AACC is joining other groups in the laboratory community in urging Congress to protect patient access to clinical laboratory services by enacting the Saving Access to Laboratory Services Act (SALSA). The bipartisan and bicameral bill would update the Centers for Medicare and Medicaid Services (CMS) payment system for clinical laboratory testing and avoid sharp payment cuts under the 2014 Protecting Access to Medicare Act (PAMA).

Under PAMA, CMS determines reimbursement for laboratory tests billed on the clinical laboratory fee schedule based on a weighted median of private payer rates. But CMS regulations exclude most hospital outreach laboratories and physician office laboratories from data collection. This approach depresses median prices and has led to deep cuts to lab reimbursement. Many tests were cut up to 30% in 2018 when the new system went into effect.

In a letter to congressional leaders, the stakeholders note that “without a sustainable solution to this problem, labs face another round of cuts of up to 15% in January of 2023. This, at a time when we remain at the forefront of patient care and responding to public health disruptions and threats such as COVID-19.”

SALSA would solve the problem by giving CMS new authority to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services, the letter said.

AACC encourages laboratory medicine professionals to write to their representatives about the issue. More information and AACC’s grassroots Laboratory Voice tool are available at www.myadlm.org/reimbursement.

Company President Convicted in $77 Million SARS-COV-2 and Allergy Testing Scheme

The Department of Justice (DOJ) announced that a federal jury convicted Mark Schena, president of Silicon Valley-based Arrayit Corporation, of participating in a scheme to mislead investors, commit healthcare fraud, and pay illegal kickbacks in connection with the submission of over $77 million in false claims for SARS-CoV-2 and allergy testing.

Schena claimed he had invented revolutionary technology to test for virtually any disease using only a few drops of blood. In meetings with investors, Schena and his publicist claimed that Schena was the “father of microarray technology,” that he was on the shortlist for the Nobel Prize, and that his company’s SARS-CoV-2 test was more accurate than PCR, DOJ said.

He also orchestrated a plan for submitting fraudulent claims to Medicare and private insurers for unnecessary allergy testing. Arrayit ran allergy screening tests on every patient for 120 different allergens regardless of medical necessity. In order to obtain patient blood specimens, Schena paid kickbacks to marketers. DOJ found that Arrayit billed more per patient to Medicare for blood-based allergy testing than any other laboratory in the United States and billed some commercial insurers over $10,000 per test.

ACOs Save Medicare $1.6 Billion

Accountable Care Organizations (ACO) saved Medicare $1.66 billion in 2021 compared with spending targets, marking the fifth consecutive year the program generated savings for the government.
Groups of doctors, hospitals, and other healthcare providers can form ACOs and get a share in the savings if their coordination saves costs compared with traditional fee-for-service medicine under Medicare. But they have to prove they maintain quality and other metrics at the same time.

Over the past decade, the Shared Savings Program has grown to one of the largest value-based purchasing programs in the country, with more than 525,000 participating clinicians providing care to more than 11 million Medicare beneficiaries. The Centers for Medicare and Medicaid Services has set a goal that 100% of people with traditional Medicare be part of an accountable care relationship by 2030.

Nearly all ACOs—99%—reported and met the quality standard required to share in savings under the Shared Savings Program in 2021. A lower number, 58%, saved enough to earn payments for their performance.