Third, laboratory testing is reimbursed as a service rather than as a product.
Second, laboratory tests are services, not products or medical devices. First, laboratories are health care service providers, not manufacturers of products offered for sale. The hearings focused on the financial influence of pharmaceutical manufacturers and manufacturers of implantable surgical devices, such as orthopedic replacements and cardiac stents) Laboratories were not the intended targets of legislation addressing the need for improved transparency in physician relationships with manufacturers.īoth because of this legislative history, and for the reasons discussed below, we do not believe that laboratories should be considered “applicable manufacturers” required to file transparency reports. The Senate Special Committee on Aging held four hearings on the physician payment sunshine issue between 20, and a review of the transcripts reveals no mention of clinical laboratories. Laboratories Should Not be Considered “Manufacturers” of “Covered” Products Although ultimately enacted as part of the Affordable Care Act, so-called “physician sunshine” legislation was initially championed by Senators Herb Kohl and Charles Grassley.The comments below set out these concerns in greater detail. In sum, the test service does not constitute a device, let alone one that is reimbursed by Medicare or currently regulated by FDA. Further, these tests also do not typically require Food and Drug Administration (FDA) approval or clearance, as also mandated by the Proposed Rule. While many laboratory services are reimbursed by Medicare and Medicaid, this does not constitute reimbursement of a device, as required by the regulations. In most instances, laboratories do not “manufacture” a “device” as required by the regulations.
Clinical laboratories are health care providers that perform tests ordered by physicians and report results that aid in the assessment of a patient’s health and help to guide care.Īs discussed below, ACLA does not believe that laboratories were ever intended to be covered by the Physician Sunshine provisions included in Affordable Care Act (ACA). ACLA members perform various types of diagnostic testing. The American Clinical Laboratory Association (ACLA) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) on issues related to the Transparency Reports and Reporting of Physician Ownership or Investment Interests Proposed Rule (the “Proposed Rule”).ĪCLA is an association representing clinical laboratories throughout the United States, including local, regional, and national laboratories. Transparency Reports and Reporting of Physician Ownership or Investment Interests
Centers for Medicare and Medicaid Services
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