On September 10, 2019, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period establishing new requirements for Medicare- and Medicaid providers to disclose “affiliations” with other providers and suppliers.
Texas House Bill 4390 tightens the notification requirements related to a breach of sensitive personal information, requires notification to the Texas Attorney General in certain breaches, and creates an advisory council related to privacy issues.
Ohio’s health care industry will soon take on significant new obligations with respect to the management of hazardous pharmaceutical waste, pursuant to a federal rule being implemented by Ohio Environmental Protection Agency (EPA).
On April 30, 2019, the U.S. Department of Health and Human Services (HHS) published a notification of enforcement discretion in the Federal Register revising the maximum annual penalty amounts for breaches under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
On April 9, 2019, federal jurors in the Northern District of Texas returned a guilty verdict against seven doctors, surgeons, and health care executives accused of participating in a $200 million bribery and kickback scheme at Forest Park Medical Center (FPMC), a physician-owned hospital in Dallas.
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.