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: 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.

Kusserow on Compliance: CMS Preclusion list

Those on Preclusion List are prohibited from MA Plan or Part D sponsor payment

Effective April 2019, under a final rule published by CMS, Part D sponsors, or their pharmacy benefit manager must screen against the Preclusion List and reject any pharmacy claim prescribed by an individual or entity on the Preclusion List. Additionally, effective April 2019, 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, where CMS has determined that the underlying conduct is 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. Only health care plans approved by CMS will have access to the Preclusion List. MA plans and Part D sponsors will be required to access the list through an Enterprise Identity Data Management (EIDM) account with CMS.  The List will be updated around the first business day of each month. 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.

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.

Kusserow on Compliance: New anti-kickback law for clinical labs

– Law creates new compliance risk areas for 2019

– Compensation of sales personnel affected

– Not limited to federal health care programs

For the new year, compliance officers should recall Congress passing into law the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), which became effective October 24, 2018. It applies to Medicare and Medicaid, as well as many commercial health insurance plans. It has the effect of eliminating “safe harbors” used by clinical labs in marketing services. The law was intended to be part of the effort to target the national opioid crisis. It makes it a criminal offense to solicit or receive any remuneration, directly or indirectly, in return for referring a patient or patronage to a recovery home, clinical treatment facility or clinical laboratory; or to offer or pay a kickback to “induce” a referral of an individual to a recovery home, clinical treatment facility or clinical laboratory, or in exchange for an individual using the services of a recovery home, clinical treatment facility or clinical laboratory. Penalties for each violation can include a fine of up to $200,000 and imprisonment of up to 10 years. The law has seven “safe harbors,” some of which are similar to the safe harbors under the federal Anti-Kickback Statute that is generally applicable to Medicare and Medicaid services, however the safe harbor for employees and independent contractors under the law expressly excludes from safe harbor protection any payment made to an employee or independent contractor that is determined or varies by:

  • the number of individuals referred;
  • the number of tests or procedures performed; or
  • the amount billed or received.

The EKRA adds an all payor (public and private) provision that enables the federal government to monitor provider arrangements intended to generate business for any laboratory services, not only those related to individuals in treatment for substance abuse disorders, payable by a federal health care program or commercial health insurer.

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.