In August 2020, the nation’s largest well being insurer, the Facilities for Medicare and Medicaid Companies (CMS), proposed its Medicare Protection of Revolutionary Applied sciences (MCIT), which supposed to supply nationwide Medicare protection on the identical day as Meals and Drug Administration (FDA) market authorization for breakthrough units. The Breakthrough Devices Program on the FDA accelerates the approval or clearance course of for sure medical units that present for simpler remedy or analysis of life-threatening or irreversibly debilitating illnesses or situations. Constructing on the Breakthrough Units Program, MCIT may have shortened the time to marketplace for breakthrough-designated units (BDD) that might meaningfully enhance sufferers’ lives.
After the transition to the Biden administration in November 2021, CMS repealed MCIT, one of many few useful Trump-era guidelines. However after sharp trade and supplier criticism, CMS introduced listening sessions to get suggestions on a alternative for MCIT referred to as Transitional Protection for Rising Applied sciences (TCET).
In a STAT article I (Andrey Ostrovsky) wrote final yr, I argued that MCIT may meaningfully assist get rid of disparities in remedy for Medicare beneficiaries and steadiness accountable continual illness administration with the necessity for social distancing within the Covid-19 period and past. Whether or not it’s referred to as MCIT or TCET, it’s crucial that CMS create an expeditious course of to cowl modern units that profit Medicare sufferers and shut well being fairness gaps, one of many essential priorities of the CMS administrator, Chiquita Brooks-LaSure.
We’ve performed an evaluation to assist CMS design TCET in order that it could actually cut back inequities in reimbursement for BDDs, particularly these targeted on mind well being, one of many essential priorities of President Biden in response to his State of the Union (SOTU) tackle.
To characterize and quantify the disparities towards mind well being within the approval and protection of BDDs, we carried out a Google seek for Expedited Entry Pathway (EAP) and BDDs starting in 2015 via March 2022. We aggregated the findings right into a spreadsheet and categorized the BDDs that had been FDA accredited or cleared, had been reimbursed by CMS, whether or not they had been digital therapeutics or diagnostics, whether or not they targeted on behavioral well being, and, as a comparator, whether or not they targeted on cardiac well being. As an exterior supply of validation, we referenced this checklist towards that of the Medical Gadget Producers Affiliation, with comparable outcomes.
Supply: Creator evaluation
To this point, 325 units have been granted breakthrough designation. This evaluation highlights that one of many challenges that MCIT was supposed to beat — the bottleneck of figuring out whether or not or not Medicare ought to cowl FDA cleared or accredited BDDs — shouldn’t be a lot of an obstacle to improvements reaching the market. Solely 34 of the 325 BDDs, or about 1 in 10, gained FDA market authorization. And the bulk, or 23 (67.6%) of the 34 BDDs with FDA market authorization, have Medicare reimbursement. There doesn’t look like a lot of a backlog of BDDs which have achieved FDA market authorization however failed to attain protection.
But a vital situation stays that TCET may resolve: There’s a rising disparity in reimbursement of 1 class of product versus one other and in reimbursing remedy and analysis of 1 illness state versus one other. Solely seven (20.6%) of the 34 BDDs with FDA market authorization are digital therapeutics or diagnostics. The one (2.9%) digital diagnostic that’s reimbursed is for a somatic or bodily situation, whereas the remaining digital therapeutic and diagnostics are usually not reimbursed and so they concentrate on behavioral well being or neurological specialties.
Supply: Creator evaluation
Digging deeper into the info, we discovered much more profound product class and illness state disparities. The overwhelming majority (19 of 20, 95%) of the FDA accredited or cleared BDDs which might be in somatic or bodily well being specialties for adults are reimbursed by Medicare. Solely one of many 20 (5%) of those units was a digital therapeutic or diagnostic and it was reimbursed.
In distinction, solely a fraction (4 of 13, 30.7%) of the FDA accredited or cleared BDDs which might be in behavioral well being or neurology specialties are reimbursed by Medicare. 5 of the 13 (38.5%) of those units are digital therapeutics or diagnostics and none of them are reimbursed.
5 out of 5 (100%) FDA accredited or cleared BDDs targeted on cardiology are reimbursed by Medicare. Zero out of 5 (0%) FDA accredited or cleared BDDs targeted on behavioral well being or neurology are reimbursed by Medicare. Put one other means, CMS is prioritizing therapeutic coronary heart valves over bolstering mind well being.
Digital therapeutics and diagnostics could allow sufferers and households to overcome barriers inherent to brick and mortar care reminiscent of transportation points, lengthy wait lists, and systemic racism amongst suppliers. CMS ought to make sure that breakthrough-designated digital therapeutics and diagnostics have an accelerated pathway to reimbursement via TCET in order that the rule doesn’t battle with the intent of the Mental Health Parity and Addiction Equity Act, the CMS Administrator Brooks-LaSure’s concentrate on closing well being fairness gaps, and President Biden’s SOTU cost to enhance mind well being.
For CMS to keep away from violating psychological well being parity legal guidelines and going towards its personal priorities, it might want to reconcile its historic critiques of MCIT. Most notably CMS leaders are concerned that underneath MCIT, CMS may have coated units with out satisfactory proof to deal with the Medicare inhabitants.
One technique to tackle Medicare-specific proof wants is to grant provisional protection and reimbursement for BDDs with FDA market authorization throughout the transitional protection interval whereas the producer develops extra proof particular to Medicare populations. This strategy might help steadiness equitable entry to care with the necessity for evidentiary assist.
CMS leaders’ considerations about MCIT’s proof limitations in Medicare populations convey up one other obstacle to this administration reaching its fairness targets. Industrial, Medicaid, and alternate insurance coverage carriers depend on Medicare protection determinations for a lot of of their very own medical coverage choices. Units that fail to get Medicare protection will lack the HCPCS codes wanted for protection with different payers. Which means that BDDs with FDA market authorization serving kids and adults underneath 65, particularly these in poverty, are systematically not getting coated.
To deal with the Medicare protection roadblock for business, Medicaid, and alternate insurance coverage carriers, CMS may create modifiers for HCPCS codes that designate which populations sure codes may very well be utilized to, reminiscent of pediatric populations and adults underneath 65.
Together with HCPCS code modifiers is probably not sufficient for TCET to handle CMS’s present protection disparities. TCET ought to name for the Heart on Medicare to enhance inner processes so that there’s extra experience and prioritization on mind well being and non-Medicare populations. With subject material specialists on these matters within the Heart for Medicaid and CHIP Companies (CMCS) and the Heart for Medicare and Medicaid Innovation (CMMI), TCET ought to require that leaders within the Heart on Medicare extra routinely collaborate with CMCS and CMMI leaders on protection determinations.
Regardless of all of those critiques, we now have to offer the Heart for Medicare credit score as a result of they did lastly open the door for digital therapeutics coding by approving the HCPCS Level II code A9291 for “Prescription digital behavioral remedy, FDA cleared, per course of remedy.” Nevertheless, Medicare nonetheless doesn’t reimburse this code and this code lacks the specificity wanted for many business insurers to systematically reimburse all mind well being targeted digital therapeutics.
Medicare additionally has made productive strides in offering reimbursement for the brand new CPT code 989X5 for “Distant therapeutic monitoring,” which may very well be utilized by some digital therapeutics for reimbursement. Nevertheless the reimbursement quantity is anemic and is usually restricted to musculoskeletal and respiratory indications.
This evaluation demonstrates that CMS’s protection processes exhibit product class and illness state disparities. These disparities contradict psychological well being parity statute, CMS Administrator Brooks-LaSure’s concentrate on fairness, and President Biden’s cost to enhance mind well being. TCET might help shut these gaps by granting provisional protection for BDDs with FDA market authorization with proof improvement, creating modifiers for HCPCS codes for non-Medicare populations, and requiring the Heart on Medicare to include specialists from CMCS and CMMI into protection determinations.