Or. Admin. Code § 410-148-0260

Current through Register Vol. 63, No. 11, November 1, 2024

Section 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.

Or. Admin. Code § 410-148-0260

HR 26-1990, f. 8-31-90, cert. ef. 9-1-90; HR 26-1993, f. & cert. ef. 10-1-93; HR 3-1995, f. & cert. ef. 2-1-95; OMAP 7-1998, f. 2-27-98, cert. ef. 3-1-98; OMAP 29-2000, f. 9-29-00, cert. ef. 10-1-00; OMAP 46-2001, f. 9-24-01, cert. ef. 10-1-01, Renumbered from 410-121-0840; OMAP 22-2003, f. 3-26-03, cert. ef. 4-1-03; OMAP 63-2003, f. 9-5-03, cert. ef. 10-1-03; OMAP 15-2004, f. 3-11-04, cert. ef. 4-1-04; OMAP 52-2006, f. 12-28-06 cert. ef. 1-1-07; DMAP 23-2009, f. 6-12-09, cert. ef. 7-1-09; DMAP 116-2024, amend filed 08/09/2024, effective 8/9/2024

To view attachments referenced in rule text, click here to view rule.

Statutory/Other Authority: ORS 413.042

Statutes/Other Implemented: ORS 414.065