Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
340B Drug Pricing Program Compliance
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more
n November 1, 2019, CMS posted the final rule establishing the payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment System for calendar year (CY) 2020...more
Food/Dietary Supplements - FDA Investigates Multiple Foodborne Illness Outbreaks – The FDA and the CDC have launched a multistate investigation of a Salmonella Concord outbreak linked to certain tahini products. ...more
GOP LAWMAKERS: EUROPE, CANADA ‘FREE RIDING’ ON US DRUG INNOVATION - More than two dozen House Republicans last week called on President Donald Trump to leverage upcoming trade negotiations to stop other nations from “free...more
Lawmakers return to Capitol Hill this week ahead of more self-imposed deadlines to resolve a series of thorny healthcare policies, including funding for the Department of Health and Human Services (HHS) and the rest of the...more
Lawmakers last week approved a stopgap budget bill to keep the government open until Dec. 22, creating a pre-Christmas showdown over a host of spending decisions and key healthcare priorities. Republican leaders on Capitol...more
On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”). This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion...more
The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more
The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect...more
This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more
In This Issue: - King v. Burwell before the Supreme Court and the Potential Congressional Response - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional...more