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Hot Topics in International Trade A Year in Review (Quickly)
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more
On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more
On March 20, 2025, House Republicans passed the “Big Beautiful Bill” (BBB) as part of H.R. 1, a sweeping legislative package that includes dramatic rollbacks of many of the clean energy tax credits established under the...more
On May 22, 2025, the House of Representatives passed its reconciliation bill, H.R. 1, entitled “One Big Beautiful Bill Act” (the “legislation”), which significantly amends the clean energy provisions that were enacted as part...more
On May 13, the House Ways and Means Committee voted to approve a $3.8 trillion tax bill that would make permanent much of the 2017 Tax Cuts and Jobs Act. The bill then moved to the House Budget Committee, where it was merged...more
Welcome to the May 2025 edition of Plugged In! As tariffs continue to dominate headlines—and create headaches—in the auto world, Mark Heusel and Hezi Wang offer a Tariff Tracker to help businesses navigate the ever-shifting...more
On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more
With a total funding of $396 million, the Reducing Industrial Sector Emissions in Pennsylvania (RISE PA) Program's goal is to significantly reduce greenhouse gas (GHG) emissions and co-pollutants from Pennsylvania's...more
The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
Welcome to Industrials Regulatory News and Trends. In this regular bulletin, DLA Piper lawyers provide concise updates on key developments in the industrials sector to help you navigate the ever-changing business, legal, and...more
The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more
Four drug manufacturers have announced plans to offer discounted drug prices to safety net providers under the federal 340B program via rebates instead of upfront discounts, despite the federal government’s position that...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
The Inflation Reduction Act of 2022 added the Section 45X Advanced Manufacturing Production Credit (Section 45X) to the Internal Revenue Code of 1986, as amended. Section 45X provides a credit against federal income tax for...more
On October 24, 2024, the US Department of Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) released final regulations (the “Final Regulations”) on the Section 45X Advanced Manufacturing Production Credit of the...more
The U.S. Department of the Treasury and IRS on Oct. 28, 2024, published final regulations regarding the Section 45X Advanced Manufacturing Production Credit of the Internal Revenue Code (Final Regulations)....more
On October 24, the Treasury Department (Treasury) and the Internal Revenue Service (IRS) issued final regulations (Final Regulations) on the Advanced Manufacturing Production Credit (Section 45X Credit), pursuant to Section...more
The Internal Revenue Service (“IRS”) and Department of the Treasury last week released final regulations (the “Final Regulations”) relating to the advanced manufacturing production tax credit under Section 45X (“45X Credits”)...more
The Department of Treasury and the Internal Revenue Service ("IRS") issued final regulations regarding the advanced manufacturing production tax credit....more
The 2024 U.S. presidential election is shaping up to be one of the most uncertain and unpredictable in history. The future and overall success of the U.S. Department of Energy's once-in-a-generation clean energy investments...more