By Kate Greenwood
[Cross-posted at Health Reform Watch]
As I have blogged about before, last year, in Kaiser v. Pfizer, the First Circuit joined the handful of courts to have approved a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid. To establish but-for causation in the case, Kaiser submitted an expert report and testimony from Dr. Meredith Rosenthal, a health economist at the Harvard School of Public Health. Dr. Rosenthal conducted a regression analysis to determine the portion of physicians’ prescribing of the drug Neurontin that was caused by the defendant’s fraudulent promotion, arriving at percentages ranged from 99.4% of prescriptions for bipolar disorder to 27.9% of prescriptions for migraine.
Pfizer argued that Dr. Rosenthal’s regression analysis should not have been admitted (and at least suggested that such an analysis should never be admitted in a third-party payer case) because regression analysis could not “take into account the patient-specific, idiosyncratic decisions of individual prescribing physicians.” Dr. Rosenthal’s report, the company argued, “merely demonstrated ‘correlation’ and not ‘causation.’” The First Circuit disagreed, upholding the lower court’s determination that the challenged evidence was admissible under Federal Rule of Evidence 702, because “regression analysis is a well-recognized and scientifically valid approach to understanding statistical data” and because it “fit” the facts of the case.
Eric Alexander, a partner at Reed Smith, made a similar argument to Pfizer’s when he critiqued a decision issued in July in a third-party payer case in the Eastern District of Pennsylvania. Writing at the Drug and Device Law blog, Alexander criticized the court for failing to address “the fundamental—to us—issue of whether an economist [Dr. Rosenthal was the plaintiff’s expert in that case, too] can ever determine why prescriptions were written.” Alexander points out that “[t]o get to millions of dollars of revenue from prescriptions, many physicians have to prescribe the drug to many patients[,]” and those physicians can “pretty much do what they want[.]” Economists, Alexander argues, should not be allowed to by-pass this complexity and simply “assume” causation.
I would argue that, as idiosyncratic as physician decision-making may be, it is not uniquely so. Continue reading
[Author's Note: Addendum and updates (latest: 10:30 am, 10/31) added below.]
A physician shall… be honest in all professional interactions, and strive to report physicians… engaging in fraud or deception, to appropriate entities.
—AMA Principles of Medical Ethics
This is a troubling series of news reports about deception and defiance on the part of some healthcare workers (HCWs) in response to what they believe to be unscientific, unfair, and/or unconstitutional public health measures (to be clear, the text is not mine (until after the jump); it’s cut and pasted, in relevant part, from the linked sources):
Gavin Macgregor-Skinner, an epidemiologist and Global Projects Manager for the Elizabeth R. Griffin Foundation, who has led teams of doctors to treat Ebola in West Africa, reported that he “can’t tell them [his doctors] to tell the truth [to U.S. officials]” on Monday’s “CNN Newsroom.”
“At the moment these people are so valuable . . . I have to ensure they come back here, they get the rest needed. I can’t tell them to tell the truth at the moment because we’re seeing so much irrational behavior,” he stated. “I’ve come back numerous times between the U.S. and West Africa. If I come back now and say ‘I’ve been in contact with Ebola patients,’ I’m going to be locked in my house for 21 days,” Macgregor-Skinner said as his reason for not being truthful with officials, he added, “when I’m back here in the US, I am visiting US hospitals everyday helping them get prepared for Ebola. You take me out for three weeks, who’s going to replace me and help now US hospitals get ready? Those gaps can’t be filled.
He argued that teams of doctors and nurses could be trusted with the responsibility of monitoring themselves, stating, “When I bring my team back we are talking each day on video conferencing, FaceTime, Skype, text messaging, supporting each other. As soon as I feel sick I’m going to stay at home and call for help, but I’m not going to go to a Redskins game here in Washington D.C. That’s irresponsible, but I need to get back to these hospitals and help them be prepared.
UPDATE: Here is the CNN video of his remarks.
The city’s first Ebola patient initially lied to authorities about his travels around the city following his return from treating disease victims in Africa, law-enforcement sources said. Dr. Craig Spencer at first told officials that he isolated himself in his Harlem apartment — and didn’t admit he rode the subways, dined out and went bowling until cops looked at his MetroCard the sources said. “He told the authorities that he self-quarantined. Detectives then reviewed his credit-card statement and MetroCard and found that he went over here, over there, up and down and all around,” a source said. Spencer finally ’fessed up when a cop “got on the phone and had to relay questions to him through the Health Department,” a source said. Officials then retraced Spencer’s steps, which included dining at The Meatball Shop in Greenwich Village and bowling at The Gutter in Brooklyn.
Update 11PM, 10/30: A spokesperson for the NYC healh department has now disputed the above story, which cites anonymous police officer sources, in a statement provided to CNBC. The spokesperson said: “Dr. Spencer cooperated fully with the Health Department to establish a timeline of his movements in the days following his return to New York from Guinea, providing his MetroCard, credit cards and cellphone.” . . . When CNBC asked again if Spencer had at first lied to authorities or otherwise mislead them about his movements in the city, Lewin replied: “Please refer to the statement I just sent. As this states, Dr. Spencer cooperated fully with the Health Department.”
(3) Ebola nurse in Maine rejects home quarantine rules [the WaPo headline better captures the gist: After fight with Chris Christie, nurse Kaci Hickox will defy Ebola quarantine in Maine]
Kaci Hickox, the Ebola nurse who was forcibly held in an isolation tent in New Jersey for three days, says she will not obey instructions to remain at home in Maine for 21 days. “I don’t plan on sticking to the guidelines,” Hickox tells TODAY’s Matt Lauer. “I am not going to sit around and be bullied by politicians and forced to stay in my home when I am not a risk to the American public.”
Maine health officials have said they expect her to agree to be quarantined at her home for a 21-day period. The Bangor Daily News reports. But Hickox, who agreed to stay home for two days, tells TODAY she will pursue legal action if Maine forces her into continued isolation. “If the restrictions placed on me by the state of Maine are not lifted by Thursday morning, I will go to court to fight for my freedom,” she says.
Some thoughts on these reports, after the jump. Continue reading
By Deborah Cho
I was excited to learn of an article in a recent issue of American Family Physician on the topic of caring for Asian American patients. The contents of the article are worth a read (most of it is available here), but it generally states that medical providers should consider the Asian American health care culture in their care of Asian American patients. That information is not new, but it does highlight important facets of the Asian American culture, such as the collectivistic approach within families to medical decisions and that many Asian American patients do not mention the use of supplements and herbals unless explicitly asked during medication review. Though these tips were worth mentioning, the main reason this article caught my attention was because it was about a population that often seems overlooked in health care.
I think one reason that there appears to be little attention on the nuances of caring for Asian American patients is buried in this phrase: “despite the common perception that all Asians are well-educated, many Asian immigrants have low educational attainment and poor medical knowledge.” (emphasis added). Perhaps we do not consider this population to be vulnerable or otherwise in need of particular concern. As the author of the AFP article notes, however, this perception is possibly misguided (“30% of Vietnamese Americans 25 years or older have completed less than a high school education (compared with 11% in non-Hispanic whites)” and “A high percentage of Asian Americans have limited English proficiency”). Continue reading
As the backlog of Medicare appeals indicates, Medicare claimants are seeking many more hearings than we can currently provide. The mismatch makes a fundamental question particularly acute: Why do we hold hearings to review Medicare coverage decisions in the first place?
It’s a question worth asking. The Affordable Care Act mandated that denials of private health insurance coverage be reviewed by external, contract medical specialists, without a hearing. (See here.) If we are comfortable with private, sometimes profit-motivated coverage decisions obtaining external review review by someone other than an Administrative Law Judge (ALJ), without a hearing, why do we feel differently about Medicare coverage decisions? Continue reading
Undoubtedly, the death toll in West Africa would be much lower if Guinea, Liberia, and Sierra Leone had better health care systems or if an Ebola vaccine had been developed already. But as Fran Quigley has observed, Ebola is much more a problem of poverty than of health. Ebola has caused so much devastation because it emerged in countries ravaged by civil wars that disrupted economies and ecosystems.
Ultimately, this Ebola epidemic will be contained, and a vaccination will be developed to limit future outbreaks. But there are other lethal viruses in Africa, and more will emerge in the coming years. If we want to protect ourselves against the threat of deadly disease, we need to ensure that the international community builds functioning economies in the countries that lack them.
Our humanitarian impulses in the past have not been strong enough to provide for the needs of the impoverished across the globe. Perhaps now that our self-interest is at stake, we will do more to meet the challenge.
One option for dealing with the backlog of Medicare claims waiting for a hearing is to settle them. That’s up to the Centers for Medicare and Medicaid Services, not the Office of Medicare Hearings and Appeals that actually oversees the process, so it’s not an administrative fix that the Office of Medicare Hearings and Appeals could actually implement alone. But it is worth considering, and the CMS has shown an openness to it by going along with the proposal for facilitated settlement and by offering to settle a big chunk of pending inpatient hospital admission disputes for 68 cents on the dollar. (See Nick Bagley’s post at the incidental economist.)
These settlement efforts have received some high-level scrutiny, however. Last month Representative Brady, Chair of the House Ways and Means Committee, Subcommittee on Health, sent the HHS a strongly-worded letter after the inpatient hospital settlement was announced, arguing that the settlement may exceed CMS’s statutory authority, among other problems. (See the letter linked here (“I question whether HHS has statutory authority for this settlement process.”)
I tend to share Congressman Brady’s skepticism. Continue reading
The heartfelt letter issued by Kaci Hickox, the nurse being held in quarantine in a New Jersey hospital, calls into question the surprising decision by Governors Christie and Cuomo to quarantine health care workers returning from West Africa. It also shines a spotlight on the all-important, but largely unexplored, question of how the less restrictive “alternative test” applies to quarantine. In her letter, Hickox describes being treated in a shockingly harsh and unsupported manner, being kept for hours in isolation at Newark International Airport, and then in a tent outside of University Hospital in Newark, given only a granola bar to eat. Even after she tested negative for Ebola, and her purported fever had vanished, she remains confined in the hospital. How, she asks, will returning health care workers be treated when they return from Africa? “Will they be made to feel like criminals and prisoners?”
Hickox’s question points to the critical flaw in the decision by Governor’s Cuomo and Christie to quarantine asymptomatic health care workers returning from Africa. By using the “big gun” of quarantine, the most restrictive public health law we have, rather than a less restrictive approach, the Governors seek to show an anxious public that they’re being tough on Ebola. No doubt this is a politically popular stance. But, as many public health experts have noted, the Governors’ approach can only impede efforts to convince health care workers to go to Africa, where they are desperately needed if the world is to be freed of Ebola. The quarantines may also discourage US-based health care workers and first responders from caring for those who are stricken stateside. If 21 days of confinement in a hospital is demanded for those who care for patients in Liberia, why won’t the same approach be used here? And if so, who will answer the 911 call?
The dangers posed by the Governors’ draconian approach demonstrate the public health importance of the basic constitutional principles that guide the law of quarantine: while governments have the right, if not the duty, to impose quarantine in appropriate circumstances to protect the public’s health, individuals can only be detained when doing is the least restrictive alternative. Exactly what that means has not been fully explored by the courts, in part because quarantine cases are relatively rare. Most modern cases concern patients with tuberculosis. These cases, including ones from New York and New Jersey (e.g., City of New York v. Doe, 205 A.D.2d 469, 614 N.Y.S.2d 8 (N.Y. App. Div., 1 Dept. 1994); City of Newark v. J.S., 652 A.2d 265 (N.J. Super. Ct. Law Div. 1993)), suggest that detention is permissible, but only upon a showing that the patient has been non-complaint with less restrictive approaches (such as directly observed therapy). Courts have also made clear that prisons are not appropriate placements for patients, and that decisions must be based on the best medical and public health evidence. And although courts have not explored these issues, it seems clear that states must provide care and support for those are unable to care for themselves due to public health orders. People who are quarantined are serving the public. We need to treat them accordingly.
In the face of Ebola, fealty to the least restrictive means principle as well as sound public health policy requires that policymakers proceed with a far more nuanced approach than we have seen from the Governors of New York and New Jersey. Without question, public health controls are appropriate, indeed necessary, in response to this awful disease. In Dallas, health officials required health care workers to sign documents agreeing to self-monitor and avoid public transportation. Because Ebola cannot be spread before someone becomes ill, even the latter may be excessive. But these measures were far less restrictive and more tailored than those now being employed in New Jersey and New York. Indeed, a wide range of measures lie between the neglect the public fears, and the over-reaction that the Governors have instituted. Both public health and the Constitution demand we explore them.
As the nation braces for possibly more Ebola cases, civil liberties should be considered, including patient privacy. As news media feature headline-grabbing stories about quarantines, let’s think about the laws governing privacy in healthcare. Despite federal laws enacted to protect patient privacy, the Ebola scare brings the vulnerability of individuals and the regulations intended to help them into sharp relief.
In 1996, Congress enacted the Health Insurance Portability and Accountability Act (HIPAA) to protect patient privacy. Specifically, HIPAA’s Privacy Rule requires that healthcare providers and their business associates restrict access to patients’ health care information. For many years, the law has been regarded as the strongest federal statement regarding patient privacy. But it may be tested in the wake of the Ebola scare with patients’ names, photographs, and even family information entering the public sphere.
Ebola hysteria raises questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy. What liberties are Americans willing to sacrifice to calm their fears? How to balance the concern for public welfare with legal and ethical privacy principles? For example, will Americans tolerate profiling travelers based on their race or national origin as precautionary measures? What type of reporting norms should govern Ebola cases? Should reporting the existence of an Ebola case also include disclosing the name of the patient? I don’t think so, but the jury appears out for many.
How to combat fear? Honor these heroes by giving them paid R &R, with their partner if they so choose, for 21 days. Give them a vacation in the guise of quarantine. Give them a reason to want to go back to fight Ebola. Give other doctors and nurses a reason to emulate them. Build or buy a nice hotel for these heroes.
And more, on why a general quarantine is a bad idea:
When officials respond to panic with quarantine they basically say they can’t trust public health officials, science and the ethics of doctors and nurses. There is no substitute for that trust. None. If state and city officials undermine trust out of panic or politics, then they destroy the best weapon we have to control Ebola — good science implemented by heroes.
In the wake of Craig Spencer’s decision to go bowling in Brooklyn, governors of three major states—Illinois, New Jersey, and New York—have imposed new Ebola quarantine rules that are inconsistent with national public health policy, are not likely to protect Americans from Ebola, and may compromise the response to Ebola in Africa, as health care providers may find it too burdensome to volunteer where they are needed overseas. Don’t we have an Ebola czar who is supposed to ensure that our country has a coherent and coordinated response to the threat from Ebola?
Of course, the term “czar” was poorly chosen precisely because Ron Klain does not have the powers of a czar. He will oversee the federal response to Ebola, but he cannot control the Ebola policies of each state. Unfortunately, on an issue that demands a clear national policy that reflects medical understanding, public anxieties will give us something much less desirable.
In the wake of another health care worker contracting Ebola, alarm bells are ringing. Last week, President Obama abruptly cancelled a campaign stop to Rhode Island to hold press conferences where he promised that federal authorities are “taking this very seriously at the highest levels of government.” Despite Obama’s assurances that the dangers associated with the disease spreading in the US are extremely low, other political camps are less convinced. Mitt Romney, the former Governor of Massachusetts, urged officials to close US borders to countries experiencing Ebola outbreaks, basically quarantining West Africa from travel to the United States.
In light of the hysteria surrounding Ebola and not Enterovirus, it’s worth thinking about our national response. Enterovirus has already claimed more lives in the US than Ebola. Think about this, the CDC warns that enteroviruses are highly contagious and already more than 500 patients have been diagnosed across 43 states in the past couple months. Yet, there has been no national outcry or demands to quarantine states, cities, local communities, or hospitals where patients were treated. Why?
Unlike the enterovirus, the face of Ebola is decidedly immigrant or “outsider.” It’s origins are Africa. Could these factors have contributed to Thomas Eric Duncan’s initial treatment at a Texas hospital and the inaccurate media accounts shortly following his diagnosis? Studies show how cognitive or implicit biases may have much to do with how we treat patients. Continue reading
by Vadim Shteyler
Interdisciplinary collaboration between all healthcare professionals involved in an individual patient’s care has been increasingly recognized as vital for providing high quality medical care. However, when it comes to hospital management, decisions affecting daily workflow are still largely made by physicians.
The movement towards an inter-professional team approach of providing medical care is still new but gaining widespread support. To characterize the disconnect between the presence of inter-professional collaboration in medical care, but its absence in healthcare management, it is valuable to understand the rationale for inter-professional teams in healthcare. Continue reading
By Emily Largent
California Proposition 46, the Medical Malpractice Lawsuits Cap and Drug Testing Doctors Initiative, is on the November 4, 2014 ballot. If approved by voters, the initiative would: increase the state’s cap on non-economic damages that can be assessed in medical negligence lawsuits; require hospitals to test certain physicians for drugs and alcohol; and require healthcare providers to check a statewide prescription drug database before prescribing or dispensing certain drugs to a patient for the first time.
The debate over Proposition 46 has been framed as a battle between doctors and lawyers. See also here or here. It’s not hard to see why. Attorneys have contributed the vast majority of the “yes” campaign‘s $9 million fund. By contrast, nearly three-fourths of the “no” campaign‘s $57 million has come from six insurance companies; other big backers include the state medical and dental associations. (It is the most expensive campaign in California this year.) While the two sides have made a variety of arguments for and against Proposition 46′s various provisions, I want to focus on the putative costs and cost-savings:
First, Proposition 46 would increase California’s current $250,000 limit on non-economic awards (which dates to the Medical Injury Compensation Reform Act of 1975) to $1.1 million, and provide for annual adjustment for inflation going forward. The non-partisan Legislative Analyst’s Office estimates that increased state and local government health care costs from raising the cap likely range from the tens of millions of dollars to several hundred million dollars annually. On the other hand, a RAND study of EDs in three states with strict malpractice limits found the caps had little effect on the cost of care. Continue reading
By Zachary Shapiro
With the emergence of new techniques in the field of reproductive technology, applications arise that seem more the realm of science fiction than reality. While many have considered stem cells to be the next frontier of modern medicine, reproductive technology may offer hope to many individuals suffering with rare and unique genetic diseases.
The term “savior siblings” refers to the use of pre-implantation genetic diagnosis (PGD) and other forms of in-vitro fertilization (IVF) in order to create a sibling for the purpose of providing biological material (bone marrow, blood, etc.) that can help treat or cure an existing terminally ill child. It is estimated that up to one percent of PGD in the United States is used to create children that are tissue matches for their siblings. See here.
There has been little meaningful discussion about savior siblings in bioethical or legal circles, and there is no formal regulation governing their use or creation in the United States. This stands in stark contrast to other countries, particularly England, France, and Australia, where a regulatory framework for the use of savior siblings has arisen along with debate over their acceptability. These countries are already discussing how to ethically deal with this extremely complicated issue. Continue reading
Join us for a Skype call and Q&A with the founder/CEO of AMF! Monday, October 27 at 5pm, Sever 102. RSVP here.
By Alex Stein
Most, if not all, nursing homes have their residents sign an agreement to arbitrate any dispute or disagreement arising out of or in connection with the care rendered to the resident by the nursing home, including claims by the resident involving, and/or arising out of conduct committed by the nursing home and/or its agents, employees, or others for whom and/or which the nursing home is, may be, or is asserted to be, legally responsible. Such agreements also stipulate that they will apply to and bind any and all persons and/or entities who and/or which may assert a claim on behalf of, or derived through, the resident, including, without limitation, the resident’s legal representative, guardians, heirs, executors, administrators, estate(s), successors and assigns.
Ostensibly, such agreements compel arbitration on the resident’s survivors who claim that the resident died prematurely as a result of the nursing home’s neglect. The Federal Arbitration Act (FAA), as interpreted in AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740 (2011), seems to support this observation. This Act requires state and federal courts to enforce arbitration agreements similarly to other contracts. Pursuant to this Act, when a resident’s survivor files a wrongful death suit against the nursing home, the court must stay the proceeding and direct the parties to arbitration.
However, a recent decision of the Oklahoma Supreme Court, Boler v. Security Health Care, L.L.C., — P.3d —- (Okla. 2014), has shown that this appearance is misleading. Continue reading