Author: WinWire
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White House Announces the Great Healthcare Plan
On January 15, 2026, the White House announced the Great Healthcare Plan. The plan calls on Congress to enact a comprehensive legislative package directed to lowering drug prices and insurance premiums. White House announcement: Fact sheet:
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CMS Publishes Proposed Medicare MFN Models
On December 23, 2025, CMS published notices of proposed rulemaking for the GLOBE (Medicare Part B) and GUARD (Medicare Part D) most-favored nation drug pricing models. Federal Register announcements: CMS announcements: Comments are due by February 23, 2026.
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BIOSECURE Act Becomes Law
On December 18, 2025, President Trump signed the BIOSECURE Act as part of the National Defense Authorization Act. The BIOSECURE Act provides that federal agencies may not contract with an entity that, in its performance of federal contracts, uses “biotechnology equipment or services” from a “biotechnology company of concern.” A company is considered a “biotechnology…
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CMS Announces IRA Prices for IPAY2027
On November 25, 2025, CMS announced the “maximum fair prices” for the second year of Medicare price controls under the Inflation Reduction Act. The prices will take effect on January 1, 2027.
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New Study Confirms IRA’s Impact on R&D
A recent study by the National Pharmaceutical Council examining the impact of the Inflation Reduction Act on oncology R&D found that the number of industry-sponsored, post-approval small molecule trials dropped by 45.3% and the number of biologic trials dropped by 32.5% after the IRA entered into force. The study reinforces how the IRA disincentivizes innovation…
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Supreme Court opinion in Kennedy v. Braidwood Management, Inc.
On June 27, 2025, the Supreme Court rejected a challenge to the appointment of the members of the U.S. Preventive Services Task Force. Under the Affordable Care Act, health insurers must cover certain preventative services recommended by the Task Force without cost sharing. Among the covered services are routine immunizations, breast cancer screening, colorectal cancer…
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President Trump Previews Pharmaceutical Tariffs
On April 8, 2025, President Trump stated that “very shortly” he is going to be announcing “major tariff on pharmaceuticals.” Industry observers expect that the tariffs will be imposed under Section 232 of the Trade Expansion Act of 1962 (19 U.S.C. §1862, as amended). Under Section 232, the Secretary of Commerce may conduct an investigation…