COVENTRY HEALTH CARE OF ILLINOIS, INC. COVENTRY HEALTH CARE OF MISSOURI, INC. Medical Management Policy and Procedure PROPRIETARY

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1 COVENTRY HEALTH CARE OF ILLINOIS, INC. COVENTRY HEALTH CARE OF MISSOURI, INC. Medical Management Policy and Procedure PROPRIETARY Policy: Infertility Evaluation and Treatment Number: MM 1306 Date Effective: 02/25/11 Page: 1 of 11 Approved By: Utilization Management Committee Approval Date: 1/24/13 1/24/13 1/24/13 VP, Medical Affairs Date VP, Health Services Date Policy Review: 2/25/11 2/17/12 1/24/13 Policy Revisions: 2/17/12 Replaces Illinois Policy #: UM A Replaces Missouri Policy #: Applicable Health Plans: Coventry Health Care of Missouri, Inc. Policy and Procedure has been reviewed for compliance with all HIPAA policies and procedures Scope: This policies apply to HMO, POS, PPO products with infertility benefits. ASO requirements may vary by groups. Purpose: To outline and specific and systematic process for Medical Management to review and identify eligibility requirements for infertility diagnosis and treatment for members.

2 Page 2 of 11 Definitions Term or Acronym AI ART Embryo Embryo Transfer Gamate GIFT Definition Artificial insemination is the introduction of sperm into a woman s vagina or uterus by noncoital methods for the purpose of conception. Assisted Reproductive Technologies are treatments and/or procedures in which the human oocytes are retrieved and the human oocytes and/or embryos are manipulated in the laboratory. ART shall include the prescription drug therapy used during the cycle where an oocyte retrieval is performed. A fertilized egg that has begun cell division and has completed the pre-embryonic stage. The placement of the pre-embryo into the uterus or, in the case of zygote intrafallopian tube transfer, into the fallopian tub A reproductive cell. In man, the gametes are sperm; in a woman, they are eggs or ovum. Gamate Intrafallopian Tube Transfer - the direct transfer of a sperm/egg mixture into the fallopian tube. Fertilization takes place inside the tube. Infertility The inability to conceive after one year of unprotected sexual intercourse or the inability to sustain a successful pregnancy. A woman shall be considered infertile without having to engage in one year of unprotected sexual intercourse. The physician may determine that a medical condition exists that renders conception impossible through unprotected sexual intercourse, or efforts to conceive as a result of one year of medically based and supervised methods of conception have failed and are not likely to lead to a successful pregnancy. ICSI IVF Intracytoplasmic spermatocyte injection is a micromanipulation technique whereby a single sperm is injected into an egg. In Vitro Fertilization is a process in which an egg and a sperm are combined in a laboratory dish where fertilization occurs. The fertilized and dividing egg is transferred into the woman s uterus.

3 Page 3 of 11 Low Tubal Ovum Transfer The procedure in which oocytes are transferred past a blocked or damaged section of the fallopian tube to an area closer to the uterus. Oocytes Oocyte Retrieval The female egg or ovum, formed in a ovary. The procedure by which eggs are obtained by inserting a needle into the ovarian follicle and removing the fluid and the egg by suction. Also called ova aspiration. Sexual Intercourse Zygote Sexual union between a male and a female. A fertilized egg before cell division begins. Policy: 1. Coventry Health Care of Illinois covers Infertility Evaluation and medically necessary Treatment when a member meets all of the following: a. Is enrolled in a fully insured group (HMO, POS, PPO) with more than twentyfive (25) employees. b. Must be a resident of the State of Illinois. c. Member or partner is infertile, as that term is defined in Illinois, who: Female has been unable to conceive after one year of unprotected sexual intercourse; Female has been unable to sustain a successful pregnancy; Female or male has been diagnosed by a physician as having a medical condition that renders conception impossible through unprotected sexual intercourse; or Female has undergone one year of medically based and supervised methods of conception, including artificial insemination, which a physician has determined to have failed and are not likely to lead to a successful pregnancy. Member or partner has not undergone a previous elective sterilization procedure. Female has not undergone their lifetime maximum of complete oocyte retrievals. 2. Coventry Health Care of Missouri provides coverage for the diagnosis of organic infertility only. This means that if the member or their spouse has ever been sterilized, there will be no benefits assigned to the member for infertility.

4 Page 4 of 11 Procedures: Coventry Health Care of Illinois covers the following Infertility Services : 1. Infertility evaluation which may include some, or all, of the following: Hysterosalpingogram Post coital test Basal body temperature charting Ovulation study: Endocrine profile LH, FSH, Estradiol, Chlamydial antibody testing, Testosterone, Prolactin, DHEAS, TSH, T-3, T-4 Serum progesterone level in luteal phase Semen analysis (covered only if spouse is a PersonalCare member) Pelvic ultrasound (1 initial diagnostic ultrasound) Cervical cultures, if appropriate Endometrial biopsy (maximum of 1) Laparoscopy or Hysteroscopy (maximum of 1) Clomid challenge (lifetime maximum of one Clomid challenge with 5 tablets) 2. Infertility Treatment: Ovarian stimulation therapies: Clomiphene Citrate Gonadotropins Artificial Insemination 3. Coverage for in vitro fertilization (IVF), gamete intrafallopian tube transfer(gift), or zygote intrafallopian transfer (ZIFT), or low tubal ovum transfer (LTOT) shall be covered only if: The covered member has been unable to attain or sustain a successful pregnancy through reasonable, less costly medically appropriate infertility treatments for which coverage is available under the plan. The covered member has not undergone four (4) complete oocyte retrievals per lifetime, except that if a live birth follows a completed oocyte retrieval, then two (2) more completed oocyte retrievals shall be covered. One complete oocyte retrieval could result in multiple IVF,GIFT, ZIFT, embryo transfers, or ICSI procedures which are covered; however, on the last covered retrieval only one procedure is covered, then the benefit is exhausted. The procedures are performed at medical facilities that conform to the American College of Obstetric and Gynecology guidelines for in vitro fertilization clinics or to the American Society of Reproductive Medicine minimal standards for programs of in vitro fertilization. Coverage is also available for travel outside 100 miles of a Participant s home for infertility related services. 4. Coventry of Missouri Commercial plans will cover the services required for the diagnosis of infertility. Members are entitled to only one work-up per lifetime. The following are the covered services for a work up: Ovulation study (including basal body temperature charts, serum progesterone, or endometrial biopsy

5 Page 5 of 11 Semen analysis (performed by PCP or urologist) Hysterosalpingogram (HSG) Clomid (1 month only. Requires an over-ride by Pharmacy) Laboratory charges Evaluation by a Reproductive Endocrinologist (3 visits) Post coital test Diagnostic Laparoscopy 5. Coventry Health Care of Illinois does not cover Infertility Services for: Members who are on an individual policy Members who are enrolled in a group (HMO, POS, PPO) with twenty-five or fewer employees, unless a rider was purchased by the group. Members who reside outside the State of Illinois Costs incurred for reversing a tubal ligation or vasectomy. Costs for medical services rendered to a surrogate for purposes of childbirth; however, medical expenses incurred by a surrogate for infertility services must be covered. Costs of preserving and storing sperm, eggs, embryos. Cost of an egg or sperm donor which are not medically necessary, any fees for nonmedical services paid to the donor. Experimental treatments. Cost for procedures which violate the religious and moral teachings or beliefs of a covered group. 6. Coventry Health Care of Missouri does not cover the following services: Reversal of voluntary sterilization. Medical cost incurred by a surrogate. Cost of preserving and storing sperm, eggs, or embryos. Cost for eggs, sperms or embryos that are not medically necessary. Mandate benefits that violate the religious beliefs of the employer group. Experimental procedures or treatments. References Illinois Infertility Law Attachments: 5 Attachments A E For printing purposes, use the attached icons. For visual purposes, see documents below. Copy of MM Infertility... Copy of MM Infertility... Copy of MM Infertility... Copy of MM Infertility... Copy of MM Infertility...

6 Page 6 of 11 Full Infertility Services Coventry Health Care has determined that benefit coverage for an Full Infertility Evaluation is available to you. This may include some or all of the following services: Per Illinois State Law regarding infertility services, only one (1) infertility evaluation is allowed per lifetime regardless of payor source. Infertility Evaluation can include the following services if not already completed: 1. Hysterosalpingogram 2. Post coital test 3. Basal body temperature charting 4. Endocrine profile LH, FSH, Testosterone, Prolactin, DHEAS, TSH, T-3, T-4 5. Serum progesterone level in luteal phase 6. Semen analysis (covered only if spouse is a Coventry Health Care member) 7. Pelvic ultrasound (1 initial diagnostic) 8. Cervical cultures if appropriate 9. Endometrial biopsy (maximum of 1) 10. Laparoscopy or hysteroscopy (maximum of 1) 11. Clomid Challenge (maximum of 1) Advanced Procedures The benefits for advanced procedures required by law are four (4) completed oocyte (egg) retrievals per lifetime of the individual, except that two (2) completed oocyte retrievals are covered after a successful live birth is achieved as a result of an artificial reproductive transfer of oocytes. For example, if a live birth takes place as a result of the first egg retrieval, then two (2) more completed oocyte retrievals for a maximum of three (3) are covered under law no matter what the outcome of the additional two retrievals; however if a live birth takes place as a result of only the fourth (4 th ) egg retrieval, then two (2) more completed oocyte retrievals for a maximum of six (6) are covered. Oocyte retrievals are per lifetime of the individual. If you had a completed oocyte retrieval in the past that was paid for by another carrier, or not covered by insurance, it still counts toward your lifetime maximum under the law as indicated above. Once the final covered oocyte retrieval is completed, only one procedure (IVF, GIFT, ZIFT, or ICSI) is covered. After that,, the benefit is maxed out and no further benefits are available under the law. Infertility Treatment may include the following advanced procedures: 1. Timed intercourse with monitoring 2. Ovarian Stimulation utilizing medications and/or injectables 3. Artificial Insemination (IUI)

7 Page 7 of In vitro fertilization (IVF),gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), Low tubal ovum transfer (LTOT), embryo transfer, intracytoplasmic sperm injection (ICSI) 5. Referral to Reproductive Endocrinologists Note: Benefits for advanced procedures such as IVF, GIFT, ZIFT, or ICSI are required only if you have been unable to attain or sustain a successful pregnancy through reasonable, less costly medically appropriate infertility treatments for which coverage is available under the policy.

8 Page 8 of 11 Limited Infertility Services For Groups Following Catholic Doctrine Coventry Health Care has determined that benefit coverage for Limited Infertility Services is available to you. This may include some or all of the following services: Per Illinois State Law regarding infertility services, only one (1) infertility evaluation is allowed per lifetime regardless of payor source. Infertility Evaluation can include the following services if not already completed: 1. Hysterosalpingogram 2. Post coital test 3. Basal body temperature charting 4. Endocrine profile LH, FSH, Testosterone, Prolactin, DHEAS, TSH, T-3, T-4 5. Serum progesterone level in luteal phase 6. Semen analysis (covered only if spouse is a Coventry Health Care member) 7. Pelvic ultrasound (1 initial diagnostic) 8. Cervical cultures if appropriate 9. Endometrial biopsy (maximum of 1) 10. Laparoscopy or hysteroscopy (maximum of 1) 11. Clomid Challenge (maximum of 1) Advanced Procedures Fertilization, using only the married couple s gametes and taking place at the natural site, can be a coverage procedure. Infertility Treatment may include the following procedures: 1. Timed intercourse with monitoring 2. Ovarian Stimulation clomiphene citrate and/or gonadotropins 3. In vitro procedures: Gamete intrafallopian tube transfer (GIFT), Low tubal ovum transfer (LTOT) 4. Referral to Reproductive Endocrinologists* *Must have separate prior authorization Note: Gamete Intrafallopian Transfer (GIFT direct transfer or sperm and ova/egg mixture into the fallopian tube) is an example of an advanced procedure and must follow Catholic-Approved Guidelines. The following must occur for coverage of the GIFT procedure: The covered member has been unable to attain or sustain a successful pregnancy through reasonable, less costly medically appropriate infertility treatments for which coverage is available under the plan. The covered member has not previously undergone lifetime maximum of completed oocyte retrievals. The procedure (GIFT) conforms with the following Catholic-approved guidelines: 1. Must use husband s semen. 2. Must use a perforated condom, during natural intercourse, to procure the husband s semen for use in the procedure. Non-covered infertility services under the Plan include, but are not limited to: In vitro fertilization (IVF), uterine embryo lavage, embryo transfer, artificial insemination (IUI), zygote intrafallopian tube transfer (ZIFT), intracellular spermatocyte injection (ICSI).

9 Page 9 of 11 Limited Infertility Services Coventry Health Care has determined that benefit coverage for an Infertility Evaluation Only is available to you. This may include some or all of the following services: Per Illinois State Law regarding infertility services, only one (1) infertility evaluation is allowed per lifetime regardless of payor source. Infertility Evaluation can include the following services if not already completed: 1. Hysterosalpingogram 2. Post coital test 3. Basal body temperature charting 4. Endocrine profile LH, FSH, Testosterone, Prolactin, DHEAS, TSH, T-3, T-4 5. Serum progesterone level in luteal phase 6. Semen analysis (covered only if spouse is a Coventry Health Care member) 7. Pelvic ultrasound (1 initial diagnostic) 8. Cervical cultures if appropriate 9. Endometrial biopsy (maximum of 1) 10. Laparoscopy or hysteroscopy (maximum of 1) 11. Clomid Challenge (maximum of 1) Note: Infertility Treatment is Not a Covered Benefit Under Your Plan

10 Page 10 of 11 Determination of Eligibility for Infertility Benefits Please fax back to the Health Services Department at (800) (Effective ) The following information is required prior to determination of benefits for infertility services. Incorrect or incomplete information may result in delay or denial of claims payment. Member Name: DOB: Member #: Name of Partner/Spouse: DOB: Please check all that apply: Member or partner is infertile, in that at lease one of the following apply : Female has been unable to conceive after one year of unprotected sexual intercourse; Female has been unable to sustain a successful pregnancy; Member or partner has been diagnosed by a physician as having a medical condition that renders conception impossible through unprotected sexual intercourse; or Female has undergone one year of medically based and supervised methods of conception, including artificial insemination, which a physician has determined to have failed and are not likely to lead to a successful pregnancy. Member and partner have not undergone a previous elective sterilization procedure. Female has not undergone 4 complete oocyte retrievals. How many previous retrievals? Attachment of semen analysis results of partner, if available **Attachment of all medical records from the physician requesting eligibility** Attachment of previous PCP and/or OB/GYN medical records for the past 12 months. Attachment of all medical records regarding any infertility services/treatment that the member or spouse has received in the past; Name of MD to perform/did perform (circle one) infertility workup. Name of MD to whom member is being referred. Signature Requesting MD: Additional Comments:

11 Page 11 of 11 Determination of Eligibility for Infertility Benefits for Groups Following Catholic Doctrine Please fax back to the Health Services Department at (800) (Effective ) The following information is required prior to determination of benefits for infertility services. Incorrect or incomplete information may result in delay or denial of claims payment. Member Name: DOB: Member #: Date of Marriage: Full Name of Husband: DOB: Please check all that apply: Member is infertile, in that she falls within one of the following : She has been unable to conceive after one year of unprotected sexual intercourse; She has been unable to sustain a successful pregnancy; She has been diagnosed by a physician as having a medical condition that renders conception impossible through unprotected sexual intercourse; or She has undergone one year of medically based and supervised methods of conception, including artificial insemination, which a physician has determined to have failed and are not likely to lead to a successful pregnancy. Member is in a conjugal relationship recognized as a legal marriage by the State of Illinois. Member and partner have not undergone a previous elective sterilization procedure. Member has not undergone 4 complete oocyte retrievals. How many previous retrievals? Attachment of semen analysis results of partner, if available **Attachment of all medical records from the physician requesting eligibility** Attachment of previous PCP and/or OB/GYN medical records for the past 12 months Attachment of all medical records regarding any infertility services/treatment that the member or spouse has received in the past. Name of MD to perform/did perform (circle one) infertility workup: Name of MD to whom member is being referred. Signature Requesting MD: Additional Comments: