Kusserow on Compliance: New analysis of OCR reports found 1800 large breaches over 7 years

In presentation at the Health Care Compliance Association (HCCA) entitled “OCR Enforcement Update,” HHS Office for Civil Rights (OCR) Senior Adviser Iliana Peters reported that the OCR continues to receive and resolve complaints of Health Insurance Portability and Accountability Act (P.L. 104-191) (HIPAA) violations of an increasing number. To date, the OCR has received 150,507 complaints, with 24,879 being resolved with corrective action measures or technical assistance.  She estimated that the OCR will receive about 17,000 complaints in 2017.

A new study published in JAMA Internal Medicine found since 2009 that 1,798 “large data breaches” involving patient information since 2009 had been reported by health care providers to the OCR.  Out of that number, 216 hospitals reported 257 data breaches, while 33 hospitals were found to have experienced multiple data breaches.  Of 141 acute care hospitals reporting breaches, 52 were major academic medical centers.  These numbers are misleading in that they represent only a small fraction of the total number of breaches, as indicated by Peters.  The reason is that smaller breaches are not required to be reported, and many breaches may not have been voluntarily reported.  The need for increased vigilance and internal controls are needed.

Latest OCR resolution

The OCR announced a resolution agreement based on the lack of a security management process to safeguard electronic protected health information (ePHI). Metro Community Provider Network (MCPN), a federally-qualified health center (FQHC), has agreed to settle potential noncompliance with the HIPAA Privacy and Security Rules by paying $400,000 and implementing a corrective action plan. MCPN filed a breach report with the OCR indicating that a hacker accessed employees’ email accounts and obtained 3,200 individuals’ ePHI through a phishing incident. As with many of the reported large breaches, the OCR found that prior to the breach incident, there was no risk analysis to assess the risks and vulnerabilities in its ePHI environment and a corresponding failure to implement any associated risk management plans to address the risks and vulnerabilities identified in a risk analysis.

Reminder tips on HIPAA compliance

As a reminder, entities should perform the following recommended steps in order to comply with HIPAA.

  1. Perform a complete a security risk analysis that addresses ePHI vulnerabilities.
  2. Engage an outside expert to independently verify that Privacy/Security Officers are meeting obligations.
  3. Properly address identified risks with corrective action measures.
  4. Follow the basics in reviewing compliance for information security risks and PHI breaches.
  5. Verify that the Code of Conduct covers reporting HIPAA violations.
  6. Ensure that policies and procedures govern receipt and removal of laptops containing ePHI.
  7. Train the workforce on HIPAA policies and procedures, including reporting violations
  8. Ensure that all business associates (BAs) have signed BA agreements (BAAs), with contact information on file.
  9. Verify that controls cover gaining access to ePHI by workforce members and users.
  10. Encrypt and password protect all laptops and mobile devices.
  11. Implement safeguards to restrict access to unauthorized users.
  12. Validate effectiveness of internal controls, policies, and procedures
  13. Review adequacy of security processes to address potential ePHI risks and vulnerabilities.
  14. Ensure that a hotline is set up to receive HIPAA-related calls.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OCR enforcement update at the HCCA Compliance Institute

“OCR Enforcement Update” was the topic of the presentation by Iliana Peters, HHS Office for Civil Rights (OCR) Senior Adviser for HIPAA Compliance and Enforcement at the Health Care Compliance Association (HCCA) Compliance Institute. She provided an update on enforcement, current trends, and breach reporting statistics.  Peters stated that the OCR continues to receive and resolve complaints of Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191)  violations of an increasing number.  She cited that OCR has received 150,507 complaints to date, with 24,879 being resolved with corrective action measures or technical assistance.  At the rate of reports being received, the OCR is estimating receiving 17,000 complaints in 2017.  She said that this year OCR has placed a major priority on privacy issues and will be issuing guidance on this, ranging from social media privacy, certification of electronic health record technology, and the rationale for penalty assessment. She spoke about OCR’s Phase 2 audits that are underway, involving 166 covered entities (CEs) and 43 business associates (BAs). These audits are to ensure CEs’ and BAs’ compliance with the HIPAA Privacy, Security, and Breach Notification Rules that include mobile device compliance.  They address privacy, security, and breach notification audits. It is expected that among the results of this effort will be increases in  monetary penalties this year.  Phase 3 will follow the same general approach currently being used, which includes review of control rules for privacy protection, breach notification, and security management.

In her comments about what the OCR has learned from its audits and investigations, Peters made the point that most HIPAA breaches still commonly occur as a result of poor controls over systems containing protected health information (PHI). A particular vulnerability has been mobile devices, such as laptops computers, that failed to be properly protected with encryption and password.

OCR advice

 Peters provided in her slide presentation considerable advice as what CEs and BAs should do to prevent breaches and other HIPAA-related problems. CEs and BAs should:

  • ensure that changes in systems are updated or patched for HIPAA security;
  • determine what safeguards are in place;
  • review OCR guidance on ransomware and cloud computing;
  • conduct accurate and through assessments of potential PHI vulnerabilities;
  • review for proliferation of electronic PHI (ePHI) within an organization;
  • implement policies and procedures regarding appropriate access to ePHI;
  • establish controls to guard against unauthorized access;
  • implement policies concerning secure disposal of PHI and ePHI;
  • ensure disposal procedures for electronic devices or clearing, purging, or destruction;
  • screen appropriately everyone in the work area against the OIG’s List of Excluded Individuals and Entities (LEIE);
  • ensure departing employees’ access to PHI is revoked;
  • identify all ePHI created, maintained, received or transmitted by the organization;
  • review controls for PHI involving electronic health records (EHRs), billing systems, documents/spreadsheets, database systems, and all servers (web, fax, backup, Cloud, email, texting, etc.);
  • ensure security measures are sufficient to reduce risks and vulnerabilities;
  • investigate/resolve breaches or potential breaches identified in audits, evaluations, or reviews;
  • verify that corrective action measures were taken and controls are being followed;
  • ensure when transmitting ePHI that the information is encrypted;
  • ensure explicit policies and procedures for all controls implemented; and
  • review system patches, router and software, and anti-virus and malware software.

Expert tips to meet HIPAA compliance requirements

Carrie Kusserow, MA, CHC, CHPC, CCEP, is a HIPAA expert with over 20 years of compliance officer and consultant experience. She pointed out that the OCR finds that most HIPAA breaches still commonly occur as a result of poor or lapsed controls over systems with PHI.  She noted that Iliana Peters stated that the OCR often encounters situations where established internal controls were not followed; in many cases, discoveries of breaches within organizations were not promptly investigated.  Also, most of the breaches currently being reported involve mobile devices, specifically laptop computers, and a failure to properly encrypt and password protect PHI. Kusserow offered additional tips and suggestions to those offered in the OCR presentation, particularly as it relates to mobile devices.

  • Conduct a complete security risk analysis that addresses ePHI vulnerabilities.
  • Ensure the Code of Conduct covers reporting of HIPAA violations.
  • Validate effectiveness of internal controls, policies, and procedures.
  • Maintain an up-to-date list of BAs that includes contact information.
  • Ensure identified risks have been properly addressed with corrective action measures.
  • Develop corrective action plans to promptly address any weaknesses or breaches identified.
  • Follow the basics in prevention of information security risks and PHI breaches.
  • Ensure policies/procedures  govern receipt and removal of laptops containing ePHI.
  • Verify workforce member and user controls for gaining access to ePHI.
  • Verify laptops and other mobile devices are properly encrypted and password protected.
  • Implement safeguards to restrict access to unauthorized users.
  • Review adequacy of security processes to address potential ePHI risks and vulnerabilities.
  • Ensure the hotline is set up to receive HIPAA-related calls.
  • Verify that all BAs have signed business associate agreements.
  • Train the workforce on HIPAA policies/procedures, including reporting violations.
  • Investigate complaints, allegations, and reports of non-compliance promptly and thoroughly.
  • Engage outside experts to independently verify controls are adequate and being followed.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Gatekeeping vital to a best practice organization

Gatekeeping should be viewed as a first line of defense, protecting not only a healthcare organization, but the patients as well. In a Health Care Compliance Association (HCCA) webinar titled “Gatekeeping & Monitoring – Developing Sound Processes for Screening, Removal & Reinstatement,” Amy Andersen, Director of Operations at Verisys Corp., noted that every organization can be sorted to a risk aversion spectrum. On one end, the most risk-averse organizations use best practice compliance to achieve stellar outcomes. On the other end, non-compliant organizations risk fines and loss of reputations. The greatest cost to organizations in terms of monetary impact to establish gatekeeping measures is the change management and system implementation. Regardless, best practices organizations need to be proactive about gatekeeping and monitoring, not after the fact.

Gatekeepers

The best way to protect organizations is to implement a gatekeeping strategy. Gatekeeping is ensuring that information is properly disseminated among an organization and its association. Thus, the first consideration for an organization is which parties are being let into the organization. Organizations should not only focus on the healthcare professionals within their organizations, but the vendors and contractors employed by the organization. Andersen noted that the vendor space was one of the most overlooked areas in protecting an organization.

Secondly, once an organization permits vendors or individuals into the organization, it must readily identify any gaps. In essence, Andersen said that the organization should understand what it knows and does not know about the admitted vendor or individual.

Finally, the organization should establish criteria for admittance of these vendors or individuals. Thus, an organization’s gatekeeping strategy should include three parts: (1) identification, (2) communication, and (3) remediation.

Identification, communication, and remediation

At a most basic level, identification starts with screening and monitoring. Some barriers to gatekeeping include data “hoarders,” those entities who do not share what they know or require you to go through a gate itself. These entities can be threats to the organization.

Andersen advised that organizations should examine and avoid unconsidered risks. In terms of credentialing, Andersen stressed “verify, verify, verify.” These risks are created when an organization silos information within itself. She cautioned against this, noting that organizations should do holistic reviews to determine whether the departments within the organization are communicating any risks effectively.

Access to information is vital. Once identification generates data for the organization, relevant information must be made visible. After policy and procedure access occurs, the organization must take action in a consistent manner. This is includes removal of individuals from the organization or vendor from a business relationship, expectations should be laid out clearly. Any auditing that is done should be unbiased and adhere to industry standards.

Value-based payments and EHRs expected to continue trajectory during reform

Despite the uncertainty surrounding health care reform under the upcoming Trump administration, health law experts project that the transition to value-based payments and further development of electronic health record (EHR) systems will be a constant in the coming years. Four of Avalere Health’s senior vice presidents offered their opinions during the 2017 Healthcare Industry Outlook webinar, making educated guesses about what upcoming changes the industry may see.

What will change?

The webinar started with the topic on everyone’s mind: what will happen to the Patient Protection and Affordable Care Act (ACA)? Broadly, the presenters expect that federal spending on health care will be capped and states will be granted more flexibility in designing their Medicaid programs. Reduction of regulations to encourage the private sector to provide a range of products in a competitive market is also to be expected.

The likelihood of repeal was discussed for several different ACA sections. The most likely to be repealed were the individual and employer mandates, subsidies, industry taxes, Medicare tax for high earners, and cuts to disproportionate share hospitals. Certain reforms, like protection for pre-existing coverage, drug related provisions, and changes to Medicare Advantage and Medicaid payment provisions are considered likely to remain. Subjects likely to be up for serious debate are Medicaid expansion, the Center for Medicare & Medicaid Innovation (CMMI), essential health benefits, and the preventive services coverage requirement.

Other areas

The focus on quality and value in health care is not expected to waver during the new administration. In light of significant regulatory and policy barriers, providers are unable to establish outcome-based contracts and create more innovative payment arrangements. More flexibility in the ability to establish and agree on value between parties is expected to be a policy pressure point.

The value discussion typically focuses on provider performance, but the presenters noted that drugs are an important value consideration, especially in light of rising costs. The traditional approach to determining drug value is expected to evolve, as frameworks had previously been established based on clinical benefit, toxicity, and product cost, which ignored patient considerations and relied too much on data from limited populations. In addition to incorporating more real world data, drug value frameworks have begun to focus on not only on health outcomes, but patient experiences and financial considerations during treatment.

Although “virtually every hospital” is using some sort of EHR system, interoperability continues to be a sticking point. In the near future, the ability to more effectively use, share, and interact with data is expected to improve. Continued advancements in studying data is also expected to change the way providers practice, including big advances in population health.