Classification: Position Paper
Status: Approved by ASCLS House of Delegates July, 2012. Revised by the ASCLS House to Delegates June 2023

In an ever-changing health care landscape, ASCLS has a duty to ensure that our patients are receiving the best quality care at the best value. The Health Care Reform position paper defines ASCLS’s stance on various topics within the realm of American health policy. This position paper builds off of the July 2012 version of the document and addresses additional topics not previously mentioned.
ASCLS believes the goals of health care reform in the United States should be to:

  • Improve patient safety, patient outcomes, and quality of care for all people;
  • Provide affordable, accessible, and quality health insurance coverage to all people;
  • Invest in evidence-based clinical health and public health practices; and
  • Promote health equity and address social determinants of health.

Goal #1: Improve patient safety, patient outcomes, and quality of care for all people.

To meet this goal, ASCLS believes that:

1. Federal and state government agencies should partner with laboratory professional organizations, clinical laboratory and hospital administrators, and educational institutions to address the critical workforce shortage of medical laboratory professionals.

Medical laboratory results provide vital information for the prevention, diagnosis, treatment, and management of health and disease. Yet our nation is facing a workforce shortage of medical laboratory professionals which jeopardizes patient access to timely and reliable test results. Addressing this crisis necessitates coordinated action from various stakeholders with a focus on the education needed for a stable pipeline of qualified professionals, as well as promoting the retention of current professionals with invaluable experience. Current vacancy rates exceed the number of medical laboratory science (MLS) and medical laboratory technician (MLT) graduates, contributing to higher labor costs in utilizing third-party travel agencies, signing bonuses, and increased overtime, all serving to further exacerbate employee burnout and turnover. A survey of medical laboratory professionals found that a striking 85 percent of respondents reported burnout, with about half considering changing careers completely and a quarter considering retirement.1 The COVID-19 pandemic has only accelerated those trends.

The federal government can directly contribute to the education and training of medical laboratory professionals by fully funding the Title VII Health Professions Programs and creating, authorizing, and fully funding a program specifically for medical laboratory professional education. Federal and state governments should also support and fully fund programs that provide workforce training in rural communities, which have been hit the hardest by shortages. Furthermore, appropriate reimbursement for laboratory testing is critical to supporting adequate staffing of qualified laboratory professionals at competitive wages in line with their level of education and experience. Additionally, egregious cuts to the Medicare Clinical Laboratory Fee Schedule driven by questionable data have devastated clinical laboratories, and greatly hindered their ability to hire and retain properly trained staff.

Additionally, it is ASCLS’s position that the medical laboratory workforce needs to be staffed by professionals trained through an accredited medical laboratory program. The 2022 proposed rule by the Centers for Medicare and Medicaid Services (CMS) that nurses holding a bachelor’s degree should be allowed to do high complexity testing endangers patient safety, patient outcomes, and quality of care because nursing programs do not provide adequate training for high complexity testing. Furthermore, allowing nurses to do high-complexity testing would exacerbate the growing nursing shortage and worsen burnout among nurses. We also assert that, with the recent addition of the Doctorate in Clinical Laboratory Sciences (DCLS) degree, DCLS-trained professionals should be allowed to serve as laboratory directors of high complexity laboratories across the nation.

ASCLS supports immigration policies that help to bolster the U.S. workforce. We encourage the federal government to continue to provide protections for individuals currently under the Deferred Action for Childhood Arrivals rule, who are also referred to as “Dreamers,” and provide them with a pathway to citizenship. ASCLS also believes that the federal government should expand the cap on the number of new H-1B specialty occupation visas per year to allow more qualified medical laboratory professionals to enter the country to help alleviate the workforce shortage.

2. The federal government should ensure the availability of quality health care supplies through efforts to strengthen the global and domestic supply chain.

The ability to provide people with proper health care is dependent on the ability to access adequate health care supplies. Supply chain shortages in the health care industry, ranging from personal protective equipment and medications to laboratory reagents and blood collection tubes, impacts patient care and safety and can result in delayed treatment and prolonged hospital or nursing home stays. The health care supply chain is affected by many factors, including, but not limited to, transportation costs, geopolitical events, and labor shortages. While health care supply chains are complex, multilevel systems, there are steps that the federal government should take to mitigate or prevent supply shortages. The federal government should require the appropriate agency(ies) to track sourcing, quality, volume, and capacity information of various health care supplies and make this information publicly available so that the data can be analyzed by interested parties. Additionally, the federal government can modernize and optimize the national stockpile as protection against health care supply shortages. Furthermore, the federal government should work with partnering nations to strengthen cooperation and diversify the global supply chain, while also supporting domestic manufacturing of health care supplies.

In addition to the need to establish a resilient and adaptable supply chain of materials to collect and test patient specimens, the United States also needs to ensure that it has a reliable source of blood products. To minimize the possibility of the country experiencing critical shortages of blood products, the federal government should encourage and support the creation of a multi-disciplinary workgroup tasked with establishing guidelines for blood product management best practices.

Goal #2: Provide affordable, accessible, and quality health insurance coverage to all people.

To meet this goal, ASCLS believes that:

1. The federal government can ensure access to quality laboratory services through the adequate Medicare reimbursement of clinical laboratories.

The ability of a clinical laboratory to hire adequate staff and perform quality testing is dependent on reimbursement for laboratory testing via the Clinical Laboratory Fee Schedule (CLFS). The failure to adequately reimburse laboratories for testing can result in diminished quality in testing, the closing of laboratories, and patient harm.

The update to the CLFS by the Protecting Access to Medicare Act (PAMA) of 2014 and its related regulations resulted in steep cuts to laboratory reimbursement due to flawed data collection. The new CLFS implemented via PAMA resulted in a decrease in reimbursement for approximately 75 percent of laboratory tests.2 In 2018, the first year PAMA cuts were implemented, the clinical laboratory industry lost nearly $670 million in revenue.3 Laboratories have now faced multiple rounds of cuts, with each cut resulting in a reimbursement reduction of 10 percent.4 The Congressional Budget Office originally projected $2.5 billion in cuts to reimbursement rates over 10 years if PAMA was implemented as Congress intended; however, the last three rounds of cuts have already reached $4 billion.5

Although the intention of PAMA was to protect health care access, its implementation is having the opposite effect. PAMA-induced cuts to Medicare reimbursement have already placed a financial burden on laboratories. As a result of the steep cuts, laboratories have had to put off hiring necessary staff and investing in new instrumentation. Additionally, laboratories have had to stop performing certain tests in-house, which has caused delays in patient care. Delayed and disrupted care leads to compromised health outcomes, ultimately resulting in higher costs for everyone, and undermining any potential cost-savings.

To ensure that all people can access quality laboratory testing, the federal government needs to simplify the CLFS data reporting process. One way to do so is for Congress to direct CMS to collect data from a statistical sampling of all major types of laboratories. Additionally, Congress could implement a five (5) percent cap on cuts in order to protect laboratories from dramatic rate decreases. The failure of the federal government to provide a permanent solution to the reimbursement of clinical laboratory services will result in dangerous consequences for patients, especially for seniors and individuals who live in rural areas.

2. Federal and state governments should enact policies that ensure that all people are able to access high quality, affordable health insurance.

ASCLS supports laws and policies that increase the number of insured people. ASCLS believes that all people should have access to quality, affordable health insurance that provides coverage for physical and mental health, dental, and vision care. Health insurance should provide the subscriber with the freedom to choose their health care provider and hospital and cover both in-person and telehealth appointments. All health insurance plans should provide coverage to individuals with pre-existing conditions. The federal government should also place caps on prescription drug prices and limit out-of-pocket expenses. State legislatures should also support expanding Medicaid. Furthermore, we support incentives to encourage and sustain safety-net providers in historically underserved and under-resourced communities. ASCLS supports price and quality transparency for all health care services so that consumers can make informed decisions about their care.

Goal #3: Invest in evidence-based clinical health and public health practices.

To meet this goal ASCLS believes that:

1. Federal and state governments should adequately fund research that focuses on improving professional and clinical practice guidelines.

The implementation of evidence-based practices in health care improves clinical outcomes and reduces health care costs and waste. The research of evidence-based practices conducted by professional organizations and nonprofits is dependent on funding. Federal and state governments in partnership with the health care community should adequately fund the research and development of evidence-based practices, including, but not limited to, research related to antimicrobial stewardship and blood product management. All government-funded research should be free for all to access to allow for the accelerated advancement of ideas and best practices.

2. The Federal government should regulate laboratory developed tests using a risk-based framework.

ASCLS believes that the federal government should create a risk-based framework for regulating laboratory developed tests (LDTs) that resembles the existing approach the U.S. Food and Drug Administration (FDA) takes toward other medical devices. LDTs deemed to be “high risk” should be required to undergo premarket review by the FDA. The regulation of LDTs is necessary for patient safety.

3. Federal, state, and local governments should adequately fund public health and invest in early prevention.

Federal, state, and local governments all have a responsibility in creating an adequate public health infrastructure that is properly funded and staffed to fulfill its mission. All levels of government should invest in and promote preventive care. This includes providing education and resources on nutrition, disease prevention and vaccines, and mental and emotional wellbeing. Public health communications and resources should be tailored to the community and presented in a way that is easy to understand. All public health practices and communications should be evidence-based.

Goal #4: Promote health equity by addressing social determinants that adversely impact the health and wellness of our nation.

To meet this goal, ASCLS believes that all levels of government should collaborate with private entities to create a health care system that is equitable and evidence-based.

ASCLS believes that all people should have the fair and just opportunity to live their healthiest life. We support state and federal-level legislation that seeks to create social, physical, and economic environments that promote attaining the full potential for health and well-being for all. We support polices that assure equity and dismantle disparities across the five main social determents of health, which include: economic stability, education access and quality, health care access and quality, safe neighborhoods and built environments, and thriving social and community contexts.

To accomplish this, ASCLS supports efforts to measure and surveil health disparities and to deploy strategies that are proven to improve health. We support policies and efforts at all levels that address health disparities, advance health equity, and improve health by using evidence-based interventions and strategies, by evaluating these interventions, and by forming multisector collaborations.

ASCLS believes that all applicable government and private entities should fund research and develop policies seeking to eliminate disparities in clinical laboratory testing and diagnostics and establish person-centered laboratory testing protocols and reference ranges. Furthermore, ASCLS believes that the federal government, in collaboration with other private entities, should establish evidence-based, equitable regulations regarding blood donor eligibility.

Footnotes

  1. Garcia, E., Kundu, I., Kelly, M., Soles, R., Mulder, L., & Talmon, G. A. (2020). The American Society for Clinical Pathology’s Job Satisfaction, Well-Being, and Burnout Survey of Laboratory Professionals. American Journal of Clinical Pathology, 153(4). https://doi.org/10.1093/ajcp/aqaa008
  2. PAMA is here, and most hospital leaders are unaware of its impact. (2018, November 28). Modern Healthcare. https://www.modernhealthcare.com/article/20181128/SPONSORED/181129937/pama-is-here-and-most-hospital-leaders-are-unaware-of-its-impact
  3. Id.
  4. American Clinical Laboratory Association. (n.d.). Stop Lab Cuts. Stoplabcuts.org. Retrieved May 27, 2023, from https://stoplabcuts.org/
  5. Id.

References

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