Advocacy in Action: EDCs, Clinical Trials, and More

What’s Happening in Washington

Washington came together in a rare act of bipartisan unity the week of December 3 to celebrate the life and legacy of President George H.W. Bush.  Most House and Senate votes and meetings were cancelled and the federal government was closed December 5 for an official day of mourning.

Shutdown Showdown Delayed until December 21 – Due to observances surrounding the death of former President George H.W. Bush, the White House and congressional leaders agreed to extend temporary funding to Friday December 21 and avert a partial government shutdown that was to begin December 8. The two-week CR would extend the current December 7 spending deadline through December 21 to allow negotiators more time to negotiate their disagreements on policy riders. The measure also extends the expiring National Flood Insurance Program and Violence Against Women Act authorities.  The President has not publicly raised any doubt about signing the stop-gap bill. Note:  Fiscal year 2019 officially began on October 1 with only 5 of the 12 regular appropriations bills enacted. Departments and agencies funded by the other 7 bills — Ag, CJS, HSec, FSGG, Interior, State, and THUD — are temporarily funded by a continuing resolution.  We will have to wait and see if a Christmas miracle provides final funding for these 7 agencies…

What We Are Working On

EDCs in the EU – As a direct result of our latest briefing in the EU Parliament and visits with Members of the European Parliament (MEPS) from France, Spain, Italy, Finland, and the Netherlands last month, 60 Members of the European Parliament (MEPs) proposed a parliamentary question regarding the European Commission’s failure to take urgent measures on endocrine-disrupting chemicals (EDCs).  The question will be considered for further discussion by the Presidents of the political parties in the European Parliament and we hope that the question will be brought up for oral debate in plenary.

Physician Payment – On Thursday, December 6, we hosted a webinar, “Evaluation & Management Coding Revisions – What You Need to Know” to discuss recent changes to evaluation and management coding and document requirements.  The webinar can be found here. Additional details about revisions to the E/M codes are available on our website.

Human Subjects in Clinical Trials – The Open Mike blog outlined NIH’s next steps for basic experimental studies involving human subjects. As indicated in an October 26 Notice, NIH will issue new funding opportunity announcements for “prospective basic science studies involving human participants.” These research activities will continue to be considered clinical trials per NIH’s updated definition. The blog indicated a significant concession in reporting of these studies, allowing flexibility to report on alternative portals instead of ClinicalTrials.gov. This addresses one of our main concerns raised in response to the recent RFI on this issue.

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