FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]

No Relief in Minnesota from Reporting Obligations

On June 24, 2013, the Minnesota Board of Pharmacy posted a letter to pharmaceutical manufacturers and drug wholesalers informing them that the Board’s request to the Minnesota legislature to repeal Minnesota Stat. §151.47(1)(f) did not occur. Rather, the Minnesota legislature modified the statute related to reporting obligations. The Minnesota Board […]

Administration Delays Implementation Of Employer Shared Responsibility Obligations Under Health Reform

The Obama Administration, through the U.S. Department of Treasury, recently announced that it was delaying implementation of key provisions of the Affordable Care Act (“ACA”) for a year. Originally scheduled to go in effect on January 1, 1014, the shared responsibility provisions of the ACA would subject employers with 50 or […]

With the 1st Pick of the 2013 Draft, the Department of Health and Human Services Selects…

Like the success of a sports team, the success of the Affordable Care Act (“ACA”) depends on many factors.  However, one critical factor contributing to the success of ACA is the enrollment of individuals in the exchanges. In an effort to promote enrollment, the U.S. Department of Health and Human […]

The Countdown until October

On June 19, 2013, the Government Accountability Office (“GAO”) released two reports, Status of CMS Efforts to Establish Federally Facilitated Health Insurance Exchanges and Status of Federal and State Efforts to Establish Health Insurance Exchanges for Small Businesses, that collectively cast doubt on whether the health insurance exchanges (the “exchanges”) […]

Available Now: CMS Templates for Data Collection and Reporting Under the Federal Sunshine Provisions

As the health care industry prepares for data collection beginning August 1, 2013, in accordance with the federal sunshine provisions in Section 6002 of the Affordable Care Act and its implementing regulations, industry must also plan ahead for reporting the data collected. Data collection and reporting are inextricably linked, as […]