Federal Register Notice - Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (July 19, 2013)

Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1601-P
P.O. Box 8013
Baltimore, MD 21244-1850

RE: Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Hospital Value-Based Purchasing Program; Organ Procurement Organizations; Quality Improvement Organizations; Electronic health Records (HER) Incentive Program; Provider Reimbursement Determinations and Appeals
Schedule, [Proposed Rule CMS-1601-P]

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed revisions to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs for CY 2014 (CMS-1601-P) published in the Federal Register on July 19, 2013. In particular, we wish to comment on proposed revisions described in item II.A.3.c.(3) regarding Proposed Updates Affecting OPPS Payments for Proposed New Packaging Policies for Clinical Diagnostic Laboratory Tests.

The American Society for Microbiology, headquartered in Washington, D.C., is the largest single life science association, with over 38,000 members worldwide. Its members work in educational, research, industrial, and government settings on issues such as the environment, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. The ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating new technologies. Therefore, the ASM has significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries including in the hospital outpatient setting.

Within the hospital outpatient setting, microbiology has particular importance. Many patients present with signs and symptoms of common infections, .e.g. urinary tract infections, upper respiratory tract infections, and a specific microbiologic diagnosis, including determination of adequate antimicrobial coverage if indicated, is essential to appropriate patient management. What is less well appreciated is the impact of individual patient results on subsequent patients. Cumulative data on prevailing etiologic agents has significant implications for early management of additional patients that present with similar syndromes, particularly in an outbreak setting. In addition, cumulative antimicrobial susceptibility patterns on key microorganism types (termed an antibiogram) are essential in selecting an empiric regimen that is likely to be effective until individual patient results are available to confirm the antimicrobial selection.

It must also be appreciated that hospital outpatient settings are an essential site for recognition of not only expected outbreaks of infectious diseases, but for recognizing newly emerging infectious syndromes. Equally essential are the sentinel laboratory services that are provided by microbiology laboratories to identify the agents associated with such syndromes. Many important outbreak and emerging infections including influenza, antibiotic resistant bacterial infections, and food and waterborne diseases first present in outpatient settings and are documented through microbiologic testing.

With the importance of microbiologic findings for both infection prevention and public health activities in an outpatient setting, it is essential that infectious disease diagnostic services are readily available, routinely performed, and adequately reimbursed. It is a concern of ASM, that packaging of infectious disease diagnostic services within an OPPS may serve as a financial disincentive to obtaining such diagnostic services and lead to greater use of empiric management strategies and loss of essential information of significant benefit to additional patients and the public.

Therefore, it our recommendation that CMS consider the exclusion of test codes associated with infectious disease diagnostic services from OPPS packaged payment, similar to the approach being taken for molecular pathology codes. While such services are integral to the primary services, the immediate patient benefit may not be appreciated, and the more broad-based population benefit is poorly appreciated. Appropriate utilization should continue to be assured through utilization of pre-pay edits including medical necessity documentation. We also recommend that appropriate agencies disseminate information on appropriate utilization based on consensus and evidence based guidelines from professional medical and laboratory organizations.

ASM stands ready to assist in providing additional documentation to support this recommendation. It is essential that infectious disease diagnostic services continue to be used appropriately to ensure early recognition and appropriate management of infectious diseases to the benefit of patients and the public.


Vickie S. Baselski, PhD, DABMM, FAAM
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board