If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services (“HRSA”) finally updated the Office of Pharmacy Affairs 340B Information System website (the “340B Website”) to allow 340B Drug Pricing Program (the “340B Program”) providers – including 340B Program-eligible hospitals and other eligible healthcare providers– to use the 340B…

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder,…

According to a February 12, 2019 Press Release from Protenus, a developer of analytics for patient privacy monitoring and compliance, 15,085,302 patient records were breached in 2018 – a startling number made even more startling by the fact that the number of breached patient records in 2018 is three times greater than the number of records breached in 2017. As evidenced by the Protenus data and information reported by the U.S. Department of Health and…

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its current form, would (i) amend the Anti-kickback Statute (“AKS”) Discount Safe Harbor to explicitly exclude discounts relating to price reductions or other remuneration offered by a pharmaceutical manufacturer to a Medicare Part D plan sponsor (“Plan Sponsor”),…

On January 9, 2019, California Attorney General Xavier Becerra filed a motion with the U.S. Bankruptcy Court for the Central District of California – Los Angeles Division (the “Court”), requesting that the court stay its December 27th Sale Order, which approved Santa Clara County’s $235 million bid to purchase two hospitals from Verity Health System of California (“Verity”).[1] The Sale Order authorized Santa Clara County’s (the “County”) acquisition of O’Connor Hospital in San Jose…

As discussed in our August 16, 2018 blog post, CMS Proposes Massive Changes to ACO Program – Pushing Providers to Accept Downside Risk, on August 9, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule referred to as “Pathways to Success” (the “Proposed Rule”) to redesign the Medicare Shared Savings Program (“MSSP” ). As proposed, the redesign would require Accountable Care Organizations (“ACOs”) to accept downside risk or shared losses…