NEJM Perspective Discusses Withholding of CMS Data Related to Substance Use Disorder and Its Impact on Research
Substance use disorder (SUD) affects 1 in 11 Americans over 11 years of age and is associated with more than 60,000 deaths in the United States each year; it also costs society hundreds of billions of dollars. Despite this, in November 2013 the Centers for Medicare and Medicaid Services (CMS) began to withhold from research data sets any Medicare or Medicaid claim with an SUD diagnosis or related procedure code. This move — the result of privacy-protection regulations overseen by the Substance Abuse and Mental Health Services Administration — affects about 4.5% of inpatient Medicare claims [recent research suggests this figure is closer to 7%] and about 8% of inpatient Medicaid claims from key research files, impeding a wide range of research evaluating policies and practices intended to improve care for patients with substance use disorders. As a consequence, VA researchers cannot see the full utilization of Veterans who also use Medicare- or Medicaid-financed healthcare. This Perspective summarizes the problem, quantifies it, describes how it arose, and argues that research access to such data should be restored.
The timing for the withholding of SUD-related data could not be worse. Just as states and federal agencies are implementing policies to address epidemic opioid abuse and coincident with the arrival of new and costly drugs for hepatitis C — a disease that disproportionately affects drug users — researchers are flying blind. The affected data sources include Medicare and Medicaid Research Identifiable Files, which contain beneficiary zip codes, dates of birth and death, and in some cases Social Security numbers. For tasks common to most health services research — such as combining patient-level data across systems (e.g., Medicare, Medicaid, or VA), associating them with community or market factors (e.g., provider density or type of health insurance plans available), or studying mortality as an outcome — these are essential variables. Moreover, many of the withheld data pertain to admissions for services that address not substance use disorders, but rather, conditions that may be exacerbated by substance abuse. Thus, the data suppression extends well beyond its intended domain, and the effects are much broader than they seem. As a result, it is now infeasible to conduct any study of patients with substance use disorders based on Research Identifiable Files. Studies of medical conditions disproportionately affecting such patients (i.e., hepatitis C or HIV) also will be hampered. Moreover, any study relying on those files cannot make full diagnosis-based risk adjustments that include SUD diagnoses, potentially leading to inaccurate data in regards to outcomes or quality among practices who that disproportionately treat persons with substance use disorders. Because the data have been altered in a systematic, nonrandom manner — with suppression affecting different populations, age groups, regions, and providers to different degrees — the results of many studies that have no apparent connection to substance use will be biased. Consequently, the federal government's new policy of withholding these important data may harm the very people it was meant to protect.
Dr. Frakt is part of Health Care Financing & Economics (HCFE) at the VA Boston Healthcare System.
Frakt A and Bagley N. Protection or Harm? Suppressing Substance Use Data. Perspective in The New England Journal of Medicine. April 15, 2015;e-pub ahead of print.