Saturday, November 23, 2013
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:
November 23, 2013 in Affordable Care Act, CMS, Constitutional, Health Care Reform, Health Law, Health Reform, HHS, Medicaid, Obama Administration, PPACA, Spending | Permalink | Comments (0) | TrackBack (0)
Friday, October 18, 2013
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.
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.
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.
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.
Tuesday, October 1, 2013
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.
Friday, September 27, 2013
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.
Tuesday, July 2, 2013
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.
Wednesday, June 26, 2013
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.
Thursday, May 30, 2013
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.