Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law.
In this installment, Brett is joined by Partner Judy O'Grady and Associate...more
After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives.
Originally published in Law360 - September 11, 2023....more
12/11/2023
/ Advertising ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
Misleading Statements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Social Media
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more
On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more
On August 13, the D.C. Circuit revived the CMS 2014 Medicare Advantage Overpayment Rule in deciding UnitedHealthcare Ins. Co. v. Becerra, a ruling that could have broad implications for Medicare Advantage (MA) insurers. See...more
Why It Matters -
Businesses should begin to address these issues now so that when COVID-19 vaccines are ready for distribution, they will be too....more
12/16/2020
/ Americans with Disabilities Act (ADA) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Employer Liability Issues ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
OSHA ,
Popular ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Title VII ,
Vaccinations
Why It Matters -
In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
10/7/2020
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Health Record Incentives ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Machine Learning ,
OCR ,
Security Risk Assessments
What is the COVID-19 Trademark Prioritized Examination Program? In an effort to address the critical need to develop medical products and services that will aid in the elimination of the COVID-19 pandemic, the United States...more
Troutman Sanders and Pepper Hamilton are producing a series of podcasts to discuss litigation topics that have been brought to the forefront by the COVID-19 pandemic and how businesses might be able to prepare and...more
In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more
Following declarations of a public health emergency by President Trump and the Secretary of the Department of Health and Human Services (HHS), HHS continues to loosen legal restrictions in an effort to mitigate harm from the...more
On March 18, the Food and Drug Administration (FDA) issued guidance in recognition of the extraordinary challenges that have impacted ongoing medical research in light of the coronavirus pandemic. “FDA Guidance on Conduct of...more
Makers, distributors, program planners and administering entities of coronavirus (COVID-19) countermeasures are protected from liability under a declaration issued by the Department of Health and Human Services (HHS)...more
3/17/2020
/ China ,
Coronavirus/COVID-19 ,
Countermeasures ,
Covered Entities ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Distributors ,
Emergency Management Plans ,
Immunity ,
Infectious Diseases ,
Manufacturers ,
Pharmaceutical Distribution ,
Popular ,
Public Health
Hemp production is a large and growing industry in the United States. Even before Congress’ passage of the Agriculture Improvement Act of 2018 (better known as the 2018 Farm Bill), the Hemp Business Journal estimated that...more
11/11/2019
/ Cannabidiol (CBD) oil ,
Decriminalization of Marijuana ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Marijuana ,
Marijuana Related Businesses ,
Regulatory Oversight ,
USDA
Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more
2/11/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Digital Health ,
Low-Income Issues ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Patient Assistance Programs ,
Pharmaceutical Industry
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
HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more
The Centers for Medicare and Medicaid Services (CMS) recently made several announcements regarding Medicare, Medicaid, and SCHIP Extension Act (MMSEA) Section 111 reporting for Non-Group Health Plans (NGHPs).
Originally...more
The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies.
Annually, the Department of Health and Human Services...more
6/15/2015
/ Department of Health and Human Services (HHS) ,
Healthcare ,
Medicaid ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
OIG ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacies ,
Reporting Requirements