CLN - Federal Insider

AACC Recommends Tightening Some Target Values in PT Overhaul

Federal Insider: May 2019

In a proposed rule, the Centers for Medicare and Medicaid Services (CMS) has laid out its plan to make significant updates to CLIA proficiency testing (PT) requirements. These updates add dozens of new analytes to the list requiring PT, including troponin, HbA1c, and 27 other nonmicrobiology tests. AACC has provided comments to CMS supporting efforts to modernize PT regulations and also recommended several changes.

In its comments, AACC supports including five additional analytes: cyclosporine, everolimus, tacrolimus, sirolimus, and methotrexate. In addition, the association suggests removing five analytes from the list: ethosuximide, LDH isoenzymes, primidone, procainamide/NAPA, and quinidine.

AACC disagrees with several CMS recommendations. For example, CMS recommends a target value of ± 20% for direct measurement of low-density lipoprotein cholesterol. However, the National Cholesterol Education Program advises laboratories to use methods with total error of ± 12%, which AACC recommends CMS adopt for PT.

CMS also proposes an acceptable range for HbA1c of ± 10%, even though the current quality goal of the College of American Pathologists is ± 6%. AACC wrote that the association is “concerned that broadening the acceptable range may have the effect of placing patients at risk of complications and an incorrect diagnosis of diabetes.”

AACC also recommends that CMS set a target value of ± 20% for cyclosporine, everolimus, tacrolimus, sirolimus, and methotrexate. The association urges CMS to develop a process that ensures that future advancements in target values are quickly adopted and implemented.

Finally, AACC objects to the CMS proposal to use percentage acceptable limits (AL) for some analytes based on biological variability data. AACC recommends that CMS conduct a pilot study that compares the existing AL criteria for the new analytes with the AL criteria based on biological variation.

CMS Launches Artificial Intelligence Health Outcomes Challenge

The Centers for Medicare and Medicaid Services (CMS) launched its first artificial intelligence (AI) health outcomes challenge, a three-stage competition aimed at accelerating AI solutions to better predict health outcomes such as unplanned hospital and skilled nursing facility admissions. CMS is partnering with the American Academy of Family Physicians and the Laura and John Arnold Foundation to award up to $1.65 million to participants.

CMS wants innovators to demonstrate how AI tools, such as deep learning and neural networks, can be used to predict adverse events using so-called explainable AI solutions. This type of software would help front-line clinicians understand and trust AI-driven data by making clear how the software algorithms arrive at their conclusions. More information is available from a new CMS website,

Private Health Insurance Remains Highly Concentrated

A report from the Government Accountability Office (GAO) underscores the paucity of choices most consumers face when shopping for private health insurance plans: Among both group and individual markets, the three largest issuers held 80% of the market or more in at least 37 of 51 states. Such a high concentration of providers means less competition and higher premiums for individuals and businesses, the report noted.

Moreover, the largest issuers increased their market share in about two-thirds of exchanges, GAO found. Many individual exchanges generally had a decreasing number of participating issuers over time, and the remaining issuers in each state often had significantly smaller market shares—on average, 12 of the 16 issuers in each state held less than 5% market share.