Sunflower Health Plan Obstetrical Home Care Programs (PDF) Form

Medical necessity criteria for obstetrical home health programs offered by vendors such as Optum. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that obstetrical home health services are medically necessary for members/enrollees meeting the following criteria: A. Obstetrical Nurse Assessment................................................................................................ 1 B. Metoclopramide or Ondansetron Infusion Therapy .............................................................. 1 C. Hydration Therapy – 1 to 4 liters .......................................................................................... 1 D. Diabetes in Pregnancy Clinical Management Program (case rate) ..................................... 2 E. Obstetrical Diabetes Management - Daily Insulin Injections or Insulin Pump .................... 2 F. Hypertensive Disorders in Pregnancy Program for Gestational Hypertension.................... 2 G. Hypertensive Disorders in Pregnancy Program for Preeclampsia....................................... 2 H. Preterm Labor Management Program .................................................................................. 3 I. Dietary Analysis..................................................................................................................... 3 J. Hydroxyprogesterone Caproate (Makena) Administration Nursing Visit............................. 3 A. Obstetrical Nurse Assessment An obstetrical nurse assessment is considered medically necessary when provided with any of the services listed in B to J. B. Metoclopramide or Ondansetron Infusion Therapy See CP.MP.34 Hyperemesis Gravidarum Treatment policy for medical necessity guidelines for metoclopramide or ondansetron therapy. If meeting criteria per policy, home visits are considered medically necessary for the same period as the infusion therapy is approved, generally up to 7 days of therapy based on clinical information. C. Hydration Therapy – 1 to 4 liters Hydration therapy is medically necessary for members/enrollees who could benefit from close surveillance for the onset of dehydration. Examples of diagnoses include: 1. Hyperemesis gravidarum; 2. Malabsorption; 3. Diagnosis, such as flu or GI virus, which impairs the patient’s ability to maintain fluid and/or food in the system. Page 1 of 12 CLINICAL POLICY OB Home Health Programs A course of up to 7 days at a time is considered medically necessary. D. Diabetes in Pregnancy Clinical Management Diabetes in pregnancy clinical management is medically necessary for pregnant members/enrollees with a diagnosis of Type 2 non-insulin dependent diabetes in pregnancy, or non-insulin dependent gestational diabetes. One visit is considered medically necessary for diabetes in pregnancy clinical management. E. Obstetrical Diabetes Management - Daily Insulin Injections or Insulin pump Obstetrical diabetes management is medically necessary for pregnant members/enrollees requiring insulin administration. An initial course of up to 7 days is considered medically necessary. Additional courses of up to 7-day spans are considered medically necessary until the member/enrollee is able to self-manage blood sugar and insulin administration. F. Hypertensive Disorders in Pregnancy Management for Gestational Hypertension Home visits for management of gestational hypertension are medically necessary for members/enrollees with one of the following: 1. Elevated or unstable blood pressure without proteinuria; 2. Member/enrollee who could benefit from education and surveillance for the potential onset of hypertension. Categories of such members/enrollees could include: a. Previous episode of hypertension during previous pregnancy; b. Chronic hypertension; c. Multiple gestation; d. Diabetes. An initial visit is considered medically necessary. G. Hypertensive Disorders in Pregnancy Management for Preeclampsia Home visits for management of preeclampsia are medically necessary for pregnant members/enrollees who are diagnosed with preeclampsia without severe features, meeting all of the following: 1. Blood pressure ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic on two occasions at least 4 hours apart after 20 weeks gestation in a member/enrollee with a previously normal blood pressure; 2. Proteinuria demonstrated by one or more of the following: a. ≥ 300 mg per 24-hour urine collection (or this amount extrapolated from a timed collection); b. Protein/creatinine ratio ≥ 0.3 mg; c. Dipstick reading of ≥ 2+ (30 mg/dL) (used only if other quantitative methods not available). An initial home visit, with additional phone or virtual follow up as needed, is considered medically necessary. Page 2 of 12 CLINICAL POLICY OB Home Health Programs H. Preterm Labor Management Program The preterm labor management program is medically necessary for pregnant members/enrollees diagnosed with preterm labor. Early signs and symptoms of preterm labor can include menstrual-like cramping; mild, irregular contractions; low back ache; pressure sensation in the vagina; or vaginal discharge of mucus, which may be clear, pink, or slightly bloody. An initial home visit, with additional virtual follow up as needed, is considered medically necessary for assessment and education. Ongoing visits are considered not medically necessary. I. Dietary Analysis A dietary analysis is medically necessary for members/enrollees with a diagnosis of obesity or malnutrition. J. Hydroxyprogesterone Caproate (Makena) Administration Nursing Visit The hydroxyprogesterone caproate nurse administration and care management program is medically necessary for members/enrollees who meet the criteria for hydroxyprogesterone caproate per CP.PHAR.14 and who require weekly home nursing visit due to any of the following circumstances: 1. High risk of non-compliance based on an identified concern or previous noncompliance; 2. Member/enrollee is on restricted activity and weekly travel to the doctor’s office for injections is potentially harmful; 3. Member/enrollee is physically unable to make weekly trips for injections or does not have adequate access to reliable transportation (either personal or through a transportation benefit). Hydroxyprogesterone caproate nurse administration in the home is medically necessary for as many weeks as hydroxyprogesterone caproate has been approved. II. It is the policy of health plans affiliated with Centene Corporation that the following services provided by a home health vendor are considered not medically necessary: A. Betamethasone therapy via multiple repeat courses or intermittent injections; B. Multiple gestation management (refer to individual program for identified risk factor); C. Continuous heparin infusion therapy; D. Patient-administered nonstress test or fetal heart rate monitoring; E. Gestational diabetes clinical management program for oral medications; F. Preterm prelabor rupture of membranes (PPROM) management. Background Optum Obstetrical (OB) Homecare includes risk assessment and education for identifying pregnant individuals at risk for complications, case management and homecare services for high- Page 3 of 12 CLINICAL POLICY OB Home Health Programs risk pregnancies. Obstetrical homecare services include providers, diagnostics, devices and timely and actionable information that help individuals make better healthcare decisions. Medically Necessary Services: Diabetes in Pregnancy Clinical Management Although universal screening criteria for gestational diabetes mellitus (GDM) has not been established, the 100g oral glucose tolerance test (OGTT) has most often been used to diagnose gestational diabetes, according to the Carpenter and Coustan or National Diabetes Data Group criteria.14 In 2008, the landmark Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study established a relationship between pregnancy outcomes and values on a 75g OGTT.15 The World Health Organization, American Diabetic Association (ADA), and the Endocrine Society of the USA endorse the 75g OGTT diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), which was based on data from the HAPO study.14 Gestational Hypertension Management The American College of Obstetricians and Gynecologists (ACOG) Task Force on Hypertension in Pregnancy recommends that patients with gestational hypertension or preeclampsia without severe features monitor blood pressure twice weekly, self-monitor fetal movement daily, and have platelet counts and liver enzymes assessed weekly.2 Few studies have evaluated whether outpatient care is a viable option for preeclamptic patients, although two small studies found positive results.19 In addition, a systematic review of three studies found no difference in clinical outcomes for mothers or babies receiving care in antenatal day units versus inpatient care.13 ACOG recommends ambulatory management at home as an option for women with gestational hypertension or preeclampsia without severe features requiring frequent fetal and maternal evaluation. Hospitalization is recommended for individuals with severe features and for individuals in whom adherence to frequent evaluation may be a concern.23 Preterm Labor Management There is little research on the management of patients after an episode of preterm labor. One underpowered study found no benefit to hospital care versus discharge home in the proportion of deliveries ≥36 weeks. It is thus recommended that the decision to manage an individual with preterm labor as an inpatient or outpatient should be made on a case-by-case basis, in conjunction with factors such as cervical dilation, vaginal bleeding, fetal status and travel time to the appropriate level of care facility.8 Hydroxyprogesterone Caproate (Makena) Administration Nursing Visit The American College of Obstetricians and Gynecologists (ACOG) released the following statement on 17p Hydroxyprogesterone Caproate:6 “Consideration for offering 17p to patients at risk of recurrent preterm birth should take into account the body of evidence for progesterone supplementation, the values and preferences of the patient, the resources available, and the setting in which the intervention will be implemented. Additional information from planned meta-analysis and secondary analyses will need to be evaluated to assess the impact this intervention has on individuals at risk of recurrent preterm birth in the United States. Page 4 of 12 CLINICAL POLICY OB Home Health Programs ACOG recognizes that the PROLONG clinical trial evaluating 17p in patients with a history of a prior spontaneous singleton preterm delivery, demonstrated no statistical difference in the co- primary outcome of preterm birth less than 35 0/7 weeks of gestation and neonatal composite index. Similarly, the rate of preterm birth less than 37 and less than 32 weeks were not different. No other differences in perinatal or maternal outcomes were detected. ACOG also understands that the authors suggest that the study was underpowered to assess treatment efficacy and that due to previous treatment guidelines, there may have been an unintentional selection bias”. More recently, ACOG released the following statement on the FDA proposal to withdraw 17p:28 “The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) this week proposed that Makena (hydroxyprogesterone caproate injection [17-OHPC]) and generic equivalents be withdrawn from the market. As of now, Makena and its approved generic equivalents will remain on the market until the manufacturers decide to voluntarily remove the drugs or the FDA commissioner mandates removal. At this time, ACOG recommendations remain unchanged, as outlined in the Oct 2019 Practice advisory and ACOG’s standing clinical guidance, “Prediction and Prevention of Preterm Birth”. Current guidelines in the United States recommend the use of progesterone supplementation in individuals with prior spontaneous preterm birth. Consideration for offering 17-OHPC to patients at risk of recurrent preterm birth should continue to take into account the body of evidence for progesterone supplementation, the values and preferences of the patient and the resources available”. Not Medically Necessary Services: Betamethasone therapy via intermittent injections ACOG recommends a single course of corticosteroids for individuals with preterm premature rupture of membranes (PPROM) between 24 and 34 weeks, as it reduces the risk of neonatal mortality, respiratory distress syndrome, intraventricular hemorrhage and necrotizing enterocolitis. However, ACOG does not recommend multiple repeated injections as weekly administration is associated with lower birthweight and head circumference. A Cochrane meta- review of repeat doses of antenatal corticosteroids states that there was lower incidence of respiratory distress and serious infant health problems in the first few weeks after birth, but no evidence of harm or benefit in early childhood. Furthermore, as ACOG noted, repeat doses of corticosteroids were associated with lower birthweight and head circumference, even though these reductions were small. Crowther and colleagues conclude by recommending further research on the long-term benefits and risks of repeat doses of antenatal corticosteroids for the infant into adulthood.12,16 Preterm Prelabor Rupture of Membranes Management A Cochrane systematic review of two small studies concludes that the majority of patients should be managed in the hospital after PPROM.1 Although the two studies suggest that outcomes are similar between women and babies managed at home or inpatient, the evidence is not sufficient to make a recommendation regarding the safety of home care for PPROM.1 An additional small study of 187 patients with PPROM indicated conventional hospitalization as the treatment of choice when compared to home management especially in the presence of PPROM before 26 weeks, non-cephalic fetal presentation and oligoamnios.29 ACOG sites the Cochrane review and also notes that the evidence is insufficient, adding that the increased risk of sudden infection and Page 5 of 12 CLINICAL POLICY OB Home Health Programs umbilical cord compression with PPROM make hospital surveillance the appropriate management choice.5 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. - - ICD 10 CM Codes A09 D69.59 E86.0 K90.49 O10.011 through O10.019 O10.411 through O01.419 O10.911 through O10.919 O11.1 through O11.9 O14.00 through O14.03 O16.1 through O16.9 O21.0 through O21.9 O24.410 through O24.419 O25.10 through O25.13 O60.00 through O60.03 O99.210 through O99.213 Infectious gastroenteritis and colitis, unspecified Other secondary thrombocytopenia Dehydration Malabsorption due to intolerance, not elsewhere classified Pre-existing essential hypertension complicating pregnancy Pre-existing secondary hypertension complicating pregnancy Unspecified pre-existing hypertension complicating pregnancy Pre-existing hypertension with pre-eclampsia Mild to moderate pre-eclampsia Unspecified maternal hypertension Excessive vomiting in pregnancy Gestational diabetes mellitus in pregnancy Malnutrition in pregnancy Preterm labor without delivery Obesity complicating pregnancy Page 6 of 12 CLINICAL POLICY OB Home Health Programs HCPCS Codes S9123 S9140 S9208 S9211 S9213 S9214 S9374 S9375 S9376 S9377 S9470 S9560 Optum specific program codes Nursing care, in the home; by registered nurse, per hour (use for general nursing care only, not to be used when CPT codes 99500-99602 can be used) Diabetic management program, follow up-visit to non-MD provider Home management of preterm labor, includes administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code) Home management of gestational hypertension, includes administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code) Home management of preeclampsia, includes administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code) Home management of gestational diabetes, includes administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code) Home infusion therapy, hydration therapy; one liter per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem 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 (drugs and nursing visits coded separately), per diem 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 (drugs and nursing visits coded separately), per diem Home infusion therapy, hydration therapy; more than three liters per day, administrative services, professional pharmacy services, care coordination, and all necessary supplies (drugs and nursing visits coded separately), per diem Nutritional counseling, dietician visit Home injectable therapy; hormonal therapy (e.g., leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem Reviews, Revisions, and Approvals Policy Created Reviewed by Specialist Revision Date 01/14 Approval Date 01/14 Page 7 of 12 CLINICAL POLICY OB Home Health Programs Reviews, Revisions, and Approvals References reviewed and updated, no criteria changes Added units to 2017 American Diabetes Association (ADA) Guidelines for clarity. All references to premature rupture of membranes is changed to prelabor rupture of membranes, per ACOG “revitalize obstetric data” definitions. Added units to H.2.b and H.2.c for clarification. Replaced Makena with hydroxyprogesterone caproate in all instances Specified that only preeclampsia without severe features is appropriate for home management, and removed diagnostic criteria which included severe features. Changed “Alere” to “Optum” Updated description to include OptionCare. Noted in D. Diabetes Clinical Management program that the case rate is with Optum. Pre- eclampsia program: I.H changed dipstick reading from 1+ to 2+. Updated background with ACOG’s statement on administration of Hydroxyprogesterone Caproate. Specialist review. Removed reference to OptionCare in description. In C. Hydration therapy, changed initial course and additional course of up to 14 visits to up to 7 visits at a time. In D. Diabetes in pregnancy, removed the word “program” form the title and criteria; deleted all criteria except the requirement for diagnosis of type 2 DM, or gestational diabetes, and specified that both are non-insulin dependent; deleted reference to case rate, and added that 1 visit is medically necessary. Combined criteria in E. for insulin injections and F. for insulin pump into E; removed criteria except for being pregnant and requiring insulin administration; changed number of medically necessary visits from 14 to up to 7 days for the initial and additional courses. For hypertensive disorders in pregnancy, replaced “program” in the title with “management;” changed number of medically necessary visits from up to 14 days with an additional 7 if needed to one visit. For preeclampsia in pregnancy, replaced “program” with “visits for management;” changed the number of initial and additional medically necessary visits from up to 7 to an additional home visit with phone follow up as needed. For preterm labor management, changed number of medically necessary visits from 3 in one week to 1 home visit in a week, with additional phone follow up as needed. Replaced all instances of “member” with “member/enrollee.” Reviewed by specialist. References reviewed and updated. Annual review. Updated table of contents. Corrected A. to state that it is medically necessary with services in A-J, not A-K. References reviewed and updated. Specialist review. Changed "Last Review Date" in the header to "Date of Last Review" and "Date" in revision log to "Revision Date". Added info in Background regarding ACOG’s Statement on FDA Proposal to Withdraw 17p Hydroxyprogesterone Caproate. Note added to HCPCS S9123 regarding CPT usage. Annual review completed. Added “without proteinuria” to I. F.1.Changed “woman” to “member/enrollee” in I.G.1. Added Page 8 of 12 Revision Date 01/17 01/18 Approval Date 01/17 01/18 01/19 01/19 12/19 12/19 11/20 12/20 12/21 12/21 12/22 12/22 CLINICAL POLICY OB Home Health Programs Reviews, Revisions, and Approvals Revision Date Approval Date “demonstrated by one or more of the following” to I.G.2. for clarity. Added “≥” to I.G.2.c. Minor rewording with no clinical significance. Background updated. References reviewed and updated.