With the upcoming election, we are in the closing months of the 117th Congress. I think it's been record-setting for proposals related to precision medicine -- but far more proposals are introduced than pass. Remember that all of these legislative proposals either get passed or simply expire, at the end of this year.
Beyond "VALID," here is a brief legislative run-down.
VALID ACT
This is the most well-known legislative proposal, a wide-ranging revamp of FDA law for diagnostics and the lab industry. Basically, the core issue is that this legislation would give far more authority to the FDA For LDT tests. I think one big impact, rarely mentioned, is FDA control over LDT marketing claims. Another would be a shift to larger- and better-capitalized entrants and labs.
VALID has been talked about for about a decade in different forms. It has been tagged to the Senate version of FDA reauthorization, but not the House version, and the outcome is still up for grabs. This is still under active revision, but see also S. 2209 / HR 4128. See article at Health Affairs here. See a subscription Genomeweb article 8/2022, "VALID Act Divides Diagnostic World," here.
SALSA
This proposal, advocated by ACLA and others, would put new guardrails around the implementation of PAMA (CMS triennial surveys for lab pricing) such as surveys every 4 years, use of targeted surveys not complete reporting, and limits to annual price decrements. See the ACLA two-pager from June 2022 here. Introduced as S. 4449 / H.R. 8188.
Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
As S 1873, HR 1946. Would allow Medicare to cover multi-cancer screening tests if FDA approved. Introduced in 1H2021. June 2022 press release from Rep. Sewell here. Stakeholder website here.
Medicare: Reducing Hereditary Cancer Act
S.3656, HR 4110. Would allow Medicare patients to have appropriate hereditary cancer tests BEFORE they have a "personal history of cancer." Stakeholder webpage here at FORCE.
Medicaid, prenatal genetic screening "Expanded Screening Access Act"
Precision Medicine Answers for Kids Today Act (Pediatric intensive care genomics)
HR 5989. Genomic testing for Medicaid, pediatrics; esp. urgent hospital cases.
Right Drug Dose Now Act (Pharmacogenetics)
HR 6875. To update the National Action Plan for Adverse Drug Event Prevention to provide educational information on adverse drug events and pharmacogenomic testing, to improve electronic health records for pharmacogenomic information, and for other purposes.
Patent Eligibility Restoration Act of 2022
Numerous articles in the patent field say it's become nearly impossible to get diagnostic test patents due to court cases (precedents) in recent years. Including a federal appeals court CareDx diagnostics patent case at the beginning of the summer. I blogged about this and provided some links. In August 2022, Sen. Tillis introduced the Patent Eligibility Restoration Act S.4734. See a law firm discussion here and here. Changes to patent law are rare, but possible.
FIND Act: Medicare Bundling in (Imaging) Diagnostics
As S. 2609, HR 4479. FIND, Facilitating Innovative Nuclear Diagnostics. SNM-MI web page here, here. Both lab diagnostics and imaging diagnostics are subject to important bundling rules that can be counterproductive. Genomic tests, after an inpatient stay, are bundled for up to 14 days post discharge, a weird regulation that has no parallel in other rules. Imaging diagnostic tracers also have harsh bundling rules. In a hospital outpatient setting, Medicare pays for a PET scan, including a nominal amount for a tracer (e.g. $300 for FDG), and any more expensive tracer is simply "bundled." (In the Part B setting, the scan and tracer are two different line items). If passed, FIND would unbundle the radiologic tracer, which for some special applications, might cost $2000-3000.
STATE LAW: BIOMARKERS
Several states have passed, or are reviewing, biomarker legislation. This is a major focus of American Cancer Society's action fund, ACS/CAN. Legislation in Louisiana was specific to cancer biomarkers, requiring commercial payer coverage if they were FDA approved, under CMS NCDs, etc. Legislation in Illinois was similar, but NOT limited to cancer biomarkers (!). Similar legislation (broad type) recently passed Assembly and Senate in California, and awaits a yay or nay from the Governor.
See a representative press release from ACS CAN in June 2022, here. See an open access PDF article about the overall effort from The Cancer Letter 11/2021 here. See the ACS CAN resources page here. See, for one specific example, the California bill SB 912 here. See a Milliman report on state by state biomarker coverage, February 2022 here. See an analysis of SB 912 here.
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21st Century Cures Act 2.0
H.R. 6000, from Rep. DeGette, is 21st Century Cures Act 2.0 (2022), and contains an omnibus list of FDA and NIH changes. I have not studied this recently, and it's probably in flux, but I provide the link to H.R. 6000 here. See a short summary from January 2022 here. As drafted, it includes ARPA-H, the giant new proposal for a translational medicine institute.
