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.

INTAKE

During the Intake process, it is recommended that the following steps occur:

Verification of Benefits

• Verify the patient’s Medicare number is accurate (do not assume an “A” or “B” after the SSN)
• Verify the effective date by utilizing your DME MAC’s website or their Interactive Voice Response (IVR) System
  • DME MAC A:  Noridian Medicare Portal or IVR at 866-419-9458
  • DME MAC B:  myCGS or IVR at 877.299.7900
  • DME MAC C:  myCGS or IVR at 866-238-9650
  • DME MAC D:  Noridian Medicare Portal or IVR at 877-320-0390
• Verify that the patient does not have a Medicare Advantage plan instead of traditional Fee for Service Medicare
• Determine if the patient has any additional insurance coverage
• If additional insurance is found, you must determine if Medicare is primary or secondary.  Suppliers should utilize the MSP tool provided by CGS to assist in determining if Medicare is Primary or Secondary. Note that if Medicare is secondary, all documentation requirements must be met and the patient must meet criteria in order for Medicare to pay.
• If Medicare is primary, determine if the secondary or tertiary payer is a “supplement” or a true “secondary”.  A supplemental plan will only pay the co-insurance and deductible portion after Medicare pays and will not pay if Medicare fully denies.
• Determine if the patient meets Medicare’s coverage criteria.  Coverage criteria can be found in your DME MAC’s Local Coverage Determinations (LCDs).
• Verify the patient will receive services at home. Place of service is almost always “home” (12).  Click here to view the full place of service listing.  See the TPN/Enteral LCD for exceptions related to services provided in a Skilled Nursing Facility (SNF).

DOCUMENTATION

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 (LCDs).

• Verbal/dispensing/preliminary order:   You must have an order from the treating physician before dispensing.  Starting January 6, 2014 you will need to ensure that the ordering/ referring physician is enrolled in the Medicare Provider Enrollment, Chain and Ownership System (PECOS) to receive payment for services.  Click here to read the ordering/ referring Dear Physician letter and see how to confirm enrollment in PECOS.  Documentation must show the verbal order was received prior to dispensing the item. The dispensing order may be a written, fax, or verbal order and must include:

  • 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)

• Beneficiary authorization
• Advance Beneficiary Notice of Noncoverage (ABN): If Medicare “covers” the therapy (an LCD exists), but the patient does not meet criteria, or you are unsure because the documentation is not clear, then an ABN must be obtained prior to or upon delivery. The ABN must provide specific a specific reason you feel Medicare may deny.  Blanket ABNs should not be used.  In other words, you should not provide an ABN to a patient just because he or she has Medicare.  You must be able to provide a reason why Medicare may deny.

• Detailed Written Order (DWO), obtained before submitting a claim, which includes:

  • Beneficiary’s name
  • Prescribing Physician’s name
  • Date of the order and the start date of the order, if the start date is different from the date of the order
  • Detailed description of the item(s): It is recommended that you include the applicable HCPCS code
  • Physician signature and signature date (signature or date stamps are not allowed)
    • For additional details on physician signatures, including electronic signatures, please see for MLN Matters® MM6698 regarding Signature Guidelines for Medical Review Purposes

  For items provided on a periodic basis, including drugs, you should include:

  • Item(s) to be dispensed – The items dispensed should include the “billable” items.  For most IV related services this includes the drug, pump rental, IV pole, infusion supplies and supply kits (catheter maintenance supply kit , infusion pump supply kit).  The only time you need to list individual items is if you intend to bill separately for them to Medicare.
  • Dosage or concentration, if applicable – Example: 750mg, every 12 hours
  • Route of administration – The route the drug, TPN, or Enteral formula being infused should be listed.  Examples include:  subcutaneous, IV, intrathecal, PO, nasogastric tube, gastrostomy tube, jejunostomy tube, etc.
  • Frequency of use – including specific amount to be dispensed, “PRN” or “as needed” are unacceptable – It is important to list the actual frequency described by the Physician.  Examples: every 12 hours, one per day, weekly, three times a week, etc.
  • Duration of infusion, if applicable – When the patient is receiving a drug infusion, you need to state the duration for each infusion.  Examples:  over 30 minutes daily for 7 days, over 12 hours nocturnally daily for 3 months, etc.
  • Quantity to be dispensed – You need to list the quantity to be dispensed per delivery/fill for each billable item to Medicare. Examples: catheter maintenance supply kit – 1 per week, infusion pump supplies – 1 per bag or cassette.
  • Number of refills – List the number of refills the physician is allowing for this written order. The physician should add the number of refills to the DWO unless that information was provided with the verbal order, or there is other documentation that provides the number of refills. Once the number of refills has been reached, you will need to obtain a new written order.
  • Click here to access a DWO self-audit tool provided by the Jurisdiction A DME MAC, NHIC.
• DME Information Form (DIF) (as applicable): can be obtained after delivery, but must be signed and dated prior to claim submission.
  

  A Revised DIF is needed when there is a change in:

  • • Supplier
    • Physician
    • The Medication being administered via an External Infusion Pump
    • Number of days per week TPN or Enteral is being administered
    • Calories (Enteral)
    • Lipids (TPN)
    • Method of Administration (Enteral)
    • HCPC Code (such as a change in the Enteral Category, or grams of TPN)

  DME Information Forms (DIFs) Usage for Enteral and Parenteral Nutrition and External Infusion Pumps – DME MAC Joint Publication Revised

• Medical Record Documentation

• • Information from the treating physician concerning the patient’s diagnosis and length of need.
  • As much documentation from the patient’s medical record as needed to assure that coverage criteria have been met.* 

*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

• Verbal/Dispensing Order
• Advanced Beneficiary Notice (ABN) (as applicable)
• Detailed Written Order (DWO)
• DME Information Form (DIF) (as applicable)

• Proof of Delivery:

  Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files.

  Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

  Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary). The signature and date the beneficiary or designee accepted delivery must be legible.

  For the purpose of the delivery methods noted below, designee is defined as any person who can sign and accept the delivery of DMEPOS on behalf of the beneficiary.

  Suppliers are required to maintain POD documentation in their files. For items addressed in this policy there are three methods of delivery:

• Method One: Delivery directly to the beneficiary or authorized representative
  • POD to a beneficiary must be a signed and dated delivery slip.
  • The POD record must include:
  • • Beneficiary’s name
    • Delivery address
    • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
    • Quantity delivered
    • Date delivered
    • Beneficiary (or designee) signature and date of signature

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.

• Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary
  • POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary.
  • An example of acceptable proof of delivery would include both the supplier’s own detailed shipping invoice and the delivery service’s tracking information.
  • The supplier’s record must be linked to the delivery service record by some clear method like the delivery service’s package identification number or supplier’s invoice number for the package sent to the beneficiary.
  • POD record must include:
    • Beneficiary’s name
    • Delivery address
    • Delivery service’s package identification number, supplier invoice number or alternative method that links the supplier’s delivery documents with the delivery service’s records
    • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
    • Quantity delivered
    • Date delivered
    • Evidence of delivery

      If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as 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.

• Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary
  When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

  When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

  Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary’s use were actually provided to and used by the beneficiary must be available upon request.

  Please note:
  Any delivery service that is used which is not owned and operated by the Infusion provider would be considered a delivery or shipping service and guidelines associated with that type of delivery method must be followed.

• 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:

http://www.cgsmedicare.com/jc/coverage/mr/Doc_Req.html

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:

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

  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 (see LCD):  a statement from the physician, copies of objective studies, and excerpts of the medical record that provide documentation of:

    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.

Intravenous Immune globulin (IVIG):  Only covered for patients with one of the following diagnosis codes:

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:

• • 1. Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,
    2. As “Bridge” therapy for patients eligible for and awaiting mechanical circulatory support (MCS)/cardiac transplantation, or as palliative care for patients not eligible for either MCS/cardiac transplantation; and,
    3. Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,
    4. There has been a documented improvement in beneficiary symptoms of heart failure while on the selected inotropic drug at the time of discharge from an inpatient or skilled nursing care facility; and,
    5. An evaluation every three months by the prescribing provider or a heart failure team with oversight by a cardiologist with training in the management of advanced heart failure, which documents the beneficiary’s cardiac symptoms and the continuing response and need for therapy. The heart failure team or physician may have no financial relationship with the supplier.

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

• Pain Management 

• Chemotherapy

• Anti-Fungal/ Anti-Viral

• Chelation

• Pulmonary Hypertension

• 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.

Additional Documentation

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.