As part of an ongoing effort to ensure compliance with the HIPAA Privacy, Security, and Breach Notification Rules, the HHS Office for Civil Rights (OCR) has begun the second phase of audits for HIPAA covered entities. The first phase of the audits was conducted in 2011 and 2012 and evaluated the controls and processes implemented by 115 covered entities in order to comply with HIPAA’s requirements. This second phase of audits builds upon the findings of that first audit, and will address compliance efforts by both covered entities and their business associates.
The second phase of the OCR audits is focused primarily on compliance with HIPAA directives related to privacy, security, and breach notifications. Currently, details about the specific documentation that will be required is unavailable, but the OCR has noted that the audit will only deal with compliance with federal guidelines. Compliance with state regulations will not be addressed at all. Still, even though the specifics of the audit are still under wraps, now is a great time to review your own compliance with HIPAA rules and begin gathering documentation.
The HIPAA Audit Process: An Overview
Earlier this summer, the OCR sent notification to all HIPAA-covered entities requiring them to confirm the contact details for their organization and all business associates that handle protected data by the end of July. Once contact details are confirmed, the OCR will send out preliminary surveys to gather more information about specific organizations and their data protection protocols. From those survey responses, several hundred organizations will be chosen for desk audits, which means that they will be required to submit specific, requested documentation as instructed.
While the Phase 2 audits have many health care executives concerned, the OCR has noted that only several hundred entities will be selected for an audit, and of those, a very small percentage (only about 25 to 50 organizations total) are expected to move on to a full, on-site audit. Still, because there is no way of knowing whether your organization will be selected for audit, you need to prepare and be ready to go should that be the case.
The OCR is quick to point out that the Phase 2 auditing process is not intended to be punitive, and that the purpose is rather to identify best practices and potential weaknesses as a means to provide better guidance to covered entities on how to more effectively comply with HIPAA regulations. That being said, regulators do note that should there be serious deficiencies discovered during the process, then there could be sanctions or other corrective actions taken.
NueMD, provider of cloud-based medical practice management software for small practices, in partnership with Porter Research and the Daniel Brown Law Group, surveyed practices and business associates about HIPAA compliance and how small practices and billing companies are coping. The survey of about 1,200 healthcare professionals, conducted during October 2014, found medical practices and billing companies are struggling to comply with regulations under the Health Insurance Portability and Accountability Act.
“Understanding HIPAA can be difficult for practices and billing companies, especially if they’re already scrambling to keep up with changes like ICD-10 and meaningful use,” said Caleb Clarke, sales and marketing director at NueMD, in a statement. “With audits looming, we wanted to get a sense of where the industry stands and provide resources to help those who may be struggling.”
NueMD surveyed practices and billing companies in all 50 states; most of the practices were small and made up of one to three providers.
In a nutshell, the survey found that:
66 percent of respondents were unaware of HIPAA audits (a staggering number)
35 percent of respondents said their business has conducted a HIPAA-required risk analysis
34 percent of owners, managers and practice administrators reported that they were “very confident” that their electronic devices that contain PHI were HIPAA compliant
24 percent of managers, owners and practice administrators at medical practices reported that they’ve evaluated all of their business associate agreements
56 percent of office staff and (non-owner) care providers at practices said they’ve received HIPAA training in the last year
HIPAA is one of the primary and most comprehensive government regulations that affect the daily activities of each healthcare organization every day.
Signed into law in 1996, the law outlines policies to protect sensitive patient data and penalties for those who don’t comply. Recent updates under the HITECH act introduced several changes that affect the responsibilities and liabilities of covered entities and business associates.
Enforcement of breaches is occurring at a more rapid pace. HITECH extended certain HIPAA security and privacy requirements and set the stage for greater enforcement, including:
Widening the scope of the law, requiring health information exchanges to be business associates of healthcare entities, and applied HIPAA privacy and security requirements directly to the HIEs.
Greater penalties for noncompliance.
Redirecting civil monetary penalties back into enforcement activities instead of into the general fund. This provides additional funds for future enforcement and incentivizes proactive enforcement activities.
Adding breach notification requirements to entities that operate personal health records or otherwise maintain personal health information for purposes other than healthcare delivery or payment.
Opening the way for enforcement by states’ attorneys general.
Also, the HITECH Act incentivizes a more aggressive pursuit of HIPAA, which means it’s more likely that healthcare organizations will now be audited more regularly.
A little more than a year ago the former Director of the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), Leon Rodriquez, referred to covered entities that did not realize they have business associate relationships in place. He went on to say that some business associates did not know that they were actually business associates. Rodriquez stressed it was both the responsibility of the covered entity and the business associate to understand this relationship does exist.
Regarding ramped up HIPAA enforcement and compliance, Rodriquez indicated future audits will be narrower in scope and include more organizations than ever before. Covered entities and their business associates also will be audited under the new permanent program, and audits will focus on vulnerabilities that could change year to year as new issues arise. This appeared to be the start of an intended awareness program and fair warning.
With Rodriquez’s departure to Homeland Security in June, it seemed like the task of continuing the drum beat message of ramped up HIPAA enforcement fell to Linda Sanches.
Sanches is OCR’s senior health information privacy advisor. In that position, she oversees the HIPAA security and breach notifications audit program and may know a thing or two about the direction OCR wants to take with future audits. Sanches recently spoke at the Health Information and Management Systems Society (HIMSS) Privacy and Security Forum. However, she did not provide any striking revelations or critical insights about these new audits, just more of what the industry seems to know already, that these audits are coming.
Much like Rodriquez did in the past, Sanches spoke more in generalities than specifics. She indicated OCR was looking at a broader view of the entire healthcare industry as possible criteria for selection of who would be targeted for an audit. Using the National Provider Identifier (NPI) database is a method being considered to select entities like hospitals, practices and dental providers for audits.
Collaboration has proven to be key when moving to a meaningful use certified electronic health record, time and time again. The same can be said about upgrading to a MU certified EHR.
From a single site opened in 1996, Santa Rosa Community Health Centers (SRCHC) has become a major provider of healthcare services in Sonoma County with more than 102 participating providers serving a patient population of 40,000 through eight facilities.
Services include family planning and reproductive health, HIV, mental health, obstetrics, outreach and education, pediatrics, primary care, senior and older care and teen services. SRCHC is a federally qualified health center, and provides more than 183,000 medical visits each year.