Report to: ASCLS Board of Directors

Report of: Government Affairs Committee (GAC)

Submitted for:July 2013 BOD Report

Prepared by: Cindy Johnson, GAC Chair

Date:July 1, 2013

Activities since the ASCLS Interim 2013 BOD Report:

  • GAC meeting was held at the Sheraton Crystal City Hotel on March 17, 2013. There were 15 members of the Government Affairs Committee in attendance. In addition, there were 17 ASCLS members in the gallery.
  • Monthly GAC conference calls were held on: April 17, 2013; May 15, 2013 and June 19, 2013.
  • ASCLS, AMT, ASCP, AGT and CLMAsponsored the 2013 Legislative Symposiumwhich was held onMarch 18 -19 at the Sheraton Crystal City Hotel and Capitol Hill. There were over 150 laboratory professionals from 36 states in attendance. The feedback from attendees was very positive. The three “leave behind” papers (I Am Your Medical LaboratoryProfessional; Clinical Laboratory Payment Cuts Jeopardize Patient Safety;and Laboratory Personnel Jobs Are Available Nationwide Reauthorize the Workforce Investment Act Including Provisions that Support Laboratory Training Programs) helped the attendees keep our message for the legislators as succinct as possible.

Legislative Updates:

  • Sequestration Budget Impact: January 1, 2013 the Clinical Laboratory Fee Schedule (CLFS) was cut by 2.95%. This is a combination of the Accountable Care Act with a 1.75% cut in the CLFS and the productivity adjustments. The sequestration law resulted in another 2% cut. The total laboratory reimbursement cut to the CLFSthat we have experienced in 2013 is4.95%.
  • Modernize Payments for Clinical Laboratory Services: The Clinical Laboratory Coalition (CLC) is urging Senators’ Max Baucus (D-MT) and Orrin Hatch (R-UT) on the Finance Committee to reject a proposed 14 percent cut in the Medical clinical laboratory fee schedules (CLFS) over a 10 year span. This additional cut would be accomplished by extending the 1.75% cut from the Affordable Care Act for 10 years. This proposal is contained in President Obama’s budget request to Congress for fiscal year 2014 that begins on October 1, 2013. The proposal calls for a reduction in the CLFS reimbursement that amounts to approximately $9.46 billion over this 10 year timeframe.
  • Sustainable Growth Rate: There appears to be momentum to overturn Medicare's sustainable growth-rate formula (SGR) for determining physician payments. The current extension to the proposed cuts is due to expire on December 31, 2013. Three influential Congressional committees—Senate Finance, House Ways and Means, and House Energy & Commerce—have held hearings for stakeholders to present their ideas on how best to replace the SGR. The Congressional Budget Office put a $138 billion price tag on its most recent 10-year score for repealing the SGR.

ASCLS will be watching potential legislative action and paying particular attention to how the fix might impact laboratory reimbursement levels (i.e. co payment for laboratory services; additional Clinical Laboratory Fee Schedule (CLFS) cuts and/or Competitive bidding).

  • OIG Report on Laboratory Payment: The Department of Health and Human Services’ Office of Inspector General (OIG) released a report “Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings” in June 2013. In the report, there is a recommendation that the Centers for Medicare & Medicaid Services (CMS) seek legislation that would allow it to establish lower payment rates for lab tests and consider seeking legislation to institute competitive bidding, co-payments and/or deductibles for lab tests. In its comments, CMS stated that it is exploring whether it has authority under current statute to revise payments for lab tests consistent with OIG’s recommendation and that a proposal to establish “deductibles and coinsurance” for lab tests is not included in the fiscal year 2014 President’s Budget.

Regulatory Updates:

  • Physician signature on laboratory test requisitions has been resolved. Physician signatures will not be required on test requisition forms.
  • Laboratory Developed Test (LDT) Legislation: On June 4, 2013 the American Clinical Laboratory Association (ACLA) filed a petition under the Federal Food, Drug and Cosmetic Act (FDCA) challenging the Food and Drug Administration (FDA) authority to regulate LDTs as “devices” under the FDCA. FDA is required to give Congress 60 days’ notice before issuing the guidance on LDTs.
  • Patient Rights to Access Clinical Laboratory Test Result Reports: The final regulation has not been finalized but possible by late summer 2013. The CLIA office has to write interpretive guidelines on best practice for implementation of these guidelines.
  • Individual quality control plan (IQCP): Judy Yost, Director, Division of Laboratory ServicesSurvey and Certification GroupCenters for Medicare & Medicaid Services, stated at the March 2013 Clinical Laboratory Improvement Act Committee (CLIAC) meeting that the IQCP will be incorporated into the CLIA Interpretive Guidelines. Judy Yoststated that the plan was sent to the laboratory accrediting agencies for their input. CMS plans to develop educational materials for the IQCP plan.
  • Proficiency Testing (PT): there have been on-going studies since 2010 on PT regulations to meet CLIA standards. Once studies are done they will go to PT providers to streamline processes before implementation.
  • Taking Essential Steps to Testing Act (S. 3391 and H.R. 6118): This bill was signed into law by President Barack Obama on December 4, 2012. CMS is rewriting the regulations based on this legislation.
  • On May 9, 2013 the Centers for Medicare and Medicaid Services (CMS) published interim pricing for 114 new molecular pathology (MoPath) CPT codes developed by its Medicare administrative contractors (MACs). Laboratories have not been paid for molecular testing performed since January 1, 2013. CMS is expected to release final pricing in September.
  • On May 24, 2013 the Centers for Medicare and Medicaid Services (CMS) announced in the Federal Register that they will host a public meeting July 10th at its Baltimore headquarters to hear recommendations on setting Medicare payment rates for new or substantial revised clinical laboratory codes for the Part B lab fee schedule in 2014. Comments on the new or revised codes are due by June 28. Final fee decisions are expected in November

GAC Publications/Articles:

  • ASCLS Today Newsletter: March 2013

There were three articles that appeared in the March edition of the newsletter that related to our committee’s action in the legislative process.

The Man in the Treeby Roslyn McQueen

How the Federal Budget (Fiscal Cliff) and the Debt Ceiling Impact the Laboratory by Angela Phillips and Rick Panning

Legislative Symposium-An Eye Opener by Jasmin Davis

  • ASCLS Today Newsletter:(May edition): Jacqueline Raetz facilitated an article with ASCLS students attending the 2013 Legislative Symposium on their experience with this advocacy effort.
  • Theresa Fruehling submitted an article on the 25th anniversary of the Clinical Laboratory Improvement Act of 1988 (CLIA ’88). This article will appear in a future edition of ASCLS Today.
  • GAC e-newsletter: Rick Panning, GAC e-newsletter editor, submitted for publication an e-edition based on the recent GAC meetings.
  • Advance for Medical Laboratory Professionals:Angela Phillips wrote an article about the 2013 Legislative Symposium with editing assistance from Rick Panning. This article will appear in a future edition under the ASCLS Voice section.

2012-2013 GAC Strategic Action Plan Updates:

  • Committee Charge #1: Identify individuals from GAC to work with the ASCLS office staff in planning and support of the Legislative Symposium. A special thanks to Elissa Passiment and Don Lavanty for their work with the five partners (ASCLS, AMT, ASCP, AGT and CLMA) in developing the presentations, position papers and the talking point documents associated with the Legislative Symposium.
  • Committee Charge #3:Create a database for those attending the Legislative Symposium to track visits, feedback and follow-up from Hill visits. J.R. Constance had completed the database for the 2013 Laboratory Legislative Symposium. Attendees were able to enter information from their “Hill” visits into the database with ease.
  • Committee Charge #6-8:

Work with the Membership Committee to develop GAC information to include in membership recruitment and retention information. Leslie Martineau, GAC liaison to this committee continues to participate in the Membership Committee conference calls.

Work with the Administration Scientific Assembly to identify appropriate topics for continuing education. The inauguralASCLS’sAdvanced Management Institute will be held on July 27-28, 2014 in Chicago, IL. In preparation for this institute, Rick Panning, Program Chair hosted conference calls in May and July with the committee members to begin program planning. In addition to the two scheduled conference calls there will be an “in-person” meeting during this year’s ASCLS annual meeting in Houston, TX on August 1st.

  • Committee Charge #9: Develop a strategy to effectively engage the state/region contact network.GAC members have been assigned to the ASCLS regions; students; new professionals and AGT for ongoing communication. During the monthly conference calls there is an opportunity for an update from each GAC liaison.
  • Committee Charges #10: Support ASCLS Executive VP and Legislative Consultant in responding to legislative and regulatory initiatives. This is done through monthly GAC conference calls and as needed.

State Laboratory Licensure Bills:

  • Minnesota: SF133 and HF203 bills: Medical Laboratory Practice Act wasintroduced on 1/28/13. Since the March 15, 2013 deadline for committee hearings was not met the laboratory licensure bill will be reintroduced during the 2014 legislative session. Committee hearings will be scheduled in both houses at the beginning of the session in January 2014.View full site
  • Virginia: Due to a short legislative session this year that the bill has been tabled until the 2014 Legislative session.
  • Texas: This year the Texas Association for Clinical Laboratory Science proposed a licensure bill with supporters from the House and Senate. This is the third session that we have presented legislation. The Texas legislature meets every odd year. This session we had no action on the Senate version (SB 761) but did have a hearing on the House version (HB 2297). Our bill would license MLS, MLT, and Categorical Lab Scientists who perform moderate or high complexity testing.
  • Missouri: The laboratory licensure committee was successful in getting House and Senate sponsors for the laboratory licensure bill. Unfortunately it was too late to get anything done during this legislative session. The sponsors suggests that the laboratory licensure committee get the bills submitted in December 2013 in hopes to have a better chance of getting hearings in both houses. The licensure committee is still discussing pros and cons of certification vs. licensure with the bill sponsors.
  • Tennessee: HB1164 and SB1269 have passed both the House and Senate. Governor Bill Haslam has signed the bill and it will go into effect on July 1, 2013. This bill has the potential to weaken the current licensure regulations by weakening personnel requirements for esoteric laboratories accredited by CAP.

Appointments to the GAC 2013-2014: ASCLS President Elect/ Appointments Committee Chair, J.R. Constance, has confirmed the following appointments:

Theresa Fruehling - reappointment

John Koenig - reappointment

Lori Murray - new appointment

Josh Pulido – new appointment (to replace Lisa Bakken)

One position still open

Concerns: None Requests for Action: None.