CG-MED-32 Ancillary Services for Pregnancy Complications

This document addresses ancillary services for pregnancy complications, specifically treatment of antepartum thromboembolytic disease and treatment of hyperemesis gravidarum.

Continuous or intermittent use of intravenous or subcutaneous anti-coagulant (for example, unfractionated or low molecular weight heparin) therapy is considered medically necessary for treatment of antepartum thromboembolytic disease.

Continuous or intermittent use of subcutaneous, intravenous or enteral anti-emetic, hydration, or nutrition therapy is considered not medically necessary when the medically necessary criteria for hyperemesis gravidarum are not met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Hyperemesis Gravidarum
When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met.

Antepartum complications can compromise the mother and fetus. Maternal-fetal evaluation, early identification of problems, and ongoing care can contribute to an optimal birth outcome. Complications that may occur in the antepartum period include:

In the past, pregnant women were hospitalized for some of these complications, dependent upon their severity. Advances in technology and medication use have allowed a reduction of hospital admissions, a decrease of inpatient days (if admitted), and continuation of care in the home setting. Home nursing care, pharmacy services, and durable medical equipment are often utilized to provide care in the home setting. Home infusion therapies generally consist of home nursing visits for maternal care and education. These services are considered skilled care and are administered by a licensed agency and in accordance to state and local laws. Examples of these therapies are:

During pregnancy, women have decreased anticoagulant activity, decreased fibrinolysis, and an increased risk of deep vein thrombosis. This is most often due to the reduced venous flow or stasis in the lower extremities caused by compression of the inferior vena-cava and pelvic veins by the enlarging uterus. Anticoagulant therapy during pregnancy is limited to parenteral therapy as oral medications cross the placenta impacting the fetus. Both unfractionated and low molecular weight heparin are effective anticoagulant medications. Low molecular weight heparin may have fewer complications in the way of thrombopenia and osteoporosis. According to the ACOG Clinical Management Guidelines: Thromboembolism in Pregnancy (2018), “the preferred anticoagulants in pregnancy are heparin compounds” (Level B evidence: recommendations are based on limited or inconsistent scientific evidence).

Although 70-85% of all pregnant women experience some nausea and vomiting, hyperemesis gravidarum is the severe and intractable form of nausea and vomiting in pregnancy typically refractory to first line therapy. At this point, controlling the nausea and vomiting with more invasive therapy may be necessary. Intractable vomiting may compromise maternal nutritional status and result in adverse fetal consequences. TPN or enteral therapy might be utilized concurrently with antiemetic therapy.

Metoclopramide and ondansetron have been used as off-label treatments for hyperemesis gravidarum after failure of other modalities including diet and activity modifications; oral, rectal or intramuscular medications; and intravenous hydration. Several authors (Buttino, 2000; Klauser, 2011) have reported that subcutaneous metoclopramide is effective for the treatment of hyperemesis gravidarum after failure of other treatments. Wegrzyniak and colleagues (2012) describe metoclopramide and ondansetron as treatment agents found to improve symptoms of hyperemesis gravidarum without causing detrimental effects to the fetus. Abas and colleagues (2014) performed a double-blind randomized controlled trial comparing ondansetron with metoclopramide in 160 women with hyperemesis gravidarum. Both drugs had similar efficacy in reducing nausea and vomiting, but side effects such as drowsiness, xerostomia, and persistent ketonuria at 24 hours were less with ondansetron.

In a Cochrane review, Boelig and colleagues (2016) evaluated 25 randomized controlled trials (n=2052) on interventions for hyperemesis gravidarum. The primary outcome was the severity, reduction, or cessation in nausea and vomiting. The researchers found that metoclopramide and ondansetron had a similar effect on severity, but metoclopramide increased dry mouth and drowsiness. Promethazine was effective but caused sedation, drowsiness, dizziness, and dystonia. Corticosteroids showed little difference from a placebo other than a lower rate of hospital readmission. Because of the heterogeneity of the studies, the researchers were not able to pool data for most of the treatments, and the results were primarily based on single studies. In addition, the studies had inconsistencies in the definition of hyperemesis gravidarum and in the measurements of outcomes. The researchers concluded that there is very little evidence that supports one treatment over another, and large, well-designed trials are needed.

McParlin and colleagues (2016) conducted a systematic review of 78 studies (n=8930), including 67 randomized trials and 11 nonrandomized trials, that compared treatments for hyperemesis gravidarum. The researchers found that for mild nausea, first-line treatments such as ginger, vitamin B6, and acupressure were associated with improvement. The benefits of nerve stimulation and acupuncture were unclear. For moderate nausea, second-line treatments such as antihistamines (alone or in combination with vitamin B6), dopamine antagonists, and serotonin antagonists were associated with improvement. The authors stated that although corticosteroids could be considered for severe nausea, benefits and risks are not clear. In addition, there was very limited evidence that clonidine was beneficial. The systematic review was limited due to the low quality and heterogeneity of the studies, and the authors were not able to complete a planned meta-analysis. In summarizing their research, they concluded that “overall, the quality of evidence was low.”

In 2018, ACOG updated their Clinical Management Guidelines: Nausea and Vomiting of Pregnancy which includes the following recommendations:

The following recommendations are based on good and consistent scientific evidence (Level A):

The following recommendations are based on limited or inconsistent scientific evidence (Level B):

The following recommendations are based primarily on consensus and expert opinion (Level C):

Level A — Recommendations are based on good and consistent scientific evidence.
Level B — Recommendations are based on limited or inconsistent scientific evidence.
Level C — Recommendations are based primarily on consensus and expert opinion.

In addition to the major recommendations noted above, ACOG states the following in regards to metoclopramide and ondansetron:

Several dopamine antagonists have been described in the medical literature for treatment of nausea and vomiting of pregnancy, such as metoclopramide and various phenothiazine medications (promethazine, prochlorperazine, or chlorpromazine)…Relief of nausea and vomiting has been demonstrated in large groups of patients…Metoclopramide use during pregnancy has not been shown to increase risk of congenital malformations…Evidence is limited on the safety or efficacy of the serotonin 5-HT3 inhibitors (eg, ondansetron) for nausea and vomiting of pregnancy; however, use appears to be increasing.

There is limited evidence regarding the clinical efficacy of the use of continuous subcutaneous microinfusion pumps to administer metoclopramide or ondansetron for the treatment of nausea and vomiting of pregnancy. Moreover, adverse effects with the use of continuous subcutaneous pumps were seen in 11–31% of selected patients.

Low molecular weight heparin (LMWH): A class of drugs used to prevent blood clotting (anticoagulants), which can be administered outpatient.

Unfractionated heparin: A class of drugs used to prevent blood clotting (anticoagulants) which are usually only given inpatient for close monitoring.

Off-label: Utilization of a United States Food and Drug Administration (FDA) approved drug for uses other than those listed in the FDA approved label.

Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

Subject: Ancillary Services for Pregnancy Complications
Guideline #: CG-MED-32	Publish Date: 12/16/2020
Status: Reviewed	Last Review Date: 11/05/2020

HCPCS
S9336	Home infusion therapy, continuous anticoagulant infusion therapy (e.g., heparin), administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9372	Home therapy; intermittent anticoagulant injection therapy (e.g., heparin); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem

ICD-10 Diagnosis
O22.20-O22.23	Superficial thrombophlebitis in pregnancy
O22.30-O22.33	Deep phlebothrombosis in pregnancy
O22.50-O22.53	Cerebral venous thrombosis in pregnancy
O22.8X1-O22.8X9	Other venous complications in pregnancy
O22.90-O22.93	Venous complication in pregnancy, unspecified
O88.211-O88.219	Thromboembolism in pregnancy

HCPCS
G0068	Professional services for the administration of anti-infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biological) for each infusion drug administration calendar day in the individual’s home, each 15 minutes
G0069	Professional services for the administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes
G0088	Professional services, initial visit, for the administration of anti-infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biological) for each infusion drug administration calendar day in the individual’s home, each 15 minutes
G0089	Professional services, initial visit, for the administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes
	Note: Codes G0068, G0069, G0088, G0089 are effective 01/01/2021.
J1020	Injection, methylprednisolone acetate, 20 mg
J1030	Injection, methylprednisolone acetate, 40 mg
J1040	Injection, methylprednisolone acetate, 80mg
J2405	Injection, ondansetron hydrochloride, per 1 mg
J2765	Injection, metoclopramide HCl, up to 10 mg
S9340	Home therapy; enteral nutrition; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9341	Home therapy; enteral nutrition via gravity; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9342	Home therapy; enteral nutrition via pump; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9343	Home therapy; enteral nutrition via bolus; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9351	Home infusion therapy, continuous or intermittent anti-emetic infusion therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9364	Home infusion therapy, total parenteral nutrition (TPN); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment including standard TPN formula, per diem
S9365	Home infusion therapy, total parenteral nutrition (TPN); one liter per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment including standard TPN formula, per diem
S9366	Home infusion therapy, total parenteral nutrition (TPN); more than one liter but no more than two liters per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment including standard TPN formula, per diem
S9367	Home infusion therapy, total parenteral nutrition (TPN); more than two liters but no more than three liters per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment including standard TPN formula, per diem
S9368	Home infusion therapy, total parenteral nutrition (TPN); more than three liters per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment including standard TPN formula, per diem
S9370	Home therapy, intermittent antiemetic injection therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9373	Home infusion therapy, hydration therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9374	Home infusion therapy, hydration therapy; one liter per day, administrative services professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9375	Home infusion therapy, hydration therapy; more than one liter but no more than two liters per day, administrative services professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9376	Home infusion therapy, hydration therapy; more than two liters but no more than three liters per day, administrative services professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9377	Home infusion therapy, hydration therapy; more than three liters per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9490	Home infusion therapy, corticosteroid infusion; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment , per diem

ICD-10 Diagnosis
O21.0-O21.9	Excessive vomiting in pregnancy

Status	Date	Action
Reviewed	11/05/2020	Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References section. Reformatted Coding section and updated with 01/01/2021 HCPCS changes, added G0068, G0069, G0088, G0089.
Reviewed	11/07/2019	MPTAC review. References section updated.
Reviewed	11/08/2018	MPTAC review. Discussion/General Information and References sections updated.
Revised	02/27/2018	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” ACOG reference updated in Clinical Indications section. Discussion/General Information and References sections updated.
Reviewed	02/02/2017	MPTAC review. Formatting updated in Clinical Indications and Discussion sections. References section updated.
Revised	02/04/2016	MPTAC review. Updated nausea and vomiting of pregnancy ACOG statement in the clinical indication section. Discussion, Definition and References sections updated. Removed ICD-9 codes from Coding section.
Revised	02/05/2015	MPTAC review. Not medically necessary statement added for hyperemesis gravidarum. Description, Coding and References sections updated.
Reviewed	02/13/2014	MPTAC review. Discussion and Reference sections updated.
Reviewed	02/14/2013	MPTAC review. Description (note), Discussion and References sections updated. Definition section added.
Reviewed	02/16/2012	MPTAC review. References updated.
Reviewed	02/17/2011	MPTAC review. Discussion/Background and References updated.
Reviewed	02/25/2010	MPTAC review. Discussion/background and references updated.
Reviewed	02/26/2009	MPTAC review. Place of service removed. References updated.
Reviewed	02/21/2008	MPTAC review. References updated.
Reviewed	03/08/2007	MPTAC review.
	04/01/2007	Updated coding section with 04/01/2007 HCPCS changes.
New	03/23/2006	MPTAC initial guideline development.