Category Archives: Advocacy and Regulations

NIH Announces New Indirect Cost Rates of 15%

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NIH announced on February 7, 2025 that effective Monday, February 10, 2025,  “In accordance with 45 CFR 75 and its accompanying appendices, this Guidance implements and makes publicly available NIH’s updated policy deviating from the negotiated indirect cost rate for new grant awards and existing grant awards, effective as of the date of this Guidance’s issuance. Pursuant to this Supplemental Guidance, there will be a standard indirect rate of 15% across all NIH grants for indirect costs in lieu of a separately negotiated rate for indirect costs in every grant.”

Read Notice Number NOT-OD-25-068 for more information.Continue reading→

Finance Committee Members Introduce Bipartisan Legislation to Ensure Medicare Patients’ Access to Cancer Detection Technologies

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Washington, D.C.–U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), with Ranking Member Ron Wyden (D-Oregon) and Finance Committee member Tim Scott (R-South Carolina), reintroduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act that would ensure Medicare beneficiaries’ access to cutting-edge tests capable of detecting multiple types of cancer before symptoms appear. Bipartisan companion legislation (H.R. 842) was also introduced in the U.S. House of Representatives. Continue reading→

The Corporate Transparency Act – Is it on Life Support?

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In Texas Top Cop Shop, Inc. et al. v. Merrick Garland, a U.S. District Court in Texas has issued a potentially major setback to the continued application of the Corporate Transparency Act (CTA), which became effective on January 1, 2024. The CTA was passed in 2021 to help gather information to assist in the support of anti-money laundering and anti-terrorism investigations and enforcement of related laws. However, the CTA required onerous reporting requirements for companies, while providing exceptions for large entities. The anticipated impact of the CTA on investment entities, small businesses, and other complex structures related to corporate governance was considered significant.Continue reading→

AdvaMed Welcomes Bipartisan Senate Bill to Expedite Medicare Coverage of Breakthrough Medical Technologies, Diagnostic Tests

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Washington, D.C. – AdvaMed, the Medtech Association, today welcomed introduction in the U.S. Senate of bipartisan legislation to expedite Medicare coverage of FDA-“breakthrough”-designated medical technologies and diagnostic tests. The legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Sen. Todd Young (R-IN) and Sen. Alex Padilla (D-CA), is similar to H.R. 1691, which the U.S. House of Representatives Ways and Means Committee passed on a bipartisan basis in June.  Continue reading→