You Can Cure* Inpatient Psychiatry With this One Weird Open Comment Period
*The word "cure" is not intended to indicate the ability to treat any medical disease or condition. The word is used in jest as it relates to payment models only.
The TL: DR: Make a comment supporting SAINT depression treatment payment in hospitals here.
The marketers behind scams understand that we do not trust them. They build their arguments by taking mistrust into account.
When promising extraordinary weight loss with nonsense herbal supplements, they target our suspicion using terminology like “using this one weird trick.”
The assumption behind that phrase is that, for particularly credulous readers, who are the target audience for scam weight loss products, the concept that there may be just one thing they're missing is very appealing. Scammers have optimized their understanding of our mistrust. They acknowledge that the solutions is “weird” to assuage incredulity.
Most healthcare workers are justifiably even more mistrustful of extraordinary claims in the general public and are debatably less credulous.
If I were to tell you that inpatient psychiatry could be vastly better, and all you had to do was one thing, I imagine you would be justly skeptical.
But, What if…it was possible?
One Proposed Rule to Bring Them All Under the 2024 Inpatient Psychiatric Prospective Fee Schedule, and Bind Them… to Current Payment Models
For the roughly 1/4 of psych hospitals operating under the Medicare Inpatient Prospective Fee Schedule, the New Technology Add-On Payment (NTAP) offers an opportunity to get new tech paid for sooner than otherwise possible.
To qualify, the technology must meet three essential criteria:
Newness: A technology is considered new until claims data reflecting the use of the technology have become available (typically up to 3 years after Food & Drug Administration [FDA] approval). The technology must also not be “substantially similar” to any existing technology.
Remember that the MEDICARE CLAIMS DATA provides the data for when newness runs out…and it can not be “me-too” technology. In other words, it has to be very new technology, not the same stuff with a different name.
Cost: The technology must be determined to be inadequately paid under the existing MS-DRG system, meaning that the average standardized charge for inpatient cases using the technology exceeds the cost threshold.
To be clear, it needs to cost MORE than can be accounted for by existing payments.
Substantial Clinical Improvement: Use of the technology must significantly improve clinical outcomes for a specified patient population, compared to currently available treatments. Clinical data must be either specific to or generalizable to Medicare patient population.
This is likely to be the highest hurdle for new technologies. Specific data demonstrating clinical IMPROVEMENT in Medicare patients is a high bar, generally, and it is expensive on average to run these kinds of studies…
The two exceptions for the above are crucial to understanding:
First, devices that obtain breakthrough designation and drugs that accept qualified infectious disease product designation from the FDA need only meet the cost criterion because the CMS assumes that those products meet the newness and substantial clinical improvement criteria. I will define breakthrough criteria because it is so important here…like the DSM, there is Criterion A:
The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.
One of Four B Criteria required to qualify:
Represents Breakthrough Technology
No Approved or Cleared Alternatives Exist
Offers Significant Advantages over Existing Approved or Cleared Alternatives
Device Availability is in the Best Interest of Patients
Breakthrough Status is a pre-approval status, so demonstrating the above with the data needed at the pre-approval stage is a crucial first step for a med device on combination drug/device approaches when it comes to the amount of work (and associated capital expense) to qualify for NTAP) add ons.
This program has been around since 2001 for general medical care; the change in 2024 is that it can now apply to both General Medical care and Inpatient Psychiatric care (in the hospitals that are on the IPPS and not Per Diem contracts):
In 2001, CMS used its discretionary authority provided under the statute to issue regulations specifying a process and criteria for granting new technology add-on pay- ments (NTAP). The program definitions established by CMS provide that only new technologies meeting specific cost thresholds and demonstrating substantial clinical im- provement over existing services would qualify for an NTAP. CMS also established specific limits to the additional payments made under the NTAP program to ensure that the Medicare program and hospitals would share in the financial risk of providing costly new technologies.
It is built to share risk with hospitals.
It is also worth noting the payment is only for issues related to operating expenses, not capital expenses. Even if I had a wildly expensive crystal ball to cure all problems, it wouldn’t be covered under this program if it didn't incur additional operating costs. Sorry, Mordor:
In fairness, the newness criteria would also be difficult to prove in the above fantasy genre example.
The math matters here and is complicated, so the following is included to give general audiences a sense of the complexity of the math involved and specialists the info needed to get calculating:
A Real-World Use Case:
Implantable cardiac pacemakers came to market under this program…
Cardiac resynchronization therapy (bi-ventricular pacing)
Cardiac resynchronization therapy (CRT-D) was FDA approved on June 26, 2002. Cardiac resynchronization therapy is a therapy for chronic heart failure and pro- vides electrical stimulation to the right atrium, right ventricle, and left ventricle to resynchronize ventricular contractions and improve the oxygenated blood flow to the body. This technology combines cardiac resynchronization therapy with de- fibrillation for patients with moderate to severe heart failure who meet the criteria for an implantable cardiac defibrillator.1
This is now a standard device for people at risk of sudden cardiac death, and many lives have been saved. The lack of devices for severe mental illness that would require fancy work in hospitals? No NTAP for IPPS till now. The degree to which psychiatric innovation has been forced to outpatient settings that assume low acuity has been driven by the lack of this very payment model “bridge” mechanism.
Call to Action
Please go to CMS.gov and review the options for NTAP payments. There are 54 potentials this year! From the “4WEB Medical Ankle Truss System” to the “Ceribell Status Epilepticus Monitor” to the “MOSUNETUZUMAB is the international, non-proprietary name for the technology under consideration,” the contestants are showing their best.
There is only one device proposed under NTAP 2024 which has specific psychiatric relevance:2
Trade Name: SAINT Neuromodulation System
Regarding the applicability of NTAP to the novel milieu of a psychiatric hospital, only SAINT (a registered trademark of Magnus Medical, Inc.), to whom I am a paid consultant3 is relevant to inpatient care in a psychiatric hospital. It gets depression to remission in 5 days in 79% of patients.
We Should Pay for FDA Cleared Depression Treatment in 5 Days!
This is the link to submit a comment on the proposed rule.
I don’t love the federal government’s choice of “green,” from an accessibility standpoint, but the link is the green button that says “Submit a Formal Comment” (bottom right), as seen here:
We have learned the power of open comments thanks to the DEA. So make our voices heard, and leave your comment today!
Unlike traditional implantable cardiac de- fibrillators (ICD), CRT-D treats 1) the symptom of heart failure and 2) the high risk of ventricular arrhythmias, which would cause sudden cardiac arrest. Prior to CRT-D, patients would have only been able to receive therapy to treat one of the two risks mentioned above.
There is a delirium monitor from Ceribell, but that is CL Psych catching something missed on a general medical service, so I stand by my “one” statement.
I have a financial conflict of interest. I was not paid to write this article. I agreed to allow their team to read it before I click publish. I have included the correspondence below. I am not an equity holder in this company. I have deep and abiding emotional conflicts of interest in the success of SAINT that are much more significant to my biases than consulting revenue.
Here is the content of the email from Magnus Medical re: this column:
A couple of comments -
CMS defines newness as the date a product is commercially available on the market - most often right after FDA clearance or approval.
Two things about this paragraph
This program has been around since 2001 for general medical care; the change in 2024 is that it can now apply to both General Medical care and Inpatient Psychiatric care (in the hospitals that are on the IPPFS and not Per Diem contracts):NTAP was always available for Psychiatric Interventions in the IP setting of Acute Care Hospitals. This is just the first technology that has come along. It certainly will not be the last.
The abbreviation should be IPPS.
Same comment for this sentence - IPPS. No NTAP for IPPFS till now.
If you want to include a link to comment on any of the NTAPs - https://www.federalregister.gov/documents/2023/05/01/2023-07389/medicare-program-proposed-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals
It was good to see you in the office yesterday.”