Good News for Health Care Reform Implementation

HCR implementation is steaming ahead. Jonathan Cohn lays out some of the key issues in a recent article in The American Prospect. A restrictive definition of “grandfathered plans” (which are not subject to the Affordable Care Act (ACA)) was an early victory for consumer advocates. Coverage appeal rules will soon be hotly contested during the rulemaking process:

Even if insurers are required to take all comers at relatively nondiscriminatory prices — “relatively” since age can be a rough proxy for medical condition — they’ll still have financial incentives to restrict care. This isn’t entirely a bad thing: Given the evidence of rampant overtreatment in American medicine, insurers should exercise some check on the use of technology, drugs, and other resources, for the sake of the patients as well as the insurers’ bottom line. But because insurers sometimes deny even necessary care, just to increase profit margins, the law seeks to limit the insurers’ authority — most obviously, by opening up treatment denials to outside appeal.

The idea sounds simple enough: Allow patients convinced they’ve been wrongly denied care to make their case to independent experts with authority to overrule the insurer. But who are the experts? How quickly must they rule? And what’s to stop insurers from ignoring the recommendations? The Obama administration has to write regulations answering all of those questions. A viable, working model exists: The National Association of State Insurance Commissioners has a framework, similar to what’s already in place in several states. HHS will consult those guidelines in devising a new scheme. The model is not perfect, but with sufficiently strong regulations it could give consumers significant new leverage.

Cohn also notes some important appointments at HHS. Having examined her work in the past, I was encouraged by the appointment of Karen Pollitz to “set up an Internet portal to provide basic information about different insurance policies.”

Nevertheless, Tim Jost warns that there are many possible obstacles ahead:
Read more

Center for Health & Pharmaceutical Law & Policy Submits Comments on Conflicts of Interest in Research to the National Institutes of Health

On August 19, 2010, on behalf of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Seton Hall Law Professors Kathleen Boozang and Carl Coleman, along with Research Fellow Kate Greenwood, submitted comments on the National Institutes of Health’s proposed revisions to its regulations governing conflicts of interest in federally-funded research.  While the Center’s November 2009 White Paper Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight endorsed limits on conflicts of interest beyond those that the NIH has proposed, the revised regulations are a step in the right direction and in its comments the Center commends the NIH for its decisive action on this issue.


Briefly, the Center:

• Supports the NIH’s proposal that that researchers disclose to their institutions any significant financial interest that “reasonably appears to be related to the Investigator’s institutional responsibilities,” with “institutional responsibilities” defined to include “activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.” This comports with the Center’s recommendation in the White Paper that investigators not be charged with determining for themselves whether one or more of their financial interests could be affected by a specific research project.

• Supports the NIH’s decision to significantly lower the monetary threshold at which a researcher’s financial interest becomes “significant” to $5,000, but argues that a lower threshold would be better. Collection of data about all of a researcher’s relationships with industry, even those that fall below the proposed $5,000 threshold, would facilitate better conflict of interest assessment and management and make possible research into the effects of conflicts on research integrity and human subject welfare.

• Supports the NIH’s decision not to exclude income from non-profit entities for lectures and similar engagements from the definition of significant financial interest and its conclusion that any equity interest in a non-publicly traded entity is significant, as are any and all intellectual property rights, but encourages the agency to revisit its decision to shield from disclosure (1) equity interests held by investigators in commercial or for-profit institutions and (2) royalties and other remuneration other than salary paid to an investigator by an institution that appoints or employs him or her.

• Notes that the draft revised regulations do not address the White Paper’s criticisms that the conflict of interest regulations place no “substantive limits on the kinds of conflicts that may exist” and fail to put forth “a required minimum response for conflicts that pose the greatest risks to participants and the integrity of the research” and encourages the NIH to consider again the benefits of setting forth required minimum responses to those conflicts that are the most problematic.

• Supports the NIH’s decision to require that grantees provide “sufficient information to enable the [agency] to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution’s management plan.”

• Supports the requirement in the draft revised regulations that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to PHS-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web.

• Supports the draft revised regulations’ requirement that investigators complete training on “the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations” before the commencement of research and then at least once every two years. As recommended in the Center’s White Paper, it would be beneficial for the training to include as well a discussion of the nature of conflicts of interest and their potential for harm.

• Recommends that the agency adopt its own suggestion that institutions be required to “maintain up-to-date, written, enforced policies” on institutional conflicts of interest, as they are for investigator conflicts, and that these policies be made publicly available via the world wide web. The nudge this requirement would provide is necessary because institutions have been slow to develop and adopt policies on institutional conflicts.

• Recommends that the section of the regulations devoted to remedies be revised to include a non-exclusive list of potential enforcement actions such as temporary withholding of cash payments pending correction of the deficiency, suspension or termination of the contract or grant in whole or in part, monetary assessments and penalties, and suspension or debarment from eligibility for future contracts or grants.

The Center’s comments in their entirety are available here.

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy. The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices.

Florida Attorney General McCollum Falls Victim to Collective Mandate, Loses Bid for GOP Nomination for Governor

Attorney General Bill McCollum, noted of late for spearheading the state suits against the Individual Mandate in health reform, has lost his bid for the Republican Party nomination for governor of Florida. Political newcomer Rick Scott, a self styled “conservative outsider” and former hospital corporation CEO, poured over $30 million of his own money into the race and won the nomination.  According to Fox News/AP, Mr. Scott, who has never run for any office before, “was active last year opposing the health care legislation in Washington.”

With 93 percent of precincts reporting, Scott led McCollum 47 percent to 43 percent.

Fox/AP also reports that the result is the culmination “of months of personal attacks, name-calling and negative TV ads….”

And that

McCollum, who racked up endorsements from big Republican names, hit Scott hard for past Medicare fraud allegations. Scott was the CEO of HCA/Columbia Hospitals when it settled the biggest Medicare fraud case in history — Scott, who was forced out as CEO by his board amid the government investigation in 1997, has said repeatedly that he didn’t know about any criminal activity and was never charged.

Tip of the Hat to JanetHasty via good ol’ twitter.

Secretary of State Hillary Clinton on the Global Health Initiative

This C-SPAN report is worth considering: “Secretary of State Hillary Clinton spoke at Johns Hopkins University’s School of Advanced International Studies on the Obama Administration’s Global Health Initiative. She discussed the six-year, $63 billion investment that focuses on improving the health of women, children and newborns throughout the world.”

You can see the video (or the transcript) by clicking on the picture.

Doctors, Patients and a Failure to Communicate

“What we have here is a failure to communicate.”  Fans of Cool Hand Luke (and who is not?) will recall the phrase in graphic detail–and for those of you without that memory, the video will provide.

A recent study highlighted in the Wall St. Journal’s Health Blog points to both a discrepancy in perception between hospital doctors and their patients and a failure to communicate.

The study was conducted by Douglas P. Olson, MD and Donna M. Windish, MD, MPH. The authors noted as “Background” in the study abstract that:

Hospital surveys indicate lack of patient awareness of diagnoses and treatments, yet physicians report they effectively communicate with patients. Gaps in understanding and communication could result in decreased quality of care. We sought to assess patient knowledge and perspectives of inpatient care and determine differences from physician assessments.

The results of the study were derived from two validated questionnaires given to inpatients treated by “house doctors” over a course of roughly eight months at one hospital.The corresponding doctors were also queried. Eighty-nine patients and 43 doctors participated.

According to WSJ:

The survey — which the authors note is limited by its reach (one institution), patient characteristics (older, indigent and less-educated than average), and general responses, rather than one-to-one-patient-physician comparisons — is published in the Archives of Internal Medicine.

The results? From the abstract:

• Only 18% of patients knew their main doctor by name.
• Sixty-seven per cent of doctors believed their patients knew them by name.
• Fifty-seven per cent of patients knew their diagnosis.
• Seventy-seven per cent of doctors believed their patients knew their diagnosis.
• Fifty-eight per cent of patients thought that physicians always explained things in a comprehensible way.
• Twenty-one per cent of doctors stated they always provided explanations of some kind.
• Sixty-six per cent of patients reported receiving a new medication in the hospital, 90% noted never being told of any adverse effects of these medications.
• Ninety-eight per cent of doctors stated that they at least sometimes discussed their patients’ fears and anxieties.
• Fifty-four per cent of patients said their doctors never did this.

Interestingly enough,the WSJ article notes that the

responses didn’t significantly differ by sex, age, race, language or payment source, for the patients, or level and type of training, for the doctors.

Only 57% of patients knew their diagnosis? Which is to say that 43% did not? 90% not told of potential adverse reactions to new medication?

Res Ipsa Loquitur.

An “Unknowable” Number of Bureaucrats

Perhaps I’ve just read too much Kafka for this to be a comfortable paragraph, but I’ll let you decide. From Politico, in “Health reform’s bureaucratic spawn“:

Don’t bother trying to count up the number of agencies, boards and commissions created under the new health care law. Estimating the number is “impossible,” a recent Congressional Research Service report says, and a true count “unknowable.”

The modern course of the law is administrative. In the end, the appropriate scope of the Congressional delegation of power falls to the Supreme Court’s “intelligible principle” doctrine and the acknowledged need for technical expertise in complex areas that require rules–such as Health Law and Health Law Finance. But that doesn’t make it all that much less scary.

The rest of the Politico article is worth a quick read. And if you’re an aspiring attorney, you might want to consider taking Administrative Law. And, of course, Health Law.

Judge Rules, Virginia Moves Forward Against Individual Mandate

Federal District Court Judge Henry E. Hudson has ruled that Virginia’s suit against the federal government for imposing an individual mandate to purchase health insurance can go forward. Which is to say that the suit survived the motion to dismiss for failure to state a claim. A primary consideration therein being whether or not Virginia had standing to bring such a claim.The judge ruled that it did.

Which means that the judge has ruled that the case can go forward and the issues be heard and then decided on their merits. No small thing, sine qua non in fact, but largely a procedural hurdle in what most believe will be a long and arduous trek through the legal system, subject to myriad appeals culminating, ultimately, before the Supreme Court.

In deciding the standing issue, Judge Hudson, according to Professor Jack Balkin, made much of the “Virginia Health Care Freedom Act– which asserts that no Virgina citizen may be forced to purchase health care insurance; that this law conflicts with the federal Affordable Care Act, and therefore Virginia has standing to challenge the act under the 10th amendment.”

Virginia’s Act was passed subsequent to the federal law in question; other states challenging the individual mandate do not, at present, have such a law to rely on. As Professor Balkin points out, however, the Virginia Act being deemed sufficient to buttress standing in a States’ rights Tenth Amendment claim is interesting– to say the least. It begs the question.

Balkin:

Indeed, the logic of the opinion seems to suggest that if Virginia had objections to any other part of the federal tax laws, it could pass a Virgina Tax Freedom Act related to that provision, claiming that the tax provision was beyond the reserved powers of the states under the Tenth Amendment. This new act would give it standing to challenge any other part of the Internal Revenue Code, and it would also get around the tax anti-injunction act. Moreover, under the logic of the opinion, every other state in the Union could also create its own tax freedom act, and each of them would also be entitled to begin a series of tax protest challenges to provisions of the Internal Revenue Code. This cannot be consistent with the purposes of the tax anti-injunction act.

If you have a minute, it would actually be well spent on reading Professor Balkins post. Even if you are not a lawyer, I think you’ll find his writing accessible– and rewarding. He frames the difficulties of the opinion well.

Having said that, in a recent post we recounted the NY Times recap of the government’s argument regarding “inactivity” and the Commerce Clause:

Ian H. Gershengorn, a deputy assistant United States attorney general, countered that the insurance requirement fitted well within the Supreme Court’s parameters for Congressional regulation of interstate commerce. A choice not to obtain coverage, he said, is not inactivity, as Virginia and the other state plaintiffs claim, but an active decision to pay for future medical care out of pocket.  Because many Americans cannot afford the cost of surgeries and hospitalization, their choice to go uninsured shifts the uncompensated cost of their care to hospitals, taxpayers and commercial policyholders.

The argument seems to have not persuaded Judge Hudson. Quoting from the opinion, Daily Finance writes:  “From a legal standpoint, the judge defined the issue as:

‘whether or not Congress has the power to regulate — and tax — a citizen’s decision not to participate in interstate commerce [by choosing not to buy health insurance.]‘”

For those of you with more interest in the subject, I would suggest these two posts:

1) “Is it Unconstitutional to Mandate Health Insurance? ,” which was originally published here on HRW by Professor Mark Hall and then later cited by the New York Times, Washington Post, etc.

And

2) “The Original Individual Mandate, Circa 1792,” which was originally published here on HRW by Bradley Latino, a Seton Hall Law student, and then by The Health Care Blog and on Maggie Mahar’s Health Beat Blog.

Developments In Domestic and Global HIV/AIDS Strategies

The White House recently released its HIV/AIDS strategy to reduce the number of new infections in the United States by 25% over the next five years.  During a press conference, President Obama observed that “[t]he question is not whether we know what to do, but whether we will do it.  Whether we will fulfill those obligations… to prevent a tragedy.”  Those obligations primarily concern reducing the number of new infections through HIV prevention programs, increasing access to and quality of care for those living with HIV, and decreasing HIV-related health disparities.  Right now there are 56,000 new infections in the United States every year.  Approximately 1.1 million Americans are living with HIV, but 1 in 5 don’t know it.

Advocates have criticized both the administration and Congress for failing to adequately fund HIV/AIDS efforts at home and abroad.  A recent AIDS Healthcare Foundation (AHF) “Who’s Better on AIDS?” advocacy advertisement unfavorably compared President Obama’s track record to that of President Bush.  (In 2003, the Bush administration implemented the President’s Emergency Plan for AIDS Relief (PEPFAR), a multibillion dollar initiative which has proved successful in lowering the AIDS death rate in Africa, though not the rate of HIV infection).   Michael Weinstein, President of AHF, told CNN that:

“when you see what this administration has done on AIDS, you have to give them very low grades.”

Obama has “consistently underfunded AIDS” programs, Weinstein said.  The president “did not mention the word AIDS for the first five months of his administration.  This national AIDS strategy has been worked on for 15 months, [and] I think it could have been done in 15 minutes.  There’s nothing new in it.”

Weinstein [also] criticized the administration’s intention to redirect money to those groups at greatest risk of contracting HIV/AIDS.  “It’s not good to pit one group against another and it’s unnecessary,” he said.  “The bottom line is that we should be seeking to get all sexually active people to get an HIV test.”

Some recent Canadian research also suggests another bottom line: treating people with HIV reduces the number of new infections.  And there the treatment is free.

The Center for Disease Control (CDC) recently presented its findings that heterosexuals living below the poverty line ($10,000 or less) in American cities were twice as likely to be infected with HIV as their higher-income neighbors.  The statistics translate to 1 in 42 people (the national average is 1 in 222 people).  Most studies focus on sexual orientation, race, and/or intravenous drug use.  None of those factors were included here though.  Kevin Fenton, a CDC HIV/AIDS expert, said that “HIV clearly strikes the economically disadvantaged in a devastating way.”  Researchers found that the risk of spreading HIV came from a lack of access to medical care and unawareness of infection.  Dr. Carlos del Rio, Chair of Global Health at Emory University’s Rollins School of Public Health, frames the issue differently as “[y]ou can talk about ‘Can we decrease the HIV burden in the United States?’  I would say, ‘What can we do to decrease poverty in the United States?’”

The 18th International AIDS Conference took place last week in Vienna, Austria.  Policymakers, researchers, advocates, and persons living with HIV met to draw attention to the epidemic and assess the global response to it.  According to the Associated Press, Julio Montaner, President of the International AIDS Society and Chairman of the Conference, opened the event by pointing to how:

the G-8 group of rich nations has failed to deliver on a commitment to guarantee so-called universal access and warned this could have dire consequences.

“This is a very serious deficit,” Montaner said.  “Let’s rejoice in the fact that today we have treatments that work … what we need is the political will to go the extra mile to deliver universal access.”

With the global economic crisis in full swing, AIDS activists are concerned about developed countries reducing their foreign aid, including funding for AIDS assistance.

In its annual report released last week, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the Kaiser Family Foundation found that global AIDS spending has “flattened.”  Although public and private sources contributed $15.9 billion in 2009, the amount was $7.7 billion short of the estimated $23.6 billion needed to combat AIDS in low and middle-income countries.  Contributing governments included the U.S. (58%), United Kingdom (10.2%), Germany (5.2%), the Netherlands (5%), France (4.4%), and Denmark (2.5%).  The report noted that “without U.S. funding, international AIDS assistance from donor governments would have significantly declined between 2008 and 2009.”

Sunlight is a Weak Disinfectant

One of the most robust “memes” in contemporary law is the power of disclosure. In health law, disclosure comes up again and again: patients need to give “informed” consent, insurers are supposed to explain their policies clearly, and conflicts of interest, when not proscribed, should at the very least be exposed. But there are growing challenges to the disclosure meme, both within health law and without.

George Lowenstein and Peter Ubel note some problems with disclosure approaches in this article on the weaknesses of behavioral economics generally:

It seems that every week a new book or major newspaper article appears showing that irrational decision-making helped cause the housing bubble or the rise in health care costs. Such insights draw on behavioral economics, an increasingly popular field that incorporates elements from psychology to explain why people make seemingly irrational decisions, at least according to traditional economic theory and its emphasis on rational choice. . . . But the field has its limits. As policymakers use it to devise programs, it’s becoming clear that behavioral economics is being asked to solve problems it wasn’t meant to address.

[T]ake conflicts of interest in medicine. Despite volumes of research showing that pharmaceutical industry gifts distort decisions by doctors, the medical establishment has not mustered the will to bar such thinly disguised bribes, and the health care reform act fails to outlaw them. Instead, much like food labeling, the act includes “sunshine” provisions that will simply make information about these gifts available to the public. We have shifted the burden from industry, which has the power to change the way it does business, to the relatively uninformed and powerless consumer.

The same pattern can be seen in health care reform itself. The act promises to achieve the admirable goal of insuring most Americans, yet it fails to address the more fundamental problem of health care costs. . . . [T]he act tries to lower costs by promoting incentive programs that reward healthy behaviors. . . . [But s]tudies show that preventive medicine, even when it works, rarely saves money.

At its worst, disclosure can become merely pro forma; as Kafka (via Trudo Lemmens) puts it, “Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.” Omri Ben-Shahar has argued that disclosure is one of many aspects of consumer protection law with little real impact on individual welfare. As Amelia Flood reports,

Ben-Shahar, who spent last summer studying all the mandated disclosure statutes in Illinois, Michigan and California, argues that consumer protection advocates have gotten it wrong when it comes to mandating information access for consumers. He says consumers get lost in a sea of technical language, unread disclaimers and long-shot lawsuits. . . . According to Ben-Shahar, disclosures are of more use to consumer ratings groups like Zagat and Consumer’s Digest than they are to most consumers.

So perhaps there is some hope here: third-party aggregators and raters might use disclosures as part of an overall effort to rate various hospitals or doctors. The question then becomes–who shall pay (and rate) the raters? One irony here is that doctor rating sites have themselves been accused of being insufficiently transparent about the ways in which they evaluate physicians. New York Attorney General Cuomo even pursued the matter. His office eventually settled with insurers who ran rating sites. They pledged to “fully disclose to consumers and physicians all aspects of their ranking system.”

What’s the lesson here? First, that consumers are, by and large, too busy to process piecemeal disclosures by professionals like physicians and other health care providers. Second, third party raters can fill some of this information gap by aggregating information. Third, this process of aggregation and rating itself will likely need to be closely supervised by a good-faith regulator, lest it fail to take into account the full range of interests (and quality of information) proper for the task.

Access to HIV/AIDS Medicines

The Campaign for Access to Essential Medicines explains why UNITAID’s efforts to develop a patent pool of HIV/AIDS treatments are so important:

Meanwhile, the US health care finance system appears to be getting into a bit of a standoff with HIV/AIDS drug makers:

Without reliable access to the medications, which cost patients in the AIDS Drug Assistance Program an average of $12,000 a year, people with H.I.V. are more likely to develop full-blown AIDS, transmit the virus and require expensive hospitalizations. Eleven states have closed enrollment in the federal program, most recently Florida, which has the nation’s third-largest population of people with H.I.V.

The need for programs like the Health Impact Fund is more urgent than ever.

Disparate Impact and the Tanning Tax

I have previously blogged in favor of a vanity tax, so I was happy to see the health reform legislation included a 10% tax on tanning salons. But not everyone is so pleased to see it:

When an article about the fallout from the tax — which took effect last week — appeared on the Washington Post’s Web site Wednesday, dozens of commenters questioned the tax’s legality. The case can seem deceptively simple: Since patrons of tanning salons are almost exclusively white, the tax will be almost entirely paid by white people and, therefore, violates their constitutional right to equal protection under the law.

Randall Kennedy dismisses that claim out of hand. But I hope the angry tanners join me in endorsing a plan to address the grave injustice here: legal scrutiny of face-whitening creams. Tax tanning, tax lightening, and we may well move closer to a society that can transcend the fickle “beauty bias.”

Virginia, the First State to Challenge the Health Care Law in Court

Effective 2014, as part of the new health care law, most U.S. citizens will be required to obtain some type of health care insurance or be hit with a tax penalty.  This federal mandate is part of an effort by the Obama administration to use the penalty (or tax) to prevent uninsured Americans from shifting their $43 billion in healthcare costs to others.

However, this mandate did not sit well with some states, as many have filed suits seeking to invalidate the law.  Virginia was the first to butt heads with the federal government in court.  In a two-hour hearing, the federal government and Virginia both made their arguments before U.S. District Judge Henry E. Hudson.

The NY Times reports that Judge Hudson, “who was appointed by the first President George Bush, questioned both sides aggressively and said he would rule within 30 days. The judge predicted that the challenges to the health care law ‘will at some point in time define the outer boundaries’ of federal regulatory power.”

Although the hearing primarily concerned the issue of whether Virginia had legal standing to bring this claim, part of that analysis requires the court to look at the likliehood of the party seeking standing to have the injury alleged redressed. The requirements for standing are nicely stated in “The ‘Lectric Law Library“:

Standing. The legal right to initiate a lawsuit. To do so, a person must be sufficiently affected by the matter at hand, and there must be a case or controversy that can be resolved by legal action.There are three requirements for Article III standing: (1) injury in fact, which means an invasion of a legally protected interest that is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical; (2) a causal relationship between the injury and the challenged conduct, which means that the injury fairly can be traced to the challenged action of the defendant, and has not resulted from the independent action of some third party not before the court; and (3) a likelihood that the injury will be redressed by a favorable decision, which means that the prospect of obtaining relief from the injury as a result of a favorable ruling is not too speculative. Lujan v. Defenders of Wildlife, 112 S. Ct. 2130, 2136 (1992) (Lujan). The party invoking federal jurisdiction bears the burden of establishing each of these elements. Id.

The state here would seem to bear the burden of showing, among other things, that any harm that may or may not be experienced by its individual citizens is a concrete and particularized harm to the state itself. As for the crux of the issues beyond standing, The NY Times reports:

[States'] central argument is that the Commerce Clause of the Constitution cannot be interpreted to allow government penalties on Americans for refusing to buy a product, or as Virginia’s lawsuit puts it for “an absence of commerce.”

“We’re saying you can’t draft someone into activity so you can regulate him,” Virginia’s solicitor general, E. Duncan Getchell Jr., told Judge Hudson.

Mr. Getchell said the Justice Department’s defense of the law “evinces hostility to federalism.” He called the law “a radical, radical claim of power” that, if upheld, would allow the federal government to require citizens to buy most any commercial product in the name of advancing the national interest.

Ian H. Gershengorn, a deputy assistant United States attorney general, countered that the insurance requirement fitted well within the Supreme Court’s parameters for Congressional regulation of interstate commerce. A choice not to obtain coverage, he said, is not inactivity, as Virginia and the other state plaintiffs claim, but an active decision to pay for future medical care out of pocket.  Because many Americans cannot afford the cost of surgeries and hospitalization, their choice to go uninsured shifts the uncompensated cost of their care to hospitals, taxpayers and commercial policyholders.

Despite Virginia’s efforts to protect the interest of the state and its citizens, not everyone in Virginia is pleased with the state’s action to nullify the new health care law.  Some citizens of Virginia seemed more concerned about affordable health care than state’s rights.  As one small business owner puts it, “…seems to me that our attorney general and our current administration are putting politics first and are not taking care of the citizens of the commonwealth of Virginia.”

The Attorney General of Virginia, Ken Cucinelli “said at a news conference after the hearing that the state has “a better than even chance of prevailing” at each step along the way to the lawsuit’s ultimate destination: the U.S. Supreme Court.”

Judge Hudson’s comment, that “the health care law ‘will at some point in time define the outer boundaries’ of federal regulatory power,” is interesting in this context. It seems to denote a question, even if not answered at this time, as to where the line lay.

Professor Mark Hall, in posts here at HRW and later picked up by the Washington Post and New York Times, would beg to differ with Mr. Cucinelli (and perhaps Judge Hudson). Professor Hall’s posts appear below:

Is it Unconstitutional to Mandate Health Insurance?

Are The Attorneys General’s Constitutional Claims Bogus?

photo credit, kjd via Flickr

Our Own Devices

Health care finance is always going to be a contentious topic. Two recent stories about devices in health care show the unexpected ways in which technological innovation can generate new burdens, worries, and ethical dilemmas for patients and their families.

Katy Butler authored a heart-rending account of her father’s decline (and her mother’s near-exhaustion as a caregiver) in the NYT last week. Her father’s stroke changed both his and Butler’s mother’s lives:

The day before [the stroke], my mother was an upper-middle-class housewife who practiced calligraphy in her spare time. Afterward, she was one of tens of millions of people in America, most of them women, who help care for an older family member.

The story of what happens next is long and complex, but for health policy makers the nub comes down to a decision the family must make about whether to implant a permanent pacemaker when her father needs surgery to repair a hernia:

[T]he cardiologist, John Rogan, refused to clear my dad for surgery unless he received a pacemaker. . ..  The decision fell to my mother — anxious to relieve my father’s pain, exhausted with caregiving, deferential to doctors and no expert on high-tech medicine. She said yes. One of the most important medical decisions of my father’s life was over in minutes. . . .

[If my father's primary care physician had] had the chance to sit down with my parents, he could have explained that the pacemaker’s battery would last 10 years and asked whether my father wanted to live to be 89 in his nearly mute and dependent state. He could have discussed the option of using a temporary external pacemaker that, I later learned, could have seen my dad safely through surgery. But my mother never consulted Fales. And the system would have effectively penalized him if she had. Medicare would have paid him a standard office-visit rate of $54 for what would undoubtedly have been a long meeting — and nothing for phone calls to work out a plan with Rogan and the surgeon.

Medicare has made minor improvements since then, and in the House version of the health care reform bill debated last year, much better payments for such conversations were included. But after the provision was distorted as reimbursement for “death panels,” it was dropped. In my father’s case, there was only a brief informed-consent process, covering the boilerplate risks of minor surgery, handled by the general surgeon.

Butler’s family’s situation was clearly a troubling one. I do not agree with her harsher critics, who charge the New York Times has used her story to promote its political agenda:

The New York Times is continuing its promotion of the Obama administration’s cost-cutting health care legislation three months after it was signed into law. Central to the newspaper’s support for the bill is its drive to cut back on “unnecessary” treatments and procedures and to target for elimination “overly generous” insurance benefits. . . . The article is a cynical attempt to utilize the author’s family’s personal story—unarguably tragic and heartrending—to make the case that artificial pacemakers are being widely over-utilized.

But I was also troubled by Butler’s quoting the following studies:

In a 1997 study in The Journal of the American Geriatrics Society, 30 percent of seriously ill people surveyed in a hospital said they would “rather die” than live permanently in a nursing home. In a 2008 study in The Journal of the American College of Cardiology, 28 percent of patients with advanced heart failure said they would trade one day of excellent health for another two years in their current state.

I have not experienced “advanced heart failure,” but I know people who do, and it’s inconceivable to me that they would trade a day of “perfect health” for two months, much less two years, of stasis. Moreover, as Alasdair MacIntyre argues in his book Dependent Rational Animals, caring for others and being dependent are essential, important human experiences.

As I read Butler’s piece, I kept wishing that society had done more (perhaps along the lines of Britain’s Social Care programs) to help her family.

But even some forms of aid for the cared for (and their caregivers) are filled with philosophical complexities. Consider the Paro, a robotic seal I blogged about in last month and back in 2006. The Paro has been approved as “a Class 2 medical device (a category that includes powered wheelchairs)” to help soothe elderly patients. Here is one example of its powers:

One recent morning, staff at Marian Manor in Pittsburgh, one of Vincentian Collaborative’s homes, circulated three Paros among residents gathered for a sing-a-long. As 77-year-old Anita Biro sat down at a table, she berated two fellow residents and told them to leave, recalls Beth Kuenzi, activities manager for the home’s dementia unit. But when Ms. Kuenzi put Paro in front of Ms. Biro, her mood changed. As Ms. Biro stroked the robot’s synthetic fur, the machine batted its eyelashes and tracked movement with its head and eyes.

“I love this baby,” Ms. Biro cooed. Aides also take Paro to residents’ rooms to get them to socialize. At another Vincentian home, Lois Simmeth, 73, doesn’t always participate in group activities, but she ventures into the hall when she hears Paro’s sounds.

“I love animals,” explains Ms. Simmeth. She whispered to the robot in her lap: “I know you’re not real, but somehow, I don’t know, I love you.”

MIT Professor Sherry Turkle concedes that the Paro has some very good effects, but wonders “Why are we so willing to provide our parents, then ourselves, with faux relationships?” Another article explores advances in “building a machine that fills the basic human need for companionship.” Turkle, again, questions the larger social context:

[S]ome social critics see the use of robots with such patients as a sign of the low status of the elderly, especially those with dementia. As the technology improves . . . it will only grow more tempting to substitute Paro and its ilk for a family member, friend — or actual pet — in an ever-widening number of situations.

“Paro is the beginning,” she said. “It’s allowing us to say, ‘A robot makes sense in this situation.’ But does it really? And then what? What about a robot that reads to your kid? A robot you tell your troubles to? Who among us will eventually be deserving enough to deserve people?”

These are all fantastic questions, all-too-ready to be answered by techno-libertarian fantasists. I look forward to tracing the degree to which the decision to approve Paro as a covered device could reflect the larger ethical concerns explored by Dov Fox in his piece on the “gap between ethics and law” in other health decisionmaking.

Caring for Dogland

I always applaud health scholarship that incisively examines inequalities of access in the United States. However, sometimes it’s important to contextualize that work by emphasizing the degree of global inequality that makes even the poor in the US relatively well off by world standards. The following passage from Korzeniewicz & Moran’s 2009 book, Unveiling Inequality gives some sense of the divergence:

The magnitude of global disparities can be illustrated by considering the life of dogs in the United States. According to a recent estimate . . . in 2007-2008 the average yearly expenses associated with owning a dog were $1425 . . . For sake of argument, let us pretend that these dogs in the US constitute their own nation, Dogland, with their average maintenance costs representing the average income of this nation of dogs.

By such a standard, their income would place Dogland squarely as a middle-income nation, above countries such as Paraguay and Egypt. In fact, the income of Dogland would place its canine inhabitants above more than 40 percent of the world population. . . . And if we were to focus exclusively on health care expenditures, the gap becomes monumental: the average yearly expenditures in Dogland would be higher than health care expenditures in countries that account for over 80% of the world population. (xv)

Certainly public policy should take into account the problem of relative deprivation, which can lead to a much worse subjective experience for those at the “bottom” of the SES distribution in a rich country than those in the middle in a poorer country. Nevertheless, the statistics above help us understand why drug companies, already frustrated by low ROI in R&D, might shift from researching cures for tropical diseases to focusing on pet anxiety medications.

The Ultimate Ends of Health Care

“I don’t want to achieve immortality through my work,’ Woody Allen said, “I want to achieve it through not dying.” The “Singularity University” is attracting Silicon Valley glitterati who think along the same lines:

[T]he Singularity — a time, possibly just a couple decades from now, when a superior intelligence will dominate and life will take on an altered form that we can’t predict or comprehend in our current, limited state . . . [will lead to a world where] human beings and machines . . . so effortlessly and elegantly merge that poor health, the ravages of old age and even death itself will all be things of the past.

Some of Silicon Valley’s smartest and wealthiest people have embraced the Singularity. They believe that technology may be the only way to solve the world’s ills, while also allowing people to seize control of the evolutionary process. For those who haven’t noticed, the Valley’s most-celebrated company — Google — works daily on building a giant brain that harnesses the thinking power of humans in order to surpass the thinking power of humans.

Ezra Klein skewers the techno-utopianism, toying with the idea that we may well be robotized before we get electronic medical records:

Right now, one of the top stories on the New York Times site is about how human beings are going to become people-computer hybrids and live forever and that vision actually seems semi-plausible until you realize that all the information about the operation to download your memories into a Macintosh will probably be kept in a manila folder in a large filing cabinet, and then it doesn’t seem so likely.

But Klein neglects the trends toward tiering in the medical system, which may well continue forking into “upper decks” where anything is possible and nether realms of penury. As Andrew Orlowski comments, “The Singularity is . . . . rich people building a lifeboat and getting off the ship.” I think that progress in bioethics depends on a rejection of that kind of thinking in favor of a more solidaristic orientation toward the needs of the worst off. As I stated in 2002,

We are all disturbed by hypothetical dystopias like Huxley’s Brave New World. But their most important flaws - the inequality, degradation, and moral irresponsibility of their inhabitants - are already apparent in [some aspects of life in the] world’s wealthiest nations[, which] spend hundreds of millions of dollars on elaborate technologies of life-extension, while contributing much less to efforts to assure basic medical care to the poorest. Public debate on regenerative medicine must acknowledge this inequality. Societies and individuals can invest in it in good conscience only if they are seriously committed to extending extant medicine to all.

If “Singularity University” turns out to be a prime philanthropic initiative of the Google guys, while the Bill and Melinda Gates Foundation sticks to “progress in fighting hunger and poverty,” I know which tech company I’ll be rooting for.

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