Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs

A nurse practitioner or clinical nurse specialist may give the dispensing order and sign and date the detailed written order in the following situations:

  • They are treating the beneficiary for the condition for which the item is needed;
  • They are practicing independently of a physician;
  • They bill Medicare for other covered services using their own provider number; and
  • They are permitted to do all of the above in the State in which the services are rendered.

A nurse practitioner or clinical nurse specialist may complete Section B and sign Section D of a CMN if they meet all the criteria described above for signing orders. See Chapter 4 of the manual for information regarding CMNs.

Signatures must comply with CMS signature requirements. Refer to the “Signature Requirements” section in this chapter.

Physician Assistant Rules Concerning Orders and CMNs

Physician assistants may provide the dispensing order and write, sign, and date the detailed written order if they satisfy all the following requirements:

  • They meet the definition of physician assistant found in §1861(aa)(5)(A) of the Act;
  • They are treating the beneficiary for the condition for which the item is needed;
  • They are practicing under the supervision of a Doctor of Medicine or Doctor of Osteopathy;
  • They have their own NPI; and
  • They are permitted to perform services in accordance with State law.

Physician assistants may complete Section B and sign Section D of a CMN if they meet all the criteria described above for signing orders.

Signatures must comply with CMS signature requirements. Refer to the “Signature Requirements” section in this chapter.

Supply Replacement/Utilization – Evidence of Medical Necessity

If replacement supplies are needed for the therapeutic use of purchased DMEPOS, the treating practitioner must specify on the prescription, or on the CMN, the type of supplies needed and the frequency with which they must be replaced, used, or consumed. DME MACs and UPICs evaluate supply utilization information as part of the medical necessity determination for DMEPOS. “PRN” or “as needed” utilization estimates for supply replacement, use, or consumption are not acceptable.

The DME MACs and/or UPICs have procedures in place to monitor utilization of replacement supplies. You must submit updated medical information of the patient’s condition resulting in changes of the equipment device, or supply utilization. Claims submitted with unexpected increases in supply utilization without supportive documentation will be denied. You must provide this information with the claim where indicated in published policy or make it available to the DME MACs or UPICs on request.

Acceptability of Faxed Orders and Facsimile or Electronic CMNs or DIFs

When reviewing claims and orders, or auditing CMNs or DIFs for DMEPOS, DME MACs and UPICs may encounter faxed, copied, or electronic orders, CMNs, and DIFs in supplier files. The DME MACs and UPICs will accept these documents as fulfilling the documentation requirements.

The DME MACs and UPICs retain the authority to request additional documentation to support the claim. If a DME MAC finds indications of potential fraud or misrepresentation of these documents or the claims submitted, they will refer the matter to the UPIC for development.

Documentation in the Patient’s Medical Record

Medicare does not automatically assume payment for a DMEPOS item that was covered prior to a beneficiary becoming eligible for the Medicare Fee-for-Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding, and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary may be required upon request of the DME MAC.

For any DMEPOS item to be covered by Medicare, the patient’s medical record must contain sufficient documentation of the patient’s medical condition to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or replacement (if applicable). The information should include the patient’s diagnosis and other pertinent information including, but not limited to, duration of the patient’s condition, clinical course (worsening or improving), prognosis, nature and extent of functional limitations, other therapeutic interventions and results, past experience with related items, etc. If the information in the patient’s medical record does not adequately support the medical necessity for the item, you are liable for the dollar amount involved unless a properly executed ABN of possible denial has been obtained. See the Advanced Beneficiary Notice section below for information about ABNs.

If an item requires a CMN or DIF, it is recommended that a copy of the completed CMN or DIF be kept in the patient’s record; however, neither a practitioner’s order, nor a CMN nor a DIF nor a supplier-prepared statement nor practitioner’s attestation by itself provides sufficient documentation of medical necessity, even though it is signed by the treating physician or you. There must be information in the patient’s medical record that supports the medical necessity for the item and substantiates the answers on the CMN (if applicable) or DIF (if applicable) or information on a supplier-prepared statement or practitioner’s attestation (if applicable). See Chapter 4 of this manual for information regarding CMNs and DIFs.

Supplier-produced records, even if signed by the prescribing practitioner, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes. Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

The patient’s medical record is not limited to the practitioner’s office records. It may include hospital, nursing home, or home health agency records and records from other professionals. Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

The documentation in the patient’s medical record does not need to be routinely sent to you or to the DME MACs or UPICs; however, the DME MAC or UPIC may request this information in selected cases. If the DME MAC or UPIC does not receive the information when requested, or if the information in the patient’s medical record does not adequately support the medical necessity for the item, then for assigned claims you are liable for the dollar amount involved unless a properly executed advance beneficiary notice (ABN) of possible denial has been obtained. See the Advanced Beneficiary Notice section below for information about ABNs.

FACE-TO-FACE EXAMINATION

Note: This section does not apply to Power Mobility Devices, as they are covered under a different statutory requirement. Refer to the Power Mobility Devices LCD. The requirements listed in this regulation do not supersede other CMS requirements for detailed written orders. Refer to the “Detailed Written Orders” section in this chapter.

These Affordable Care Act requirements are effective for claims for all of the specified items that require a new order (prescription) on or after July 1, 2013. A delay in enforcement has been made by DME MACs. Other auditing entities may enforce these requirements. This delay in enforcement does not apply to the prescription requirements for a Written Order Prior to Delivery or to the requirement to include the prescriber’s NPI on the prescription.

As a condition for payment, Section 6407 of the Affordable Care Act (ACA) requires that a practitioner (Medical Doctor (MD), Doctor of Osteopathic Medicine (DO) or Doctor of Podiatric Medicine (DPM), physician assistant (PA), nurse practitioner (NP) or clinical nurse specialist (CNS)) has had a face-to-face examination with a beneficiary within the six (6) months prior to the date of the written order for certain items of DME.

This face-to-face requirement includes examinations conducted via the Centers for Medicare & Medicaid Services (CMS)-approved use of telehealth examinations (as described in Chapter 15 of the Medicare Benefit Policy Manual and Chapter 12 of the Medicare Claims Processing Manual – CMS Internet-Only Manuals, Pub. 100-02 and 100-04, respectively).

For the treating practitioner prescribing a specified DME item:

  • The face-to-face examination with the beneficiary must be conducted within the six (6) months prior to the date of the prescription.
  • The face-to-face examination must document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.
  • All Medicare coverage and documentation requirements for DMEPOS also apply. There must be sufficient medical information included in the medical record to demonstrate that the applicable coverage criteria are met. Refer to the applicable Local Coverage Determination for information about the medical necessity criteria for the item(s) being ordered.

The treating practitioner that conducted the face-to-face examination does not need to be the prescriber for the DME item; however, the prescriber must:

  • Verify that the qualifying in-person visit occurred within the 6-months prior to the date of their prescription; and,
  • Have documentation of the qualifying face-to-face examination that was conducted.

The prescriber must provide a copy of the 5EO for the item(s) ordered to you before the item(s) can be delivered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required by Medicare:

  • For all claims for purchases or initial rentals
  • When there is a change in the original prescription for the accessory, supply, drug, etc.
  • On a regular basis (even if there is no change in the original order) only if it is so specified in the Documentation section of a particular medical policy
  • When an item is replaced
  • When there is a change in the supplier, and the new supplier is unable to obtain a copy of a valid order and documentation from the original supplier.

The first bullet, “For all claims for purchases or initial rentals”, includes all claims for payment of purchases and initial rentals for items not originally covered (reimbursed) by Medicare Part B. Claims for items obtained outside of Medicare Part B, e.g. from another payer prior to Medicare participation (including Medicare Advantage plans), are considered to be new initial claims for Medicare payment purposes.

Date and Timing Requirements

There are specific date and timing requirements:

  • The date of the face-to-face examination must be on or before the date of 5EO and may be no older than six months prior to the prescription date.
  • The date of the face-to-face examination must be on or before the date of delivery for the item(s) prescribed.
  • The date of the 5EO must be on or before the date of delivery or date shipped if the shipping date is used as the date of service. The shipping date may be defined as the date the delivery/shipping service label is created or the date the item is retrieved for delivery. However, such dates should not demonstrate significant variation.
  • You must have the completed 5EO in your file prior to the delivery of these items.

All other date and timing requirements specified in the CMS Program Integrity Manual regarding specific items or services remain unchanged.

Upon request by the contractor you must provide documentation, from the treating practitioner, of the face-to-face examination and the completed 5EO.

Claim Denial

Claims for the specified items subject to ACA 6407 that do not meet the requirements specified above will be denied as statutorily noncovered – failed to meet statutory requirements.

If you deliver the item prior to receipt of the 5EO, it will be denied as statutorily noncovered. If the 5EO is not obtained prior to delivery, payment will not be made for that item even if a written order is subsequently obtained. If a similar item is subsequently provided by an unrelated supplier who has obtained a written order prior to delivery, it will be eligible for coverage.

The above face-to-face requirements apply to the HCPCS codes listed as subject to 42 CFR 410.38(g).

Refer to the Pricing, Data Analysis and Coding (PDAC) Contractor website for information on coding at www.dmepdac.com.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered; therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period. Entries in the beneficiary’s medical record must have been created prior to, or at the time of, the initial date of service to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary’s medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. Information used to justify continued medical need must be timely for the date of service under review. Any of the following may serve as documentation justifying continued medical need:

  • A recent order by the treating practitioner for refills
  • A recent change in prescription
  • A properly completed CMN or DIF with an appropriate length of need specified
  • Timely documentation in the beneficiary’s medical record showing usage of the item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified in policy.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

You are responsible for monitoring utilization of DMEPOS rental items and supplies. Monitoring of purchased items or capped rental items that have converted to a purchase is not required. You must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

Beneficiary medical records or your records may be used to confirm that a DMEPOS item continues to be used by the beneficiary. Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:

  • Timely documentation in the beneficiary’s medical record showing usage of the item, related option/accessories, and supplies.
  • Your records documenting the request for refill/replacement of supplies in compliance with the refill documentation requirements section. This is deemed to be sufficient to document continued use for the base item as well.
  • Your records documenting beneficiary confirmation of continued use of a rental item.

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified in policy.

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