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Lab Group Eyes Suit Over FDA's LDT Plan; Upton Asks FDA To Help Craft Diagnostic Reg Alternative

The American Clinical Laboratory Association’s legal counselors told laboratory stakeholders Monday (May 4) that they are “ready, willing and able to litigate” against FDA over its proposed framework for laboratory-developed tests (LDTs) -- which brings such tests under the agency's medical device classification system -- soon after the House Energy and Commerce chair asked FDA to help lawmakers craft a new diagnostic regulatory framework for inclusion in the panel's 21st Century Cures bill.

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More than 60 patient groups and members of the Partnership to Improve Patient Care are asking HHS to make the Health Care Payment Learning and Action Network patient-centered by including patient groups in the network and using best practices from the FDA and Patient-Centered Outcomes Research Institute to solicit patient engagement with the initiative.

CMS announced Monday (May 4) that for the first time it is using authority under the Affordable Care Act to expand a demonstration, called the Pioneer Accountable Care Organization Model, even though many Pioneer ACOs dropped out of that demo.

Standard & Poor Analysts said Friday (May 1) that CMS may be forced to adjust the Affordable Care Act's temporary risk corridor program if it wants to maintain budget neutrality, the statements coming after a review of industry filings found a significant funding gap for 2014 claims.

As House and Senate leaders worked last week to finalize a bicameral GOP 2016 budget resolution deal, seven high-profile Democratic senators sent negotiators a letter saying that recent food recalls show the need for lawmakers to embrace the $109.5 million funding bump for FDA requested by the president in order for the agency to implement the Food Safety and Modernization Act (FSMA).

The National Health Council (NHC) told CMS in a recent letter that the group would be happy to allow Healthcare.gov to link to its out-of-pocket cost calculator in exchange for free access to the agency's public-use files (PUFs).

House and Senate GOP committee leaders asked congressional Medicaid payment advisers to analyze a wide array of proposals to reform the program's financing, including a “capped allotment” structure, and to include Medicaid savings to offset the cost of any future recommendations.

Reps. Sam Graves (R-MO) and Adam Schiff (D-CA) reintroduced legislation to reform CMS' policies surrounding Recovery Auditors, much to the delight of the American Hospital Association, which released a report Friday (May 1) detailing its allegations that the auditors' practices are harming hospitals.

A proposed regulation implementing an Affordable Care Act provision that prohibits discrimination in health care programs appears to be under review at the White House Office of Management and Budget (OMB).