Every Claim We Publish, and Where It Came From
Every regulatory, legal, coverage and pricing claim on this site is a record with a source, a date, and a review deadline. All 46 of them are listed here, most urgent first. If a claim is overdue, the build that produced this page would have failed — so if you are reading it, nothing here is past its review date.
None of these are due for review in the next 30 days.
| Claim | Statement | Source | As of | Next review | Confidence |
|---|---|---|---|---|---|
dea.telehealth_flexibilityfederal | Through 31 December 2026, clinicians registered with the DEA may prescribe controlled medicines such as ketamine after a video telemedicine visit, without an in-person examination first. This is the fourth temporary extension. Each of the previous three was issued close to its expiry date, so the position may change late in 2026. | Drug Enforcement Administration Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities (90 FR 61301) | 1 Jan 2026 | 16 Oct 2026 | high |
dea.special_registrationfederal | The DEA's proposed rule to create a special registration for prescribing controlled medicines by telemedicine, published on 17 January 2025, is still only a proposal and has not been finalised. No final rule and no withdrawal notice has been published. A rule can also be shelved without a formal withdrawal, so this should not be read as a statement that the DEA intends to finalise it. | Drug Enforcement Administration Special Registrations for Telemedicine and Limited State Telemedicine Registrations (Proposed Rule, Docket DEA-407) | 17 Jan 2025 | 16 Oct 2026 | moderate |
fl.telehealthstate | Florida's telehealth restriction on prescribing controlled substances applies to Schedule II medicines only. Ketamine and esketamine are Schedule III, so that restriction does not apply to them, and Florida law does not otherwise require an in-person examination first. Federal DEA telemedicine flexibilities run separately and expire at the end of 2026, and they require video rather than a phone call. Spravato cannot be prescribed for home use in any case, because it must be given in a certified setting. | The Florida Senate Fla. Stat. 456.47 — Telehealth | 18 Jul 2026 | 16 Oct 2026 | high |
fl.medicaid.spravatostate | Florida Medicaid is delivered through Statewide Medicaid Managed Care. Spravato does not appear on the Florida Medicaid preferred drug list at all; it is governed instead by separate published clinical criteria requiring prior approval, and by a minimum age of 18. We confirmed the absence by searching the full preferred drug list effective 1 July 2026. | Florida Agency for Health Care Administration Florida Medicaid Drug Criteria | 1 Jul 2026 | 16 Oct 2026 | high |
fl.medicaid.pastate | Florida Medicaid approves Spravato for people aged 18 and over with treatment-resistant depression, where prior antidepressant trials of at least four weeks each did not work. Florida permits Spravato on its own for treatment-resistant depression — no companion oral antidepressant is required. Approvals are granted in three-month blocks. The state document does not name a specific number of prior antidepressants that must have failed, so we do not publish one. It also contains no REMS wording, though the federal REMS rules apply regardless. | Florida Agency for Health Care Administration Florida Medicaid Spravato (esketamine) Prior Authorization Criteria | 28 Apr 2026 | 16 Oct 2026 | high |
spravato.rems.locatorfederal | The official SPRAVATO REMS programme website is the only authoritative way to find a certified treatment centre, and it can also be reached by phone at 1-855-382-6022. | SPRAVATO REMS Program SPRAVATO REMS — treatment centre locator | 18 Jul 2026 | 14 Jan 2027 | high |
withme.savingsfederal | Through the Spravato withMe savings programme, eligible patients with commercial insurance may pay as little as $10 per treatment for the medicine itself, subject to yearly maximum benefits and quantity limits. The programme covers the medicine, not the office visit or the two-hour observation, which is often the larger share of the bill. The official terms state that a yearly maximum applies but do not publish the amount, so we do not either. Terms are set per calendar year. | Johnson & Johnson SPRAVATO withMe Savings Program — Program Requirements | 18 Jul 2026 | 14 Jan 2027 | moderate |
withme.government_exclusionfederal | The Spravato withMe savings programme is not available to anyone using a state or federal government health programme, including Medicare, Medicaid, TRICARE, the Department of Defense, and the Veterans Administration. | Johnson & Johnson SPRAVATO withMe Savings Program — Program Requirements, 'Other requirements' | 18 Jul 2026 | 14 Jan 2027 | high |
spravato.wacfederal | Spravato's list price is not published by the manufacturer or in any free public source. At launch in 2019 the wholesale acquisition cost was around $590 for a 56 mg dose and $885 for an 84 mg dose, and the current list price is very likely higher. Wholesale acquisition cost is published only in paywalled pricing compendia. The figures here are seven years old and come from a secondary source, so we do not use them to produce a dollar estimate — the estimator suppresses Spravato cash figures rather than presenting a number this weak. | Drugs.com Spravato Prices, Coupons, Copay Cards and Patient Assistance | 5 Mar 2019 | 14 Jan 2027 | low |
medicare.partb_coinsurancefederal | Under Original Medicare Part B in 2026 you pay a $283 yearly deductible first, and after that you generally pay 20% of the Medicare-approved amount for covered services. Deductible and premium amounts are set annually and change each January. | Centers for Medicare and Medicaid Services Medicare costs | 1 Jan 2026 | 14 Jan 2027 | high |
uhc.spravato_criteriafederal | UnitedHealthcare applies one national policy rather than a separate rule per state. It covers Spravato with prior approval for treatment-resistant depression, and requires a diagnosis made by a mental health professional, a baseline score on a recognised depression scale, failure of at least two antidepressants taken for at least eight weeks each at the highest tolerated dose, and a provider or setting certified under the Spravato REMS programme. This is a national policy, so it reads the same wherever you live — which is why it is recorded once here rather than repeated in each state. UnitedHealthcare runs parallel medical and pharmacy versions; which one applies depends on how your clinic bills, and prior approval is needed either way. | UnitedHealthcare Policy 2026D0069Q — Ketalar (ketamine) and Spravato (esketamine) | 1 May 2026 | 14 Jan 2027 | high |
uhc.iv_ketaminefederal | UnitedHealthcare's national policy states that ketamine injection is investigational, and therefore not proven or medically necessary, for psychiatric conditions including depression, bipolar disorder and post-traumatic stress disorder. This is the clearest published statement of why commercial insurance rarely pays for IV ketamine. This describes one commercial insurer. It does not describe any state Medicaid programme, none of which publishes criteria for racemic ketamine either way. | UnitedHealthcare Policy 2026D0069Q — Ketalar (ketamine) and Spravato (esketamine) | 1 May 2026 | 14 Jan 2027 | high |
fl.commercial.spravatostate | Florida's major commercial insurers all require prior approval for Spravato, and most no longer require a companion oral antidepressant. Florida Blue covers it under the medical benefit and does not require a companion antidepressant for treatment-resistant depression. Sunshine Health is the exception: its published criteria still require one. Sunshine Health's document carries no revision date and its requirement predates the FDA's monotherapy approval — worth asking whether it still applies. We could not locate Humana's Florida commercial policy, so we make no claim about it. | Florida Blue, UnitedHealthcare and Sunshine Health Florida Blue MCG 09-J3000-37; UnitedHealthcare 2026D0069Q; Sunshine Health Spravato Criteria | 15 Apr 2026 | 14 Jan 2027 | moderate |
fl.price.ivstate | Florida clinics that publish their prices charge roughly $400 to $600 for a single IV ketamine infusion, most often quoted as part of a six-infusion starting course. Based on five Florida clinics that publish prices. Miami-area concierge practices generally do not publish any, and they sit above this band. | Published Florida clinic price lists Jacksonville, Tampa and South Florida clinic pricing pages | 18 Jul 2026 | 14 Jan 2027 | moderate |
fl.price.imstate | Only one Florida clinic we found publishes a price for intramuscular ketamine, at $300 a session. That is a single data point rather than a market rate. One clinic is not a band. Treat this as an example of what one Florida clinic charges, not as what you should expect. | Published Florida clinic price list South Florida ketamine pricing page | 18 Jul 2026 | 14 Jan 2027 | low |
fl.price.lozengestate | At-home oral ketamine is sold to Florida residents by national telehealth companies as a subscription — roughly $1,290 for a six-session course. No Florida clinic we checked publishes lozenge pricing. This is a national company charging the same price everywhere, not a Florida market rate, and it is sold as a course rather than per session. Per-session figures quoted in marketing are derived from the subscription, not separately payable. | Mindbloom Ketamine therapy in Florida | 18 Jul 2026 | 14 Jan 2027 | low |
fl.price.spravato_cashstate | No Florida clinic we checked publishes a self-pay price for Spravato. Providers route pricing through an insurance check first, so a self-pay patient has to ask for an individual quote. Our estimator does not produce a self-pay Spravato figure, because there is no Florida evidence strong enough to build one on. | Published Florida clinic Spravato pages Florida Spravato provider pages | 18 Jul 2026 | 14 Jan 2027 | low |
ketamine.schedulefederal | Ketamine and its mirror-image form esketamine are Schedule III controlled substances under federal law, which means they have accepted medical uses but can be misused. Esketamine has no separate DEA listing; it is covered as an enantiomer of ketamine, and the Spravato label carries the CIII designation. | U.S. Drug Enforcement Administration Controlled Substances — Alphabetical Order | 18 Jul 2026 | 18 Jul 2027 | high |
ketamine.off_labelfederal | Only esketamine (Spravato) is FDA-approved to treat depression. Racemic ketamine given by IV, injection, or under the tongue has no FDA approval for any psychiatric condition and is used off-label — that is, an approved drug used for an unapproved purpose. | U.S. Food and Drug Administration SPRAVATO (esketamine) nasal spray, CIII — Full Prescribing Information | 30 Apr 2025 | 18 Jul 2027 | high |
spravato.approval_trdfederal | The FDA approved Spravato (esketamine) nasal spray on 5 March 2019, for use with an oral antidepressant, for adults with treatment-resistant depression. | U.S. Food and Drug Administration NDA 211243 Original Approval Letter — Spravato | 5 Mar 2019 | 18 Jul 2027 | high |
spravato.monotherapyfederal | On 17 January 2025 the FDA approved Spravato for treatment-resistant depression in adults either on its own or together with an oral antidepressant, so a companion oral antidepressant is now optional for this use — though it is still permitted. This applies to the treatment-resistant depression indication only. The separate indication for major depressive disorder with acute suicidal ideation still requires an oral antidepressant — see spravato.approval_mdd_si. Widely-cited secondary sources give 21 January 2025; that is the manufacturer's announcement date, not the FDA action date on the approval letter. | U.S. Food and Drug Administration NDA 211243/S-016 Supplement Approval Letter — expansion of the indication to include monotherapy | 17 Jan 2025 | 18 Jul 2027 | high |
spravato.approval_mdd_sifederal | On 31 July 2020 the FDA separately approved Spravato, used together with an oral antidepressant, for depressive symptoms in adults who have major depressive disorder with acute suicidal thoughts or behaviour; for this use the oral antidepressant is still required, and it is not a substitute for hospital care when hospital care is needed. | U.S. Food and Drug Administration NDA 211243/S-004 Supplement Approval Letter | 31 Jul 2020 | 18 Jul 2027 | high |
spravato.rems.settingfederal | Spravato is available only through a restricted safety programme called a Risk Evaluation and Mitigation Strategy (REMS), and may only be given in a certified healthcare setting under a provider's direct observation. Patients never take it home. | U.S. Food and Drug Administration SPRAVATO Prescribing Information, Section 5.5 — REMS | 30 Apr 2025 | 18 Jul 2027 | high |
spravato.rems.observationfederal | A healthcare provider must monitor the patient for at least two hours after every Spravato dose before deciding they are ready to leave. | U.S. Food and Drug Administration SPRAVATO Prescribing Information, Section 2.5 — Post-Administration Observation | 30 Apr 2025 | 18 Jul 2027 | high |
spravato.rems.drivingfederal | After a Spravato dose you must not drive or operate machinery until the next day, following a restful night's sleep, so you need to arrange a ride home from every session. | U.S. Food and Drug Administration SPRAVATO Prescribing Information, Section 5.9 — Impaired Ability to Drive and Operate Machinery | 30 Apr 2025 | 18 Jul 2027 | high |
spravato.side_effectsfederal | In treatment-resistant depression studies the most common side effects of Spravato were dissociation, dizziness, nausea, sedation, vertigo, reduced sense of touch, anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, and headache. The label lists a different set for the major-depressive-disorder-with-acute-suicidality indication. The two lists should not be conflated. | U.S. Food and Drug Administration SPRAVATO Prescribing Information, Highlights — Adverse Reactions | 30 Apr 2025 | 18 Jul 2027 | high |
neuroplasticity.evidencefederal | Laboratory and animal research suggests ketamine and esketamine may work partly by increasing BDNF and mTOR signalling, which strengthens connections between brain cells — but human evidence is limited and mixed, so this is a promising theory rather than a proven explanation. This is a narrative review, not a systematic review, and it reports mixed clinical findings. It does not support any personal recovery timeline. | International Journal of Molecular Sciences Variations in BDNF and Their Role in the Neurotrophic Antidepressant Mechanisms of Ketamine and Esketamine: A Review | 5 Dec 2024 | 18 Jul 2027 | low |
crisis.988federal | If you are in crisis, call or text 988 to reach the 988 Suicide & Crisis Lifeline, or text HOME to 741741 to reach the Crisis Text Line. Both are free and available 24 hours a day. | 988 Suicide and Crisis Lifeline 988 Suicide & Crisis Lifeline | 18 Jul 2026 | 18 Jul 2027 | high |
ketamine.trd_definitionfederal | Treatment-resistant depression usually means major depression that has not improved after at least two different antidepressant medicines taken at an adequate dose for long enough — often about six to eight weeks each — though exact definitions vary by study and by insurer. Commercial payers and state Medicaid programmes each publish their own prior-authorisation wording; the clinical definition and the coverage definition are not always identical. | U.S. Food and Drug Administration SPRAVATO Prescribing Information — Indications and Clinical Studies (TRD definition used in trials) | 30 Apr 2025 | 18 Jul 2027 | high |
spravato.efficacy_trdfederal | In the pivotal short-term trials that supported FDA approval, adults with treatment-resistant depression who received Spravato with an oral antidepressant improved more on the Montgomery–Åsberg Depression Rating Scale than those who received a placebo nasal spray with an oral antidepressant. Trial populations are selected, monitoring is intensive, and individual response cannot be predicted from group averages. | U.S. Food and Drug Administration SPRAVATO Prescribing Information, Section 14 — Clinical Studies | 30 Apr 2025 | 18 Jul 2027 | high |
ketamine.iv_trd_evidencefederal | Randomised trials and systematic reviews report that a single sub-anaesthetic intravenous infusion of racemic ketamine can reduce depressive symptoms within hours in some adults with major depression or treatment-resistant depression, but the effect often fades within days to a week without a maintenance strategy, and racemic ketamine has no FDA psychiatric indication. This is research evidence, not an FDA approval. Off-label use remains lawful medical practice when a licensed clinician judges it appropriate. | American Journal of Psychiatry / PubMed McIntyre et al. — Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression (2019 review) | 1 Apr 2019 | 18 Jul 2027 | moderate |
ketamine.contraindications_cautionfederal | Spravato is contraindicated in people with aneurysmal vascular disease, arteriovenous malformation, or a history of intracerebral haemorrhage, and in anyone with a known hypersensitivity to esketamine, ketamine, or excipients — and a careful medical history is required before any ketamine-class treatment because blood pressure commonly rises after a dose. | U.S. Food and Drug Administration SPRAVATO Prescribing Information — Contraindications and Warnings | 30 Apr 2025 | 18 Jul 2027 | high |
ketamine.bipolar_evidencefederal | Evidence that ketamine or esketamine treats bipolar depression is more limited than for unipolar major depression: small randomised trials and open-label series suggest short-term antidepressant effects in some patients, but sample sizes are small, follow-up is short, and no ketamine product is FDA-approved specifically for bipolar disorder. Do not read this as a treatment recommendation. A bipolar diagnosis changes the assessment and the risk profile; only a treating clinician can decide. | Journal of Affective Disorders / PubMed Bahji et al. — Comparative efficacy of racemic ketamine and esketamine for depression (including bipolar samples) | 1 Apr 2020 | 18 Jul 2027 | moderate |
ketamine.bipolar_switch_riskfederal | Because ketamine-class medicines can elevate mood rapidly, people with bipolar disorder carry a recognised risk of switching into hypomania or mania; responsible protocols usually require an established mood-stabiliser regimen, close observation after sessions, and a plan for what to do if activation or reduced need for sleep appears. The Spravato label focuses on dissociation, sedation, abuse potential and suicidal thoughts rather than a dedicated mania-switch section; the clinical risk is also described in the bipolar-depression literature cited on this page. | U.S. Food and Drug Administration SPRAVATO Prescribing Information — Warnings and Precautions (psychiatric adverse reactions) | 30 Apr 2025 | 18 Jul 2027 | moderate |
ketamine.bladder_riskfederal | Long-term, high-frequency recreational ketamine use is associated with ketamine-induced ulcerative cystitis — painful bladder, frequency, urgency and, in severe cases, irreversible damage — and while psychiatric clinic doses are far lower, urinary symptoms should be reported early rather than ignored. Most cystitis case series describe chronic recreational exposure, not a standard six-infusion clinic course. Absence of a published clinic-dose incidence figure is not proof of zero risk. | StatPearls / NCBI Bookshelf Ketamine Toxicity — Pathophysiology (urinary tract) | 1 Jan 2023 | 18 Jul 2027 | moderate |
ketamine.dependencefederal | Ketamine is a Schedule III controlled substance with accepted medical use and a recognised potential for psychological dependence, tolerance with repeated high-dose exposure, and a withdrawal picture that can include craving, sleep disturbance and mood changes after heavy non-medical use. Schedule status describes abuse potential relative to other controlled drugs; it is not a prediction that a monitored clinic course will produce dependence. | U.S. Drug Enforcement Administration Controlled Substances — Alphabetical Order; Schedule III listing for ketamine | 18 Jul 2026 | 18 Jul 2027 | high |
ketamine.half_lifefederal | After intravenous dosing, ketamine's elimination half-life in adults is typically about two to three hours, with psychoactive effects that peak during the infusion and usually settle over the following hours — which is why clinics plan observation time and why next-day driving rules still apply after esketamine. | U.S. Food and Drug Administration KETALAR (ketamine hydrochloride) injection — Clinical Pharmacology | 1 Jan 2022 | 18 Jul 2027 | high |
ketamine.drug_testfederal | Standard workplace urine drug screens do not routinely include ketamine; detection usually requires a specific assay, and published detection windows after use are often on the order of a few days in urine depending on dose, frequency, metabolism and the laboratory method. Employers, courts and sports bodies may order expanded panels. If a drug test is pending, disclose prescribed treatment to the medical review officer rather than relying on a generalisation. | StatPearls / NCBI Bookshelf Ketamine Toxicity — Laboratory evaluation and detection context | 18 Jul 2026 | 18 Jul 2027 | moderate |
ketamine.at_home_monitoring_gapfederal | At-home and microdosing ketamine programmes remove the on-site monitoring that clinic protocols use to catch blood-pressure spikes, severe dissociation, sedation and diversion — so the convenience trade-off is a real safety gap, not a minor difference in setting. Spravato cannot be taken at home under the REMS. Compounded at-home racemic products are a different regulatory pathway and are not REMS-certified substitutes. | U.S. Food and Drug Administration SPRAVATO REMS rationale — healthcare-setting administration and observation requirements | 30 Apr 2025 | 18 Jul 2027 | high |
spravato.boxed_warningfederal | Spravato carries a boxed warning for sedation, dissociation, respiratory depression, abuse and misuse, and suicidal thoughts and behaviours — the same class of risks that justify the REMS clinic-only distribution system. | U.S. Food and Drug Administration SPRAVATO Prescribing Information — Boxed Warning | 30 Apr 2025 | 18 Jul 2027 | high |
fl.board.mdstate | Florida licenses medical doctors through the Florida Board of Medicine and osteopathic physicians through the Florida Board of Osteopathic Medicine, both under the Department of Health. Licences for both, and any disciplinary history, are checked through a single Department of Health search portal. | Florida Department of Health MQA Search Services — Licence Verification | 18 Jul 2026 | 18 Jul 2027 | high |
fl.scopestate | Florida medical doctors and osteopathic physicians may administer ketamine within their scope of practice. Florida's autonomous registration for advanced practice registered nurses does allow controlled-substance prescribing, but it limits autonomous practice to primary care — family medicine, general paediatrics and general internal medicine — so it does not cover a psychiatric or anaesthesia ketamine practice. A certified registered nurse anaesthetist works under an approved protocol with physician supervision. Physician assistants are never autonomous in Florida. Florida law requires the physician assistant prohibited-drug list to include general anaesthetics, and ketamine is labelled as one. Whether that reaches the low doses used for depression is unsettled, and no Florida board has ruled on it. | Florida Legislature Fla. Stat. 464.0123; 464.012; 458.347 | 18 Jul 2026 | 18 Jul 2027 | moderate |
fl.cpomstate | Florida does not have a general prohibition on corporate ownership of medical practices. What it regulates instead is clinic licensing: operating a clinic in Florida requires a licence from the Agency for Health Care Administration, with each location licensed separately. Practices wholly owned by physicians — or by advanced practice registered nurses — are exempt from that licensing requirement. Florida separately treats fee-splitting and patient brokering as serious offences, so the absence of a corporate-practice ban does not mean referral arrangements are unregulated. | The Florida Senate Fla. Stat. 400.991; Fla. Stat. 400.9905 | 18 Jul 2026 | 18 Jul 2027 | moderate |
fl.pdmp.reportingstate | Florida's monitoring system is E-FORCSE, run by the Department of Health. Dispensers must report each Schedule II to V controlled substance dispensed, no later than the close of the next business day. The law expressly excludes all acts of administration from reporting, along with dispensing inside the corrections system and dispensing to anyone under 16. | Florida Department of Health Prescription Drug Monitoring: E-FORCSE; Fla. Stat. 893.055 | 18 Jul 2026 | 18 Jul 2027 | high |
fl.pdmp.querystate | Before prescribing or dispensing any controlled substance to a patient aged 16 or over, a Florida prescriber or dispenser must consult E-FORCSE to review that patient's dispensing history. This covers every controlled substance, not just opioids. The only exceptions are non-opioid Schedule V medicines and patients admitted to hospice. If the system is unavailable, the prescriber must record why and may not prescribe more than a three-day supply. That three-day figure is a ceiling during an outage, not a general exemption. | The Florida Senate Fla. Stat. 893.055(8) | 18 Jul 2026 | 18 Jul 2027 | high |
fl.pdmp.ketaminestate | Partly, and it depends on how you receive it. Ketamine is Schedule III in Florida, so a prescription written for you does trigger the database check. But an infusion given to you inside a clinic is an act of administration, which Florida expressly excludes from the database — so nothing about that dose is recorded, and there is nothing to check. Compounded ketamine sent to your home from a pharmacy is squarely covered. Spravato is the harder case: it is genuinely prescribed even though you take it at the clinic. No Florida guidance addresses medicines dispensed by a pharmacy to a clinic, so we do not state a settled answer. | Florida Legislature Fla. Stat. 893.03(3)(e); Fla. Stat. 893.055 | 18 Jul 2026 | 18 Jul 2027 | moderate |
How to read this
As of is the date the underlying fact carries — when a rule took effect, or when a price was surveyed. It does not move on its own. Next review is when we have committed to check the source again. Rules that change fast, like the federal telehealth position and state drug lists, are checked every 90 days; statutes every year.
Confidence is our honest assessment of the evidence, not of how much we like the answer. A claim marked low usually means the underlying information is not published anywhere reliable — self-pay Spravato pricing is the clearest example, and it is why our estimator refuses to give you a self-pay Spravato figure at all.
Think something here is wrong? Tell us. We publish our corrections with dates.