L11561-LCD

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Local Coverage Determination (LCD) for Parenteral Nutrition (L11561)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number 18003

Contractor Type DME MAC

Jurisdiction J - G

LCD Information

Document Information

LCD ID Number L11561

LCD Title Parenteral Nutrition

Contractor's Determination Number PEN

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993 Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/05/2011

Revision Ending Date

CMS National Coverage Policy

CMS Pub. 100-3 (National Coverage Determinations Manual), Chapter 1, Section 180.2 Indications and Limitations of Coverage and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

Statutory coverage criteria for parenteral nutrition are specified in the related Policy Article.

GENERAL:

Parenteral nutrition is the provision of nutritional requirements intravenously. It is covered for patients who qualify under the Prosthetic Benefit requirements outlined in the Parenteral Nutrition Policy Article.

No more than one month's supply of parenteral nutrients, equipment or supplies is allowed for one month's prospective billing. Claims submitted retroactively, however, may include multiple months.

The ordering physician is expected to see the patient within 30 days prior to the initial certification or required recertification (but not revised certifications). If the physician does not see the patient within this timeframe, he/she must document the reason why and describe what other monitoring methods were used to evaluate the patient's enteral nutrition needs.

NUTRIENTS:

Parenteral nutrition solutions containing little or no amino acids and/or carbohydrates would be covered only in situations A, B or D discussed in the Parenteral Nutrition - Policy Article.

A total caloric daily intake (parenteral, enteral, and oral) of 20-35 cal/kg/day is considered sufficient to achieve or maintain appropriate body weight. The ordering physician must document in the medical record the medical necessity for a caloric intake outside this range in an individual patient. This information must be available on request.

The ordering physician must document the medical necessity for protein orders outside of the range of 0.8-1.5 gm/kg/day, dextrose concentration less than 10%, or lipid use greater than 1500 grams (150 units of service of code B4185) per month.

The medical necessity for special parenteral formulas (B5000-B5200) must be justified in each patient. If a special parenteral nutrition formula is provided and if the medical record does not document why that item is reasonable and necessary, it will be denied as not reasonable and necessary.

EQUIPMENT AND SUPPLIES:

Infusion pumps (B9004-B9006) are covered for patients in whom parenteral nutrition is covered. Only one pump (stationary or portable) will be covered at any one time. Additional pumps will be denied as not reasonable and necessary.

If the coverage requirements for parenteral nutrition are met, one supply kit (B4220 or B4222) and one administration kit will be covered for each day that parenteral nutrition is administered.

RELATED CLINICAL INFORMATION:

When nutritional support other than the oral route is needed, tube enteral nutrition is usually preferable to parenteral nutrition for the following reasons: (1) In a fluid restricted patient, tube enteral nutrition permits delivery of all necessary nutrients in a more concentrated volume than parenteral nutrition and (2) tube enteral nutrition allows for safer home delivery of nutrients.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIER:

BA – Item used in conjunction with parenteral enteral nutrition (PEN) services EY – No physician or other health care provider order for this item or service HCPCS CODES:

B4164 PARENTERAL NUTRITION SOLUTION: CARBOHYDRATES (DEXTROSE), 50% OR LESS (500 ML = 1 UNIT) - HOMEMIX

B4168 PARENTERAL NUTRITION SOLUTION; AMINO ACID, 3.5%, (500 ML = 1 UNIT) - HOMEMIX

B4172 PARENTERAL NUTRITION SOLUTION; AMINO ACID, 5.5% THROUGH 7%, (500 ML = 1 UNIT) - HOMEMIX B4176 PARENTERAL NUTRITION SOLUTION; AMINO ACID, 7% THROUGH 8.5%, (500 ML = 1 UNIT) - HOMEMIX B4178 PARENTERAL NUTRITION SOLUTION: AMINO ACID, GREATER THAN 8.5% (500 ML = 1 UNIT) - HOMEMIX

B4180 PARENTERAL NUTRITION SOLUTION; CARBOHYDRATES (DEXTROSE), GREATER THAN 50% (500 ML=1 UNIT) - HOMEMIX

B4185 PARENTERAL NUTRITION SOLUTION, PER 10 GRAMS LIPIDS

PARENTERAL NUTRITION SOLUTION; COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH

B4189 ELECTROLYTES, TRACE ELEMENTS, AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, 10 TO 51 GRAMS OF PROTEIN - PREMIX

PARENTERAL NUTRITION SOLUTION; COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH

B4193 ELECTROLYTES, TRACE ELEMENTS, AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, 52 TO 73 GRAMS OF PROTEIN - PREMIX

PARENTERAL NUTRITION SOLUTION; COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH

B4197 ELECTROLYTES, TRACE ELEMENTS AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, 74 TO 100 GRAMS OF PROTEIN - PREMIX

PARENTERAL NUTRITION SOLUTION; COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH

B4199 ELECTROLYTES, TRACE ELEMENTS AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, OVER 100 GRAMS OF PROTEIN - PREMIX

B4216 PARENTERAL NUTRITION; ADDITIVES (VITAMINS, TRACE ELEMENTS, HEPARIN, ELECTROLYTES) HOMEMIX PER DAY

B4220 PARENTERAL NUTRITION SUPPLY KIT; PREMIX, PER DAY B4222 PARENTERAL NUTRITION SUPPLY KIT; HOME MIX, PER DAY B4224 PARENTERAL NUTRITION ADMINISTRATION KIT, PER DAY B5000

PARENTERAL NUTRITION SOLUTION: COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH ELECTROLYTES, TRACE ELEMENTS, AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, RENAL - AMIROSYN RF, NEPHRAMINE, RENAMINE - PREMIX

PARENTERAL NUTRITION SOLUTION: COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH

B5100 ELECTROLYTES, TRACE ELEMENTS, AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, HEPATIC

- FREAMINE HBC, HEPATAMINE - PREMIX

PARENTERAL NUTRITION SOLUTION: COMPOUNDED AMINO ACID AND CARBOHYDRATES WITH

B5200 ELECTROLYTES, TRACE ELEMENTS, AND VITAMINS, INCLUDING PREPARATION, ANY STRENGTH, STRESS

- BRANCH CHAIN AMINO ACIDS - PREMIX

B9004 PARENTERAL NUTRITION INFUSION PUMP, PORTABLE B9006 PARENTERAL NUTRITION INFUSION PUMP, STATIONARY B9999 NOC FOR PARENTERAL SUPPLIES

E0776 IV POLE

ICD-9 Codes that Support Medical Necessity Not specified.

AsteriskNoteText

Diagnoses that Support Medical Necessity Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity Not specified.

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

A DME Information Form (DIF), which has been completed, signed, and dated by the supplier, must be kept on file by the supplier and made available on request. The DIF for Parenteral Nutrition is CMS Form 10126. The initial claim must include an electronic copy of the DIF.

Information describing the medical justification for parenteral nutrition must be available upon request. This information shall describe which criterion (A-H) in Non-Medical Necessity Coverage and Payment Rules in the related Policy Article serves as the basis for coverage. This information is generally recorded in the patient's medical record. Some sources, not all-inclusive, are described below:

• For situations A-D, copies of the operative report and/or hospital discharge summary and/or x-ray reports and/or physician letter, which demonstrate the condition and the necessity for parenteral therapy.

• For situations E and H (when appropriate), results of the fecal fat test and dates of the test.

• For situations F, and H (when appropriate), copy of the report of the small bowel motility study and a list of medications that the patient was on at the time of the test.

• For situations E-H, results of serum albumin and date of test (within 1 week prior to initiation of parenteral nutrition, PN) and a copy of a nutritional assessment by a physician, dietitian or other qualified professional within 1 week prior to initiation of PN, to include the following information:

1. Current weight with date and weight 1-3 mo. prior to initiation of PN;

2. Estimated daily calorie intake during the prior month and by what route (e.g., oral, tube);

3. Statement of whether there were caloric losses from vomiting or diarrhea and whether these estimated losses are reflected in the calorie count;

4. Description of any dietary modifications made or supplements tried during the prior month (e.g., low fat, extra medium chain triglycerides, etc.)

• For situations described in H, a statement from the physician, copies of objective studies, and excerpts of the medical record giving the following information:

1. Specific etiology for the gastroparesis, small bowel dysmotility, or malabsorption;

2. A detailed description of the trial of tube enteral nutrition including the beginning and ending dates of the trial, duration of time that the tube was in place, the type and size of tube, the location of tip of the tube, the name of the enteral nutrient, the quantity, concentration, and rate of administration, and the results;

3. A copy of the x-ray report or procedure report documenting placement of the tube in the jejunum;

4. Prokinetic medications used, dosage, and dates of use;

5. Nondietary treatment given during prior month directed at etiology of malabsorption (e.g., antibiotic for bacterial overgrowth);

6. Any medications used that might impair GI tolerance to enteral feedings (e.g., anticholinergics, opiates, tricyclics, phenothiazines, etc.) or that might interfere with test results (e.g., mineral oil, etc.) and a statement explaining the need for these medications.

A Revised DIF is required when:

1. Nutrients billed with a different code are ordered, or

2. The number of days per week administered is changed

A new Initial DIF is required when parenteral nutrition services are resumed when they are not required for two consecutive months.

Special nutrient formulas, HCPCS codes B5000-B5200, are produced to meet unique nutrient needs for specific disease conditions. The patient’s medical record must adequately document the specific condition and the need for the special nutrient. This information shall be available upon request.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices

Utilization Guidelines Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision Advisory Committee Meeting Notes

Start Date of Comment Period 04/30/1993

End Date of Comment Period 06/14/1993

Start Date of Notice Period 08/01/1993

Revision History Number 008

Revision History Explanation Revision Effective Date: 02/04/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Preamble statement

Deleted: Least costly alternative for B5000-B5200

Moved: Statement about pumps and IV poles used in facilities to policy article DOCUMENTATION REQUIREMENTS:

Added: Information about documenting the need for B5000-B5200

Revision Effective Date: 10/01/2009 INDICATIONS AND LIMITATIONS OF COVERAGE:

Corrected instructions for when to submit a revised DIF

Marked policy as Least Costly Alternative; policy did not change just was not indicated.

03/01/2008 In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

06/01/2007 In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

Revision Effective Date: 01/01/2007 DOCUMENTATION REQUIREMENTS:

Removed: CMN requirements. Added: DIF instructions.

LCD ATTACHMENTS:

Removed: CMN Added: DIF

03/01/2006 In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006 (March 2006 publication) INDICATIONS AND LIMITATIONS OF COVERAGE:

Moved statement about coverage in a SNF to Policy Article.

Revised statement concerning the quantity of lipids requiring additional documentation. HCPCS CODES AND MODIFIERS:

Added: B4185

Deleted: B4184, B4186 DOCUMENTATION REQUIREMENTS:

Deleted paragraph referring to pre-1996 dates of service.

Revision Effective Date: 01/01/2006 LMRP converted to LCD and Policy Article DOCUMENTATION REQUIREMENTS:

Removed documentation requirements for claim submission.

Revision Effective Date: 04/01/2003 HCPCS CODES AND MODIFIERS:

Added: EY modifier, BA modifier

INDICATIONS AND LIMITATIONS OF COVERAGE:

Adds standard language concerning coverage of items without an order. CODING GUIDELINES:

Adds use of the BA modifier DOCUMENTATION REQUIREMENTS:

Adds standard language concerning use of EY modifier for items without an order.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

10/01/1996 – Corrected error as follows: “However, parenteral nutrition provided by an outside supplier to a Part A covered patient is eligible for Part A coverage and is billed to the DMERC.” – corrected to “However, parenteral nutrition provided by an outside supplier to a Part A covered patient is eligible for Part B coverage and is billed to the DMERC.”

04/01/1996 – There were many changes from the previously published policy. One revision is that routine recertifications are changed from the previous 3, 9 and 24 months to a requirement for a recertification only at 6 months. For patients who have had their initial certification and at least one routine recertification (e.g., at 3 months) approved by the DMERC prior to July 1, 1996, no further routine recertification will be required.

If an initial certification is approved but there has been no recertification prior to July 1, 1996, then a recertification will be required 6 months from the date of initial certification regardless of the date of initial certification. For example, if the initial certification was December 1, 1995 and no recertification is submitted prior to July 1, 1996, then the DMERC would expect recertification with the June 1, 1996 claim, not with the March 1, 1996 claim.

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Reason for Change Maintenance (annual review with new changes, formatting, etc.)