AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Podcast: Owner's Outlook: Maximize and Safeguard Reimbursement Through Design - Diagnosing Health Care
HealthLaw HotSpot - A Look at Alternative Reimbursement Models in Value-Based Care
The Important and Thriving Role of Private Medical Practices
Value-Based Care and Its Impact on Providers
The Year Ahead: Litigation Hot Spots at a Glance
Teleworking: Amazing or amazingly complex?
(Video) Reimbursement of College Tuition and Fees After COVID-19
Value-based health care: compliance infrastructure
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Value-based health care: fraud & abuse laws
Value-based health care: issues for pharmaceutical companies
Condo Water Invasion: Potential Medical Liability?
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more
On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more
As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s...more
On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
The US Food and Drug Administration has updated its Information Sheet on payments to clinical trial subjects, including travel reimbursements, and announced a public meeting on enrollment criteria, signaling the agency’s...more
Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
At least once a month, life science clients reach out to us to ask us about best practices on a particular topic or to benchmark a proposed activity against what others in the industry might be doing. One such request,...more