Aiming to scale up Centers for Disease Control and Prevention (CDC) resources to improve pediatric reference intervals, AACC is asking Congress to boost the agency’s Environmental Health Laboratory budget by $10 million. Two dozen professional associations, laboratories, and medical centers have signed on to AACC’s call for funding.

In a letter to Sens. Roy Blunt and Patty Murray, AACC noted that while reference intervals for adults are generally reliable, there are considerable inconsistencies and large gaps in the ranges provided for children. “Accurate and actionable reference intervals are particularly important for our youngest patients, who are often unable to verbally communicate their symptoms,” the letter says. “Unfortunately, most laboratories are unable to obtain enough samples from healthy children to develop their own accurate pediatric reference intervals.”

The letter stresses that when test results fall outside of a reference interval, pediatricians may order a medical intervention to address the condition. “If the diagnosis is mistaken for any reason, including a faulty reference interval, the result could be harmful for the young patient. Therefore, it is critical that reference intervals be correct,” the letter states.

AACC also emphasizes that the CDC already has the infrastructure in place to take on this problem. The CDC Environmental Health Laboratory can generate the needed reference intervals with clinical samples obtained from its National Health and Nutrition Examination Survey.

LAB Act Aims to Fix PAMA Problems

AACC is endorsing the Laboratory Access for Beneficiaries (LAB) Act, a bill intended to make sure laboratory tests are paid appropriately under the Centers for Medicare and Medicaid Services (CMS) clinical laboratory fee schedule. The Protecting Access to Medicare Act of 2014 (PAMA) introduced a market-based reimbursement system for laboratory testing, but AACC and other groups have voiced concern that the current methodology employed by CMS is flawed. The way CMS has collected data—focusing on large, national laboratories—has resulted in what many see as excessive cuts in laboratory reimbursement that may jeopardize patient access to laboratory services.

The LAB Act would delay by 1 year the next round of PAMA reporting requirements so that hospitals recently designated to submit payment data would have more time to comply with the mandate. It also would direct the National Academy of Medicine to study the methodology used by CMS and whether the data used to determine the new rates are representative of the laboratory market.

Currently, more than 90% of the private sector payment information CMS has used for making rates has come from independent commercial laboratories, with only 8% coming from physician office laboratories (POLs) and just 1% from hospital laboratories. In a letter to Rep. Scott Peters, a Democrat from California who sponsored the bill, AACC says that it believes modifying the current methodology to include more payment data from hospitals and POLs may improve the validity of the payment rates.

ACA Insurance Enrollment Declines for Those Without Subsidies

The Centers for Medicare and Medicaid Services (CMS) released a report showing that overall monthly enrollment in the Affordable Care Act health insurance exchanges remained steady in both 2018 and 2019—about 10 million people—while average 2019 premiums actually declined by a small amount—the first drop ever in premiums.

However, the report also found a precipitous drop in enrollment among those who do not qualify for government help in paying their premiums for plans offered under the exchange.

Between 2016 and 2018, 2.5 million people who did not qualify for subsidies left the market, a 40% drop. These enrollment declines among unsubsidized enrollees coincided with increases in average monthly premiums of 21% in 2017 and 26% in 2018.

CMS Administrator Seema Verma said that “people are fleeing the individual market” and that the “ongoing exodus of the unsubsidized population” proves premiums on the exchanges remain unaffordable.