The Intake process for Medicare patients, whether billing for payment or for denial, is essential to withstanding audits and submitting timely and accurate appeals. Receipt of payment does not guarantee all CMS guidelines have been met. Payments are at risk for recoupment on audit if guidelines have not been met.
During the Intake process, it is recommended that the following steps occur:
Verification of Benefits
Documentation to be Obtained at Intake
It is important that you understand the documentation requirements for each of the services you provide. An overview is provided here, but for more specific questions regarding documentation requirements, refer to your DME MAC’s Supplier Manual and Local Coverage Determinations (LCD’s).
• A description of the item(s)
• The beneficiary’s name
• The name of the physician
• The date of the order and the start date, if the start date is different from the date of the order
• The physician’s signature (written order) or supplier’s signature (verbal order)
For items provided on a periodic basis, including drugs, you should include:
A Revised DIF is needed when there is a change in:
DME Information Forms (DIFs) Usage for Enteral and Parenteral Nutrition and External Infusion Pumps – DME MAC Joint Publication Revised
*Supplier generated forms that contain diagnosis, length of need and/or justification of criteria, even those signed by the physician, are NOT deemed by Medicare to be part of the medical record and will not stand alone during an audit or an appeal. The medical record must support the information generated by the supplier.
Documentation needed for audits and appeals
The following documents should be sent with all audits and appeals
The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the item is delivered directly by the supplier, the date the beneficiary received the DMEPOS item must be the date of service on the claim.
Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.
If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.
Refill Records: Beneficiary or Authorized Representative’s attestation of the refill request. The date of the request must be prior to the date of delivery and should be documented. The request must include a description of the items being requested and documentation that the supply is approaching exhaustion by the expected delivery date. Note: Enteral supply kit HCPCS codes (B4034-B4036) are daily allowances which are considered all inclusive and therefore refill requirements are not applicable to these HCPCS codes. You must meet the refill requirement for enteral formula.
Contact for refills – Contact may take place no sooner than fourteen (14) days prior to the delivery/shipping date
Delivery for refills – Refills should be delivered no sooner than ten (10) days
prior to the end of the usage period
Medical Record Documentation: the patient’s medical record must contain sufficient information to support the medical necessity for the items provided and the frequency of use. This information should include, at a minimum, diagnosis, severity and duration of condition, clinical course details, prognosis, and other interventions and results. Documentation should be created on or just prior to the initial date of service to establish medical necessity. Ongoing need for the item(s) must also be documented periodically (at least yearly) by the prescribing physician. See below for additional documentation suggestions.
The DME MACs have a number of “Dear Physician” letters that are helpful when seeking to obtain supporting documentation.. Click here for a PDF of the Enteral CERT letter. Click the following URL to access other Dear Physician letters for Jurisdiction C:
Therapy Specific Documentation
Enteral: Several DME MACs provide “Documentation Checklists.” View the Enteral checklist at: http://www.cgsmedicare.com/jc/coverage/mr/PDF/MR_checklist_EnteralNutrition_int.pdf
TPN: In order to determine what additional documentation may be required, it is necessary to first determine which criteria your patient meets. Medical records related to these diagnosis/criteria should then be provided. Usually a patient will meet at least one of the following qualifying situations:
Situation A: Massive Bowel Resection
Situation B: Short Bowel Syndrome
Situation C: Bowel Rest
Situation D: Complete Mechanical Small Bowel Obstruction
Situation E: Severe Malabsorption
Situation F: Severe Motility Disturbance
Situation G/H: “Other” Qualifying conditions require documentation of a failed Tube Trial, a 3 month weight history, Serum Albumin level, Enteral nutrition attempts AND a moderate GI abnormality similar to A-F above.
Click here to access the Dynamic TPN Policy Decision Tree
In addition to general medical record documentation related to the above criteria, the following should be provided specifically:
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 TPN.
For situations E and G/H: Results of the fecal fat test (when appropriate) and dates of the test.
For situations F, and G/H (when appropriate): Copy of the report for the small bowel motility study and a list of medications that the beneficiary 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 TPN) and a copy of a nutritional assessment by a physician, dietitian or other qualified professional within 1 week prior to initiation of TPN that includes:
Current weight with date and weight 1-3 mo. prior to initiation of TPN
Estimated daily calorie intake during the prior month and by what route (e.g., oral, tube)
Statement of whether there were caloric losses from vomiting or diarrhea and whether these estimated losses are reflected in the calorie count
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 (see LCD): a statement from the physician, copies of objective studies, and excerpts of the medical record that provide documentation of:
Specific etiology for the gastroparesis, small bowel dysmotility, or malabsorption
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
A copy of the x-ray report or procedure report documenting placement of the tube in the jejunum
Prokinetic medications used, dosage, and dates of use
Nondietary treatment given during prior month directed at etiology of malabsorption (e.g., antibiotic for bacterial overgrowth)
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.
Intravenous Immune globulin (IVIG): Only covered for patients with one of the following diagnosis codes:
Immunodeficiency with increased immunoglobulin M [IgM]
Severe combined immunodeficiency [SCID] with reticular dysgenesis
Severe combined immunodeficiency [SCID] with low T- and B-cell numbers
Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
Major histocompatibility complex class I deficiency
Major histocompatibility complex class II deficiency
Other combined immunodeficiencies
Combined immunodeficiency, unspecified
Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
Common variable immunodeficiency with predominant immunoregulatory T-cell disorders
Common variable immunodeficiency with autoantibodies to B- or T-cells
Other common variable immunodeficiencies
Common variable immunodeficiency, unspecified
Documentation supporting the diagnosis must be provided. Intravenous Immune globulin has it’s own LCD, it is not covered under the External Infusion Pumps LCD.
Inotrope: Administration of parenteral inotropic therapy using the drugs dobutamine (J1250), milrinone (J2260) or dopamine (J1265) for beneficiaries with American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Stage D heart failure (HF) or New York Heart Association (NYHA) Class IV HF, if a beneficiary meets all of the following criteria:
Guideline-directed medical therapy (GDMT) is compliance with optimal medical therapy as defined by ACCF/AHA guideline–recommended therapies (primarily Class I recommendations). These include the use of diuretics, ACE inhibitors or ARB antagonists, beta-blockers, aldosterone antagonists, hydralazine & isosorbide dinitrate, and statins, as appropriate.
For an external infusion pump and related inotropic drugs covered prior to 12/01/2015, if the Medicare coverage criteria in effect on the initial date of service were met, the pump and drug(s) will continue to be covered for claims with dates of service on or after 12/01/2015 as long as the beneficiary continues to meet medical need.
DRUGS ADMINISTERED VIA AN EXTERNAL INFUSION PUMP:
Very few drugs are covered by Medicare Part B. The equipment, supplies and drugs are interdependent – all must be covered for any to be covered. The External Infusion Pump Policy should be referenced for coverage criteria and documentation requirements for specific drugs therapies. External Infusion Pump Checklist
Sub-Q Immune Globulin – Only the following Ig products are covered under the External Infusion Pumps policy when given subcutaneously:
J1559 – Immune Globulin (Hizentra), 100mg
J1561 – Immune Globulin (Gamunex-C/Gammaked), non-lyophilized (e.g. liquid), 500mg
J1562 – Immune Globulin (Vivaglobin), 100mg
J1569 – Immune Globulin (Gammagard Liquid), non-lyophilized (e.g. liquid), 500mg
J1575 – Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immuneglobulin
Inotropic (see details above)
Drugs are only covered as a “supply” to a covered DME infusion pump. Drugs billed alone (without a covered pump being used) will be denied as statutorily noncovered (no benefit).
Disposable drug delivery systems, including elastomeric infusion pumps (A4305, A4306, A9274) are non-covered devices because they do not meet the Medicare definition of durable medical equipment. Drugs and supplies used with disposable drug delivery systems are also non-covered items.
The DME MACs do not process claims for implantable infusion pumps (E0782, E0783, E0785, and E0786) or drugs and supplies used in conjunction with an implantable infusion pump. Claims for these items must be submitted to the local carrier.
The suggested documentation items listed here are just that – suggested. It is important that you read the audit and submit all documentation requested in that audit. If you feel additional documentation not requested would help support your claim then you should submit it. In an appeal situation, you should determine which pieces of documentation will best support your appeal.