November 30, 2012
Worth Reading This Week
- 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
November 29, 2012
More testing of Douglas
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.
November 28, 2012
More on ACA Implementation
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.
Comparative Health DataA treasure trove of data on different health care systems and their comparative performance collected, here, by the Commonwealth Fund. [NPT]
November 27, 2012
ACA Litigation - The Gift that Keeps On Giving
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
November 26, 2012
Odd Surrogacy Decision
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.