Number: 0061 Policy - Aetna · 2015-08-20 · Number: 0061 (Replaces CPB 144) Policy. Notes: 1. For...
Transcript of Number: 0061 Policy - Aetna · 2015-08-20 · Number: 0061 (Replaces CPB 144) Policy. Notes: 1. For...
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Clinical Policy Bulletin:
Nutritional Support
Number: 0061 (Replaces CPB 144)
Policy
Notes:
1. For members with such a plan benefit, specific nutritional support is considered to be a
medical item only when it is administered enterally (i.e., by feeding tube) or parenterally
(i.e., by intravenous administration) where the member has either (a) a permanent* non-
function or disease of the structures that normally permit food to reach the small bowel;
or (b) disease of the small bowel that impairs digestion and absorption of an oral diet,
either of which requires enteral or parenteral feedings to provide sufficient nutrients to
maintain weight and strength commensurate with the member's overall health status.
Note: Not all benefit plans cover nutritional support even in the circumstances stated
above. Please check benefit plan descriptions.
2. In general, Aetna Better Health does not consider oral nutrition a medical item.
However, Aetna Better Health covers nutritional support that is taken orally (i.e., by
mouth) in cases of severe diseases such as End Stage Renal Disease (ESRD), cancers
and chronic medical conditions with low Body Mass Index (BMIs). Oral nutrition is
not considered a medical item. See section on Special Medical Foods below.
3. Regular food products are not considered medical items. Regular food products include
baby food, gluten-free food products, high protein powders and mixes, low carbohydrate
diets, normal grocery items, nutritional supplement puddings, weight- loss foods and
formula (products to aid weight loss), or other regular grocery products that can be
mixed in blenders and used with an enteral system regardless of whether these regular
food products are taken orally or parenterally. However, food thickeners are covered up
to 72 ounces. Amounts exceeding the 72 hours are considered on a case by case basis.
Determinants of the route of administration of nutritional support include the functional status of
the gastrointestinal tract and the anticipated duration of therapy.
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1. Enteral Tube Feedings
Enteral nutrition is the provision of nutritional requirements through a tube into the
stomach or small intestine.
The short-term methods of enteral tube feedings include nasogastric, nasoduodenal and,
less frequently, nasojejunal tubes. Long-term enteral feedings are best administered by a
percutaneous gastrostomy or jejunostomy tube.
Aetna considers enteral tube feedings medically necessary when the member has either
(a) permanent* non-function or disease of the structures that normally permit food to
reach the small bowel; or (b) disease of the small bowel that impairs digestion and
absorption of an oral diet, either of which requires tube feedings to provide sufficient
nutrients to maintain weight and strength commensurate with the member's overall
health status.
The member's condition could be either an anatomic abnormality (e.g., obstruction due to
head and neck cancer or reconstructive surgery, etc.) or a motility disorder (e.g., severe
dysphagia following a stroke, neuromuscular or disease of the central nervous system that
interferes with the ability to chew or swallow, etc.). Enteral nutrition is not considered
medically necessary for members with a functioning gastrointestinal tract whose need for
enteral nutrition is due to reasons such as anorexia or nausea associated with mood disorder,
end-stage disease, etc.
The member must require tube feedings to maintain weight and strength commensurate
with the member's overall health status. Adequate nutrition must not be possible by dietary
adjustment and/or oral supplements. Enteral nutrition may be considered medically
necessary for members with partial impairments (e.g., a member with dysphagia who can
swallow small amounts of food or a member with Crohn's disease who requires prolonged
infusion of enteral nutrients to overcome a problem with absorption).
Note: Enteral nutrition products that are administered orally and related supplies are not
covered.
*Note: The member must have a permanent impairment. Permanence does not require a
determination that there is no possibility that the member's condition may improve sometime
in the future. If the judgment of the doctor, substantiated in the medical record, is that the
impairment can reasonably be expected to exceed 3 months (90 days), the test
of permanence is considered met. This is consistent with Center for Medicare and
Medicaid Services (CMS) guidelines.
Formulas consisting of semi-synthetic intact proteins or protein isolates (e.g., Enrich,
Ensure, Ensure HN, Ensure Powder, Isocal, Lonalac Powder, Meritene, Meritene Powder,
Osmolite, Osmolite HN, Portagen Powder, Renu, Sustacal, Sustagen Powder,
Travasorb) are considered medically necessary for enteral feeding of the majority of older
members who meet criteria for enteral feeding. Formulas consisting of natural intact proteins
or protein isolates (e.g., Compleat B, Compleat B Modified, Vitaneed) are considered
medically necessary for enteral feeding of members with an allergy or intolerance to semi-
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synthetic formulas. Calorically dense formulas are also considered medically necessary for
enteral feedings if they are indicated. The medical necessity for special formulas for enteral
feedings must be justified in each member.
Infant Formula
Note: Infant formulas and breast milk additive to prevent necrotizing enterocolitis in
premature infants are only covered if administered via the tube-feeding route and the
criteria for coverage of enteral feedings are met. Infant formulas given orally are not
covered.
Equipment
Appropriate nutrients, administration supplies, and equipment are considered medically
necessary for persons who meet criteria for enteral feedings. Tube feedings are usually
given by gravity feedings or syringe. Pumps are considered medically necessary durable
medical equipment (DME) only where gravity feedings or syringe feedings have caused
complications or are otherwise not indicated (e.g., gravity feeding is not satisfactory due to
reflux and/or aspiration, severe diarrhea, dumping syndrome, administration rate less than
100 ml/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube
used for feeding). More than 3 nasogastric tubes or 1 gastrostomy/jejunostomy tube every 3
months is rarely considered medically necessary.
Note: Some Aetna plans exclude coverage of DME and supplies. Please check benefit
plan descriptions.
2. Parenteral Nutrition/Total Parenteral Nutrition (TPN)
Parenteral nutrition involves the delivery of micronutrients and macronutrients through
catheters in central or peripheral veins. In most instances, the central venous route is
utilized; for long-term total parenteral nutrition (TPN), a central catheter (e.g., Hickman,
Broviac, PIC) is burrowed through a subcutaneous tunnel on the anterior chest.
Generally, the parenteral approach is considered medically necessary only if adequate
nutritional intake is not possible via the oral or tube-feeding route.
Aetna considers parenteral nutrition medically necessary for members who meet any of the
following criteria:
1. Documentation of a failure of enteral (i.e., oral or tube feeding) nutrition, as
defined by either of the following:
1. A non-edematous or post-dialysis documented loss of greater than 10 % of
body weight over a 3-month period; or
2. Total protein less then 6 g/dL or serum albumin less than 3.4 g/dL;
2. A condition in which it is necessary for the gastrointestinal tract to be totally non-
functioning for a period of time;
3. Evidence of structural or functional bowel disease that makes oral and tube
feedings inappropriate;
4. Hyperemesis gravidarum (only in cases of failed medical management or when
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used in a step-therapy program);
5. Member is peri-operative (regardless of disease state) and unable to tolerate oral or
tube feedings.
Parenteral nutrition may be either “self-mixed” (i.e., the member or family caregiver is
taught to prepare the nutrient solution aseptically) or “pre-mixed”. The doctor must
justify the need for pre-mixed parenteral nutritional solutions.
Parenteral nutrition is not considered medically necessary for members with a
functioning gastrointestinal tract whose need for parenteral nutrition is only due to:
6. A physical disorder impairing food intake such as the dyspnea of severe
pulmonary or cardiac disease;
7. A psychological disorder impairing food intake such as depression;
8. A side effect of a medication;
9. A swallowing disorder;
10. A temporary defect in gastric emptying such as a metabolic or electrolyte
disorder;
11. Disorders inducing anorexia such as cancer;
12. Renal failure and/or dialysis.*
*Members receiving intra-dialytic parenteral nutrition must meet the criteria for total
parenteral nutrition set forth above.
Aetna considers intra-peritoneal nutrition experimental and investigational. Aetna
considers intra-peritoneal amino acid (IPAA) supplementation medically necessary for
members on peritoneal dialysis when all of the following criteria are met:
13. Inability to administer or tolerate adequate oral protein nutrition, including food
supplements, or enteral tube feeding; and
14. The combination of some oral or enteral intake that, when combined with IPAA,
will meet the individual's nutritional goals; and
15. There is evidence of inadequate dietary protein intake and protein malnutrition.
Equipment
If the criteria for parenteral nutrition are met, medically necessary nutrients,
administration supplies, and equipment are considered medically necessary.
3. Special Medical Foods Taken Orally
Note: Aetna covers special medical foods only when mandated by state law.
Special medical foods are used for the treatment of inborn errors of metabolism
(histidinemia, homocystinuria, maple syrup urine disease [MSUD], phenylketonuria [PKU],
and tyrosinemia). The special oral formulas are designed to restrict intake of one or more
amino acids. Some states now have mandates requiring coverage of these
dietary formulas.
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Aetna does not cover banked breast milk, food supplements, specialized infant
formulas, vitamins and/or minerals taken orally (i.e., by mouth).
Food supplements, specialized infant formulas (e.g., Alimentum, Elecare, Neocate, and
Nutramigen), lactose-free foods, vitamins and/or minerals may be used to replace
intolerable foods, for lactose intolerance, to supplement a deficient diet, or to provide
alternative nutrition in the presence of such conditions as allergies, gastrointestinal
disorders, hypoglycemia, and obesity. Food supplements, lactose-free foods, specialized
infant formulas, vitamins and/or minerals taken orally are not covered, even if they are
required to maintain weight or strength and regardless of whether these are prescribed by
a physician.
Most Aetna plans do not specifically include coverage of infant formulas when taken
orally. In the absence of a specific inclusion or state mandate, specialized infant formulas
are not covered.
Background
Parenteral nutrition involves the delivery of micronutrients and macronutrients through catheters
in central or peripheral veins. In most instances, the central venous route is utilized, and for
long-term total parenteral nutrition a central catheter (e.g., Hickman, Broviac, PIC) is burrowed
through a subcutaneous tunnel on the anterior chest.
Enteral nutrition can be administered via a small catheter placed through the nose into the
stomach or by a surgically placed catheter into the stomach or intestines. Enteral nutrition
therapy may supplement protein and calories in a variety of situations where oral nutrition is not
adequate, with the intention of providing part or all of the daily requirements. Specialized diets
for specific diseases or pathophysiologic situations may be administered via enteral nutrition.
These specialized diets may involve restricting a particular element of the diet (e.g., fat, lactose),
adding a particular nutrient that may be required in larger amounts than are available from a
regular diet (e.g., calcium, potassium), or altering the consistency of the diet (e.g., high-fiber,
full-liquid).
The need for specialized foods is very common, and for most conditions, the specialized food is
needed for the person's entire lifetime. For example, in Europe and the United States, the
prevalence of lactose intolerance is 7 to 20 % in Caucasians, and is as high as 80 to 95 % among
Native Americans, 65 to 75 % among Africans and African Americans, and 50 % in Hispanics
(Scrimshaw et al, 1988). The prevalence exceeds 90 % in some populations in eastern Asia.
Another example of a common medical condition requiring a specialized diet is celiac disease
(also called gluten-sensitive enteropathy and non-tropical sprue), with a prevalence of almost
1 % of the population (Fasano et al, 2003). There are many other examples where specialized
diets are prescribed, which could extend to specialized diets for hypertension, diabetes, or
cardiovascular disease.
Sullivan et al (2010) evaluated the health benefits of an exclusively human milk-based diet
compared with a diet of both human milk and bovine milk-based products in extremely
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premature infants. Infants fed their own mothers' milk were randomized to 1 of 3 study groups.
Groups HM100 and HM40 received pasteurized donor human milk-based human milk fortifier
(HMF) when the enteral intake was 100 and 40 ml/kg/day, respectively, and both groups
received pasteurized donor human milk if no mother's milk was available. Group BOV received
bovine milk-based HMF when the enteral intake was 100 ml/kg/day and preterm formula if no
mother's milk was available. Outcomes included duration of parenteral nutrition, morbidity, and
growth. The 3 groups (total n = 207 infants) had similar baseline demographic variables,
duration of parenteral nutrition, rates of late-onset sepsis, and growth. The groups receiving an
exclusively human milk diet had significantly lower rates of necrotizing enterocolitis (NEC; p =
0.02) and NEC requiring surgical intervention (p = 0.007). The authors concluded that for
extremely premature infants, an exclusively human milk-based diet is associated with
significantly lower rates of NEC and surgical NEC when compared with a mother's milk-based
diet that also includes bovine milk-based products.
Ganapathy et al (2012) evaluated the cost-effectiveness of a 100 % human milk-based diet
composed of mother's milk fortified with a donor human milk-based HMF versus mother's milk
fortified with bovine milk-based HMF to initiate enteral nutrition among extremely premature
infants in the neonatal intensive care unit (NICU). A net expected costs calculator was
developed to compare the total NICU costs among extremely premature infants who were fed
either a bovine milk-based HMF-fortified diet or a 100 % human milk-based diet, based on the
previously observed risks of overall NEC and surgical NEC in a randomized controlled study
that compared outcomes of these 2 feeding strategies among 207 very low birth-weight infants.
The average NICU costs for an extremely premature infant without NEC and the incremental
costs due to medical and surgical NEC were derived from a separate analysis of hospital
discharges in the state of California in 2007. The sensitivity of cost-effectiveness results to the
risks and costs of NEC and to prices of milk supplements was studied. The adjusted incremental
costs of medical NEC and surgical NEC over and above the average costs incurred for extremely
premature infants without NEC, in 2011 US$, were $74,004 (95 % confidence interval [CI]:
$47,051 to $100,957) and $198,040 (95 % CI: $159,261 to $236,819) per infant, respectively.
Extremely premature infants fed with 100 % human-milk based products had lower expected
NICU length of stay and total expected costs of hospitalization, resulting in net direct savings of
3.9 NICU days and $8,167.17 (95 % CI: $4,405 to $11,930) per extremely premature infant (p <
0.0001). Costs savings from the donor HMF strategy were sensitive to price and quantity of
donor HMF, percentage reduction in risk of overall NEC and surgical NEC achieved, and
incremental costs of surgical NEC. The authors concluded that compared with feeding
extremely premature infants with mother's milk fortified with bovine milk-based supplements, a
100 % human milk-based diet that includes mother's milk fortified with donor human milk-based
HMF may result in potential net savings on medical care resources by preventing NEC.
Aetna's policy on parenteral and enteral nutrition is similar to Medicare policy. Medicare
provides reimbursement under the part-B prosthetic-device benefit for parenteral and enteral
nutrition. Consistent with its policy of covering supplies necessary for use of prosthetics,
Medicare will generally cover medically necessary supplies, equipment, and nutrients associated
with parenteral and enteral nutrition if the coverage requirements for enteral or parenteral
nutritional therapy are met under the prosthetic device benefit provision.
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CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
99507
99601
+ 99602
Other CPT codes related to the CPB:
36555 - 36571
43246
43510
43653
43752
43760
43761
43810 - 43832
+ 44015
44372
44373
44500
49440
49441
49446
49450
49451
49452
74340
HCPCS codes covered if selection criteria are met:
B4087 Gastrostomy/jejunostomy tube, standard, any material, any type, each
B4088 Gastrostomy/jejunostomy tube, low-profile, any material, any type, each
B4102 Enteral formula, for adults, used to replace fluids and electrolytes (e.g.,
clear liquids), 500 ml= 1 unit
B4103 Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g.,
clear liquids), 500 ml = 1 unit
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B4104 Additive for enteral formula (e.g., fiber)
B4149 Enteral formula, manufactured blenderized natural foods with intact
nutrients, includes proteins, fats, carbohydrates, vitamins and minerals,
may include fiber, administered through an enteral feeding tube, 100
calories = 1 unit
B4034 - B4086,
B4102 - B9999
Enteral and Parenteral Therapy (except food thickener)
S5497 Home infusion therapy, catheter care/ maintenance, not otherwise
classified; includes administrative services, professional pharmacy services,
care coordination, and all necessary supplies and equipment (drugs and
nursing visits coded separately), per diem
S5498 Home infusion therapy, catheter care/ maintenance, simple (single lumen),
includes administrative services, professional pharmacy services, care
coordination, and all necessary supplies and equipment (drugs and nursing
visits coded separately), per diem
S5501 Home infusion therapy, catheter care/ maintenance, complex (more than
one lumen), includes administrative services, professional pharmacy
services, care coordination, and all necessary supplies and equipment
(drugs and nursing visits coded separately), per diem
S5502 Home infusion therapy, catheter care/ maintenance, implanted access
device, includes administrative services, professional pharmacy services,
care coordination, and all necessary supplies and equipment (drugs and
nursing visits coded separately), per diem (use this code for interim
maintenance of vascular access not currently in use)
S5517 Home infusion therapy, all supplies necessary for restoration of catheter
patency or declotting
S5518 Home infusion therapy, all supplies necessary for catheter repair
S5520 Home infusion therapy, all supplies (including catheter) necessary for a
peripherally inserted central venous catheter (PICC) line insertion
S5521 Home infusion therapy, all supplies (including catheter) necessary for a
midline catheter insertion
S5522 Home infusion therapy, insertion of peripherally inserted central venous
catheter (PICC), nursing services only (no supplies or catheter included)
S5523 Home infusion therapy, insertion of midline central catheter, nursing
services only (no supplies or catheter included)
S9342 Home therapy; enteral nutrition via pump; administrative services,
professional pharmacy services, care coordination, and all necessary
supplies and equipment (enteral formula and nursing visits coded
separately), per diem
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S9343 Home therapy; enteral nutrition via bolus; administrative services,
professional pharmacy services, care coordination, and all necessary
supplies and equipment (enteral formula and nursing visits coded
separately), 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 (lipids,
specialty amino acid formulas, drugs other than in standard formula and
nursing visits coded separately), per diem
S9365 Home infusion therapy, total parenteral nutrition (TPN); 1 liter per day,
administrative services, professional pharmacy services, care coordination,
and all necessary supplies and equipment including standard TPN formula
(lipids, specialty amino acid formulas, drugs other than in standard formula
and nursing visits coded separately), per diem
S9366 Home infusion therapy, total parenteral nutrition (TPN); more than 1 liter
but no more than 2 liters per day, administrative services, professional
pharmacy services, care coordination, and all necessary supplies and
equipment including standard TPN formula (lipids, specialty amino acid
formulas, drugs other than in standard formula and nursing visits coded
separately), per diem
S9367 Home infusion therapy, total parenteral nutrition (TPN); more than 2 liters
but no more than 3 liters per day, administrative services, professional
pharmacy services, care coordination, and all necessary supplies and
equipment including standard TPN formula (lipids, specialty amino acid
formulas, drugs other than in standard formula and nursing visits coded
separately), per diem
S9368 Home infusion therapy, total parenteral nutrition (TPN); more than 3 liters
per day, administrative services, professional pharmacy services, care
coordination, and all necessary supplies and equipment including standard
TPN formula (lipids, specialty amino acid formulas, drugs other than in
standard formula and nursing visits coded separately), per diem
HCPCS codes not covered for indications listed in the CPB:
A9152 Single vitamin/mineral/trace element, oral, per dose, not otherwise
specified
A9153 Multiple vitamins, with or without minerals and trace elements, oral, per
dose, not otherwise specified
B4100 Food thickener, administered orally, per oz
Other HCPCS codes related to the CPB:
S9123 Nursing care, in the home; by registered nurse, per hour (use for general
nursing care only, not to be used when CPT codes 99500-99600 can be
used)
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S9124 Nursing care, in the home; by licensed practical nurse, per hour
S9433 Medical food nutritionally complete, administered orally, providing 100%
of nutritional intake
S9434 Modified solid food supplements for inborn errors of metabolism
S9435 Medical foods for inborn errors of metabolism
S9810 Home therapy; professional pharmacy services for provision of infusion,
specialty drug administration, and / or disease state management, not
otherwise classified, per hour (do not use this code with any per diem code)
ICD-9 codes covered if selection criteria are met (not all inclusive):
140.0 - 154.8 Malignant neoplasm of lip, oral cavity, pharynx, esophagus, stomach, small
intestine including duodenum, colon, rectum, rectosigmoid junction, and
anus
195.0 Malignant neoplasm of head, face, and neck
260, 261, 262 Kwashiorkor, nutritional marasmus or other severe, protein-calorie
malnutrition
263.0 - 263.9 Other and unspecified protein-calorie malnutrition
438.82 Late effect of cerebrovascular disease, dysphagia
530.5 Dyskinesia of esophagus
643.00, 643.01 &
643.03
Mild hyperemesis gravidarum, unspecified as to episode of care, delivered,
with or without mention of antepartum condition, or antepartum condition
or complication
643.10, 643.11 &
643.13
Hyperemesis gravidarum with metabolic disturbance, unspecified as to
episode of care, delivered, with or without mention of antepartum
condition, or antepartum condition or complication
643.20, 643.21 &
643.23
Late vomiting of pregnancy, unspecified as to episode of care, delivered,
with or without mention of antepartum condition, or antepartum condition
or complication
643.80, 643.81 &
643.83
Other vomiting complicating pregnancy, unspecified as to episode of care,
delivered, with or without mention of antepartum condition, or antepartum
condition or complication
643.90, 643.91 &
643.93
Unspecified vomiting of pregnancy, unspecified as to episode of care,
delivered, with or without mention of antepartum condition, or antepartum
condition or complication
787.20 - 787.29 Dysphagia
V44.1 Gastrostomy status
V44.4 Other artificial opening of gastrointestinal tract
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ICD-9 codes not covered for indications listed in the CPB:
290.0 - 319 Mental disorders
584.5 - 586 Renal failure
V45.1 Renal dialysis status
Other ICD-9 codes related to the CPB:
270.1 - 277.9 Disorders of amino-acid transport and metabolism, carbohydrate transport
and metabolism, lipoid metabolism, plasma protein metabolism, mineral
metabolism, calcium metabolism, fluid, electrolyte, and acid-base balance,
and other and unspecified disorders of metabolism
358.0 - 358.9 Myoneural disorders
536.0 - 536.9 Disorders of function of stomach
555.0 - 564.9 Noninfectious enteritis and colitis, intestinal obstruction without mention of
hernia, diverticula of intestine, and functional digestive disorders, not
elsewhere classified
579.0 - 579.9 Intestinal malabsorption
777.1 - 777.9 Perinatal disorders of digestive system
779.3 Feeding problems in newborn
783.0 Anorexia
783.21, 783.22 Abnormal loss of weight and underweight
783.3 Feeding difficulties and mismanagement
783.41 Failure to thrive
783.7 Adult failure to thrive
786.09 Other dyspnea and respiratory abnormalties
V10.00 - V10.09 Personal history of malignant neoplasm of gastrointestinal tract
The above policy is based on the following references:
1. Centers for Medicare & Medicaid Services (CMS). Enteral and parenteral nutrition
therapy covered as prosthetic device. Medicare Coverage Issues Manual Section 65-10.
Baltimore, MD: CMS; effective July 11, 1984.
2. Tricenturion LLC. 18.2 Parenteral nutrition. Medicare Local Medical Review Policy.
Durable Medical Equipment Regional Carrier (DMERC) Regions A and B. Columbia,
SC: Tricenturion; effective July 1, 1996.
3. Tricenturion LLC. 18.1 Enteral nutrition. Medicare Local Medical Review Policy.
Durable Medical Equipment Regional Carrier (DMERC) Regions A and B. Columbia,
SC: Tricenturion; effective April 1, 2002.
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