Kusserow on Compliance: October 2017 Work Plan update

This year, the OIG is updating their annual Work Plan during the year, rather than annually. The Work Plan sets forth various audits and evaluations that are underway or planned during the fiscal year and beyond. The updates will include the addition of newly initiated Work Plan items and removal of completed items. In conducting its work, the OIG assesses relative risks in HHS programs and operations to identify those areas most in need of attention. In evaluating potential projects to undertake, the OIG considers a number of factors, including mandates set forth in laws, regulations, or other directives; requests by Congress, HHS management, or the Office of Management and Budget; top management and performance challenges facing HHS; work performed by other oversight organizations (e.g., GAO); management’s actions to implement OIG recommendations from previous reviews; and potential for positive impact. In addition to working on projects that often result in audits, reviews, and reports, the OIG also engages in a number of legal and investigative activities that are separately reported.

5 New Projects Added

  1. Secretary Price’s Use of Chartered Aircraft for Federal Travel. Federal Travel Regulations provide limited instances in which chartered aircraft can be used for official Government business. OIG initiated a review of HHS Secretary Price’s use of chartered aircraft for Federal travel. He subsequently resigned and agreed to payback funds improperly expended.

 

  1. Specialty Drug Coverage and Reimbursement in Medicaid. Medicaid spending on specialty drugs has rapidly increased. There is no standard definition for specialty drugs. They may be expensive; be difficult to handle, monitor or administer; or treat rare, complex or chronic conditions. OIG plans are to determine states’ definitions of, and payment methodologies for, Medicaid specialty drugs and determine how much states paid for specialty drugs; and review strategies that states use to manage specialty drug costs, such as formularies, cost sharing, step therapy, and prior authorization.

 

  1. FDA Oversight of Risk Evaluation and Mitigation Strategies to Address Prescription Opioid Abuse. Opioid abuse and overdose deaths are at epidemic levels in the United States. The FDA has been provided legal authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS), when the FDA determines that the risk of using a drug outweighs its benefit. Through the REMS program, the FDA intends to “increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.” The OIG will conduct an evaluation on how the FDA determined the need for opioid REMS and determine the extent to which they have held pharmaceutical companies with required opioid REMS accountable for REMS assessments. The OIG also plans to determine the extent to which the FDA has held opioid REMS sponsors accountable for REMS goals to mitigate risks of misuse, abuse, addiction, overdose, and serious complications because of medication errors.

 

  1. Drug Traceability Test. Potentially dangerous drugs, including diverted, counterfeit, and imported unapproved drugs, can enter the supply chain and pose a threat to public health and safety. The Drug Supply Chain Security Act (DSCSA) provides the FDA and others with new tools to prevent the introduction of harmful drugs into the supply chain and to identify and remove them. DSCSA requires trading partners to exchange drug product tracing information when they take ownership of drugs, resulting in a tracing record that the FDA and others can use to investigate suspect and illegitimate drugs. Ensuring that DSCSA’s drug product tracing requirements function as intended will help the FDA respond effectively to potentially harmful drugs in the supply chain. The OIG plans to determine the extent to which selected drugs can be traced from the dispenser back to the manufacturer. This study—part of OIG’s body of work in this area—builds on the OIG’s previous examinations of trading partners’ early experiences exchanging drug product tracing information by testing the accuracy of those tracing records.

 

  1. Review of Medicare Payments for Bariatric Surgeries. Bariatric surgery is performed to treat comorbid conditions associated with morbid obesity. Medicare Parts A and B cover certain bariatric procedures if the beneficiary has (1) a body mass index of 35 or higher, (2) at least one comorbidity related to obesity, and (3) been previously unsuccessful with medical treatment for obesity. Treatments for obesity alone are not covered. The Comprehensive Error Rate Testing program’s special study of certain Healthcare Common Procedure Coding System codes for bariatric surgical procedures found that approximately 98 percent of improper payments lacked sufficient documentation to support the procedures. OIG auditors will review supporting documentation to determine whether bariatric services performed met the conditions for coverage and were supported in accordance with federal requirements.

 

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

Kusserow on Compliance: The OIG on Health IT security

Many are not aware of the fact that the HHS OIG boasts having an A-class team that focuses on IT controls and engages in what they refer to as penetration testing or “hacking” into IT systems and networks. With 100 million health care records already compromised and medical records serving as a top target for hackers, healthcare related cybersecurity has become a high priority for the OIG. Health IT offers some unique challenges, in that health records are for a lifetime, whereas credit cards may have a shelf life, if they’re compromised, of just a day or two. This makes them very valuable for criminals that can often realize 60 times more than what a stolen credit card can yield on the dark web. Compromised health information could have wide-ranging consequences, including affecting credit and even someone filing a false tax return with the information. In addition to people’s personal information, there is concern about health care provider and managed care proprietary information.

The OIG IT audits begin with setting an audit objective, which varies according to what they are trying to accomplish. The OIG desires to provide transparent and objective assessments of the security posture of the systems within HHS and those that receive funding from HHS. The OIG engages in penetration testing, as a means to help strengthen IT vulnerabilities. By engaging in penetration testing or “hacking into” IT networks, the OIG is able to provide chief information officers, and sometimes CFOs, with information regarding particular vulnerabilities. Among the common testing of IT systems is determining whether passwords are being changed periodically.  The OIG stated guiding philosophy is that “what gets checked gets done.” By identifying vulnerabilities, they draw management attention to addressing them and raising their awareness to cybersecurity.

The OIG wants to ensure that funds for cybersecurity, and ultimate for technology, are being used judiciously, and overall the OIG is working every day to protect sensitive personal and proprietary data. The OIG is using its resources to enhance awareness around cybersecurity.  The OIG focuses much of its resources on IT controls for the Medicare enrollment database; however the OIG does not confine its work to the Medicare and Medicaid space. The OIG is also looking at IT security at NIH, Indian health hospitals throughout the country, and FDA information on drugs and medical devices. The OIG typically addresses reports to senior level personnel, such as the CEO and Chief Information Officer, and often addresses reports to state administrators for Medicare and Medicaid.

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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Kusserow on Compliance: OIG reports the new Medicaid data system inadequate

The OIG reported that historical inadequacies in Medicaid data have hindered program integrity, research, budgeting, and policy. As a result the OIG has designated the improvement of Medicaid data as a top management HHS challenge. In 2016, the federal Government and states spent $574 billion on Medicaid, serving more than 74 million enrolled individuals. Complete, accurate, and timely Medicaid data are vital for the effective administration and oversight of the Medicaid program by states and the federal Government. The Transformed Medicaid Statistical Information System (T-MSIS) is a new data system that was developed to improve the completeness, accuracy, and timeliness of Medicaid data. The OIG provided a status update on the implementation of T-MSIS, building on its previous review of the 2013 T-MSIS pilot.

In conducting its review, the OIG analyzed the implementation status of T-MSIS using 40 states’ approved plans for data submission; and interviewed staff from CMS and 16 states about their experiences implementing T-MSIS. The OIG reported the following:

  1. States and CMS reported early implementation challenges resulted in delays with T-MSIS
  2. Technological problems and competing priorities for states’ resources caused delays
  3. The goal date for when T-MSIS will contain data from all states has been repeatedly postponed
  4. CMS expects that all states will be reporting to T-MSIS by the end of 2017
  5. 21 of 53 state programs were submitting data to T-MSIS
  6. States and CMS continue to raise concerns about completeness and reliability of the data
  7. States indicate that they are unable to report data for all the T-MSIS data elements
  8. Even with a revised data dictionary for each data element, states and CMS report concerns about states’ varying interpretations of data elements
  9. Without uniform interpretations of data elements, the data submitted will not be consistent across states, making any analysis of national trends or patterns inherently unreliable.

The OIG concluded that successfully getting all states’ data into T-MSIS requires states and CMS to prioritize T-MSIS implementation. However because of CMS’s history of delaying target dates for implementation, the OIG expressed concerned that CMS and states will delay further rather than assign the resources needed to address the outstanding challenges. The OIG further noted that without a fixed deadline, some states and CMS may not make the full implementation of T-MSIS a management priority.

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: Measuring compliance program effectiveness using validated and reliable knowledge surveys

The OIG from its earliest compliance guidance documents has recommended the use of “[q]uestionnaires developed to solicit impressions of a broad cross section” of the workforce. Evaluating effectiveness through the use of questionnaires or surveys can measure the compliance culture and/or knowledge of the organization. Such surveying of employees are one of the two methods suggested for evidencing compliance program effectiveness by the HHS OIG in its Compliance Guidance for Hospitals and Supplemental Guidance for Hospitals. The agency noted that “as part of the review process, the compliance officer or reviewers should consider techniques such as…using questionnaires developed to solicit impressions of a broad cross-section of the hospital’s employees and staff.” It further reinforced this by stating it “recommends that organizations should evaluate all elements of a compliance program through “employee surveys.”   The OIG also stated that “[t]he existence of benchmarks that demonstrate implementation and achievements are essential to any effective compliance program.”

Steve Forman, CPA, has 35 years experience as a compliance officer and health care compliance consultant. He has used compliance surveys for over 20 years to measure program effectiveness and has found them to be an extremely inexpensive method to provide great insight into the compliance program’s effectiveness. However, he notes that it is critical that the survey being used has been professional developed, as well as validated and tested over many organizations. In addition, it is necessary for employees to have confidence in the fact that their scoring will not be attached to them. This means that the survey needs to be independently administered that ensures the confidentiality and anonymity of participants. It is very useful for organizations gaining feedback from employees by querying them on their knowledge of the compliance program elements drawn from their general observations and personal experiences. Results from a survey can evidence employees’ knowledge; awareness and understanding of the compliance program are used to identify positives and weaknesses of the compliance program.  It can provide empirical evidence of the advancement of program knowledge, understanding, and effectiveness.

Jillian Bower has been overseeing administration of knowledge surveys with health care organizations for more than 6 years at the Compliance Resource Center (CRC). The CRC has been employing compliance surveys since 1993.  The most popular survey for Compliance Officers is the Compliance Knowledge Survey© that tests the knowledge of the compliance program’s structure and operations, including the understanding of the role of the Compliance Officer, how the hotline functions, etc. It specifically focuses on the OIG’s seven elements of an effective compliance program and uses simple closed-ended questions with “Yes and “No” answers choices that requires no more than 20 to 30 minutes to complete. Reports from this survey runs 30 pages or more that includes tips for addressing weaknesses and benchmarks results against the universe of those who have used the same survey three ways; (a) overall results, (b) by topic, and (c) individual questions. The biggest benefit of the Compliance Knowledge Survey© is being able to benchmark the results of an organization with the universe of those that have used the same survey by overall results, topical areas, and by question.

Carrie Kusserow with 15 years experience as a compliance officer and consultant has found that reports of survey results can evidence both strengths in the compliance program, as well as areas opportunities for improvements in the Compliance Program. It is one way that compliance program effectiveness can be objectively measured with credible metric evidence. Using the same survey over time, permits measurements that can benchmark progress in Compliance Program development and in tracking improvements.

Al Bassett, JD, has assisted in building and evaluating compliance program effectiveness more than just about anyone in the country over the last 20 years. He has routinely employed employee surveys as a tool to obtain the most out of a compliance effectiveness review. He has found that a compliance knowledge survey parallels and reinforces his findings from document reviews, observation of program operations, and interviews of key staff. In addition, he has surveys administered to provide the foundation for focus group meetings. Findings from a survey can identify potential weakness, but does explain the “why” for the issue. He cautions that for reliable and credible result, the survey should be professionally developed and administers.  From experience he notes that internally developed questionnaires naturally raise employee suspicion that the questions are being designed to bias the results in favor of the organization.  There is also the concern that if administered internally, anonymity in responding to questions would be lost. Another issue is that the credibility of the results is not likely to provide convincing evidence to any outside authorities. A properly developed survey will also address a response-set bias, where respondents may always answering the questions as “yes” or “no”. It is therefore important to have a few reverse scored questions included.

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.