CLFS Reform: Data Collection to Set Market-based Pricing

If you work in a U.S. clinical laboratory that performs tests on the CLFS

If you work in a U.S. clinical laboratory that performs tests on the Clinical Laboratory Fee Schedule (CLFS):

To inform AMP's advocacy efforts, we would like to ascertain the following:
1. The potential impact and administrative burden of the reporting requirements of the CLFS reform provision of the new SGR patch legislation.

2. The extent to which laboratories perform tests defined rather narrowly in the new law as “Advanced Diagnostic Laboratory Tests.”

Background:
A new U.S. law “SGR patch” contains rather sweeping reforms to the Clinical Lab Fee Schedule (CLFS) that is intended to reduce cuts to, as well as determine and apply market-based payment for, CLFS tests – see Section 216 beginning on page 35 of http://www.gpo.gov/fdsys/pkg/BILLS-113hr4302ih/pdf/BILLS-113hr4302ih.pdf (paste this URL into your browser).

The law requires laboratories to report payment and test volume data every 3 years (annually for "Advanced Diagnostic Laboratory Tests") or face civil penalties.

Labs that introduce certain new “Advanced Diagnostic Laboratory Tests” could benefit because the bill calls for payment for these new tests to be based on the actual list charge during the initial three quarters after introduction of the new test.

Thank you very much for taking the time to provide an insight into some potential impacts of the new law.

Question Title

* 1. What is the setting of your laboratory?

Hospital / Medical Center based

Independent, not hospital / medical center based

Other (please specify)

Question Title

* 2. What department will be responsible for reporting to CMS the payment rate paid by each payor for each test on the CLFS and the volume of such tests for each payor?

Hospital business office

Corporate business office

Laboratory business office

Laboratory, i.e., one of the professionals, technologists, or secretaries

Other (please specify)

Question Title

* 3. What is the total number of all CLFS tests performed in your lab annually, i.e., test volume?

Fewer than 10,000

10,000 - 49,999

50,000 - 99,999

100,000 - 499,999

500,000 - 999,999

1,000,000 or more

Question Title

* 4. The CLFS Reform provision of the SGR patch legislation provides for special pricing methodology for “Advanced Diagnostic Laboratory Tests”

According to the bill, the term “Advanced Diagnostic Laboratory Tests”means a clinical diagnostic laboratory test covered under this part that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and meets one of the following criteria:
(A) The test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result.
(B) The test is cleared or approved by the Food and Drug Administration.
(C) The test meets other similar criteria established by the Secretary.

We interpret this definition to mean an “Advanced Diagnostic Laboratory Test” is a laboratory developed test (LDT) that is also either:
• A multiplex test with MAAA
• FDA cleared or approved (note that LDTs can be submitted to FDA)

Does your laboratory offer a tests (tests) that could meet this definition? If so, please insert the test name(s) in the "Other" field and the annual number performed annually.

No, we do not perform any assays that could meet the definition.

Yes, we perform assays that could meet the definition. They are listed in the "Other" field.

Other (please specify)

Question Title

* 1. What is the setting of your laboratory?

Question Title

* 2. What department will be responsible for reporting to CMS the payment rate paid by each payor for each test on the CLFS and the volume of such tests for each payor?

Question Title

* 3. What is the total number of all CLFS tests performed in your lab annually, i.e., test volume?

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* 5. Other comments