Tag: Congress

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 […]

Lawmakers release new version of 21st Century Cures legislation

Yesterday, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative.  This draft is the latest step in the Committee’s year-long attempt to accelerate new medical innovations and improving the way they are brought to market.  According […]

Early 2015 Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of 21st Century Cures, a significant report from the Federal Trade Commission (FTC) […]

FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015.   This guidance is a first for the FDA and comes as a product of negotiations with the medical device industry over Medical Device User Fee Amendments […]

CMS Sunshine Updates – Webinar Slides, Reporting Specifications, Letter from Congress

There have been several recent and noteworthy developments related to Centers for Medicare & Medicaid Services (CMS) Open Payments.  As we told you here and here, CMS held a follow-up webinar this week to address additional questions related to Sunshine registration and reporting.  The slides from this webinar are available on the CMS Open Payments website.  Notably, […]