a provider's EMR. It may be accessed through a browser but it will be built on APIs that limit us to interactions with some of the proprietary data locked up in the EMR.
Chilmark Research has an insightful post, here, listing a number of explanations for Google Health's death. Google itself explained the demise of its PHR project as follows, "[W]ith a few years of experience, we’ve observed that Google Health is not having the broad impact that we hoped it would. There has been adoption among certain groups of users like tech-savvy patients and their caregivers, and more recently fitness and wellness enthusiasts. But we haven’t found a way to translate that limited usage into widespread adoption in the daily health routines of millions of people."
But, I wonder whether putting that quote through Google Translate would produce something closer to "we do search across web data but the government decided to spend $27 billion of your money creating electronic records silos built on proprietary formats that neither we nor any of your other doctors can search." If that's anywhere close to the real reason why they are burying Google Health, surely it raises the question of whether we will be praising the current Administration's EMR project design after the stimulus money runs out. [NPT]
Friday, June 24, 2011
Frank McClellan, Health Disparities, Health Care Reform, Morality, and the Law: 'Keep Your Government Hands Off My Medicare', SSRN/Temple Law Review
Lance Gable, Reproductive Health as a Human Right, SSRN
David Hyman, Convicts and Convictions: Some Lessons from Transportation for Health Reform, SSRN/U. Pa. Law Review
Barry Furrow, Regulating Patient Safety: The Patient Protection and Affordable Care Act, SSRN/U. Pa. Law Review
Henry Aaron, The Independent Payment Advisory Board — Congress’s “Good Deed”, NEJM
Thursday, June 23, 2011
Thirty-five years ago, in Virginia State Board of Pharmacy, the Supreme Court recognized its "commercial speech" doctrine so it could protect the interests of consumers in paying lower prices for their prescription drugs. Yesterday, in Sorrell v. IMS Health, the Court invoked the commercial speech doctrine on behalf of pharmaceutical company marketing strategies that drive up the cost of prescription drugs.
The decision is troubling for a number of reasons. First, it allows pharmacies to sell information from patients' prescriptions so drug companies can use that information in ways that are harmful to patient interests. But any information gleaned from patients by health care providers should be used only for the good of the patients. Second, the Court sacrificed patient interests in favor of corporate speech interests even though there were absolutely no restrictions on what drug companies can say to physicians when marketing their drugs. Third, the Court raised its level of review for commercial speech from "intermediate scrutiny" to the more rigorous level of scrutiny it employs for non-commercial speech.
While in some sections, the Court wrote an opinion that could have broad implications for regulations of other corporate speech, there also were parts that suggested a narrower reading. For example, the Court viewed the Vermont statute as targeting the use of prescription data by drug company marketers while letting just about anyone else use the same data. The Court suggested that a statute would past muster if it broadly protected prescription information with narrow exceptions for use (e.g., a statute more like HIPAA). Still, it's difficult to see how the FDA's ban on off-label promotion of drugs by pharmaceutical companies can survive judicial scrutiny after this decision.
I have previously commented on Sorrell v. IMS Health, as a co-author of an amicus brief, a Pharma FaceOff panelist, and a blogger. I’m disappointed by today’s ruling, for reasons largely elaborated in Justice Breyer’s dissent. As he observes, the majority opinion “reawakens Lochner’s pre-New Deal threat of substituting judicial for democratic decision-making where ordinary economic regulation is at issue.” But I’m not surprised at theLochner revival, given the First Amendment maximalism of the Citizens United Court. For this Court, “free expression” will have to do in the information age what “freedom of contract” did for the early decades of the 20th century: erase even small and incremental steps toward a fairer social order.
Bill McGeveran has characterized Kennedy’s majority opinion in the case as relatively limited, a surgical strike against an overreaching and incompetent state legislature. I want to respond to his interpretation in a future post, after I’ve digested the opinion a bit more. But for now, I’d like to focus a bit of attention on the types of problems Vermont was addressing, to give the case more of a human face. For behind all the familiar Kennedy rhetoric about sacred speech, deeply disturbing industry practices motivated Vermont’s law.
Both PhRMA and IMS Health want us to believe that the case is about the life-saving power of a marketer to recommend drugs to oblivious doctors once it has access to their prescribing records. Never mind that, as co-blogger (and doctor) David Orentlicher notes, “For $98 a year . . . physicians can subscribe toThe Medical Letter on Drugs and Therapeutics, a respected and independent, biweekly newsletter that provides evaluations of prescription (and over-the-counter) drugs.” Maybe detailing, on occasion, saves lives. But, as the dissent observes, Vermont’s law allowed doctors to permit distribution of their prescribing records in order to receive personalized solicitations. They only needed to opt in.
In a 6-3 decision, the Supreme Court struck down Vermont's effort to protect patient prescription information from use by pharmaceutical companies for marketing purposes. I'll have more to say later, but the Court was concerned much more about the first amendment interests than the patient protection interests.
Wednesday, June 22, 2011
The FDA unveiled its new warnings for cigarette packaging and advertising, the first change in warnings in more than 25 years. You can see the new graphics and find out other information at the FDA's website. One warning depicts a man smoking through a tracheostomy with the caption that cigarettes are addictive.
Tuesday, June 21, 2011
The big news in environmental health today is yesterday’s ruling by the Supreme Court that the lawsuit brought by several U.S. states claiming that Greenhouse gases emitted by five power companies was a nuisance could not go forward. In American Electric Power v. Connecticut, the Judges ruled in an 8-0 decision that the Clean Air Act pre-empted any federal common law nuisance claim, and the Environmental Protection Agency, not the Court, would determine how to address any dangers to the public. The decision was widely reported included good summaries in the LA Times, NY Times, and the Washington Post.
The draft rules are due out shortly, but it is likely they will be severely weakened or delayed by legislation or other pressure from Congress. House Republicans made this clear in last week’s Energy and Commerce subcommittee hearings, as reported here. To this writer, the opinion was expected, and is good law, since the EPA is about to release its greenhouse gas rule, has the scientific expertise to evaluate the health risks, and is charged with implementing the Clean Air Act. But the courts will inevitably end up deciding whether the rule is adequate, and if it is found lacking, the states may still be able to attempt to recover for the harm caused by the gases. A key part of the opinion, delivered by Justice Ginsberg, was a reminder that plaintiffs have a remedy in the federal courts in the event that the EPA fails to act or fails to issue reasonable regulations. The Republicans need to be read this warning carefully. If Congressional opponents end up pressuring EPA too much and sidetracking the rule, as threatened, a federal tort claim can be refiled, and this time it could be successful.
We have long believed that the eradication of wrong site and wrong patient surgery ranks amongst the lowest hanging adverse event fruit. Since the Joint Commission introduced its "timeout" and other procedures, available here, surely the problem is in decline. According to a perceptive Washington Post/KHN piece by Sandra Boodman, available here, that doesn't seem to be the case. The following extract quoting the Joint Commission president is illustrative:
“I’d argue that this really is rocket science,” said Mark Chassin... he thinks such errors are growing in part because of increased time pressures. Preventing wrong-site surgery also “turns out to be more complicated to eradicate than anybody thought,” he said, because it involves changing the culture of hospitals and getting doctors — who typically prize their autonomy, resist checklists and underestimate their propensity for error — to follow standardized procedures and work in teams.
Sunday, June 19, 2011
Guest Blogger Lindsay F. Wiley: The Joint Action and Learning Initiative for a New Global Health Agreement
My last global health law post, on WHO’s new PIP Framework for influenza pandemic preparedness, ended on a rather depressing note about the low likelihood of a strengthened commitment to global health equity at a time when money is tight. I’m going to attempt a rebound today with a post on an ongoing effort to promote a new international agreement on global health.
Larry Gostin and several international colleagues recently published an article on PLoS Medicine heralding their establishment of a new Joint Action and Learning Initiative to promote a new international agreement on national and global responsibilities for health. The article describes the formation of a coalition of civil society organizations and academics from the U.S., the U.K., Germany, Belgium, Norway, India, China, and South Africa to research “key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement and supporting civil society mobilization around the human right to health.” The authors propose that a new agreement is needed to inform global health commitments as the Millennium Development Goals’ time-frame draws to a close. The Joint Action and Learning Initiative (JALI) aims to “clarify the health services to which everyone is entitled under the right to health, the national and global responsibilities for securing this right, and global governance structures that can realize these responsibilities and close major health equities.” In coming months, the JALI will undertake efforts to create the political space required for negotiation of a new agreement addressing these issues.
The agreement was initially proposed by Gostin as a possible Framework Convention (on the model of something like the U.N. Framework Convention on Tobacco Control or the U.N. Framework Convention on Climate Change). Elsewhere, I’ve argued that a Framework Convention on Global Health could make a major contribution to global efforts to adapt to the anticipated health impacts of climate change. Environmental degradation, which is being exacerbated by climate change, is already responsible for a significant portion of global disease burden – especially through its contribution to malaria and diarrheal illness. These problems have tended to be neglected by current law and policy structures. Public health specialists have a a fairly well-developed body of interventions for promoting better health through interventions like drinking water and sanitation improvements and vector control. What has been sorely lacking is the political will to commit sufficient resources to supporting these efforts in the communities where they are most needed. It’s a governance failure that Gostin’s proposed agreement might effectively address.
Recently, as I’ve been working on a project at the intersection of international disaster law and international health law, I’ve begun to think that the Framework Convention model is perhaps not ideally suited to the focus of the JALI’s proposed global health agreement. A different model, the Framework Agreement, might be a better fit. Framework Conventions are international instruments designed to set forth overarching commitments that will be fleshed out later in the form of protocols. For example, the Kyoto Protocol provided the emissions reduction targets that gave content to the broad commitments outlined in the Framework Convention on Climate Change. Such a model works well to structure continuing negotiation of concrete, binding obligations. But the subject of the proposed global health agreement – which would aim to meet “the basic survival needs of the world’s least healthy people” – might lend itself to a more flexible soft law mechanism. Framework Agreements – such as the highly successful Hyogo Framework for Action on Building the Resilience of Nations and Communities to Disasters – work well as a platform for promoting and supporting Member States’ domestic efforts to reach internationally agreed-upon goals and commitments to assistance.
Whatever form it takes, a new international agreement on global health could go a long way toward correcting what I perceive as an imbalance in international health law between the real health policy priorities of poor countries and the legal obligations imposed on them (primarily through the recently revised International Health Regulations, which include significant obligations to build rapid disease surveillance and response capacity to address disease outbreaks with potential for cross-border spread) to ensure “global health security” in the face of mutual interdependence.
Saturday, June 18, 2011
The New York Times reports that the Obama administration is ending its controversial program for granting waivers from a requirement of the Patient Protection and Affordable Care Act. The Act requires health care plans to provide at least $750,000 of annual coverage this year and higher minimum levels in 2012 and 2013. Starting in 2014, annual coverage limits will be eliminated.
More than 1,000 health care plans have been exempted from the $750,000 minimum, but no more applications for a waiver will be granted after September 22.
Friday, June 17, 2011
Rachel Behrman Sherman et al, New FDA Regulation to Improve Safety Reporting in Clinical Trials, NEJM
Nicole Huberfeld, Federalizing Medicaid, SSRN/U. Pa. J. Const. L.
Akhil Amar, The Lawfulness of Health-Care Reform, SSRN/Yale LJ Online
Barbara Evans, Much Ado About Data Ownership, SSRN/Harv. J. L & Tech.
If Medicaid were a person this week would probably have seen it resigning to spend more time with its family.
First, according to an audit study by Bisgaier and Rhodes published in the New England journal, here, 66% of the callers to Illinois specialty clinics for their children reporting Medicaid–CHIP coverage were denied an appointment, compared with 11% of the callers reporting Blue Cross Blue Shield insurance. When appointments were offered to both cohorts, the wait for an appointment was roughly twice the number of days for a publicly insured child compared to a privately insured one. Over at The Incidental Economist, here, Harold Pollack makes some excellent points about this study and Medicaid generally. And, Ezra Klein at the Post, here, has his usual succinct commentary both on the audit and the furore surrounding it.
According to Robert Pear, writing in the New York Times, here, the downward spiral of Medicaid seems unstoppable. The $90 billion stimulus package is about over, physician reimbursement will decrease, and hospitals are looking to cross-subsidize some of their Medicaid patient expenditures from the privately insured. The bottom line-Medicaid patients are not an influential voting block, federal funding is not going to increase and states have to reduce costs. Sommers and Epstein, again in the New England Journal, here, provide more data noting that Medicaid absorbs 12% of state revenues and, because the program is countercyclical, during the recession states are facing lower revenues while enrollment increases. They also tie the Medicaid issue into healthcare reform noting, "Although states will receive a large infusion of federal dollars under the ACA, other less-publicized features of the legislation render Medicaid a looming fiscal threat and administrative challenge. In combination with political considerations, these factors have made Medicaid the perfect ideological punching bag for conservatives." And, if you thought that using managed care companies to delver Medicaid services would reduce costs and improve, you should read this sobering report from the Commonwealth Fund, here.
If you can't stomach the current deficit debate and what is likely to happen to Medicaid as discussed here, then look forward courtesy of Nicole Huberfeld's upcoming piece "Federalizing Medicaid," available here. Nicole argues:
Medicaid is often described as a classic example of cooperative federalism, but the program’s design is creating more discord than cooperation. An overlooked fact is that Medicaid is not a purposefully structured cooperative federalism program. Medicaid is an outgrowth of very old assumptions about the role that localities play in providing welfare-type programs. Despite being an area of traditional state regulation, healthcare should no longer be left to the economic and political whims of the states: Medicaid should be federalized. Admittedly, some would oppose centralization on the ideological grounds that more federal government power is bad, and more state or local power is good. But Medicaid was built on a feeble foundation that allowed a patchwork program to continue and has been solicitous of state control over welfare programs ever since -- not exactly a strong argument for the significant medical variations that occur as a result of Medicaid’s divided structure. In other words, Medicaid is not an effective Brandeisian “laboratory of the states.”
Tuesday, June 14, 2011
Ezra Klein, here, explores a scenario where, with ACA protections in place, the employer tax deduction could be traded for an Exchange option for Medicare, and why it's unlikely to happen. Meanwhile Politico, here, speculates on whether Democratic support for Medicaid is as strong as it seems. [NPT]
Monday, June 13, 2011
My colleague, Steve Vladeck, has an interesting post up on PrawfsBlawg about the Obama administration's brief in Douglas v. Independent Living Center, in which the Supreme Court will determine whether the Supremacy Clause provides sufficient basis for a private cause of action to enforce the equal access provision of the Medicaid Act: http://prawfsblawg.blogs.com/prawfsblawg/2011/06/enforcing-medicaids-equal-access-provision.html.
I've been so fortunate to have Steve as a colleague this past year. He was my go-to federal courts expert as I was teaching Medicaid litigation and we had a wonderful time co-teaching a class session on the ACA litigation.
I wonder how much time, if any, others have chosen to devote to Medicaid litigation in the health law survey course. The students definitely found it challenging, but overall they seemed to appreciate the cross-over with constitutional law and federal courts.