Friday, November 30, 2012
- Jessica Mantel, Accountable Care Organizations: Can We Have Our Cake and Eat it Too? SSRN
- Kieran Healy & Kimberly Krawiec, Custom, Contract, and Kidney Exchange, SSRN/Duke L.J.
- Eliott Fisher et al, A framework for evaluating the formation, implementation, and performance of accountable care organizations, Health Affairs
- Ronald Bayer et al, Repackaging Cigarettes — Will the Courts Thwart the FDA? NEJM
- Vicki Girard, Reducing Unlawful Prescription Drug Promotion: Is the Public Health Being Served by an Enforcement Approach that Focuses on Punishment? SSRN/FDLI Food & Drug Forum
Thursday, November 29, 2012
Last term the Supreme Court decided Douglas v. Independent Living Center, a decision that almost shut down Supremacy Clause implied rights of action but instead deferred to CMS's authority to approve states' reimbursement cuts in Medicaid. Litigants now appear to be testing the boundaries of both the majority and the dissent in Douglas. A few weeks back, I mentioned a Seventh Circuit decision that endorsed the Douglas dissent's desire to severely limit implied rights of action (which would have substantially closed the courthouse doors to Medicaid providers and enrollees).
Now, a different aspect of the case has been tested. In Emma C. v. Eastin, California argued that the Douglas majority's remand deprives federal courts of jurisdiction where a federal agency approves of the state's approach to using federal funding. The district court flatly rejected this proposition, holding that the federal agency's imprimatur was not only absent, but even if it were not, agency approval does not deprive federal courts of their ability to review compaints regarding improper state acts in conditional spending programs. Though Emma C. is an IDEA case, one can imagine that California was ready to tackle the same proposition in additional Medicaid cases. No link is available, but the case can be found at 2012 WL 5904750 (N.D. Cal., Nov. 26, 2012). (Thanks to Sam Bagenstos at DisabilityLawBlog for the pointer.)
Douglas seems bound to return to the Court either through Medicaid or another conditional spending vehicle soon. Too many states are interested in testing the dissent's desire to limit implied causes of action for this decision to be a sleeper.
Wednesday, November 28, 2012
Last week, I posted on the NPRM concerning ACA standards for wellness programs, and promised more postings on federal activities implementing ACA in weeks to come. I plan to blog about the proposed rules for essential health benefits and for market reforms banning pre-existing condition exclusions in subsequent weeks. Today, I want to call readers' attention to an important request for information that appeared in yesterday's Federal Register on quality management in affordable insurance exchanges. This RFI has a 30-day time window: comments must be submitted by December 27, 2012.
As plans compete on coverage and costs, quality must not fall through the cracks. ACA places some quality requirements on insurers offering qualified health plans in the exchange marketplace. These include implementation of quality improvement strategies, contracting requirements to enhance patient safety, and public reporting of quality data. ACA also requires HHS to develop systems for rating care quality and enrollee satisfaction, information that is to be made available for consumers. Finally, ACA requires HHS to develop a methodology to calculate value in a health plan.
The RFI seeks information about current practices in the following areas:
--the current landscape of quality improvement strategies, especially those used to improve health outcomes, prevent hospital readmissions, improve patient safety and reduce errors, implement wellness and health promotion, and reduce health disparities
--the challenges to measuring and reporting quality improvement over time
--current public reporting and transparency efforts
--monitoring currently used by health insurance plans to monitor provider and hospital performance
The RFI also seeks information about the applicability of quality improvement measures to the health insurance exchange marketplace. Among other matters, it specifically requests comments about how exchanges might evaluate quality across plans, promote data collection and transparency, and develop strategies for meeting anticipated methodological challenges with public reporting of quality data. It also seeks input about priority areas for quality rating in exchanges, such as delivery of preventive services. Finally, the RFI seeks input about the factors HHS should consider in designing an approach to measure the value of plans that would be meaningful to consumers.
It seems likely that readers of this blog might have something to say about these critical issues regarding quality and transparency. I do hope this RFI, with its 30-day comment period, doesn't get lost in the press of the end of the semester, finals, and the holidays.
Tuesday, November 27, 2012
With the holiday season upon us, many of us start thinking about gifts--both getting and receiving. Despite the apparent fiirm establishment of the Affordable Care Act as law with the reelection of President Obama and the Democratic gains in the Senate, opponents of the law continue to shower us with the gift of endless litigation about the law's constitutionality and legality.
In addition to the numerous employer lawsuits regarding the contraception coverage mandate that continue to work their way through the courts, there are at least four additional major challenges to provisions of the law, or the law itself. The Pacific Legal Foundation is supporting a lawsuit challenging the constitutionality of the ACA because the bill was first passed by the Senate, rather than the House of Representatives, violation of the Constitution's Origination Clause. Oklahoma is following the Cato Institute's playbook for taking down the ACA by arguing that in states where the federal government is running the health insurance exchanges mandated by the law, subsidies for individuals to purchase insurance on the exchanges are not authorized. Maine is leading the charge to dismantle Medicaid by challenging the ACA's "maintenance of effort" provision, which requires states to preserve their existing Medicaid programs until the ACA is fully implemented, unless the state certifies that it will have a budget deficit. And yesterday, Liberty University's lawsuit challenging the mandate that employers provide health insurance coverage as unconstitutional, and challenging the individual mandate on religious freedom grounds, was revived by the United States Supreme Court by being remanded to the 4th Circuit for a decision on the merits, (with no opposition from the Obama administration, which must think that this is an opportunity to make some favorable law). And a slew of proposed regulations implementing some major provisions of the ACA were recently promulgated. These are likely to provide additional fodder for legal challenges.
Should keep us busy for quite a while. Ho-Ho-Ho.
Cross-Posted on Healthy Interests
Monday, November 26, 2012
In an odd twist to a surrogacy arrangement, the New Jersey Supreme Court concluded that a three-year old child has no legal mother. An infertile couple used in vitro fertilization to create an embryo from the husband's sperm and an egg from an anonymous donor. The pregnancy was carried by a gestational surrogate. Both the egg donor and the surrogate relinquished any parental rights, and a trial court judge had issued a pre-birth order for the husband and wife to be listed as parents on the child's birth certificate.
However, the state intervened and argued that the wife could become the child's parent only through a post-birth adoption. The intermediate court of appeals agreed, and the supreme court deadlocked on the question, leaving the appellate decision intact. The intended mother has moved for adoption, which is expected to be approved.
Friday, November 23, 2012
- Richard Epstein & David Hyman, Fixing Obamacare: The Virtues of Choice, Competition and Deregulation, SSRN/NYU Annual Survey of American Law
- Brendan Maher & Radha Pathak, Enough about the Constitution: How States Can Regulate Health Insurance under the ACA, SSRN/Yale Law & Policy Rev.
- Mark Rothstein, The Case Against Precipitous, Population-Wide, Whole-Genome Sequencing, SSRN/JLME
- J. Oberlander, The Future of Obamacare, NEJM
Cross-posted at Bill of Health
Wednesday, November 21, 2012
On November 20, the Obama administration took three important steps in implementing ACA. The administration issued notices of proposed rulemaking (1) prohibiting health insurers from discriminating on the basis of preexisting or chronic conditions; (2) outlining policies and standards for determining the essential benefits package that must be included in coverage; and (3) setting standards for employer-based wellness programs. In this post, I take up the NPRM concerning employer-based wellness programs; later posts will deal with the pre-existing conditions and essential benefits proposals.
"Wellness" programs are controversial because they may discriminate against individuals with health conditions, because they are seen as unjustifiable paternalistic restrictions on liberty, and because there are concerns that they may be subterfuges for additional charges. They are praised for their potential to improve health, to engage insured individuals in health-improvement efforts, and to reduce overall health care costs. The section of ACA that allows plans to vary premiums for participants who meet wellness targets has attracted limited discussion in the controversies over ACA. However, as ACA is implemented it seems likely that interest in these programs will grow--with cost implications for individuals that are not trivial.
The NPRM proposes a common standard for wellness programs in group health plans, group health insurance, and individual health insurance. There are two types of wellness plans: participatory wellness plans that are programs available to all participants (such as a discounted gym membership) and "health-contingent" programs that reward individuals for satisfying a standard based on a health factor (such as a premium discount for maintaining normal blood pressure or complying with a prescribed plan of care). Both types of wellness programs must be made available to all participants, but health-contingent plans are the more controversial and must satisfy additional requirements. To be non-discriminatory, health-contingent plans must meet 5 standards:
--individuals must be eligible for the reward at least once a year
--the maximum permissible reward may not exceed 30% of the total cost of coverage (this is an increase from 20% for previously-covered plans); tobacco cessation programs may offer rewards up to 50%
--the rewards must be available to all similarly situated individuals--and there must be reasonable alternatives for individuals for whom it is medically inadvisable to meet the standard or for whom the standard would be unreasonably difficult to meet because of a medical condition. Plans may require individuals to request alternatives. Plans must pay the costs of participation in educational or weight-reduction programs. Alternatives must accommodated the recommendations of the individual's physician and may seek reasonable physician verification.
--programs must be reasonably designed to promote health or prevent disease, and may not be subterfuges for increased charges
--programs that state methods for qualifying for the reward must specify that alternatives may be available for qualifying.
The NPRM asks specifically for comments on many of these standards for health-contingent programs. The NPRM can be located here, http://www.ofr.gov/OFRUpload/OFRData/2012-28361_PI.pdf, and will be published in the Federal Register on November 26. Comments should be identified by "Wellness Programs" and may be submitted to the Department of Labor through http://www.regulations.gov. Comments are due January 25, 2013.
Friday, November 16, 2012
- Kevin Outterson, Regulating Compounding Pharmacies after NECC, NEJM\
- Katherine Pratt, A Constructive Critique of Public Health Arguments for Anti-Obesity Soda Taxes and Food Taxes, SSRN/Tulane L.Rev.
- Ronald Bayer, Lawrence Gostin, & Daniel Marcus-Toll, Repackaging Cigarettes — Will the Courts Thwart the FDA? NEJM
- Richard Saver, Is It Really All about the Money? Reconsidering Non-Financial Interests in Medical Research, SSRN/JLME
Thursday, November 15, 2012
Viral today: a woman living in Ireland died due to physicians' refusal to abort a non-viable fetus. See reporting here: http://www.nytimes.com/2012/11/15/world/europe/hospital-death-in-ireland-renews-fight-over-abortion.html?nl=todaysheadlines&emc=edit_th_20121115 and here: http://www.irishtimes.com/newspaper/frontpage/2012/1114/1224326575203.html?via=mr.
To be clear, Dr. Halappanavar was not living in a third world country without access to medical care; she was not at home; she was in the hospital being monitored and seeking help when she died. She was told that she was living in a Catholic country and could not be helped so long as the fetal heartbeat was detectable.
Not only was this death unjust and unnecessary, the patient's treatment was retrograde and barbaric. In light of candidates' recent remarks regarding access to abortion, as if pregnancy and childbirth were not medical concerns, this tragedy serves as the worst kind of cautionary tale: women die when this basic and safe medical procedure is unavailable.
Wednesday, November 14, 2012
Monday, November 12, 2012
On Tuesday evening, November 13, PBS will be airing, "The Suicide Plan," an impressive look at underground aid in dying (or assisted suicide). Despite legal prohibitions on aid in dying, patients and their advocates may resort to the practice for relief of suffering. The show illuminates factors that drive people to defy the law, the costs to dying patients and their families when aid in dying is prohibited, and the concerns that observers express about the practice.
Friday, November 9, 2012
- Sam Bagenstos, Federalism by Waiver after the Health Care Case, SSRN
- Thomas Lambert, Why the Affordable Care Act, as Construed by the U.S. Supreme Court, Will Fail, SSRN/Regulation
- Brietta Clark, Medicaid Access, Rate Setting and Payment Suits: How the Obama Administration is Undermining Its Own Health Reform Goals, SSRN/Howard LJ
- Peter Neumann and James Chambers, Medicare's Enduring Struggle to Define “Reasonable and Necessary” Care, NEJM
- Barak Richman, Concentration in Health Care Markets: Chronic Problems and Better Solutions, SSRN/American Enterprise Institute
Wednesday, November 7, 2012
Many things happened last night: the President was re-elected, "Obamacare" survived, physician-assisted suicide was defeated in Massachusetts, recreational use of marijuana (with accompanying taxes and blood concentration levels for driving) was approved in Washington and Colorado but not in Oregon, medical marijuana passed in Massachusetts but not in Arkansas (although the defeat was not overwhelming), same sex marriage prevailed at the ballot box in three states (Maine, Maryland, and Washington) with a fourth (Minnesota) defeating a constitutional amendment to ban it, and TEN women (one openly lesbian) were elected to the US Senate. In Massachusetts, Elizabeth Warren defeated Scott Brown, the Senatorial straw that almost broke the back of health reform. In my own state of Utah, red and Romney as they come, Jim Matheson (a 5-term incumbent "blue dog" Democrat running for Congress in the state's new 4th District after his district had been carved up by the state legislature) survived a challenge from an African-American Republican woman, Mia Love, who had been given an evening speaking slot at the Republican Convention and attracted lots of conservative funding as a result. And Salt Lake County again has a Democrat as mayor, this time Ben McAdams, a Mormon who is an outspoken opponent of discrimination on the basis of sexual orientation.
Although much will be written and said about what did and what did not happen in the election, demographic shifts should stand out in the analyses. The exit polling demographic picture assembled by the AP shows stunning differences by age, race and ethnicity, income, education, and even sex. Some of the pre-election polling results underestimated these differences because the polls were conducted using land-line rather than cellular phones. In some areas (Utah's 4th District may be one), the demographic shifts defied deliberate attempts to gerrymander districts to ensure safe seats. President Obama's acceptance speech welcomed these shifts, and I hope that the post-election developments will as well.
Tuesday, November 6, 2012
Several weeks ago, the New York Times reported that a California businessman loaded a fishing boat with 100 tons of iron dust and dumped it into the Pacific Ocean off of western Canada, in a rogue ecological experiment purportedly designed to stimulate the recovery of a local salmon fishery for the native Haida people. The experiment was privately funded by a native Canadian group, and sparked outrage in the scientific community because of the possible ill effects this dumping could have on the environment and the lack of government or international scientific oversight for the experiment.
Although this experiment has no direct relationship to health-care law, the problem of privately funded experiments that could have endanger as well as benefit the public health (known as "dual-use research of concern") exists in spades in the health-care world. Last winter, there was controversy about two experiments that were done on bird flu virus, which ultimately transformed the virus into one that was more easily transmissible between mammals through the air than the "wild" bird flu virus. When the two teams of scientists that performed these experiments sought to publish their studies in scientific journals, controversy ensued when the Natioanl Science Advisory Board for Biosecurity (NSABB) initially recommended that the research be redacted before publication, to ensure that a bioterrorist or unscrupulous hostile government could not duplicate the experiments and produce a potent and deadly biological weapon. The brouhaha died away after the NSABB reversed itself, and the studies were published in full, so far without incident.
But what if the research was truly a road map for a bioterrorist, and had not been publicly funded? What if somebody like the native Canadian group in the iron dust experiment decided to privately fund a "rogue" scientist to produce a dangerous pathogen, who then sought to publish the research? Would the government or the international scientific community have any ability to stop the publication? The closest we have come to this problem was in the case of United States v. The Progressive, Inc., where an amateur physicist cobbled together a "how to" manual on building a hydrogen bomb from publicly available sources. He gave the article to The Progressive magazine, whose editor decided that dealing with the government prior to publication would be better than dealing with the consequences afterwards, and notified the Department of Energy of the article prior to publication. What ensued was a courtroom drama, with the government seeking a prior restraint against the magazine, and the magazine receiving a megaton (pun intended) of publicity and a likely trip to the United States Supreme Court. However, it all became moot when another author disclosed similar data in a letter published in numerous newspapers, and the legal issue was never resolved.
My current research focuses on the problem of dual-use research of concern in the public health arena, the dangers of privatizing such research, and the inadequacy of our current legal tools to deal with such a situation. The iron dust ecological experiment may be an unfortunate harbinger of things to come in the public health arena, should we continue down the path of cutting government spending on research and farming out important scientific work to private and commercial interests.
Cross-Posted on Healthy Interests
Friday, November 2, 2012
Three days at the American Public Health Association’s annual meeting has provided me with enough information/inspiration for dozens of posts. But the most interesting thing I learned, and would like to share, is the very complicated dance now being performed by the FDA’s new Center for Tobacco Products’ efforts to regulate in the face of the Tobacco’s industry ingenious efforts at evading regulation by developing a range of new products attractive to children which are either “not cigarettes” or “not smoked” but do not necessarily pose different health risks than those already identified from smoking cigarettes. It’s highly likely that many of our students have a product like “Snus” in their mouth during class. Here’s a recent 60 Minutes Report describing the phenomena
As the CDC reported recently, “Although total cigarette consumption continued an 11-year downward trend with a 2.5 percent decline from 2010 to 2011, dramatic increases in use of non-cigarette smoked tobacco products have slowed the long decline in overall consumption of smoked tobacco products.”
The CTP is doing its best to keep children from being addicted to tobacco. But it is a new operation operating under many restrictions. As many of you may know, on June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. Before that, the FDA was prohibited from regulating tobacco at all. However, the political compromises that led to the FSPTCA being passed has made for some very odd restrictions on its ability to directly address the marketing of tobacco to children. For example, one of the things the FSPTCA did was ban flavored tobacco because of its appeal to children. But since cigars are exempt from regulation, imagine the wholesome images of new dads handing out cigars, the industry has developed “mini” cigars that not only look and feel like cigarettes but also have the kinds of appealing to kids. As the Washington Post reports:
“[t]hey come in ice cream flavors such as strawberry, watermelon, vanilla and chocolate. They are packaged in colorful wrappers. “Little cigars” are finding a niche among teens, who like the price — about a dollar — and the taste.
Young smokers say these cigarette-size little cigars and cigarillos — slimmer versions of big cigars — look better and can be bought one at a time instead of spending more than $5 for a pack of cigarettes. Many teens also think that they are less addictive.”
- Christopher J. Phillips et al, Moneyball and Medicine, N Engl J Med
- Marc Rodwin, Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform, SSRN/JLME
- Aaron S. Kesselheim et al, A Randomized Study of How Physicians Interpret Research Funding Disclosures, N Engl J Med
- Katie Keith et al, Implementing the Affordable Care Act: State Action on Early Market Reforms, SSRN/Commonwealth Fund
Thursday, November 1, 2012
In what may be the first case to apply both of the Medicaid decisions from last Term, the Seventh Circuit issued a preliminary injunction last week against Indiana's new law preventing Planned Parenthood from receiving either federal or state funding.
House Bill 1210 prohibits Indiana state agencies from contracting with or making grants to any entity that performs abortions or maintains or operates a facility in which abortions are performed and that receives state or federal funds, even if abortion services are provided with non-government funds. Hospitals and ambulatory surgery centers are not subject to the law, but all other healthcare providers are limited by this restriction, which prevents even indirect funding of entities that may perform abortions. Planned Parenthood and Medicaid enrollees made three claims to support their motion for a preliminary injunction to prevent implementation of this law: (1) the funding restriction violates Medicaid's "free choice of provider" provision, 42 U.S.C. 1396a(a)(23), which protects Medicaid enrollees' ability to choose who will provide their services; (2) the restriction is preempted by a federal law providing block grants to states for preventing STDs; and (3) the law operates as an unconstitutional condition on the funds granted by Indiana. The United States supported Planned Parenthood's position on the Medicaid claim (CMS has denied Indiana's request for a State Plan Amendment to exclude abortion providers from any Medicaid funding administered by the state; the determination is being appealed).
This set of claims allowed the 7th Circuit to evaluate the big question of remedies under the Medicaid Act, which the Supreme Court narrowly dodged in Douglas v. Independent Living Center last term. As to the question of private rights of action to enforce the 'free choice of provider' provision, the court determined that even under Gonzaga University v. Doe's restrictive analysis, Medicaid enrollees and Planned Parenthood may proceed under section 1983. Though many provisions in the Medicaid Act have been deemed outside the reach of 1983 rights of action, this particular provision contains individual rights-style language that other circuits have deemed to fit within the Gonzaga requirement for "individually focused terminology." Based on the likely success of this first claim, Judge Sykes granted the request for a preliminary injunction. Interestingly, Indiana appears to have pushed an NFIB-style coercion argument (we could lose all of our funding if we don't comply with 1396a(a)(23), so a private right of action is inappropriate); but, the court rejected that defense because the theory that spending legislation can never create private rights of action seems to be too extreme - even for the circuit that misinterpreted the nature of the states' obligations in Medicaid in Bruggeman v. Blagojevich.
Even though it permitted the 1983 claim to proceed, the court considered the remaining two claims. Evaluating open-ended federal grant for preventing STDs, the court noted that the majority in Douglas did not decide whether private parties may enforce federal spending programs through Supremacy Clause claims. But, relying on the strongly-worded dissent authored by Chief Justice Roberts, Judge Sykes concluded that no private right of action is available to enforce possible preemption of the state's use of the block grant at issue. Although the block grant does not contain the kinds of specific requirements that Medicaid does, the application and adoption of the dissent from Douglas is still notable. The court quickly dismissed the unconstitutional condition claim as being answered by Maher v. Roe and Harris v. McRae, both of which found that funding restrictions are not an undue burden on access to abortion. Though this is the correct interpretation of these cases, I maintain that the cases are wrongly decided.
I suspect we will see additional fighting in Indiana, but for now, the 7th Circuit has given us a small window into what will undoubtedly be a new line of cases attempting to limit Medicaid enforcement mechanisms. This set of considerations will only become more prominent as we approach the Medicaid expansion in 2014.