BP should be monitored for at least 2 hours after SPRAVATO® administration. If not currently enrolled, you can search for Medicare plans that cover Spravato. This policy is applicable to BlueCHiP for Medicare products only. Spravato is a federally controlled substance because it can be abused or lead to dependence. © Johnson & Johnson Health Care Systems Inc. 2021. Side effects may include being dizzy, feeling detached from reality, bladder problems and elevated blood pressure. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. Please don't continue suffering in silence from your depression. Would you take a brief survey so we can improve your experience on our website ? The use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy. https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Pneumatic compression pumps are only covered for purchase when the patient has completed a successful trial. Treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior: dissociation, dizziness, sedation, blood pressure increased, hypoesthesia, vomiting, euphoric mood, and vertigo. Patients treated in outpatient settings (e.g., medical offices and clinics) must be enrolled in the program. … You’ll need to enrol in Medicare to access our services. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO®. Part D Medicare coverage is an optional benefit that covers prescription drugs. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. SPRAVATO® is contraindicated in patients with: Sedation: In clinical trials, 48% to 61% of SPRAVATO®-treated patients developed sedation and 0.3% to 0.4% of SPRAVATO®-treated patients experienced loss of consciousness. Medicare covers a portion of several types of stem cell therapies. Pediatric Use: The safety and effectiveness of SPRAVATO® in pediatric patients have not been established. It was only approved by the Food and Drug Administration in March, 2019. The patient may have to pay a monthly premium for Medicare and then pay a co-insurance and a deductible for many services. Find out if you’re eligible to enrol. Long-Term Cognitive Impairment: Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. Monitoring during and following each treatment for a minimum of two hours is critical. Spravato is not known to be safe and effective for children. Medicare.org Frequently Asked Questions (FAQ). All claims and other submissions to payers should be in compliance with all applicable requirements. CNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. It is informally referred to as “medicare”. If a retail pharmacy meets the REMS requirement and dispenses the drug directly to the administering provider, Spravato would be covered under the pharmacy benefit. Included in the eligibility criteria is enrollment in Medicare Part A and/or Part B. The Kaiser Family Foundation reports that critics argue the approval followed limited trials, and there is a lack of information about safety for long-term use. Privacy Policy | Legal Notice | Site MapSite Map | Contact UsContact Us, Indications and Important Safety Information, Prior Authorization, Exceptions, & Appeals, Indication & Important Safety Information, Benefits Investigation Form - Tips for Completing, Savings Program – Submitting Medical Claims. Medicare; Drug Info; Side Effects; Images; Advertisement. Medicare-covered services include, but are not limited to: Eyeglasses (Limited) Medicare covers one pair of eyeglasses with standard frames (or one set of contact lenses) after cataract surgery that implants an intraocular lens. Medicare & Medicare Advantage Info, Help and Enrollment. Medicare is the federal government’s insurance coverage for those aged 65 and over or with certain medical conditions. ... Care Plus, United Health Care, Medicare Health Insurance, Preferred Care Partners, and Molina Insurance. For Commercial Products, see related policy section. SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of: WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS, See full prescribing information for complete boxed warning. Third party trademarks used herein are trademarks of their respective owners. Applicable Codes In patients whose BP is elevated prior to SPRAVATO® administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATO® therapy should take into account the balance of benefit and risk in individual patients. Due to adverse events (sedation, dissociation, etc.) As with other medical treatments, contact your specific insurance provider to confirm whether SPRAVATO ® is covered for you. It's a great question because…, People who need help getting in and out of their chair daily due to life changes such as aging, arthritis,…, Everything You Need to Know Many things have changed since Medicare Part C was formally introduced by legislation in 1997.…. an individual must be monitored by a healthcare provider while administering the medication and for at least two hours after … Keep reading to find answers to your questions surrounding insurance reimbursement and Ketamine. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Program does not cover the cost to give you your treatment. Covered Service: Yes Prior Authorization Required: Yes Additional Information: Must be prescribed by, or in consultation with, a psychiatrist or psychiatric nurse practitioner with prior authorization through Navitus Medicare Policy: Prior authorization is dependent on the member’s Medicare coverage. Medicare formulary requirements. Esketamine works by altering the actions of specific chemicals in the brain to help alleviate symptoms of depression that are not treatable with standard antidepressants alone. (Opens in a new browser tab). A common brand name form of esketamine is Spravato and can be administered as a nasal spray only by a physician in a medical facility. Medicare covers the costs of Entresto and displays the following types of this medication: ENTRESTO 24 MG-26 MG TABLET (Sacubitril and Valsartan) SPRAVATO® is contraindicated in patients for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage). If you are using a government-funded healthcare program to pay for SPRAVATO ® or have no insurance coverage and need help paying for your medication: Janssen CarePath can provide information about other resources that may be able to help with your out-of-pocket medication costs for SPRAVATO ® . Medicare is the basis of Australia's health care system and covers many health care costs. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Medicare is a federal program that provides health insurance coverage to the following types of people: While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. FAX: 1-844-268-7263 (All fields must be completed and legible for Precertification Review) Please indicate: ... Any person who knowingly files a request for authorization of coverage of a medical … If a retail pharmacy meets the REMS requirement and dispenses the drug directly to the administering provider, Spravato would be covered under the pharmacy benefit. Patients in need of this drug may find the cost paid by an insurance company, government, or non-profit organization. On average, Medicare pays anywhere from 70-80% of traditional commercial insurance plans again leaving providers with the determination if they can operationally afford to deliver quality care at the reimbursable price. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. Assess BP prior to administration of SPRAVATO®. But therapy must be medically necessary and the procedure must have FDA approval. What is the Medicare Annual Election Period (AEP)? Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Closely monitor for sedation with concomitant use of CNS depressants. These could include the shingles vaccine, the pneumonia vaccine, the tetanus vaccine and more. It’s time for you to try this revolutionary new treatment. Hepatic Impairment: SPRAVATO®-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time. This program provides financial assistance to eligible individuals to cover coinsurance, copayments, healthcare premiums and … Covered Service: Yes Prior Authorization Required: Yes Additional Information: Must be prescribed by, or in consultation with, a psychiatrist or psychiatric nurse practitioner with prior authorization through Navitus Medicare Policy: Prior authorization is dependent on the member’s Medicare coverage. Because these plans are offered through Medicare-approved private insurance companies, this basically means that each Medicare … Dear Savvy Senior: Is acupuncture a viable treatment for pain, and is it covered by Medicare? Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure. If you already enrolled in Part D prescription drug coverage, check your plan’s formulary, or list of covered drugs. Our Medicare Resource Guide provides important information for your patients to consider as they are selecting their insurance coverage. (Opens in a new browser tab), Do Your Medicare Benefits Cover Your Spouse? Depending on how their insurance covers SPRAVATO™, the quantity limit is 3 devices per day or up to 23 devices per 28-day period. Does Medicare Cover Depression Medications? Phone: 1-866-752-7021 . This site is published by Johnson & Johnson Health Care Systems Inc. Terms … No adverse effects of SPRAVATO® nasal spray on cognitive functioning were observed in a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATO® have not been evaluated beyond one year. Pneumatic compression pumps will be covered by Medicare for the treatment of lymphedema & chronic venous insufficiency with venous stasis ulcers. Impaired Ability to Drive and Operate Machinery: Before SPRAVATO® administration, instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep. At the end of four weeks, there was no statistically significant difference between groups on the primary efficacy endpoint of change from baseline to Week 4 on the Montgomery-Åsberg Depression Rating Scale (MADRS). The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol. Patient insurance benefits investigation and other Janssen CarePath program offerings are provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of Actelion Pharmaceuticals US, Inc., Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc., and Janssen Products, LP (Janssen). As we said earlier, Part A is the part of Medicare that covers hospitalization and inpatient care, which means it pays for any hospital costs related to hospital care or any medical care in a received in a skilled nursing facility or nursing home. Key Points. MindPath Care Centers now accepts Medicare, BCBS, Cigna, Aetna, and Tricare for SPRAVATO ® treatment. Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO® caused cognitive performance decline 40 minutes post-dose. What you pay for Keytruda will depend on your insurance plan, if you have a deductible or coinsurance, or your state’s coverage for Keytruda. If you already enrolled in Part D prescription drug coverage, check your plan’s formulary, or list of covered drugs. Spravato is proven and/or medically necessary for the treatment of treatment-resistant depression (TRD) when all of the following criteria are met: Initial Therapy: o Diagnosis of major depressive disorder (treatment-resistant), … ... in a regular pharmacy. If you are uninsured or need help with your co-pay, the manufacturer may also offer assistance. Help with the costs of seeing a doctor, getting medicines and accessing mental health care. Aside from the question of whether or not Spravato is included in Medicare coverage, discuss with your doctor the benefits and risks of using the drug to be sure this medicine is right for you and that you are comfortable with any potential side effects. Spravato can cause severe drowsiness, or feelings of being disconnected from your body or thoughts or surroundings. Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. It is not a national program – under legislation, our provinces and territories are required to fund hospital and doctor services and make sure their residents have reasonable access to these services. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO®. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Use in this population is not recommended. MindPath Care Centers now accepts Medicare, BCBS, Cigna, Aetna, and Tricare for SPRAVATO ® treatment. In most situations, Velcade is administered in your doctors office or clinic and would be covered under Medicare Part B. Can't find the answer you're looking for? All rights reserved. We help all Australians access a wide range of health services. This site is intended for use in the United States. Although Medicare Part D formularies vary, they must all cover certain categories. When you enrol, you’ll get a Medicare … Esketamine and Spravato are typically administered by a doctor or other … Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age. Covered Service: Yes Prior Authorization Required: Yes Additional Information: Must be prescribed by, or in consultation with, a psychiatrist or psychiatric nurse practitioner with prior authorization through Navitus Medicare Policy: Prior authorization is dependent on the member’s Medicare coverage. Note: Spravato has a black box warning for sedation and dissociation, potential for misuse and abuse, and increased risk of suicidal thoughts and behaviors. SPRAVATO® is not approved in pediatric (<18 years of age) patients. They are accurate as-of April 2020 and the information may be updated. Exceptions. SPRAVATO® may cause fetal harm when administered to pregnant women. I triple-questioned the customer service person to make sure there was no confusion. The efficacy of SPRAVATO ® for the treatment of TRD in geriatric patients … Receive price alerts for Spravato and other prescription … Does Medicare Cover Annual Wellness Visits? The most common side effects include disassociation (having trouble thinking), dizziness, nausea, vertigo, anxiety, feeling tired, … Medicare traditionally covers 80% of the agreed-upon amount which then leaves 20% for either secondary insurance or for the patient’s responsibility. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. The medication is typically covered in full or will have a copayment based on your insurance coverage plan. Although Part D is optional, those who are undecided during the eligibility period may be charged a late enrollment fee if they decide to sign up later. ... the member’s benefit plan includes coverage for it and whether the plan requires covered services to be medically necessary. Assess each patient’s risk for abuse or misuse prior to prescribing and monitor all patients for the development of these behaviors or conditions, including drug-seeking behavior, while on therapy. Benefits investigations & prior authorizations, Enroll eligible patients in Savings Program, Individuals over age 65 with a work history, Individuals with certain disabilities who have been disabled for at least 2 years, Individuals diagnosed with end-stage renal disease (ESRD). SPRAVATO® is available only through a restricted program under a REMS. It also covers the costs of hospice care and home health services. MEDICAL CRITERIA Initial Evaluation Pregnancy: SPRAVATO® is not recommended during pregnancy. If not currently enrolled, you can search for Medicare plans that cover Spravato. Spravato must be administered in the presence of a certified healthcare provider and is covered under the medical benefit. Terms expire at the end of each calendar year and may change. SPRAVATO (esketamine) MB1921 . This drug is likely to be covered under your medical benefit if you have insurance. All I needed to do at this point is find a physician participating in the program who accepts Medicare. machine kicks into gear to support the launch of Spravato/Esketamine, the first FDA approved Ketamine-derived treatment, Kevin Nicholson (President, CEO of Ketamine Wellness Centers) digs into the details that tend to receive less attention. Background: In order for a mental health service to be covered by Medicare, the service must be for the diagnosis and treatment of mental illness. While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. Janssen CarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the HCP under appropriate authorization following the provider's exclusive determination of medical necessity. Closely monitor blood pressure with concomitant use of SPRAVATO® with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)]. Patients in need of this drug may find the cost paid by an insurance company, government, or non-profit organization. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Sites that are "Now Treating Patients" may not be accepting new patients. Embryo-fetal Toxicity: SPRAVATO® may cause fetal harm when administered to pregnant women. o Spravato dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Initial authorization will be for no longer than 4 weeks. If you have Medicare supplement plan F your share for the drug would be $0. REQUEST YOUR FREE MEDICARE BENEFITS CHECKUP TODAY! As a Medicare beneficiary, there are two ways for you to get prescription drug coverage (Medicare Part D): through a stand-alone Medicare Prescription Drug Plan, if you have Original Medicare, or through a Medicare Advantage Prescription Drug plan. ... Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Your podiatry visit may be fully or partially covered by a Medicare rebate if you meet specific criteria set out by Medicare and are approved by your General Practitioner through their clinical assessment and professional discretion. The medicine, which is used in conjunction with an antidepressant administered orally, is designed for adults who suffer from treatment-resistant depression (TRD). CMS's Coverage Issues Manual can be found on the CMS website. Part D Medicare coverage is an optional benefit that covers prescription drugs. Andrew Sivatjian Licensed Insurance Agent since 2006, One of the most common questions we receive is, "Can you laminate your Medicare card?" The patient may have to pay a monthly premium for Medicare and then pay a co-insurance and a deductible for many services. Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO® and refer to an appropriate healthcare provider as clinically warranted. Items & Services Not Covered Under Medicare MLN Booklet Page 7 of 17 ICN MLN906765 December 2020 Services furnished onboard a ship in a U.S. port or furnished within 6 hours of when the ship arrived or departed. … The efficacy of SPRAVATO® for the treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO® plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. Medicare-linked plan policies will only apply to benefits paid for under Medicare rules, and not to any other health benefit plan benefits. In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure. SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS): SPRAVATO® is available only through a restricted program called the SPRAVATO® REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®. Before enrolling in a Medicare Prescription Drug Plan or Medicare Advantage plan that includes drug coverage, you should review the plan’s formulary to see which drugs it covers. Please indicate specific dose: TRD Induction Phase TRD Maintenance Phase Spravato will come with a black box warning, the strictest safety warning put in the labeling of prescription drugs by the FDA. Eligible commercially. Note: REQUIRES PRECERTIFICATIONFootnotes* Aetna considers esketamine (Spravato) nasal spray medically necessary for the treatment of treatment-resistant depression (TRD) in adults (18 years of age or older) when the following criteria are met: 1. As an alternative to Original Medicare, you can enroll in a Medicare Advantage plan that includes Part A, Part B, and Part D coverage. Indications. Spravato is a brand name for esketamine, which enters the body through a nasal spray. Healthcare settings must be certified in the program and ensure that SPRAVATO. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visual disturbances, seizures, diminished consciousness, or focal neurological deficits) immediately for emergency care. Medicare Coverage for Spravato. Dissociation: The most common psychological effects of SPRAVATO® were dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization (61% to 84% of SPRAVATO®-treated patients developed dissociative or perceptual changes). There is no income There is a monitoring period of two or more hours with our medical staff which has a flat fee of $150 per visit. nor does it apply to Medicare. If you (or your spouse) did not pay Medicare taxes while you worked, and you are age 65 or older and a citizen or permanent resident of the United States, you may be able to buy Part A. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Applicable Codes Check with the payer to confirm whether there are specific coverage requirements or information needed as part of the Medicare prices are provided by the Centers for Medicare and Medicaid Services (CMS). Dental splints used to treat a dental condition are excluded from coverage under 1862(a)(12) of the Act. Learn more about Medicare and how it works. To access coverage for Spravato under the pharmacy benefit for a UnitedHealthcare member with pharmacy benefits managed by UnitedHealthcare and administered by OptumRx, a prior authorization should be requested through OptumRx. Only dispensed and administered in healthcare settings. Drugs not covered under Medicare Part D. Since each Medicare Part D Prescription D plan decides which drugs not to cover on its formulary, the list here is not complete. Controlled Substance: SPRAVATO® contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act. esketamine. If so, a clinical coverage review will be conducted as part of … Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO®, during pregnancy. Under such circumstances, Medicare does not pay for this procedure. SPRAVATO (esketamine) MB1921 . Many major commercial and Medicare plans now cover SPRAVATO ® treatment for depression. Spravato is unproven and not medically necessary for the following: Anesthetic agent Drops given by your doctor will be covered under Medicare Part B, while drops you use at home will be covered under Part D. For TMJ disorders NSAIDs can help with the pain of TMJ disorders. New Brunswick Medicare pays for the following insured practitioner services: most medically required services provided by a physician in either a physician’s office or in an approved hospital; and certain specified surgical dental procedures provided by a dentist when the service is medically required and rendered in an approved hospital. To find out if you are eligible and your expected premium, go the Medicare.gov eligibility tool. Patients will need to arrange transportation home following treatment with SPRAVATO®. The most common adverse reactions with SPRAVATO® plus oral antidepressant (incidence ≥5% and at least twice that of placebo nasal spray plus oral antidepressant) were: TRD: dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk. SERVICE: Esketamine (Spravato ... Medicare coverage rules supersede guidelines in this policy. SPRAVATO® may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment, and to be “spaced out.” Monitoring for signs of abuse and misuse is recommended. We have information in different languages about What's covered by Medicare. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. And that’s covered under Medicare. Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. SPRAVATO®-treated subjects required a greater effort to complete the cognitive tests at 40 minutes post-dose. Increase in Blood Pressure: SPRAVATO® causes increases in systolic and/or diastolic blood pressure (BP) at all recommended doses. Blue Cross Blue Shield (BCBS), Medicare, and Aetna are some of the insurances that are currently covering Spravato treatment. Medicare coverage for many tests, items and services depends on where you live. Many major commercial and Medicare plans now cover SPRAVATO ® treatment for depression. Treatment may include up to three devices administered on the same day. There is a quantity limit of 24 devices in a 24-day period for one use per lifetime. Under Medicare you can be treated as a public patient in a public hospital, at no charge. Females and Males of Reproductive Potential: SPRAVATO® may cause embryo-fetal harm when administered to a pregnant woman. Centers for Medicare and Medicaid Services ..... 8 References ... Coverage Rationale . Lactation: SPRAVATO® is present in human milk. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Closely monitor blood pressure with concomitant use of MAOIs. Items & Services Not Covered Under Medicare MLN Booklet Page 7 of 19 ICN MLN906765 December 2020. Program limits apply. There are risks to the mother associated with untreated depression in pregnancy. At the time of writing this, state and federal insurance plans such as Medicare, Medicaid, TriCare, and other Veteran Affairs-affiliated plans do not accept Ketamine Infusion Therapy as a covered treatment. Part A will help cover inpatient costs while Part B will cover a portion of outpatient costs.
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