DAR File No. 30378

Health, Health Care Financing, Coverage and Reimbursement Policy

R414-71

Medical Supplies -- Parenteral, Enteral, and IV Therapy

NOTICE OF PROPOSED RULE

DAR File No.: 30378
Filed: 08/30/2007, 12:04
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This amendment is necessary to define "medical food" and to clarify access requirements, service coverage, limitations, and reimbursement for enteral and oral nutrition services for Medicaid recipients. It adds limited oral nutrition as a Medicaid benefit.

Summary of the rule or change:

This amendment adds limited oral nutrition benefits and defines medical food and limits Medicaid nutritional coverage to medical foods. This amendment establishes the age and medical criteria necessary for Medicaid coverage of total and supplemental nutrition. It also establishes the limited Medicaid coverage for oral nutrition. It establishes prior authorization requirements for nutritional coverage.

State statutory or constitutional authorization for this rule:

Sections 26-18-3 and 26-1-5, and 42 CFR 440.70 and 42 CFR 441.15

Anticipated cost or savings to:

the state budget:

There is an estimated annual cost of $52,255 to the General Fund and $122,745 in federal funds to pay for the expansion of nutritional services.

local governments:

There is no budget impact because local governments do not fund or receive nutritional services.

small businesses and persons other than businesses:

Businesses that provide nutritional supplies will experience approximately $175,000 in additional sales. Qualifying Medicaid clients will receive an additional $175,000 in nutritional services.

Compliance costs for affected persons:

There are no anticipated compliance costs to any persons, because this amendment expands benefits without imposing additional costs.

Comments by the department head on the fiscal impact the rule may have on businesses:

No unacceptable fiscal impact is expected on businesses impacted by this rule change. This will be evaluated after the public has an opportunity to comment. David N. Sundwall, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Health Care Financing, Coverage and Reimbursement Policy
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY UT 84116-3231

Direct questions regarding this rule to:

Melissa Frost at the above address, by phone at 801-538-6381, by FAX at 801-538-6099, or by Internet E-mail at mlfrost@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

10/15/2007

This rule may become effective on:

10/22/2007

Authorized by:

David N. Sundwall, Executive Director

R414. Health, Health Care Financing, Coverage and Reimbursement Policy.

R414-71. Medical Supplies -- Parenteral, Enteral, and IV Therapy.

R414-71-1. Introduction and Authority.

(1) Eligible Medicaid recipients with chronic physical illnesses, trauma, or terminal disease, who are able to live at home or in a long term care facility but who cannot be sustained with oral feeding, and, therefore rely on total parenteral nutrition (TPN) or enteral nutrition (EN) to sustain life, are covered under this program.

(2) Limited coverage is provided for total oral nutrition and supplemental oral or tube nutrition using medical foods. Food and nutrition are not covered as medical assistance under section 1905 (a) of the Social Security Act except as listed in Subsection R414-71-4(5).

([2]3) The IV therapy program provides medications, solutions, blood factors, chemicals, or nutrients by injection or infusion for eligible Medicaid recipients who reside at home or in a nursing facility.

([3]4) The provision of services and supplies is under the authority of 42 CFR 440.70 and 42 CFR 441.15, Oct. 200[3]5 ed.

 

R414-71-2. Definitions.

(1) Total Parenteral Nutrition (TPN) means total nutrition administered by intravenous, subcutaneous or mucosal infusion.

(2) Enteral Nutrition (EN) means by nasogastric, jejunostomy or gastrostomy tube into the stomach or intestines to supply nutrition when a non-functioning gastrointestinal tract is present due to pathology or structure.

(3) Nutrients means those products with specific formulas used to supply the total nutritional intake of the [patient]recipient by gastrostomy, jejunostomy or nasogastric tube.

(4) Nutritional Supplement[s] means [products, such as Ensure,]medical foods that are used occasionally to supplement a regular but possibly inadequate diet.

(5) Cassettes mean prepackaged containers or envelopes of semi-disposable needles and tubing which provide a pathway for the TPN or IV medication to pass from container to vein.

(6) WIC is the federal nutritional program for women, infants and children.

(7) Medical food as defined in 21 U.S.C. 360ee(b)(3), means 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. To be considered a medical food, a product must be:

(a) created for oral or tube feeding;

(b) labeled for dietary managment of a medical disorder, disease, or condition;

(c) labeled for use under medical supervision; and

(d) primarily obtained through hospitals, clinics and other medical and long term care facilities.

 

R414-71-3. Client Eligibility Requirements.

TPN, EN and IV services are provided to categorically and medically needy eligible individuals.

 

R414-71-4. Program Access Requirements.

(1) TPN and total EN is available to individuals with a:

(a) missing digestive organ;

(b) long term or permanently non-functioning gastrointestinal tract; or

(c) short term non-functioning gastrointestinal tract which may occur following a surgical procedure.

(2) IV therap[ies]y requires a physician's order or prescription and [require ]prior authorization.

(3) TPN, EN or other related nutritional products require a physician's order or prescription which must specify the kilo calories necessary per day. Parenteral infusion[s are] is identified and reimbursed per daily kilocalorie requirements.

(4) EN products must be given by gastrostomy, jejunostomy or nasogastric tube to qualify for coverage under the EN Program.

(5) Total oral nutrition and supplemental oral or by tube nutrition is available for Early and Periodic Screening, Diagnosis and Treatment (EPSDT) eligible children if it is an integral part of another EPDST service or has a curative or healing effect on the recipient beyond that which would be provided by ordinary food.

 

R414-71-5. Service Coverage.

(1) TPN and EN systems, related supplies, equipment, and nutrients are covered as prosthetic devices if they replace normal nutritional function of the esophagus, stomach or bowel.

(2) TPN or EN therapy is a covered benefit for clients residing at home or in a long term care facility.[

(3) Parenteral solutions and IV therapy provided by infusion or enteral therapy are benefits for clients residing in a long term care facility.]

([4]3) The following services are allowed for clients residing at home or in a long term care facility:

(a) parenteral solutions;

(b) a monthly parenteral nutrition administration kit which includes all catheters, pump filters, tubing, connectors, and syringes relating to the parenteral infusions;

(c) enteral solutions for total enteral therapy;

(d) IV medications, blood factors, and solutions;

(e) enteral administration kits; and

(f) heparin flush and heparin.

([5]4) [Medicaid may approve n]Nutritional supplements are[for] covered for infants and children ages 0 [to]through 5 who live at home and are in the WIC program, for quantities which exceed 8 ounces per day and time which exceeds 60 days if the:

(a) target weight of a child cannot be attained with expected oral feedings;

(b) oral feedings are present but too extended due to weakness, illness, or disease to the infant; or

(c) child is concurrently using a ventilator or oxygen, or has a tracheostomy.

([6]5) IV Therapy and treatment which may include injections or infusions are a covered service. IV therapy may include:

(a) pain medication therapy;

(b) antibiotics and antimicrobials;

(c) fluids such as glucose and fluid replacement;

(d) electrolytes;

(e) blood products;

(f) IV supply kit for [patient]recipients residing at home;

(g) extension tubing set for peripheral or midline catheter; or

(h) solutions used to cleanse or irrigate the catheter for which a national drug code (NDC) code exists.

([7]6) Administration supplies, syringes, bags, pumps, tubes, and administration kits for providing TPN, EN and IV therapies are covered with reasonable limitations as to amounts and length of administration as medically indicated and according to current standard medical practices.[

(8) All TPN and EN solutions, equipment, and nutritional products and most IV supplies require prior authorization. There must be a reasonable medical expectation that an improved quality of life will result from the TPN, EN, or IV therapy. A copy of the physician's prescription must be on file with the provider as part of the prior authorization request.

(a) The attending physician must justify through diagnosis and applicable history the need for a pump for metered dosage, continuous infusion, extremely small doses which cannot be measured accurately without a pump for metered dosage, continuous infusion, extremely small doses which cannot be measured accurately without a pump, or other special medical needs requiring a pump. For nutritional pumps, the medical need determination must establish that syringe feeding or gravity feeding is not satisfactory due to aspiration, diarrhea, or dumping syndrome, or other unique medical manifestations. The simplest form of feeding by syringe must be ruled out prior to authorizing a nutritional pump.

(b) For TPN or EN a new prior authorization shall be obtained every two months to renew the type of feeding or therapy in use for home health patients. Extended use of TPN or EN without home health intervention may be approved for a longer period of time.

(c) The home health agency and the pharmacy shall make separate prior authorization requests for their respective services and supplies.

(d) IV products, including IV catheters, require prior authorization. Gravity flow supplies and equipment do not require prior authorization.

(e) Nutritional supplements require prior authorization. Documentation must include:

(i) medical condition of the patient;

(ii) weight loss or expected gain to a specific level;

(iii) expected duration of supplementation, including quantity and frequency of administration.]

(7) Total nutrition without a feeding tube and supplemental nutrition with a feeding tube are covered for children 0 through 20 years of age if the requirements of subsections (a) through (e) are met. Nutritional supplements are covered for children 5 through 20 years of age if the requirements of subsections (a) through (e) are met

(a) The prescribed nutritional product is a medical food.

(b) Current disease or dysfunction of the digestive tract, including dysphagia, causes nutritional deficiency with insufficient nutrients to maintain body weight by impaired delivery of nutrients to the small bowel or due to impaired digestion and absorption by the small bowel, or both.

(c) The client's physician provides documentation to the Department:

(i) that the client has been unable to reach or maintain weight in the 10th percentile for the client's age and sex by taking food orally for the three months prior to the request;

(ii) that the client's specific diagnosis and current condition require medical food supplementation; and

(iii) by peer review medical literature that the prescribed medical food will improve body weight, the clinical outcome, and limit disease progression for the client's specific diagnosis and current condition when compared to nonmedical food.

(8) Oral supplemental nutrition is covered for adults and children to treat inborn errors of metabolism subject to all criteria listed in Section R414-71(7).

(9) To reauthorize ongoing care the following is waived:

(a) The need to document the recipient's weight under the 10th percentile;

(b) If the client's medical diagnosis has not materially changed, the need to resubmit peer review medical literature if it has been previously submitted.

 

R414-71-6. Limitations for TPN or EN Therapy.

The specific limitations for TPN or EN therapy are as follows:

(1) Cassettes shall be supplied with the parenteral administration kits and not as separate items.

(2) Enteral nutrients, IV diluents, injectable medications, and solutions are available as allowed in the pharmacy program with the limitations stipulated therein.

(3) Baby foods such as Similac, Enfamil, [and ]Mull-Soy [are]or other foods generally used as breast milk substitutes [and ]are not medical foods, and are not covered by Medicaid.

(4) Kits, bags and pumps are not covered benefits with nutritional supplements unless administered by a tube.

(5) A monthly supply and administration kit containing all supplies except the catheter is a Medicaid benefit only for [patient]recipients residing at home. Bags can not be reimbursed separately if a kit is supplied.

(6) Total and supplemental nutrition [is]are not available for persons with nutritional need resulting from psychological problems or a failure to thrive.

(7) Equipment such as IV poles, disposable swabs, antiseptic solutions and dressings for the catheter are not reimbursable by Medicaid for nursing home patients, but are provided by the nursing home under a per diem rate.

(8) General nutrition is included in the per diem rate paid by Medicaid under a contract with a long term care facility and is not separately reimbursable for its patients.

(9) Nutritional supplements are not covered for [patients]adults residing at home or in a long term care facility. [Only total nutrition for patients residing at home is covered with the exception of]Total nutrition for children age 0 through 5 [who are]is covered under the WIC program, as stated in Subsection R414-71-5([5]4).

(10) A [P]pharmacy provider[s] may be reimbursed for TPN or EN supplies, nutrients and medications. There is no additional reimbursement to the pharmacist for preparing the medication, such as filling syringes, mixing solutions, or adding drugs to an infusion solution. Pharmacists bill Medicaid using National Drug Codes. Heparin for flushing the infusion catheter is billed through the pharmacy point of sale system using the NDC for heparin.

(11) To begin an infusion, an intravenous catheter[s] may be placed by a home health agency nurse who has been trained for IV catheter placement, a physician, or a physician's assistant whose training and protocols allow for this service.

 

R414-71-7. Reimbursement.

(1) HCPCs coding is used for reimbursement. Reimbursement fees are established by discounting historical charges, by discounting Medicare fees for HCPCs codes for the geographic region, and by professional judgment to encourage efficient, effective and economical services. Adjustments to the fee schedule are made in accordance with appropriations and to produce efficient and effective services to be in accordance with the provisions of 4.19-B of the State Plan.

(2) The Department pays the lower of the amount billed and the rate on the schedule. A provider shall not charge the Department a fee that exceeds the provider's usual and customary charges for the provider's private-pay patients.

(3) Providers must accept the Medicare assignment for clients eligible for both Medicare and Medicaid benefits. All third party payors, including Medicare, must be billed prior to billing Medicaid.

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: [August 5, 2004]2007

Authorizing, and Implemented or Interpreted Law: 26-18-3; 26-1-5