Or. Admin. Code § 410-148-0260 - Home Enteral Nutrition
(1)
Indications and limitations of coverage and medical appropriateness: The
Division may cover home enteral formula, oral nutritional supplements,
equipment, supplies, and services for clients of any age. Refer to Table
148-0260-1 and the following guidelines:
(a)
Enteral nutrition refers to nutritional formula administered by tube or orally
fed into the gastrointestinal tract (HCPCS codes may include, but are not
limited to, B4149 through B4162). Depending on the route of administration,
additional equipment and supplies may be covered;
(b) Blenderized enteral formula, whether
administered by tube or orally fed, describes formulas containing natural foods
that are blenderized and packaged by a manufacturer. Code B4149 must not be
used for foods that have been blenderized by the beneficiary or
caregiver;
(c) Refer to the product
classification list on the Medicare Pricing, Data Analysis and Coding (PDAC)
contractor website for appropriate Healthcare Common Procedure Coding System
(HCPCS) codes assigned to formula, supplements, equipment, and
supplies;
(d) If the formula, item,
or supply is not listed on the PDAC contractor website, the provider must
contact the PDAC contractor for a coding determination. The Medicare Pricing,
Data Analysis and Coding contractor is responsible for assisting DMEPOS
providers and manufacturers in determining which HCPCS code shall be used to
describe DMEPOS items;
(2) Enteral formula and nutritional
supplements administered orally;
(a) Prior
authorization is required.
(b)
Enteral formula and oral nutritional supplements documented as the primary
source of nutrition, for a client of any age, meets criteria for expedited
prior authorization review;
(c)
Oral nutritional formula and supplements may be approved when the following
criteria has been met:
(A) For Adults:
(i) An assessment performed by a registered
dietitian or treating practitioner, at onset and annually thereafter,
documenting the client is unable to meet their recommended caloric/protein or
micronutrient needs through regular, liquified, blenderized, or pureed foods in
any modified texture or form; and
(ii) Documentation showing the prescribed
oral nutritional formula and/or nutritional supplements are an integral part of
treatment for a nutritional deficiency as identified by one of the following
conditions:
(I) Diagnosed acute or chronic
malnutrition; or
(II) Documentation
of weight, either currently or historically, supported by oral nutritional
supplements; or
(III) Increased
metabolic need resulting from severe trauma; or
(IV) Malabsorption difficulties (e.g.,
short-gut syndrome, fistula, cystic fibrosis, renal dialysis); or
(V) Inborn errors of metabolism (e.g.,
fructose intolerance, galactosemia, maple syrup urine disease (MSUD), or
phenylketonuria (PKU); or
(VI)
Ongoing cancer treatment, advanced Acquired Immune Deficiency Syndrome (AIDS)
or pulmonary insufficiency; or
(VII) Oral aversion or other psychological
condition making it difficult for a client to consume their recommended
caloric/protein or micronutrient needs through regular, liquified, blenderized,
or pureed foods in any modified texture or form;
(B) For EPSDT Beneficiaries as defined in
Chapter 410 Division 151:
(i) An assessment
performed by a registered dietitian or treating practitioner, at onset and
annually thereafter, documenting the prescribed nutritional formula and/or
nutritional supplementation is medically necessary and appropriate as an
integral part of treatment for any condition noted above (I-VII) or for the
prevention of nutritional deficiency or malnutrition as identified by one of
the following:
(I) Documentation showing the
client is unable to meet their recommended caloric/protein or micronutrient
needs through regular, liquified, blenderized, or pureed foods in any modified
texture or form; or
(II)
Malabsorption or other diagnosed medical condition which involves dietary
restriction as part of the treatment, including but not limited to food
allergy, Eosinophilic disorders (EoE), Food Protein Induced Enterocolitis
(FPIES); or
(III) Documented
delayed growth or failure to thrive;
(ii) For EPSDT beneficiaries, the terms
medically necessary and medically appropriate are defined in OAR Chapter 410
Division 151;
(3) Enteral formula administered by tube for
a client of any age:
(a) Enteral nutrition is
covered for a client of any age who requires feedings via an enteral access
device (tube) to provide sufficient nutrients to maintain weight and strength
otherwise not possible by dietary adjustment and/or oral supplements;
(b) Supplies:
(A) The unit of service for the supply
allowance (B4034, B4035, B4036, or B4148) is one (1) per day;
(i) Enteral feeding supply kit allowances
(B4034, B4035, B4036, and B4148) are all-inclusive with the exception of B4105
in-line digestive enzyme cartridge.
(ii) Two in-line digestive enzyme cartridges
(B4105) per day is considered reasonable and necessary for clients diagnosed
with Exocrine Pancreatic Insufficiency (EPI);
(iii) The feeding supply allowance (B4034,
B4035, B4036, and B4148) must correspond with the method of administration
(syringe, pump, gravity, elastomeric control fed);
(I) The daily supply allowances include, but
are not limited to, a catheter/tube anchoring device, feeding bag/container,
flushing solution bag/container, administration set tubing, extension tubing,
feeding/flushing syringes, gastrostomy tube holder, dressings (any type) used
for gastrostomy tube site, tape (to secure tube or dressings), Y connector,
adapter, gastric pressure relief valve, declogging device;
(II) Prior authorization is required for
specialty supply items (e.g., Farrell Valve) and there must be documentation to
support the need;
(B) Three nasogastric tubes (B4081, B4082,
and B4083), or one gastrostomy/jejunostomy tube (B4087 or B4088) every three
(3) months is considered reasonable and necessary. One back-up
gastrostomy/jejunostomy tube (B4087 or B4088) may be covered when prescribed
for an EPSDT beneficiary as defined in Chapter 410 Division 151. For those
clients requiring more frequent changes or replacement of a non-functional
tube, prior authorization is required and there must be documentation to
support the need;
(4) Initial delivery of each enteral formula,
oral supplement, equipment, and supplies:
(a)
For each new formula or supplement prescribed, suppliers shall provide a sixty
(60) day supply regardless of which delivery method is utilized.
(b) The prescribed length of need must exceed
sixty (60) days for this rule to apply;
(5) Refill requirements for formula items and
supplies provided on a recurring basis:
(a)
For all formulas, nutritional supplements, and supplies that are provided on a
recurring basis as refills to the original order, suppliers are required to
have contact with the client or designee either by call, text, or email prior
to dispensing to confirm any changes or modifications to the order;
(b) Contact with the client or designee
regarding refills shall take place no less than 35 calendar days prior to the
end of usage for the current product and the next scheduled delivery/shipping
date;
(c) For delivery or shipment
of refills, the supplier shall dispense the formula and supplies no less than
thirty (30) calendar days prior to the end of usage for the current product
regardless of which delivery method is utilitzed;
(A) Regardless of utilization, a supplier
must not dispense more than a 1-month quantity of formula or supplies on a
recurring basis;
(B) Automatic
shipments on a pre-determined basis, even if authorized by the client or
designee, are not allowed;
(C)
Suppliers may dispense more than a 1-month quantity of formula or supplies only
on a periodic basis to ensure continuation of care during times of travel or
when the client is away from the home for an extended period of days.
Documentation of the reason for the additional quantity and client's travel or
time away from home, shall be kept on file with the supplier and made available
to the Division upon request.
(6) For enteral nutrition equipment, all
repair and maintenance are subject to rule OAR
410-148-0080;
(7) Food thickener (B4100) administered
orally:
(a) A thickener is an additive that
decreases the flow rate of thin liquids. A thickener, when medically necessary
and medically appropriate, shall be covered when prescribed for a client of any
age who has participated in a swallowing evaluation or study and for the
treatment of a swallowing disorder resulting from one of the following:
(A) A diagnosis of dysphagia which negatively
impacts the ability to swallow; or
(B) Chronic diseases such as, but not limited
to, Parkinson's, dementia, reflux disease, stroke, neuromuscular
disease/disorder, and spinal cord injury; or
(C) Treatment of head, neck, or throat
cancer; or
(D) Documented
aspiration of food or liquid associated with chronic illness or
disease.
(b) Annual
follow up with treating practitioner is required to ensure the food thickener
remains medically necessary and to confirm any changes or modifications to the
order.
(8) Oral
nutritional formula and supplements may be covered through the point-of-sale
pharmacy system. Refer to the Pharmaceutical Services administrative rules,
Chapter 410 Division 121, for coverage and prior authorization
requirements;
(9) Human donor milk:
(a) Refer to the Prioritized List Guideline
Note for coverage guidelines;
(b)
Prior authorization is required;
(10) Procedure codes:
(a) Refer to Table 148-0260-1;
(b) Codes that have "PA" indicated require
prior authorization;
(11)
Billing instructions:
(a) The allowance for
all items includes delivery regardless of which delivery method is
utilized;
(b) Oral formula and/or
nutritional supplements can be billed through the on-line point of sale
pharmacy system, or by paper using the CMS 1500 claim form or the electronic
837P claim form. Providers are required to use the product's National Drug Code
(NDC) and Healthcare Common Procedure Coding System (HCPCS) code when billing
the CMS 1500 or electronic 837P claim form;
(12) Documentation requirements:
(a) The purchase, rental, or repair of
durable medical equipment and the purchase of supplies must have an order from
the prescribing practitioner prior to dispensing items to a client;
(b) A new prescription is required when:
(A) There is a change in the item(s),
frequency of use, amount prescribed, a change in the length of need, or a
previously established length of need expires.
(B) A new prescription is required
annually;
(c) For
services requiring prior authorization (PA), submit documentation that supports
coverage criteria in this rule are met;
(d) All nutritional formula, equipment,
supplies, and services shall be documented as medically appropriate and
medically necessary by the registered dietitian and/or treating practitioner;
(A) "Medically Appropriate" has the meaning
given that term in OAR Chapter 410 Division 120 for adult beneficiaries, and as
defined in Chapter 410 Division 151 for EPSDT beneficiaries;
(B) "Medically Necessary" has the meaning
given that term in OAR Chapter 410 Division 120 for adult beneficiaries, and as
defined in Chapter 410 Division 151 for EPSDT beneficiaries;
(e) Documentation that coverage
criteria have been met must be present in the client's medical records. These
records shall be kept on file with the DME provider and made available to the
Division on request.
Notes
To view attachments referenced in rule text, click here to view rule.
Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 414.065
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