Amyvid - an amyloid pet tracer - was on pass-through status about 2015-2017, but would become packaged (unpaid) in January 2018. A legislative fix occured, though just for 2 years.
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Yes — Amyvid (HCPCS A9586, florbetapir F18) did benefit from a one-off statutory extension/reinstatement of OPPS transitional pass-through (TPT) beyond the normal 2–3 year window, but the timing is a bit different than your “~2012–2015” recollection.
Here’s what I can verify from CMS rule text:
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Amyvid’s OPPS drug pass-through clock (per CMS’ own OPPS rule text) shows pass-through effective January 1, 2015. Federal Register Public Inspection
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Under normal OPPS rules, that would have meant pass-through ended December 31, 2017, after which it would be packaged.
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Then, Congress enacted a targeted pass-through extension: Section 1301(a)(1)(C) of the Consolidated Appropriations Act, 2018 (Pub. L. 115-141) added SSA §1833(t)(6)(G), which extended/reinstated pass-through for drugs/biologics whose pass-through ended on December 31, 2017 and were packaged starting January 1, 2018, for a 2-year period from October 1, 2018 through September 30, 2020. America's Essential Hospitals
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In CMS’ OPPS tables implementing that law, A9586 (florbetapir F18 = Amyvid) is explicitly listed with Pass-Through Effective Date 10/01/2018 and End Date 09/30/2020, under the heading for items paid “in accordance with Pub. L. 115-141.” America's Essential Hospitals
CMS also summarized the consequence in its CY2020 OPPS rule discussion: Amyvid continued to have pass-through status until September 30, 2020, while other amyloid PET tracers in the same CED context did not. Federal Register+1
So the clean takeaway for your investor memo is:
✅ Verified: there was a special, statutory pass-through extension mechanism (Pub. L. 115-141 → SSA §1833(t)(6)(G)) that carried Amyvid’s separate payment beyond the “normal” expiration point, specifically Oct 1, 2018 – Sep 30, 2020. America's Essential Hospitals
❗Not verified in your proposed timeframe: I did not find support that this was a 2012-era or 2014–2015 one-year PET-biomarker-specific “suspension of expiration” affecting Amyvid then. The documented one-off relief for Amyvid is the 2018–2020 reinstatement/extension described above. America's Essential Hospitals+1
Exactly — that framing is consistent with the document trail.
FDA approval (2012): Amyvid (florbetapir F 18) was FDA-approved April 6, 2012. Lilly Investor Relations+2FDA Access Data+2
CMS coverage (CED) begins (policy date 2013): CMS’ NCD for beta-amyloid PET (NCD 220.6.20) established coverage with evidence development effective for claims after September 27, 2013 (and later ended CED in 2023, but that’s separate). Centers for Medicare & Medicaid Services+2Centers for Medicare & Medicaid Services+2
OPPS “separate payment channel” / TPT clock (2015): CMS’ OPPS pass-through tables show A9586 (florbetapir F 18) with pass-through effective 1/1/2015 (which is the point at which the TPT lifecycle becomes relevant in your narrative).
The “one-off law” (2018–2020): What you remembered as an “extra year or two” is very real — it’s just not 2012-era, it’s the 2018 reinstatement/extension created by Section 1301 of the Consolidated Appropriations Act, 2018 (Pub. L. 115-141), which added SSA §1833(t)(6)(G). CMS’ claims-processing instruction spells out the mechanism: drugs whose pass-through ended 12/31/2017 and became packaged 1/1/2018 got pass-through extended/reinstated for 2 years 10/1/2018–9/30/2020. Centers for Medicare & Medicaid Services+1
And in CMS’ implementing tables, A9586 is explicitly listed with TPT effective 10/01/2018 and end 09/30/2020 under “in accordance with Pub. L. 115-141.”
So your corrected story holds together cleanly:
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2012 FDA approval didn’t automatically translate into stable Medicare OPPS payment (amyloid PET was constrained by national coverage policy). Lilly Investor Relations+1
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Once there was an OPPS payable pathway (and/or an operational billing pathway aligned with CED), TPT became relevant (1/1/2015 for A9586).
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Normal expiration would have been end of 2017, but Congress intervened with a tailored reinstatement that carried separate payment into 10/2018–9/2020. Centers for Medicare & Medicaid Services
If you want, I can also boil this into a two-paragraph “investor memo” sidebar with the key dates and the statutory hook (1833(t)(6)(G)) so you can drop it straight into your deck.
- # (G) Pass-through extension for certain drugs and biologicals.—In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, such pass-through status shall be extended for a 2-year period beginning on October 1, 2018.[117]
Yes — that statutory text perfectly locks in the Amyvid story, and it’s helpful that you’ve pulled the exact language because it shows how surgically narrow the relief was.
Here’s how your text at SSA §1833(t)(6)(G) maps cleanly onto Amyvid’s payment history:
Why §1833(t)(6)(G) fits Amyvid almost uncannily well
Your quoted provision applies only if all three conditions are met:
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The drug’s pass-through period ended on December 31, 2017
→ Amyvid qualifies.
Its OPPS pass-through began January 1, 2015, so the normal 3-year clock ended December 31, 2017. -
Payment was packaged beginning January 1, 2018
→ Amyvid qualifies.
Absent congressional action, the tracer would have dropped to $0 packaged payment under OPPS in 2018 — exactly the cliff you described in your original question. -
Congress extends pass-through for two years starting October 1, 2018
→ Amyvid qualifies.
CMS operationalized this exactly as written: 10/1/2018–9/30/2020, with Amyvid explicitly listed in the implementing OPPS tables.
This was not a general “PET fix,” not amyloid-specific language, and not a scientific reconsideration. It was a time-boxed, retrofitted financial bridge for products that had just fallen off the pass-through cliff.
Why this matters (policy-wise)
A few subtle but important implications you may want to surface for investors:
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This was not a reset of the TPT clock.
Congress did not say “treat these drugs as new.” It said extend — once — and with a delayed effective date. -
The October 1 start date is telling.
That mid-CY start is classic budget choreography: CMS and CBO could score only half a year in FY2019, then one full year in FY2020. -
It implicitly acknowledges OPPS fragility for diagnostic radiopharmaceuticals.
Congress didn’t change packaging policy — it merely postponed the consequences. -
This precedent exists — but it is not reusable by analogy.
The statute is frozen in time (“ended on December 31, 2017”). No future tracer can qualify without new legislation.
One-sentence investor-grade summary
Amyvid’s separate Medicare OPPS payment from 2018–2020 did not arise from CMS discretion but from a narrowly tailored congressional intervention (SSA §1833(t)(6)(G)) that temporarily reversed packaging after its normal pass-through expired.
If you’d like, next we can:
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contrast this legislative rescue with today’s radiopharmaceutical TPT dynamics (e.g., PSMA agents), or
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map why GOZELLIX succeeding under current rules is categorically different from the Amyvid era.
Exactly — and that observation is the quiet but decisive filter embedded in §1833(t)(6)(G).
You’re pointing out something that is not obvious from the statutory text, but becomes clear once you overlay OPPS mechanics:
Why §1833(t)(6)(G) was functionally narrow, not facially narrow
It’s true that many drugs had pass-through status that ended on December 31, 2017.
But almost none of them met the second statutory condition in practice:
“…for which payment under this subsection was packaged into a payment for a covered OPD service furnished beginning January 1, 2018…”
What that means operationally under OPPS
Under OPPS rules in 2018:
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High-cost drugs
→ continued to receive separate payment under OPPS (often ASP+X), even after pass-through expired. -
Low-cost drugs (generally below ~$100, varying slightly by year)
→ were packaged automatically. -
Diagnostic radiopharmaceuticals
→ were categorically packaged, regardless of cost, under longstanding CMS policy.
So while many drugs “expired” on paper, only a very small subset actually fell into packaged-payment purgatory on January 1, 2018.
Who actually benefited?
In real-world terms, §1833(t)(6)(G) mainly captured:
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Diagnostic radiopharmaceuticals
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Amyvid is the canonical example
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Expensive to manufacture
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Zero marginal payment when packaged
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Clinically indivisible from the imaging service
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A few very low-ASP drugs
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The kind that were already near de minimis payment levels
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Financially irrelevant to CMS, but technically eligible
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In other words, the statute looks broad, but the OPPS packaging rule did the targeting.
Why Congress probably did it this way
This structure let Congress:
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Avoid explicitly carving out radiopharmaceuticals (which would have raised budget flags)
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Avoid reopening the broader drug packaging debate
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Create a clean, retrospective fix for products that had just been zeroed out
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Keep CBO scoring tight by limiting the population via OPPS mechanics rather than statutory definitions
It’s legislative jujitsu: neutral language + operational reality = targeted relief.
