Saturday, June 1, 2013
Guest Bloggers Mary Ann Chirba and Alice A. Noble - Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell  came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.
Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells. ASCs are found throughout the body. Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells. It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.
A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices. Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells? In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.
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.
On May 29th, HHS issued the final rule governing wellness incentives in group health plans. While the incentives themselves are not a surprise, the scope they are given is worthy of ongoing attention. Wellness incentives have been controversial because of their potential for intrusion into individual choice, their subtle (or not so subtle) coerciveness, their valorization of a particularly model of health, and the possibility that they will impose differential burdens and costs on people with disabilities or other disfavored groups. The final rule attempts to meet these objections in several helpful ways.
Nonetheless, the final rule still will allow programs that are differentially burdensome as a result of factors other than health status. It will also allow programs under which it is more difficult for some than for others to obtain rewards because of their states of health. In programs that give rewards for health outcomes, alternatives must be available for those who do not meet targets—but the reasonableness standard for these alternatives permits requirements that may be differentially burdensome so if they are medically appropriate and follow the recommendations of the patient’s personal physician. HHS supports wellness programs as engaging individuals in their health, as encouraging them in healthy behaviors and discouraging them in unhealthy behaviors, and as incentivizing people to make use of recommended health care services such as screenings.
The rule includes two types of wellness programs. “Participatory” programs are those which make participation available to all similarly situated individuals. Such programs may differentiate among bona fide employment-based classifications or the participant’s relationship to the plan beneficiary, but otherwise must be available to all similarly situated participants regardless of health status. If so, participatory plans do not need to meet any further non-discrimination requirements. An example is a plan that gives participants a premium discount for attending a health education class. Although such participatory programs are facially non-discriminatory, they may impose very different burdens on people depending on their life circumstances. Attending a class at the end of the working day may be a comparably simple matter for a single man without dependents and with a reliable form of transportation. It may be a quite different matter for a single mother of children who is dependent on day care and public transportation. The rule is specific that such factors should not be taken into account in determining whether a program is available to all similarly situated participants regardless of health status and thus non-discriminatory.
“Health contingent” programs make a reward such as a premium discount available to participants based on their meeting a specified health-related goal. The goal might be activity-only (e.g. participating in a walking program) or outcome-based (e.g. achieving a targeted cholesterol level). These programs must meet five non-discrimination requirements. These are: (1) each participant must be given an opportunity to qualify for the reward at least once a year; (2) the reward must not exceed 30% of the total cost of employee coverage under the plan (or 50% if the program is designed to address tobacco use); (3) the reward must be available to all similarly situated individuals, with reasonable alternatives for those who cannot meet the standard for medical reasons; (4) the program must be designed to promote health or prevent disease and not be a subterfuge for discrimination; and (5) the plan must disclose in all descriptive materials the possibility of alternative methods for qualifying for the reward or of a waiver of the applicable standard. The rule is structured to give plans an affirmative defense to a claim of discrimination for meeting these five requirements.
The rule is designed to clarify the relationship between the five non-discrimination requirements and health contingent wellness programs. Most importantly from the perspective of non-discrimination, the rule requires alternatives for a larger group for health contingent wellness programs than for activity only programs. For the latter, alternatives must be available for anyone for whom “it is either unreasonably difficult due to a medical condition to meet the otherwise applicable standard, or for whom it is medically inadvisable to attempt to satisfy the otherwise applicable standard.“ For a walking program, this would include anyone whose medical condition made it unreasonably difficult or medically inadvisable to participate. It would not include people who lacked the time to walk, lacked the energy to walk for non-medical reasons such as tending to a sick child, who did not enjoy going out in the cold in winter, or who simply preferred a sedentary life. For health contingent programs, a reasonable alternative must be provided for anyone who does not meet the initial standard—for example, for someone whose cholesterol level is determined to be too high. This is a welcome development in the final rule, as it is aimed to prevent wellness programs from simply being underwriting based on health status in a different guise.
Plans are given flexibility in determining what counts as a reasonable alternative but list a number of relevant factors to be taken into account. If the alternative is an educational program, the plan must make it available or assist the participant in finding it—and the plan may not require the participant to pay the program costs. Time commitments must be reasonable. For diet programs, plans are required to pay membership fees but not the cost of food. Another helpful clarification in the final rule is that plans must accommodate the recommendations of the individual’s personal physician regarding medical appropriateness.
Nonetheless, the burdens imposed by these plans may be substantial. The permissible size of the award is calculated based on the total cost of the health plan—that is, both the employer and the employee’s premium contribution. The reward may not exceed 30% (50% in the case of a program addressing smoking). This is potentially a very significant cost. For example, if a total premium is $900/month and the employee’s share is $200/month—a not unusual amount—the “reward” could be $270/month—leaving an employee who fails the wellness program effectively paying more than double the premium costs than an employee who meets the program’s standard.
The full text of the rule is here.
Wednesday, May 29, 2013
The Supreme Court will not be hearing Indiana's argument that it can deny governmental funding to healthcare providers who perform abortions. The Seventh Circruit had held that Indiana's prohibition on government funding was an impermissible limitation on Medicaid's free choice of provider provision, a violation of the statutory rights promised to Medicaid enrollees. Media coverage by such news outlets as NPR and BNA has indicated that the abortion funding prohibition was the sole issue at stake in this petition, noting that this petition was a test case for the ten or so states that have passed legislation aimed at defunding Planned Parenthood. While this point is important and true, the petition submitted by Indiana told a much bigger story.
Indiana used the Seventh Circuit's decision as a vehicle for asking the Court to completely eliminate Section 1983 rights of action for Medicaid enrollees. Indiana had petitioned the Court with a similar question in Indiana Family and Social Services v. Bontrager, the petition for which was denied a few weeks ago. Indiana asked the Court to take the cases as companion cases, which is evident from the petition filed in Secretary of Indiana Family and Social Services Administration v. Planned Parenthood of Indiana, but not in the media coverage. Even though the petition in Bontrager was denied, Court watchers still considered Indiana's petition and Planned Parenthood's cross petition possible grants.
I suspect that the denial was due to agreement with the substance of the Seventh Circuit's decision that this kind of restriction on Medicaid funding is inappropriate (or a desire to stay out of the abortion fray for now, given that Arizona, Hobby Lobby, and others may be filing petitions soon). However, I also suspect that at least four of the justices are willing to revisit the garbled jurisprudence surrounding section 1983 actions thanks to Gonzaga. Michigan filed amicus briefs supporting Indiana's petitions, which were signed by about eleven states, that focused on the federalism and separation of powers implications of section 1983 actions against states that fail to comply with the Medicaid Act. Unsurprisingly, the states' briefs rejected not only section 1983 rights of action, but also Supremacy Clause actions, which were at issue in last term's Douglas v. Independent Living Center. The states cited the dissent authored by Chief Justice Roberts rejecting Supremacy Clause actions by Medicaid enrollees and providers as evidence that all of the private actions against states should end.
So, keep your eyes and ears open - as I mentioned a few weeks ago, the Court is hearing an ADEA case in the October 2013 term that may become a referendum on 1983. Or, the Court may be waiting for just the right Medicaid remedy case. Either way, it seems reasonable to expect that the Court will take up the Medicaid enforceability through 1983 question again in the not-too-distant future.
Monday, May 27, 2013
According to an article in the NYT, an artist has collected DNA samples from litter on sidewalks, such as chewing gum and cigarette butts, and used those samples to extract and sequence DNA that she then used to make computer models of their owners' faces. She then printed 3-D masks that she is showing at her upcoming exhibit called Stranger Visions. The artist hopes her exhibit will spark a dialogue over genetic surveillance.
The NYT article explains that
[w]hile staring at the wall of her therapist’s office, the artist Heather Dewey-Hagborg noticed a strand of hair stuck in a hanging print. Walking home, she noticed that the subways and sidewalks were littered with genetic material on things like chewing gum and cigarette butts, some still moist with saliva. Curious about what she could learn, Ms. Dewey-Hagborg began to extract and sequence DNA from these discarded materials. Then — and here it gets a little eerie — she began to make computer models of their owners’ faces, using genetic clues to print 3-D masks that she concedes “might look more like a possible cousin than a spitting image.” Hanging these portraits along with the original samples, she says, is “a provocation designed to spur a cultural dialogue about genetic surveillance.” After the June exhibitions, Ms. Dewey-Hagborg will show her work early next year at the New York Public Library. She has also collaborated on a tongue-in-cheek project called DNA spoofing, which purports to offer ordinary people some techniques to avoid detection by scrambling their genetic material.
Talk and exhibition at Genspace in Brooklyn on June 13. Exhibition at QF Gallery in East Hampton, N.Y., opens June 29.