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NJ Judge Deals Blow To Ongoing IRA Litigation Efforts, Rules In Gov’t Favor

A New Jersey district court on Monday (April 29) rejected separate cases filed by Johnson & Johnson and Bristol Myers Squibb that alleged the Inflation Reduction Act’s Medicare drug price negotiation authority violates the Constitution’s free speech and takings clauses, marking the third and fourth cases in which a federal court has sided with the government over drug makers and industry.

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FDA Adds Significant Enforcement Discretion ‘Carve Outs’ In Final LDT Rule

FDA has finalized its controversial rule asserting authority over laboratory-developed tests (LDTs) with some concessions to the barrage of negative feedback it received from industry stakeholders, including adding more categories of tests that will continue to receive enforcement discretion.

Privacy News

FTC Issues Controversial Breach Notification Rule Despite Two Commissioners’ Dissent

The Federal Trade Commission on Friday (April 26) finalized a controversial plan to extend the scope of its Health Breach Notification Rule to include personal health information collected by health apps and other technology that fall outside the Health Insurance Portability and Accountability Act, despite warnings from stakeholders the agency could be sued and dissenting opinions from two commissioners alleging FTC was overstepping its authority.

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Democratic lawmakers and other stakeholders are applauding the Biden administration for fully rescinding a Trump-era rule that allowed more employers to band to together to create association health plans (AHPs) in a rule finalized Monday (April 29) -- presumably in time to avert a potential effort to negate the move via the Congressional Review Act by Republican lawmakers who say rescinding the Trump rule takes away choices for employers who are desperate for affordable options.

The Biden administration’s final Affordable Care Act nondiscrimination rule clarifies acceptable practices within digital health services, including in the use of artificial intelligence algorithms and telehealth services, complementing action taken by several federal agencies to regulate digital health.

The Senate Committee on Armed Services will hear testimony Tuesday (April 30) on Department of Defense (DOD) initiatives to ensure pharmaceutical safety, in a hearing that is likely to touch on issues of generic drug quality and American dependence on pharmaceuticals manufactured in China.

Senate Budget Chair Sheldon Whitehouse (D-RI) is calling to boost incentives to participate in primary care ACOs after a new CBO estimate indicated primary care ACOs, along with independently run ACOs and ACOs with higher baseline spending, are more likely to produce savings.