Public and Regulatory Policy
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Public and Regulatory Policy Committee
Chair: Erin Davis
Chair-elect: Jennifer Nowaczyk
Our mission is to advocate on behalf of ICCAC by influencing international, regional, and state public policies relating to mechanical circulatory support. As a committee, we monitor legislation and regulatory agencies as they relate to MCS. These include but are not limited to, NIH, FDA, CMS, the Joint Commission, DNV, UNOS, and other international or regional regulatory bodies. Our vision is to review upcoming regulatory changes, inform our members about open comment periods, and create relevant society-level responses, approved by the ICCAC Board of Directors, to be delivered to appropriate regulatory bodies.
Scope and Objectives
- Monitor legislation and regulations involving MCS therapies and report to ICCAC Board Quarterly. These include, but are not limited to, NIH, FDA, CMS, the Joint Commission, DNV, UNOS, and other international or regional regulatory bodies that the committee is made aware of by International ICCAC members.
- Inform ICCAC membership of upcoming policy and regulatory changes relating to MCS therapy
- Create society-level responses to open public comment periods for MCS therapy–related policy or regulation changes
We are excited to have 15 members on our committee who met 3 times in 2022 and worked on the content uploaded to this website. We finalized our mission and vision of the committee and plan to provide the ICCAC membership with ongoing monitoring of the following regulatory bodies and societies:
- Joint Commission
- CDC / Coding Clinic
- MCS-related Societies: ISHLT, ASAIO, AHA, ACC, STS, HFSA, AAHFN, ESC, TFCA
Joint Commission & DNV Fall 2022 UPDATES!
The committee members worked with Joint Commission and DNV experts to compile a short reference of 2022 updates from these regulatory bodies. Remember to always review Joint Commission and DNV information with your representative for your program's regulatory body.
European Society of Cardiology (ESC) Updates: Pulmonary Hypertension 2022
Please see below for a summary of updates provided by ESC on Pulmonary Hypertension.
MCS-related BILLING / CODING Updates
There is a new IPPS/OPPS 2023 Hospital reimbursement document live October 2022. Our committee did not find significant changes to DRG 001, 002, 003, 215, 268-270. We recommend reviewing these documents within your own program with your institution's billing/coding department.
Medicare will be decreasing physician reimbursement in 2023 with the adjusted Physician Fee Schedule (PFS) for 2023. This has caused a lot of stir, including with cardiologists and electrophysiologists. To learn more about this topic see Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule | CMS.
HFSA: Dr. Trachtenberg, Dr. Cowger, et al. just published the 2023 HFSA Expert Consensus Statement on the Medical Management of Patients on Durable Mechanical Circulatory Support in the Journal of Cardiac Failure. Check out the full online publication by clicking the following link.
HFSA Medical Management Durable MCS
ISHLT: Dr. Bernhardt, Dr. Copeland, et al. just published the 2023 ISHLT/HFSA Guideline on Acute Mechanical Circulatory Support in the Journal of Heart and Lung Transplantation. Check out the full online publication by clicking the following link.
Join our committee!
We welcome additional members anytime who would like to join. We specifically are seeking out members with interest and knowledge of the administrative side of MCS therapy. We also do not yet have Non-US focus and will welcome that addition, if and when we have interest in that area.
Chair and Committee Member Requirements
- At least 3 members are recommended to maintain the efficiency of the committee. There is no maximum number of members.
- Recommend at least 1 international member, but not a requirement. Any International ICCAC member is invited to join committee calls to bring to attention international policies or regulations relating to MCS therapy
- Recruitment is achieved through current ICCAC membership, MCS collaboration board, emails, social media, and word of mouth via colleagues
- Chair of the committee is strictly voluntary and the individual who volunteers shall remain in the chair position for a minimum of 1 year
- If there are no other volunteers to follow the Chair position, the individual in the chair position can maintain in this role until another volunteer is found
- Co-Chair (if established) will take over January of the following year and will change to “Chair” status at to which time active recruitment for future co-chairs will take place
- Minimum 1 year as MCS clinician
- Active ICCAC Member
- Active committee members must participate in >50% of meeting phone calls. Should schedule conflicts occur, an email including project updates will suffice.
- Industry ICCAC members may fully participate in the committee, but may not hold the Chair or Co-Chair position
- Focus on disseminating meaningful MCS
Policy & Regulatory content for our members (currently US only)
- Social Media
- EZ Texts
- Timely (monthly) News Flash
- 2 Webinars
- Engage Transplant/MCS Financial Coordinators
- Review and comment for CMS IPPS/OPPS billing/coding open for public comment May 2023
If you have suggestions for items you'd like reviewed and reported on this year, please email the committee at email@example.com
The information provided by the International Consortium of Circulatory Assist Clinicians (ICCAC) is for educational purposes only. This information should not be perceived as prescriptive or complete in its purview. The information provided represents the opinions of the society and no one individual within the society. Please confirm with your local and governmental bodies for full and current language. ICCAC makes no claims, promises, or guarantees about the accuracy and completeness of the included information. The information provided does not constitute legal, business, or medical advice, as such should not be wholrelied upon. You are the sole responsible party for understanding and complying with laws that apply to you and your organization. Whenever possible, ICCAC will attach available reference materials that generate the comments posted by this committee.
If you have any questions, please contact ICCAC@VADCoordinator.org.