the publicly available rate on the first day the new ADLT is obtainable by a patient who is covered by private insurance, or marketed to the public as a test a patient can receive, even if the test has not yet been performed on that date.
Among other changes, ADLTs now include tests offered and furnished by only a single laboratory that consists of "an analysis of multiple biomarkers of DNA, RNA, or proteins.
Data submitted when applying for ADLT status does not receive special confidentiality protections unless the trade secret exception to the federal Freedom of Information Act can be satisfied.
New ADLTs (those that have not received payment on the CLFS prior to January 1, 2018) receive premium pricing based on actual list charge for the first three quarters the test is offered in an effort to recognize their uniqueness and the resources expended by laboratories to develop them.
Laboratories must initially report data for New ADLTs by the end of the second quarter of the premium payment period.
ADLTs are laboratory tests covered under Medicare Part B that are offered and furnished only by a single laboratory, not sold for use by a laboratory other than the original developing laboratory (or a successor owner), and are either an analysis of multiple biomarkers of DNA, RNA or proteins combined with a unique algorithm to yield a single patient-specific result, or tests cleared or approved by the FDA.
CMS will recoup the difference between the actual list charge and 130 percent of the weighted median private payer rate if a New ADLTs actual list charge is subsequently determined to be greater than 130 percent of the weighted median private payor rate determined under PAMA.
Most significantly, commenters opposed the agency's proposal to exclude proteomics (protein-based biomarker) testing from treatment as ADLTs
Payment rates under the revised CLFS will be updated to reflect market rates paid by private payors every three years for most tests, except for ADLT
rates, which will be updated every year, to reflect market rates paid by private payors.
In exchange for Unison assets, Fiberstars will provide ADLT
with warrants to purchase one million shares at one penny each, 250,000 of which are exercisable when the Fiberstars price on the Nasdaq national market reaches $6.
In exchange for the assets, Fiberstars will provide ADLT with warrants to purchase one million Fiberstars common shares at one penny each, 250,000 of which will be exercisable when the Fiberstars price on the national Nasdaq market reaches $6.
Commenting on the announcement, ADLT Chairman and Chief Executive Officer Wayne R.