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: Tips on what to expect from hotline vendors

The U.S. Sentencing Commission and HHS Office of Inspector General (OIG) make it clear that for any compliance program to be effective, it must have active compliance communication channels that meet defined capabilities. Translated, this means organizations must have an employee hotline that permits reporting sensitive matters outside the normal supervisory channels. The failure to establish a credible internal compliance reporting channels often drives individuals to report externally to the OIG and DOJ as “Whistlblowers.”  Internally operated and managed hotlines are generally a bad idea because they are extremely inefficient, costly, and seldom meet any minimum standards. Internal hotlines raise the question of whether anonymity is truly offered and whether employees will ever sufficiently trust calling an employee. It is therefore not surprising that 80 percent of organizations participating in the 2018 Compliance Benchmark Survey Study reported using a hotline vendor. Hotline vendors have the training and experience to handle complainants. However, determining who can provide the best service at the right price is a challenge.

 

What to Expect from Hotline Vendors

    1. Two levels of service are needed: (a) live operator answered calls and (b) a web-based reporting system which prompts individual complainants. Over the last decade there has been a marked trend towards reporting via the web—today web-based reporting almost equals operator answered calls. Organizations should pass on any vendor that does not provide both services.

     

    1. Avoid start up hotline services and ask for a statement of their experience. The more a service knows about hotline operations, the less likely they are to encounter problems or mishandle information.

     

    1. Use only vendors knowledgeable with issues, concerns, and regulatory issues unique to the health care sector. Also, ensure they recognize and ask the right questions about high risk areas identified by the HHS OIG, including those related to the Stark Law and the Anti-Kickback Statute.

     

    1. Avoid any vendor contract that won’t permit cancellations without cause with a simple 30-day written notice. Hotline vendors should hold clients by good service not by contracts. In any contract with a vendor, look to see if cancellation of service is restricted. If so, consider finding a way out of the arrangement and in obtaining service elsewhere.

     

    1. Vendor contracts should include a provision requiring a full written report within the same day of receipt of a call. Urgent matters should be reported immediately via phone.

     

    1. The hotline must provide an option for The U.S. Sentencing Commission, DOJ, and OIG call for anonymity in their guidelines. In the health care sector, nearly two-thirds of all hotline reporters request anonymity. Anonymity is generally in the best interest of the organization as there is no burden of protecting identity if it is unknown. The hotline vendor should have as part of their service a means of communication between the compliance officer and an anonymous reporter. Insist on having that included in the service.

     

    1. Avoid any vendor that provides reports by facsimile or email, as they are not secure and where PHI may be involved could be a complicating HIPAA privacy factor. Web-based reporting is the most secure with notification of a report being provided via email.

     

    1. Compare costs of service, keeping in mind that a vendor should be able to provide their services at a set fee that can be used for comparison purposes. A good rule of thumb is that the cost of a hotline service should not be more than $1 per employee per year. Periodically, compare costs of the vendor being used against other vendors. It may prove to be an opportunity to save money.

     

    1. Look for any inclusive vendor services, such as providing operating protocols for following up on allegations and complaints received through the hotline, as well as other related policies. More reputable firms also provide newsletters or report updates to keep clients up to date on issues relating to their hotline function. Find out what they offer.

     

    1. Look for a vendor that will provide personalized service and is easily accessible and responsible for any and all issues that arise under the contract. Avoid the frustration of interactive voice response (IVR) phone systems, which move callers from one office to another before reaching a stranger who may or may not be able to answer questions.

     

    1. Like any other vendor, the company should have at least one- to three-million dollars liability coverage.

     

    Richard Kusserow will be available to answer any questions related to hotlines at booth 412 at the Las Vegas HCCA Conference.

     

     

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: Temporary staffing and interim compliance officers

When individuals from a compliance office, including compliance officers, retire, move to new organizations, or are replaced for any reason, it can leave a gap in the day to day management of the compliance efforts that can create a serious risk. This underscores the importance of not only finding a suitable replacement quickly, however, that process can be time consuming. As such, it is not surprising that many organizations turn to engaging temporary expert assistance, including acting the use of Interim Compliance Officers (ICOs). This decision is often made with the realization that having a gap in the program over a period of months, or designating someone internally to do the work can be dangerous. Smaller organizations are not likely to have anyone sufficiently qualified to carry out all the duties. It is also risky to have someone making decisions, or failing to make decisions, that may create liabilities. The worst decision is selecting someone to take on the role of compliance officer as a temporary set of secondary duties to his or her current job. This will always lead the individual to continue giving priority to their regular job and do as little as possible in compliance.

Temporary staffing has the advantage of quickly filling immediate needs, including addressing any pending issues or problems. Properly experienced professionals can hit the ground quickly and be effective, not just be a placeholder. This approach will permit the organization to continue its search for the permanent replacement.  Using a properly qualified outside expert presents a lot of advantages. The expert can bring the experience of having served in other organizations and dealing with many of the same issues already addressed by prior jobs.  Important also is that they have not been invested in any prior decisions, nor have they been aligned with any parties in the organization. Most importantly, the expert brings “fresh eyes” to the program. An outside expert can provide an objective assessment on the state of the compliance program, offer suggestions, and give guidance for improvements.

Finding the right ICO with a lot experience and technical skills can make significant improvements for any compliance program in a relatively short order.  In fact, it may be the most economical means to have an independent evaluation of a compliance program. However, care needs to be taken when deciding on an expert. It is important that someone is not hired who is a “cast off” from another organization. As such, it is important that references be checked carefully to be assured of someone who is competent and reliable. It is important to design the engagement to bring maximum return of benefit for the cost. Therefore, in the case of an ICO, consideration should be given to the added scope of work. Organizations should expect to have the outside expert:

  • provide an independent assessment of the status of the compliance program;
  • make an assessment of high-risk areas that warrant attention;
  • be able to efficiently and effectively address compliance risk issues that may arise;
  • offer suggestions to build a firmer foundation for the compliance program;
  • review the existing Code, compliance policies, and other guidance;
  • evaluate the quality and effectiveness of compliance training;
  • develop a “road map” for the incoming compliance officer to follow;
  • assist in identifying and evaluating candidates for the permanent position;
  • assess resources needed to effectively operate the compliance program;
  • identify or build metrics that evidence compliance program effectiveness; and
  • develop comprehensive briefings for management and board on the state of the program.

Finally, for even fairly large organizations, a true compliance expert can hold things together for several months without having to be full time on site. Most organizations can keep their compliance program operating with many of the added benefits noted above, using an expert for 50 to 80 hours per month. After all, the ICO is holding the compliance program together, not building it.

 

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: CMS and Veterans Affairs partnering to address fraud and abuse

The Department of Veterans Affairs (VA) and CMS announced a partnership to share data, data analytics tools, and best practices for identifying and preventing fraud, waste, and abuse. The Veterans Health Administration is a large integrated health care system operated by the VA and has many issues already being addressed by CMS. Through the Veterans Health Administration, the VA is itself the provider, operating an integrated network of 168 medical centers, more than 1,000 outpatient clinics, 250 brick-and-mortar pharmacies, and seven mail-order pharmacies. The VA health system employs over 200,000 health care professionals and covers about nine million veterans in the US.

The new alliance is intended to enhance ongoing efforts between the country’s two largest public-private health-care payment organizations. This collaboration is intended to identify new and innovative ways to seek out fraud, waste, and abuse. CMS estimates that its program integrity activities saved Medicare operations $17 billion in fiscal 2015. Much of this arises from new practices and technologies that will now be shared with the VA, which will be able to capitalize on the advancements in analytics CMS has made and hopefully it will be able to close existing gaps in its own claims payment process. CMS also noted in its announcement that VA invited industry experts in November 2017 to provide information on the latest commercial sector tools and techniques to enhance VA’s fraud detection capabilities.

 

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.