Balancing privacy, research, and care delivery

The following originally appeared on The Upshot (copyright 2015, The New York Times Company).

Researchers who want to study Medicare or Medicaid patients with substance-use disorders — and illnesses disproportionately affecting them like H.I.V. and hepatitis C — are, at best, working with biased data. At worst, they’re flying blind.

That’s because agencies within the Department of Health and Human Services, without public notice and because of patient privacy concerns,decided in 2013 to remove researchers’ access to certain types of Medicare and Medicaid data. Without these data — all relating, even tangentially, to patients with substance-use disorders — health researchers fear they will be hampered in their quest to improve care.

Consider patients seen by the Veterans Health Administration. Because patients use health care from other providers, too, a researcher might need to combine V.H.A. data with that from Medicare and Medicaid to assess and improve outcomes from treatment. Suppose treatment for alcohol addiction reduced the likelihood of an accident that would land a patient in the emergency room. Because many emergency room visits are outside the V.H.A. system, Medicare and Medicaid data are essential to measuring this effect of treatment. If researchers can’t see it, they can’t improve it. (Full disclosure: I am employed as a health economist with the V.H.A. The views expressed are my own and do not necessarily reflect the positions of the Department of Veterans Affairs.)

When health care researchers received Medicare and Medicaid data last year, some of them noticed — to their shock — that much of it was missing. (Because they weren’t told of this, many didn’t even notice until the news broke last December.)

All told, the suppression affects about 7 to 8 percent of inpatient hospital medical records or about 1 million Medicare or Medicaid beneficiaries. A smaller proportion of records pertaining to outpatient care and nursing home care is also withheld. The systematic removal of this much data can lay waste to a significant segment of research.

Pointing to decades-old regulations designed to protect patients’ privacy,Aaron Albright, Media Relations Group director for the agency overseeing Medicare and Medicaid, said that release of data pertaining to patients with substance-use disorders was not permitted “without patient consent.”

The caution is understandable. Substance-use disorders carry stigma. Some patient advocates have expressed concerns that medical data could be used by law enforcement to incarcerate patients or to separate children from their parents. Perhaps the information could be used to deny employment. Without robust privacy protections, these concerns could deter some patients from seeking treatment.

But as the University of Michigan law professor Nicholas Bagley and Idescribed in the New England Journal of Medicine, the problem for research is substantial. Because detailed, individual-level health care data from private insurers is often costly or difficult to obtain, for decades Medicare and Medicaid data have offered the best available window into health care use, outcomes and costs. And for all those years, those data were made available and in full.

Regulations that justify the withholding of these research data also stymie the delivery of health care. Doctors’ offices and hospitals are not allowed to share patient data pertaining to substance-use disorders or treatment without each patient’s consent to each transmission of information.

This may have been tenable when records were entirely on paper and were rarely shared across providers. But now that many have gone digital, with data sharing more commonplace and encouraged, it’s far more onerous. Many organizations, therefore, exclude such information from their electronic data systems, which can put patients at risk.

Imagine that a doctor sees a patient who does not disclose a history of opioid addiction, which was diagnosed at another doctor’s office. If that physician prescribes a narcotic painkiller, he could fuel the patient’s addiction, with potentially lethal results. But today, the prescribing physician couldn’t be told about the condition absent patient consent — even if the two physicians are working together to coordinate that very patient’s care.

Can we exchange and analyze patient data to improve care while minimizing the risk of and harm from breaches of privacy? It’s already standard for researchers to work in secure data environments. They’re already subject to criminal penalties if they don’t adhere to strict data protection protocols. You cannot obtain access to Medicare and Medicaid research data without submitting to those conditions.

Yes, as tight as the data protections already are, they could always be strengthened, though at some cost. (For example, access to certain types of Census Bureau data requires a background check, fingerprinting and an in-person interview.)

The current privacy protection pulls at some of the ambitions of health care reform.

The Affordable Care Act and other recent legislation promote the exchange of electronic medical data and analysis of such data to enhance the quality and efficiency of health care. In the midst of an opioid epidemic — as we are — and as we struggle to finance new and costly drugs for hepatitis C — which disproportionately affects drug users — the timing of the Medicaid and Medicare data suppression could hardly be worse.

The administration announced this month that it would be revisiting the relevant regulations. This gives the government an opportunity to balance privacy concerns with data access for research and coordination across providers.


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