보험인정기준 상세내용

■ 고시 개정 전체내용



1. 각 약제별 허가사항 및 「암환자에게 처방ㆍ투여하는 약제에 대한 요양급여의 적용기준 및 방법에 관한 세부사항」의 범위 내에서 아래와 같은 경우에 투여 시 요양급여를 인정하며, 동 인정기준 외에는 약값 전액을 환자가 부담토록 함.



- 아 래 -

가. 림프조영, 침샘조영

나. 간암의 경동맥화학색전술(TACE, transarterial chemoembolization) 시행 시 사용

다. 난임 진단 검사 중인 여성에서의 자궁난관조영: 1회에 한하여 인정함.



2. 허가사항 범위를 초과하여 간암 진단목적의 간동맥조영술에 투여시 요양급여를 인정함.



■ 고시 개정 고시번호(시행일자)

고시 제2023-101호(2023.6.1.)



■ 고시 개정 사유

○국내·외 허가사항, 교과서, 가이드라인, 임상논문, 학회(전문가) 의견 등을 참조

- '난임 진단 검사 중인 여성에서의 자궁난관조영'에 대한 식약처 허가사항이 추가(’21.6월)됨에 따라 1회에 한하여 인정하는 급여기준 마련



■ 관련근거

· Harrison's Principles of Internal Medicine 21e > Chapter 396: Infertility and Contraception

· Goldman-Cecil Medicine, e2 > CHAPTER 223 Reproductive Endocrinology and Infertility

· 산부인과학 지침과 개요 2015 > Chapter 40. 여성불임

· Current Medical Diagnosis & Treatment 2021 > 18-11: Infertility

· Comprehensive Gynecology, 5e > 40 Infertility: Etiology, Diagnostic Evaluation, Management, Prognosis

· Williams Gynecology, 4e > CHAPTER 20: Evaluation of the Infertile Couple

· Pfenninger and Fowler's Procedures for Primary Care > Chapter 134. Hysterosalpingography and Sonohysterography

· Meyler's Side Effects of Drugs, 2016, 239-297 > Iodinated contrast media

· Fertility: assessment and treatment for people with fertility problems (CG156) 2017

· GLANVILLE et al. The use of oil-soluble contrast media for tubal flushing in infertility: A consensus statement from ACCEPT (Australasian CREI Consensus Expert Panel on Trial evidence) Aust N Z J Obstet Gynaecol 2020; 60: 667？670

· ACOG COMMITTEE OPINION - Infertility Workup for the Women’s Health Specialist. Obstet Gynaecol 2019;133;6:e377-384.

· Practice Committee of the American Society for Reproductive Medicine, Fertility evaluation of infertile women: a committee opinion. Fertil Steril 2021;116:1255-65.

· Wang, et al. Tubal flushing for subfertility. Cochrane Database of Systematic Reviews 2020

· Wang, et al. Effectiveness on fertility outcome of tubal flushing with different contrast media: systematic review and network meta-analysis. Ultrasound Obstet Gynecol 2019; 54: 172？181.

· Fang et al. Oil-based versus water-based contrast for hysterosalpingography in infertile women: a systematic review and meta-analysis of randomized controlled trials. Fertil Steril 2018;110:153？60.

· Dreyer et al. Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women. N Engl J Med 2017;376:2043-52.

· van Rijswijk et al. Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial. Fertil Steril 2020;114:155-62.

· Zhang, et al. Ethiodized poppyseed oil-based contrast medium is superior to water-based contrast medium during hysterosalpingography regarding image quality improvement and fertility enhancement: A multicentric, randomized and controlled trial. eClinicalMedicine 2022;46: 101363



■ 변경 전 고시번호(시행일자)

고시 제2021-194호(2021.7.6.)