Category: Fraud and Abuse

HHS Releases Long-Awaited Proposed Rules Related to AKS, Stark, CMP Laws for Value-Based and Coordinated Care Arrangements

The U.S. Department of Health and Human Services (HHS) announced today the release of two long-awaited proposed rules to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. As previously discussed, these proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care and arise from […]

Q3 GOVERNMENT SETTLEMENTS ROUND-UP: LIFE SCIENCES

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Sept. 26, 2019 $108M Deferred prosecution agreement Forfeiture […]

OIG Report on Reasonable Assumptions in Manufacturer Reporting

Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of assumptions made by a sample of drug manufacturers participating in the Medicaid Drug Rebate Program (MDRP) […]

OIG Publishes Advisory Opinion on an Arrangement Involving an Excluded Individual

In OIG Advisory Opinion No.19-05, the Department of Health and Human Services Office of the Inspector General (OIG) concluded that it would not impose sanctions against a requestor under the civil monetary provision of the Social Security Act (SSA) that prohibits certain persons from contracting with individuals or entities known […]

Final Rule Issued by CMS re: New Enforcement Authorities to Reduce Criminal Behavior in Medicare, Medicaid and CHIP

The Centers for Medicare & Medicaid Services (CMS) issued late last week a final rule with comment period titled, Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-FC) (Final Rule). The Final Rule is intended to proactively prevent fraud and abuse against the Federal health care programs, including Medicare, Medicaid […]

OIG Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions

On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its hospital customers (“Customer”) who purchase the following three products for use in a joint replacement surgery: (i) […]