Labs Express Concern About New MolDx Policy Requiring Registration of Molecular Test Panels

Groups representing clinical laboratories are coming out in opposition to a new alert issued by Palmetto GBA requiring labs that perform tests in Medicare regions JE or J11 to register molecular test panels and bill with a single CPT code and a unique molecular diagnostic service program (MolDx) identifier. According to the Dec. 4 alert (M00101), Palmetto considers the performance of multiple molecular biomarkers ordered together to be a panel of tests, regardless of whether the test requisition lists the tests as a panel or individually. Palmetto says that based on data analysis of MolDx claims, labs are submitting multiple biomarker “panels” as individual tests similar to the submission of the previous stacking codes. For example, a lab receives a patient specimen and performs the following tests:

• CYP2C19, cv (CPT 81225)
• F2, 20210G>A (CPT 81240)
• F5, Leiden (CPT 81241)

Palmetto says the panel of three tests listed above should be registered and claims submitted with CPT code 81479 and a single MolDx ID. If a lab also performs one of three panel’s biomarkers on patient specimens, each biomarker must also be registered and receive a unique ID to submit on claims when only that biomarker is performed. Again, a single CPT code should be billed with a unique ID. Palmetto says that to bill correctly for the example above, the lab must register four tests and receive identifiers for MolDx submission (see example below).

EXAMPLE OF MOLECULAR PANEL WITH IDENTIFIERS
TEST NO.	TEST NAME	BIOMARKER	ID	CPT CODE
1	Clotting Test Panel	CYP2C19, cv, F2, 20210G>A, F5, Leiden	Z1234	81479
2	CYP2C19	CYP2C19, cv	Z5678	81225
3	F2, 20210G>A	F2, 20210G>A	ZA234	81240
4	F5, Leiden	F5, Leiden	ZA567	81241
Source: Palmetto GBA

  Effective Nov. 17, 2014, labs should start to register all panels and obtain a unique MolDx identifier for each panel. If a lab does not perform single biomarker tests, they must notify the registry of this registration error. CCLA Requests Meeting With CMS The California Clinical Laboratory Association (CCLA) has requested an urgent meeting with Centers for Medicare and Medicaid Services (CMS) officials about this new policy and is requesting that implementation of the edit alert be delayed until the agency has had an opportunity to review stakeholder comments and determine the impact of the policy on Medicare beneficiaries. According to CCLA, the new policy would effectively require labs to register as panels all possible combinations of their biomarkers. “This approach makes no sense since it does not base the “panels” in any manner on how the tests are marketed or otherwise grouped by the laboratory,” says CCLA in the letter. “Moreover, since Palmetto knows which biomarkers are covered by Medicare, Palmetto is in as good a position to identify and register these ‘panels’ as are the laboratories that perform the testing. In addition, Palmetto’s proposal would needlessly require different laboratories that test for the same biomarkers to separately register what may be identical panels.” CCLA also argues that the alert does not provide “due process” for labs or Medicare beneficiaries that was guaranteed to labs through negotiated rulemaking and reconfirmed under the Protecting Access to Medicare Act. What’s more, the alert is contrary to previously expressed guidance and concerns regarding panels raised by both CMS and the Health and Human Services Office of Inspector General. CCLA also believes that the alert violates the molecular pathology (MoPath) coding initiative. “This alert is intended to be a repricing exercise and is in violation of the MoPath coding initiative that was designed to provide granularity to these codes. . . . Prices were set under the MoPath initiative as recently as last year. Utilizing the CMS mandated gap-fill procedure, National Limit Amounts were determined and price protection for codes on the [Clinical Laboratory Fee Schedule] were guaranteed by PAMA through 2016." Takeaway: Labs are fighting a plan by Palmetto GBA to require them to register molecular test panels. Side Box: MolDx Panel Plan Timeline 

• Effective Jan. 1, 2015, Palmetto GBA will start lab notification. Labs that have submitted panel test claims will receive a list of MolDx IDs that require panel registration.
• Each lab will be given 30 days from the receipt of the list to correct test registration.
• Effective April 1, 2015, MolDx will set edits to reject tests performed as panels and registered and submitted with a CPT code for each biomarker in the panel.
• During this period, Palmetto will continue to interrogate the claims data for incorrect submission.