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
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
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
This marks the second issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more
The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more
Report on Medicare Compliance 31, no. 14 (April 18, 2022) - The Department of Justice (DOJ) said April 11 it has intervened in a whistleblower lawsuit against Methodist Le Bonheur Healthcare (MLH) in Memphis, Tennessee,...more
The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more
2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more
Digital Health Companies Look Toward IPOs as M&A Stabilizes - Digital health funding in 2019 suggests more companies will be looking to go public or be acquired in the coming years, according to a report from seed fund and...more
Outlook for This Week in the Nation's Capital - The 116th Congress. The 116th Congress, with 100 new members of the US House of Representatives (63 Democrats), convenes on Thursday, January 3, with Democrats returning to...more
Administration - Trump Administration Announces HRA Regulatory Proposal to Prevent Adverse Selection - The Trump administration announced a regulatory proposal to permit employees to go to the individual market to...more
Outlook for This Week in the Nation's Capital - Farm Bill Re-vote? Last week’s vote on the farm bill failed after the Freedom Caucus refused to support the measure. A roll call vote on the motion to reconsider was postponed...more
Outlook for This Week in the Nation's Capital - Farm Bill. The House is trying to move its bill to reauthorize farm programs this week but it’s unclear at this point if it will have the votes to pass....more
Congress returned from its spring recess with a host of issues to address—trade, Trump administration nominations and opioid legislation sitting atop the priority list. Given the ongoing data scandal at Facebook, privacy...more
Another Continuing Resolution. Or Two? Within days of passing the CR to reopen the government, multiple Members of Congress expressed the possibility of needing another CR to fund the government after February 8. ...more
Uncertain. What better word to describe a year in which a new administration came to power and began to chart a new course for health policy, the fate of the Affordable Care Act (ACA) hung in the balance, and courts grappled...more
Another short-term continuing resolution is all but guaranteed as the current continuing resolution will expire later this month and budget talks last week did not result in a deal or hint at one in the near future. As the...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
The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
Review of 340B Program Omnibus Guidelines Extended – Last week, the White House Office of Management and Budget (OMB) posted that the review of the 340B Program Omnibus Guidelines had been extended. The Health Resources and...more