The preliminary determinations include a delay of decision-making on a series of new codes describing drug testing, continuation of “gap-filling” for Multi-Analyte Assays with Algorithmic Analysis and Molecular Pathology codes, and a preliminary pricing decision for a new colorectal cancer screening test.  The U.S. Centers for Medicare & Medicaid Services (CMS) will accept comments until November 8, 2014.

On October 9, 2014, the U.S. Centers for Medicare & Medicaid Services (CMS) released its preliminary determinations regarding the method for determining 2015 payment rates for new procedure codes under the Medicare Clinical Laboratory Fee Schedule (CLFS).  Highlights of the determinations include deferral of a decision to price a series of new codes describing drug testing; continuation of “gap-filling” for Multi-Analyte Assays with Algorithmic Analysis and Molecular Pathology codes, including genomic sequencing procedures (commonly referred to as next generation sequencing); and a preliminary pricing decision for a new colorectal cancer screening test, coverage for which was finalized the same day that the preliminary determinations were released.  CMS will accept comments and public requests for reconsideration of these preliminary decisions until November 8, 2014. 

Background

Each July, CMS hosts a public forum in which stakeholders are afforded the opportunity to provide public comment and input on pricing for new or substantially modified codes paid under the CLFS.  The July 2014 public meeting was well attended and included discussions of many genetic, molecular and chemistry lab testing codes. 

CMS released the preliminary determinations based in part on information gathered during the July 2014 public meeting.  In general, CMS agreed with stakeholder feedback, accepting most crosswalking and gap-filling recommendations. 

Additional highlights from the 2015 preliminary pricing decisions are outlined below.

Drug Testing

The American Medical Association (AMA) created 63 new codes describing a series of tests for the presence of various drugs.  The codes include both presumptive tests and definitive tests, and are intended to replace the existing G0430 and G0431 for qualitative drug screening, as well as a broad range of established codes for quantitative drug level determination.  At the July 2014 public meeting, CMS heard public comment regarding pricing for these codes.

In its preliminary decision, CMS reiterated its long-standing concerns about the potential for fraudulent and abusive billing of these drugs tests, and decided to delay decision-making on pricing for the new codes.  CMS is concerned that the structure of the new drug testing codes may not prevent abusive billing.  CMS states that it will continue to evaluate coding and pricing for these tests.  It is unclear how CMS will handle the discontinuation of some drug testing codes in 2015 if CMS does not accept and price the new codes to report those analytes that were established by the AMA for 2015.

Multi-Analyte Assays with Algorithmic Analyses

For 2015, the AMA created four new codes describing Multi-Analyte Assays with Algorithmic Analyses (MAAAs).  These codes represent continued advancements in the highly complex field of molecular testing.  MAAAs are developed by clinical laboratories or in vitrodiagnostic manufacturers to address specific clinical questions or issues, such as the likelihood that a tumor will recur in the future, the likelihood that a tumor will respond to a particular drug treatment regimen, whether or not a patient is experiencing rejection of a heart transplant, the activity of disease in patients with rheumatoid arthritis, and the likelihood that a nodule in the thyroid is benign. 

With the preliminary 2015 payment determinations, CMS proposes to continue its practice, begun with its 2014 final payment determinations, of deferring coverage and pricing decisions for MAAAs to the local Medicare Administrative Contractors (MACs).  Deferring coverage and pricing decisions places the MACs in the best position to determine if a particular test should be covered.

Tier 1 Molecular Pathology Codes

CMS was presented with a series of three new Tier 1 Molecular Pathology (MoPath) codes for pricing in 2015.  The 2015 preliminary pricing determinations also continue CMS’s practice of deferring coverage and pricing decisions for MoPath codes to the MACs.  CMS acknowledges that it must continue to gather additional information about how these tests are performed and signals that it plans to set national rates for MoPath codes in the future.

Genomic Sequencing Procedures

CMS released preliminary pricing determinations for 21 Genomic Sequencing Procedure (GSP) codes representing tests addressing biologically complex clinical questions for which values from multiple analytes must be considered.  Much like MAAAs, GSPs require robust computational and bioinformatic analysis and report curation in order to accurately translate individual biomarker values into patient-specific results that can be interpreted and acted upon by a treating physician.  CMS’s decision to allow the MACs to gap-fill prices for these codes is a clear indication that CMS believes there are no analogues on the current CLFS that can be used to adequately describe these codes.

Colorectal Cancer Screening

CMS announced a crosswalk pricing decision for G0464, “Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3).”  CMS accepted the industry recommendation of a crosswalk to a combination of Code 81315 “PML/Retinoic Acid Receptor Alpha translocation,” Code 81275 “KRAS mutation analysis” and Code 82274 “Fecal Occult Blood Testing.”  This crosswalk combination would result in a payment, at 2014 CLFS rates, of $502.01.

CMS also published on October 9, 2014, its Final Decision Memorandum establishing coverage for this novel colorectal cancer screening test.

Other

CMS declined to price CPT 89337 “Cryopreservation, mature oocyte(s),” because CMS determined that this code does not describe a clinical diagnostic laboratory test.

Comments and Reconsideration of Pricing Decisions

Interested stakeholders who would like to make comments on these pricing decisions—either supporting or recommending alternatives—should consider submitting comments as quickly as possible.  Because of the delay in the release of the preliminary decisions and the need to release final pricing decisions in late November or early December for 2015 implementation, CMS will have a very short window to review and act on any comments. 

Once the final determination is published, those rates will go into effect for 2015.  However, in the 2008 Physician Fee Schedule Final Rule, CMS established a process whereby it would accept public requests for reconsideration of its final pricing decisions that will affect pricing for the subsequent year (i.e., 2016).  CMS will continue to follow this process, despite the delay in the release of the 2015 preliminary rates.  Once finalized, stakeholders will have 60 days to request formal reconsideration of pricing decisions.  CMS will include a discussion of any reconsideration requests in the July 2015 public meeting.

In addition, under the Protecting Access to Medicare Act of 2014, payment rates under the CLFS will be subject to triennial adjustment (or for advanced diagnostic laboratory tests, annual adjustment) beginning with CY2017 based upon laboratory reporting of private payer payment rates for tests.  Therefore, the annual preliminary and final determinations for new or substantially revised codes under the CLFS will not have the continuous impact on pricing in the future that these determinations have had in the past.