Rethinking IMS Health v. Sorrell: Privacy as a First Amendment Value

Today the Supreme Court will hear oral arguments in IMS Health v. Sorrell. The case pits medical data giant IMS Health (and some other plaintiffs) against the state of Vermont, which restricted the distribution of certain “physician-identified” medical data if the doctors who generated the data failed to affirmatively permit its distribution.* I have contributed to an amicus brief submitted on behalf of the New England Journal of Medicine regarding the case, and I agree with the views expressed by brief co-author David Orentlicher in his excellent article Prescription Data Mining and the Protection of Patients’ Interests. I think he, Sean Flynn, and Kevin Outterson have, in various venues, made a compelling case for Vermont’s restrictions. But I think it is easy to “miss the forest for the trees” in this complex case, and want to make some points below about its stakes.**

Privacy Promotes Freedom of Expression

Privacy has repeatedly been subordinated to other, competing values. Priscilla Regan chronicles how efficiency has trumped privacy in U.S. legislative contexts. In campaign finance and citizen petition cases, democracy has trumped the right of donors and signers to keep their identities secret. Numerous tech law commentators chronicle a tension between privacy and innovation. And now Sorrell is billed as a case pitting privacy against the First Amendment.
Read more

Recommended Reading: Interesting Takes on the Individual Mandate

In her pithy, provocative essay The Freedom of Health (forthcoming in the University of Pennsylvania Law Review), Abigail Moncrieff argues that there exists a nascent constitutional right to “freedom of health” — that is, to “individual autonomy in healthcare decision-making.”  The right is primarily a negative one, a “freedom to reject care” not to demand it (in contrast to the international human “right to the highest attainable standard of health”).  But Professor Moncrieff argues that there is also a “freedom to obtain care” that is “implicit in and therefore tethered to the [Supreme] Court’s reproductive rights jurisprudence” but which “also gained five non-precedential votes in the assisted suicide case.”  Among other implications, Professor Moncrieff argues that the freedom of health complicates the analysis of the constitutionality of the Patient Protection and Affordable Care Act’s individual mandate.  She explains that

“today’s insurance contracts are not mere risk pools, gathering and distributing funds for healthcare consumption at the discretion of the insured.  Instead, today’s contracts give insurers variable amounts of discretion, under ‘medical necessity’ review, to decide whether or not their insured can buy various kinds of healthcare with the pool’s money.  That is, insurance companies today use their contracts to steer individuals towards certain healthcare consumption decisions, often refusing to cover treatments that they deem ineffective, unnecessary, or even just inordinately costly. … There seems, therefore to be a colorable claim that the mandate infringes the freedom of health by requiring individuals to enter discretion-limiting insurance contracts–requiring individuals to give a third-party insurer the power to influence or even to direct their healthcare spending.”

While Professor Moncrieff ultimately concludes that PPACA’s individual mandate does not unconstitutionally impinge on the freedom of health because it is narrowly tailored to achieve the compelling government interests in “[e]xpanding health insurance coverage and decreasing costs of insurance on the individual market,” this in no way diminishes the timeliness or relevance of her essay.  It seems inevitable that we will confront much closer cases in the not-too-distant future.

Theodore Ruger’s Can a Patient-Centered Ethos Be Other-Regarding?  Ought It Be? (published as part of a symposium on patient-centered health and ethics at 45 Wake Forest L. Rev. 1513 (2010)) also takes on the individual mandate, explaining that it “reflect[s] the principle of group solidarity” in that it “will drive more healthy Americans into larger private risk pools, and the prices they pay will in many cases be higher than is appropriate for their own age- and health-adjusted actuarial risk; this mandate will effectively result in a redistributive tax on youth and good health.”  Professor Ruger’s essay explores the tension between, on the one hand, the principle of group solidarity reflected in the individual mandate and elsewhere in PPACA and, on the other, the “preference for individualization in American medicine” and “the correlative resistance to therapeutic standardization among providers and patients.”  Professor Ruger notes that there is a “normative clash” between those who believe “medicine could be, or ought to be, standardized through collectivized expert agencies” and those who favor a “patient-centered conception of decisional authority.”  Disputes like the controversy in late 2009 over the United States Preventive Services Task Force’s breast cancer screening recommendations, are “bound to recur in a system that is becoming increasingly interconnected, particularly given the scholarly and bureaucratic interest in giving greater prominence to expert cost-effectiveness research and best-practices standardization.”  Professor Ruger discusses several ways that “concern for broader systemic goals” might be incorporated into a “patient-centered ethos of medical care,” but is skeptical that medical ethics will, or ought to be, dislodged from its individualistic focus.  Instead, he concludes his thought-provoking essay by raising the possibility of “enhanc[ing] sensitivity to patient concerns on the part of the public and private institutions that in future decades will exert more standardizing and collectivizing pressures on the individual therapeutic relationship[.]“

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.

Who’s the New Guy? – Obama Announces Choice for Next CMS Director

President Obama has announced his choice for the position of director of the Centers for Medicare & Medicaid Services (CMS), Dr. Donald Berwick, a pediatrician, professor, and advocate of improving patient care.  The CMS has been without a permanent administrator since 2006.  Berwick, whose appointment must be approved by the Senate before he may assume the position, certainly has the credentials for the important role the CMS director will surely play in the coming years.  Still, whether Republican Senators will be basing their confirmation decision on credentials or resentment of health care reform’s passage is yet to be seen.

Berwick is best known for founding the Institute for Health Care Improvement.  The Institute for Health Care Improvement is a non-profit think tank that is dedicated to helping hospitals improve their patient care delivery.  As attested to by the Institute’s co-founder Dr. Paul Batalden, Berwick takes incremental approaches to improving patient care that are cost-effective and do not lead to the rationing of care.  For example, Berwick finds that reducing the prevalence of hospital-acquired infections through something as small as keeping medical equipment sterile can help to bring down the rate of medical errors.

Berwick is also a proponent of utilizing medical information sharing, and is often called blunt in regard to how he finds the American health care system inefficient in delivering patient care.  Additionally, Berwick has advocated for patient rights on numerous levels, using a philosophy of patient-centered medicine.  He wants doctors to be rewarded based on the health care outcomes of their patients instead of how many procedures a doctor has performed. Having a leader interested in implementing infrstructural changes which incentivize outcomes as opposed to procedures as paydays without regard to outcome, is, many think, a step in the right direction. It is also worth noting that Berwick himself will be taking more than a 66% pay cut if he is appointed as the director of the CMS.

While Berwick may not have functioned as the head of a health care system in his career, he is not new to the world of national health policy.  In 1998, he was on President Clinton’s advisory commission that recommended ways to reduce medical mistakes and ensure consumer protection in the American health care system.  And also served at that same time as  Chair of the agency that is now known as the Agency for Healthcare Research and Quality. Berwick has also played a part in improving Britain’s National Health Service, for which he was given an honorary knighthood by Queen Elizabeth II.

Since Obama’s health care overhaul “contemplates key roles for both programs in extending insurance coverage to 32 million people at a cost of $938 billion over 10 years,” if selected to be the CMS’s director, Berwick will certainly need to bring his A-game in helping change the way our current health care system consumes Medicare and Medicaid resources.  Many also hope that good Medicare reforms will start a trend, motivating private insurance companies to also make cost-saving changes.  Before that challenge, Berwick will have to get past a Senate confirmation.  Republican Senators are likely going to make the process a rigorous one, where they will grill Berwick on how exactly he plans to effect the new health care reform legislation.

Given the importance of the CMS and the fact that it currently has no director, it would behoove the Senate to quicken the process of Berwick’s selection, considering his credentials and commitment to the rights and needs of American patients.  As the Washington Post said, “supporters and opponents of the new health-care legislation ought to be able to agree that leaving the agency without a confirmed head is not healthy.”  The job needs to be filled, and instead of using political tactics through rehashing the health care reform debate, the Senate should focus on the many qualities that Berwick has to offer.