For patients who have an elevated PSA at baseline, a second PSA test is recommended to rule out a spurious elevation. In the U.S., the drug is available only through a restricted program called the AVEED Risk Evaluation and Mitigation Strategy (REMS) Program. An analysis of testosterone implants for androgen replacement therapy. Up until now, Alaska was one of 10 states that still explicitly denied Medicaid coverage for gender-affirming treatment, including surgery, hormone treatment and therapy. The 211 men in the Bone Trial underwent assessment of volumetric bone mineral density (vBMD) and bone strength by quantitative computed tomography (QCT) scanning at baseline and 12 months. Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS National Coverage Determinations (NCDs), and all Medicare payment rules. Transgender individuals also have the right to access universal health care and insurance programs. Universally accepted methods of calculating FT do not exist. Tao J, Liu X, Bai W. Testosterone supplementation in patients with chronic heart failure: A meta-analysis of randomized controlled trials. Contemporary assay techniques to assess TT include immunoassays (IA) and mass spectrometry (MS). Yes, Medicare will cover hormone therapy for transgender beneficiaries the same way it would for any other beneficiary. This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity. Of the 394 men in the testosterone arm, 301 required 504 adjustments of the dose at months 3, 6, and/or 9 to maintain the testosterone level within the target range. At RevitalizeYou MD, we offer safe and high-quality hormone treatments for your needs. If you dont find the Article you are looking for, contact your MAC. Please note that codes (CPT/HCPCS and ICD-10) have moved from LCDs to Billing & Coding Articles. In the United States, there are three ways that residents can avail themselves of health insurance: individual plans, employer-sponsored health plans, and government-based programs like Medicare and Medicaid. End Users do not act for or on behalf of the CMS. Hypertension, type 2 diabetes, stroke, heart attack, cardiovascular diseases, and higher levels of cholesterol are also some of the other complications from hormone replacement therapy. The median serum testosterone concentration of the men treated with testosterone increased from unequivocally low at baseline to mid-normal for young men by month 3 and remained at that level during the 12 months of treatment. This is an oral softgel that is taken twice daily. They excluded men with any cancer and those with severe cardiac, renal, or hepatic disease. For patients who have an elevated PSA at baseline, a second PSA test is recommended to rule out a spurious elevation. One transdermal patch (Androderm, Topical agents are administered daily in a low dose such that the risk of supraphysiological or subtherapeutic levels is minimized. Important cross-sectional and longitudinal studies have reported different prevalence rates of hypogonadism in men. However, you also have the responsibility to be informed and inquire with your provider beforehand if they will be to cover your hormone therapy. Guidelines for the diagnosis of male hypogonadism as well as testosterone treatment and contraindications to testosterone have been developed by the American College of Physicians (ACP) and endorsed by the American Academy of Family Physicians.22 Similar recommendations have been made by the Endocrine Society15 as well as the American Urological Association.14 Testosterone therapy impairs fertility by suppressing pituitary LH secretion (essential for spermatogenesis), as well as shrinks testicular tissue. Ayele HT, Brunetti VC, Renoux C, Tagalakis V, Filion KB. Furthermore, it is not known whether improving the testosterone level to that of a healthy male, improves or worsens cardiovascular disease risk. While Part A and Part B can provide coverage for the necessary gender affirmation surgery and other medical procedures, they may not pay for the costs of your hormone medications. Men over age 50 years (or 40 years if they are at high risk) who begin testosterone treatment should be reevaluated for prostate cancer 3 months and 1 year after beginning treatment and thereafter according to the standard of care. To qualify for Medicare coverage, procedures must be classified by the insurance company as medically necessary rather than cosmetic. Because levels are suppressed by glucose ingestion. Minneapolis, Minnesota 55455. Administration of testosterone to older men also increases muscle mass and, in some studies, increases muscle strength. All of the above makes analysis of testosterone deficiency treatment very difficult. The update was made in light of the U.S. Supreme Courts decision in Bostock v. Clayton County and subsequent court decisions. A possible exception is a hypogonadal man who had a radical prostatectomy for cancer confined to the prostate and has been free of disease and has had an undetectable PSA for at least 2 years. Similar estimates were obtained for deep vein thrombosis and pulmonary embolism outcomes. While several studies have investigated the association between testosterone and the risk of arterial thrombosis, limited information is available regarding its risk of VTE, outside of the known increased risk of VTE due to testosterone induced erythrocytosis. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Despite the recognition of MS as a reference technique, the reliability of results depends upon regular calibration maintenance, which is labor intensive and limits the ability to achieve consistently high throughputs without deterioration. Taken together, the evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular related eventsincluding non-fatal MI. Bhasin S, Brito JP, Cunningham GR, et al. Effect of testosterone solution 2% on testosterone concentration, sex drive and energy in hypogonadal men: Results of a placebo controlled study. The TTrials, in short, demonstrated that testosterone treatment of symptomatic older men with low testosterone levels is efficacious in improving sexual function, anemia, and bone density, all to modest degrees. Finkle WD, Greenland S, Ridgeway GK, et al. A man who has a history of prostate cancer should not be treated with testosterone. Although testosterone was not associated with more cardiovascular or prostate adverse events than placebo, a trial of a much larger and longer trial would be necessary to assess these risks with greater certainty. You should also find out if your plan has a specific medical policy with specific Medicare Advantage guidelines and conditions on coverage for transition-related care .If you have a Medicare Advantage plan, we recommend you apply for preauthorization before accessing transition-related care. been made to provide accurate and complete information, CMS does not guarantee that there are no errors in the information displayed Five studies had a high risk of bias, largely driven by unclear randomization and outcome assessment. Medically Necessary Treatment. special, incidental, or consequential damages arising out of the use of such information, product, or process. These results are also consistent with another 16 week placebo-controlled study of a different testosterone gel in 751 men with a mean age of 55 years who had low testosterone levels.18, Testosterone has long been recognized to stimulate the growth of muscles and increase muscle strength, resulting in greater muscle development during puberty in men than in women. Hormone replacement therapy can usually come in the form of pills, injectables, pellets, and topical or transdermal medications like creams, gels, and patches. without the written consent of the AHA. Doctor visits. 25 A systematic review and meta-analysis of 27 placebo-controlled Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials. Serum PSA levels increased from 1.14 0.86 ng/mL (mean 6 SD) at baseline by 0.47 1.1 ng/mL at 12 months in the testosterone group and from 1.25 0.86 ng/mL by 0.06 0.72 ng/mL in the placebo group. The possibility of skin transfer to another person is very low if the patient follows the package insert directions that include washing hands thoroughly after application and avoiding skin contact until the gel has dried completely. on this web site. The Tracking Sheet provides key details about the Proposed LCD, including a summary of the issue, who requested the new/updated policy, links to key documents, important process-related dates, who to contact with questions about the policy, and the history of previous policy considerations. Furthermore, testosterone therapy is associated with an increased risk in erythrocytosis, sleep apnea, and acne. Huang G, Pencina KM, Li Z, et al. Tests were administered at baseline, 6 months, and 12 months. Obesity can give rise to low testosterone, insulin resistance, the metabolic syndrome, and cardiovascular changes. Calof, et al.,32 performed a meta-analysis of RCTs to determine the risks of adverse events associated with testosterone replacement in older men. If your Medicare Advantage prescription drug plan or your Medicare Part D plan cover hormone replacement therapy drugs, your costs may vary depending on your plan. Its also important to have a doctors authorization notice at hand to inform that the medical treatment that you are seeking is mandatory. Applies To: Commercial and Medicaid Expansion. These costs include your plans premiums, deductibles, coinsurance, and copayments. The serum testosterone concentration at approximately 5 weeks would provide an approximate average for the interdosing period. If you are over 18 years old, you need a medical professional to provide documentation that it is medically necessary. You do not have to appeal with your insurer. WebMassHealth covers medically necessary puberty blockers and gender-affirming hormone therapy (GAHT). MACs develop an LCD when there is no national coverage determination (NCD) (e.g., when an item or service is new) or when there is a need to further define an NCD for the specific jurisdiction. Prostate-specific antigen (PSA) testing must be done within the last 12 months prior to prescribing testosterone AND there will be ongoing monitoring throughout therapy. Native testosterone is absorbed well from the intestine, but it is metabolized so rapidly by the liver that it is virtually impossible to maintain a normal serum testosterone concentration in a hypogonadal man with oral testosterone. NCDs do not contain claims processing information like diagnosis or procedure codes nor do they give instructions to the provider on how to bill Medicare for the service or item. All rights reserved. Applicable FARS\DFARS Restrictions Apply to Government Use. Testosterone treatment should not be initiated if the patient has a prostate nodule or induration, a PSA > 4 ng/mL or > 3 ng/mL in men at increased risk of prostate cancer (e.g., African American men or those who have a first-degree relative with diagnosed prostate cancer), a hematocrit > 48%, untreated severe OSA, or severe lower urinary tract symptoms.15, Due to the risk of erythrocytosis, all patients should undergo a baseline measurement of hemoglobin/hematocrit prior to commencing testosterone therapy. Among older men, the 2-fold increased risk was associated with testosterone prescription regardless of cardiovascular disease history, although this analysis was based on relatively small numbers of MI cases in each subgroup. Check your health insurance policy. If you change your name and/or sex after you enroll in a plan, you should be able to update the information when you log in. Sample sizes ranged from 101 to 790 men, and testosterone duration from 3 to 36 months. Both puberty blockers and GAHT are prescribed and managed by a health care provider trained in managing GAHT, like an endocrinologist or a PCP. In terms of long-term care for older women and men, the benefits of Medicare coverage may be limited. It is difficult to ascertain which condition caused the other. The significant association of low TT levels with high apnea-hypopnea index (AHI) values suggest that gonadal dysfunction is a consequence of OSA rather than a primary condition independent of the hypothalamic-pituitary-gonadal axis. In the men with anemia of known cause, testosterone also substantially increased the hemoglobin concentration by 1 g/dL (52% vs. 19%) and corrected the anemia (60% vs. 14.8%). The enrollees participated in 1 or more of 3 main trials (the Sexual Function Trial [n = 470], the Physical Function Trial [n = 390], and the Vitality Trial [n = 474]). Its usually triggered by a conflict between ones assigned gender marker at birth and their gender identity. Benefits that some Medicaid plans offer include: Prescription drug coverage. Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. This means that every time you see your therapist, you are responsible for that amount. Coverage for HRT as prescribed by a doctor will depend on your provider. Illness and certain medications, such as opiates and glucocorticoids, can temporarily affect testosterone concentrations through central and peripheral effects.11 When low testosterone is suspected, serum TT is initially measured, sometimes followed by measurement of FT. Additional laboratory tests may be required to characterize the etiology of hypogonadism as primary or secondary. All Rights Reserved (or such other date of publication of CPT). The main disadvantage of the topical agents are their high cost ($100 to $150 per month), as well as the potential risk of inadvertent transfer of hormone to women or children through skin contact. conducted a small retrospective review of 153 non obese men with obstructive sleep apnea (OSA) and found a significant association between OSA severity, oxygen desaturation index (ODI), and a reduced testosterone level in 3 men > age 50. A subgroup of 493 men in the TTrials met criteria for age-associated memory impairment (AAMI), based on subjective memory complaints and objective memory performance lower than younger men. In addition, theres a new Medicaid LCD document IDs begin with the letter "L" (e.g., L12345). Snyder PJ, Bhasin S, Cunningham GR, et al. From a clinical aspect, the same result should be obtained if blood was drawn from the same patient, at the same time, and sent to different laboratories, a scenario that is not common at present. However, the price to pay for hormone treatment can be restrictive and may get you to think twice. Serum testosterone levels are subject to variation diurnal, seasonal, and age-related. Such providers would be competent at addressing mental health needs of transgender people. This page displays your requested Local Coverage Determination (LCD). Unless you get extra help with your bills, you would be responsible for out-of-pocket costs. However, if you and your doctor believe the surgery is reasonable or medically necessary, you can appeal Medicares decision. This method is very complex and is typically only available in reference laboratories. CMS and its products and services are Overall, when hypogonadal older men with normal baseline PSA are treated with testosterone, 5% had an increase in PSA 1.7 ng/mL, and 2.5% had an increase 3.4 ng/mL. Medicare covers routine preventive care regardless of gender markers.Medicare covers routine preventive care, including mammograms, pelvic and prostate exams. No fee schedules, basic unit, relative values or related listings are included in CPT. This billing code should be used by your physician or hospital when submitting billing claims for services where gender mis-matches may be a problem. Sign up to get the latest information about your choice of CMS topics in your inbox. Variables include low testosterone level definition, clinical symptoms used for the diagnosis of hypogonadism, the population studied, and the inclusion or exclusion of comorbid conditions in older men.6, The Hypogonadism in Males (HIM) study estimated the prevalence of hypogonadism [TT < 300 ng/dl] in men aged 45 years visiting primary care practices in the U.S. Of 2162 patients, 836 were hypogonadal, rendering a prevalence rate of 38.7%. This email will be sent from you to the The primary trial endpoint was % change in noncalcified coronary plaque volume over the 12-month treatment period. WebOverview This is a general description of the benefits available through Indiana Medicaid (other than the Healthy Indiana Plan) based upon a member's eligibility. Potentially reversible pituitary disease or chronic diseases such as hemochromatosis, should be assessed with further testing. Elevated LH/FSH confirms primary hypogonadism and the potential need for replacement hormone. authorized with an express license from the American Hospital Association. 2) Try using the MCD Search and enter your information in the "Enter keyword, code, or document ID" box. Medicare covers medically necessary hormone therapy.Medicare also covers medically necessary hormone therapy for transgender people. If you are under 16, you need a medical professional to provide documentation that you are eligible and ready for the treatment and other requirements, such as proof that you understand the outcomes, risks, and benefits of beginning hormone therapy and that you have the necessary psychological and social support and your health insurance companys prior approval. Testosterone treatment of 1 year for older men with low testosterone was not associated with more cardiovascular events; however, the number of men and the duration of treatment were not sufficient to draw definitive conclusions about the risks. Thus, they excluded men with a history of prostate cancer and those whose risk (using the Prostate Cancer Risk Calculator) of any prostate cancer was > 35% and that of high-grade prostate cancer was > 7%. One transdermal patch (Androderm) is available in the U.S. An annual analysis from Out2Enroll shows that most insurers that offer silver marketplace plans through HealthCare.gov did not incorporate transgender exclusions in their individual market plans beginning with the 2017 plan year. No changes between Proposed LCD and Final LCD. You can appeal Medicares decision up to four times after your first appeal. However, estimates were accompanied by a wide 95% CIs, and a clinically important increased risk cannot be ruled out. You can read more about the types of services that Sample sizes ranged from 101 to 790 men, and testosterone duration from 3 to 36 months. If you are having an issue like this please contact, You are leaving the CMS MCD and are being redirected to the CMS MCD Archive that contains outdated (No Longer In Effect) Local Coverage Determinations and Articles, You are leaving the CMS MCD and are being redirected to, For services performed on or after 02/13/2022, For services performed on or after 05/05/2022, AMA CPT / ADA CDT / AHA NUBC Copyright Statement, Issue - Explanation of Change Between Proposed LCD and Final LCD, Coverage Indications, Limitations, and/or Medical Necessity, Symptomatic hypogonadism (congenital or acquired) due to a disorder of the testicles, pituitary gland, or brain, Gender dysphoria in a member who is able to make an informed decision to engage in hormone therapy. Every Medicare Advantage plan must cover everything that Original Medicare covers, and most Medicare Advantage plans may offer prescription drug coverage. Four testosterone gels (Androgel. It is prudent to make sure that traditional cardiovascular disease risk factors including smoking, hypertension, hyperlipidemia, and diabetes have been assessed and are appropriately managed in men prescribed testosterone replacement.

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