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1 month ago | 
mondaq.com | Erin Estey Hertzog |Ross Margulies |Adam Finkelstein |Patrick Brennan
On May 12, CMS released draft guidance outlining how the agency willimplement negotiation under the Inflation Reduction Act's (IRA)Medicare Drug Price Negotiation Program (the "Program")for initial price applicability year (IPAY) 2028. The guidance alsosets expectations for manufacturers and dispensing entities toeffectuate negotiated Maximum Fair Prices (MFPs) in IPAY 2026,2027, and 2028 and potentially renegotiate for IPAY 2028 the MFPsinitially negotiated for IPAY 2026 or 2027.
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Jan 28, 2025 | 
mondaq.com | Ross Margulies |Alexander Somodevilla |Steven Chen
Dyslexia is a neurobiological disorder affecting up toone in five children, including over 80% of those with learningdisabilities.1 Despite its widespreadprevalence, many children are not properly screened or tested andoften miss out on evidence-based interventions to address theassociated challenges.
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Jan 28, 2025 | 
mondaq.com | Steven Chen |Ross Margulies |Alexander Somodevilla
Dyslexia is a neurobiological disorder affecting up toone in five children, including over 80% of those with learningdisabilities. Despite its widespread prevalence, manychildren are not properly screened or tested and often miss out onevidence-based interventions to address the associated challenges.
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Nov 28, 2024 | 
jdsupra.com | Haider Andazola |Ross Margulies
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments.
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Nov 22, 2024 | 
mondaq.com | Ross Margulies |Haider Andazola
On November 12, Johnson & Johnson (J&J) filed suit
against the Health Resources and Services Administration (HRSA) in
D.C. federal district court, arguing that the 340B statute
explicitly provides flexibility for manufacturers to decide how to
offer 340B pricing, either through upfront discounts or
post-purchase rebates, and that HSRA has not prohibited such an
arrangement through its agreement with manufacturers (known as the
Pharmaceutical Pricing Agreement (PPA)).
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Nov 8, 2024 | 
jdsupra.com | Erin Estey Hertzog |Ross Margulies
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments.
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Oct 16, 2024 | 
jdsupra.com | Patrick Brennan |Erin Estey Hertzog |Ross Margulies
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments.
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Jul 4, 2024 | 
mondaq.com | Andrew London |Ross Margulies |Beth Neitzel |Marilyn Icsman
FH
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Foley Hoag provides innovative, strategic legal services to public, private and government clients. We have premier capabilities in the life sciences, healthcare, technology, energy, professional services and private funds fields, and in cross-border disputes. The diverse experiences of our lawyers contribute to the exceptional senior-level service we deliver to clients.
On June 28, 2024, in Loper Bright Enterprises v.
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Jun 12, 2024 | 
mondaq.com | Ross Margulies |Kian Azimpoor
Most health-care entities—including drug and device
manufacturers, payers, and providers—have multiple touch
points with federal regulation. The US Department of Health and
Human Services (HHS) is both a direct regulator of the health-care
products and services available to the public (such as through the
Food and Drug Administration) and the nation's largest
purchaser of health care (most notably through the Medicare
program).
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Jun 4, 2024 | 
law360.com | Ross Margulies |Andrew London |Patrick Brennan
By Ross Margulies, Andrew London and Patrick Brennan (June 4, 2024, 2:09 PM EDT) -- On May 21, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in the consolidated cases of United Therapeutics Corporation v. Carole Johnson and Novartis Pharmaceuticals v. Carole Johnson, holding that the Section 340B drug pricing program does not prohibit drug manufacturers from imposing contract pharmacy restrictions.... Law360 is on it, so you are, too.
