During its 2014 Annual Meeting in National Harbor, MD, last week, the Association for Molecular Pathology (AMP) distributed position papers on two topics of interest to the laboratory community: a section in the proposed Protecting Access to Medicare Act of 2014 (PAMA) that would impose penalties on hospitals and labs that fail to accurately report highly specific payment data; and a draft guidance from the U.S. Food and Drug Administration that redefines creators of laboratory developed procedures (LDPs) as “manufacturers” and thus makes them subject to burdensome regulations.
As to the former, the AMP stated its concern that “this payment data will be difficult or impossible for hospitals, and many independent and physician owned laboratories to provide using their current laboratory information and billing systems. Molecular pathology testing is often performed on hospital outpatients and is not reimbursed as part of the Hospital Outpatient Prospective Payment System, and therefore, tracking systems to monitor the required reporting elements are not in place.”
The association offered the following solution: “PAMA should be amended to remove the comprehensive reporting burden from laboratories. Congress should instruct CMS to develop a method to sample claims to collect the required data. If Congress chooses not to do this, it is imperative that PAMA be amended to protect laboratories from penalties that unintentionally omit reportable data. In addition, the legislation should also be amended to clarify that new software or other infrastructure systems do not have to be purchased to successfully report or provide a timeline under which upgrades can be made in stages. The threat of penalties of $10,000 per day should be eliminated for those laboratories that make good faith efforts to comply with reporting requirements.”
As to the latter, the AMP noted that “FDA guidance is unjustified and will have a detrimental impact on both patients and providers for whom these LDPs are a critical piece of clinical care. AMP members are not manufacturers, but highly experienced professional health care providers….The procedures they develop, perform, continuously monitor, and continually improve distinguish LDPs from medical devices…. AMP believes that medical device regulations are poorly suited for the oversight of clinical laboratories, and that any regulatory changes are best achieved by updating the CLIA regulations.”
The solution: “AMP urges Congress to direct FDA to engage in the transparent notice and comment rulemaking process prior to extending its medical device regulations to clinical laboratories. Notice and comment rulemaking will ensure that an appropriate cost-benefit analysis is performed, and that all stakeholders have an opportunity to provide feedback and receive Agency responses during the regulatory process.” Learn more about the AMP Annual Meeting.
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