Kusserow on Compliance: OIG Advisory Opinion 18-14

The OIG’s continued interest and concerns about arrangements that could implicate the Anti-Kickback Statute was reaffirmed recently by another advisory opinion on the subject. A drug company (Requestor) that markets an injectable drug to treat a specific and rare form of epilepsy (the Syndrome) raised the concern with the OIG. The Requestor sought an advisory opinion as to whether the arrangement would be susceptible to sanctions related to the federal Anti-Kickback Statute (AKS). The proposed arrangement would have the Requestor providing a drug to hospitals on a consignment basis, at no cost to the hospitals or any payors, to treat inpatients diagnosed with the Syndrome.  In addition, the company would provide additional free vials to patients that are uninsured after they are discharged. The OIG found that the proposed arrangement implicates the AKS, in that free provision of the drug would constitute remuneration to hospitals that serve as a referral source for the drug. Specifically, hospitals would serve as a direct referral source when their employed physicians prescribe the drug to inpatients or outpatients.  Hospitals could also serve as an indirect referral source for the Drug through inclusion of the Drug in the hospitals’ drug formulary, thereby keeping it stocked and readily available to prescribing physicians. In this manner, the arrangement could induce hospitals to arrange for or recommend additional future purchases of the drug. The OIG highlighted the arrangement’s risks with respect to over-utilization, increased costs to federal health care programs, corruption of medical decision-making, patient steering, and unfair competition.

 

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 © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Board compliance expertise needed to protect against liabilities

– OIG “White Papers” and CIAs are must-reads for compliance officer

– CIA board member certification mandates is a “game changer”

– Boards need “compliance literate” members

– Compliance officers should not wait for boards’ engagement of experts

Government regulators have advised for decades that effective Compliance Programs begin at the top with the Board and cascade down through the executive leadership and the compliance officer to all employees. The OIG and American Health Lawyers Association (AHLA) issued three communications that underscore the Board compliance duties and responsibilities. The most recent is “Practical Guidance for Health Care Governing Boards on Compliance Oversight” which advised Boards to have compliance expertise available to make sure they meet all fiduciary duties and obligations in overseeing corporate compliance.

Carrie Kusserow, with 20 years experience as a compliance officer and consultant who brought organizations through CIA mandates, has found the Practical Guidance particularly significant.  It calls for Boards to engage Compliance Experts to assist them in meeting their obligations and it is noteworthy that it provides almost identical language to the language used in CIAs regarding Boards’ use of Compliance Experts. In cases where the OIG finds that the Board has not been providing the proper oversight of the compliance program, the OIG really nails the organization down in the CIA mandates, which now require personal certifications of board members. She suggests that Compliance Officers should review recent CIAs to learn what the OIG considers as best practices for a Board in engaging a Compliance Expert to be on call for advisory services.

Steve Forman, a CPA with more than twenty years experience as a Compliance Officer, compliance consultant, and has been engaged on many occasions as Board Compliance Expert.  He notes that the CIA mandates for Boards to engage a Compliance Expert because most board compliance oversight lacks members who are experts in compliance. Whereas Board Audit Committees always include “financially literate” members, most Board committees providing compliance program oversight lack members who are “compliance literate.” The result is relatively few boards have with anyone with compliance expertise to assist in proper oversight and support for the Compliance Program. His best advice for Boards is to include someone who is “compliance literate” that knows what questions to be asked and assess program effectiveness.

For more information on this subject, contact Carrie Kusserow (ckusserow@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 Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

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

Kusserow on Compliance: OIG Work Plan update

The OIG Work Plan sets forth various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and beyond. Projects included in the Work Plan span the Department and include CMS. The OIG also plans work related to issues that cut across departmental programs, including state and local governments’ use of federal funds. At the end of December, the OIG announced two new projects led by the Office of Evaluation and Inspection beginning in 2019. They are:

  1. T-MSIS Data Assessment: Usefulness of National Data to Monitor Opioid Prescribing in Medicaid. Although all States have been submitting T-MSIS data, it does not mean the data are complete and without complete data, it cannot be used as a national dataset to help Medicaid manage critical issues such as the opioid crisis. The will OIG determine whether T-MSIS contains the data necessary to identify recipients of opioid prescriptions through Medicaid who may be at risk of opioid abuse nationally.  The OIG intends to interview states to determine the challenges they face, if any, in submitting the data necessary to identify and prevent beneficiary harm from opioid misuse.

 

  1. States’ Compliance with FFS and MCO Provider Enrollment Requirements. The OIG noted that provider enrollment is a key program integrity tool to protect Medicaid from fraudulent and abusive providers. The 21st Century Cures Act requires states to enroll all Medicaid providers, both those in Medicaid fee-for-service (FFS) and managed care organizations (MCOs). This study, by the OIG, is mandated by the Cures Act and will survey state Medicaid agencies about their enrollment of FFS and managed care providers and implementation of required provider enrollment screening activities.

 

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: OIG second half 2018 semiannual report to Congress

The OIG recently released its second 2018 Semiannual Report for 2018 that highlighted its key accomplishments, areas of top concern, and a summary from reports, congressional hearings, legal and investigative activities. The OIG reported for FY Fiscal Year 2018: (a) audit recoveries of $521 million; (b) investigative recoveries of $2.91 billion; (c) 764 criminal actions against individuals or entities; (d) exclusion of 2,712 individuals and entities; and (e) civil actions against 813 individuals or entities. The OIG highlights reported included the following:

  1. In response to the Opioid Crisis, the OIG (a) released a data analysis toolkit to assist both the private and public sector in combating the crisis; (b) engaged in the largest fraud takedown of providers participating in opioid related fraud; (c) reported on the effect of the opioid epidemic and opioid prescribing practices on Medicare Part D and its beneficiaries; and (d) conducted its first state specific Medicaid review targeted toward the opioid epidemic.
  2. Took several actions during this reporting period to combat health and safety issues affecting this population and made recommendations for specific grantees that failed to meet health and safety requirements.
  3. Focused on improving the quality of care in hospice settings and protecting hospice benefits from fraud, waste, and abuse that included enforcement actions against a large hospice chain; and released a portfolio of highlights and 15 recommendations for improving hospice care for Medicare beneficiaries.
  4. Identified waste by inpatient rehabilitation facilities (IRFs) that did not meet Medicare’s necessary and reasonable coverage requirements; and identified $631 million in overpayments related to replacement positive airway pressure device supplies that did not comply with Medicare requirements.
  5. Found that MCOs were identifying few cases of fraud and abuse and failed to refer the incidents to the state when they were identified.
  1. Findings that many adult day care facilities fail to meet certain requirements to ensure the health and safety of individuals in the facilities’ care; and recommended that states correct instances of patient harm and improve oversight of staffing, training, and administration in adult day care facilities.

 

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 © 2019 Strategic Management Services, LLC. Published with permission.