The Finn Sawyer Access to Cancer Testing Act amends the Social Security Act to require Medicare, Medicaid, and CHIP to cover specified cancer diagnostic and laboratory tests — defined to include microarray, DNA/RNA sequencing, whole‑exome and other next‑generation sequencing (NGS), plus their clinical interpretation — when furnished to an individual diagnosed with cancer. It also directs HHS to run an education and awareness program about genomic testing for clinicians and the public.
The bill matters because it converts an often‑uncertain payer landscape for tumor genomic profiling into explicit statutory coverage for federal programs, prescribes limits on frequency, and fixes a Medicare payment rule. That combination could materially change uptake of molecular testing, the revenue outlook for clinical labs, and how oncology teams plan testing and treatment.
At a Glance
What It Does
The bill adds a new statutory definition for 'cancer diagnostic and laboratory tests' and requires Medicare to cover them subject to frequency limits; it amends payment rules so Medicare pays a set share relative to existing lab payment formulas and waives the beneficiary deductible for these tests. Medicaid is required to include the tests as medical assistance and benchmark plans must add them by 2027; CHIP coverage begins in 2025 for targeted populations. HHS must run an education program, in coordination with NHGRI, and promote GME/CME training in molecular diagnostics.
Who It Affects
The law targets clinical laboratories that perform NGS and other molecular diagnostics, oncology clinicians who order and interpret those tests, Medicare and Medicaid program administrators (and state Medicaid programs), and pediatric and low‑income patients covered through CHIP/Medicaid. Academic and commercial labs that supply sequencing and interpretation services will be directly affected.
Why It Matters
It eliminates statutory ambiguity about federal coverage of tumor sequencing and interpretation, creating predictable program obligations and a baseline reimbursement approach. That predictability can accelerate adoption of precision oncology but also shifts cost and utilization risk onto federal and state health programs.
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What This Bill Actually Does
The bill creates a new category in the Social Security Act for 'cancer diagnostic and laboratory tests' and explicitly lists microarray analysis, DNA sequencing, RNA sequencing, whole‑exome sequencing, other next‑generation sequencing methods, and the clinical explanation or interpretation of those results. Coverage is limited to individuals who have been diagnosed with cancer; the statute ties coverage to the clinical context rather than to specific technology brands or proprietary tests.
For Medicare, the bill instructs coverage of those tests once the provision takes effect (the statute schedules Medicare coverage to begin a fixed period after enactment) but places three frequency limits: one test at initial diagnosis, one test at any recurrence, and additional tests only 'as necessary' for treatment planning or monitoring response/progression. The bill also amends Medicare payment law so that payment for these tests equals 80 percent (or 100 percent for assignment‑related billing) of the lesser of the provider’s charge or the hypothetical amount that would have been paid under the diagnostic laboratory fee schedule rules; it removes the beneficiary deductible for these tests.For Medicaid, the act adds the tests to the statutory definition of medical assistance and makes them a mandatory covered benefit, requires benchmark plans to include them beginning January 1, 2027, and provides a delayed compliance window for states that need legislative action to conform their plans.
CHIP is required to cover these tests for targeted low‑income children (and pregnancy‑related assistance for targeted low‑income pregnant women where applicable) beginning January 1, 2025. Separate from coverage and payment changes, the bill directs HHS, coordinated with the National Human Genome Research Institute, to run an education and awareness program for physicians and the general public about genomic testing, and to encourage inclusion of molecular diagnostics training in graduate medical education and continuing medical education for oncology clinicians.Operationally, implementation will require CMS rulemaking or subregulatory guidance to define coding, billing, and what qualifies as 'as necessary' monitoring; it will also require states to update Medicaid plans and benchmark plan designs.
The combined statutory changes move federal programs from a posture of case‑by‑case coverage determinations toward consistent baseline coverage for tumor profiling and interpretation services that inform targeted therapies and clinical trial eligibility.
The Five Things You Need to Know
The bill creates a new statutory definition (section 1861(nnn)) that explicitly covers microarray analysis, DNA sequencing, RNA sequencing, whole‑exome sequencing, other next‑generation sequencing, and their clinical explanation/interpretation when furnished to someone diagnosed with cancer.
Medicare coverage is limited by frequency: one test at diagnosis, one at recurrence, and additional tests only when necessary for treatment planning or monitoring response or progression.
Medicare payment for these tests is set at 80% (or 100% for assignment‑related payments) of the lesser of the laboratory’s actual charge or the amount that would have been paid under the clinical diagnostic laboratory fee schedule rules; the beneficiary deductible does not apply.
Medicaid is required to treat the tests as medical assistance and include them in mandatory coverage, and benchmark plans must include coverage beginning January 1, 2027 (with a statutory safe harbor for states needing enabling legislation); CHIP must cover the tests for targeted low‑income children (and applicable pregnant women) starting January 1, 2025.
HHS, in coordination with the National Human Genome Research Institute, must run an education and awareness program for physicians and the public on genomic testing and promote incorporation of molecular diagnostics training into GME and CME for oncology.
Section-by-Section Breakdown
Every bill we cover gets an analysis of its key sections.
Short title
Designates the bill as the 'Finn Sawyer Access to Cancer Testing Act.' This is the only formal naming provision and has no operational effect beyond the title.
Adds statutory definition and mandates Medicare coverage
Amends section 1861 to add a new subsection (nnn) that defines 'cancer diagnostic and laboratory tests' to include NGS modalities and interpretation furnished to individuals diagnosed with cancer. It then inserts coverage for these tests into the definition of covered services so Medicare recognizes them as payable items. This change converts tests that were often handled through local coverage determinations and contractor policies into an explicit covered category under the statute.
Sets frequency limits, modifies payment rules, and waives deductible
Specifies frequency rules: coverage generally once at diagnosis, once at recurrence, and otherwise as necessary for planning or monitoring. Amends section 1833 to prescribe payment methodology: Medicare pays 80% (100% assignment) of the lesser of actual charge or what would have been payable under section 1834A if the test were a standard clinical diagnostic lab test. It also amends 1833(b) to exclude these tests from the beneficiary deductible and adjusts exclusions in 1862(a)(1) to permit denial when tests are performed more frequently than allowed. Practically, this creates a statutory floor for reimbursement but leaves details—coding, fee schedule comparators, and determinations of 'necessary' repeats—to CMS implementation.
Makes the tests a mandatory Medicaid benefit and sets benchmark timing
Adds the tests to the list of medical assistance items in section 1905(a) and makes coverage mandatory under section 1902(a)(10)(A). It requires benchmark plans to include coverage starting January 1, 2027, and provides a delayed compliance window for states that need enabling legislation—protecting states from being out of compliance while they enact implementing law. States will need to update their plans, establish payment approaches consistent with federal law, and determine whether to adopt the Medicare payment methodology or another reasonable approach within federal rules.
Requires CHIP coverage beginning Jan 1, 2025 for targeted populations
Adds a provision to section 2103(c) requiring that Child Health Insurance Program coverage include the defined cancer diagnostic and laboratory tests for targeted low‑income children beginning January 1, 2025; the mandate also applies to pregnancy‑related coverage for targeted low‑income pregnant women if the state offers that option. This creates an earlier federal coverage date for CHIP than for Medicaid benchmark inclusion and will require state CHIP administrators to update benefit specifications and provider communications.
Education and awareness program on genomic testing
Directs HHS, coordinated with the National Human Genome Research Institute, to develop and run an education and awareness program for physicians and the public about genomic testing and the role of genetic counselors. It also instructs HHS to encourage inclusion of molecular diagnostics training in graduate medical education and continuing education for oncology specialties. The statute does not appropriate funds; CMS and NIH program offices will decide delivery mechanisms, curriculum scope, and resource allocation during implementation.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- People with cancer covered by Medicare, Medicaid, or CHIP — gain clearer, statutory coverage for genomic tumor profiling and interpretation that can expand access to targeted therapies and trial eligibility.
- Clinical and commercial laboratories that provide NGS and interpretive services — receive an explicit federal coverage pathway that reduces reimbursement uncertainty and potentially increases test volume.
- Oncology clinicians and multidisciplinary tumor boards — get a more predictable payer response when ordering molecular profiling, simplifying clinical decision‑making and care planning.
- Pediatric cancer patients and pregnant women covered under CHIP — obtain earlier statutory protection (effective Jan 1, 2025) for access to genomic testing compared with Medicaid benchmark timing.
Who Bears the Cost
- Medicare program and federal budget — will absorb increased utilization and reimbursement obligations for covered tests, subject to the statutory payment limits.
- State Medicaid programs and state budgets — face added mandatory coverage obligations and potential increases in claims for expensive sequencing and interpretive services (the statute offers a compliance window but not funding).
- Clinical laboratories and hospital billing departments — must implement new coding, billing processes, and documentation practices to demonstrate when repeat testing meets the statutory 'necessary' standard, creating short‑term administrative costs.
- HHS and NHGRI program offices — carry responsibility for designing and running the education program without a specified appropriation in the bill, which could strain existing resources or require reallocation.
Key Issues
The Core Tension
The bill trades the certainty of statutory coverage for the hard choices of defining clinical necessity and containing costs: it encourages wider use of tumor genomic testing to improve personalized care, but leaves payers and regulators to draw the line between appropriate, beneficial use and overuse—a decision that pits patient access and innovation against program sustainability and safeguards against low‑value testing.
The bill settles a key coverage question by statute but leaves critical operational decisions to HHS and CMS. 'As necessary for planning or monitoring' is clinically sensible language but legally vague: CMS will need to set standards for documentation, permissible intervals, and how clinical judgment interacts with utilization management. Without clear, narrowly tailored guidance, contractors or plans could impose rigid prior authorization or deny claims, undermining the law’s intent.
The payment approach—80% (or 100% assignment) of the lesser of actual charge or a hypothetical 1834A amount—creates practical tensions. If CMS’s comparator under 1834A understates the resource needs of complex NGS plus interpretation, labs may be paid well below current commercial rates, prompting shifts in pricing strategies, consolidation, or selective contracting.
Conversely, generous actual charges could raise program spending, driving stricter utilization controls. For states, the mandatory Medicaid coverage and benchmark inclusion mean fiscal pressure; the statutory grace period for state law changes delays immediate compliance but not the long‑term budget impact.
Finally, the education program addresses supply‑side barriers (clinician knowledge, genetic counselor availability) but will not, by itself, solve workforce shortages or interpretive capacity constraints. Without parallel investments in workforce development and infrastructure (for example, interpretation pipelines, standardized reporting), increased coverage could strain clinical workflows and produce variable test utilization and quality across regions.
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