HealthLawProf Blog

Court Will Examine Legality, Not Merits, of Health Care Reform

Professor Jennifer Bard of Texas Tech University School of Law makes the point in an Op Ed written for the Houston Chronicle that "[w]hatever the opinion Supreme Court decides about the constitutionality of the Affordable Care Act (ACA), one thing is certain: it will not be based on an assessment of the merits of a national health care system." She goes on to explain that the Supreme Court's ruling on ACA 

will be a ruling about whether there is explicit constitutional authority for the way Congress chose to fund a system to make health insurance affordable and accessible to all Americans. In other words, the decision is about how Congress chose to fund the system it set up, not the system itself.

There is no legal dispute, either in the written opinions of in any of the courts that have reviewed the bill so far, or among anyone else, that Congress has the power to spend the money it collects in any way it believes will promote the nation's best interests. Article 1, Section 8, Clause 1 of the U.S. Constitution gives a lawfully elected Congress the power to tax and spend the money collected in order to promote the "general welfare" of the country. Since then, the Supreme Court has interpreted this clause very broadly and granted Congress nearly unlimited discretion in deciding what does, and does not, promote the general welfare. The dispute here is about whether Congress acted within its authority in how it structured the finances of this law, not about the law's merits.

There would be no Supreme Court case if Congress had raised taxes and implemented a 100 percent federally funded national health care system. This is because the Constitution is explicit in granting Congress "spending power," and no individual citizen, or state, can make a legal challenge to how Congress spends its money. The remedy we have for Congress raising taxes and spending the money in ways we do not like is to vote them out of office.

Just as the court would not be able to review Congress' decision to fund health care had it done so by raising taxes, it could also not review a decision to fund college tuition or, for that matter, lawn care (which it does by making home mortgage interest deductible).

This matter is before the Supreme Court because rather than face the bad publicity of raising taxes, Congress chose a way to fund increased access to health care by making it impossible for free riders to take advantage of the system. The way the "mandate" works is to provide everyone with access to affordable health insurance, but allow no one to game the system by choosing not to pay for it while they were healthy and then taking advantage of the coverage when they got sick. Again, the Supreme Court isn't interested in whether or not preventing freeloading is a good idea. It's interested in whether Congress has the authority to solve a problem that is sapping our country's strength - lack of access to affordable health care - without raising taxes.

The money that people are spending on health care and on very expensive health insurance is money they are not spending on houses, cars, services or other goods necessary to get the economy going again.

No mistake, the legal issues about the extent of Congress' authority to raise money without raising taxes are very interesting ones that will keep many a law professor busy for the far foreseeable future. But to suggest, as many commentators and politicians have, that if the Supreme Court strikes down ACA it is because it has decided it won't work or because people don't like it is, at best, wrong. And to further state that this is a good thing because the Supreme Court is listening directly to the voice of the people is extremely worrisome. Congress, consisting of those folks we vote for to represent us in Washington, is the "voice of the people." The Supreme Court is the voice of the Constitution. And the court's job is to make sure that the federal government doesn't overstep its boundaries by taking on powers not authorized by the Constitution.

So whether the court issues an opinion that upholds the ACA in some form or that strikes it down completely, it's important to remember that this will be a decision based on "inside the Constitution" issues that are most often heard inside a law school classroom. The court's decision on the legality of the act will be based on how Congress chose to raise the money to pay for it - not on whether or not it was worth paying for. A decision striking down the act doesn't mean the Constitution prohibits the government from subsidizing or even paying completely for health care or that our current system of financing health care works, and a decision upholding it does not mean the Supreme Court thinks it will increase access to affordable care.

[KVT]

Guest Blogger Leslie Francis: Of “Datapaloozas”: Their Delights—and Dangers

For the last three Junes, HHS has sponsored “Datapaloozas”: summits (otherwise known as the “Health Data Initiative Forum I, II, and III”) designed to highlight the vast resources of health information possessed by the federal government (and elsewhere); to showcase the impressive knowledge to be gained from their use; and to stimulate the development of innovative consumer, community, and industry tools that capitalize on their capabilities.  These data summits have so grown in popularity that they are now held in the Washington, D.C., Convention Center.  Todd Park, the dynamic former chief technology officer of HHS and now White House chief technology officer, is the enthusiastic champion of these events.  “Data liberation” is the rallying call.

These events are moments of genuine excitement.  This year’s was keynoted by a speech from HHS Secretary Sebelius, highlighting the importance of innovation in health care.  Attended by over 1600 people, the Datapalooza starred “Rockstars” of health care innovation—and also featured the music of at least one more conventional rock star, Jon Bon Jovi.  Major sponsors of this year’s Datapalooza were the Robert Wood Johnson Foundation; the California HealthCare Foundation; the Department of HHS; the Institute of Medicine; esri, a commercial provider of geospatial technologies; Healthways, a commercial provider of well-being services; the Jewish Healthcare Foundation; and Feinstein Kean Healthcare, a communications firm serving the health care industry.  As this sponsor list indicates, the Datapalooza is of great public health, research, and commercial interest.

A primary feature of these Datapaloozas is prizes for health apps that demonstrate creative marriages of technology and data in the effort of improving individual or community health.  At this year’s event, the RWJ Foundation announced that Symcat’s symptom checker was the winner of its $100,000 developer challenge prize. Symcat is a start-up company founded by two medical students at Johns Hopkins that uses “big data” analysis to help consumers make good decisions about their health.  Using Symcat, consumers can enter information about their symptoms, receive information drawn from CDC data, and get physician referrals drawn from RWJ data. 

Another prize awarded at the Datapalooza is “Go Viral to Improve Health,” a challenge for college and university students offered by the Institute of Medicine.  The goal of the challenge is to develop an app or a social networking platform that responds to their community’s health needs.  This year’s winner of the $10,000 prize was VaxNation, an app that lets families keep up with their immunizations.  At the Datapalooza, Aetna announced another large prize—of $100,000 to be shared between two winners of a challenge to develop apps for Aetna’s CarePass Platform.

Many other apps were also featured at the Datapalooza, some in plenary or breakout sessions and others in a large exhibition space.  Among the featured companies were Castlight Health, a “Health Care Shopping breakthrough” allowing consumers and companies to reduce costs; Humetrix, with its iBlueButton app that allows patients to download health information for their providers; MEDgle, a scalable decision support tool for both physicians and patients; and myDrugCosts, an app that allows consumers to search for lower cost generic equivalents of  drugs they have been prescribed,

Not all of the featured apps were commercial, either. For example, the Cancer Survivor Query System maintained by the National Cancer Institute allows patients to input individual data to estimate their survival probabilities given different treatment options.  This system uses public use data sets to generate the predictive information.

In many respects, these developments are to be celebrated.  Open government—and open governmental resources—bring a wide variety of public benefits.  But there is a dark side.  With data flows and data uses come the obvious data risks—to security, privacy, and confidentiality.  HIPAA—the current regulatory structure applying to most of the information gleaned in patient care today—is not up to the Datapalooza challenge, for several important reasons, two of which I’ll highlight in this post.

First, HIPAA simply gives de-identified data a pass.  Data that have been de-identified to its standards are not considered protected health information and so do not come within HIPAA’s scope.  Most of the data employed by the Datapalooza developers is de-identified data, hence outside of HIPAA. There is much controversy about the likelihood that de-identified data can be re-identified—but agreement that probabilities rise with the combination and increased power of data sets.  Combinations—“mash ups”—of data are exactly what the Datapalooza is intended to encourage.  Even without re-identification, an additional concern about the use of de-identified data is the probability of drawing reliable inferences about individuals once data cells are sufficiently small and populations sufficiently homogeneous.  And there is always the question of whether everyone whose data are involved in a particular use would be happy—or at least not morally outraged—by the use of data drawn from them in that way.

Second, under the HIPAA privacy rule data transfers for public health purposes do not require patient authorization, at least as long as they are public health purposes authorized by appropriate law.

 Perhaps this is as it should be, given the importance of public health to communities.  Nonetheless, this means that patients may be largely unaware of data flows that are occurring and must trust public health entities to protect data adequately both when data are used by the entities themselves and when the data are made available to others.  Without careful agreements to ensure that downstream uses remain appropriate—and supervision to follow up—public data may be at genuine risk.

My goal in this post has not been to downplay the genuine accomplishments of the Datapalooza, nor could it be.  But it has been to highlight the variety of activities that are being encouraged, and the importance of adequate security and privacy protections to accompany them.  Next year, I would hope to see a “security” or “privacy” challenge at least as rich as the one offered by the IOM to college and university students. 

- Leslie Francis

Trusting PhRMA?

I might have been persuaded by Justice Stephen Breyer's dissent on behalf of drug company sales representatives in Christopher v. SmithKline until I got to his reliance on the ethics code of the Pharmaceutical Research and Manufacturers of America (PhRMA). [The majority rejected a claim by sales representatives (detailers) that they were entitled to overtime pay under the Fair Labor Standards Act because they were not really engaged in sales.]

As Breyer observed, the PhRMA ethics code "refers to detailers as 'delivering accurate, up-to-date information to healthcare professionals'" and "explains why a detailer should not (hence likely does not) see himself as seeking primarily to obtain a promise to prescribe a particular drug, as opposed to providing information so that the doctor will keep the drug in mind with an eye toward using it when appropriate" (emphasis added).

Perhaps Breyer is correct that drug company detailers see themselves as educators, rather than salespersons, in accordance with the PhRMA ethics code. But it's difficult to square that view with the reality of the detailers' compensation. As the majority pointed out, detailers receive substantial incentive pay (more than 30 percent of gross pay for one of the plaintiffs) that is based on sales volume of the detailers' assigned drugs in their sales territory. They are not given bonus pay based on the extent to which doctors in their sales territory are knowledgeable about their assigned drugs.

Breyer's dissent is also difficult to square with his dissent in Sorrell v. IMS Health last year. In supporting restrictions on the use of patient prescription data by detailers, Breyer characterized the activities of detailers as "sales discussions." He also defended the restrictions on the ground that they would counter the tendency of the data to "help sell more of a particular manufacturer's particular drugs . . . by diverting attention from scientific research about a drug's safety and effectiveness."

When I worked at the American Medical Association and helped develop its ethics guidelines on the relationship between physicians and drug companies, I remember meeting a detailer who was responsible for promoting just one drug. You can bet he was consumed with generating high sales of the drug.

[DO] [cross-posted at Concurring Opinions]