HealthLawProf Blog

KY Governor-Elect Bevin and Health Care Federalism Post-ACA

Matt Bevin will soon become Kentucky's Republican Governor, which has created consternation regarding his plans for discontinuing Kentucky's successful implementation of the Affordable Care Act (ACA).  While on the campaign trail, Governor-Elect Bevin first promised to end the Medicaid expansion; then he promised to cap new Medicaid enrollment; and then he promised to reject "Obamacare" but keep Medicaid expansion on Kentucky's terms.  Governor-Elect Bevin also promised to dismantle Kynect, widely considered a model state-run health insurance exchange.  Each of these promises leads to a complex realm of statutory provisions, governance choices, and inter-governmental dynamics.  Each also has real implications for the neediest in our health care system as well as the ongoing negotiations between the federal government and the states in a post-ACA, post-NFIB federalism world.  

First, could Governor-elect Bevin completely end the Medicaid expansion in Kentucky?  Yes, but not instantaneously.  The Medicaid Act creates a right for any person who meets its eligibility requirements to be enrolled upon approval of her application. The Medicaid Act has mandatory eligibility categories and optional eligibility categories, and the federal government must match state funding by at least 50 cents on each Medicaid dollar.  As enacted, the ACA built on this design by expanding eligibility to anyone under age 65 earning less than 133% of the federal poverty level, and the expansion was mandatory.  States would have been required to enroll the newly eligible population and could not alter the expansion without a waiver from the Department of Health and Human Services (HHS).  The ACA funded 100% of the cost for newly eligible beneficiaries until 2017, then decreases the match gradually to 90% over the next several years.

States that complied with the ACA submitted State Plan Amendments to HHS to expand eligibility; Kentucky was one of them.  But, NFIB v. Sebelius made the ACA's Medicaid expansion unenforceable by HHS, or "optional."  HHS issued guidance after NFIB explaining that states could opt-in to expansion at any time and that they could subsequently opt-out. Although HHS opined that post-expansion opt-out (my phrase) is consistent with NFIB, it has not clarified how such an opt-out would work.  Because Governor Beshear expanded Medicaid by executive order, Governor-Elect Bevin would be able to reverse expansion at the state level with another executive order.  But, Kentucky would also need to submit a State Plan Amendment to HHS for approval, which can take 2-3 months when non-controversial.  The state would also need to determine whether the newly eligible beneficiaries (approximately 400,000 people) are eligible for Medicaid through another category of eligibility, such as pregnancy or disability.  Some would qualify for tax credits to purchase insurance in the exchange, but many would not qualify for Medicaid or tax credits at that point.  Beneficiaries have a right to appeal dis-enrollment, but for most that appeal will not lead anywhere.  So, post-expansion opt-out would not occur immediately or without cost, but it is possible.

Second, could Bevin cap enrollment?  No.  States cannot limit enrollment of Medicaid beneficiaries under the Medicaid Act; they may only do so if they have a specific waiver granted by the Department of Health and Human Services (HHS).  HHS has explained that capped enrollment will not be approved because it is inconsistent with the universal coverage goals of the ACA.   

Third, could Kentucky amend Medicaid expansion like Indiana, which Bevin has admired in public remarks?  A waiver from HHS is necessary to expand Medicaid differently than the ACA required.  So far, such waivers have been granted to seven states, underlining states' empowerment after NFIB to negotiate a version of health care reform that Congress never envisioned.  In addition to that vertical cooperative federalism, states are experiencing noticeable horizontal federalism, learning from one another what concessions can be won from HHS. Republican governors of waiver states have touted that they expanded Medicaid their way, spinning the waivers as a win for red state values.  And, many of the concessions granted by HHS have reflected a more typically conservative agenda.  For example, Arkansas, Michigan, Iowa, Indiana, Pennsylvania, New Hampshire, and Montana have negotiated compromises such as placing the newly eligible population in the exchanges with federal Medicaid dollars supporting their purchase of private plans ("premium assistance"); required premiums and co-payments, especially for people earning more than 100% of the federal poverty level; wellness requirements; limiting payment for non-emergency use of ambulances and imposing co-payments for ER use; private third-party administration; and other adjustments.  Notably, HHS rejected work requirements, which reflect "able-bodied" rhetoric that is so politically prevalent.  (In a forthcoming paper with Jessica Roberts, I debunk the myth of self-reliance in health care, which underlies the work linkage proposals.)  

Some of these waiver concessions may improve insurance coverage; for example, a person who earns close to 133% of the federal poverty level is likely to "churn" between Medicaid coverage and private insurance coverage, and the premium assistance model may make that movement smoother and less likely to result in loss of coverage (time will tell).  But, some concessions have harmful effects, such as enforceable premiums that drop coverage for anyone who does not pay, as studies have shown that cost sharing is a barrier to care for low-income Americans. Further, Indiana's waiver is arguably the most complex, raising questions as to why a complicated system should replace one that is relatively simple and working well (other than ideology).  Bevin says it's economics, but a Deloitte study performed for Kentucky showed that is not true.

If one thing is clear from states' negotiations with HHS, the agency is strongly motivated by increasing enrollment and by universal coverage policy entrenchment.  This could cut both ways for Kentucky, which would be in uncharted waters as a waiver-seeking state that could be the first post-expansion opt-out.  Kentucky's Medicaid expansion covers nearly 10% of the state's population, and HHS surely would take a very hard look at any waiver application that makes the already-insured lose coverage.  HHS would also be aware that timing is tricky, and Medicaid enrollment could disappear and then reappear for the newly eligible in Kentucky, leaving needy people with gaps in coverage (and thus gaps in care).  

Finally, could Governor-Elect Bevin dismantle Kynect?  Yes, a state-based exchange can be disbanded, but not immediately.  The open enrollment for 2016 that is underway cannot be stopped, and HHS wants a year's notice before a state moves to the federally-run exchange.  Dismantling Kynect will cost tens of millions of dollars according to current estimates.  And, the state must ensure that privately insured people do not lose coverage in an exchange transition.  

Kentucky has experienced the largest drop in uninsurance in the nation due to Governor Beshear's implementation of the ACA, and modifications enacted without due care could result in hundreds of thousands of people losing health care coverage.  Change for the sake of change may be an interesting political experiment to some, but it has real world implications for the low income individuals relying on regulatory stability for their health insurance access.  

 

 

Congress, too, is mystified by long-delayed Equal Access regs

Members of the House Committee on Energy and Commerce and the Senate Committee on Finance sent a letter today to Secretary Burwell, urging HHS to issue the Equal Access regulations that have been in limbo since 2011.  This is an important and much-needed call for action in the wake of Armstrong v. Exceptional Child Center, which shut down private rights of action for Medicaid providers seeking fair reimbursement from states in federal courts.  The letter explicitly recognizes the harm that the Court's recent decision will inflict on the Medicaid program, which I've written about on this blog (most recently here) in the context of both Armstrong and Douglas v. Independent Living Center.  

Though the draft regulations were not perfect, and in fact would benefit from putting some real teeth into HHS's review of states' payment decisions on equal access to care for Medicaid beneficiaries, they would at least ensure that HHS is actively overseeing states' payment rate decisions.  Currently, states are able to change rates with very little intervention from HHS, which often involves decreasing payment rates to balance state budgets.  Now that the Court has tasked HHS with enforcing the equal access provision, rather than the providers who HHS admittedly relied on to raise flags about states' low payment rates, HHS must complete the draft regulations.  Perhaps this direct plea from members of key committees will refocus HHS's attention on these important regulations.

"Very Real Consequences" for Medicaid and Beyond

Back in January, I commented on the oral arguments in Armstrong v. Exceptional Child Center, the Medicaid reimbursement case that the Supreme Court decided yesterday.  I noted then that Justice Breyer seemed confused about Medicaid's operation; that Justice Kennedy appeared to be on the fence; and that the four dissenters from Douglas v. Independent Living Center appeared wedded their 2012 position that no private right of action is available under the Supremacy Clause.  Sure enough, the Court eliminated private enforcement of the Medicaid Act's payment adequacy provision ("30(A)") against non-compliant states.  This decision is a major victory for states, a questionable victory for the Obama Administration, and a potential defeat for access to care in the Medicaid program.

Justice Scalia authored the majority opinion (joined by Justices Thomas, Roberts, Alito, and Breyer), which began with an intentional description of Medicaid as a Spending Clause program.  Justice Scalia noted that states agree to spend federal funds "in accordance with congressionally imposed conditions."  The majority then effectively constructed a clear notice rule for the Supremacy Clause, indicating that the Supremacy Clause provides a "rule of construction" but does not "create a cause of action" unless Congress "permits the enforcement of its laws by private actors."  Although purporting to empower Congress, the majority actually limited the reach of federal legislation by requiring Congress to explicitly confer private rights of action under federal laws.  As a Brief by Former Administrators of HHS made clear (in Douglas and again in Armstrong), Congress and HHS rely on private actions to enforce the Medicaid Act, in part because the law has such a broad reach and the agency's staffing is so limited.  Contrary to the majority's bizarre characterization of private enforcement of federal laws as limiting, in the Medicaid context, private enforcement is critical for implementing the purposes of 30(A), which was written to ensure equal access to medical care for Medicaid beneficiaries.  30(A) requires on-the-ground observation for assessing states' payment adequacy, which HHS cannot do without the assistance provided by privately initiated enforcement actions.

The majority then cited Chief Justice Roberts' dissent in Douglas to support its position that Congress deliberately excluded private enforcement from the Medicaid Act.  This is simply not true. Congress did not "foreclose" or "exclude" private enforcement from the Medicaid Act, either in 1965 when Medicaid was enacted, or when 30(A) amended the Act.  In fact, Congress debated language that would have prevented providers and beneficiaries from seeking relief in federal court when states violate the Medicaid Act, but Congress never has added such language to the Medicaid Act.  Nevertheless, the majority concluded that the Secretary of HHS is solely responsible for enforcing 30(A) pursuant to her authority under 42 U.S.C. §1396c to withhold Medicaid funds from non-compliant states.  The Secretary is reluctant to withhold funds in Medicaid because such an act would harm beneficiaries, but the majority did not engage this quandary, instead deeming 30(A) judicially unmanageable, even though lower federal courts have guided states toward adequate payment decisions for years.  The majority also seems to be setting up HHS to fail; if the agency actually withheld Medicaid funding, the state might respond with a claim of coercion under NFIB v. Sebelius, thereby further undermining the program's operations.  (Justices Scalia, Thomas, Alito, and Kennedy would have struck down the Medicaid expansion in its entirety under the newly crafted doctrine of coercion in that case.)

The majority circled back to Medicaid's status as a spending program in Part IV of its opinion, which Justice Breyer did not join, and which may resurrect a theory of spending programs as being like contracts and unlike other federal laws.  Though the Court has long relied on the Pennhurst contract analogy for federal conditional spending programs, in some cases (e.g. Barnes v. Gorman), the Court has suggested that the "third party beneficiaries" of spending programs have no enforceable rights in those programs.  The majority opinion very briefly noted that "contracts between two governments" cannot be enforced by beneficiaries of those contracts - citing Justice Thomas's concurrence in PhRMA v. Walsh - as if the federal government and the states were co-equal sovereigns.  This dicta brings all Medicaid provider and patient actions into question, whether they are raised under the Supremacy Clause or section 1983, the other avenue for Medicaid private enforcement.  The majority thus opened the courthouse doors to further eroding of conditional spending statutes in the context of the Medicaid Act. [more after the jump]

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2012 All Over Again

In 2012, the Supreme Court heard two important Medicaid cases, one in January of 2012 pertaining to payment rates (Douglas v. ILC), and the other in March 2012 pertaining to the ACA's Medicaid expansion (NFIB v. Sebelius). In Douglas, the Court's majority deferred to HHS, allowing the agency to exercise primary jurisdiction over California's Medicaid payment rates and punting the question regarding Supremacy Clause actions by Medicaid providers against noncompliant states. And, in NFIB, the Court decided that Medicaid's modification under the ACA was not Medicaid enough for purposes of Spending Clause doctrine but was Medicaid enough for purposes of the remedy, which was to limit HHS's authority to terminate Medicaid funding for states that refused to expand Medicaid eligibility under the terms of the ACA.  Confused yet? So is the Court, and that's a potential problem. 

Fast forward to 2014, and the Court is once again hearing a Medicaid reimbursement rate case and an ACA case, in the same time frame as 2012, both of which could be very disruptive.  The Medicaid rate case is Armstrong v. Exceptional Child Center, and the weirdly confused oral arguments occurred today. The question the Court granted from the petition for certiorari was whether private parties can enforce the Medicaid Act's equal access provision ("30(a)") against a noncompliant state when HHS has not demanded compliance from the state through payment of adequate reimbursement rates. Armstrong may have far-reaching implications for the Medicaid program, for implied rights of action, and for federal courts' jurisdiction over Supremacy Clause actions, to name a few possible dimensions. Steve Vladeck, author of a very important amicus brief on behalf of former HHS officials, has posted about some of these issues.  Rather than re-hash his fine commentary, or Will Baude's pithy overview for SCOTUSblog this morning, I will quickly share some impressions of today's oral arguments.

First, the justices had no idea how Medicaid works, which matters quite a lot when it may be the vehicle for constitutional change. Justice Breyer, for example, did not appear to understand the difference between the state describing how it would set payment rates and the state actually setting the amount of money it would pay to reimburse health care providers for their services.  Here, Idaho created a methodology for rate setting that was approved by HHS, but then its legislature decided to use a different rate setting methodology tied to the state's budget. Breyer kept using the example of a doctor submitting a bill for $80 when all he could receive was $60, but the example was inapposite. Another minor example is that the prohibition against balance billing was news to the justices. Another example is Justice Alito's hypothetical about states that allow for medical marijuana being sued because feeral law does not permit possession of marijuana, which had no apparent relevance for the Medicaid preemption questions at hand.

James Piotrowski, on behalf of Exceptional Child Center tried to limit the conversation to whether the state actually followed the plan that CMS approved (which it appears Idaho did not). He also tried to explain why a broad-based Supremacy Clause/Spending Clause decision would be both unnecessary and dangerous, and he advocated for a limited ruling that would allow this set of plaintiffs to seek an injunction to force the state to abide by the reimbursement plan that HHS approved.  

The trouble is that the Solicitor General, as he did in 2012, promoted the view that no private rights of action should be permitted. Justices Sotomayor and Kagan quickly called out Mr. Kneedler on HHS’ deep disagreement with this position. Kneedler asserted that HHS does not want these private actions, even though HHS pointedly did not sign the SG's brief, and even though the amicus brief here and in Douglas on behalf of former HHS officials (of all political stripes) clearly explained that HHS both expects and needs private actions to occur. In both cases, the former HHS officials explained that the agency is so woefully understaffed and underfunded that it could never police all of the states' reimbursement rates on a claim by claim basis.

The four dissenters from Douglas were relatively quiet during oral arguments today. In 2012, the Chief Justice authored a dissent that would have denied private rights of action under 30(a) to force states to pay adequate payment rates for equal access to health care providers. I suspect that Roberts, Scalia, Alito, and Thomas remain in the same positions, unless they were convinced that Idaho should have just stuck to the plan and their legislature drove off the rails after CMS approved their rate setting methodology. The real question will be if Kennedy sees this action as some kind of affront to state sovereignty given his affinity for federalism resolutions. If so, then Supremacy Clause actions will be lost for 30(a) litigants, and states will run over Medicaid providers who cannot enforce the adequate payment language in the Medicaid Act. In the very moment that more and more states are negotiating Medicaid expansion under the power given to them by the Court in NFIB, this would be a dangerous precedent both theoretically and on the ground. More to come.

 

Circuit Split in One Day: Tax Credits, Halbig and King (or, The Latest ACA Headache)

This has been cross-posted for a more general audience at ACSblog. Though it contains more background than most healthlawprof readers will need, analysis comes after the jump.

The D.C. Circuit held in Halbig v. Burwell that the IRS cannot provide tax credits to individuals who purchase private health insurance in states with federally-run insurance exchanges, potentially depriving millions of middle and low income Americans access to affordable health insurance.  Improbably, while the blogosphere lit up, the Fourth Circuit held in King v. Burwell that the IRS properly interpreted the Affordable Care Act (ACA) to provide tax credits in all exchanges whether run by a state or the federal government. Members of the Obama Administration immediately declared they will seek rehearing by the D.C. Circuit en banc.  The standard of review for petitions for rehearing is rigorous, but given the importance of the case, and the new circuit split, rehearing is conceivable.  Further, it is not unreasonable to anticipate that the Supreme Court ultimately will grant a petition for certiorari in either or both of these cases. If it is upheld, Halbig could be the most damaging decision in the ACA litigation wars yet.  For those not mired in the details of the ACA and its ongoing legal challenges, here’s why.

 

The ACA attempts to create near-universal insurance coverage by making Americans insurable and by commanding insurers to play by uniform rules.  The ACA was created because, in 2008, one in five Americans did not have health insurance coverage.  To make this number tangible, imagine everyone you know with blue eyes… and now imagine they do not have health insurance.  That’s how many were uncovered, and the lack of coverage was just about that random too.  In the United States, if you don’t have health insurance, you don’t have access to consistent healthcare.  The ACA has clear goals, but it is a muddy scrum of legislative drafting that never underwent a conference committee process, and that imprecision has facilitated the litigation in these cases.

To avoid adverse selection (the problem of free riding), the ACA requires Americans to carry minimum essential coverage or face a tax penalty (upheld in NFIB v. Sebelius); however, if insurance premiums would cost more than 8% of an individual’s income, then no tax penalty will be assessed.  To facilitate health insurance coverage, the ACA created health insurance exchanges, also called marketplaces, where individuals and small groups can purchase health insurance that provides standardized benefits without exclusions for preexisting conditions and other disequalizing prohibitions.  People who earn 100-400% of the federal poverty level are eligible for federal tax credits that assist in paying premiums for private insurance on the exchanges (“premium assistance tax credits,” codified at 26 U.S.C. 36B), increasing substantially the number of people who can afford to purchase private health insurance. 

 States were given a choice to create exchanges with federal funding under ACA section 1311, and if they opted not to, then the federal government would create “such” exchange in the state under ACA section 1321.  Sixteen states and D.C. created their own exchanges before January 1, 2014, so currently two-thirds of states have federally-run exchanges.  This landscape is shifting slightly as some states’ exchanges fail and they move to federal mechanisms, while other states are still eyeballing the federal money available until 2015.  What matters here is that the majority of exchanges were federally-run on the day that Halbig was decided.

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Continued Skepticism re "Wellness Programs"

A big part of the job of being a Health Law Prof is to help students understand the intersection of the many legal specialties that comprise the big tent of "Health Law."  Wellness Programs are a good way of doing that because one of the key features of the Affordable Care Act is the flexibility it provides employers to link the cost their employees pay for health insurance with the individual employee's participation in a company sponsored "welleness program."  Here's an article I wrote explaining how PPACA went about doing that.  Here's a link to the Department of Labor's summary of the current rules and a good overview by the law firm Nixon-Peabody.  This report from Rand is an overview of what these programs are and how companies have increasingly fallen in love with them.   At this point just about every insurance company is offering to create one--here's some information from Aetna.  

The problem is, there's very little evidence that these programs do anything to demonstrably improve health (whatever that may mean).  And quite a bit that they may promote many different kinds of social injustice.

 This article in the Harvard Business Review does a great job describing the kinds of programs that are now descending on employees and how they are creating disatsifaction without any scientifically supportable improvement in "health."

There is also a growing literature suggesting that these programs may disproportionately discourage workers who employers aren't that unhappy to see go--but might not legally be able to actually fire.  Here is some very interesting testimony by Jennifer Mathis Director of Programs, Bazelon Center for Mental Health Law
On Behalf of the Consortium of Citizens with Disabilities.

Michelle Mello at Harvard has coined the term "life-style discrimination" to describe the ways Wellness Programs may target individuals employers may perceive as undesirable because they are obese, smoke or have other non-job related characteristics.

Studying Wellness Programs--and the issues they raise--can be an accessible entry point for students who can easily be intimated by the regulatory complexity of health law and can also be a bridge to understanding how fundamentally the Affordable Care Act has affected the way health care will be paid for and delivered as our students begin their careers in advising those struggling to implement these new regulations.

 

 

 

 

IRS Rule Providing Tax Credits In Federal Exchanges Upheld

On Wednesday, Judge Friedman (U.S. District Court, District of Columbia) granted summary judgment to Secretary Sebelius in Halbig v. Sebelius (2014 WL 129023).  Individual plaintiffs and small businesses, supported by the Cato Institute, Competetive Enterprise Institute, and others, challenged the availability of tax credits in federally-run Health Insurance Exchanges as exceeding the IRS's administrative authority.  The court found that the statute, Congress's intent, and the legislative history of the Affordable Care Act supported the IRS's regulations.  Thus, tax credits will be available in Exchanges whether the insurance is purchased on an exchange created by a state or an exchange created by the federal government standing in the state's shoes. The opinion engaged in careful statutory analysis and found the first part of the Chevron test answered the legal questions the plaintiffs presented (though a footnote provided a quick second step analysis anyway).  Professor Gluck called this decision a big win for the ACA given that Chevron deference was not necessary in the court's analysis, and the court's methodical statutory analysis is certainly persuasive. (Professor Bagley posted a similarly sanguine analysis here.) By all accounts, this decision is a win for the Obama Administration.

This solid decision ought to end this frivolous litigation, but the plaintiffs have already stated that they will file an appeal.  As I discussed here and here, even though these challenges have no statutory traction, the plaintiffs are financially well supported, and they have the means to continue pressing their theories up the federal court ladder.  And, the political climate inspires unhappy policy losers to pursue their desired outcome through the judicial branch when they have lost in the legislative and executive branches.  Although the decision in NFIB v. Sebelius allowed the ACA to move forward, it opened the courthouse doors to litigation such as this, which pushes legal reasoning in directions that would not have been considered serious before the successes of the NFIB litigation.  While I do not believe that Halbig et al. have a real case for preventing tax credits in federally-run exchanges, that will not necessarily prevent another federal court from finding a differently.

Dynamic Medicaid Expansion

Yesterday's reports on the annual meeting of the Republican Governors Association indicated disarray over the Medicaid expansion, and an opinion piece in the NYT highlighted the common story that only half of states are expanding their Medicaid programs.  If CMS is counting, then this tally is correct, as the federal agency can only account for those states that have submitted the proper documentation for expansion.  But this is not the only way to consider the states' decisionmaking regarding the expansion.  I have just posted a short essay preliminarily detailing research I have performed over the last several months, which reveals that many states currently counted as "not participating" are acting to expand their Medicaid programs.  Here is the abstract:

In the run up to the ACA’s effective date of January 1, 2014, the sleeper issue has been the Medicaid expansion, even though Medicaid stands to cover nearly a quarter of the United States citizenry. While the national press has portrayed a bleak picture that only half of the states will participate, the Medicaid expansion is progressing apace. Though this thesis may sound wildly optimistic, it is more than predictive; it is empirically based. I have gathered data on the implementation of the Medicaid expansion during the crucial months leading up to the operation of the insurance provisions of the ACA, and it is clear that most states are moving toward expansion, even if they are currently classified by the media as “not participating” or “leaning toward not participating.” The data thus far reveals counterintuitive trends, for example that many Republican governors are leading their states toward implementation, even in the face of reticent legislatures and a national party’s hostility toward the law. Further, the data demonstrates dynamic negotiations occurring within states and between the federal and state governments, which indicates that the vision of state sovereignty projected by the Court in NFIB v. Sebelius was incorrect and unnecessary.

 

Resources for Learning About (and Tracking) Violations of Research Law and Ethics

Even health law professors who do not teach a class in research law may be asked to participate in their university's programs for training researchers.  Now that the government is back in business, this seemed like a good time to feature some resources to help bring you up to speed.  The information below focuses on some of the main Federal Government sources of not just information but very high quality educational material.  All of this information is accurate as of today--but any web resource can suffer from link rot, and a direct Google search should lead you to all of these sources and more.

The most general place to start is actually not in the Federal Government, but rather CITI on-line training resources.  Although today their website says that these materials are no longer available to the public for free, it is likely that anyone associated with an institution that conducts federally funded research is a subscriber.   The unavailability of CITI to the public is unfortunate, but the amount of training provided for free by the federal government is beyond the scope of any individual human's ability to absorb information--everything from this point on is free!

 The Federal Government's regulation of research misconduct, research integrity and protection of human and animal subjects of research (yes, all of these things are different) is scattered not just among the various entities sponsoring research, but also within agencies.  While all have adopted "The Common Rule" when it comes to humans, in fact there can be significant differences in policies and regulations (especially in situations not involving humans).  Here are some places to start looking. 

   The location of this information depends both on the kind of research and the source of funding.   For research funded by the department of health and human services (biomedical research primarily) the relevant agency is the Office for Research Integrity (ORI) which " oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration" and this is the website that tracks cases they are and have investigated.

Here's a movie they produced on avoiding research misconduct.  It's available with  Spanish and  Chinese subtitles

If the research safety violations involves people, you need to go to the entity within HHS currently known as the Office for Human Research Protections (OHRP)(remembering the "s" at the end of "Protections" shows you to be an insider).  This is a vast repository of both reference material and current reports of active cases--you might want to look at this overview first.

If you are getting funding directly from the National Institutes of Health, you will want to check in with Human Subject Research Protections (HSRP) program (note the "s") and their rules and guidance.  More information to be found here.

NIH also sponsors its own Human Subject Research Protection Online Training.  Also available in Spanish.

Research under the supervision, although not necessarily funding, of the FDA is monitored its Bioresearch Monitoring (BIMO) program is a comprehensive program of
on-site inspections and data audits designed to monitor all aspects of the
conduct and reporting of FDA regulated research.   This is not to be confused with the FDA's Office of Criminal Investigations which has a broader scope and covers not just research but all FDA monitored activities.

Actually,  "all" is an understatment because Recalls, Market Withdrawals and Safety Alerts are tracked elsewhere and there may be some spillover. Ditto MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  If the violations directly concern human safety you should check here and in general at the Center for Drug Evaluation and Research

 

The National Science Foundation (NSF) is another major source of information.  The research it sponsors differs from that sponsored by NIH because it extends far beyond biomedical activities.  Indeed, NSF is the place to look for information about social science or behavioral research.

Here's where to look for  human subjects.  For more general wrongdoing, consult the NSF Office of the Inspector General.

The National Academy of Engineering has devoted considerable resources to issues of research ethics, misconduct and integrity which are available in its online Ethics Center.  Texas Tech University also provides extensive resources in Engineering Ethics through the Murdough Center.

The Institute of Medicine is often asked by Congress to investigate issues in Biomedical and Health Research.

The Department of Energy is a major player in the field of research ethics/human subject protection (it does considerable nuclear and genetics research) and has many resources.

It's very hard to distinguish between "bioethical" issues and "legal" issues when it comes to research, so another very important source of information is the Presidenial Commission for the Study of Bioethics.  which recently put out a remarkable report on Human Subject Research Violations which took place during the 1940's in Guatemala. (spoiler, the U.S. Public Health Service was giving people syphillis).

In future posts, I will dig deeper and provide more governmental and private sector resources.

Happy Exchange Day!

Despite best efforts to prevent the exchanges, or marketplaces, from going on line, today the exchanges have begun to do the work of facilitating a health insurance home for people in the United States.  If you live in a state that has declined to create its own exchange, then you should visit https://www.healthcare.gov/, the federal website for the federal health insurance marketplace.  Though there were reports of the site crashing, as of 3:00 this afternoon it seems to be working.  And, the site will guide you to your state's marketplace site, as necessary.  No need to rush though, as open enrollment lasts through March of 2014.

Many probably saw Governor Beshear's op-ed in the New York Times last week regarding the reasons that Kentucky has created its own state-based exchange (and will accept federal funding for the Medicaid expansion), here.  The commentary seems even more relevant in the wake of the House Republicans shutting down the federal government over health insurance.

More states are expanding Medicaid than you might think

Big news in the world of ACA implementation: CMS approved Arkansas' proposed waiver for an alternative mechanism for Medicaid expansion, which is to be called the Arkansas Health Care Independence Program.  Arkansas proposed a premium assistance program, wherein newly eligible Medicaid beneficiaries will obtain insurance through the Arkansas health insurance exchange by receiving financial assistance for premium costs.  This will place the new Medicaid population in qualified health insurance plans, i.e. private health insurance, which is administratively more expensive than government-sponsored insurance, but it may help to deal with the problem of "churn" between Medicaid and Marketplace-based private insurance.

CMS's approval of Arkansas' Medicaid demonstration program is significant for a number of reasons, but here I'd like to focus on what I think is one of the biggest: this waiver approval will pave the way for other states that are "undecided" to finally declare their intent to expand their Medicaid programs.  I believe this will happen relatively quickly, because most states are already working on expansion.  You would not think this is true from the national media's reporting on the Medicaid expansion.  If you have been following any of the many color-coded maps depicting the five possible categories of expansion (expanding, not expanding, leaning toward expanding, leaning toward not expanding, and alternative model), you would think that just over half of the states are participating in the Medicaid expansion.  The national media has gotten this story wrong, because they do not pick up on the negotiations, investigations, committees, special commissions, and other ways in which the "leanging toward not participating" states are actually exploring how they can expand their Medicaid programs.  To understand how dynamic the state decision making is, you have to track the local newspapers that follow every move of the state legislatures and their conversations with their governors (which I have been doing all summer).

After NFIB v. Sebelius was decided, I wrote that most states would still expand their Medicaid programs.  It appears that most states are now working toward Medicaid expansion in some form.  In future posts, I will explain this dynamic federalism story in more detail.  For today, I will emphasize that CMS has opened the door to more state waivers, which will lead to more states expanding their Medicaid programs.  Though I am not necessarily on board with federalism by waiver, espcially given states' history of waiver mistakes and failures, I do think that in this instance, alternative expansion is better than no expansion.  Otherwise, many of our poorest citizens will be left out of the attempt at national insurance coverage, not paying a penalty, but not having access to much-needed healthcare either.    

Informed Consent in the NICU? Bioethicists Disagree

Teaching the regulation of human subject research gives me the ability to demonstrate, just about every class period, how blurry the line can be between what is legal and what is ethical.  What individuals must do as a matter of law and what they cannot do as a matter of law are very different from what they should do.  I tell my students that outside the assessment of legal risk, "should" is a business decision, a science decision, an ethics decision, a public relations decision or some combination of all four--and it's one other people (clients) are going to make for themselves. 

A tip of the hat Fran Miller who clued me in to some very recent events  that provide a perfect example of the relationship between law, ethics and science in human subject research.   Many will have read the New York Times article about a letter  sent by the Office of Research Protection (OHRP) to the lead researcher University of Alabama at Birmingham (UAB) criticizing a study they had run in 23 major medical centers involving infants requiring oxygen support in the neonatal intensive care unit (NICU).     Called the SUPPORT Study (and please follow the links--the complexities here are beyond a blog post), it was intended to find out the safe, but effective, limits for providing a premature infant supplemental oxygen.  Too little oxygen, of course, affects breathing but too much oxygen, we have known for a long time, causes blindness. The babies were randomized to receive different levels of oxygen and the results measured.

Whether or not the study should have ever been approved is a matter of debate-the fact that many of the babies involved had worse results than they would have under standard of care and even the fact that one of the babies involved does not, in and of itself, mean that the study was illegal or unethical. Here's the explanation by the researchers themselves. This is the Government version.  

 The issue under dispute is not the study itself--it's the consent process.  Soon after the letter became public and OHRP began the process of assessing wehther there should be sanctions, what in theory is OHRP's sister institution, the NIH which provided funding for the study, criticized the warning and supported the SUPPORT study (these puns are invevitable).   And soon afterwards OHRP backed down--agreeing to hold a public hearing.

What's so interesting about this dispute for lawyers is cogently explained by Lois Shepherd, the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical  Ethics, Professor of Public Health Sciences, and Professor of Law at the  University of Virginia in her analysis posted at the Hasting's Center Bioethics Forum Blog.    She points out that the ethicists and scientists supporting UAB don't necessarily disgree that the parents lacked complete information about the risks.    That the law, in other words, wasn't complied with.   But, they argue, the importance of the study outweighed a flawed consent process--and moreover, in a letter published by the New England Journal of Medicine they challenge OHRP's ability to, in essence, substitue it's judgment of whether disclosure was sufficient for that of the IRB giving initial approval. 

 

 That's a big deal.   45 CFR 46.116 specifies that consent for human subject research funded by the federal government must include (among other things--read the whole thing yourself) that "a description of any reasonably foreseeable risks or discomforts to the subject”; and “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”  According to OHRP and those who support it, UAB's experiment did not meet that standard because, among other things, it did not disclose to the parents that there was a risk of death.  

But who decides whether or not the information was sufficient?

As a lawyer, I would say that the fact that Congress, in its infinite wisdom, set up a system in which OHRP has the power to review the decisions of individual IRB's answers this question immediately.  Of course OHRP can substitute its judgment for that of the individual IRBS approving this study-that's what it's there for.  

 But in the real world, things are not so clear and it's always possible for Congress to change the balance of power.  In my view that would be a huge mistake--it's hard to imagine what else has to happen in order to prove the point that when it comes to protecting human research subjects science cannot reglate itself.  There must be outside oversight that reflects the view of the electorate at large--the general population of human subjects--rather that of those whose primary goal is to advance science.

Is it possible to have a system where the needs of the many outweigh those of the few?  Where in the face of great benefit to all future premature infants it is acceptable to give some premature infants less than the standard of care?  Sure--it's possible.  But it's not how, so far, the United States has chosen to regulate human subject research.

 

JSB

 

US v. Windsor: Some Constitutional Uncertainty, Many Healthcare Implications

The Court's decision striking down section 3 of DOMA in United States v. Windsor was unsurprising, yet still a relief to many.  Section 3 defined marriage for federal statutory purposes to mean only marriage between one man and one woman.  Based on the late March oral arguments in Windsor, as well as Justice Kennedy's majority opinions in Lawrence v. Texas and Romer v. Evans, the common wisdom was that federalism would be the prevailing reasoning because the states historically have governed family law matters, including marital status.  One of Justice Kennedy's projects has been revitalization of the Court's enforcement of federalism to protect the states, especially as a method to protect individual liberties (see, e.g., Bond v. United States). 

And so it was.  Justice Kennedy provided both structural and substantive reasons for striking down section 3 of DOMA.  From a structural perspective, Justice Kennedy's majority emphasized traditional state dominion over marriage, writing: "By history and tradition, the definition and regulation of marriage ... has been treated as being within the realm of the separate States."  Though the opinion walked right up to the federalism line, it stopped short of holding that DOMA exceeded congressional authority or violated the Tenth Amendment.  Instead, the majority moved forward on substance and held that the federal government cannot take away the marriage right and its attendant societal status once conferred by the states.  To do so was a violation of gay couples' liberty and dignity.  The Court also hinted at an equal protection analysis, condemning Section 3 as creating second class marriages in states that recognize same-sex unions.  The majority applied only rational basis review, rather than heightened scrutiny, holding that DOMA was motivated by anti-gay animus and served no legitimate governmental purpose. 

Neither the federalism, nor the equal protection, nor the due process analysis was either complete or clear cut, and each opens more questions than it closes.  For example, Justice Kennedy views the experiment of the states to protect individual liberty, and here, it happens that twelve states do protect liberty, more than the federal government.  But, this view of federalism's aspirational work does not address the 37 or so states that do not protect the liberty interests of their gay citizens from state discrimination let alone the federal government's limited view of gay rights.  And, this reversion to assessing traditional state law domains does not advance modern conceptions of federalism that acknowledge most state law is ineffibly intertwined with federal law by virtue of statutory interconnectedness, conditional spending, or other cooperative federalism mechanisms.  Instead, Justice Kennedy seemed to be reaching back to the dual sovereign model of doctrinal federalism.

Fortunately, this regressive model of federalism does not seem to hinder the work that Windsor is likely to do with regard to DOMA's far-reaching effects on healthcare.  For example, marital status influences not only access to affordable private health insurance (which is usually easier and cheaper through marriage), but also qualification for the Federal Employees Health Benefits Program as well as Social Security, the gateway for Medicare at age 65.  Section 3 also affected Medicaid enrollment and spend-down requirements for the elderly entering nursing homes.  The Medicaid/DOMA issue was presented to the Court in a petition for certiorari that the Court has not granted or denied yet.  Back in October, I highlighted the First Circuit's decision in Massachusetts v. Department of Health and Human Services, which was mentioned in passing by Justice Kennedy as a case that would suffer vacatur if the Court dismissed for lack of standing.  It seems fair to read approval of the First Circuit's decision into Kennedy's cite, which makes me think the Court will not grant the petition.

In addition to public and private health insurance issues, some healthcare delivery issues are likely to be resolved by Windsor as well.  For example, many stories have detailed how hospitals have turned away same-sex partners under the guise of HIPAA privacy.  Other tales have highlighted how substituted decision-making at the end of life can devolve to estranged family members when same-sex partnerships are not recognized as giving the gay spouse decisional authority that would ordinarily be given without a second thought to a heterosexual spouse.  Doctors' offices have refused to recognize same-sex spouses as parents of children who need medical attention.  And, care for infants of same-sex couples may become easier now that the Family Medical Leave Act will apply to same-sex marriages.  It seems that the federal recognition of gay marriage that will flow from Windsor will be beneficial in many healthcare situtations, even in states that do not recognize same-sex marriage.  Federal agencies have much work to do interpreting the word marriage in the coming days, but it seems that these decisions will facilitate a more functional approach to families' experiences in the healthcare system.

[NH]

Are Health Care Providers Deliberately Misunderstanding HIPAA--And if So What You Can Do About it?

Ever since HIPAA was implemented in 2002, it has been used by health care providers to make life more difficult for patients by preventing their family members from being with them in care areas and by refusing to share information with those the patient wants to be kept informed.   This has caught the interest of the U.S. House Energy and Commerce Sub-Committee  has been holding hearings into various consumer issues regarding HIPAA.  I think this review is long overdue--and that  HHS is well aware of how providers are misusing HIPAA. The problems are so prevalent that the HHS website actually has a myth-buster section. 

So what can a family do?  A good step is to be skeptical when told that something is being done "because of the law."  As I have explained again and again to health care providers and lawyers, “If you think something that a) the patient or his family wants or b) is in the best interests of his care is prohibited by HIPAA, you don’t understand HIPAA.”  Ask for clarification from the hospital's lawyer--will you get that person on first call?  Maybe not, but be persistent.

 Inform yourself on the HHS website.  There is also a very useful FAQ section that addresses questions like, “is it illegal for a family member to pick up a prescription for a patient” (no) and  It starts with an over-all statement of principle: “The Privacy Rule provides federal protections for personal health information held by covered entities, and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.”

Moreover, there is no provision in HIPAA that requires or allows a health provider to step in as “guardian of privacy” for a patient who is not conscious or competent.  When there is an identifiable surrogate decision maker, that person can make any decision about disclosure that the patient could have made himself.   And, no, there need not be any written document expressly allowing sharing of information with the surrogate.  Moreover, if a person has legal authority to make medical decisions, then he is entitled to review the medical records so that the decision can be an informed one.

At this point, more than ten years later, it’s reasonable to wonder if some of these “misunderstandings” are fostered by the fact that they make things easier for the providers in that it limits time consuming questions—like, “why isn’t my mother receiving pain medication?”  or “what are our options for Mom’s care?”  Certainly the posts in this nursing blog suggests that’s the case.  Here’s my favorite from Ortho-RN, “We usually don't allow family in the recovery room... I don't feel it's a place where family belongs.. No privacy, totally in HIPPA violations. Families like to be nosey and watch other things, and things do not always go smoothley...” (sic) Here’s another insight into how  providers see their obligations

 A brief foray into common sense should demonstrate the absurdity of these restrictive interpretations.  The  premise should be that outside a few narrow health & safety exceptions,  no one other than the patient is in a better position to decide who can and cannot have information about the medical care being provided.  And keeping family members away because of the risk they will see "other patients" is an absurdity.  None of us have the right to receive health care in complete seclusion.  Maybe high profile patients can pay for private wings—but all of us are stuck with the reality that in going to receive health care we may well be seen by other people, including those who know us. Finally, health care providers themselves are not entitled to protection from the observations and questions of family and friends about the care of their loved ones.  Could there be times during an emergency when the team can't stop and talk.  Sure.  But if these would be reasonable requests for information from the patient, then they are reasonable from the people the patient trusts most to protect his interests.