CPT code deliberations come out of the dark
For the first time, laboratory groups had an advance say in how new tests will be coded and reimbursed in the next year’s clinical laboratory fee schedule.
The Centers for Medicare and Medicaid Services, or CMS, held a public meeting Aug. 6 to hear coding and payment recommendations for 10 new clinical laboratory tests published in the June 29 Federal Register. When new tests are introduced, CMS has to set the rates at which the procedures will be paid. In the past, the process has taken place without input from the laboratory industry. The Aug. 6 meeting was the first time stakeholders have been given the opportunity to make recommendations before the clinical lab fee schedule is published—and that they did, complete with their rationale for crosswalking and gap-filling.
Providers have long believed that the closed and arbitrary nature of the process stifles the development and introduction of new medical technologies. Last year’s Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act requires CMS to establish a process that permits public consultation before it sets coding and payment determinations for new clinical lab tests.
Stephen Bauer, MD, a member of the CAP Professional and Economic Affairs Committee, says the CAP has long pushed for an appropriate process that would specify timetables and allow for the gathering of information. Although CMS is still developing the procedure, Dr. Bauer, who attended the meeting and presented the CAP’s comments to the CMS, says the meeting was "a good first step toward improving what was previously considered to be a black box process." Others agreed, saying the pilot forum provided experience that will make it possible for CMS to develop the long-awaited new process.
Dee Simons, associate vice president of payment and policy at AdvaMed, says its members were pleased with the meeting and that it was a "phenomenal forum" for anyone wishing to learn about new technologies. Referring to the differences in opinion about two tests in particular—the new C-reactive protein and nucleic acid hepatitis C tests—Simons says, "I believe it would be more helpful in the future for CMS to listen to debate."
Stakeholders agreed in large part on whether codes should be crosswalked or gap-filled. CMSuses the crosswalk method if it determines that a new CPT code is clinically similar to or part of an existing CPT code or multiple codes. The new code is assigned the related existing local fee schedule amount and resulting limitation amount. If no comparable existing test is available, CMS uses the gap-fill method. Each Medicare carrier determines a payment amount for its area for use in the first year. CMS then uses the amounts set by the carriers to establish a national limitation, typically by the end of the first year.
The only real differences of opinion centered on which codes to crosswalk to. The biggest discrepancies occurred with the high-sensitivity C-reactive protein (hsCRP) and nucleic acid hepatitis C tests.
The CAP recommended that the new hsCRP test be crosswalked to 82784 Gamma globulin; IgA, IgD, IgG, IgM, each, another analyte commonly performed via nephelometry. Joanne Glisson, of the American Clinical Laboratory Association, recommended that the test be crosswalked to 83883 Nephelometry, each analyte not elsewhere specified. Joan Logue, representing Health Systems Concepts Inc., a consulting firm, said the new test should be crosswalked to 83520 Immunoassay, analyte, quantitative, not otherwise specified, because it is a marker for coronary artery disease while the older CRP test is a less sensitive, qualitative assay that may be elevated in a variety of conditions.
On the other hand, Alice Weissfeld, PhD, and Vickie Baselski, PhD, representing the American Society for Microbiology, recommended that hsCRP be gap-filled. "Although it would seem logical on the basis of analyte equivalence to crosswalk high-sensitivity CRP to the standard code, 86140, the underlying issues of previous failure to acknowledge cost considerations for specific methods leads us to conclude that this code should be a candidate for a gap-fill process," they said.
For the nucleic acid hepatitis C test, ACLA and Health Systems Concepts recommended a crosswalk to 87901 for HIV genotyping, saying the new test was similar in technology and complexity. The CAP recommended the test be gap-filled because it isn’t comparable to any existing test in CPT. The ASM recommended, too, that the test be gap-filled. Said Dr. Baselski, "We believe a gap-fill approach is indicated since there is not a single uniform composite code set that describes all methods for HCV genotyping."
Other new codes vetted at the meeting:
- Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations
- Oncoprotein, HER-2 neu
- Inhibin A
- Cytomegalovirus direct fluorescent antibody
- Enterovirus direct fluorescent antibody
- Infectious agent antigen detection by immunoassay with direct optical observation; C. difficile toxin A
- Infectious agent antigen detection by immunosassay with direct optical observation; Streptococcus, group B
- Infectious agent antigen detection by immunoassay with direct optical observation; Influenza.
Many presenters called for CMS to make known its rationale for its various decisions, as well as provide the data used to make the decisions. Tom Gustafson, director of purchasing and policy group, Center for Medicare Management, said CMS is investigating how it can achieve this.
A summary of the Aug. 6 meeting is posted at www.hcfa.gov/audience/ planprov.htm. CMS will soon publish in the Federal Register the new process for establishing coding and payment determinations.
Coulson Duerksen is a writer in Washington, DC.