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.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2019 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.

Free Health Law Webinar–Lessons Learned that We Hope Not to See Repeated

It’s your last chance to register for the fourth and final free webinar in Wolters Kluwer Legal & Regulatory, U.S.’s four-part webinar series in partnership with Alston & Bird focusing on best practices for handling internal and external healthcare fraud and False Claims Act investigations.

“Lessons Learned That We Hope Not to See Repeated” will discuss some of the most notorious investigation failures that have occurred in healthcare organizations, and the speakers will offer advice on how to avoid pitfalls. To register, visit the link below:
Lessons Learned that We Hope Not to See Repeated 
Wednesday, February 6, 2019 at 2 PM EST
Featured speakers: Frank Sheeder and Mitch Mitchelson, Partners at Alston & Bird

For information on the full webinar series, visit http://health.wolterskluwerlb.com/2018/10/wk-announces-free-webinar-series-on-healthcare-investigations/

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.