Completion of the Elements of PEN CMN (Rev. 1, 10-01-03)

by  Jared Staheli, MPP
Jun 18th, 2015

The patient's name, address, and HICN and the nature of the certification (i.e., initial, renewed, or revised) must be entered on all certifications by the supplier, physician, or physician's designated employees. The supplier identifying information is required on all PEN certifications.

All medical and prescription information must be completed from the patient's records by the attending/ordering physician, or an employee of the physician authorized to act on the physician's behalf, and reviewed and signed by the physician.

1. Place of Service - The CMN must identify the site where the patient is receiving PEN services. A patient may receive services at home, in a nursing home setting (e.g., skilled nursing facility), or another site that must be indicated by the supplier/physician.

2. Patient's General Condition - The attending physician must complete information about the patient's age, height, and weight. The general condition of the patient also includes an estimated duration of therapy (i.e., in months, years, or for life), the ambulatory status, and whether the patient is conscious. The physician should also indicate food allergies/sensitivities, other medical treatments, therapies, and/or medical conditions that may affect the patient's nutritional needs.

3. Patient's Clinical Assessment - The attending physician must indicate all the diagnoses related to the PEN therapy and describe the patient's functional impairment of the digestive tract that precludes the enteral patient from swallowing and the parenteral patient from absorbing nutrients. The physician must certify that PEN therapy meets the requirement that a patient is not able to maintain weight and strength due to pathology or nonfunction of the ingestion system and that the enteral therapy serves as the source of nutrition for the patient who has a functioning digestive tract, but whose disability prevents ingestion of sufficient nutrients to the alimentary tract for metabolism. Nutritional supplements for patients capable of ingesting normally, even if required to maintain weight and strength, cannot be covered under the prosthetic device benefit. The physician must have a basis for certifying or recertifying the need for PEN services. The physician is expected to see the patient within 30 days prior to certifying or recertifying PEN services. However, if the physician did not see the patient, he/she must explain why and describe what other monitoring methods were used to evaluate the patient's PEN needs.

4. Patient's Nutritional Prescription - Subsequent to an examination of the patient and/or a review of the patient's medical information, the attending physician must complete the patient's nutritional requirements (prescription) to certify the PEN therapy provided. For the parenteral patient, the CMN must contain the following information:

• The infusion frequency per week,

• The route of administration,

• A reason for the use of pre-mixed parenteral formulas,

• An explanation for the use of special formulas such as hepatic, renal, or stress

• formulas, and

• The amino acid/dextrose formula components of the parenteral solution mix.

Amino acids serve as a source of protein. Adult parenteral nutrition patients generally need 1 to 1.5 grams of protein per day for each kilogram (2.2 pounds) of body weight. Dextrose concentrations less than 10 percent must be explained by the physician. The physician must document the reason for using more than 12 units (@ 500ml per unit) of lipids per month.

Parenteral nutrition may be either "self-mixed" (i.e., the patient is taught to prepare the nutrient solution aseptically) or "pre-mixed" (i.e., the nutrient solution is prepared by trained professionals employed or contracted by the PEN supplier). The attending physician must provide information to justify the reason for "pre-mixed" parenteral nutrient solutions.

Renal dialysis patients sometimes undergo parenteral therapy to replace fluids and nutrients lost during dialysis. Patients are usually infused less than daily and parenteral feeding is often supplemental and, therefore, not covered as a PEN benefit. The renal dialysis patient must meet all the requirements for PEN coverage. The attending physician must document that the patient, despite the need for renal dialysis, suffers from a permanently impaired functional impairment that precludes swallowing or absorption of nutrients.

For the enteral patient, the attending physician must include the following information on the CMN:

• The name of the nutrient product or nutrient category,

• The number of calories per day (100 calories = 1 unit),

• The frequency per day,

• The method of administration (i.e., syringe, gravity, or pump),

• The route of administration (i.e., nasogastric tube, gastrostomy tube, jejunostomy tube, percutaneous enteral gastrostomy tube, or naso-intestinal tube), and

• The reason for the use of a pump.

Categories of enteral nutrition are based on the composition and source of ingredients in each enteral nutrient product. Category IB of enteral nutrients contains products that are natural intact protein/protein isolates commonly known as blenderized nutrients. Additional documentation is required to justify the necessity of Category IB nutrients. The attending physician must provide sufficient information to indicate that the patient:

• Has an intolerance to nutritionally equivalent (semi-synthetic) products;

• Had a severe allergic reaction to a nutritionally equivalent (semi-synthetic) product; or

• Was changed to a blenderized nutrient to alleviate adverse symptoms expected to be of permanent duration with continued use of semi-synthetic products.

Enteral nutrient categories III through VI require additional medical justification for coverage. These categories represent formulas for special needs or use.

• Category III (code B4153): hydrolyzed protein/amino acids. These products contain a high nitrogen availability as a result of chemical treatment to reduce high molecular protein compounds into smaller molecules and amino acids that are easier to digest.

• Category IV (code B4154): defined formulas for special metabolic needs and conditions such as abnormal glucose tolerance, renal disease, liver disease, HIV, respiratory insufficiency, and malnutrition.

• Category V (code B4155): modular components (proteins, carbohydrates, fats).

• Category VI (code B4156): standardized nutrients. These products contain low residue ingredients.

If the patient exhibits a problem with any particular formula in Nutrient Category I (HCPCS B4150) or II (HCPCS B4152), the physician must document the unfavorable events that resulted in prescribing a higher category formula.

Generally, daily enteral intake of 750 to 2,000 calories is considered sufficient to maintain body weight. Patients with medical complications may require an intake outside the range. The attending physician must document the reason for prescribing less than 750 calories per day or more than 2000 calories per day.

Enteral nutrition may be administered by syringe, gravity, or pump. The attending physician must specify the reason that necessitates the use of an enteral feeding pump. Some enteral patients may experience complications associated with syringe or gravity method of administration. Contractors provide coverage for enteral pumps if the medical necessity is documented by the attending physician on the CMN. Examples of circumstances that indicate the need for a pump include, but are not limited to:

• Aspiration or Dumping Syndrome;

• Severe diarrhea remedied by regulated feeding;

• Insulin-dependent diabetics who require a flow rate of less than 100cc's per hour for proper regulation of nutrients;

• Patients with congestive heart failure who require a pump to prevent circulatory overload; or

• Patients with a jejunostomy tube for feeding.

The DMERC reviews the claims to ensure that the equipment for which payment is claimed is consistent with that prescribed (e.g., expect a claim for an I.V. pole, if a pump is used).

5. Attending Physician's Signature and Identification - A handwritten, original signature and date must be on each certification. The form must be dated to show reasonable association to the dates of active PEN therapy. The full name, address, telephone number (including area code), and Unique Physician Identification Number (UPIN) allows the contractor to determine if the prescriber is authorized to order Medicare services and facilitate claims development.

1. PEN Supplier's Identification - The PEN supplier's name, address, telephone number, and PEN identification number must be on each certification. This information allows the contractor to determine if the supplier is authorized to provide PEN supplies and facilitate claims development.