This nerdy blog compares the new 21CC proposal (which is stated to be only a draft for comment), prior bill HR5333, and MCIT. To cut to the chase, I report on 5 points.
NOTABLE
* MCIT had no "new benefit category" creation, but HR333 and 21CC do. But, doing this raises some odd nerdy problems if it is tied to one unique index device.
* MCIT had no numerical limitation, and neither does 21CC. However, HR5333 had a numeric limit of 5.
* MCIT had no coverage & evidence requirements, but these are prominent in HR5333 and 21CC.
TRIVIA
* MCIT had a two year lookback, but 21CC had a hard date of March 2021.
* MCIT was for a life of four years, 21CC/HR5333 for 3 years after a payment change is implemented.
* 21CC/HR5333 allow breakthrough lab tests to be paid higher than fee schedule rates, but no obligation, targets, or rules for this.
Status Quo Now
Medicare coverage is currently "in place" - inscribed in the Code of Federal Regulations - per January 2021 final rule. However, it is "stayed" (delayed) until December 2021 per a May rule.
See 86 FR 2987, January 14, 2021, creating regulation at 42 CFR 405.601-607.
Brief Description for 21CC Version 2 (June 2021)
Section 404. Coverage and payment for Breakthrough Devices under the Medicare Program.
Working with Reps. DelBenes (D-WA) and Bilirakis (R-FL) to include the Ensuring Patient Access to Critical Breakthrough Products Act. This policy would codify current Medicare coverage of innovative technology (MCIT) at CMS.
Status of Critical Breakthrough Act
See December 2019, HR 5333.
https://www.congress.gov/bill/116th-congress/house-bill/5333?s=1&r=3
Congressional summary as,
The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a three-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary.
The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).
HR 5333 had a limitation that "no more than 5 devices" would be covered and paid under the rule [at (a)(2)]. Coverage began on the approval day and ends 3 years after CMS updates the relevant payment system.
CMS could require additional data, to be planned no longer than 1 year after the FDA approval, and such data minimizing burden and not duplicative of any required FDA trials.
Coverage had to be "proposed" for what would occur after the 3 year period (not just passive). Payment after three years followed applicable rules, "taking into account additional data and evidence collected." Note that CMS payments generally are unrelated to medical evidence (e.g. based on invoices, costs, or time, not on quality of clinical trials.)
There is a specific remark that additional amounts may be paid [(d)(3)(D)] for clinical laboratory tests relative to fee schedules, perhaps recognizes that clinical laboratory tests are often paid based on generic fee schedules (e.g. 81415, exome test, $4780). However, there is no word as to what such an additional amount ought be or if it was voluntary for CMS.
The proposal defines "specified breakthrough products" as a term of art of breakthrough products with no benefit category under Medicare. "The term ‘specified breakthrough device’ means a breakthrough device with respect to which no Medicare benefit category exists." [at (e)(1)]. Since devices with no benefit category likely have no payment modality or rules, the bill states:
The Secretary may use methodologies under existing payment systems established under this title, may provide for appropriate adjustments to such methodologies, or may establish a new payment methodology under this title, to provide for payment for a specified breakthrough device to ensure the payment basis for such payment covers costs of the specified breakthrough device are covered by such payment.
Coverage (and payment) for a breakthrough device can continue after the 3 year period if it is shown to:
(1) improve quality of outcomes, OR, (2) improve the delivery of care, OR, (3) reduce spending without lowering quality of care.
Regarding the option to form, during this process, a "new payment methodology." CMS has wrestled with payment methodologies for AI-based services already. See an interesting discussion that occurred in a RAND-sponsored white paper on defects in the current RVU pricing system (here). For example, CMS was concerned that if they paid $50 per-click license fees (for software) as a practice expense, it would trigger indirect costs (for nurses, for rent) that don't exist.
Note the legislation around breakthrough devices seems to assume they will have higher prices than existing products; for example, if a DRG was built around a $2000 product and a BT device was better but cost $1000, the rules seem to fall apart as regards payment, or might even require lower payment if read strictly, carved and set to the device cost, but the coverage would still be required.
Comparison of 21CC and MCIT and 5333
In the lay summary, 21CC is billed as enacting into law MCIT. However, there are a range of provisions in 5333, not found in MCIT, which are used. In addition, there is at least one notable change from 5333.
MCIT versus both 21CC and 5333
With regards to MCIT, that regulation at 405.601-7 was very short, and simply provided 4 years of coverage for BT devices from the day of FDA approval and per the indicated use allowed by FDA. Any existing payment rules would apply - period. There was no provision for BT devices outside a benefit category, they were null under MCIT. There was no required data (which CMS can require under 5333 and 21CC) and there was nothing in the MCIT rule about CMS planning for and acting toward the post-coverage period.
MCIT had a two-year lookback period (if half the four-year period was still viable, the MCIT device was covered). 21CC is for devices after March 15, 2021.
21CC vs 5333
The most notable difference is that HR5333 had a "limitation on number" near the top of the bill, limiting devices to know more than 5. This is simply deleted from 21CC. Yay.
The Odd World of "Specified Devices" = Those Without Benefit Category
The same oddity occurs in HR5333 and 21CC. There is explicit coverage for devices that have no benefit category (and text regarding the need to whip up a payment system on the fly for the same). This coverage (i.e. this de novo benefit category" can be extended infinitely if the device improves quality, as described above. However, the benefit category train track appears to apply ONLY to the SPECIFIC device approved in the breakthrough pathway. If the company later updates to a new model, not under BT approval, the benefit category status appears to be lost. Let's say 3 or 4 companies enter that category, and create even better and more effective devices, but not BT devices any more. They wouldn't be covered under the benefit category, since it seems to be verbally tied specific to only the index first breakthrough device. If this power to create a benefit category is kept in the legislation, this section needs some careful thought and revision.
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It's probably too nerdy to worry about, but MCIT clearly included diagnostics in its final version (January 2021). HR5333 and 21CC refer early on to being valid for devices "approved or cleared for use in treating an indication." Since sometimes regulatory text carefully discusses "treating or diagnosing" a disease as two different things, this HR5333 phrasing might be interpreted by a overtrained policymaker as meaning only therapeutic devices not diagnostic ones. This wouldn't be consistent with HR5333/21CC as a whole, since it has explicit sections on payment rules for clinical lab tests.
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