FOIA: JOA Noridian/MolDx

 Based on a February 3, 2020 letter, on June 1, 2023, I received a redacted MAC MOLDX JOA from CMS.   It was redacted only for personnel names.   It's a pretty dry document, stipulating business responsibilities and negotiation rules.   There are several remarks that at various points, Noridian requested edits [not shown], which MolDx rejected.  It's document 020320207041 at CMS FOIA.

There has been debate whether MolDx includes only DNA RNA.  The legal JOA clearly refers to a reference document, the MolDx Manual, and that (public at MolDx) clearly defines the scope of the program as including DNA, RNA, proteins, and metabolites.  That would seem to be the end of debate.

The MolDx Manual also states the program includes "MDTs and LDTs" defined as molecular diagnostic tests and laboratory developed tests.   It frequently refers to MDT and LDT, but the meaning by using both is obscure; as defined, MDT seems to include relevant LDTs.

A auto generated Chat GPT 4 summary is here:

This document describes an operating agreement, also known as Joint Operating Agreement (JOA), between Palmetto GBA's MolDX team and Noridian Jurisdiction F 75FCMC18C0029 Medicare Administrative Contractor (MAC). The agreement concerns the joint responsibilities of both parties to effectively administer services within the scope of the MolDX program.

Key takeaways from the document include:

This agreement is designed to regulate the delivery of services in the MolDX program, which involves molecular diagnostics testing. Providers of these services operate across multiple jurisdictions, thus necessitating clear and consistent processes.

The agreement specifies that the parties are not partners or joint ventures, and no party has the power to bind the other.

The agreement is set to continue until either party's contract with CMS for related services terminates or until CMS provides other instructions.

Both parties have committed to adhere to the Freedom of Information Act, HIPAA, and Privacy Act requirements.

The roles and responsibilities of both the MolDX team and Noridian MAC have been clearly laid out.

Key roles and responsibilities of the MolDX team include:

1. Administering the MolDX program as defined in the MolDX manual, which includes managing registered tests, assisting MAC with implementing MolDX registration, providing technical assessments on submitted dossiers for new tests, and being the primary interface with lab providers.
2. Providing technical assistance and educational material to MAC.
3. Developing and maintaining a model Molecular Diagnostic Testing (MDT) LCD and a network of clinical and academic experts.  [*]
4. Supporting MAC MDT LCD and MolDX LCD publication and administration. [*]

Key roles and responsibilities of the Noridian MAC include:

1. Coordinating publication of the MDT policy elements as a Jurisdictional Local Coverage Determination (LCD) and maintaining the policy per MolDX guidelines.
2. Identifying and directing unregistered tests to the MolDX program for registration and technical documentation requirements.
3. Participating in monthly MolDX processing meetings with Palmetto and other MAC contractors.

Dispute

A dispute resolution process is in place that involves escalating the dispute to higher levels if not resolved within certain timelines.

Non-compliance issues are addressed by submitting the matter in writing to the relevant contracting officers and representatives.

Change requests and interim changes to the JOA can be made via a Memorandum of Understanding (MOU) until the next scheduled revision.

The JOA amendment process stipulates quarterly updates in the first year and semiannual updates thereafter.

The JOA includes a glossary section and details on JOA amendments, noncompliance issues, dispute resolution, change requests, and interim JOA changes.

##

MolDx Manual Clips

https://www.palmettogba.com/Palmetto/moldx.Nsf/files/MolDX_Manual.pdf/$File/MolDX_Manual.pdf?Open&

[*] Points 3 and 4 refer to the MDT, a "master LCD" written at the beginning of the MolDx program, sort of like the Constitution supports all other laws.  However, the MolDx MDT is an unusually document as it primarily says that anything not made payable by MolDx is deniable [with no further facts, evidence, or details].  Therefore, it is unlikely that an LCD Challenge to the MDT would fail.

__________________

What do the parties want to accomplish:

Palmetto GBA's MolDx program:

The Molecular Diagnostic Services (MolDx) Program, run by Palmetto GBA, seeks to bring clarity and consensus to the coding and coverage of molecular diagnostic tests (MDx tests). Its goal is to improve the availability and quality of molecular diagnostics, facilitate coverage of testing services that provide a tangible benefit to patient care, and support advancements in personalized medicine. They would likely want to continue to advance in these areas, potentially through partnerships that enhance their technological capabilities, improve their service offerings, or increase their market share.

Noridian:

Noridian is a healthcare solutions and services company with a focus on administration and customer service for government and private healthcare programs. Noridian's primary goals typically involve improving healthcare delivery through efficient administration, reducing costs, and enhancing patient experience. They could seek to accomplish more efficient claims processing, improved fraud detection, better customer service, and expanded offerings through partnerships