Kusserow on Compliance: OIG Strategic plan outlines top priorities for 2020 – 2025

 The HHS Office of Inspector General (OIG) has identified seven major initiatives as part of its strategic plan for the period between 2020 and 2025. The initiatives include: (1) fraud and abuse protections; (2) safeguarding the Medicare trust funds; (3) protecting beneficiaries from prescription drug abuse; (4) combating health care cybersecurity threats; (5) promoting patient safety and accuracy of payments in home and community settings; (6) leveraging technology; and (7) ensuring HHS managed care and new health care models produce value.

  1. Fraud and Abuse Protections. OIG audits of national Medicaid data found substantial improper payments to providers for Medicaid Services; states were not always correctly determining lack of eligibility of individuals for Medicaid benefits. These two areas will be a focus for OIG oversight.
  2. Safeguarding the Medicare Trust Funds. The OIG plans to use data analytics to identify program areas and geographic areas of high-risk. It should provide strategic oversight of emergency preparedness and response affecting Medicare beneficiaries, Medicare Advantage, prescription drug spending, and the transition to value-based care.
  3. Protecting Beneficiaries from Prescription Drug Abuse, Including Opioids. The OIG’s efforts will focus on identifying opportunities to improve the efficiency and effectiveness of monitoring and identifying and holding accountable those engaged in fraud and abuse related to prescription drugs. Major efforts will include empowering partners through data sharing and education.
  1. Combatting Health Care Cybersecurity Threats. The OIG will increase efforts to combat cybersecurity threats, including hacking attacks, manipulation of medical devices, and inappropriate access to U.S. genomic data. The OIG will perform more cybersecurity audits of HHS agencies and programs, in partnership with other agencies, to conduct investigations that may involve espionage or foreign threats.
  1. Promoting Patient Safety and Accuracy of Payments in Home and Community Settings. The OIG plans increased efforts to reduce improper payments for services in noninstitutional settings, including home health. The OIG’s plans include outreach, education, audits, evaluations, inspections, investigations, and administrative enforcement.
  1. Leveraging Technology as it Intersects with HHS Programs. The OIG highlights that technology can be used to increase the efficiency, quality, and accessibility of the health care system. The OIG will work with other HHS agencies, patients, and providers to educate and oversee the use of health technology to positively impact providers and patients. The OIG will also assess how it can use Artificial Intelligence to foster value and quality in HHS programs.
  1. Ensuring HHS Managed Care and New Healthcare Models Produce Value. As CMS programs shift to value-based care and payment, the OIG has identified three elements that are critical to achieving better value, quality, and outcomes: (1) aligning program incentives with improved health outcomes; (2) strengthening program integrity; and (3) delivering innovative technology. The OIG will oversee the continued transition to value-based programs and will address and combat any issues of fraud, waste, and abuse.

 

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 LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: DOJ moves on first criminal cases of COVID-19 fraud

The Department of Justice (DOJ) brought fraud charges against the president of a medical technology company in connection with a scheme to commit health care fraud with the submission of over $69 million in false and fraudulent claims for allergy and COVID-19 testing. The allegation is that he defrauded Medicare through illegal kickbacks and bribes and then turned to exploiting the pandemic by fraudulently promoting an unproven COVID-19 test to the market. The hoax leveraged off the fear of the pandemic with the company touting that his laboratory was the only one in the world that offered revolutionary “microarray technology,” which tested allergies and COVID-19 based on a drop of blood that was 250,000 times smaller than the amount required by technology touted by others.

The press announcement stated that beginning in or around 2018 and continuing to in or around February 2020, the company president and others paid kickbacks and bribes to recruiters and doctors to run an allergy screening test, using his Arrayit product, on every patient regardless of medical necessity, and then made numerous misrepresentations about the results. As the COVID-19 crisis began to escalate in March 2020, he and others made false claims concerning Arrayit’s ability to provide accurate, fast, reliable and cheap COVID-19 tests in compliance with state and federal regulations, and made numerous misrepresentations to potential investors about the COVID-19 tests and Arrayit’s future prospects for COVID-19 testing. The company president stated that it was simple to develop a test for COVID-19 because the switch from testing for allergies to testing for COVID-19 was a simple and easy step, but he and others never disclosed that there were questions about the validity of its data and the accuracy of its COVID-19 test. The press announcement reaffirmed that investigating COVID-19 fraud scams billed to federal health programs continues to be a top priority, noting that ongoing public health crisis has spawned a rash of fraudulent schemes.

 

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Continued confusion regarding the CMS preclusion list

Those on list are prohibited from MA Plans or Part D Sponsors payment

Questions continue arise concerning the CMS Preclusion List final rule. The Preclusion List is a list generated by CMS that contains the names of prescribers, individuals, and entities that are unable to receive payment for Medicare Advantage (MA) items and service and or Part D drugs prescribed or provided to Medicare beneficiaries. The rule mandates Part D sponsors, or their pharmacy benefit managers, to screen against the Preclusion List and reject any pharmacy claim prescribed by an individual or entity on it. MA plans must deny payment for a health care item or service furnished by an individual or entity on the list. Plans and sponsors must also notify impacted beneficiaries who received care or a prescription from a provider on the Preclusion List in the last twelve months. The list includes those who are currently revoked from Medicare, are under an active reenrollment bar, and whose underlying conduct CMS has determined to be detrimental to the Medicare program; or have engaged in behavior for which CMS could have revoked the prescriber and determined the underlying conduct would have led to the revocation. Such conduct includes, but is not limited to: felony convictions and OIG exclusions. CMS indicated that individuals or entities appearing on the List of Excluded Individuals/Entities (LEIE) and/or the System for Award Management (SAM) list would also be placed on the Preclusion List.

MA plans and Part D sponsors are required to access the list through an Enterprise Identity Data Management (EIDM) account with CMS. The list is updated monthly.  The causes for most of the confusion is that only plans approved by CMS are granted access to the Preclusion List. As a result, many if not most, organizations use a vendor for sanction screening services. However, the vendors are not always given access to the List.  The way around this obstacle has been for Plans to give their vendor the list and have them include it in their screening services. Another point of confusion is that technically, it is not a sanction list. It includes many parties who have not been formally sanctioned to be included on the OIG LEIE, although many on the list are also on the LEIE.

 

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: DOJ, OIG promote a ‘Culture of Compliance,’ Strategic Management can help

The Department of Justice (DOJ) “Evaluation of Corporate Compliance Programs” notes that an effective compliance program includes “[t]he company’s culture of compliance.” It also states it is important for a company to create and foster a culture of ethics and compliance with the law and for executive leadership to implement a culture of compliance from the top. The DOJ calls for its prosecutors to assess whether the company has established processes that incorporate the culture of compliance into its day-to-day operations. The OIG stresses similar points in its Compliance Program Guidance by stating that compliance efforts need to be designed to establish a culture that promotes prevention, detection and resolution of instances of conduct that violate applicable laws, regulations, health care program requirements, and ethical and business practices. The OIG further advises that consideration should be given to using questionnaires that solicit impressions of a broad cross-section of employees and staff. Elsewhere the OIG recommends evaluations of compliance program through “employee surveys.” The U.S. Sentencing Commission Guidelines notes the importance of organizations to develop institutional compliance cultures that discourage criminal conduct and that an effective compliance program must “promote an organizational culture that encourages ethical conduct and a commitment to compliance.”

Solution to Measuring and Benchmarking Compliance Culture

Since 1993, Strategic Management has employed its healthcare compliance culture benchmark survey, on behalf of hundreds of health care organizations with more than three quarters of a million surveyed population. It was developed by a former DHHS Inspector General with the assistance of two PhD experts. The survey design measures employee attitude and perceptions concerning the compliance environment; and has been tested and validated to provide reliable results. The huge database of users permits organizations to benchmark their results against that universe. The results provide invaluable metrics of program effectiveness and can establish a baseline from which future surveys can be used to benchmark improvement. The report provides insights into how effective the compliance program has been in changing and improving the compliance culture of an organization. Employing this tool is surprisingly inexpensive and costs only a small fraction of a full compliance program effectiveness evaluation or even gap analysis.  They are also less costly than developing and delivering a home grown survey that are not validated or tested for reliability. Reports from the Survey runs 30 to 50 pages and include tips for addressing any weaknesses; and benchmarks results against the huge universe of those who have used the same survey three ways: (a) overall results, (b) by category, and (c) individual questions.

 

For more information on a Compliance Culture Survey, contact Kash Chopra, JD (703-535-1413) or at  KChopra@strategicm.com .

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.