6 minute read
What recent CLIA changes mean for reps and their customers
from REP May 21
CLIA Update 2021
By Jim Poggi
2020 and 2021 (so far) have been years of great change for us and our customers, largely precipitated by the COVID-19
pandemic. But there have been other far-reaching impacts on the laboratory business and our customers for other reasons. In this month’s column, I will shed some light on CLIA changes and what they mean for reps and their customers.
CLIA lab certificate fees increased by 20% at the end of 2018
With so many other fundamental changes in our market, while this change did not exactly slip by without notice, it has not generated the level of noise I might have expected. Arguably, the reductions imposed by PAMA on payment for tests performed under the Clinical Lab Fee Schedule have had more discussion and more impact than the 20% increase in CLIA certificate fees.
What does the 20% increase look like? Taking the example of a customer performing 50,000 non-waived tests annually, their fee before the increase was $1,100 every two years. It is now $1,320.
What is the net impact? Based on 50,000 tests, the cost of the CLIA certificate increases cost per test by less than one quarter of a cent. It went from $0.011 per test to $0.0132 per test. This analysis assumes 50,000 tests per year for the biennial period against the new fee structure.
While there is an increase, it should be immaterial for most customers and have a negligible impact on their lab operation. As the first cost increase since CLIA was implemented in 1982, the 20% increase is a downright bargain. The cumulative price increase experienced on the general U.S. economy since 1982 has been 87.5%, so in contrast this increase is well below that of other products, fees and services we have experienced in that time. At the same time, the legislation that set CLIA into motion requires that the program be self-funding. So, while I am speculating, it is not unreasonable to assume we will not need to wait another 25 years or more before the next fee schedule increase. Imagine, if you will, what it would be like if we could buy a home, a car or any other major purchase with only a 20% increase beyond the cost of that item in 1982.
Changes in proficiency testing
In February 2019, CMS proposed rule changes for proficiency testing under CLIA to improve quality of results, especially for newer analytes. In summary, a few tests were exempted from proficiency testing, but a larger number including newer analytes such as BNP, hs-CRP and others were added. In addition, criteria for acceptable performance were tightened for chemistry, immunology and hematology assays due to improved performance of analytical platforms since CLIA was enacted in 1982. Further changes impacted management of CLIA waived assays by CLIA moderate and high complexity labs. For microbiology tests, the proposal would create new broad categories of tests subject to proficiency testing owing to the substantial number of new test methodologies now available for microbiology assays compared to 1982. It is not clear whether these changes have already been enacted, but your key lab suppliers should be in a position to update you for their specific test platforms.
An extraordinary increase in Multianalyte Tests with Algorithms
Most of these tests are molecular tests for cancer or other genetic pre-dispositions (heart disease, epilepsy, hearing loss, and a myriad of other clinical conditions). This has been an astounding break through and has dramatically changed diagnostic, treatment and management of a large number of diseases, though cancer and respiratory conditions have been the big beneficiaries. Cancer deaths have declined by 29% from 1991 to 2017, with the largest drop in history of 2.2% realized in 2017. In addition to Americans quitting smoking and improving their overall commitment to a healthy lifestyle, new diagnostic tests have made meaningful impact here.
Interestingly, these new tests are not limited to genotyping the patient for either predisposition to a disease state or to their tumor cells. They also look at changes in protein expression of tumor cells and metabolic changes
that result from development of cancer. We have also seen genotyping of SARS CoV-2, HIV, HPV and other pathogens, owing to the recognition that different pathogen genotypes have differing levels of pathogenicity, ease of transmission and predisposition to further co-morbidities. This is a relatively new frontier and progress is being made meaningfully across the health care spectrum for cancer and other clinical conditions, including identification and classification of infectious agents, particularly respiratory pathogens. SARS CoV-2 is a classic recent example.
More than 100 MAAA test profiles have been added to the CLFS since 2019, and the number is sure to continue growing rapidly. This increase does not include the new SARS ColV-2 tests introduced in the past months under Emergency Use Authorization. More than 300 new RT-PCR, antigen and antibody tests for COVID-19 have been introduced to the U.S. market as a response to the COVID-19 pandemic.
It is important to note that not only are the new wave of MAAA tests highly clinically significant, providing diagnostic information undreamed of a few short years ago, they also command the highest level of reimbursement in the CLFS. A sampling of the top 288 MAAA tests showed an average reimbursement of about $900, with a range from $12,000 to $145.
Will they migrate from their current position as high complexity tests mostly performed in tertiary care settings to the physician office setting? Time and trends in simplification of test systems and methods will tell, but past trends indicate that the most clinically useful tests certainly will. As test requests for more clinically valuable tests continue to increase, the number of sites performing them typically increase as well, with manufacturers creating simpler, more accessible testing platforms. As an example, genomic classification of prostate cancer tissue (which can help determine whether a specific prostate cancer will be aggressive or not) has increased three-fold in the past 10 years and continues to increase as awareness in the clinical community and among the public sheds light on its usefulness.
In summary, the tests now available to our customers, regulations pertaining to their performance and the costs associated with our customers’ CLIA licensing have undergone considerable transformation. Contact your key lab manufacturers to get their insight and be sure to inform your customers. The well-informed distributor is a valuable consultative resource. Staying informed keeps you relevant and assures your customers have the information they need to run an excellent laboratory.
