No. 30378: R414-71. Medical Supplies - Parenteral, Enteral, and IV Therapy

DAR File No.: 30378
Filed: 01/10/2008, 08:10
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

Medicaid, based on a public hearing and other comments, proposes to amend its original rule filing and put the rule back out for additional comments. The proposed amendments to the original filing clarify Medicaid policy regarding program access and service coverage for nutritional supplements and oral nutrition.

Summary of the rule or change:

This change clarifies Medicaid policy regarding program access and service coverage for nutritional supplements and oral nutrition. It also makes other minor clarifications. (DAR NOTE: This change in proposed rule has been filed to make additional changes to a proposed amendment that was published in the September 15, 2007, issue of the Utah State Bulletin, on page 40. Underlining in the rule below indicates text that has been added since the publication of the proposed rule mentioned above; strike out indicates text that has been deleted. You must view the change in proposed rule and the proposed amendment together to understand all of the changes that will be enforceable should the agency make this rule effective.)

State statutory or constitutional authorization for this rule:

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

Anticipated cost or savings to:

the state budget:

The original filing estimated an annual cost of $52,255 to the General Fund and $122,745 in federal funds to pay for the expansion of nutritional services. There is no anticipated change in that budget impact based on the further amendments proposed by this filing.

local governments:

There is no budget impact because local governments do fund or provide oral nutrition for Medicaid clients.

small businesses and persons other than businesses:

The original filing estimated that 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. There is no anticipated change in that budget impact based on the further amendments proposed by this filing.

Compliance costs for affected persons:

There are no compliance costs because this change only clarifies Medicaid policy regarding nutritional supplements and oral nutrition for Medicaid clients.

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:

Craig Devashrayee at the above address, by phone at 801-538-6641, by FAX at 801-538-6099, or by Internet E-mail at [e-mail]

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:

03/03/2008

This rule may become effective on:

03/10/2008

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

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

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

 

. . . . . . .

 

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 therapy requires a physician's order or prescription and 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 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)](4) 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. All total oral nutrition or supplemental nutrition must be a medical food for reimbursement by Medicaid.

 

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) 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;]IV medications, blood factors, and solutions;

(d) [IV medications, blood factors, and solutions;]heparin flush and heparin;

(e) [enteral administration kits; and]enteral solutions for total enteral therapy through a tube; and

(f) [heparin flush and heparin.]enteral administration kits.

(4) Nutritional supplements are covered for infants and children ages 0 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]beyond what WIC allows if:

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

(b) the oral feedings are present but [too extended ]due to weakness, illness, or disease [to ]the [infant]child's nutritional level is difficult to maintain; or

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

(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 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.

(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.

(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]c) are met. Nutritional supplements are covered for children 5 through 20 years of age if the requirements of subsections (a) through ([e]c) 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]two 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 Sub[S]section R414-71-5(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, or IV 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, Mull-Soy or other foods generally used as breast milk substitutes are not medical foods, and are not covered by Medicaid.]A monthly supply and administration kit containing all supplies except the catheter is a Medicaid benefit only for recipients residing at home. Bags can not be reimbursed separately if a kit is supplied.

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

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

(6) [Total and supplemental nutrition are not available for persons with nutritional need resulting from psychological problems or a failure to thrive.]Breast milk from breast milk banks and infant formulas such as Similac, Enfamil, or other foods generally used as breast milk substitutes are not medical foods, and are not covered by Medicaid unless formulated for use through a feeding tube.

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

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

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

(10) [A pharmacy provider 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.]Nutritional supplements are not covered for adults residing at home or in a long term care facility. Total nutrition for children ages 0 through 5 is covered under the WIC program as stated in Subsection R414-71-5(4).

(11) [To begin an infusion, an intravenous catheter 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.]A pharmacy provider 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.

 

. . . . . . .

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: [2007]2008

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