On August 12, 2021, the Seventh Circuit joined the Third, Eighth, Ninth, and D.C. Circuits in holding that the “objective reasonableness” standard for determinations of scienter, as set forth by the Supreme Court in Safeco Insurance Co. of America v. Burr, 551 U.S. 47, 70 (2007), applies in the context of False Claims Act (FCA) litigation.  In doing so, the Seventh Circuit observed that, under Safeco, a defendant cannot possess the requisite scienter under the…

Effective January 1, 2022, common prohibitions against “balance billing” under hospital professional service contracts will likely become moot due to certain superseding federal prohibitions under the federal No Surprises Act enacted December 27, 2020.  As detailed below, certain hospital-based physicians, including radiologists, anesthesiologists, and pathologists, should keep these new federal billing prohibitions in mind when entering into new hospital professional services agreements (“PSAs”) and revisit their existing agreements to determine whether any changes are appropriate.…

On August 2, 2021, the U.S. Food and Drug Administration (“FDA”)  published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”).  See 86 Fed. Reg. 41,384–85. This final rule, which takes effect as of September 1, 2021, withdraws and replaces a final rule…

The flurry of Covid-19 vaccine administration that marked the mid spring to early summer resulting in millions of doses administered daily has given way to a steady stream of approximately 700,000 doses of vaccine administered daily, according to some analysis of CDC data. But now that August has arrived so has the need for regularly scheduled pediatric vaccines to be administered as schools open up again. Also, next month marks the beginning of flu season…

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates. Rebate for Discarded…

Just when the procedures thought they were out(patient), CMS pulls them back in(patient). Last year, in the final CY 2021 Outpatient PPS rule, CMS announced its intention to eliminate the Inpatient Only (IPO) List by January 1, 2024. The IPO list featured more than 1,700 procedures that were surgically invasive or required more than 24 hours of post-operational recovery time. As a result, any procedure on the list would only be paid for by…

Starting in 2019, the Department of Health and Human Services Office for Civil Rights (“OCR”) has taken an increased interest in protecting patients’ right of access to protected health information (“PHI”) under the Health Insurance Portability and Accountability Act (“HIPAA”). Over the past twenty months, OCR has announced nineteen settlements under its Right of Access Initiative (“Initiative”), demonstrating OCR’s continued commitment to enforcing patients’ rights. Reed Smith has closely tracked this Initiative. Additional commentary on…