News at a Glance – Jan 2016

CMS Transitions Away from Meaningful Use As We Know It. Acting CMS Administrator Andy Slavitt announced Jan. 11 at the J.P. Morgan Healthcare Conference in San Francisco that the Centers for Medicare & Medicaid’s (CMS) Meaningful Use program that awards incentives for using certified electronic health records (EHR) will be ending in 2016. “The Meaningful Use program as it has existed, will now be effectively over and replaced with something better,” said Slavitt. About a week later, on Jan. 19, Slavitt co-authored a CMS Blog entry with Karen DeSalvo, acting assistant secretary for health at the Department of Health & Human Services, discussing a “transition from the staged meaningful use phase to the new program as it will look under MACRA.” The blog stated, however, that MACRA “continues to require that physicians be measured on their meaningful use of certified EHR technology for purposes of determining their Medicare payments,” and existing regulations—including stage 3 meaningful use requirements—are still in effect.

CDC Future Plans Include Laboratory Safety. Laboratory safety and diagnosis of infections figure prominently in the Centers for Disease Control and Prevention’s (CDC) review of 2015 and its agenda for 2016. After establishing the Office of the Associate Director for Laboratory Science and Safety (OADLSS) in 2015, the agency said its goals for 2016 include using “lessons learned and best practices to mitigate” lab risks. The OADLSS is intended to lead “development and enhancement of laboratory safety programs,” “provide transparent flow of information across the laboratory community regarding laboratory science, safety and quality and sharing of best practices,” and oversee lab safety and quality management at the CDC. Other items on CDC’s 2016 agenda include: issuing a 2016 report on antibiotic resistance, and prescribing practices and an interactive web platform offering access to relevant antibiotic resistance data; promoting the Global Health Security Agenda’s objective to enable detection and prevention of infectious diseases throughout the world.

Congress Lobbies CMS on PAMA Regulations. Members of Congress have been busy pleading with the Centers for Medicare & Medicaid Services (CMS) to delay and revise the implementation of the Protecting Access to Medicare Act (PAMA). Dec. 14, 2015, 19 U.S. Senators signed a letter to Andy Slavitt, Acting Administrator of CMS expressing their concern about the timeline for implementing PAMA and objecting to exclusion of a “significant part of the laboratory market,” and the definition of Advanced Diagnostic Laboratory Tests (ADLTs). Days later, 44 members of the House of Representatives, submitted a letter to CMS objecting to the reporting timeline, exclusion of protein biomarkers from the definition of ADLTs and arguing that a “number of laboratories are prohibited from participating in the reporting process” which could “skew the market data, resulting in Medicare rates that are not reflective of true market prices.” Finally, Chairman of the Senate Committee on Finance, Orrin Hatch, and Ranking Member Ron Wyden wrote to Slavitt Jan. 6, 2016, saying use of Tax Identification Numbers to identify reporting laboratories would exclude “important segments of the laboratory market, especially hospital outreach laboratories,” which they note serve beneficiaries and compete with community-based labs. Instead, they suggested Clinical Laboratory Improvement Act numbers be used to identify reporting labs.