“As Opening Day arrives, the Court finds its guiding principle in Yogi Berra’s aphorism, “It’s déjà vu all over again.”” – Judge James Boasberg, Gresham v. Azar. On March 27, United States District Court for the District of Columbia Judge James Boasberg ruled that Department of Health & Human Services Secretary Azar’s approval of work and community engagement requirements in Arkansas and Kentucky were arbitrary and capricious, halting their implementation. The Gresham v. Azar opinion…

The Trump Administration took several steps this past week in support of its efforts to transform the Medicaid program. In testimony before Congress on Thursday, March 14, HHS Secretary Alex Azar confirmed the agency is engaging in discussions with states interested in receiving federal Medicaid funding through block grants. The same day, oral arguments were heard in challenges to the Section 1115 work and community engagement waivers granted in Kentucky and Arkansas, with Judge Boasberg…

On March 13, 2019, The Joint Commission released Sentinel Event statistics for 2018.  There were 801 sentinel events in 2018, with 87% being voluntarily self-reported.  According to the Joint Commission, it is estimated that less than 2 percent of all sentinel events are reported.  The Joint Commission defines a sentinel event as: Any unexpected occurrence involving death or serious physical and psychological injury, or the risk thereof.   Serious injuries specifically include a loss of limb…

On February 14, 2019, the Center for Medicare and Medicaid Innovation (CMMI) announced the Emergency Triage, Treat, and Transport (ET3) Model that aims to transform the ambulance system.  Medicare-enrolled ambulance service suppliers and hospital-owned ambulance providers will participate in the model.   CMMI believes this model will improve quality and lower costs by reducing hospitalizations and avoidable transports. Currently, Medicare provides payment for emergency ground ambulance services when a beneficiary is transported to a hospital, critical…

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, device manufacturers rely on predicate devices to demonstrate the safety and efficacy of a new device.  The guidance expands the…

On January 1, 2019, all hospitals are required to make public a list of their standard charges.  As a reminder, Section 2718(e) of the Public Health Service Act, as enacted by the Affordable Care Act, requires: “each hospital operating within the United States” to “make public (in accordance with guidelines developed by the Secretary) a list of the hospital’s standard charges for items and services provided by the hospital, including for diagnosis-related groups established under…

On Friday, December 14, Judge Reed O’Connor of the Federal District Court in the Northern District of Texas issued a declaratory judgment holding the shared responsibility provision (also referred to as the “Individual Mandate”), and with it, the entire Affordable Care Act (“ACA”), to be unconstitutional. The case is Texas v. United States and California (Civil Action No. 4:18-cv-00167) (previous HL Pulse discussion here). Judge O’Connor did not issue an injunction and the ACA…