Report to: ASCLS Board of Directors
Report of: Government Affairs Committee (GAC)
Submitted for: Annual Meeting 2014 HOD Report
Prepared by: Rick Panning, GAC Chair
Date: July 1, 2014
Conference calls: Monthly calls occurred for all months except March (legislative symposium) and July (Annual meeting) for which live meetings occurred.
2013-2014 GAC Strategic Plan:
The 2013-2014 GAC Strategic Plan that was based on the committee charges from ASCLS President J.R. Constance with committee members. The following assignments have been made.
§ Committee Charge: Association of Genetic Technologists (AGT) representation. We are pleased to have AGT representatives, Helen Bixenman, and Jen Crawford and Kathy Sudduth continue as members of our committee.
§ Committee Charge #1: GAC to work with the ASCLS office in planning and support of the 2014 Legislative Symposium. Rick Panning worked with Elissa Passiment and Patrick Cooney in preparation for this symposium.
§ Committee Charge #2, #3, and #4: Develop consistent, ongoing communication of legislative and regulatory issues to all members.
Þ E- newsletter editor: Mr. Panning. E-newsletter pubished in December 2013.Two issues were sent to ASCLS members in June 2014. They summarized the legislative symposium and summarized the impact of the PAMA (Protecting Access to Medicare) legislation passed on March 31, 2014
Þ CLS Journal Focus Series
§ A three part series of articles was published in the Spring 2014 issue of CLS. An introductory article for the series and a post test were also submitted. Rick Panning was author (with many thanks to editor Suzanne Campbell)
· Accountable Care Organizations (ACO) and their role of the laboratory
· The impact of the Affordable Care Act on the laboratory
· Legislative and Regulatory issues impacting the laboratory
Þ ASCLS Today:
§ September 2013: Debbie Shell
§ April 1, 2014: Student article related to legislative symposium (Tjeresa Fruehling and students)
§ June 1, 2014: Workforce legislation (Kyle Riding)
§ Committee Charge #5-6: Work with the membership services committee to develop GAC information to be used in membership recruitment and retention information. Work with the Administration Scientific Assembly to identify appropriate topics for continuing education. Leslie Martineau is our representative to the Membership Committee. Multiple members of GAC are also part of the Admin SA. Input into the content of the first Advanced Management Institute (July 2014) has been provided.
§ Committee Charge #7 and #9:
Þ Evaluate the initial effectiveness of the regional liaisons expectations document and make necessary changes. Develop a strategy to engage the state/region contact network. Review and update the government affairs handbook.
Þ Regional Liaisons – 2013-2014 assignments:
Region I – Leslie Martineau
Region II – Kyle Riding
Region III – Angela Phillips
Region IV – Linda Goosen
Region V – Lori Murray
Region VI – John Koenig
Region VII – Becky See
Region VIII – Debbie Shell
Region IX – Donna Reinbold
Region X – Josh Pulido
Student and New Professional Liaison: Theresa Fruehling
Þ Government Affairs Handbook: Theresa Freuhling, Jackie Raetz and Kyle Riding are developed and updated the document, a Beginner’s Guide and accompanying PowerPoint presentation. Kyle Riding has helped to edit the final document.
§ Committee Charges #10: Support ASCLS Executive VP and Legislative Consultant in responding to legislative and regulatory initiatives. This was done through monthly GAC conference calls and as needed.
Legislative Updates:
Topics for Legislative Symposium
o Modernization of the fee schedule
o Influencing Congress to stop cuts to CLFS
o Workforce challenges
§ Workforce Investment Act (WIA) Reauthorization
§ Allied Health Special Projects and Grants Programs
· Zeroed out several years ago
· Main apparatus for clinical lab programs to be initiated and continued
·
Fee Schedule Modernization: ASCLS, CLMA, and ASCP originally agreed to approach the Hill about legislation to establish a negotiated rulemaking. Ultimately this and the proposed CMS modernization have been shelved by the PAMA legislation (see next topic.
SGR (Sustainable Growth Rate) fix legislation (PAMA – Patient Access to Medicare Act, H.R. 4302)
§ Basically will do away with the CMS-proposed CLFS modernization effort and replace it with an effort to change the rationale for CLFS reimbursement to a market based approach. In addition to this aspect, it will require a significant data submittal component by January 2016 which will be very challenging to hospital and clinic laboratories and much simpler for large private reference labs.
§ ASCLS was part of a follow-up meeting with CMS to express concerns and offer input into the process.
§ Concern about the data collection requirements for laboratories and the impact on laboratory reimbursement
HHS workforce funding (through HRSA): There seems to be increased awareness of the need for funding of allied health, nursing and medical schools. There will be a meeting in late June with the goal of reinvigorating funding for allied health, even though it is not included in the President’s budget.
Wyden/Grassley request for stakeholder input regarding digital laboratory data. We should send our input to the GAC committee and we can consolidate for the congressional committee. Senator Wyden is a new committee chair. This is an opportunity for us to demonstrate the vital importance lf laboratory data for patient care and population health. This data can be used to improve quality, needs to be accessible to consumers and can also aid in research, outcomes and comparative effectiveness. Deb Rodahl has already provided feedback and that feedback was shared with the committee. We will also share this request with Scott Aikey for an IT perspective. Theresa Fruehling is going to reach out to Senator Grassley as a constituent.
Regulatory Update:
On September 23 in the Federal Register the proposed rule with the proficiency testing changes was published. This proposed rule is not a surprise as it is a result of the TEST act. They have proposed 3 tiers of sanctions. ASCLS will respond in the 60 day comment period. The proposal provides flexibility for CMS to have a tiered level of response to the referrals of PT to other CLIA labs.
Laboratory Developed Tests(LDT): No further movement within FDA.
FDA released guidance on point of care testing for home environment and healthcare environment. ASCLS provided cvomments. This will have a significant impact for glucose meters in the hospital as they were not approved for critical care patient use and therefore become moderately or highly complex and impact the personnel requirements. Because this is a guidance document, FDA is not required to respond, but may modify the guidance document.
CMS bundling of outpatient laboratory services is of concern as well. Means a specific loss of laboratory revenue that will be paid to the hospital as part of a package under the Ambulatory Patient Classification (APC)
Committee members will be providing feedback to Elissa on the new 2015 CPT codes. Elissa will be attending the July 14 CMS meeting to review reimbursement recommendations. Primary changes are in drugs/toxicology and molecular.
Patient access to laboratory results: final rule in Q1 2014. 8 months to implement.
State Licensure Updates:
· Minnesota passed all Senate committees, but failed to be able to have a House committee hearing.
· Missouri did not introduce in 2014
· Virginia decided to not introduce a bill
· Texas legislature does not meet this year. Texas had a legislative committee hearing in June and ccmpleted a petition.
· Idaho, North Carolina and South Carolina are at various stages of drafting legislation.