Kusserow on Compliance: HIPAA enforcement update

At the 2018 HCCA Compliance Institute HIPAA Policy and Enforcement Update, it was reported that since September 2009 through the end of 2017 there were 2178 reports filed with the HHS OCR involving breaches affecting 500 or more individuals. In addition to large breaches, there were over 300,000 reports of breaches of protected health information (PHI) affecting fewer than 500 individuals. Individuals affected by the large breaches were about 177 million. So far, OCR’s website has posted 38 breaches as of April 2018. In all, nearly one million patients may have had their PHI put at risk by these incidents with the number continuing to grow. The breakdown of type of large breaches includes:

  • Loss/Theft continues as the most often reported problem; nearly half of the cases.
  • Laptops and other portable storage devices represented one fourth of large breaches.
  • Hacking/IT Incidents account for about one in five reported incidents.
  • Paper records accounted for another fifth of the large breaches

10 largest 2018 incidents to date by number of patient records affected

  1. 582,174 – California Department of Developmental Services, 4/06/2018, Unauthorized Access/Disclosure Incident
  2. 279,865 – Oklahoma State University Center for Health Sciences, 1/05/2018, Hacking Incident
  3. 134,512 – St. Peter’s Ambulatory Surgery Center LLC- d/b/a St. Peter’s Surgery & Endoscopy Center, 2/28/2018, Hacking Incident
  4. 70,320 – Tufts Associated Health Maintenance Organization, Inc. reported on 2/16/2018 an Unauthorized Access/Disclosure Incident
  5. 63,551 – Middletown Medical P.C.,  3/29/201 an Unauthorized Access/Disclosure
  6. 53,173 – Onco360 and CareMed Specialty Pharmacy, 1/12/2018, Hacking Incident
  7. 36,305 – Triple-S Advantage, Inc., 2/02/2018, Unauthorized Access/Disclosure Incident
  8. 35,136 – ATI Holdings, LLC and its subsidiaries, 3/12/2018, Hacking Incident
  9. 34,637 – City of Houston Medical Plan reported on 3/22/2018 a Theft of Laptop Incident
  10. 30,799 – Mississippi State Department of Health, 3/26/2018, Unauthorized Access/Disclosure

Top 10 Recurring Compliance Issues

  1. Pattern of disclosure with sensitive paper PHI
  2. Business Associate Agreements
  3. Risk analysis issues
  4. Failure to manage identified risk, e.g. Encryption of data
  5. Lack of transmission security
  6. Lack of appropriate auditing
  7. No patching of software
  8. Insider threats from employees and contactors
  9. Improper disposal of data
  10. Insufficient data backup and contingency planning

HHS OCR calls for health care organizations to establish contingency plans to keep patient data secure and mandate that covered entities and business associates have such plans. In their March newsletter, OCR officials urged health care organizations to figure out which IT systems are critical, to understand how to function in a disaster, and to back up PHI so it can be retrieved if the original data are lost or taken offline. Once developed, the plan should be routinely tested to identify gaps and ensure updates for plan effectiveness and increase organizational awareness. The plan should be reviewed and updated on a regular basis when there are changes: technical, operational, or in personnel.

 

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.

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Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Using sanction-screening tools vs. outsourcing the entire process

In order to save time and costs, more and more health care organizations have been moving to outsource functions that are not core business activities. Compliance programs have been part of that trend: (1) 80 percent of compliance offices use vendors to provide hotline services, (2) 50 percent of compliance offices use vendors to provide policy development tools, and (3) two-thirds of compliance offices use vendors to provide E-learning tools. Included in the growing list of outsourced tasks has been the movement to address the rapidly growing cost and time commitment obligations related to sanction-screening. Two-thirds of compliance offices use a vendor search engine tools to assist in sanction-screening that saves an organization from downloading the sanction databases and developing a search engine. This is a trend driven by the rapid development of many new databases against which to screen employees, medical professionals, contractors, vendors, etc., including the following:

  • OIG List of Excluded Individuals and Entities (LEIE)
  • GSA Excluded Parties List System (EPLS)
  • 40 Medicaid states now have sanction data bases requiring monthly screening
  • Drug Enforcement Administration (DEA)
  • FDA

All this has increased the burden of sanction-screening exponentially, not only for the compliance office, but also human resource management for new hires and periodic screening of current employees and procurement with vendors and contractors. Medical credentialing is involved as result of having to screen physicians who are granted staff privileges. Using vendors has been a great help, but the most difficult part of the process is resolving “potential hits.” This can be a considerable effort and many organizations have to dedicate staff for investigation and resolution of these hits. It is complicated by the fact that most sanction data does not provide sufficient information to make positive identification. As a result of this heavy burden, many have moved beyond simply using a vendor tool to outsourcing the entire process to vendors. The following address selecting a sanction-screening vendor and outsourcing the process.

 

Tips for selecting sanction-screening vendor

 

Tips for outsourcing the sanction-screening process

  • Determine the cost of moving from use of a vendor search engine tool to outsourcing the screening, along with investigation and resolution of “potential hits.”
  • Inquire as to the methodology they follow in resolving potential “hits,” a critical part of any screening effort.
  • Ensure the vendor provides a certified report of the results that can be made part of the compliance office records.
  • Review an example of the type of reports they would provide to determine if it meets the documentary needs of the organization.

 

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.

Kusserow on Compliance: Emerging government enforcement priorities for 2018

At the HCCA conference in April, there were several presentations regarding the government’s enforcement priorities. There were a number of emerging issues that were the subject of considerable attention: the opioid crisis, electronic health record (EHR) fraud, and telehealth/telemedicine. By far, the area given the most attention was the opioid crisis.  More than a dozen presenters included comments in their presentations on this subject, including presenters from the DOJ, OIG, CMS, and the OCR. This is not surprising in that last October the President declared this to be a national public health care crisis and marshaled regulatory and enforcement agencies to actively focus on steps to alleviate it. Other agencies not present at the HCCA are included in this effort, such as the FDA, FCC, CDC, Indian Health Service, Veterans Administration, Department of Defense TRICARE program, and others. At the federal and state level, there is increased legislative, regulatory, and enforcement actions activity related to substance abuse and behavioral health services. In January, the Attorney General announced the DEA was increasing its focus on pharmacies and prescribers who dispense unusual or disproportionate amount of such drugs. He also has created the Prescription Interdiction and Litigation (PIL) task force to aggressively deploy and coordinate all available criminal and civil law enforcement tools to address the crisis. Both DOJ and OIG presenters noted the July 2017 “take down” of 412 defendants in 41 different judicial districts. The defendants included over 100 doctors, nurses, and other medical license professionals. Together these individuals were responsible for over $1.3 billion in false billings.

The second most reported topic concerned cyber and IT security of Protected Health Information (PHI). This was a main topic in the presentation by OCR, but was alluded to in seven other presentations on cybersecurity and threats and complying with HIPAA Privacy and Security standards. The OCR reported that since 2009, there have been 2178 reports of breaches over 500 files with more than 300,000 cases of breaches affecting fewer than 500 files. The OCR has responded to over 170,000 complaints that resulted in over 25,000 cases being resolved with corrective action measures.  The OCR expects about 17,000 new complaints this year.  The top 10 recurring issues involve: (1) disclosure of sensitive paper information, (2) business associate agreements, (3) risk analysis, (4) failure to manage risks, such as with encryption, (5) lack of transmission security, (6) failure of ongoing auditing, (7) no patching of software, (8) insider threats, (9) improper disposal of records, and (10) insufficient backup of information and contingency planning.

Several sessions focused on physician arrangements and how they could implicate the Anti-Kickback Statute and Stark Laws.  Statistics from DOJ indicated the continuing trend of increased number of qui tam cases that has grown from 426 in 2015 to around 500 in 2017 with annual settlements averaging about $2.5 billion per year.

New cases involving Meaningful Use Fraud were reported with the promise that more new cases were under development.  Another area getting a lot of enforcement attention by the DOJ and OIG relate to telehealth and telemedicine. Cases surfacing now are focusing on claims arising from billings for these areas that did not qualify as such.  Only certain telehealth services are covered by Medicare and providers should take care to follow CMS guidance on what qualifies.

It is interesting to compare these priorities with results for the 2018 Compliance Benchmark Survey of compliance officers. There was no mention of the opioid crisis, as it was just an emerging national issue at the time the survey was taken. HIPAA security/cyber-security was the highest priority. It is troubling that corrupt arrangements with referral sources remains the number one regulatory and enforcement priority for the OIG and DOJ but is ranked fifth in priority to respondents. The other major and continuing enforcement priority related to claims submissions and that ranked third in priority by compliance officers.  A complementary webinar relating to this survey will be presented on May 9th.

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 © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Changes in the Stark Law

Over the years, the Stark law has evolved considerably from regulatory requirements to use by the DOJ in enforcement of the False Claims Act. Unlike the Anti-Kickback Statute, which is enforced by the OIG, the Stark law is considered regulatory and under CMS jurisdiction. The Stark law was designed to prohibit doctors from referring Medicare patients to hospitals, labs, and colleagues with whom they have financial relationships, unless they fall under certain exceptions. Stark prevents hospitals from paying providers more when they meet certain quality measures, such as reducing hospital-acquired infections, while paying less to those who miss the goals. Providers have registered numerous concerns that the Stark Law is inhibiting their ability to participate in Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) reforms. The CMS Administrator, Verma, has acknowledged the difficulty of reconciling the Stark Law’s restrictions with the current shift to value based payment structures, noting that that the Stark Law “was developed a long time ago” with current payment systems and operations being different, requiring some changes in the rules. This is not the first time CMS has tried to move the easing of rules concerning the Stark law. In 2015, CMS published a Proposed rule relaxing aspects of the Stark law, including easing of some of the strict liability features of the law and the CMS burden in dealing with the interpretation of key terms, requirements, and other issues.  After reviewing an enormous amount of self-disclosures, CMS realized that a large part of its docket involved arrangements that may technically violate the statute but do not actually pose significant risks of abuse, thus necessitating some changes and clarifications.

Inter-Agency Group formed to focus on easing Stark Barriers

During a January, 2018 American Hospital Association webinar, the CMS Administrator announced plans to convene an inter-agency group consisting of CMS, the OIG, HHS General Counsel, and the DOJ to focus on how to minimize the regulatory barriers of the Stark law that began in 1989 and underwent expansion in the 1990s. Verma noted that the review is in line with CMS’s “Patients Over Paperwork” initiative, which is in accord with the President’s Executive Order that directs federal agencies to “cut the red tape” to reduce burdensome regulations.

Congress Acts

Regardless of the results of the inter-agency review, the fact remains that only so much can be done by regulatory policy changes. All real changes must be made in the law will necessarily have to come from Congress. The Bipartisan Budget Act of 2018 imposed changes on laws related to health care fraud and abuse. On one side they quadrupled fines and doubled potential prison time from five to ten years for violation of the Anti-Kickback Statute.  The Civil Monetary Penalties (CMP) law penalties were doubled. On the other side, Congress moved to reduce some of the burdens by codifying CMS regulatory guidance. Some specific relief involved expired leases and personal services contracts that, if otherwise compliant, will remain protected as long as the terms and conditions continue unchanged.

 

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.