On April 3, 2019, the federal Food and Drug Administration (FDA) published a notice in the Federal Register (available in full here) announcing a public hearing and related comment period regarding stakeholders’ experience with products containing the cannabis derivative cannabidiol, popularly known as “CBD.”
On March 26, 2019, the U.S. Senate Committee on Health, Education, Labor & Pensions held a hearing to evaluate a rule proposed by the Office of the National Coordinator for Health Information Technology ) to implement certain provisions of the 21st Century Cures Act (related to health information technology.
On February 6, 2019, the U.S. Department of Health and Human Services (HHS) published a proposed rule that would amend the “Discounts” safe harbor under the Anti-Kickback Statute and create two new safe harbors respectively protecting “Point-of-Sale Reductions in Price for Prescription Pharmaceutical Products” and “PBM Service Fees.”
Effective October 1, 2018, the Centers for Medicare and Medicaid Services (CMS) implemented important changes to the Medicare Inpatient Prospective Payment System (IPPS) affecting the documentation of hospital inpatient admissions.
Roche Molecular Systems, Inc. v. Cepheid, No. 2017-1690 (Fed. Cir. Oct. 9, 2018) (Roche), marks yet another decision from the Federal Circuit affirming invalidity under 35 U.S.C. §101 of diagnostic claims.
On July 31, 2018, the Centers for Medicare and Medicaid Services (CMS) published its proposed changes to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2019.
A U.S. House Subcommittee recently held a hearing to discuss potential reforms to the Medicaid 340B program. Although it remains unclear exactly what will come of these discussions, here are the top three changes 340B providers should watch for.
The Bipartisan Budget Act of 2018 (the act), signed into law by President Trump on February 9, 2018 includes provisions that more than double the penalties to which health care providers may be subject under the federal health care fraud and abuse laws.
Congressmen Earl Blumenauer (D-OR) and Tim Murphy (R-PA) recently introduced the Overdose Prevention and Patient Safety Act (the act), a measure that would align the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (42 C.F.R. Part 2) with the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA).
On May 1, 2017, the Third Circuit affirmed the dismissal of a False Claims Act (FCA) case in which the eelator had asserted that Genentech concealed information about side effects of its cancer drug, Avastin. U.S. ex rel. Petratos, v. Genentech Inc., et al., Case No. 15-3805 (3rd Cir. May 1, 2017).
Jonathan Ishee and Nita Garg, health care attorneys in the Vorys Houston office, co-authored an article for the Houston Business Journal’swebsite titled “Texas Senate Passes Bill Easing Restrictions on Telemedicine.”
On April 13, 2017, the Department of Health and Human Services (HHS) finalized a regulation intended to stabilize the Affordable Care Act (ACA) marketplaces by creating policies beneficial to the insurance industry.