Article - Billing and Coding: Endometrial Hyperplasia Treatment with Intrauterine Device (Hormone-Eluting) (A55951)

CMS National Coverage PolicyN/AArticle TextThe endometrium may develop endometrial hyperplasia (EH), which includes non-neoplastic entities (disordered proliferative endometrium, benign hyperplasia, simple and complex hyperplasias without atypia) characterized by a proliferation of endometrial glands, and endometrial intraepithelial neoplasms (EIN), and all atypical complex hyperplasia characterized by neoplastic features but without invasion. EH frequently results from chronic estrogen stimulation unopposed by the counterbalancing effects of progesterone. The majority of women with EH will present with abnormal uterine bleeding. Management treatment options of EH include surveillance, progestin therapy, or hysterectomy. All management strategies should be accompanied by removal of the source of unopposed estrogen, as this is the main etiology of endometrial neoplasia.This article addresses the management of EH with an insertion of a progestin-containing intrauterine device (IUD) with the delivery of progestins over five years, as an accepted method of treatment in patients with abnormal uterine bleeding who are unable to tolerate oral megestrol or develop high-risk complications of oral megestrol, who are not reasonable surgical candidates or who wish to preserve fertility. Women who are at a high risk of surgical complications due to medical comorbidities or surgical history should be evaluated and counseled regarding whether surgery or progestin therapy is the preferable option.Per ACOG Committee Opinions, for most women with atypical EH/EIN who are postmenopausal, hysterectomy rather than progestin therapy is recommended.WPS GHA has determined that the use of a progestin-containing IUD with the delivery of progestins over five years, may be approved for use in the Medicare beneficiary who presents with endometrial hyperplasia without atypia.Per Medicare regulations, contraceptive devices or medications are not allowed for payment. For this reason the service, 58300, insertion of IUD has an "N" status in the Medicare Physician Fee Schedule, which means the service cannot be covered when billed to Medicare.Since the CPT code for IUD insertion will be auto-denied, providers should bill this service using CPT code 58999, the appropriate diagnoses listed in this article and the product description "hormone IUD for endometrial hyperplasia" in Item 19 of the CMS-1500 form or the electronic equivalent.Coverage for this method of treatment must be reasonable and necessary for the diagnosis, or treatment of illness, or to improve the functioning of the patients clinical condition, the standard of medical practice regarding the effectiveness of the IUD for the diagnosis and condition and meet all other applicable Medicare statutory and regulatory requirements.The patients medical record must clearly document the specific clinical circumstances supporting the medical necessity for services included within this Article.Evaluation to include abnormal uterine bleeding,Evaluation should not be performed without complaint of post-menopausal bleeding,Evidence of transvaginal ultrasound on file with documented stripe greater than 4mm.Pathology biopsy report:Simple/benign hyperplasia: a progesterone IUD is a reasonable treatment option.A Copper IUD is not a reasonable treatment option.EIN/complex EH: documentation supports patient is a poor surgical candidate. Current nonsurgical management options are limited to hormonal therapy.This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.