All posts by Sarah K. diFrancesca

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 […]

OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items: Secretary Price’s Use of Chartered Aircraft for Federal Travel. OIG is reviewing Secretary Price’s use of chartered aircraft for Federal travel […]

Nevada Releases Procedures for Pharmaceutical Representative Registration

The Nevada Department of Health and Human Services (DHHS) recently released procedures related to pharmaceutical representative registration in response to Nevada SB 539. An overview of Nevada SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry, is available here. The procedures require registration by pharmaceutical representatives that physically […]

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. […]

OIG Releases August Work Plan Items

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The August updates released this week include 4 new Work Plan items: Review of Patient Safety Organization Program, including implementation of the program among hospitals and oversight by Agency for Healthcare Research […]

OIG Work Plan Will Now Be Updated Monthly; 14 New Items Added for July

The Office of Inspector General (OIG) for Health and Human Services (HHS) recently announced that it will begin updating its Work Plan initiatives monthly rather than its previous twice-yearly publications, which was most recently released in November 2016. The OIG Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken […]

CMS Publishes 2016 Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) published today the Open Payments data reported earlier this year by applicable drug, device, biologic and medical supply manufacturers and group purchasing organizations (GPOs) related to payments and transfers of value to physicians and teaching institutions, and ownership or investment interests held by […]

Maine Enacts Gift Ban Law

Yesterday, An Act To Prohibit Certain Gifts to Health Care Practitioners became law in Maine without the signature of the Governor. 32 MRSA § 13759 prohibits licensed pharmaceutical and medical device manufacturers and wholesalers from providing a gift to a practitioner. Exceptions include: noncash items of minimal value that directly benefit the practitioner’s patients, […]

Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit Organizations

As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in adopting legislation aimed at addressing pharmaceutical price increases and other recent industry concerns. Diabetes Drug Pricing Reports February […]

FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding its planned research titled, “Experimental Study on Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The FDA explained that direct-to-consumer […]