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.
Saturday, May 25, 2013
It's no secret that the night staff of a hospital are both over-worked and over-tired. Nor is it any secret that many medical errors occur at night. But until we look at the totality of the human factors making up medical error, we are unlikely to make significant headway in addressing it. A review of the literature suggests that the reason isn't a lack of understanding about the factors which cause human errors, it's concern about the cost of addressing them.
The authors of a recent study in the Journal of the American Medical Association titled, Relationship Between Occurrence of Surgical Complications and Hospital Finances conclude that not only aren’t hospitals doing all they can to reduce medical errors, they actually have no financial incentives to do so.
I'd suggest that financial incentives are behind ineffective efforts to address the issues of staff over-work and the inherent dangers of intermittent shift work.
It's no surprise that another widely reported recent study has found that reductions in the hours medical residents work has not resulted in increased patient safety. The study authors conclude that this is because although residents worked less hours, they did not have a reduced work load. So, like Lucille Ball in the chocolate factory, the trying to cram more work in the same amount of time increased resident error.
The findings of that study need to be seen in combination with the vast amount of scientific research on the increase in errors caused during night shifts. A recent study of nurses working night shifts showed that “on average, the error rate increase 6% after the second night shift in a row, 17% after the third successive night shift and an astounding 35% higher on the fourth night shift.” See also this and this article by the Joint Commission. Although no one disputes the reality that human beings perform best in the day time, every hospital must be fully staffed 24 hours a day. The information is both anecdotal and research based. But no one seems to be listening.
An article in Nursing World does an excellent job of using available research to describe the scope of the problem, but implies that it can be effectively addressed by nurses proactively paying more attention to their sleep patterns. It advises nurses working the night shift to “take control of sleep.” In fact the NSF “recommends that nurses wear wrap around sunglasses when driving home so the body is less aware that it is daylight.” This advice ignores the scientific reality that humans are not as effective or alert at night as they are in the day time. Nor does it consider the human reality that medical shift workers do not have the luxury of using their days to sleep. Like everyone else living in a diurnal world, they must cope with the tasks of family and daily living.
Techniques like wearing dark glasses may work in making a shift to a new rhythm--like travelling to another time zone. But given the unlikeliness of medical staff to convert to a permanent change in their circadian rhthyms, as if they were working in a submarine (and that doesn’t work very well either) the answer is to address the reality that humans are less effective at recognizing problems and completing complex tasks at night. But that’s not where the problem solving is going.
May 25, 2013 in Cost, Effectiveness, Health Care, Health Care Costs, Health Care Reform, Health Economics, Health Law, Hospital Finances, Hospitals, Insurance, Medical Malpractice, Nurses, Patient Safety, Payment, Physicians, Policy, Public Health, Quality, Quality Improvement, Reform, Research, Science and Health, Substance Abuse | Permalink | Comments (0) | TrackBack (0)
Friday, May 24, 2013
Guest Bloggers Mary Ann Chirba and Alice A. Noble - A Decade's Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers
On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died and 741 more became ill after contracting fungal meningitis from contaminated steroid injections made by the New England Compounding Center (NECC). Committee member Sen. Pat Roberts (R-KS) stated that given prior reports of problems with NECC, this tragedy could have been averted but for a “shocking failure to act” by NECC, state and federal regulators, and Congress.
As NECC’s role in the meningitis outbreak came to light,gaps in regulatory oversight did, too. The federal Food Drug and Cosmetic Act (FDCA) currently recognizes only two categories of pharmaceutical manufacturers: commercial pharmaceutical companies and compounding pharmacies. To qualify as the latter under federal law, the entity must make individual or small batch, patient-specific drugs and do so only with a physician’s prescription for that patient. Compounded drugs must be either be unavailable in the commercial market or needed in commercially unavailable doses or combinations. The FDCA exempts such compounders from its pre-marketing requirements applicable to commercially manufactured drugs. Thus, federal law clearly covers commercial pharmaceutical manufacturers, state law just as clearly oversees and licenses pharmacies but as the NECC case demonstrates, there is nothing clear about the responsibility for inspecting, licensing or otherwise overseeing compounders that do not fill prescriptions on a per patient basis.
Instead of compounding in response to an individual prescription, the New England Compounding Center made large batches of drugs for institutional buyers such as hospitals. Many of its drugs were commercially unavailable but some were knock-offs of marketed FDA-approved drugs – a practice which is clearly unauthorized. NECC’s business model was certainly not unique; neither was the limited and erratic response of state and federal regulators to complaints about the facility’s unsafe manufacturing practices. Congress knew that large-scale compounders existed along with concerns about their safety. Several members of the Senate HELP Committee had worked on curative legislation for over ten years, but made few inroads until the NECC crisis prompted the HELP Committee to shift from park into drive.
In its current form, S. 959’s Pharmaceutical Compounding Quality and Accountability Act pursues two overriding objectives: clarifying lines of regulatory authority and accountability, and ensuring that a compounded drug is what it says. As they have been, traditional compounders would continue to be regulated by state law and commercial manufacturers would remain subject to federal law. To these two categories of drug manufacturers, however, S.959 would amend the FDCA to add a third type of drug manufacturer to fit the NECC-type mode. “Compounding manufacturers” that compound sterile drugs before receiving a prescription, and ship in interstate commerce (excluding shipments within a hospital system) would now be regulated exclusively by federal law. The bill permits States to impose heavier requirements, but preempts state laws that do less.
Friday, May 17, 2013
Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too. However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population. For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective. But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery. The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.
The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”
We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices. The salt reduction report was commissioned by the Institute of Medicine In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs. Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.
Part of the issue is funding. Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort. But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.
This isn’t a new observation. Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure. But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.
Of course there will always be the problem of knowing the unknowable. But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.
May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)
Thursday, May 16, 2013
Guest Bloggers Professors Alice A. Noble and Mary Ann Chirba - The ACA’s Tobacco Use Rating: Implementation, Inconsistencies and Ironies
As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.
Time will tell if this uniquely American system will achieve the goals of reform, i.e., expanding access to care while improving its quality and controlling costs. Unexpected and unintended consequences, some fortunate and others not, will certainly flow from such a system. This post will consider the insurance market reforms, specifically, PHSA § 2701, “Fair Health Insurance Premiums,” added by ACA § 1201 and some unexpected and seemingly unintended consequences related to the tobacco use rating provision.
Section 2701, which takes effect beginning in 2014, prohibits discriminatory premium rates by limiting the variables that insurers in the small group and individual market may use in setting premium rates. Prior to the ACA, insurers had greater latitude in setting premiums based on personal factors such as gender or health status. This often resulted in unaffordable insurance premiums for those most in need of health coverage: individuals with serious or chronic health conditions or small groups that included uch individuals. The ACA prohibits this type of underwriting in the small group and individual markets by permitting insurers to consider only four factors when setting premiums in these markets: 1) whether the coverage is for self-only or family enrollment; 2) the geographic area; 3) the age of the insured premiums may vary by a ratio of no more than 3:1 for adults); and 4) tobacco use (premiums may vary by a ratio of no more than 1.5:1).
Individuals who use tobacco may be required to pay up to 50% more for their health insurance premiums. For the sake of this provision, tobacco use is defined as using tobacco products on average of four or more times per week within no longer than the past six months, excluding religious or ceremonial uses of tobacco. Permitting a tobacco-use premium is consistent with the ACA’s larger focus on individual responsibility: because tobacco use is voluntary and offers no health benefit, tobacco users should bear a significant portion of the higher health care costs associated with that activity. It is conceivable that over time, other voluntary activities, such as weight control, may be added to the list of permissible factors used to set premiums.
Like so many other aspects of the ACA, implementing the tobacco-use premium provision is anything but straightforward especially in light of highly fragmented health insurance markets. In addition to the type of plan or policy, grandfather status under the ACA, an insurer’s ability to employ tobacco-use rating also depends on state law and the application of federal wellness programs regulations.
Several of the thornier aspects of this crazy quilt are especially deserving of attention, as follows:
1. Type of Insurance Coverage
The ACA’s tobacco use rating provision does not apply to the following kinds of insurance plans:
- Self-insured employer-sponsored plans, whether large or small
- Grandfathered plans in all markets
- Insured plans in the large group market through 2016
- Insured plans in the large group market after 2016, but only if the state does not permit insurers to offer large group policies on the state’s health insurance exchange
These exceptions mean that, starting in 2014, and at least until 2017, the tobacco use premium applies only to individual and small group plans that are both insured and non-grandfathered, whether offered in or off state exchanges. As noted below, in 2017, upon the election of the state, large insurance issuers may also be subject to the provision.
Warning: some of this post is HIPAA-wonky. But read on: the punch line is that HIPAA does not protect the living or the dead from blanket release of medical records to their personal representatives—unless state law provides otherwise or patients have thought to specify in advance that they do not want anyone to see the record or parts of it and state law gives them this opportunity. This means that the default position is that personal representatives may see highly sensitive health information, including mental health records or sexual or reproductive histories: veritable skeletons in family medical closets.
In an important recent decision, the 11th Circuit has held that the federal Health Insurance Portability and Accountability Act (HIPAA) preempts a Florida statute that gave spouses and other enumerated parties the right to request the medical records of deceased nursing home residents. Opis Management Resources v. Secretary, Florida Agency for Health Care Administration, 2013 U.S. App. LEXIS 7194 (April 9, 2013). The nursing homes had refused to respond to requests for records made by spouses and attorneys-in-fact, arguing that these requesters were not “personal representatives” under Florida law. The requesters filed complaints with HHS’s Office for Civil Rights, which determined that the refusals were consistent with HIPAA. The Florida Agency for Health Care Administration issued citations against the homes for violating Florida law, and the homes went to court seeking a declaratory judgment that the Florida statute was preempted by HIPAA.
The statute in question, Fla. Stat. § 400.145(1) (2013), requires nursing homes to release records to the spouse, guardian, surrogate, or attorney-in-fact of a resident or a deceased resident, unless the release has been expressly prohibited by the resident. Disclosures must include both medical and psychiatric records, with the exception of psychiatric progress notes and consultation reports. The Agency interpreted this statute to authorize release to personal representatives as permitted by the HIPAA Privacy Rule, 45 C.F.R. § 164.502(g)(4)(2013). This section of the Privacy Rule specifies that personal representatives have the same authority to access health information that individuals do, and that executors or others authorized to act on behalf of a decedent must be treated as personal representatives with respect to protected health information. The Privacy Rule also permits covered entities to disclose to persons involved in the deceased individual’s care or payment for care information relevant to that involvement, unless the disclosure is contrary to the known expressed preferences of the decedent, 45 C.F.R. § 164.510(b)(5)(2013).
HIPAA preempts contradictory state law and state law inconsistent with its purposes, 42 U.S.C. § 1320d-7 (2013). It does not preempt more stringent state privacy protections, 45 C.F.R. § 160.203(b)(2013). The 11th Circuit determined that the Florida statute provided less protection than HIPAA, because it allowed individuals to act as thought they were personal representatives without a proper HIPAA authorization in seeking records. HIPAA only allows a personal representative under state law to request records pursuant to a proper HIPAA authorization. The exception for individuals involved in care, or in paying for care, is a very narrow one, again not permitting the broad grant of authority found in the Florida statute. The court refused to read the Florida statute as in effect amending Florida law with respect to identifying personal representatives, leaving that task to the legislature.
In general, HIPAA defers to state law concerning the legal power of individuals acting for the person to access medical records. In many states, statutes simply give designated surrogates or proxies the authority to seek whatever records patients themselves would be able to request in accord with HIPAA. For decedents, the HIPAA requirement is simply that requests for records must come from the state-designated personal representative via a HIPAA authorization. (Custodians of health care records may, to be sure, refuse to release records under special circumstances such as danger to the person or others.)
The decision in Opis Management does not change the scope of this HIPAA deference; it simply insists that Florida comply with HIPAA authorization requirements. But there is a genuine problem here for states to consider regarding access to medical records, for both the living and the dead. Currently, the default position is access to the entire medical record, with limited exceptions. This means that unless patients have thought to specify otherwise under state laws that give them this opportunity, personal representatives may have access to veritable skeletons in the family medical closet: mental health records, sexual histories, reproductive histories, determinations of parentage, and much more that patients might have believed would be kept confidential. In the days of silo-ed paper medical records, records would have been difficult to find or obtain. But in today’s emergent world of interoperable medical records, the results for confidentiality may be serious indeed.
Tuesday, May 14, 2013
Coming right on the heels of the story by Steven Brill, Why Medical Bills are Killing Us, Time (March 4, 2013), the federal Centers for Medicare and Medicaid Services released the data for 3,300 hospitals that covers bills submitted from virtually every hospital in the country in 2011 for the 100 most common treatments and procedures performed in hospitals, like hip replacements, heart operations and gallbladder removal.
Barry Meier, Jo Craven McGinty and Julie Creswell reported on this data release in their New York Times story Hospital Billing Varies Wildly, Government Data Shows (May 8, 2013):
[H]ospitals charge Medicare wildly differing amounts — sometimes 10 to 20 times what Medicare typically reimburses — for the same procedure, raising questions about how hospitals determine prices and why they differ so widely.
A hospital in Livingston, N.J., charged $70,712 on average to implant a pacemaker, while a hospital in nearby Rahway, N.J., charged $101,945.
In Saint Augustine, Fla., one hospital typically billed nearly $40,000 to remove a gallbladder using minimally invasive surgery, while one in Orange Park, Fla., charged $91,000.
In one hospital in Dallas, the average bill for treating simple pneumonia was $14,610, while another there charged over $38,000.
[B]illing records showed that Keck Hospital of the University of Southern California charged, on average, $123,885, for a major artificial joint replacement, six times the average amount that Medicare reimbursed for the procedure and a rate significantly higher than the average for other Los Angeles area hospitals. ... Centinela Hospital Medical Center, also in Los Angeles and owned by Prime Healthcare Services, charged $220,881 for the same procedure.
One of the many disturbing aspects of this billing morass is that those who are least likely to afford these high costs are the most likely to have to pay the highest amounts for bills that may bear little relationship to the actual cost of treatment.
Medicare does not actually pay the amount a hospital charges but instead uses a system of standardized payments to reimburse hospitals for treating specific conditions. Private insurers do not pay the full charge either, but negotiate payments with hospitals for specific treatments.
Since many patients are covered by Medicare or have private insurance, they are not directly affected by what hospitals charge. Experts say it is likely that the people who can afford it least — those with little or no insurance — are getting hit with extremely high hospitals bills that may bear little connection to the cost of treatment.
“If you’re uninsured, they’re going to ask you to pay,” said Gerard Anderson, the director of the Johns Hopkins Center for Hospital Finance and Management.
Saturday, May 11, 2013
Remembering the Bad Old Days of HIV/AIDS Exceptionalism--and How News from Kansas, an HBO Documentary, and Dancing with the Stars Can Teach Students To See it When it Happens Again
The controversy in Kansas over Sub HB 2183, which was passed into law on April 17th, 2013, puts me in mind of how difficult it is to explain the period of time when "aids specific" laws emerged. My purpose in highlighting this situation is not to get deeply involved in Kansas law or politics. It is pull together some material that may be helpful for teaching public health law to students unaware of the lessons we have learned from the laws proposed, and passed, specifically in response to the emergence of HIV/AIDS during the 1980’s. Without an understanding of the fear and panic that accompanied a disease for which there was no test, no treatment, no vaccine and which quickly killed young, healthy people within months of starting symptoms, it is easy to minimize the risk of such a thing happening today.
What Happened in Kansas
As I understand it, Sub HB 2183 was presented as a statute similar to those in almost every state intended to protect first responders and others who face occupational exposure to infectious
diseases and pathogens. It gives the State’s Department of Health the authority to develop a mechanism for mandatory testing or even isolation of the person who is the possible source of infection
if he is unable to give consent or if no surrogate decision maker can be found. Time is of the essence in these situations and the goal is to provide prophylactic treatment as soon as possible—not to stigmatize the source of infection.
One of the effects of Sub HB 2183 was to eliminate a bill passed in 1986 which specifically prohibited the State from quarantining individuals based on a diagnosis of HIV/AIDS. This led to concerns that people living with HIV/AIDS in Kansas would no longer be protected. Ann Gotlib explains these concerns, and their historical context, clearly in IJFAB-the International Journal of Feminist Approaches to Bioethics.
In an open letter to concerned citizens, the Secretary of Kansas’ Department of Health & Environment explained that “This bill was never about isolation or quarantine related to persons with HIV infection.” Instead, the bill “provides the authority for the secretary…to adopt administrative regulations for prevention and control of HIV in addition to the other specified infectious diseases under current law.” He continues to explain that the Bill reflects an attempt to modernize an old statute from that era, KS 65001, that specifically prohibits the state from quarantining or isolating individuals diagnosed with HIV/AIDS.
Without getting in to Kansas politics and law any deeper, KS 65001 is indeed is a good example of an “AIDS specific” law of that era in that it prohibits the State from quarantining individuals based on a diagnosis of HIV/AIDS. Indeed, according to the Kansas Equality Coalition, the Bill passed based on a compromise that involved creating “a list of diseases ‘not’ subject to quarantine, and to include HIV/AIDS in that list.”
What Kansas Can Teach
Public Health Students Today
Whatever the motivation for the legislation or its effect on
the citizens of Kansas, the controversy deserves attention and study just as would thediscovery of a “living fossil.” It gives us direct access to studying the past.
For anyone else looking for ways to bring that time alive, here are a few words about my experience
Thursday, May 9, 2013
Among the many states with Republican governors balking at taking federal money for the ACA Medicaid expansion, a few such as Arkansas and Ohio are exploring a compromise with HHS: use Medicaid expansion money to purchase coverage through health exchanges for people whose income level (up to 138% of poverty) qualifies for the expansion. The proposals are modeled on the use of Medicaid funds to purchase employer-provided insurance for people who qualify for Medicaid and cannot afford their employers’ insurance. But the strategy is fraught with peril.
According to a Kaiser Family Foundation issue brief, two problems with the premium assistance proposals are paramount: whether they will provide the levels and types of coverage that Medicaid would provide and whether they will turn out to be more expensive than direct expansion of Medicaid coverage would be.
With respect to levels of coverage, current premium assistance programs require states to provide “wrap-around” coverage for gaps between Medicaid and employer-provided insurance. The essential benefit package required for plans offered through exchanges are benchmarked to existing plans in their respective states. Thus there will be considerable differences among the states in plans offered through the exchanges. Needed wrap-around coverage will vary accordingly. States such as Ohio, however, are seeking to negotiate with HHS to obtain waivers for the wraparound requirements and threatening to reject the Medicaid expansion if they are not given flexibility.
With respect to cost, programs must demonstrate cost effectiveness in the sense that they provide the same levels of coverage (including wrap around) for equivalent costs. According to the Kaiser issue brief, difficulties on this score may also be significant. Premium assistance programs to date have been fairly small and focused on populations where cost-savings can be expected. On the other hand, an advantage may be allowing families to purchase the same insurance for all family members.
At the recent tenBroek symposium, disability rights advocates voiced particular concern about the prospect that HHS might consider granting states waivers for wraparound coverage. Coverage for home health services, durable medical equipment, or longterm care may be particularly important for people with disabilities but not included in essential benefit packages offered through exchanges. If HHS does agree to flexibility in wraparound coverage, important safety net benefits may be lost despite expansion of Medicaid coverage.
With millions of new enrollees poised to enter the Medicaid program in 2014, Medicaid's remedy quandry will become a more pressing issue. The Medicaid Act contains no obvious remedy for Medicaid providers or Medicaid beneficiaries when states fail to deliver the healthcare promised by the Medicaid Act. For years, the default private right of action was Section 1983, but when Gonzaga University v. Doe was decided in 2002, lower federal courts interpreted the decision as a new limit on § 1983 actions for many sections of the Medicaid Act, which I wrote about here.
The narrowing scope of 1983 rights of action has led to the Supremacy Clause cause of action that was at issue in Douglas v. Independent Living Center last term, and that question almost certainly will make its way back to the Supreme Court. In fact, states have been trying to get the Court to further restrict, even terminate, 1983 actions for Medicaid, though so far the petitions for certiorari have been denied. (Very recently, the Court denied Indiana such a petition, which was a bit of a surprise to Court observers.)
Nevertheless, stay on the alert. The Court is hearing a section 1983 case in the October 2013 term, and it could be an opportunity for the Roberts Court to pick up where Gonzaga left off. The case is Madigan v. Levin, and it involves use of § 1983 to bypass the limited remedies available in the ADEA. The Court could issue a limited decision in the case by simply determining that the ADEA's remedial scheme is comprehensive and leaves no room for additional age discrimination related claims. Or, Madigan could open the door to an articulation of this Court's interpretive take on 1983 that would very likely reject a broader swath of 1983 claims.
Tuesday, May 7, 2013
Guest Bloggers Mary Ann Chirba and Alice A. Noble - Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.
In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].
In April, the governor of Georgia signed H.B. 499 [link: http://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.
This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]
It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.
The intersection of federal standards and state personal injury litigation against a regulated industry is nothing new. It has long played a role, for instance, in product liability claims ranging from medical drugs and devices to motor vehicles. The literature is already quite deep as to whether federal regulations preempt state requirements or have evidentiary value at trial, and we will not add to it today. What is of particular interest with the Georgia law and, therefore, will be the focus of this discussion is: (1) why the ACA has fueled concerns of expanded malpractice liability, and (2) whether the Georgia law achieves any real gains in shielding physicians or other health care providers from malpractice liability beyond what already exists under state law.
Put simply, we consider: why was the Georgia law passed, and does it really accomplish anything?
Publication of Symposium Issue - Capacity, Conflict, and Change: Elder Law and Estate Planning Themes in an Aging World
The 2012-13 Symposium Issue of the Penn State Law Review Capacity, Conflict, and Change: Elder Law and Estate Planning Themes in an Aging World is now available on-line. This Symposium Issue arose out of collaboration between two sections of the Association of American Law Schools (AALS) for the Annual Meeting in January 2013. The leadership of the Section on Trusts and Estates and the Section on Aging and the Law called for a dialogue among law faculty members who teach, research and write in these and related fields, with a special eye to the demographics of population aging. This Symposium Issue is a collection of the formal papers that arose out of this dialogue.
Monday, May 6, 2013
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This year's Petrie-Flom Conference was devoted to the FDA in the 21st Century. If the distribution of conference papers is any harbinger, it appears likely that food is and will continue to play a diminishing role in the agency's future. Out of the two days of panels, only ONE was devoted to food. Moreover, the dependence of the FDA on user fees for any funding increases can only be expected to swell the sections of the agency devoted to drugs and devices while food regulation languishes--the Food Safety Modernization Act (FSMA) notwithstanding. Obesity, it seems, is a medical (or public health) problem, not a food problem. In general, however, the conference was a wonderful confluence of FDA history, FDA policy, and FDA possibilities. I strongly urge blog readers to check out the liveblogging from the conference (on the link above in this paragraph, as well as the conference recording when it appears).
For readers of this blog, one of the more relevant discussions concerned transparency in clinical trial data. Trudo Lemmens called attention to the just-issued interim ruling of the General Court of the EU regarding document release by the European Medicines Agency (EMA). Two pharmaceutical manufacturers, AbbVie and InterMune, challenged the EMA's decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications. The EMA's decisions to release were taken in accordance with its 2010 access-to-documents policy. This access policy aims to protect the privacy of individual data while allowing independent scrutiny of the results of clinical trials; the EMA has announced that it will continue the policy for other document requests not at issue in the interim ruling.
Worth reading on the subject of transparency more generally is Lemmens' recent article in JMLE on human rights and pharmaceutical knowledge governance. In the article, Lemmens argues that pharmaceutical companies' control over knowledge production is a significant global public health problem. Viewing the issue in human rights terms can prioritize it on the public policy agenda and blunt restrictions on information access based in trade obligations and trade secrets. Lemmens bases the human rights argument in the human right to health which, he contends, creates obligations for states to implement determinants of the right to health, including information. Lemmens also suggests grounding in the right to life for production of important safety information. Privacy is invoked on the other side of data transparency--as indeed it was during the discussions at Petrie Flom. In response, Lemmens notes the irony of invoking protection of individuals in one dimension--privacy--against protection of individuals in another dimension--health and safety. As a solution, he suggests that the apparent impasse should be transcended by models "based on meaningful citizen involvement in public health-oriented science." Lemmens also defends establishment on an international framework for sharing clinical trial safety and effectiveness data, given the global structure of pharmaceutical research today.
The Ohio State University Moritz College of Law Welcomes New Health Law Faculty Members Micah Berman and Efthimios Parasidis
The Ohio State University Moritz College of Law welcomes two new health law faculty members, Professors Micah Berman and Efthimios Parasidis. A big Ohio welcome to both!
Here are their short bios:
Micah Berman’s expertise is in public health law and policy. He will hold a joint appointment at Ohio State’s College of Public Health and at Moritz. Berman most recently was an associate professor at New England Law in Boston, where he founded and directed the Center for Public Health and Tobacco Policy. In addition to working on tobacco-control issues at the centers in Boston and Columbus, Berman contributed to similar initiatives as a senior advisor for the Food and Drug Administration (FDA). He has published his scholarship in a number of leading publications, including American Journal of Law & Medicine (forthcoming), Brooklyn Law Review, and American Journal of Public Health.
Berman graduated with distinction from Stanford Law School and received a Bachelor of Arts, summa cum laude, from Brandeis University. He previously was a trial attorney with the U.S. Department of Justice’s National Criminal Enforcement Section, Antitrust Division and a litigation associate at Stinson Morrison Hecker LLP in St. Louis, Missouri.
Efthimios Parasidis has spent a career studying biotechnology, bioethics, intellectual property, and related areas. He is an assistant professor of law at St. Louis University School of Law – one of the nation’s leading health law programs – and has served on the Law and Policy Workgroup of the Missouri Health Connection, which is responsible for creating Missouri’s health information exchange. As a co-principal investigator with researchers from the National Institutes of Health, his recent research includes analyzing the policies of the top 200 research institutions in the U.S. to see what compensation they provide for participants injured in a research study. His scholarship has been published in top journals, including Ohio State Law Journal, Connecticut Law Review, Wisconsin Law Review, and Tulane Law Review.
Parasidis holds a bachelor’s degree from The College of New Jersey, a master’s degree in bioethics from the University of Pennsylvania Perelman School of Medicine, and a J.D. from the University of Pennsylvania Law School. He was an associate at Jones Day and Dickstein Shapiro LLP in New York City. He also worked for the Office of the New York State Attorney General; co-founded Global Health Outcomes Inc., a health care research and analytics firm; and is a co-inventor on a patent application related to health information technology and comparative effectiveness research. Parasidis was also a Fulbright Fellow in Greece.
Sunday, May 5, 2013
Professor Alice A. Noble is a Senior Lecturer in the Legal Studies Program at Brandeis University and Adjunct Lecturer at Brandeis University’s The Heller School and Boston College Law School. She holds a law degree from Villanova University School of Law and a Master of Public Health degree from Harvard School of Public Health. In addition to teaching at Boston College Law School and Brandeis University, she has taught numerous courses at Harvard School of Public Health and Tufts Medical School. Courses taught include Genetics, Law, and Social Policy, Health Law and Ethics, Health Law and Policy, Advanced Legal Writing, Law and Public Health, Managed Care Law and Regulation, among others. She has practiced personal injury and medical malpractice defense litigation, has conducted funded research on health policy issues, and was a fellow in medical ethics at Harvard Medical School and a Senior Researcher at The American Society of Law, Medicine & Ethics. She has a number of peer-reviewed publications on topics such as medical malpractice, managed care, and hospital law. She is a contributor to the Health Affairs Blog. Alice has been an invited speaker on various matters, including national health care reform. Along with Professor Mary Ann Chirba and Attorney Michael Madigan, Alice is a co-author of the forthcoming Health Care Reform: Law and Practice (Matthew Bender--LexisNexis, 2013).
Professor Mary Ann Chirba holds a J.D. from Boston College Law School, a D.Sc. and M.P.H. in Health Policy from the Harvard School of Public Health, and a B.A. in Biology from Colgate University. She is a Professor at Boston College Law School where her courses have included Comparative Health Law, Legal Reasoning, Health Care Law and Policy I and II, Advocacy Writing, and Product Liability Law. At the Harvard School of Public Health, Professor Chirba has taught courses on FDA Law, Pharmaceutical Product Safety, “The Tobacco Wars,” Current Developments in Health Law, Managed Care Law & Regulation, and Medical Malpractice & Risk Management. Her research interests focus broadly on how law and regulation can promote or impede desired health outcomes, with a particular emphasis on the regulation of medical drugs and devices, emerging federal and state regulations and international guidelines for adult stem cell therapies, and federal and state health care reform efforts. She is a co-author of the forthcoming treatise entitled Health Care Reform: Law and Practice (Matthew Bender 2013).
Wednesday, May 1, 2013
The following are the top ten SSRN downloads for Health Law for the period between March 2 and May 1, 2010: