Tuesday, December 5, 2017

2014 MOLDX Statement of Work (Part of Palmetto JM Contract)

In 2014, Palmetto GBA won a competitive bid for Jurisdiction M, which includes in its statement of work a special section "C.7.38" for the "Molecular Diagnostic Test Project."

The recompete document archive is online at FedBizOpps, here.

The SOW is titled, "JM J.01 AB MAC Statement of Work 07 16 14.doc".  I've put a cloud copy here, and the SOW C.7.38 is clipped below (page 181 forward).

C.7.38.1 Develop Molecular Diagnostic Test Pricing Process

The Contractor will establish/maintain a documented process to detail a pricing for complex gene/mutation panels, new technology based tests, and multi-analyte assays with algorithmic analyses (MAAAs) that are not priced nationally. The process will enable analysis, coverage, and pricing strategy recommendations for these tests.

The Contractor shall compile and maintain a file of established molecular diagnostic tests defined by AMA CPT© Tier I and Tier II molecular pathology codes that are not nationally priced. This file will identify lab developed tests (LDTs) and FDA cleared tests.  The Contractor shall provide file updates on an as needed basis to the CMS COR and/or designee.

In addition to the master file, the Contractor will establish/maintain a documented process to detail a payment methodology for complex gene/mutation panels, new technology based tests, and multi-analyte assays with algorithmic analyses (MAAAs) that are not nationally priced. The process will enable the Contractor to evaluate and provide pricing recommendations for these tests.

The Contractor will append the current MoIDx activity with the following responsibilities:
  • ·       Review/update the file on a quarterly basis
  • ·       Assist CMS in all efforts to address pricing and coverage challenges


C.7.38.2 Maintain Master Test Registry [aka Z codes]

Maintain a Master Test Registry with a user interface that allows test providers an avenue to register individual tests and allow stakeholders a tool to look-up registered tests.  The Master Test Registry will enable the following functions:
  • ·       Create and/or adopt, and maintain a unique identifier (code) for each unique test
  • ·       Provide an automated registration process that enables submission of all required information in a standardized, electronic format
  • ·       Maintain an online test listing resource for registered test look-up
  • ·       Safeguard required proprietary data elements

C.7.38.3 Review of Evidence

To support the efficient review of tests in light of the rapid technological advancements in the MoIDx industry, the Contractor will establish a consistent methodology which the Contractor will use for reviewing evidence for requested test indications. The methodology will use an evidence framework that is consistent with the ACCE criteria developed by the Centers for Disease Control and Prevention (CDC) for the evaluation of genetic tests. 

The Contractor shall consider the analyses articulated from 2009 onward in national coverage determinations (NCDs) pertaining to molecular diagnostic tests to be examples of the application of the ACCE criteria to Medicare coverage. The Contractor will establish methods to collect and analyze claims data. As requested, the Contractor will provide recommendations to CMS regarding local coverage variation and system edits.

C.7.38.4 Develop Master Edit File

The Contractor will expand the current file developed through the J1 MoIDx work [California] and prepare this file for shared system (SS) integration. Once the SS edit module is complete and activated, on a quarterly basis the Contractor will produce and submit to CMS a Master Edit File for MAC distribution. This file will include all necessary identifier/CPT/NPI crosswalks, coverage assigned and any non-fee-schedule pricing required. To develop this file the Contractor will perform the following tasks:
  • ·       Review all newly registered tests
  • ·       Establish price (non-fee schedule)/coverage by ID
  • ·       Develop a list of recommended edits including but not limited to the following as appropriate:

o   Frequency
o   ID to procedure code editing
o   ID to ICD-9-CM/ICD-10
o   LCD recommendations
  • ·       Assist CMS in the development and maintenance for Shared System (MCS/FISS) edits to utilize the MoIDx Master Edit File.

C.7.38.5 Prescribed Methodology of Evidentiary Review for Complex Molecular Tests, New Test Methodologies

The Contractor, with an established network of technical and clinical experts, will employ recognized and generally accepted technical assessment methods to perform the following tasks:

  • ·       Create a complete submission process for all supporting application documentation that includes information needed to make evidence based coverage decisions for each test. Maintain the submitted documentation in a retrievable format that supports evidence based decision making.
  • ·       Maintain appropriate evidence/administrative records connected to all coverage policies and make this information readily available to CMS upon request.
  • ·       Publish and maintain any LCDs and related articles on the Medicare Coverage Database.
  • ·       Maintain the submitted documentation in a test specific retrievable format that supports the medical review process.

  • ·       When the available evidence is insufficient to support coverage for routine use in some indications, consider whether the use of the test for beneficiaries enrolled in certain clinical studies will support beneficiary access to covered testing for one or more of those indications. Approved clinical studies would:

o   Be registered on www.clinicaltrials.gov; and
o   Have a methodologically appropriate study protocol to answer the relevant evidence questions regarding beneficiary health outcomes; and
o   Provide assurance that findings are published peer-reviewed clinical literature; and
o   Provide CMS with interim and final data as requested.

  • Provide 1st level of appeals “white papers” that support evidence based decision making for non-covered molecular assays.  [Eg help CMS win the appeal by justifying the non coverage]

C.7.38.6 Ongoing MoIDX Program Education

To support the MoIDX Program, the Contractor will develop a robust educational program to perform the following tasks:
  • ·       Develop program launch materials
  • ·       Develop MoPath correct coding manual
  • ·       Create educational articles for MAC/CMS
  • ·       Provide MAC and Provider Community SME POCs

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