by Linda Goossen, Ph.D., MT(ASCP)
ASCLS Government Affairs Committee Chair

One hundred and thirty clinical laboratory professionals from 43 states met March 20 and 21, 2017 for the 29th Annual Legislative Symposium. This annual event was sponsored by five professional organizations – the American Society for Clinical Laboratory Sciences (ASCLS), the Clinical Laboratory Management Association (CLMA), the American Society for Clinical Pathology (ASCP), the American Medical Technologists (AMT), and the Association of Genetic Technologists (AGT) – and representatives from each of these groups welcomed the attendees. This annual two-day event first enables attendees to learn about the legislative and regulatory issues at the federal level that impact laboratories, laboratory professionals, and ultimately our patients. Second, attendees become equipped to take the issues to their senators and representatives and thus advocate on behalf of the profession.

Patrick Cooney – ASCLS Legislative liaison, Michael McCarty – AMT Legal Counsel, and Matt Schultz- ASCP Director of Government Affairs spoke about the current congressional environment, which had been heavily impacted by the recent presidential election and new people in leadership positions. Our meetings on Capitol Hill this year focused on three legislative or regulatory issues that currently are impacting clinical laboratories:  (1) oversight of Laboratory Developed Tests (LDTs), (2) Preserving Access to Medicare Act (PAMA) recalculation of the Clinical Laboratory Fee Schedule, and (3) the Clinical Laboratory Workforce. 

Laboratory Developed Tests are defined by the Food and Drug Administration (FDA) as in vitro diagnostic tests that are designed, manufactured, and used within a single laboratory. In 2014, the FDA released draft guidance to provide enhanced oversight of LDTs. The FDA proposed a three-tier risk-based framework for this oversight. High-risk (class III medical devices) and moderate-risk (class II) LDTs would be subject to premarket review requirements, FDA registration, listing, and reporting requirements. Low-risk LDTs (class I) and LDTs for rare diseases or unmet medical needs would be under FDA enforcement discretion for applicable premarket review and quality systems requirements; they would be required to comply with registration and listing and adverse event reporting within six months of the release of FDA’s final guidance. While FDA received many comments on their proposed guidance, final guidance was never released.

During January 2017, the FDA released a discussion paper on LDTs and announced that, at the request of various stakeholders, it would not issue a final guidance on the oversight of LDTs, and thus allow for further public discussion on an appropriate oversight approach as well as give congressional authorizing committees the opportunity to develop a legislative solution.  ASCLS agreed that LDTs must be regulated to ensure their clinical validity, accuracy, and overall patient safety. While ASCLS agrees with the majority of the FDA’s stance on oversight of LDTs, the Society did have some questions and concerns and, therefore, ASCLS developed a response to the FDA’s discussion paper. The symposium attendees discussed the current status on the oversight of LDTs with their representatives and provided them with a “leave behind” explaining ASCLS reaction to the FDA discussion paper. 

The second issue that we spoke to our representatives about is the Preservng Access to Medicare Act of 2014 (PAMA). Signed into law on April 1, 2014, section 216 of PAMA includes the most extensive revision of the Clinical Laboratory Fee Schedule (CLFS) since it was established in 1984. The proposed rule required “applicable” clinical laboratories to report private payor payment rates and the test volume associated with those payment rates for laboratory services reimbursed under the CLFS. 

The proposed rule defines "applicable laboratory" as a laboratory that receives a majority of its Medicare revenue – from the CLFS or the Physician Fee Schedule. In the proposed rule, CMS defined applicable laboratories based on an entity’s IRS Taxpayer Identification Number (TIN). In the final rule – in response to comments from ASCLS and other laboratory-related organizations – CMS modified the definition of an applicable laboratory to be at the National Provider Identifier (NPI) level, rather than the TIN level. CMS stated that this change would allow the inclusion of hospital outreach laboratories; however, that interpretation does not consider that most of those laboratories do not have a separate NPI number. As currently defined, data from virtually all hospital laboratories and physician office laboratories would be excluded. Excluding pricing data from hospitals and smaller laboratories would allow CMS to base industry-wide payment rates on data drawn from large reference laboratories that have significant economies of scale and, typically, much lower payment rates. The result of this bias in reporting will be a significant lowering of the Medicare Fee Schedule as well as private payor rates to a level that the laboratory community fears will result in decreases in in-house testing, new technologies, funding for raises and benefits, and subsequently more tests being sent to reference labs and ultimately the loss of jobs and the bankruptcy of clinical laboratories. 

Under PAMA, CMS can lower the price of individual tests up to 10% in 2018, 2019, and 2020 followed by price cuts of up to 15% in 2021, 2022, and 2023.  Attendees urged that the deadline for data collection and reporting be extended twelve months, to March 31, 2018; that the implementation of the new CLFS be delayed until January 1, 2019; and that the definition of “applicable” lab be changed to mean a facility identified by a Clinical Laboratory Improvement Act (CLIA) number, so that true market-based reimbursement rates can be calculated. On March 30, one day before the data submission deadline, CMS announced a 60-day period of enforcement discretion for reporting applicable data under the CLFS, thereby extending the due date for data submission from March 31 to May 30, 2017. 

The third critical issue impacting clinical laboratories is the shortage of clinical laboratory personnel. The demand for the services of clinical laboratory personnel is growing, primarily due to the aging population, the aging of the laboratory workforce, and the expanded access to health care services provided by health care reform. Long-term and pervasive shortages of qualified professionals to fill many clinical laboratory and other allied health positions are expected. The U.S. Department of Labor’s Bureau of Labor Statistics (BLS) anticipates needed growth of 12,000 new medical laboratory professionals per year to meet the growing demand. Academic programs currently produce just 5,000 graduates a year, leading to a crisis in the clinical laboratory workforce. 

In September 2016, the VA Office of the Inspector General (OIG) conducted its third determination of the Veterans Health Administration (VHA) occupations with the largest staffing shortages. Once again they determined that the largest critical need occupations were Medical Officer, Nurse, Psychologist, Physician Assistant, Physical Therapist, and Medical Technologist.  In light of the current employment outlook for clinical laboratory personnel and other allied health professionals, as documented by the BLS, attendees urged their representatives in Congress to (a) enhance recruitment and retention efforts for medical laboratory personnel within the VHA, (b) authorize and appropriate funding for a program within the Public Health Services Act to ensure training for citizens seeking to enter the clinical laboratory workforce, and (c) authorize the Government Accountability Organization (GAO) to study the shortage of clinical laboratory personnel and make recommendations to Congress. 

On March 21, 2017, over 130 clinical laboratory professionals rode the Washington D.C. Metro system to Capitol Hill to tell our senators and representatives who we are, what we do, and to stress how critical our services are to the health of the people we serve. The experience of advocating on behalf of our profession is rewarding. The importance of our five organizations speaking with one voice as we advocate for the laboratory profession and ultimately for our patients cannot be understated.  Our united voice makes a much greater impact than individual voices.