The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more
Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more
Pharmaceutical drug pricing and reimbursement continues to make headlines nationwide. In a recent development, Maryland’s Prescription Drug Affordability Board (PDAB) finalized its list of selected drugs for affordability...more
Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more
New York expanded its existing efforts at monitoring and understanding prescription drug prices by enacting legislation addressing prescription drug price transparency. Effective June 19, 2024, S.599-A/A.1707 amends the New...more
As Prescribed and Health Law Scan subscribers know that the end of the holidays means the annual J.P. Morgan (JPM) Healthcare Conference is only days away. To make the most of the 2024 conference and conference-adjacent...more
Connecticut will bolster its existing prescription drug reporting and transparency regime with new requirements on pharmaceutical sales representative registration and updates to existing manufacturer transparency reporting,...more
Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more
As their 2023 sessions draw to a close, mostly part-time state legislatures have continued their efforts throughout the spring to promote drug price transparency across the prescription drug supply chain. Notable among these...more
6/22/2023
/ Drug Pricing ,
Florida ,
Healthcare ,
Healthcare Reform ,
HIPAA Omnibus Rule ,
New Legislation ,
Omnibus Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drug Coverage ,
Prescription Drugs
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and...more
The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report...more
HB 2536 requires pharmaceutical manufacturers to disclose to the Texas Health and Human Services Commission (HHSC) when a drug’s price increases 15% or more compared to the previous year, or 40% or more over three calendar...more
Clearing the way for consideration by the US House of Representatives, the Ways and Means Committee has unanimously approved bipartisan legislation aimed at increasing drug price transparency by manufacturers and pharmacy...more
While Maryland became the first state in the nation to pass legislation creating a Prescription Drug Affordability Board, it may not be the last. Several other states are exploring similar legislation but legal challenges may...more
Recently introduced legislation would expand the US Physician Payments Sunshine Act to include reporting of financial ties between pharmaceutical and medical device manufacturers and patient advocacy organizations. Any such...more