CVS Pharmacy (“CVS”), reportedly the largest retail pharmacy chain, has agreed to pay the Department of Health and Human Services (“HHS”) $2.25 million and submit a Corrective Action Plan (“CAP”) to HHS after an extensive nationwide investigation by the HHS Office of Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) which revealed that CVS employees disposed of protected health information (“PHI”) in violation of the Health Insurance Portability and Accountability Act’s (“HIPAA”) Privacy Rule. In addition, CVS Caremark, the parent company of CVS, simultaneously entered into a Consent Order with the FTC to resolve claims that CVS had engaged in unfair or deceptive trade practices in violation of the FTC Act by failing to use reasonable and appropriate measures to prevent unauthorized access to PHI and by disseminating a false or misleading privacy notice about CVS’s protection of PHI. In the Consent Order, the FTC specifically highlighted CVS’s failure to render PHI unreadable before disposal as well as its claim in its privacy notice that maintaining the privacy of its customers’ PHI was central to its operations as examples of unfair or deceptive trade practices. The CVS settlement is noteworthy for two reasons: (1) it is the first joint enforcement action between OCR and the FTC and (2) although it is the second substantial monetary settlement for alleged HIPAA violations, the $2.25 million resolution amount dwarfs the first settlement for $100,000 between HHS and Providence Health in July 2008.
In 2006, media exposés revealed that CVS employees disposed of prescription drug bottles with labels containing patient information, pharmacy orders, and other items potentially containing PHI in unsecured dumpsters that could be accessed by anyone. These exposés prompted a joint investigation between the OCR and the FTC which the agencies allege confirmed the allegations against CVS and resulted in the payment of the resolution amount, the CAP, and the FTC Consent Order.
The CAP, which applies for three years, requires CVS to: (1) develop privacy policies and procedures that provide for administrative and physical safeguards for the disposal of all non-electronic PHI; (2) implement a training program that instructs employees on how to adequately dispose of PHI; (3) develop plans to monitor compliance and report any noncompliance with the privacy policies and procedures; and (4) engage an independent third-party to conduct an assessment of CVS’s compliance with the privacy policies and procedures. The CAP also requires CVS to provide an initial “Implementation Report” as well as an annual “Periodic Report” to the OCR and to retain all documents related to compliance with the CAP for six years. The Consent Order with the FTC, which applies for twenty years, requires CVS to establish and implement a comprehensive information security program designed to protect the security, confidentiality, and integrity of customer personal information and to engage an independent third party to conduct an initial assessment of CVS’ compliance with its privacy procedures (which can be the same assessment required by the CAP) as well as biennial assessments thereafter for the remainder of the twenty-year duration of the Consent Order.
The CVS settlement is just one of several recent developments that may herald the dawn of a new era of increased HIPAA enforcement. Last November, the HHS Office of Inspector General published a report that encouraged the Centers for Medicare and Medicaid Services (“CMS”), which enforces HIPAA’s Security Rule, to conduct more frequent compliance reviews of HIPAA-covered entities. This week, President Obama signed the economic stimulus package into law, which requires HIPAA-covered entities to notify affected individuals, HHS and the media of information security breaches, and also substantially revises HIPAA, providing for steeper fines and enabling state Attorneys General to bring enforcement actions for HIPAA violations.