Data Privacy & Security/HIPAA/HITECH

Backing up electronic health record data may become an important aspect of complying with and mitigating risk under the Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) if the U.S. Health and Human Services Office of Civil Rights (OCR) heeds legislators’ recommendations.

On April 29, 2016, the Joint Commission released an update (“Update”) providing for the use of text messaging to submit orders for patient care, treatment, or services to the hospital or other health care settings for all accreditation programs. Back in 2011, the Joint Commission believed that the technology necessary to secure contents of a text message, verify the identity of the person sending the message, and retain the original message within the medical record were not readily available, and, therefore, prohibited the use of text messaging to submit orders. However, this has changed as reasonably accessible technology has been developed which mitigates the security and record retention risks the Joint Commission previously identified. In the Update, the Joint Commission said, “effective immediately, licensed independent practitioners or other practitioners in accordance with professional standards of practice, law and regulation, and policies and procedures may text orders as long as a secure text messaging platform is used and the required components of an order are included.”

Based on recent news stories and our experience, it appears that cybercriminals may be targeting healthcare providers with ransomware attacks. Publicly reported incidents and others of which we are aware have involved providers ranging from clinics and imaging centers to hospitals, and these entities have had to pay hundreds to thousands of dollars to gain access to their medical records, billing records or other vital computer systems – often after significant interruption of operations. On March 31, 2016, the U.S. Dept. of Homeland Security issued an alert about these attacks as a result of recent attacks on businesses including healthcare facilities and hospitals worldwide.

When governing information, it works well to identify and bundle rules (for legal compliance, risk, and value), identify and bundle information (by content and context), and then attach the rule bundles to the information bundles. Classification is a great means to that end, by both framing the questions and supplying the answers. With a classification scheme, we have an upstream “if-then” (if it’s this kind of information, then it has this classification), followed by a downstream “if-then” (if it’s information with this classification, then we treat it this way). A classification scheme is simply a logical paradigm, and frankly, the simpler, the better. For day-to-day efficiency, once the rules and classifications are set, we automate as much and as broadly as possible, thereby avoiding laborious individual decisions that reinvent the wheel.

Recent remarks made by the Centers for Medicare & Medicaid Services (“CMS”) Acting Administrator Andy Slavitt at a healthcare conference indicated that CMS will be ending the “meaningful use” electronic health record (“EHR”) Incentive Program in 2016, five years ahead of its original final end date of 2021. Acting Administrator Slavitt did not elaborate on the specifics of what will replace meaningful use, but stated it would likely be tied to the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) and would include various streamlined quality reporting programs. MACRA emphasizes a new Merit-Based Incident Payment System and alternative payment models, and according to Acting Administrator Slavitt, this new law warrants a new streamlined regulatory approach to EHR as well.

My New Year’s resolutions will likely be broken early and often in 2016. My consequences are mostly non-monetary: a few more pounds, a little less savings, and not winning the triathlon in my age group. Your consequences, as a HIPAA-covered entity or business associate, for not complying with the Privacy and Security Rules could be much greater, and could put you into serious debt to the HHS Office of Civil Rights (OCR). Therefore, we propose that you resolve now to become fully HIPAA compliant in 2016.

OCR delivered an early holiday gift, wrapped in the Director’s Sept. 23, 2015, report to the Office of Inspector General. In that report, she disclosed that OCR will launch Phase 2 of its HIPAA audit program in early 2016, focusing on noncompliance issues for both covered entities and business associates.

So, grab that cup of hot cocoa and peruse this review of 2014-2015 HIPAA enforcement actions, which should help identify noncompliance issues on which OCR will focus in 2016.

The Office of the Inspector General (OIG) for the U.S. Department of Health & Human Services recently published its Fiscal Year 2016 Work Plan, which summarizes OIG’s priorities over the coming year. Notably, the 2016 Work Plan demonstrates the OIG’s expanded focus on delivery system reform and the effectiveness of alternate payment models, coordinated care programs, and value-based purchasing.

There were also noteworthy areas of new focus for several provider types, including skilled nursing facilities, hospice organizations, ambulatory surgical centers, and physician practices.  Below we have highlighted a few key areas from the FY 2016 Work Plan that will likely impact these providers. Please note this is not intended to be a comprehensive summary of the 2016 Work Plan and is focused only on the new OIG focal areas for these certain providers.

Cancer Care Group, P.C. settled alleged violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules on September 2 with the U.S. Department of Health & Human Services Office for Civil Rights (OCR) for $750,000. Cancer Care, a radiation oncology private physician practice located in Indiana, also agreed to adopt a corrective action plan to remedy defects in its HIPAA compliance program.

The Anthem breach sent alarm waves through the health care industry and the employer health plan community. With 78.8 million affected individuals for Anthem and 11 million for the companion breach of Premera Blue Cross, the combined size ranks among the largest data breaches in history.

The Anthem and Premera breaches signal a sea change in the threat environment for health plans, a new reality that requires a fresh look at data security. Prudent employers with group health plans should take that fresh look now, by strengthening the data security provisions in their business associate agreements (BAAs) with third-party plan administrators, and also by updating their HIPAA-required security risk assessments.