Category: Corporate Compliance
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 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 […]
Two Enacted State Laws Permit Truthful Off-Label Promotion
Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free […]
OIG Releases December Work Plan Items; Focus on Opioid Prescribing Continues
As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The December updates include 6 new Work Plan items: Status Update on States’ Efforts on Medicaid-Provider Enrollment. OIG will follow-up on a previous review to determine the extent to […]
OIG Releases November Work Plan Items; Focus on Opioid Prescribing and Telemedicine
As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The November updates include 4 new Work Plan items: Opioids in Medicaid: Concerns about Extreme Use and Questionable Prescribing in Selected States. Focusing on the opioid public health […]
California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers related to certain price increases of some already marketed drugs and the introduction of new drugs onto the […]
OIG Releases September Work Plan Items; Includes Part D Sponsor Reporting of Rebates and Price Concessions to Medicare
As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The September updates include 9 new Work Plan items: Federal Marketplace Enrollment Systems. OIG will assess operational readiness, internal controls, and IT security in preparation for the fifth open enrollment period. […]
