October 10, 2006 - ASM Submits Comments on CMS Proposed Revisions to the Physician Fee Schedule for Calendar Year 2007

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1321-P
7500 Security Boulevard
Baltimore, MD 21244-1850

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) on its Proposed Revisions to Payment Policies under the Physician Fee Schedule for Calendar Year 2007, as announced in the Federal Register on August 22, 2006 [Vol. 71, No. 162, CMS-1321-P]. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 42,000 microbiologists, professionally employed as scientists and science administrators working in a variety of areas, including biomedical, environmental, and molecular fields as well as in clinical microbiology and immunology.

Many of our members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating new technologies. Thus, our Society has a significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries. The ASM will limit its comments to the sections of the proposed rule that pertain to clinical diagnostic laboratory tests.

Clinical Diagnostic Laboratory Tests


Section II. N. 1, 2 a. – c. Public Consultation for Medicare Payment for New Outpatient Clinical Diagnostic Laboratory Tests

Section 942(b) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), requires the Secretary to establish fee schedules for clinical laboratory tests under Medicare Part B. It also specifies annual procedures for consulting the public on how to establish payment for the new or revised clinical laboratory test codes to be included in the annual update of the clinical laboratory fee schedule. CMS has conducted its “Laboratory Public Meeting” on an annual basis since 2002 as a result of Section 531(b) of the Benefits Improvement and Protection Act of 2000, and, as recommended by the Institute of Medicine in its 2001 Report on Medicare Laboratory Payment Policy. ASM has appreciated the opportunity to participate in these public meetings to recommend payment methodology approaches for new microbiology and immunology laboratory tests. In particular, we support the CMS criteria for establishing payment decisions which is based on test purpose, test method, test cost, and the specific recommendation to crosswalk the new test to an existing code, or to gapfill the new test if there is no comparable test. We also appreciate the additional comment period provided after tentative payment determinations are made available by CMS. ASM believes that this kind of open and transparent process allows for a successful coordination of science, business, and program integrity interests which ensures quality laboratory medicine for Medicare beneficiaries. As such, we are pleased that CMS is proposing to codify this important public process.

ASM also supports that CMS provide the rationale, data or responses to comments from the public in its proposed and final payment determinations. Section 1833(h)(8)(B) of the MMA requires the Secretary to provide “an explanation of the reasons for each determination and the data on which the determinations are based” for both the proposed and final determinations. To date, ASM has not been privy to this information regarding proposed or final payment methodology for new laboratory tests. The only information that is provided is CMS’s proposed or final payment methodology, and, the recommendations made by each of the organizations that participated and/or submitted comments to the Laboratory Public Meeting. ASM believes that providing this additional information would help to strengthen the payment methodology process by making it more transparent. In addition, ASM recommends that codes for which significant descriptor changes have been made, be open for public comment on appropriate payment methodology. Historically the process has publicized only new codes established by the American Medical Association.

II. N. 2. d. Proposed Payment for a New Clinical Diagnostic Laboratory Test – Crosswalking and Gapfilling (§414.408)

ASM supports CMS in its proposal to establish the payment amount for new laboratory tests via “crosswalking” and “gapfilling” methodology. We are pleased that CMS is clarifying the process by which the gapfilling methodology is applied, including the elimination of payment of new gapfilled tests at carrier specific amounts after the first year. ASM agrees with CMS that a gapfilled test can be payed at the carrier specific rate during the first year, but, that beginning in the second year, the test would be reimbursed at the national limitation amount, based on the median of the carrier gapfill amounts. In addition, ASM recommends that CMS provide guidance to carriers to help in setting carrier specific gapfilled rates so that there is consistency in determining reimbursement of new laboratory tests from carrier to carrier. Guidance could be based on the criteria used to determine payment for new test codes in CMS’s annual Laboratory Public Meeting, i.e. test purpose, test methodology and test costs, and, recommendations could be solicited from the public sector during the annual meeting. Guidance might also encourage the use of scientific studies and professional guidelines to support the appropriate utilization and reimbursement for such new tests.

II. N. 3. a. Quality

ASM supports the use of a standardized terminology such as the Logical Observation Identifiers Names and Codes (LOINC) database to promote development of quality monitors for laboratory medicine. However, we appreciate that CMS acknowledges that there are significant functional, operational and other challenges that would need to be addressed before Medicare could begin to collect laboratory values in a comprehensive manner using common vocabulary standards. In particular, most traditional microbiology test results are reported in a narrative fashion, not using easily categorized qualitative or quantitative values. Further, narratives are often tailored to meet specific clinical needs of diverse patient population types. Therefore, the creation of common narratives to report microbiology test results would take a significant amount of time and scientific expertise. The ICD-10-PCS project more than a decade ago laid a foundation for such an endeavor, but is clearly outdated at this point. ASM stands ready to assist CMS should it decide to initiate the development of a process by which to define and categorize microbiology reporting for purposes of quality improvement.

II. N. 3. c. Other Lab Issues - Proposed Clinical Diagnostic Laboratory Date of Service (DOS) for Stored Specimens

ASM appreciates CMS’s clarification of the date of service of a clinical diagnostic laboratory test that uses a stored or archived specimen on a hospital inpatient. We support CMS’s proposal to use the date the specimen is obtained from storage for subsequent outpatient testing, even if the specimen is obtained less than 31 days from the date it was collected. ASM also supports that certain conditions to insure program integrity must be met which are outlined in the proposed regulation, as follows:

  • The test is ordered by the patient’s physician at least 14 days following the date of the patient’s discharge from the hospital.
  • The test could not reasonably have been ordered while the patient was hospitalized.
  • The procedure performed while the beneficiary is a patient of the hospital is for purposes other than collection of the specimen needed for the test.
  • The test is reasonable and medically necessary.

Again, thank you for the opportunity to provide comments on the Proposed Revisions to Payment Policies under the Physician Fee Schedule for Calendar Year 2007. Should you desire additional information about ASM’s comments, please contact Suzy Leous in ASM’s Office of Public Affairs, at 202-942-9262 or sleous@asmusa.org


Vickie S. Baselski, Ph.D., Chair, Committee on Professional Affairs, Public and Scientific Affairs Board