June 25, 2007 - ASM Sends Comments to OMB Regarding CMS's Draft Advanced Beneficiary Notice

OMB Human Resources and Housing Branch
Attention: Carolyn Lovett
New Executive Office Building
Room 10235
Washington, DC 20503

Dear Ms. Lovett:

The American Society for Microbiology (ASM) appreciates the opportunity to review and comment on CMS-R-131, Centers for Medicare and Medicaid Services; Agency Information Collection Activities: Submission for OMB Review; Comment Request published Friday May 25, 2007 in the Federal Register, Volume 72, Number 101, pages 29322 - 29323. The ASM opposes the implementation of a generic, all-purpose Advanced Beneficiary Notice (ABN) which would replace the laboratory specific ABN (CMS-R-131-L) implemented in June 2002.

The ASM is the largest, single life sciences society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents approximately 42,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical laboratory fields. 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 the performance of new technologies. Our clinical laboratory members are involved on a day-to-day basis with testing procedures for many infectious and immunologic diseases, including procedures based on molecular diagnostic techniques. Many of these procedures are covered in existing National and Local Coverage Decisions. Therefore, ASM members have a significant interest in ensuring that any revisions to current ABNs be necessary, reasonable, and convenient for use in a variety of laboratory settings. Further, the complexity of laboratory medicine renders it extremely important that ABNs for laboratory services be designed to enhance beneficiary understanding of reasons for denial of payment for services.

The ASM does not believe that the elimination of the laboratory specific ABN will serve beneficiary interests. For complex infectious and immunologic diseases, it is not the laboratory which notifies the beneficiary about the medical rationale for tests, test procedures, and potential reasons for non-coverage of tests. Instead the ordering physician or other authorized provider is responsible for this notification. The current laboratory specific form clearly identifies the reasons for the denial of laboratory tests as one of three categories: medical necessity, frequency, and investigational/experimental status. This allows an important distinction to be made between laboratory services and other medical services that is more understandable to beneficiaries.

Further, the ASM has other questions and concerns regarding the generic ABN proposal. First, it is unclear whether there is a new requirement that laboratories acquire an ABN when services are never covered due to regulatory interpretations of Medicare statute. Second, CMS has failed to give any reason why it has been deemed necessary to eliminate the laboratory specific ABN which was discussed and agreed upon by stakeholders in 2002. Third, laboratories that have implemented the laboratory specific ABN (Form CMS-131-R-L) will be required to make expensive and time consuming adjustments to information technology systems, as well as invest significant time and effort in educating both laboratorians and ordering providers about the changes in the ABN process, should the general, all-purpose ABN be implemented.

In conclusion, the ASM sees no benefit to the elimination of the laboratory specific ABN, and in fact, foresees significant issues with the removal of this ABN and its replacement with a generic ABN.

Thank you for the opportunity to provide comments.


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