Groups representing more than 150,000 medical laboratory professionals are pushing back against plans by the Centers for Medicare and Medicaid Services (CMS) to extend the Molecular Diagnostic Service (MolDx) program to Medicare contractors across the nation. Officials with Palmetto GBA, the Medicare contractor that developed and currently administers the program, have said they intend to work with other Medicare administrative contractors to deploy key elements of the MolDx program (test registration, new test evaluation, and inclusion of the test ID on the claim). Under the MolDx program, labs that perform molecular diagnostic testing and bill in Jurisdiction E (formerly J1) or Jurisdiction M (formerly J11) must register their tests, obtain a unique identifier, and provide additional information on the test that Palmetto uses to determine coverage. According to an analysis conducted by G2 Intelligence in September, Palmetto had issued coverage decisions for 18 tests and noncoverage decisions for 49 tests. In an Oct. 30 letter to CMS Administrator Marilyn Tavenner, the groups say that fundamentally, they believe the MolDx program and its extension to other Medicare contractors creates serious concerns about Medicare beneficiaries’ access to medically necessary testing used to diagnose disease, identify potential therapies, and monitor the progress of […]
Groups representing more than 150,000 medical laboratory professionals are pushing back against plans by the Centers for Medicare and Medicaid Services (CMS) to extend the Molecular Diagnostic Service (MolDx) program to Medicare contractors across the nation.
Officials with Palmetto GBA, the Medicare contractor that developed and currently administers the program, have said they intend to work with other Medicare administrative contractors to deploy key elements of the MolDx program (test registration, new test evaluation, and inclusion of the test ID on the claim).
Under the MolDx program, labs that perform molecular diagnostic testing and bill in Jurisdiction E (formerly J1) or Jurisdiction M (formerly J11) must register their tests, obtain a unique identifier, and provide additional information on the test that Palmetto uses to determine coverage. According to an analysis conducted by G2 Intelligence in September, Palmetto had issued coverage decisions for 18 tests and noncoverage decisions for 49 tests.
In an Oct. 30 letter to CMS Administrator Marilyn Tavenner, the groups say that fundamentally, they believe the MolDx program and its extension to other Medicare contractors creates serious concerns about Medicare beneficiaries’ access to medically necessary testing used to diagnose disease, identify potential therapies, and monitor the progress of therapy for life-threatening diseases such as breast, colon, and lung cancer. The groups include the College of American Pathologists, the Association for Molecular Pathology, the American College of Medical Genetics and Genomics, the American Society for Clinical Pathology, the American Society for Clinical Laboratory Science, and the American Society for Histocompatibility and Immunogenetics.
“Actions taken by some Medicare contractors follow neither the letter nor the spirit of the law, which require that coverage decisions be transparent and based on medical evidence,” they write. “Further, we are concerned that Medicare assumes that tests performed primarily in pediatric population would never have other uses in adults that would be covered by Medicare. This assumption is resulting in inappropriately denying access to medically indicated testing for younger Medicare beneficiaries who are eligible based on disability status. Yet another consequence is that by not pricing tests that are primarily performed in the pediatric population, some state Medicaid programs are not paying for the appropriate molecular pathology procedures.”
Takeaway: Plans to expand Palmetto’s MolDx program to other Medicare contractors are raising concern among laboratories, who argue the program restricts beneficiary access to important tests.
