Groups Weigh In on PFS; LCDs, 88185, Prostate Biopsy Code Among Concerns

Laboratory and pathology groups weighed in recently on proposed changes to the Physician Fee Schedule (PFS) for 2015. Chief among their concerns are proposed changes to the local coverage determination (LCD) process for lab tests, a proposal to use a single code for prostate biopsies, and plans to revalue CPT 88185 (flow cytometry, each additional marker). In the rule issued July 3, the Centers for Medicare and Medicaid Services (CMS) proposed several significant changes to the LCD process for all clinical laboratory tests, including shortening the comment period, changing the requirement for a carrier advisory committee (CAC) meeting, specifying a timeline for publication of a final LCD, and changing timing of a new LCD taking effect. Both the American Clinical Laboratory Association (ACLA) and the College of American Pathologists (CAP) oppose shortening the comment period on draft LCDs from 45 days to 30 days, saying that the current allotment of 45 days is often insufficient given that each of the Medicare administrative contractors (MACs) posts draft LCDs in a different place and communicates with stakeholders in a different manner, making it difficult for labs and other stakeholders to keep abreast of all the various proposals and develop comments within 45 days. But ACLA and CAP differ on whether they think LCDs should become effective immediately upon publication. “Making the LCD effective immediately upon publication is a ‘double edged sword,’” notes ACLA. While having an immediate effective date would make tests available to beneficiaries more quickly, in cases where a noncoverage determination is announced, “it can be difficult for laboratories offering the test to respond to such an abrupt policy change,” says ACLA, which recommends that changes in coverage conditions continue to be effective 45 days after a final decision is made. CAP, however, supports making the final LCD effective immediately upon publication “assuming that the agency does not shorten the current 45-days LCD comment period and provides adequate process transparency.” Currently, MACs are required to hold both open public meetings to discuss draft LCDs with interested parties and also to present the draft policy to the CAC. CAP opposes plans to have the sole authority to determine the necessity of a CAC meeting rest with a MAC, as the new rule proposes. ACLA suggests that CMS provide MACs with more guidance about the circumstances under which the CAC should be involved. At a minimum, CACs should be consulted on noncoverage LCDs and on LCDs that restrict coverage, it says. Any changes to the LCD process for clinical laboratory tests should be consistent with Congress’s goals in enacting the LCD provision in the Protecting Access to Medicare Act (PAMA), stresses ACLA, noting that CMS does not state whether or not articles may be used in lieu of LCDs to announce noncoverage of clinical laboratory tests. This has been a source of contention between MACs and labs for some time, especially as it relates to coverage decisions made by Palmetto under the Molecular Diagnostics Services Program. “Articles are not subject to the same requirements as LCDs; therefore, when a contractor issues an article that effectively denies coverage for a test, affected laboratories do not have the same ability to comment or submit information on the test at issue,” says ACLA. Section 216 of PAMA requires that for LCDs issued on or after Jan. 1, 2015, “a Medicare administrative contractor shall only issue a coverage policy with respect to a clinical diagnostic laboratory test in accordance with the process for making a local coverage determination . . . including the appeals and review process for local coverage determinations.” Given the attention that Congress has paid to this issue, it is somewhat surprising that CMS would propose changes to the LCD process that reduce the procedural protections that currently apply to clinical laboratory LCDs, says ALCA. The association urges CMS to make clear in the final rule that articles may not be used to announce noncoverage decisions in lieu of an LCD. Prostate Biopsy Code CMS is proposing to use just one Healthcare Common Procedure Coding System (HCPCS) code—G0416—to describe all prostate needle biopsy procedures regardless of the number of specimens and regardless of the methodology (standard prostate biopsy versus saturation prostate biopsy). It proposed to delete G0417, G0418, and G0419. CMS also is proposing G0416 as a potentially misvalued code and seeks input on the appropriate work relative value units, work time, and direct practice expense inputs. “CMS continues to be completely misguided in its approach to these codes,” says ACLA. “As we have discussed with the agency repeatedly, HCPCS codes G0416 through G0419 originally were developed to apply to a relatively rare procedure, prostate needle biopsies, which are done under general anesthetic and involve biopsy of the entire prostate in order to determine if previously diagnosed prostate cancer is spreading. “However, last year, CMS decided to apply these codes to a standard biopsy, which is a far more common procedure, done under local anesthetic, and which involves taking fewer biopsies to determine if cancer could be present in the first instance,” ACLA continues. “These latter types of procedures always previously were billed under CPT 88305. It is inappropriate for CMS to treat these two vastly different procedures as the same and to include them under the same HCPCS code.” ACLA also argues that the code should not be considered a misvalued code. CMS notes that most prostate biopsies are billed for 10 to 12 biopsies. The current rate for the G code is $651.26, or about $54.25 per specimen, for a standard 12-biopsy specimen. The reimbursement rate already is almost 30 percent below the level that ACLA believes is appropriate, which would be 12 units of 88305, or approximately $847, the association says. “CMS has failed to explain why it believes that a significant reduction in HCPCS code G0416 may be appropriate when it bundles the codes together,” writes ACLA. “Moreover, CPT 88305 itself was significantly reduced several years ago, on the basis that is was misvalued; therefore, to reduce the payment even further below the current levels seems unwarranted.” CAP also believes CMS should use CPT 88305 for prostate biopsies, urging the agency to withdraw its proposal to use G0416 for the pathology of all prostate specimens. “We believe that the additional revaluation and scrutiny finalized by the agency in the 2014 final rule for surgical pathology code 88305, together with greater granularity in payment, addresses the agency’s intent to establish straightforward coding and accurate payment for these services,” says the college in its comments. CPT 88185 CMS says it intends to revalue CPT 88185. ACLA is calling on CMS to withdraw its proposal to review 88185 as a potentially misvalued code, arguing that the agency has not said why it thinks the code is misvalued other than it is one of the “top 20 codes by specialty in terms of allowed charges.” If CMS does intend to adopt a new valuation for 88185, “despite its inappropriate selection as a potentially misvalued code, it should do so using the process it is proposing for valuation of new, revised, and potentially misvalued codes,” says ACLA. The new valuation should be published for comment in the 2016 PFS proposed rule, rather than in the 2015 PFS final rule. The final PFS rule for 2015 is expected to be published on or around Nov. 1, 2014. Takeaway: Industry groups oppose several proposed changes to Medicare policies for 2015, including policies that govern the way LCDs are issued and challenged.