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Parenteral nutritional support (PEN), also known as parenteral hyperalimentation, is used for patients with medical conditions that impair gastrointestinal absorption to a degree incompatible with life. It is also used for variable periods of time to bolster the nutritional status of severely malnourished patients with medical or surgical conditions. PEN involves percutaneous transvenous implantation of a central venous catheter into the vena cava or right atrium. A nutritionally adequate hypertonic solution consisting of glucose (sugar), amino acids (protein), electrolytes (sodium, potassium), vitamins and minerals, and sometimes fats is administered daily. An infusion pump is generally used to assure a steady flow of the solution either on a continuous (24-hour) or intermittent schedule. If intermittent, a heparin lock device and diluted heparin are used to prevent clotting inside the catheter.
Enteral nutrition (EN) is used for patients with a functioning intestinal tract who have disorders that prevent nutrients from being successfully transported to and/or absorbed in the small intestine or who have life threatening disorders of body chemistry and require formulas specially formulated to prevent toxicity. Enteral nutrition consists of nutritional support given orally or through any of a variety of enteral tubes used in specific medical circumstances. Feedings may be intermittent or continuous and may be administered using an infusion pump.
Participating providers are required to follow the American Dietetic Association Medical Nutrition Therapy Protocols for Parenteral and Enteral Feeding Support.
1. Nutrients and their method of administration for parenteral nutrition must be specifically ordered by a physician.
2. Parenteral feeding support (PEN) in the home is considered medically necessary in the treatment of inanition associated with conditions resulting in impaired intestinal absorption, including the following conditions, but not limited to, any of the conditions listed in the "Code Reference" section.
3. The following criteria must be met prior to the initial implementation of PEN:
1. Unintentional weight loss greater than 5% over 1 month or 10% over 6 months from usual body weight; adjust for body part amputation;
1. Nutrients and their method of administration for enteral nutrition must be specifically ordered by a physician.
2. Enteral nutrition that meets the definition of Medical Food (see Policy Guidelines) when administered through enteral feeding tubes (e.g. NG tubes, NE tubes, G-tubes, J-tubes) is considered medically necessary for the following functional impairments:
A. Central nervous system disorders in which the patient is unable to swallow because a damaged brain or spinal cord can no longer communicate with the muscles of the alimentary tract. This leads to interference with the neuromuscular coordination of chewing and swallowing and risk for aspiration. The paralysis may be a result of, but not limited to:
1. Cerebral vascular accident
B. An anatomic or mechanical functional impairment that results in a specific inability to swallow or may prevent food from reaching the stomach (e.g. esophageal obstruction or stricture, cancer of the neck, larynx, or tongue).
C. Hyper metabolic conditions or disease leading to an inability to maintain weight and strength commensurate with his or her general condition. Examples include: extensive burns, congenital heart defects, and end stage renal disease.
D. Disorders of the gastrointestinal tract leading to dysfunction of absorption, digestion, utilization, secretion, and storage of nutrients, such as cystic fibrosis, Crohn’s disease, ulcerative colitis, and short gut syndrome.
E. Inborn errors of metabolism which require special formulas to prevent development of serious physical or mental disabilities.
3. Nutritional formulas that meet the definition of Medical Food (see Policy Guidelines) when administered orally are considered medically necessary for patients where the formula is the sole source of nutrition (greater than 75% of daily caloric intake) and the formula is a specialized elemental formula that is labeled and used for the dietary management of a specified disease/disorder/condition for which there are distinctive nutritional requirements to avert the development of serious physical or mental disabilities or to promote normal development. Examples of such conditions include end stage renal disease and inborn errors of metabolism. The physician's order and medical records must clearly document the specific medical disorder, disease, or condition.
4. Enteral feeding (per tube or orally) is not medically necessary if 25% of estimated calories needed per day or less are being administered. This is considered supplemental and will be denied as not medically necessary, except when transitioning off of total parenteral nutrition (TPN).
Approved PEN or EN services (those that require a physician's prescription) may include, but are not limited to, the following:
Benefits will not be provided for the following:
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medical Food is defined in Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: the product must be a food for oral or tube feeding; the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and the product must be intended to be used under medical supervision.
Coverage of PEN and EN feeding support is intended for patients who cannot eat, not for those who will not eat.
Global allowances for PEN and EN feeding support in the home include nursing services, cost of supplies, clinical pharmacy service, dietitian monitoring, supply delivery and administrative overhead.
Benefits may be provided for placement of central venous catheters and nasogastric, nasojejunostomy, gastrostomy or jejunostomy feeding tubes when policy guidelines have been met for PEN or EN.
The total cost of renting equipment should not exceed the purchase cost of the equipment.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY6/1994: Approved by Medical Policy Advisory Committee (MPAC) as Home Hyperalimentation
5/1999: MPAC reviewed, updated and renamed policy, HCPCS T0015, T0030, T0045, T0060 added
3/5/2002: Prior authorization deleted
3/12/2002: New 2002 HCPCS B4164, B4168, B4172, B4176, B4178, B4180, B4184, B4186, B4189, B4193, B4197, B4199, B4216, B4220, B4222, B4224, B5000, B5100, B5200, B9000, B9002, B9004, B9006, B9998, B9999 added
3/19/2002: Fifth digit required for 643.0X, review on an "Individual basis" for 577.0 and 643.0X has been deleted
5/2/2002: Type of Service and Place of Service deleted
5/28/2002: Code Reference section updated, CPT 99560, 99561, 99562 added, HCPCS B4081, B4082, B4083, B4086, S5520, S5522, S9123, S9124, S9340, S9341, S9342, S9343, S9364-S9368, S9374-S9379, S9524 added
8/26/2003: Code Reference section updated, CPT code 97802, 99341-99350, 99601, 99602 added, CPT code 99560, 99561, 99562 deletion dated of 6/30/2003 added, ICD-9 procedure code 99.15 added, ICD-9 diagnosis codes 530.3, 537.89, 560.9, 577.0, 643.0X, 750.3, 751.2, 756.79 listed separately, 643.0X fifth digit added, ICD-9 diagnosis code 141.0-141.9, 150.0-150.9, 151.0-151.9, 195.0, 197.8, 198.89, 210.0-210.9, 211.0, 211.1. 230.0-230.2, 232.4, 234.8, 235.0-235.2, 235.5, 238.8, 239.0, 239.8, 261, 783.21 added, HCPCS B4034, B4035, B4036, B4081, B4082, B4083, B4086, B4164, B4168, B4172, B4176, B4178, B4180, B4184, B4186, B4189, B4193, B4197, B4199, B4216, B4220, B4222, B4224, B5000, B5100, B5200, B9000, B9002, B9004, B9006, B9998, B9999, S9123, S9124, S9374-S9379, S9524 deleted, HCPCS S9364-S9368 listed separately, HCPCS G0108, G0109, S5517, S5518 added, HCPCS H0201, H0300, H0301, H0600 BCBSMS deletion date of 9/30/2003 added, HCPCS S5520, S5522 description revised, HCPCS T0015, T0030, T0045, T0060 “BCBSMS deletion date of 9/30/2003, see codes G0108-G0109 and 97802” added, Notes “**B4150 is the code used for all categories. Processors will recode any codes from B4151-B4156 to B4150” and “B4081-B4086 are included in the global service H0300 or H0301. B4081-B4086 will be bundled with either H0300 or H0301 on the claim” deleted, conditions moved from "Code Reference" section to "Policy" section
3/23/2005: Code Reference section reviewed, CPT code 97803, 97804 added covered codes, CPT 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350 description revised, CPT 99560, 99561, 99562 deleted, HCPCS B4102, B4103, B4104, B4157, B4158, B4159, B4160, B4161, B4162, B4164, B4168, B4172, B4176, B4178, B4180, B4184, B4186, B4189, B4193, B4197, B4199, B4216, B5000, B5100, B5200 added covered codes, HCPCS B4151, B4156 description revised and deletion date of 12/31/2004 added, HCPCS B4152, B4153, B4154, B4155 description revised, HCPCS T0015, T0030, T0045, T0060 deleted, non-covered codes table added, HCPCS B4149 added non-covered codes
3/9/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.
10/23/2006: Policy reviewed, no changes
9/20/2007: Code Reference section updated. ICD-9 2007 revisions added to policy
9/15/2008: Code reference section updated per the annual ICD-9 updates effective 10-1-2008
9/28/2009: Code reference section updated. New ICD-9 diagnosis codes 239.81, 239.89, 756.72 and 756.73 added to covered table. Deleted statement added to ICD9 diagnosis code 239.8.
4/29/2010: Policy statement clarified that benefits will not be provided for over-the-counter nutritional supplements or enteral nutrition.
3/26/2012: further policy clarification about nutritionals
08/31/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 99.15, ICD-9 diagnosis code 239.8, and HCPCS codes B4151, B4156, B4184, and B4186 from the Code Reference section.
01/01/2016: Policy statement updated to revise criteria for coverage of enteral nutrition by tube or orally. The definition of Medical Food added to the Policy Guidelines. Code Reference section updated to add the following ICD-10 diagnosis codes to the Covered Codes table: E70.0, E70.21, E70.41, E71.0, E71.110, E71.111, E71.120, E71.121, E72.11, E72.21, E72.22, E72.23, E84.11, E84.19, I69.091, I69.191, I69.291, I69.391, I69.891, K90.4, K90.89, N18.4, N18.5, N18.6, Q20.1, Q20.2, Q20.3, Q20.4, Q20.5, Q20.8, Q22.6, Q23.4, and T31.20 - T31.99. Code description revised for HCPCS codes B5000, B5100, and B5200.
05/31/2016: Policy number added.
07/25/2016: Code Reference section updated to make the following correction: ICD-10 diagnosis code K891.2 should be K91.2.
SOURCE(S)Hayes Medical Technology Directory
Blue Cross Blue Shield Association policy #1.02.01
Highmark Blue Cross Blue Shield Enteral Nutrition policy
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Not Medically Necessary Codes