Category: Corporate Compliance

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 […]

OIG Work Plan Round-up: 12 New Items Added for August 2019 Including Medicare DRG, Diabetes Testing Strips, Telehealth Services

The Office of Inspector General (OIG) for Health and Human Services (HHS) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG. Monthly updates to the OIG Work Plan can be found on the Recently Added page. All current Work Plan items are available on the […]

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) […]

FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]