Announcement Made 2 Days After OCR Announces $4.3 Million HIPAA Civil Penalty Against Cignet

General Hospital Corporation and Massachusetts General Physicians Organization Inc. (Mass General) has agreed to pay the U.S. government $1,000,000 to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.  The incident giving rise to the agreement involved the loss of protected health information (PHI) of 192 patients of Mass General’s Infectious Disease Associates outpatient practice The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced the Resolution Agreement two days after announcing that its first official assessment of a civil monetary penalty CMP under HIPAA – a $4.3 million against Cignet Health of Prince George’s County, Md., (Cignet).  Read more details here

HIPAA Privacy Rule restricts the use, access and disclosure by covered entities of PHI and other individually identifiable health care information to those outlined within the Rules.  Under HIPAA covered entities also are responsible for establishing and enforcing policies and procedures that safeguard PHI against improper use, access or disclosure by employees, business associates, and other third parties. Noncompliance with the Privacy and Security Rules exposes a covered entity to criminal prosecution and penalties, civil penalties or both.  The Privacy Rule requires health plans, health care clearinghouses and most health care providers (covered entities) to safeguard the privacy of patient information, including such information during its disposal.  Under amendments to HIPAA enacted under the HITECH Act, business associates now also are accountable and subject to direct liability for failing to comply with HIPAA’s requirements. Amendments to HIPAA under the HITECH Act, further expand the risks and responsibilities of health care providers and other covered entities.

Announced just two days before the Mass General Resolution Agreement, the Cignet CMP announced February 22, 2011 is the first CMP ever assessed by OCR under the HIPAA Privacy Rule.  The assessment resulted after OCR found Cignet violated 41 patients’ HIPAA rights and committed other HIPAA violations. The $4.3 million CMP against Cignet applies the expanded HIPAA violation categories and increased HIPAA civil monetary penalty amounts authorized by HIPAA amendments made by Section 13410(d) of the Health Information Technology for Economic and Clinical Health (HITECH) Act. Read more details.

Even before the Mass General Resolution Agreement and Cignet CMP announcements, HIPAA Privacy exposures of covered entities for failing to comply with HIPAA already had risen significantly.  While OCR had not assessed any civil monetary penalties against any covered entity for violation of HIPAA before Cignet, OCR’s collection of $1 Million from Rite Aid in a 2010 Resolution Agreement, $2.25 million from CVS Pharmacy, Inc. under a 2009 Resolution Agreement and $100,000 from Providence Health & Services under a 2008 Resolution Agreement demonstrated that covered entities could face significant civil liability for willful violations of the Privacy Rules.  In addition to these civil enforcement actions by OCR, the Department of Justice has secured several criminal convictions or pleas under HIPAA’s criminal provisions. OCR data confirms that the covered entities involved in these actions included health care providers, health plans, and others.  Coupled with the HITECH Act changes, these and other enforcement actions signal growing potential hazards for covered entities and their business associates that  fail to properly manage their HIPAA compliance obligations and risks.

The Mass General and Cignet announcements and other enforcement actions demonstrate that OCR is moving forward on its announced plans to hold health plans, health care providers, health care clearinghouses (covered entities) and their business associates that violate HIPAA accountable. Added to other recent developments, the Mass General and Cignet enforcement actions demonstrate that OCR’s commitment to enforcing HIPAA and illustrate the significant exposures that covered entities and business associates risk by disregarding their HIPAA obligations. 

As stated by OCR Director Georgina Verdugo when announcing the Mass General Resolution Agreement,  stating, “We hope the health care industry will take a close look at this agreement and recognize that OCR is serious about HIPAA enforcement. It is a covered entity’s responsibility to protect its patients’ health information.”

“To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules,” Verdugo added, “A robust compliance program includes employee training, vigilant implementation of policies and procedures, regular internal audits, and a prompt action plan to respond to incidents.”

Covered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures. Health plans and other covered entities as well as their business associates should tighten privacy policies, breach and other monitoring, training and other practices to mitigate against exposures in light of recently tightened requirements and new enforcement risks.  To minimize the potential that the health plan’s sharing of information with the employer will create or spread HIPAA or other privacy risks to the employer or members of its workforce, employers and other plan sponsors and members of their workforce also should take steps to ensure not only that their health plan documents, policies and procedures, as well as those policies and practices applicable to the employer, its human resources, and benefits advisors when accessing or handling health plan or other medical information on behalf of the employer, rather than the plan, are appropriately designed and administered.

Act To Manage HIPAA Exposures

In response to these expanding exposures, covered entities and their business associates should review the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration the Cignet, Rite Aid, Provident and CVS enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable.  As part of these compliance and risk management efforts, most covered entities and their business associates will find it advisable to devote significant attention to the business associate relationship and its associated business associate agreements.  

For Help With Investigations, Policy Review & Updates Or Other Needs

If you need assistance in auditing or assessing, updating or defending your HIPAA, or other health or other employee benefit, labor and employment, compensation, privacy and data security, or other internal controls and practices, please contact the author of this update, attorney Cynthia Marcotte Stamer at cstamer@solutionslawyer.net or at (469)767-8872.

The Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Committee, a Council Representative on the ABA Joint Committee on Employee Benefits, Government Affairs Committee Legislative Chair for the Dallas Human Resources Management Association, and past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer works, publishes and speaks extensively on HIPAA and other privacy and data security, health plan, health care and other human resources and workforce, employee benefits, compensation, internal controls and related matters.

For more than 23 years, Ms. Stamer has counseled, represented and trained employers and other employee benefit plan sponsors, plan administrators and fiduciaries, insurers and financial services providers, third party administrators, human resources and employee benefit information technology vendors and others privacy and data security, fiduciary responsibility, plan design and administration and other compliance, risk management and operations matters.  She also is recognized for her publications, industry leadership, workshops and presentations on privacy and data security and other human resources, employee benefits and health care concerns.  Her many highly regarded publications on privacy and data security concerns include “Privacy Invasions of Medical Care-An Emerging Perspective.” ERISA Litigation Manual. BNA, 2003-2009; “Privacy & Securities Standards-A Brief Nutshell.” BNA Tax Management and Compliance Journal. February 4, 2005; “Cybercrime and Identity Theft: Health Information Security beyond HIPAA.” ABA Health eSource. May, 2005 and many others.  She also regularly conducts training on HIPAA and other privacy and data security compliance and other risk management matters for a broad range of organizations including the Association of State and Territorial Healthcare Organizations (ASTHO), the Los Angeles County Health Department, a multitude of health plans and their sponsors, health care providers, the American Bar Association, SHRM, the Society for Professional Benefits Administrators and many others.  Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, and many other national and local publications. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see www.CynthiaStamer.com or contact Ms. Stamer directly.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also may be interested reviewing some of our other Solutions Law Press resources available at http://www.solutionslawpress.com including:

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If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at www.SolutionsLawPress.com.

©2011 Cynthia Marcotte Stamer.  Non-exclusive right to republish granted to Solutions Law Press.  All other rights reserved.