Originally Published IVD Technology March 2002
Industry News
Industry applauds Medicare final rule for lab tests
Richard
Park
| Alpha-fetoprotein Blood counts Blood glucose testing Carcinoembryonic antigen Collagen, crosslinks (any method) Digoxin therapeutic drug assay Fecal occult blood Gamma glutamyl transferase Glycated hemoglobin/glycated protein Hepatitis panel HIV testing (prognosis including monitoring) HIV testing (diagnosis) Human chorionic gonadotropin Lipids Partial thromboplastin time Prothrombin time Prostate-specific antigen Serum iron studies Thyroid testing Tumor antigen by immunoassay—CA125 Tumor antigen by immunoassay—CA15-3/CA27 Tumor antigen by immunoassay—CA19-9 Urine culture |
| The Centers for Medicare and Medicaid Services have recently published a final rule describing new Medicare coverage policies for these 23 lab tests. |
"We’re very pleased with the final rule," says Dee Simons, associate vice president for payment and policy at AdvaMed (Washington, DC). "It was what we expected and what we had worked on. In general, all of our in vitro diagnostics member companies are very pleased with the outcome."
The Centers for Medicare and Medicaid Services (CMS; Baltimore) published the final rule in the November 23, 2001, Federal Register. The rule outlines new national Medicare coverage and administrative policies for 23 clinical laboratory tests (see Table). It specifies the conditions under which Medicare will pay for the tests as well as the appropriate CPT and ICD-9 codes to be used, and is binding on local carriers and other fiscal intermediaries. The tests included under the new rule make up about 60% of all Medicare laboratory claims.
"Compared with the proposed rule published in March 2000, the changes for these tests are fairly minimal," said a CMS spokesperson. "Basically, we made a few coding changes in the policies, and there were some clarifications in the policy for collagen crosslinks and human chorionic gonadotropin."
The final rule was developed in consultation with members of the laboratory community and other healthcare providers, as well as medical device manufacturers, through a negotiated rule-making process. Industry analysts believe that such a process provided an ideal method for all the concerned parties to express their opinions and be involved.
"The negotiated rule-making process is the correct way to determine criteria because it brings all of the stakeholders into one room," says Simons.
As for the resulting new policies, analysts believe they will be beneficial to the industry as a whole, primarily by providing consistency regarding coverage policy.
"For IVD manufacturers—particularly those operating on a national scope—the final rule makes coverage policy more uniform and predictable from region to region," says Jeff Bush, manager for reimbursement and managed-care affairs at Becton, Dickinson and Co. (Franklin Lakes, NJ). "As for reimbursement of these or new tests, however, this rule does not alter existing reimbursement levels nor does it include processes for new tests that would require CMS to make a new payment decision. I am hopeful that additional forthcoming regulations will address needs in the payment realm for the initial setting of reimbursement for new tests, the appropriate adjustment of payments for existing tests, and the openness of the process related to these activities."
A copy of the final rule is available via the Federal Register Web site at http://www.access.gpo.gov/su_docs/fedreg/a011123c.html.
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©2002 IVD Technology
