Medical Coverage Guidelines are subject to change as new information becomes available.

Transcription

1 ABORTION Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. Description: Spontaneous Abortion: Commonly referred to as miscarriage. The delivery or loss of the products of conception before the 20 th week of pregnancy without induction or instrumentation. Fetal weight is approximately 500 grams. Non-Spontaneous Abortion: Medically-induced abortion. The purposeful interruption of an intrauterine pregnancy with the intention other than to produce a live born infant. A medically-induced abortion can be by surgical or non-surgical means. O230.8.docx Page 1 of 8

2 Description: (cont.) Non-Viability: To a reasonable degree of medical probability, the fetus is not expected to live longer than 30 days outside of the womb. A fetus is not considered non-viable for purposes of this provision if a pregnancy is terminated at a stage of pregnancy too early to determine viability. Viability: To a reasonable degree of medical probability, the fetus is expected to live longer than 30 days outside of the womb. Fetal and/or Multi-Fetal Reduction: Fetal and/or multi-fetal reduction is the selective first-trimester termination of a fetus or fetuses. Selective termination of an anomalous fetus in a multiple pregnancy is usually a second-trimester procedure. Surgical Abortions: Surgical abortions include vacuum aspiration, dilation & evacuation, dilation & extraction and induction. O230.8.docx Page 2 of 8

3 Description: (cont.) Non-Surgical Abortion: Medications administered to induce abortion. Medications include: Mifeprex (mifepristone) Also known as RU-486. Mifeprex is an antiprogesterone administered orally. Used alone or in combination with misoprostol to end an early pregnancy defined as 49 days (7 weeks) or less, as calculated from the beginning of last menstrual period. Mifeprex is administered by a healthcare provider. Cytotec (misoprostol) Cytotec is a prostaglandin administered orally or vaginally. Used alone or in combination with mifepristone to end an early pregnancy defined as 49 days (7 weeks) or less, as calculated from the beginning of last menstrual period. Cytotec is administered or dispensed by a healthcare provider. Methotrexate Methotrexate is an antimetabolite administered orally or as an injection. Used in combination with misoprostol to end an early pregnancy defined as 49 days (7 weeks) or less, as calculated from the beginning of last menstrual period. Methotrexate is administered by a healthcare provider. Hemabate (carboprost tromethamine) Hemabate is a prostaglandin administered intramuscularly. Used between the 13th and 20th gestational week, as calculated from the beginning of last menstrual period. Hemabate is administered by a healthcare provider. Prostin E2 (dinoprostone) Prostin E2 is a prostaglandin administered vaginally. Used between the 12th and 20th gestational week, as calculated from the beginning of last menstrual period. Prostin E2 is administered by a healthcare provider. O230.8.docx Page 3 of 8

4 Criteria: Abortion: ABORTION IS COVERED IN VERY LIMITED CIRCUMSTANCES IN MOST PLANS. REFER TO THE MEMBER S SPECIFIC BENEFIT PLAN BOOK. If benefit coverage for abortion is available, non-spontaneous, medically-induced abortion (by surgical or non-surgical means) of a fetus, including fetal and/or multi-fetal reductions is considered eligible for coverage. If benefit coverage for abortion is available, the following medications administered and/or dispensed in an office-based setting are considered eligible for coverage when given as part of a non-spontaneous, medically-induced abortion that is medically necessary and eligible for coverage: 1. Mifepristone (Mifeprex) 2. Misoprostol (Cytotec) 3. Methotrexate 4. Carboprost tromethamine (Hemabate) 5. Dinoprostone (Prostin E2) If benefit coverage for abortion is not available, non-spontaneous, medically-induced abortion (by surgical or non-surgical means) of a fetus, including fetal and/or multi-fetal reductions is a benefit plan exclusion and not eligible for coverage. Medically Necessary Abortion: Non-spontaneous, medically-induced abortion when the treating physician certifies in writing that the pregnancy would endanger the life or health of the mother is considered medically necessary and eligible for coverage. Non-spontaneous, medically-induced abortion because the fetus is/will be non-viable is considered medically necessary and eligible for coverage. A fetus is not considered non-viable for purposes of this provision if a pregnancy is terminated at a stage of pregnancy too early to determine viability. The following medications administered and/or dispensed in an office-based setting are considered eligible for coverage when given as part of a non-spontaneous, medically-induced abortion that is medically necessary and eligible for coverage: 1. Mifepristone (Mifeprex) 2. Misoprostol (Cytotec) 3. Methotrexate 4. Carboprost tromethamine (Hemabate) 5. Dinoprostone (Prostin E2) O230.8.docx Page 4 of 8

5 Criteria: (cont.) Medically Necessary Abortion for Plans Receiving Public Funds or Tax Monies That Have Elected This Benefit Option: Non-spontaneous, medically-induced abortion is considered medically necessary and eligible for coverage when the treating physician certifies in writing that the abortion is medically necessary in order to save the life of the mother or to avert substantial and irreversible impairment of a major bodily function of the woman having the abortion. Note: Notwithstanding any other law, public monies or tax monies of this state or any political subdivision of this state SHALL not be expended directly or indirectly to pay the costs, premiums or charges associated with a health insurance policy, contract or plan that provides coverage, benefits or services related to the performance of any abortion unless an abortion is necessary to either: 1. Save the life of the woman having the abortion 2. Avert substantial and irreversible impairment of a major bodily function The following medications administered and/or dispensed in an office-based setting are considered eligible for coverage when given as part of a non-spontaneous, medically-induced abortion that is medically necessary and eligible for coverage: 1. Mifepristone (Mifeprex) 2. Misoprostol (Cytotec) 3. Methotrexate 4. Carboprost tromethamine (Hemabate) 5. Dinoprostone (Prostin E2) Abortion for Plans Specifically Excluding Abortion: Non-spontaneous, medically-induced abortion is a benefit plan exclusion and not eligible for coverage. O230.8.docx Page 5 of 8

6 Resources: 1. American College of Obstetricians and Gynecologists. Committee Opinion; Multi-Fetal Pregnancy Reduction & Selective Fetal Termination. 04/1991; 2000 (94). 2. American College of Obstetricians and Gynecologists. Committee Opinion; Perinatal & Infant Mortality Statistics. Compendium of Selected Publications. 12/1995; 2000 (167). 3. American College of Obstetrics and Gynecologists. Compendium of Selected Publications American College of Obstetricians and Gynecologists. Induced Abortion Frequently Asked Questions. Accessed 05/01/ Arizona Revised Statutes State health care exchange; abortion coverage; prohibition; exceptions. Accessed 10/23/2011; 05/08/ Arizona Revised Statutes Use of Public Funds or Insurance for Abortion Prohibited; exception. Accessed 10/23/2011; 05/08/ Blue Cross Blue Shield of Arizona. Benefit Plan Booklet. 8. External Consultant Review. Clinical Pharmacist. 01/31/ InterQual Care Planning Criteria; Procedures Adult. Obstetrics & Gynecology. 10. National Guideline Clearinghouse. Medical Management of Abortion. 12/17/ State of Arizona. Arizona Senate Bill Stubblefield PG, Carr-Ellis S, Borgatta L. Methods for induced abortion. Obstet Gynecol. Jul 2004;104(1): The Merck Manual. 17 th Edition O230.8.docx Page 6 of 8

7 Resources: (cont.) FDA Product Approval Information for Hemabate: - FDA-approved indication: Hemabate Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. FDA Product Approval Information for Prostin E2: - FDA-approved indication: Prostin E2 Vaginal Suppository is indicated for the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period. Prostin E2 is also indicated for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Prostin E2 is indicated in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). O230.8.docx Page 7 of 8

8 Resources: (cont.) FDA Product Approval Information for Mifeprex: - FDA-approved indication: Mifeprex is indicated for the medical termination of intrauterine pregnancy through 49 days pregnancy. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 day cycle with ovulation occurring at mid-cycle. The duration of pregnancy may be determined from menstrual history and by clinical examination. Ultrasonographic scan should be used if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected. Treatment with Mifeprex and misoprostol for the termination of pregnancy requires three office visits by the patient. Mifeprex should be prescribed only by physicians who have read and understood the prescribing information. Mifeprex may be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Physicians must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary. Day One: Mifeprex Administration Patients must read the Medication Guide and read and sign the patient agreement before Mifeprex is administered. Three 200 mg tablets (600 mg) of Mifeprex are taken in a single oral dose. Day Three: Misoprostol Administration The patient returns to the healthcare provider two days after ingesting Mifeprex. Unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two 200 μg tablets (400 μg) of misoprostol orally. During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms (see ADVERSE REACTIONS). The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of the misoprostol. In addition, the name and phone number of the physician who will be handling emergencies should be provided to the patient. Day 14: Post-Treatment Examination Patients will return for a follow-up visit approximately 14 days after the administration of Mifeprex. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred. O230.8.docx Page 8 of 8