Clinical UM Guideline

 

Subject: Ancillary Services for Pregnancy Complications
Guideline #:  CG-MED-32 Publish Date:    03/29/2018
Status: Revised Last Review Date:    02/27/2018

Description

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

Note: Please see the following related documents for additional information:

Clinical Indications

Thromboembolytic Disease

Medically Necessary:

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.

Hyperemesis Gravidarum

Medically Necessary:

  1. Continuous or intermittent use of subcutaneous, intravenous or enteral anti-emetic, hydration or nutrition therapy is considered medically necessary for treatment of hyperemesis gravidarum when the following interventions have failed:
    1. Diet and activity modification (for example, clear liquid diet in conjunction with bedrest, temporarily discontinuing prenatal vitamins or iron supplements); and
    2. Oral, rectal or intramuscular medication (for example, promethazine, prochlorperazine, diphenhydramine or trimethobenzamide); then
  2. When hyperemesis is not responding to the above, the following order of treatment may be used:
    1. Intravenous hydration; then
    2. Subcutaneous or intravenous metoclopramide therapy; then
    3. Subcutaneous or intravenous ondansetron therapy.
  3. Continuous or intermittent use of enteral or total parenteral nutrition therapy is considered medically necessary when nutritional needs are compromised and the above therapies have been ineffective.
  4. Based on the American College of Obstetricians and Gynecologists, Clinical Management Guidelines: Nausea and Vomiting of Pregnancy, methylprednisolone may be efficacious in refractory cases; however, due to the risk profile, it should considered as a last-resort treatment (American College of Obstetricians and Gynecologists [ACOG], 2018).

Not Medically Necessary:

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.

Coding

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.

HCPCS

 

J1020

Injection, methylprednisolone acetate, 20 mg

J1030

Injection, methylprednisolone acetate, 40 mg

J1040

Injection, methylprednisolone acetate, 80mg

J2405

Injection, ondansetron hycrochloride, per 1 mg

J2765

Injection, metoclopramide HCl, up to 10 mg

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

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

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

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

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

Discussion/General Information

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 (2011; reaffirmed 2017), “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):

Levels of Recommendations Definitions

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.

Furthermore, ACOG reports:

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.

Definitions

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.

Xerostomia: Feeling of a dry mouth.

References

Peer Reviewed Publications:

  1. Abas MN, Tan PC, Azmi N, Omar SZ. Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. Obstet Gynecol. 2014; 123(6):1272-1279.
  2. Bates SM. Preventing thrombophilia-related complications of pregnancy: an update. Expert Rev Hematol. 2013; 6(3):287-300.
  3. Bates SM, Ginsberg JS. How we manage venous thromboembolism during pregnancy. Blood. 2002; 100(10):3470-3478.
  4. Buttino L Jr, Coleman SK, Bergauer NK, et al. Home subcutaneous metoclopramide therapy for hyperemesis gravidarum. J Perinatol. 2000; 20(6):359-362.
  5. Davis SM, Branch DW. Thromboprophylaxis in pregnancy: who and how? Obstet Gynecol Clin North Am. 2010; 37(2):333-343.
  6. Fell DB, Dodds L, Joseph KS, et al. Risk factors for hyperemesis gravidarum requiring hospital admission during pregnancy. Obstet Gynecol. 2006; 107(2 Pt 1):277-284.
  7. Goodwin TM. Hyperemesis gravidarum. Obstet Gynecol Clin North Am. 2008; 35(3):401-417.
  8. Greer IA. Anticoagulants in pregnancy. J Thromb Thrombolysis. 2006; 21(1):57-65.
  9. Hamaoui E, Hamaoui M. Nutritional assessment and support during pregnancy. Gastroenterol Clin North Am. 2003; 32(1):59-121.
  10. James AH. Prevention and management of venous thromboembolism in pregnancy. Am J Med. 2007; 120 (10 Suppl 2):S26-34.
  11. Klauser CK, Fox NS, Istwan N, et al. Treatment of severe nausea and vomiting of pregnancy with subcutaneous medications. Am J Perinatol. 2011; 28(9):715-721.
  12. Lee NM, Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011; 40(2):309-334, vii.
  13. McParlin C, O'Donnell A, Robson SC, et al. Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review. JAMA. 2016; 316(13):1392-1401.
  14. Phillips OP. Venous thromboembolism in the pregnant woman. J Reprod Med. 2003; 48(11 Suppl):921-929.
  15. Sanu O, Lamont RF. Hyperemesis gravidarum: pathogenesis and the use of antiemetic agents. Expert Opin Pharmacother. 2011; 12(5):737-748.
  16. Schoenbeck D, Nicolle A, Newbegin K, et al. The use of a scoring system to guide thromboprophylaxis in a high-risk pregnant population. Thrombosis. 2011:652796.
  17. Sonkusare S. The clinical management of hyperemesis gravidarum. Arch Gynecol Obstet. 2011; 283(6):1183-1192.
  18. Veenendaal MV, van Abeelen AF, Painter RC, et al. Consequences of hyperemesis gravidarum for offspring: a systematic review and meta-analysis. BJOG. 2011; 118(11):1302-1313.
  19. Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012; 5(2):78-84.

Government Agency, Medical Society and Other Authoritative Publications:

  1. American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no. 84: prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007 (reaffirmed 2017); 110(2 Pt 1):429-440.
  2. American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no. 123: thromboembolism in pregnancy. Obstet Gynecol. 2011 (reaffirmed 2017); 118(3):718-729.
  3. American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no. 138: inherited thrombophilias in pregnancy. Obstet Gynecol. 2013 (reaffirmed 2017); 122(3):706-717.
  4. American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no. 189: nausea and vomiting of pregnancy. Obstet Gynecol. 2018; 131(1):190-193.
  5. Boelig, RC, Barton, SJ, Saccone G, et al. Interventions for treating hyperemesis gravidarum. Cochrane Database Syst Rev. 2016;(5):CD010607.
  6. Diphenhydramine Hydrochloride. In: DrugPoints® System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated January 5, 2018. Available at: http://www.micromedexsolutions.com. Accessed on January 8, 2018.
  7. Diphenhydramine Hydrochloride. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised October 13, 2015. Accessed on November 10, 2017.
  8. Lockwood C, Wendel G. Committee on Practice Bulletins—Obstetrics. Practice bulletin no. 124: inherited thrombophilias in pregnancy. Obstet Gynecol. 2011; 118(3):730-740.
  9. Matthews A, Haas DM, O'Mathúna DP, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2014;(3):CD007575.
  10. Metoclopramide. In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated December 28, 2017. Available at: http://www.micromedexsolutions.com. Accessed on January 8, 2018.
  11. Metoclopramide. Lexicomp Online, American Hospital Formulary Service (AHFS) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised December 1, 2014. Accessed on November 10, 2017.
  12. Ondansetron Hydrochloride. In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated January 2, 2018. Available at: http://www.micromedexsolutions.com. Accessed on January 8, 2018.
  13. Ondansetron Hydrochloride. Lexicomp Online, American Hospital Formulary Service (AHFS) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised December 6, 2016. Accessed on November 10, 2017.
  14. Prochlorperazine. In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated January 5, 2018. Available at: http://www.micromedexsolutions.com. Accessed on January 8, 2018.
  15. Prochlorperazine. Lexicomp Online, American Hospital Formulary Service (AHFS) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised March 15, 2011. Accessed on November 10, 2017.
  16. Promethazine. In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated January 5, 2018. Available at: http://www.micromedexsolutions.com. Accessed on January 8, 2018.
  17. Promethazine. Lexicomp Online, American Hospital Formulary Service (AHFS) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised December 1, 2009. Accessed on November 10, 2017.
  18. Reglan (Metoclopramide Hydrochloride). Deerfield, IL. Baxter Healthcare Corp. November 2010. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf. Accessed on January 8, 2018.
  19. Zofran (Ondansetron Hydrochloride). Research Triangle Park, NC. GlaxoSmithKline. March 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020007s047lbl.pdf. Accessed on January 8, 2018.
Index

Hyperemesis Gravidarum
Pregnancy Complications
Thromboembolytic Disease

History

Status

Date

Action

Revised

02/27/2018

Medical Policy & Technology Assessment Committee (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.