Tag: transparency

OIG Releases Updated Mid-Year Work Plan: Open Payments, Clinical Laboratory Payments & Opioid Billing Trends Added to Agenda

The Health and Human Services Office of Inspector General (OIG) released last week an updated mid-year Work Plan for FY2015, which removes items that have been completed, postponed, or canceled and includes new items that have been started since October 2014. The FY2015 OIG Work Plan that we previously discussed is […]

CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law.  In addition to summarizing the process and outcome of the 2014 reporting period, the recently released annual report includes a few key takeaways for pharmaceutical and medical device manufacturers […]

Connecticut Delays Payment Reporting Until 2017

Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015.  This deadline was delayed until 2017 by recently enacted Public Act 15-4.  Additionally, Public Act 15-4 changed the reporting period from […]

West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP). This includes section 16-29H-8 of the Code, which requires prescription drug manufacturers and labelers to annually report advertising and promotion costs for the prior calendar […]

CMS Issues Additional Sunshine FAQs

The Centers for Medicare & Medicaid Services (CMS) released this week 5 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals in connection with the federal Sunshine Act.  The FAQs generally relate to […]

On a Roll . . . Vermont Attorney General Posts Two More Enforcement Actions for Gift Ban & Disclosure Law

The Vermont Attorney General (VT AG) posted its third round of enforcement actions of 2015 against a manufacturer of surgical microscopes and a dental products company.  You can read Cooley’s posts about the first two 2015 enforcement actions here and here. The Assurance of Discontinuance for Premier Dental Products Company states that it provided allowable expenditures […]

Vermont AG Posts Second Enforcement Action of 2015 Related to State Disclosure Law

Last week, the Vermont Attorney General (VT AG) posted its second enforcement action of 2015, this time against a dental products manufacturer.  You can read about the first 2015 enforcement action here.  According to the Assurance of Discontinuance, Heraeus Kulzer, LLC provided allowable expenditures and/or permitted gifts to Vermont health care professionals in […]

Vermont AG Announces Another Disclosure Law Enforcement Action

As discussed here and here, the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s Prescribed Products Gift Ban and Disclosure Law, 18 V.S.A. §§ 4631a, 4632.  Last week, the VT AG posted another enforcement action […]

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug, device, biological, or medical supply that provides a payment or transfer of value to an advanced practice registered nurse (APRN) practicing in the state […]

CMS Releases New Video Tutorial for 2014 Sunshine Reporting; Q&A Session Next Week

The Centers for Medicare and Medicaid Services (CMS) released today a 20 minute on-demand video tutorial related to the 2014 Open Payments reporting program.  The video provides an overview of the registration, reporting and certification processes, as well as CMS resources available related to Open Payments.  According the CMS, the […]