Lawsuit targets HHS’ unlawful implementation of 2014 Medicare legislation, regulation that would jeopardize beneficiaries’ access to critical lab services
Washington, D.C. – With millions of Medicare beneficiaries facing potential shortages in critical laboratory tests and diagnostics, the American Clinical Laboratory Association (ACLA) continued the push for summary judgment in its lawsuit against the U.S. Department of Health and Human Services (HHS) for failing to comply with Congress’s commands and unlawfully using flawed data in the transition to a market-based payment system.
ACLA filed its reply brief in support of its motion for summary judgment and in opposition to the government’s cross-motion. HHS has until April 20 to file its final brief.
The lawsuit, ACLA v. Azar, asserts that HHS disregarded Congress’s instructions in implementing the Protecting Access to Medicare Act (PAMA), legislation intended to establish a fair and predictable market-based payment system for clinical laboratories. Instead, HHS took a haphazard approach and, rather than collecting accurate information about the market, collected data from less than 1 percent of laboratories nationwide. By excluding more than 99 percent of the nation’s laboratories, HHS violated the statute and undermined Congress’s goal of protecting beneficiaries and supporting value-based care delivery.
As the latest filing notes, “[E]xcluding important sectors of the clinical diagnostic laboratory market from PAMA’s reporting requirement means Armageddon for laboratories serving elderly patients in skilled nursing facilities, nursing homes, and other long-term care facilities. If the Secretary’s failure to require data reporting for all applicable laboratories is not corrected, one of ACLA’s member companies will be out of business within ‘one or two years’ – after having been in operation for more than 45 years as a family-owned business.”
“We’re at a critical inflection point for millions of beneficiaries who depend on vital lab tests and diagnostics for their health,” ACLA President Julie Khani said. “The Secretary’s actions require an urgent and immediate remedy to prevent harm to the most vulnerable seniors.”
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.