Oscar Insulin Delivery Systems and Continuous Glucose Monitoring (CG029) Form

Understanding Diabetes Mellitus

Diabetes mellitus, commonly known as diabetes, is a chronic medical condition characterized by elevated blood glucose levels. This can occur due to insufficient insulin production by the pancreas, an organ located in the abdomen, or the body's inadequate response to insulin. Insulin is a hormone that enables glucose to enter cells, providing them with energy. In diabetes, blood sugar accumulates due to a lack of insulin or the body's improper response to it.

Types of Diabetes

• Type 1 diabetes: The pancreas produces little or no insulin.
• Type 2 diabetes: The body's cells do not respond effectively to insulin, and sometimes the pancreas does not produce enough insulin.

Management and Treatment

Managing diabetes necessitates regular monitoring and treatment, which often includes lifestyle adjustments, self-care, and medication to regulate blood glucose levels and reduce the risk of complications. Plan members diagnosed with Type 1 or Type 2 diabetes who meet specific medical necessity criteria and adhere to the American Diabetes Association (ADA) standards of care may be eligible for certain supplies and equipment covered by the plan, such as blood sugar monitoring tools¹and insulin injection devices. Those with advanced disease or requiring more frequent insulin administration may qualify for continuous glucose monitoring and specialized insulin delivery systems.

Plan Coverage Details

• For details on the medical necessity criteria for medical nutrition counseling, refer to the Plan Clinical Guideline: Medical Nutrition Therapy (CG010).
• For information on the medical necessity criteria for diabetes equipment and supplies, consult the Plan Clinical Guideline: Diabetes Equipment and Supplies (CG028).

A prescription or recommendation from a physician or licensed healthcare professional is required for diabetic supplies and equipment.

The Plan also covers home glucose monitors and self-monitoring blood sugar products as an alternative to continuous glucose monitors (CGMs). To obtain a standard blood glucose meter from the preferred brand, please contact CVS/Caremark, the Plan's Prescription Benefit Manager.

Definitions

"Artificial Pancreas" devices are closed-loop, integrated continuous blood glucose monitor and insulin delivery system. Special built-in software measures the blood glucose similar to continuous glucose monitoring and automatically releases a specified amount of insulin in real-time and without patient interaction. The system may also have a glucagon administration component for episodes of hypoglycemia for which it is then referred to as a bihormonal, fully-automated artificial pancreas.

"Basal Rate" is the steady flow at which low levels of short-acting insulin are released to control blood glucose between meals and during sleep; this measurement ranges by time of day and is used in insulin pumps.

"Blood Glucose" is the main sugar found in the blood and the body's main source of energy. It is also called glucose or blood sugar. The blood level of glucose is noted in milligrams per deciliter (mg/dL). When blood sugar is too high for long periods of time, complications can occur as a result of blood vessel damage.

"Blood Glucose Monitors" are small, portable machines used to check blood glucose levels in the ambulatory setting. A member will prick his/her fingertip and place a small sample of blood into the device for a glucose reading. There are a number of different types of blood glucose monitors for specialized situations, such as those for members with visual impairments.²

"Bolus" is an extra amount of insulin taken to cover an expected rise in blood glucose, often related to a meal or snack.

"Cartridge" (or a reservoir) holds the insulin and is locked into an external continuous subcutaneous insulin infusion pump device.

"Continuous Glucose Monitoring (CGM)" serves as an alternative to self-monitoring of blood glucose (SMBG) with a home glucose monitor for patients who have diabetes and require multiple daily measurements.

"Disposable Insulin Infusion Pumps" are insulin-delivery devices that consist of disposable components. Both the OmniPod and V-Go insulin delivery systems have disposable components, but they differ in that the OmniPod system is programmable, whereas the V-Go system is non-programmable.

"External Continuous Subcutaneous Insulin Infusion (CSII) Pumps" or "Insulin Infusion Pumps" are non-implantable insulin-delivery devices that can be worn on a belt, kept in a pocket, or attached directly to the skin. An insulin pump connects to narrow, flexible plastic tubing that ends with a needle inserted just under the skin. Users set the pump to give a basal amount of insulin continuously throughout the day. Pumps release bolus doses of insulin (several units at a time) at meals and at times when blood glucose is too high, based on programming done by the user. Insulin infusion pumps serve as an alternative to multiple daily injections of insulin. The infusion cannula should be changed every 2-3 days to avoid lipid hypertrophy at the infusion site. Insulin infusion pumps can be differentiated by programmable/non-programmable, disposable/reusable, and subcutaneous/transdermal/implantable.

"Flash Glucose Monitoring" refers to glucose monitoring that does not have an alarm, does not require self-monitoring of blood glucose (SMBG), and functions intermittently and on-demand rather than continuously (e.g., FreeStyle Libre System).

"Gestational Diabetes Mellitus (GDM)" is a type of diabetes mellitus that develops only during pregnancy and usually disappears upon delivery, but increases the risk that the mother will develop diabetes later. GDM is managed with meal planning, activity, oral agents, and, in some cases, insulin.

"Hemoglobin A1c (HbA1c)" is a test that measures a person's average blood glucose level over the past 2 to 3 months. It is also known as "A1C" or "glycosylated hemoglobin".

A1C should be measured at least twice annually for stable glycemic control and at least quarterly for unstable glycemic control.³ A1C test results may be affected by age, certain conditions, ethnicity, genetic traits, and pregnancy; the ADA recommends that treating providers review for discrepancies between A1c results and blood glucose results.

"Hyperglycemia" is excessive blood glucose. Fasting hyperglycemia is blood glucose above a desirable level after a person has fasted for at least 8 hours. Postprandial hyperglycemia is blood glucose above a desirable level 1 to 2 hours after a person has eaten.

"Hypoglycemia Unawareness" is a state in which a person does not feel or recognize the symptoms of hypoglycemia. People who have frequent episodes of hypoglycemia may no longer experience the warning signs of it.

"Hypoglycemia" is a condition that occurs when one's blood glucose is lower than normal, usually less than 70 mg/dL. Signs include hunger, nervousness, shakiness, perspiration, dizziness or lightheadedness, sleepiness, and confusion. If left untreated, hypoglycemia may lead to unconsciousness. Hypoglycemia is treated by consuming a carbohydrate-rich food such as a glucose tablet or juice. It may also be treated with an injection of glucagon if the person is unconscious or unable to swallow.

"Implantable Insulin Pump" is a device similar in function to an external insulin pump, however the components are implanted rather than worn or carried externally.

"Infusion Set" connects the insulin in an external continuous subcutaneous insulin infusion pump delivery device to a person’s body. The set consists of narrow, flexible plastic tubing that ends with a needle inserted just under the skin.

"Insulin" is a hormone made by the beta cells of the pancreas. Insulin allows glucose to enter the cells in the body for use in energy production, and when it is inadequate, the sugar remains in the blood leading to diabetes. There are a variety of oral and parenteral medications that can increase insulin production, increase the body’s sensitivity to existing insulin and reduce blood sugar. Insulin can also be injected or infused when lifestyle changes and non-insulin medications are inadequate.

"Remote Glucose Monitoring" refers to the transmission of blood glucose readings to an external device, such as the patient’s phone, computer, or to a physician/healthcare provider. It can be a standalone device or integrated into the continuous glucose monitor system.⁴

"Type 1 Diabetes" is an autoimmune condition that occurs when the beta cells of the pancreas are unable to produce enough insulin and therefore blood glucose cannot enter cells to be used for energy. Type 1 diabetes is often referred to as “insulin-dependent” because these patients require insulin daily to maintain their blood glucose at acceptable levels.

"Type 2 Diabetes" is a condition that occurs when either the pancreas doesn't produce enough insulin or the body cells become resistant to insulin. Type 2 diabetes is much more common than Type 1, and is often treated with combinations of lifestyle changes and non-insulin medications, although insulin can be required later in the disease course. Many individuals with Type 2 Diabetes are “insulin-requiring”.

Clinical Indications

General Criteria

The Plan considers insulin pump delivery systems or continuous glucose monitoring systems (CGMS) and its components medically necessary when ALL of the following general criteria are met AND the medical necessity criteria for the devices below are met:

1. The requested product has received U.S. Food and Drug Administration (FDA) approval/clearance AND is age-appropriate for the member; AND
2. The member has a diagnosis of diabetes mellitus; AND
3. Recent clinical documentation⇅ within the last six (6) months is provided showing ALL of the following:
   • A prescription for the requested product with ALL of the following:
     1. Product to be dispensed; and
     2. Quantity to be dispensed (or frequency of testing); and
     3. Prescriber’s signature and date; and
   • Hemoglobin A1c test results.

NOTE: ⇅All of the above documentation must be updated every 6 months to show compliance with treatment options. If any of the required documentation is more than 6 months old, it must be updated as soon as possible before any renewal request for coverage.

4. Additional criteria, as outlined below, must also be met depending on the specific equipment and supplies requested:

5External Insulin Pump Delivery Systems Criteria➔ For members who have been on an external insulin pump delivery system prior to enrollment with the Plan, please see Continued Care Criteria below.→ For a replacement, see Replacement Insulin Pumps Criteria below.

The Plan considers non-implantable insulin infusion pumps and supplies medically necessary when ALL of the following criteria are met:

1. The “General Criteria” for equipment and supplies above are met; AND
2. Prescribed by or in consultation with an endocrinologist; AND
3. Chart documentation is provided for the member showing ALL of the following:
   • Diagnosis of type 1 or type 2 diabetes mellitus with uncontrolled hyperglycemia; and
   • Is beta cell autoantibody positive OR insulinopenic, as confirmed by BOTH of the following:
     1. A fasting C-peptide level measured with a concurrently obtained fasting glucose less than or equal to (≤) 225 mg/dL; and
     2. The measured fasting C-peptide level meets ONE of the following:
        1. is undetectable (absolute insulin deficiency); or
        2. is less than or equal to 110% of the lower limit of normal established by the laboratory; or
        3. is less than or equal to 200% of the lower limit of normal established by the laboratory AND the member has documentation of renal insufficiency and creatinine clearance less than or equal to (≤) 50ml/minute; and
   • At least ONE of the following:
     • A child, where multiple daily insulin injections would be impractical or inappropriate;

• Complications of inadequate glycemic control (e.g., neuropathy, nephropathy, retinopathy) indicative of more intensive insulin regimens; or
• Dawn phenomenon unresponsive to management with long-acting insulin agents (e.g., insulin glargine or detemir); or
• For initial requests, HbA1c greater than 7% or above individualized target, despite an adequate regimen of multiple daily injections; or
• Hypoglycemic episodes requiring third-party assistance (e.g., seizure, loss of consciousness, glucagon administration, transport to an emergency room, hospitalization); or
• Recurrent hypoglycemia (<60 mg/dL on at least two occasions despite adherence to recommended diabetic treatment plan); or
• Pregnancy or planning for pregnancy; or
• Wide swings in blood glucose values before meal time (e.g., regular fluctuations of preprandial blood glucose to levels <60 mg/dL and/or >140 mg/dL); and
• Completion of a comprehensive diabetes education program; and
• Currently uses three (3) or more insulin injections daily; and
• History of frequent self-adjustments of insulin doses for at least 6 months prior; and
• Self-monitors blood glucose at least three (3) times per day (e.g., before meals and at bedtime) for the immediate two (2) months prior; and
• Member or designated caregiver can be adequately trained and is motivated to adhere to blood glucose monitoring at least 3 times per day, or the member qualifies for continuous glucose monitoring; and
• Provider team (e.g., physician, nurses, diabetes educators, and dietitians) is experienced in the management and support of patients with insulin infusion pumps.

When BOTH the General Criteria and External Insulin Pump Delivery Systems Criteria above are met OR were previously met and the member has a continued documented need for an insulin pump delivery system, the Plan considers the following quantities medically necessary:

Table 1: External Insulin Pump Delivery Systems & Supplies Medically Necessary Quantities

*Quantities are suggested guidance and are subject to review of the medical record and prescription. Requests that exceed the suggested quantity must be submitted with clinical documentation of medical necessity.

Replacement Insulin Pump Delivery Systems Criteria

Replacement Insulin Pump Delivery Systems are considered NOT medically necessary for the purpose of adding convenience features or new technologies (e.g., adding a wireless communication system to the glucose monitor). Replacement insulin pumps are considered medically necessary when recent chart documentation (within last 6 months) indicates ALL of the following:

1. The member continues to meets the General Criteria above; AND
2. The member has demonstrated adherence to diabetes management and use of devices; AND
3. The request is for ONE of the following:
   • A pediatric member requiring a replacement pump with larger insulin reservoir due to growth; or
   • Replacement of a malfunctioning pump that is no longer under warranty OR cannot be refurbished and restored to fully functional order.

Continuous Glucose Monitoring (CGM) Systems Criteria

The Plan considers Continuous Glucose Monitoring Systems and its components medically necessary when the member meets ALL of the following criteria:

1. The “General Criteria” for equipment and supplies above; AND
2. Documented diagnosis of diabetes mellitus; AND
3. At least ONE of the following:
   • Long-term continuous glucose monitoring is needed for the member’s diabetes management, as evidenced by clinical documentation in the past 6 months showing:
     1. The member has documented adherence to diabetic treatment plan and can be trained to use a CGM; and
     2. The member consistently checks blood glucose at least 3 times daily; and
     3. The member meets at least ONE of the following:
        • Type 1 diabetes; or
        • Type 2 diabetes treated with basal insulin who have hemoglobin A1c above goal, despite appropriate changes in insulin therapy and compliance with the treatment plan; or
        • On intensive insulin therapy, defined as 3 or more injections of insulin per day or the use of an insulin pump; or
        • Pregnant; or
        • Problematic hypoglycemia, defined as having a history of:
          • Frequent/severe hypoglycemia; or
          • Nocturnal hypoglycemia; or
          • Hypoglycemia unawareness;

• Severe hypoglycemia (≥2 episodes with blood glucose <54 mg/dL in the past 30 days); or
• Short-term CGM is necessary, as indicated by BOTH of the following:
  1. Additional information on blood glucose levels is needed, as indicated by at least ONE of the following:
     1. Dawn phenomenon, known or suspected; or
     2. Hypoglycemic unawareness; or
     3. Nocturnal hyperglycemia, known or suspected; or
     4. Postprandial hyperglycemia, known or suspected; or
     5. Significant change to the treatment regimen, such as starting insulin or transitioning from multiple daily doses to an insulin pump; or
     6. Unexplained hyperglycemia; and
  2. Monitoring is limited to a maximum of three (3) to 14 days and for no more than 2 episodes within a 12-month period.

Implantable Glucose Monitoring (e.g., Eversense, Eversense E3 CGM System)➔ For members who have been on this implantable glucose monitor prior to enrollment with the Plan, please see Continued Care Criteria below.

The Plan considers the initial request for long term (90-180 days) FDA approved or cleared implantable glucose monitoring medical necessary when ALL of the following criteria are met:

1. The “General Criteria” for equipment and supplies above are met; AND
2. Diagnosis of Type 1 or 2 diabetes mellitus; AND
3. The member is age 18 years or older; AND
4. The member has inadequate glycemic control despite compliance, with trial and failure of ONE of the below:
   • Standard blood glucose monitors with frequent self-monitoring finger sticks; or
   • Flash glucose monitoring; or
   • Continuous glucose monitoring (non-implantable); or
   • Allergy to adhesive or other materials in non-implantable CGM devices; AND
5. The insertion of the glucose sensor in the upper arm will be conducted by a healthcare practitioner; AND
6. Long-term continuous glucose monitoring is needed for the member’s diabetes management, as evidenced by clinical documentation in the past 6 months showing:
   1. The member has documented adherence to diabetic treatment plan and can be trained to use a CGM; and
   2. The member consistently checks blood glucose at least 3 times daily; and
   3. The member meets at least ONE of the following:
      1. Type 1 diabetes; or
      2. Type 2 diabetes treated with basal insulin who have hemoglobin A1c above goal, despite appropriate changes in insulin therapy and compliance with the treatment plan; or
      3. On intensive insulin therapy, defined as 3 or more injections of insulin per day or the use of an insulin pump; or
      4. Problematic hypoglycemia, defined as having a history of:
         1. Frequent/severe hypoglycemia; or
         2. Nocturnal hypoglycemia; or
         3. Hypoglycemia unawareness; or
         4. Severe hypoglycemia (≥2 episodes with blood glucose <54 mg/dL in the past 30 days); AND
7. The member does not have any of the following contraindications:
   • Critically ill or hospitalized; or
   • Expecting to undergo an MRI (magnetic resonance imaging) procedure within 90-days for Eversense or 180-days for Eversense E3 (Eversense sensor and transmitter are incompatible and must be removed before MRI procedure); or
   • Has another active implantable device, e.g., an implantable defibrillator (passive implants are allowed, e.g., cardiac stents); or
   • History of dexamethasone or dexamethasone acetate contraindication, or allergies to systemic glucocorticoids; or
   • Need mannitol or sorbitol intravenously, or as a component of an irrigation solution or peritoneal dialysis solution; or
   • Pregnant or nursing; or

Receiving immunosuppressant therapy, chemotherapy, or anticoagulant therapy.

When the General Criteria, along with the criteria for Continuous Glucose Monitoring (CGM) Systems OR Implantable Glucose Monitoring, are satisfied, or have been satisfied in the past, and the member demonstrates an ongoing documented need for a CGM, the Plan deems the following quantities to be medically necessary:

Table 2#: Personal/Long-term CGMS Medically Necessary Quantities

#This is not an exhaustive list. When medical necessity criteria is met for products not listed, quantitiesfor supplies will reflect FDA-approved or cleared indications for use.

The sensor insertion and removal procedures must be performed by a healthcare provider. ⇟Quantities are suggested guidance and are subject to review of the medical record and prescription. Requests that exceed the suggested quantity must be submitted with clinical documentation of medical necessity.

Table 3#: Professional Diagnostic/Short-Term CGMS Medically Necessary Quantities

#This is not an exhaustive list. When medical necessity criteria is met for products not listed, quantitiesfor supplies will reflect FDA-approved or cleared indications for use. ⇟Quantities are suggested guidance and are subject to review of the medical record and prescription. Requests that exceed the suggested quantity must be submitted with clinical documentation of medical necessity.

Medical Necessity Criteria for Requests to Switch Continuous Glucose Monitoring Systems

➤ For all other requests, please see Initial Requests or Continued Care Criteria below

The Plan considers requests to switch Continuous Glucose Monitoring Systems medically necessary if the member meets ONE of the following:

1. The member has an allergy or reaction to their current CGM system adhesive or components that is unable to be managed or resolved; OR
2. The member requires a switch to a CGM system compatible with their insulin pump orautomated insulin delivery system; OR
3. For members enrolled in an Oscar-designated disease management program - the member requires a switch to a CGMS meeting designated program requirements (i.e., switch their non- Dexcom Glucose Monitor to a Dexcom branded CGM device).

Exception Criteria for Additional Receivers/Readers (see Table 2: Personal/Long-term CGMS Medically Necessary Quantities)

The Plan recognizes that there may be situations where an additional receiver/reader for a covered stand-alone Continuous Glucose Monitoring (CGM) system is needed prior to the 3-year replacementperiod for select products. In such cases, the following criteria must be met:

1. The currently owned receiver/reader must be non-functional and unable to be repaired or replaced by the manufacturer.

Documentation should clearly indicate that the receiver/reader is no longer operational and cannot be fixed or replaced.

1. The member or healthcare provider must have made reasonable attempts to troubleshoot and resolve the issue with the non-functional receiver/reader. Documentation should demonstrate the efforts made to troubleshoot the device and the inability to repair or replace it.¹3

NOTE: Replacement is limited to one receiver/reader per 3-year. Exceptions may be considered for special populations, such as children who may accidentally damage the device within the 3- year period. In such cases, documentation should clearly demonstrate that the monitoring needs of the individual cannot be adequately met with the approved replacement limit.

Artificial Pancreas / Hybrid Closed-Loop Insulin Delivery Systems (e.g., MiniMed 630G, 670G, 770G)

➔ For members who have been on this hybrid insulin system prior to enrollment with the Plan, please see Continued Care Criteria below.

The Plan considers hybrid, closed-loop insulin delivery systems medically necessary when ALL of the following criteria are met:

1. The “General Criteria” for equipment and supplies above are met; AND
2. The member meets the criteria for a new or replacement “external insulin infusion pump”; AND
3. The member meets the criteria for a new or replacement “continuous glucose monitoring”; AND
4. The member has documented adherence to a diabetic treatment plan and can be trained (or member’s guardian) to use the device; AND
5. The requested system is FDA approved or cleared AND is being prescribed for use in accordance to the device-specific FDA limitations (when applicable), such as:
   • Age recommendations or restrictions (e.g., the member must be ≥2 years old diagnosed with type 1 diabetes for MiniMed 770G); or
   • Contraindication to or interference by medications (e.g., Tylenol [acetaminophen]); or
   • Hearing or visual impairments prevent recognition of pump signals and/or alarms; or
   • Daily insulin dosage (units) does not meet minimum dosage requirements for device functionality.

Continued Care Criteria for Continuing Treatment After Initial Trial

The Plan considers continuous glucose monitoring, insulin delivery systems, hybrid closed-loop insulin delivery systems, removal and replacement of glucose sensor for Eversense (including members who have been on the device/monitor prior to enrollment with the Plan) medically necessary when ALL of the following criteria are met:

1. The member continues to meet the “General Criteria” above.
2. There is documented provider evaluation within the last 6 months that demonstrates the member's adherence to their diabetic treatment plan and devices. This evaluation should assess the member's compliance with the prescribed treatment regimen and use of the continuous glucose monitoring system, insulin delivery system, hybrid closed-loop insulin delivery system, or Eversense glucose monitoring system.¹4

Experimental or Investigational / Not Medically Necessary

The Plan does not consider medically necessary the replacement or repair of units or associated equipment when lost or damaged due to neglect or improper care.

The following products, supplies, or indications are considered experimental, investigational, or convenience features:

1. Fully-Automated Bihormonal Artificial Pancreas Devices
   • Rationale: At this time, there are no commercially available or FDA approved bihormonal artificial pancreas systems. Several small cross-over studies looking at this device demonstrated a lower mean glucose in the intervention group and fewer episodes of hypoglycemia. However, there have been no long-term safety or efficacy studies, and some of the existing studies have found similar results between single hormone (insulin) and bi-hormonal (insulin and glucagon) systems.
2. GlucoWatch Biographer Monitor (Cygnus Inc.) or any other hypoglycemic wristband alarm (A9280)
   • Rationale: The clinical utility of these devices has not yet been demonstrated in any randomized clinical trials. The MITRE (Minimally Invasive Technology Role and Evaluation) study was a large clinical trial on 400 patients with diabetes on insulin. The study concluded that there was a small, short-term clinical benefit that subsided over time. Furthermore, the Biographer monitor had less impact on HbA1C than both standard treatment and continuous blood glucose monitoring.²⁰-²¹, ³², ⁹², ¹¹⁴
3. Implantable Insulin Pumps
   • Rationale: There have been studies demonstrating potential clinical benefit of implantable insulin pumps, however they do not currently have U.S. Food and Drug Administration (FDA) approval at this time, and the ADA 2023 guidelines do not mention implantable insulin pumps as a recommended treatment for diabetes.
4. Lasette™ Laser Blood Glucose Monitoring Device or other similar laser lancets
   • Rationale: Evidence for the clinical benefit of laser blood glucose monitoring over standard blood glucose monitoring is limited in the medical literature; therefore, these devices are considered experimental or investigational.
5. Remote Glucose Monitoring (e.g., mySentry, MiniMed Connect, Dexcom Share) is not covered as a separately reimbursable or standalone device or service. Integrated remote glucose monitoring, such as when a CGM device has the ability to share data to a smart phone or through an app, may be considered medically necessary when the clinical criteria for CGM are met.
   • Rationale: There is limited evidence that telemonitoring or otherwise sharing glucose values results in an improvement in outcomes. A 2017 study by Lee et al conducted on 107 patients, 54 of which were frequent users of self-telemonitoring and 53 who were not, showed a small but significant difference in A1c values at 6 months. This study was limited by its non-randomized nature, small population, and potential confounding factors. Other studies have shown no benefit of telemonitoring of diabetes patients in terms of glycemic control.¹⁵

The use of standalone devices or telemonitoring services for remote glucose monitoring has yet to be fully explored, and further data is needed to determine if there is any potential benefit to this technology.^{123, 124, 1266}.

Subcutaneous insulin infusers, including but not limited to, i-Port^a. Rationale: There is a lack of clinical evidence supporting the use of insulin infusers and diabetes outcomes. Blevins et al (2008) conducted a randomized controlled crossover trial comparing outcomes of i-Port vs. standard insulin injection in 74 patients. A1c levels were similar among all subjects at the initiation and completion of the study, demonstrating no observable clinical benefit. Patients did report that it was more difficult to control their blood sugar levels with standard insulin injections; however the differences were non-significant (p=0.16).¹⁴