The ASCLS Legislative symposium is a 2-day event. The first day of the symposium focused on providing background information on current legislative issues affecting laboratories, as well as advocacy techniques and strategies; thus, ensuring attendees were comfortable and ready to talk to their representatives the next day. The second day consisted of individual appointments with the selected representatives. I met several veterans that attend the symposium every year. They were very passionate, welcoming, and caring. They took me under their wing and provided extra support and guidance. During the symposium the main topics were PAMA, SALSA, and the workforce shortage. There were also some discussion regarding VALID and recent CLIA personnel regulations changes.
The Protecting Access to Medicare Act (PAMA) , was first introduced in 2014. While its title would suggest that the original purpose was to regulate the cost of medical cost, making healthcare more accessible to patients; it essentially had the opposite effect. PAMA was introduced to change the way Medicare pays for clinical diagnostic laboratory tests under the Clinical Laboratory Fee Schedule (CLFS). The plan was to establish reimbursement rates based on data obtained from surveying several hospitals and laboratories across the country. However, it was soon evident that the sample was not representative of the real market, and implementation of these rates would have resulted in over 70% of fee schedules being cut, and a total of $4 billion in cuts to the laboratories providing the services [2, 3].
To prevent the detrimental effects these cuts would bring to laboratories and to patient access to lab services, Congress had delayed CLFS reporting periods three times, and has delayed the cuts twice to maintain patient access to lab services. Nonetheless, a permanent solution is yet to be implemented (Fig1),. Enter the "Saving Access to Laboratory Services Act" (SALSA) . This bill would give The Centers for Medicare & Medicaid Services (CMS), new authority to collect market data and amends the misrepresentation from the PAMA Act. Additionally, it also reduces the reporting burden on labs and sets a limit on how much rates can be changed over a given period of time, protecting laboratories from dramatic rate increases or cuts. CMS regulates all laboratory testing, performed on humans in the U.S, excluding research .
While the “Verifying Accurate Leading-edge IVCT Development Act of 2021”, (VALID) , was discussed, it was only to provide attendees with background information. Some Professional organizations are in favor of this bill while others oppose it. This act would give the FDA more authority to regulate diagnostic tests. The current regulations allow the FDA to regulate laboratory developed tests. The VALID act would extend their authority to devices intended for use in the diagnosis of disease .
Similarly, the proposed ruling from the CMS to amend CLIA regulations on who can perform high complexity testing was examined. The new ruling allows for BSN holders to perform high complexity testing . While it seems most professional organizations oppose this ruling, it is another topic for which there is not a consensus. Some groups believe it is just a matter of interpretation that will not have practical applications for laboratory performed tests. Interestingly enough, CLIA contains regulation on who can perform high complexity testing in the clinical laboratory setting but has no specific guidelines for histotechs. As shocking as it seems, HT and HTLs are CLIA Exempt .
In these intrinsically complicated times we are living in, it was refreshing to learn that there are still causes we can all come together to support. The efforts to prevent PAMA from affecting laboratories and patients’ access to care have been a bipartisan effort. The workforce shortage is also affecting everyone the same, and it has provided another great opportunity for all of us to come together and work towards the same goal.
Our main goal was to present a united front to advocate for clinical laboratory professionals across the United States, therefore we focused on asking our representatives and senators to support SALSA, and to sponsor the Medical Laboratory Professional Relief Act in response to the nationwide shortage of medical laboratory professionals. ASCLS drafted this bill to promote a grant program to assist allied health schools to recruit the necessary faculty and to provide the clinical training necessary to enter the profession. Additionally, the bill would also create a loan repayment program for clinical professionals in exchange for service in medically underserved communities. Part of our mission was to find a senator or representative willing to introduce this bill. A mission that is still ongoing. If you would like to read the draft and help find a sponsor you may contact ASCLS, Patrick Cooney, or Jim Flanigan.
While the experience of coming together with other lab professionals to protect and advance our field was inspiring, fun, and exciting, one of the main takeaways for me, was that we can make a difference from wherever we are. Our house and senate representatives are public servants but are not familiar with our profession and our impact in healthcare. We have been charged with the responsibility to increase our visibility and to educate them on these issues, so that they can promote the best policies. You can find your congress senators and representatives here .
Glossary of Terms
The American Society for Clinical Laboratory ScienceCMS:
Centers for Medicare and Medicaid ServicesPAMA:
Protecting Access to Medicare ActSALSA:
Saving Access to Laboratory Services ActVALID:
Verifying Accurate Leading-edge IVCT Development Act of 2021NSH:
National Society for HistotechnologyCLIA:
Clinical Laboratory Improvement AmendmentsCLFS:
Clinical Laboratory Fee ScheduleLAB Act:
Laboratory Access for Beneficiaries ActMedPAC: The Medicare Payment Advisory Commission References
Written By Maria F. Artiles, A.S., A.A., B.S., HT(ASCP)
- Protecting Access to Medicare Act. 2014.
- ASCLS, Clinical Laboratory Reimbursement in the United States. 2022.
- Services, C.f.M.a.M., PAMA regulations. 2022.
- Saving Access to Laboratory Services Act. 2022.
- Services, C.f.M.M., Clinical Laboratory Improvement Amendments (CLIA). 2022.
- VALID Act of 2021. 2021.
- Services, T.C.f.M.a.M., Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. 2022, Federal Register.
- Centers for Medicare & Medicaid Services, D.o.H.a.H.S., Title 42. Chapter IV. Centers for Medicare & Medicaid Services, Department of Health and Human Services. FederalRegister.gov.
- Congress, L.o., Find Your Members. 2022.