Many people ask “what it is like to work in Washington D.C. in the midst of the election?” In reality, the Presidential election is a distant news story here. The frenzy of activity in the nation’s capital is fed by our work with members of Congress as well as ongoing communication with our regulatory partners at the Food and Drug Administration, Centers for Disease Control and Department of Health and Human Services.
Support for ZIKA implementation costs
ABC is working in conjunction with the HHS and Hill leaders to develop a plan to support the implementation costs incurred by blood centers when they had to “drop everything” to comply with the FDA guidance recommending universal individual donor nucleic acid testing for Zika. According to member survey results, the majority of ABC blood centers are participating in the Investigational New Drug cost recovery program. ABC is seeking funding to reimburse blood centers for the “aggravation factor” of the short timeline that resulted in having to put other programs on hold, delay needed blood center projects, and one-time costs of additional training and paperwork involved with the change. Stay tuned for more information soon and please share your thoughts on this with your ABC team.
OPPS Final Rule
On November 1, CMS released the final rule for Medicare hospital outpatient reimbursement (also known as OPPS). Earlier this year, ABC filed comments with the Centers for Medicare and Medicaid Services (CMS), a division of the HHS on the proposed rule. Read more in depth about our comments and the final rule responses to them in our Regulatory News section.
Blood Donor Deferral Policy Comment Letter
As you might recall, the FDA has requested comments to assist the agency in their commitment to reevaluate and update blood donor deferral policies as new scientific information becomes available. ABC, in conjunction with AABB and ARC, is in the process of finalizing our joint comment to be submitted at FDA’s request. These comments are intended to assist FDA in identifying key issues that should be considered at the time FDA begins the reevaluation process for deferral polices. Suggested topics for further research include: study of the implementation aspects of the one year deferral for men who have sex with men. Confirmation that infection marker rates have not been impacted; and analysis of questions for individual behavioral assessment.
All of this activity is taking place in the midst of a government transition. Approximately 100 HHS senior leaders, all political appointees, will tender their resignation letters soon to allow the new administration, whomever that may be, to select their own people for these positions. Election fatigue? No time for it. The beat goes on in Washington, D.C. and ABC is working daily to make sure that your voice is heard.
Christine Zambricki DNAP, CRNA, FAAN; Chief Executive Officer