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1 Intramuscular (IM) 17α-Hydroxyprogesterone (Makena ): Progesterone for Prevention of Preterm Birth [For the list of services and procedures that need preauthorization, please refer to Go to Comunicados a Proveedores, and click Cartas Circulares.] Medical Policy: MP-RX Original Effective Date: May 27, 2010 Revised: June 15, 2016 Next Revision: June, 2017 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and Medical Card System, provider s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION 17α-Hydroxyprogesterone (Makena ), also commonly called hydroxyprogesterone caproate, 17OHP-C, or 17P, is a synthetic progestin that is administered via intramuscular (IM) injection. Hydroxyprogesterone caproate has been designated an orphan drug by the United States Food & Drug Administration (FDA) for preterm birth risk reduction. The effectiveness of Makena is based on improvement in the proportion of women who delivered at less than 37 weeks of gestation. It has been classified in FDA pregnancy risk category B under the conditions of the intended use. No adequate and well-controlled studies exist in women during the first trimester of pregnancy. Direct clinical benefit (e.g., improvement in neonatal morbidity and mortality) has not been established. While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate have been demonstrated only in a selected group of women, which will be further detailed in the Indications Section of this medical policy. The American College of Obstetricians and Gynecologists (ACOG) recommends that progesterone supplementation for the prevention of recurrent preterm birth be offered to women with a singleton pregnancy and a prior spontaneous preterm birth at less than 37 weeks of gestation due to spontaneous preterm labor or premature rupture of membranes (AHFS, 2016). COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage. INDICATIONS (MCS) considers the administration of Intramuscular (IM) 17αhydroxyprogesterone (also 17P/Makena ) as medically necessary for Both the Commercial and Classicare (Advantage) Lines of Business (LOB), for risk reduction of preterm labor, when All of the following criteria are met: 1

2 1. Female patient is 16 years of age or older; and 2. History of spontaneous preterm birth (<37 weeks); and 3. Singleton pregnancy; and 4. When initiating treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation; and 5. Treatment will be completed when the pregnancy reaches 37 weeks of gestation or birth; whichever comes first. LIMITATIONS 1. 17α-Hydroxyprogesterone s (Makena ) recommended administration period is limited, as per the American College of Obstetricians & Gynecologists (ACOG), starting at weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth. 2. While there are many risk factors for preterm birth, safety and efficacy of 17α- Hydroxyprogesterone (Makena ) has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is Not intended and Not medically covered for use in women with multiple gestations or other risk factors for preterm birth α-Hydroxyprogesterone (Makena ) is Not intended for use to stop active preterm labor. The effect of Makena in active labor is unknown. Therefore, the use of this drug for this aforementioned use is Not medically covered. 4. Safety and effectiveness in pediatric patients less than 16 years of age have not been established. Therefore, the use of this drug for female patients with <16 years of age is Not medically covered α-Hydroxyprogesterone (Makena ) is Not intended for use in postmenopausal women. Safety and effectiveness in postmenopausal women have not been established. Therefore, the use of Makena for postmenopausal women is Not medically covered. 6. Insufficient evidence exists to assess if 17α-Hydroxyprogesterone (Makena ) and cerclage together have an additive effect in reducing the risk of preterm birth in women at high risk for preterm birth. Therefore, the use of these two methods together is Not medically covered. CONTRAINDICATIONS/WARNINGS 1. Known sensitivity to the drug or any ingredient (e.g., castor oil or benzyl alcohol) in the formulation. Allergic reactions, including urticaria, pruritus, and angioedema have been 2

3 reported with use of hydroxyprogesterone and other products containing castor oil. Discontinue use if allergic reactions occur. 2. Patients with current or history of thrombosis or thromboembolic disorders. 3. Patients with known, suspected or past history of breast cancer or other hormone-sensitive cancers, such as cervical cancer, uterine cancer, or vaginal cancer. 4. Undiagnosed abnormal vaginal bleeding, unrelated to pregnancy. 5. Patients with hepatocellular cancer, benign liver tumors, or active hepatic disease. 6. Patients with cholestatic jaundice of pregnancy. 7. Patients with uncontrolled hypertension. Close monitoring of patients who develop hypertension while receiving therapy is recommended; careful consideration should be given to whether the benefit of use warrants continuation of therapy α-Hydroxyprogesterone (Makena ) should be used cautiously in patients with diabetes mellitus and prediabetes, as decreased glucose tolerance has been observed in some patients with progestin treatment α-Hydroxyprogesterone (Makena ) should be used cautiously in patients with a history of depression, for it may exacerbate this condition in some patients α-Hydroxyprogesterone (Makena ) may cause some degree of fluid retention. Therefore, use hydroxyprogesterone cautiously in patients with preeclampsia, cardiac disease, renal dysfunction, epilepsy, asthma or any other condition that might be influenced by this effect. 11. Postmarketing surveillance of hydroxyprogesterone included reports of cervical incompetence, premature rupture of membranes, cervical dilation, shortened cervix, and urinary tract infection, among others. HOME SERVICES 1. Medical necessity for home management for the administration of intramuscular 17αhydroxyprogesterone (Makena ) will be evaluated independently. 2. MCS requires that home visits be recorded in the progress notes and appointments must be recorded on a patient tracking form. ADMINISTRATION 1. Weekly intramuscular (IM) injection only (every 7 days); Not to be administered via intravenous (IV) administration. 3

4 2. 17α-Hydroxyprogesterone (Makena ) is administered by slow IM injection (over 1 minute or longer) by a clinician, and should not be self-administered by the patient. CODING INFORMATION CPT Codes (List may not be all inclusive) CPT Codes DESCRIPTION Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular. *Current Procedural Terminology (CPT ) 2016 Professional Edition. American Medical Association: Chicago, IL. HCPCS CODES (List may not be all inclusive) HCPCS CODES DESCRIPTION J1725 Injection, hydroxyprogesterone caproate, 1mg S9208 Home management of preterm labor, including administrative services, professional pharmacy services, care coordination, and all necessary supplies or equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code). [This HCPCS Code should only be reported with female patients]. *2016 HCPCS LEVEL II Professional Edition (American Medical Association). Note 1 : S-codes are excluded for Classicare LOB. S-codes only apply to Commercial LOB claims. ICD-10 Codes (List may not be all inclusive) ICD-10-Codes DESCRIPTION O Supervision of pregnancy with history of preterm labor, second trimester O Supervision of pregnancy with history of preterm labor, third trimester REFERENCES 1. AMAG Pharmaceuticals, Inc. (2016). AMAG Pharmaceuticals Announces FDA Approval of New Single-Dose, Preservative-Free Makena (hydroxyprogesterone caproate injection). Released: February 23, Accessed June 14, Available at URL address: Announces-FDA-Approval-of-New-Single-Dose-Preservative-Free-Makena-hydroxyprogesteronecaproate-injection.html 2. AMAG Pharmaceuticals, Inc. (2016). News Release: AMAG Pharmaceuticals Announces the U.S. Commercial Launch of New Single-Dose, Preservative-Free Makena (hydroxyprogesterone caproate injection). Released: April 4, Accessed June 14, Available at URL address: 4

5 3. American College of Obstetricians and Gynecologists (ACOG) (2016). Practice Bulletin (Clinical Management Guidelines for Obstetrician-Gynecologist): List of Titles for February Accessed June 7, Available at URL address: 4. American College of Obstetricians and Gynecologists (ACOG) (2016). Practice Bulletin [PB] (Clinical Management Guidelines for Obstetrician-Gynecologists) Number 130: Prediction and Prevention of Preterm Birth. Published Date: October Accessed June 7, Available at URL address: mbirth_oct2012.pdf 5. American College of Obstetricians and Gynecologists (ACOG) (2013). 17P Plus Cerclage Decreases Preterm Labor Risk. Publication Date: May 6, Accessed June 14, Available at URL address: Releases/2013/17P-Plus-Cerclage-Decreases-Preterm-Labor-Risk 6. American College of Obstetricians and Gynecologists (ACOG), District II (2009). Preventing Preterm Birth: The Role of 17α Hydroxyprogesterone Caproate. Accessed June 7, Available at URL address: 7. American College of Obstetricians and Gynecologists (ACOG) (2008). Committee Opinion Use of progesterone to reduce preterm birth. Number 419, October Accessed June 7, Available at URL address: n.pdf 8. American College of Obstetricians and Gynecologists (ACOG) with the Society for Maternal-Fetal Medicine (SMFM) (2011). Information Update on 17a-Hydroxyprogesterone Caproate (17P). Publication Date: October 13, Accessed June 7, Available at URL address: 9. American Hospital Formulary Service (AHFS) Drug Information (2016). Hydroxyprogesterone Caproate (68:32): pp American Society of Health-System Pharmacists: Bethesda, MD. Accessed June 7, American Journal of Obstetrics & Gynecology (AJOG) with the Society for Maternal-Fetal Medicine (SMFM) (2012). Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Published: May Accessed June 7, Available at URL address: Da Fonseca, E.B.; Bittar, R.E.; Damião, R.; Zugaib, M. (2009). Prematurity prevention: the role of progesterone. Curr Opin Obstet Gynecol., 21(2): Accessed June 7, Available at URL address: Da Fonseca, E.B., Bittar, R.E., Carvalho, M.H, Zugaib, M. (2003, Feb). Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. American 5

6 Journal of Obstetrics and Gynecology, 188(2), Accessed June 7, Available at URL address: Gold Standard / Elsevier. Clinical Pharmacology (2014). Hydroxyprogesterone. Last Revision: January 9, Accessed June 7, Available at URL address: sterone&t=0 14. Lumara Health (2016). Makena (hydroxyprogesterone caproate injection) Billing Guide. Accessed June 9, Available at URL address: Lumara Health (2016). Highlights of Prescribing Information (Package Insert) for Makena (Hydroxyprogesterone Caproate) for intramuscular use. Initial U.S. Approval: Revised 12/2015. Accessed June 9, Available at URL address: Meis P.J., Society for Maternal-Fetal Medicine (2005). 17 hydroxyprogesterone for the prevention of preterm delivery, 105(Pt 1), Accessed June 9, 2016 Available at URL address: Meis, P.J., Klebanoff, M., Thom, E., Dombrowski, Sibai, B., Moawad, A.H., Spong, C.Y. (2003). Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate. The New England Journal of Medicine, 348(24), Accessed June 9, Available at URL address: Micromedex DrugPoint Summary (2016). Hydroxyprogesterone Caproate Indications and Contraindications. Accessed June 7, Available at URL address: National Institute of Health (NIH) (2007, August 1). NIH News Releases - Progesterone Treatment Does Not Prevent Preterm Birth in Twin Pregnancy. Accessed June 9, Available at URL address: Patel, Y. & Rumore, M. (2012, July). Controversies in Practice: Hydroxyprogesterone Caproate Injection (Makena) One Year Later. Pharmacy and Therapeutics, 37(7), Accessed June 9, Available at URL address: and at URL address: UpToDate / Norwitz, E.R. (2016). Progesterone supplementation to reduce the risk of spontaneous preterm birth. Literature review current through: May This topic last updated: March 29, Accessed June 16, Available at URL address: 6

7 22. U.S. Food & Drug Administration (FDA) (2012, June 15). Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena). Page Last Updated: 08/03/2012. Accessed June 9, Available at URL address: U.S. Food & Drug Administration (FDA) (2006). 17α-Alpha Hydroxyprogesterone Caproate for Prevention of Preterm Birth. Overview of FDA Background Document. Accessed June 9, Available at URL address: 01-FDA-Background.pdf 24. U.S. National Library of Medicine (NLM) / National Institutes of Health / Health & Human Services / DailyMed (2016). Highlights of Prescribing Information (Package Insert) for hydroxyprogesterone caproate injection for intramuscular use. Updated March 4, Accessed June 9, Available at URL address: Watson Laboratories, Inc. (2009). Progesterone Injection USP in Sesame Oil for Intramuscular Use Only Rx only *E1. Revised: 2/2009 (Archived). Accessed June 9, Available at URL address: POLICY HISTORY DATE ACTION COMMENT May 27, 2010 Origination of Policy June 15, 2011 Yearly revision July 9, 2012 Revised References updated. To the Exclusion Criteria Section: Added Uncontrolled for Hypertension. To the Contraindications Section: Changes were made to: #5, #7, #10 & #11. New Contraindications #12-18 were added. To the Coding Information Section: Deleted HCPCS Code J3490 = Unclassified drug. Added new HCPCS Code J1725=Injection, hydroxyprogesterone caproate, 1mg. June 24, 2013 Revised References updated. Added new references: numbers 2, 5-10, 19, 21, & To the Administration Section added: Hydroxyprogesterone is administered by slow IM injection (over 1 minute or longer) by a clinician, and should not be selfadministered by the patient. August 8, 2013 Revised References updated. February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section was added to the policy. 7

8 June 24, 2014 Revised References updated. New references were added, numbers 8, 16, & 23. To the Description Section: Deleted: Preterm birth is defined as a delivery that takes place between approximately 22 weeks gestation (the time of fetal viability) and 37 weeks gestation; birth before 22 weeks gestation is considered a miscarriage. Hydroxyprogesterone caproate is a synthetic derivative of progesterone sharing the pharmacologic actions of all progestins. 17α-hydroprogesterone (17-P) has minimal progestational activity; however, the esterified form, hydroxyprogesterone caproate has significant progesterone effects and a prolonged duration of action, from 7 to 14 days. The drug also has reported androgenic, estrogenic, and glucocorticoid activity. Hydroxyprogesterone caproate is used for the treatment of amenorrhea and for the treatment of dysfunctional uterine bleeding caused by fibroids or uterine cancer. The drug stimulates a proliferative endometrium into secretion as well as stimulates the growth of mammary alveolar tissues. Hydroxyprogesterone caproate s mechanism of action in endometrial cancer is not understood; however, the drug has antineoplastic activity. Although progestins have been used in the first trimester of pregnancy to prevent habitual abortion or threatened abortion, their use is not without risk and adverse effects. All progestins, including hydroxyprogesterone caproate have potential teratogenic effects including female fetus masculinization. They have a pregnancy use category of D where studies have demonstrated fetal risk, but that use of the drug may outweigh potential risks. More recent research studies use hydroxyprogesterone caproate to prevent preterm labor during second trimester when teratogenic risk is disminished. Preterm births occur in approximately one of every eight pregnancies and result in significant morbidity and mortality. The precise mechanism for hydroxyprogesterone caproate in prevention of preterm labor and delivery is unknown, although it is understood that progesterone has beneficial effects towards the maintenance of pregnancy. In the past intramuscular (IM) injections of 17 alpha hydroxyprogesterone were used routinely to prevent premature labor. However, the drug was shown to have teratogenic (tending to produce abnormalities in the formative or developmental stage). Most recently there has been renewed research interest in intramuscular injection of 17-alphahydroxyprogesterone caproate (17P). 17P is a weakly acting naturally occurring progesterone metabolite, which when coupled with Caproate dextram works as a long acting progestin when administered intramuscularly. 17P is not commercially available, but can be manufactured locally by compounding pharmacies. Intravaginal progesterone suppositories have also been investigated. The American College of Obstetricians and Gynecologists (ACOG) Committee released the following opinion on 2008 and reaffirmed it on 2011: Recent studies support the hypothesis that progesterone supplementation reduces preterm birth in a select group of women. Despite the apparent benefits of progesterone, the ideal progesterone formulation is unknown. The American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice and the Society for Maternal Fetal Medicine believe that further studies are needed to evaluate the optimal preparation, dosage, route of administration, and other indications for the use of progesterone for the prevention of preterm delivery. Based on current knowledge, it is important to offer progesterone for pregnancy prolongation to only women with a documented history of a previous spontaneous birth at less than 37 weeks of gestation. Added: 17α-Hydroxyprogesterone, also commonly called hydroxyprogesterone caproate, 17OHP-C, or 17P, is a synthetic progestin that is administered via Intramuscular (IM) injection. This drug is used to reduce the risk of preterm birth in women with a 8

9 singleton pregnancy, who have a history of single spontaneous preterm birth. Hydroxyprogesterone caproate has been designated an orphan drug by the United States Food & Drug Administration (FDA) for this use. Direct clinical benefit (e.g., improvement in neonatal morbidity and mortality) has not been established. While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate have been demonstrated only in a selected group of women, which will be detailed later on under the Indications Section of this medical policy. The American College of Obstetricians and Gynecologists (ACOG) recommends that progesterone supplementation for the prevention of recurrent preterm birth be offered to women with a singleton pregnancy and a prior spontaneous preterm birth at less than 37 weeks of gestation due to spontaneous preterm labor or Premature Rupture of Membranes (PROM) (AHFS, 2013). To the Contraindications/Limitations Section: To #4 deleted: or cerebral apoplexy. Deleted #6: Missed abortion. To the Administration Section: To #1 deleted information inside de parenthesis after Weekly intramuscular (IM) injection: suggested range of time in between injections is 5 to 9 days, progesterone stays in the body for approximately; and information was rewritten as to read as it follows: (every 7 days). February 9, 2015 Revised Revised and modified title to read as it follows: Intramuscular (IM) 17α- Hydroxyprogesterone (Makena ): Progesterone for Prevention of Preterm Birth. To the References Section: References updated. New references were added, numbers 2-3, & Deleted: American College of Obstetricians and Gynecologists (ACOG) (2012). Practice Bulletin (PB): Management of preterm labor. PB Number 127. Obstetrics Gynecology 119 (6): Available at URL address: Deleted: American Congress of Obstetricians and Gynecologists (ACOG) (2013). Important Updates on State Legislation, Rules and Medicaid: 17-Hydroxyprogesterone Caproate Benefit Updated. Available at URL address: XI/Important%20Updates.aspx. Deleted: National Guideline Clearinghouse (NGC) (2012, June 10). Guideline Title: Management of preterm labor. Bibliographic Source: Management of preterm labor; 2012 Jun. 10 p. (ACOG practice bulletin; no. 127). Available at URL address: To the Indications Section: Revised and modified coverage statement to read as it follows: (MCS) considers the administration of Intramuscular (IM) 17α-hydroxyprogesterone (also 17P/Makena ) as medically necessary for Both the Commercial and Classicare (Advantage) Lines of Business (LOB), for risk reduction of preterm labor, when All of the following criteria are met. Added new Indication #1, as stated by the US FDA: Female patient is 16 years of age or older. Deleted Note 1: Initiation for late prenatal care, 17P may be initiated as late as 26 weeks, 6 days gestation. Deleted Note 2: Progesterone therapy as a technique to prevent preterm labor is considered experimental/investigational in pregnant women with other risk factors for preterm delivery, including but not 9

10 limited to, multiple gestations, short cervical length, positive tests for cervicovaginal fetal fibronectin, and a prior cervical cerclage or a uterine anomaly. To the Limitations Section: Created new section separated from the Contraindications Section. Added the following Limitations: 1. 17α-Hydroxyprogesterone (Makena ) administration period is limited, as per the American College of Obstetricians & Gynecologists (ACOG), to weeks of gestation, regardless of trans-vaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth. 2. While there are many risk factors for preterm birth, safety and efficacy of 17α-Hydroxyprogesterone (Makena ) has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is Not intended and Not medically covered for use in women with multiple gestations or other risk factors for preterm birth α-Hydroxyprogesterone (Makena ) is Not intended for use to stop active preterm labor. The effect of Makena in active labor is unknown. Therefore, the use of this drug for this aforementioned use is Not medically covered. 4. Safety and effectiveness in pediatric patients less than 16 years of age have not been established. Therefore, the use of this drug for female patients with <16 years of age is Not medically covered α-Hydroxyprogesterone (Makena ) is Not intended for use in postmenopausal women. Safety and effectiveness in postmenopausal women have not been established. Therefore, the use of Makena for postmenopausal women is Not medically covered. 6. Insufficient evidence exists to assess if 17α-Hydroxyprogesterone (Makena ) and cerclage together have an additive effect in reducing the risk of preterm birth in women at high risk for preterm birth. Therefore, the use of these two methods together is Not medically covered. To the Contraindications/Warnings Section: Deleted: Multi-fetal pregnancy. Deleted: Short cervix and no prior preterm birth. Deleted: Previous medically indicated preterm birth. Revised and modified order of Contraindications/Warnings, as per the Pharmacy Compendium: Clinical Pharmacology (CP). To #1, added to parenthesis: & benzyl alcohol. To #2 revised and modified content to read as it follows: Patients with current or history of thrombosis or thromboembolic disease. To #3 revised and modified content to read as it follows: Patients with known, suspected or past history of breast cancer or other hormonesensitive cancers, such as cervical cancer, uterine cancer, or vaginal cancer. To #5 revised and modified content to read as it follows: Patients with hepatocellular cancer, benign liver tumors, or active hepatic disease. To #8 revised and modified content to read as it follows: 17α- Hydroxyprogesterone (Makena ) should be used cautiously in patients with diabetes mellitus. To #9 & #10, added at beginning: 17α-Hydroxyprogesterone (Makena ). Deleted: Safety and efficacy have not been established for postmenopausal females (for 50 years of age). Therefore, the use is not intended for postmenopausal females. Deleted: Safety and efficacy have not been established in Infants, Children, and Adolescents < 16 years of age. Deleted: Hydroxyprogesterone is not intended for use to stop active 10

11 preterm labor; its effect in active labor is unknown. Deleted: Hydroxyprogesterone is not indicated for use in neonates or infants, and studies continue to study the effect of hydroxyprogesterone on neonatal outcomes following maternal use. To the Administration Section: To #1 added: Not to be administered via intravenous (IV) administration. To #2 added at beginning: 17α-Hydroxyprogesterone (Makena ). To the Exclusion Criteria Section: Deleted entire Section. Deleted: Known Fetal Anomaly; Current or Planned Cervical Cerclage; & Seizure Disorders. June 15, 2016 Revised References updated. Added #1, 2 & 18. Deleted #5, 14, 15, 17 & 26 To the Description Section: Opening sentence: Replaced this use with preterm birth risk reduction. Added: The effectiveness of Makena is based on improvement in the proportion of women who delivered at less than 37 weeks of gestation. It has been classified in FDA pregnancy risk category B under the conditions of the intended use. No adequate and wellcontrolled studies exist in women during the first trimester of pregnancy. Replaced later on with further detailed on. To the Indications Section: To #1: Added words recommended and starting at. To the Contraindications/Warnings Section: To #1: Added sentence: Allergic reactions, including urticaria, pruritus, and angioedema have been reported with use of hydroxyprogesterone and other products containing castor oil. Discontinue use if allergic reactions occur. To #7: Added sentence: Close monitoring of patients who develop hypertension while receiving therapy is recommended; careful consideration should be given to whether the benefit of use warrants continuation of therapy. To #8: Added phrase and prediabetes, as decreased glucose tolerance has been observed in some patients with progestin treatment. Added new contraindication #11: Postmarketing surveillance of hydroxyprogesterone included reports of cervical incompetence, premature rupture of membranes, cervical dilation, shortened cervix, and urinary tract infection, among others. To the Home Services Section: Rephrased sentence: Deleted at home services and used for home management. To the Coding Section: Added new ICD-10-CM codes: O09.212, O & O Deleted ICD-10 codes: O60.00, O60.02, O60.03, O60.10X0, O60.10X1, O.60.10X2, O60.10X3, O60.10X4, O60.10X5, O60.10X9, O60.20X0, O60.20X1, O60.20X2, O60.20X3, O60.20X4, O60.20X5, O60.20X9, Z

12 This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member s plan in effect as of the date services are rendered., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion., (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide. 12