Policy News
CMS Finalizes Accelerated Approval Pathway for Devices
The Transitional Coverage for Emerging Technologies (TCET) pathway was finalized by the Centers for Medicare & Medicaid Services (CMS). It aims to provide Medicare beneficiaries with more timely access to new medical technologies. It also seeks to improve the quality of life for people with Medicare and encourage innovation. Medical devices must meet the following…
Read MoreBiosecure act Fails to be Enacted
The Biosecure Act missed its expected ride through the U.S. Congress when the Senate failed to include it in the National Defense Authorization Act. However, it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed Chinese “biotechnology companies of concern.” The U.S.…
Read MoreNo R&D Tax Amortization Relief
The Tax Relief for American Families and Workers Act of 2024, the $78 billion tax package passed by the House in January that would’ve restored full expensing under Internal Revenue Code Section 174 continued to be blocked by Senate Republicans through the end of session and thus died. The Senate’s failure to move forward the…
Read MoreLatest Bill Introduced That Threatens Ethical Animal Research
SB 1019, or “Queenie’s Law”, was recently introduced by Sens. Wojno and Polehanki, as a companion to 2023 legislation in the Michigan House as a response to research studies conducted at Michigan’s public universities. If enacted, public bodies, i.e., research institutions, would be prohibited from using “a dog for experimental purposes in a manner that…
Read MoreHouse Approves BIOSECURE Act
The U.S. House of Representatives recently passed HR 8333, commonly known as the BIOSECURE Act. The bill passed 306-81, far exceeding the two thirds vote required to pass. The text of this bill was unamended from the version approved by the House Committee on Oversight and Accountability in May (the “House bill”). Analysts have said…
Read MoreCMS Finalizes Expedited TCET Coverage Pathway
The Centers for Medicare & Medicaid Services (CMS) finalized a new Transitional Coverage for Emerging Technologies (TCET) Pathway to expedite Medicare coverage of some FDA-approved breakthrough products. Under this finalized pathway, eligible US Food and Drug Administration (FDA) designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for several years…
Read MoreFirst Drugs Subject to Inflation Reduction Act Price Provisions
The Centers for Medicare & Medicaid Services (CMS) announced recently the prices that they have set for the first 10 medications as an outcome of the Inflation Reduction Act’s drug provisions. For the first time, the law provides Medicare the ability to directly “negotiate” (in effect, set, as otherwise significant penalties are imposed) the prices…
Read MoreState Supports Establishing Innovation Evergreen Fund
A new $60 million Michigan Innovation Fund to help launch Michigan-based startups got the support of the Michigan legislature last month, as it was included in the $82.5 billion state budget lawmakers passed for the 2025 fiscal year. While the $60 million met most lawmakers’ expectations, three House representatives are sponsoring a pending bill package that would…
Read MoreEfforts Continue to Repeal Onerous R&D Amortization Rules
The Tax Relief for American Families and Workers Act of 2024 or HB 7204 was introduced that would, among other things, repeal current rules and allow a business to deduct of R&D costs in the tax year that they occur and thereby incentivize long-term investments in innovation. Such repeal has been a top policy priority…
Read MoreState R&D Tax Credit to be Reestablished
A package of bills that would reestablish a state research & development (R&D) tax credit in Michigan – HBs 4368, 5099, 5100, 5101 and 5102 – passed by the Michigan Senate in bipartisan fashion 22-13 on March 19, 2024. As proposed, taxpayers and authorized businesses with 250 or more employees could claim up to $2.0…
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