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1 week ago | 
jdsupra.com | Shoshana Golden |Stephanie Trunk
There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota. As PDABs march toward declaring the price of certain drugs to be unaffordable for state residents and establishing a maximum price or reimbursement for certain drugs in their states, some pharmaceutical manufacturers have begun to challenge the constitutionality of PDABs in court.
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1 week ago | 
afslaw.com | Stephanie Trunk |Shoshana Golden
On As PDABs march toward declaring the price of certain drugs to be unaffordable for state residents and establishing a maximum price or reimbursement for certain drugs in their states, some pharmaceutical manufacturers have begun to challenge the constitutionality of PDABs in court. In March, a federal court in Colorado tossed out one of these suits on the basis that the manufacturer lacked the requisite standing.
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4 weeks ago | 
jdsupra.com | Aida Al-Akhdar |Hillary Stemple |Stephanie Trunk
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s long-standing interpretation of the Anti-Kickback Statute (AKS).
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1 month ago | 
afslaw.com | Stephanie Trunk |Hillary Stemple |Aida Al-Akhdar
On In a ruling issued on March 31, a federal judge upheld the OIG’s interpretation of the AKS, which formed the basis for the agency issuing an unfavorable advisory opinion to Vertex Pharmaceuticals Incorporated regarding the company’s proposed fertility assistance program. The court’s ruling is the latest blow to the pharmaceutical industry’s efforts to narrow the scope of the AKS.
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1 month ago | 
afslaw.com | Stephanie Trunk
On Highlights of the conversation include:Evolving regulations for off-label pharmaceutical promotion. Enhancing a firm’s global footprint by building trust with sovereign governments. Examining new compliance challenges stemming from AI technology. Navigating US Food and Drug Administration guidance as an unreliable indicator of enforcement priorities. Increasing scrutiny of the role of medical affairs. Finding balance between patient access and regulatory compliance. Contacts
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Nov 24, 2024 | 
mondaq.com | Stephanie Trunk
This past July, we reported on the Centers for Medicare &
Medicaid Services (CMS) release of the 2025 proposed Hospital
Outpatient Prospective Payment System (HOPPS) and Physician Fee
Schedule (PFS) rules. CMS has now released the 2025 final rules,
though they will not be published in the Federal Register for
several more weeks.
Our alert on CMS' release can be found here.
The HOPPS final rule can be found here, with a high-level summary in the CMS fact
sheet available here.
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Nov 22, 2024 | 
jdsupra.com | Shoshana Golden |Stephanie Trunk
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.
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Nov 21, 2024 | 
afslaw.com | Stephanie Trunk |Shoshana Golden
Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here. The PFS final rule can be found here, with the companion CMS fact sheet available here. Both rules are effective January 1, 2025. Below is an overview of the relevant provisions for pharmaceutical manufacturers and the pharma community.
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Nov 21, 2024 | 
natlawreview.com | Stephanie Trunk
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.
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Sep 3, 2024 | 
afslaw.com | Douglas Grimm |Stephanie Trunk |Shoshana Golden
On Drug Manufacturers Prevail on Appeal in Challenges to HRSA’s Efforts to Limit Contract Pharmacy ConditionsThe 340B Program provides certain health care organizations, referred to as “covered entities,” with access to discounted outpatient drugs from manufacturers. Many covered entities, lacking their own pharmacies, enter into agreements with outside pharmacies, or “contract pharmacies,” to dispense discounted drugs to patients.
