In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across...more
Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed...more
4/16/2024
/ Agents ,
Beneficiaries ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Compensation ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Fair Market Value ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Mental Health ,
OIG
At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our...more
10/19/2023
/ Acquisitions ,
Artificial Intelligence ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Investment ,
Investors ,
Life Sciences ,
Medicare ,
Mergers ,
Technology
The digital health market, as represented by the HLTH showroom floor, is packed with companies focused on care coordination and care management for various health and wellness specialties, diseases, and chronic conditions, as...more
At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be...more
Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of...more
For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...more
6/16/2023
/ Abortion ,
Class Action ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Pharmaceutical Industry ,
Planned Parenthood of Southeastern Pennsylvania v Casey ,
Prescription Drugs ,
Roe v Wade ,
SCOTUS ,
Texas
The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more
4/17/2023
/ Abortion ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
Executive Branch ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
Reproductive Healthcare Issues ,
State and Local Government
Following remarks made on March 2 and March 3, 2023 at the American Bar Association’s 38th Annual National Institute on White Collar Crime, the U.S. Department of Justice (“DOJ”) issued revisions to its Evaluation of...more
3/21/2023
/ Clawbacks ,
Compliance ,
Compliance Manuals ,
Compliance Monitoring ,
Corporate Governance ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Executive Compensation ,
Incentives ,
Instant Messaging Apps ,
Mobile Devices ,
Pilot Programs ,
Shareholders ,
White Collar Crimes
The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more
12/13/2022
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth
A major California-based health care system, Sutter Health, and several of its medical practice foundation affiliates have agreed to pay a total of $90 million to settle allegations that they violated the False Claims Act...more
9/14/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Medicare Advantage ,
Risk Adjustment Formula ,
Settlement ,
Whistleblowers
The COVID-19 pandemic has caused unprecedented economic disruptions worldwide. Businesses that were previously flourishing are now seeing rapid declines in demand and revenue, disruptions in their supply chains, and other...more
4/10/2020
/ Board of Directors ,
Business Interruption ,
Coronavirus/COVID-19 ,
Corporate Governance ,
New Guidance ,
No-Action Relief ,
Ordinary Business Exception ,
Proxy Season ,
Proxy Statements ,
Publicly-Traded Companies ,
Rule 14a-8 ,
Securities and Exchange Commission (SEC) ,
Shareholder Proposals ,
Shareholders ,
Tax Planning
As women in professional industries such as finance, healthcare, and law continue to make strides in breaking down barriers, there still remains great gender disparity when examining the leadership levels. Host Michael Cohen...more
It has been a little over a year since the leaking of the infamous Granston memo, an internal U.S. Department of Justice memorandum that provides guidance to government attorneys on when to exercise their authority to invoke...more
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters
On October 24, 2018, President Trump signed the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act” (the “SUPPORT...more
11/7/2018
/ Anti-Kickback Statute ,
Health Care Providers ,
Kickbacks ,
Laboratories ,
New Legislation ,
Opioid ,
Patient Safety ,
Pharmaceutical Industry ,
Physician-Owned Hospitals ,
Physicians ,
Prescription Drugs ,
Substance Abuse ,
Trump Administration