Frequently Asked Questions - Final Rule CMS-1713-F - Standard Written Orders - JD DME

Joint DME MAC Publication

On January 1, 2020, new rules took effect governing written orders for all durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). Suppliers have asked questions about the new standard written order (SWO) and other details outlined in the Standard Documentation Requirements Policy Article (A55426). The following Q&A is intended to provide answers to those frequently asked questions.

Question 1: The CMS final rule CMS-1713-F was effective January 1, 2020. When will CMS and the DME MACs publish updated information?
DME MAC Response: The DME MACs have published the Standard Documentation Requirements Policy Article (A55426) and it is effective now. The DME MACs and CMS are working diligently to update all educational material to reflect the new guidance, including the Program Integrity Manual, Local Coverage Determinations (LCDs) and other collateral educational material.

Question 2: Can a DME supplier dispense an item on a verbal dispensing order or must all orders now be in writing before dispensing?
DME MAC Response: For items that do not require a WOPD, a supplier may dispense an item without a written order. However, a SWO must be communicated to the supplier prior to claim submission. Note that suppliers should be aware that state laws, rules or regulations may require an order before dispensing an item.

Question 3: The new standard written order (SWO) has multiple elements, one of which is the "order date." What should suppliers use for this date?
DME MAC Response: Ideally, it should be reflective of when the order was first communicated to the supplier, in order to support the dates of service on the claim.

Question 4: What will reviewers use when there's an Order Date (based on the phone call from the TP) and then the TP elects to enter a date of their signature?
DME MAC Response: Since only one date is required, we will accept the date the order was communicated to the supplier as the "order date" and will review the reported date in concert with the medical record.

Question 5: The CMS final rule CMS-1713-F does not speak to any requirement for frequency of item dispensed. If frequency is no longer required, then would a new order be required for every dispense?
DME MAC Response: While frequency is no longer a required order element, the SWO does require Quantity to be Dispensed for those items where more than one (1) item is dispensed or where dispensing occurs on a periodic basis (e.g., dressings, drugs, supplies, etc). Note also that while the SWO has a limited number of required order elements, suppliers/providers are permitted to add elements that may provide clarity for issues such as LON, frequency of use, dosage form/strength, refills frequency, etc.

Suppliers may also wish to consult state law or regulation since some states may have additional requirements for the elements of an order/prescription.

Question 6: With LON no longer a requirement on the order/prescription, are orders good for lifetime?
DME MAC Response: Suppliers are reminded that length of need (LON) is not necessarily equated with the need for a new prescription. Note that some LCDs and NCDs time-limit prescriptions (i.e., the LCD or NCD stipulates that a new prescription is needed every XX months). In addition, there may be state laws, rules or regulations governing the valid length of a prescription. For LON specifically, reviewers will look to the medical records to determine LON.

Question 7: With respect to the "quantity to be dispensed, if applicable" requirement on the SWO, would it suffice to state that the quantity is "2 per day" or does the quantity have to read a specific number for a month supply, e.g., "60 per month"?
DME MAC Response: Either description of quantity would suffice; however, for claim review purposes, expressing the quantity as a weekly or monthly amount is preferable. Note that the "if applicable" applies to drugs, dressings and other DMEPOS items where the dispensed quantity is typically more than one (1) item or that dispensing happens on a recurring basis. Consult the applicable LCD and related Policy Article for additional details.

Question 8: How do the DME MACs define "treating physician?" For example, a surgeon in the hospital provides supplies that are needed immediately post-op but following discharge, the beneficiary sees their primary care provider for continued care. Will the patient's primary care practitioner be considered the "treating practitioner" for subsequent supply orders?
DME MAC Response: Per the example, if the patient's primary care practitioner has knowledge of, and documentation to support (e.g., face-to-face) the condition that requires his or her writing an order/prescription, there is no preclusion to the patient's primary care practitioner providing subsequent orders/prescriptions.

Question 9: For items subject to the face-to-face encounter and written order prior to delivery requirement, must the SWO be signed by the same treating practitioner who completed the face-to-face encounter?
DME MAC Response: For power mobility devices, the treating practitioner that conducted the face-to-face encounter must complete the SWO.

For items other than power mobility devices that will appear on the "Required Face-to-Face Encounter and Written Order Prior to Delivery List," the treating practitioner that conducted the face-to-face encounter does not need to be the prescriber for the DMEPOS item; however, to demonstrate compliance with the regulation, the prescriber must:

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

Question 10: If a patient experiences a change in treating practitioners, and a SWO is generated by the patient's supplier that prepopulates the wrong treating practitioner's name, is it acceptable for the supplier to strike through the wrong name, fill in the correct name, sign and date the change and submit the corrected order to the patient's treating practitioner for signature?
DME MAC Response: Yes, it is acceptable to use standard clinical practice to strike through and provide the updated information.

Question 11: I am a treating practitioner but also a supplier. Do I have to write an SWO to myself to dispense DMEPOS?
DME MAC Response: No. The SWO regulations do not require that a treating practitioner (e.g. MD/DO or NP/PA/CNS) who is also the supplier to create a separate SWO so long as the elements of a SWO is included in the beneficiary's medical record.

Question 12: Does the NPI of the MD/DO/DPM who is both the prescriber and supplier need to be in the patient's chart on the ordered DOS? Physicians typically do not include the prescribing practitioner's NPI in the medical records.
DME MAC Response: The SWO, or in this question the medical record serving as the SWO, requires either the NPI or the name of the treating practitioner. If the treating practitioner's name is included in the medical records, there is no need for the NPI to be included as well.

Question 13: The final rule CMS-1713-F mentions a "Master List of DMEPOS Items Potentially Subject to Face-To-Face Encounter and Written Orders Prior to Delivery and/or Prior Authorization Requirements", a "Required Face-to-Face Encounter and Written Order Prior to Delivery List" and a "Required Prior Authorization List." Can you provide more information?
DME MAC Response: With the final rule CMS-1713-F, CMS set out criteria for identifying DMEPOS items potentially subject to face-to-face encounters and written order prior to delivery, in addition to prior authorization. These criteria define the DMEPOS items on the Master List, which is updated annually. From this Master List, CMS creates two Required Lists - a "Required Face-to-Face Encounter and Written Order Prior to Delivery List" and a "Required Prior Authorization List." The Required Prior Authorization List was updated and published in the Federal Register on Friday, February 7, 2020. It may be viewed at: https://www.federalregister.gov/documents/2020/02/11/2020-02644/medicare-program-update-to-the-required-prior-authorization-list-of-durable-medical-equipment with additional information on the CMS web site at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items. The Required Face-to-Face Encounter and Written Order Prior to Delivery List has not yet published. CMS will provide a minimum of a 60-day notice in the Federal Register for items appearing on either list.

Question 14: Since CMS has yet to publish the "Required Face-to-Face Encounter and Written Order Prior to Delivery List", what DMEPOS items are currently subject to a face-to-face evaluation and written order prior to delivery?

DME MAC Response: The Medicare statute (see Social Security Act, Title XVIII, §1834(a)(1)(E)(iv)), stipulates for power mobility devices that "[P]ayment may not be made for such covered item unless a physician (as defined in section 1861(r)(1), a physician assistant, nurse practitioner or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) has conducted a face-to-face examination of the individual and written a prescription for the item." Furthermore, CMS regulation at 42 CFR 410.38 requires that the written order must be communicated to the supplier prior to delivery of the power mobility device. Until CMS publishes the "Required Face-to-Face Encounter and Written Order Prior to Delivery List", only power mobility devices and items designated as requiring an in-person visit in an LCD or NCD, are subject to the face-to-face encounter and/or written order prior to delivery.

Question 15: For power mobility devices, are suppliers permitted to use a template for the SWO, like the previous 7-element order (7EO) template, so long as the information is completed by the treating practitioner?
DME MAC Response: For power mobility devices, the treating practitioner must complete the elements of the SWO. A supplier may create a template for use by the treating practitioner to complete the SWO elements. For items other than power mobility devices, the supplier may prepare the SWO for the treating practitioner's signature.

Question 16: Is it permissible for the DMEPOS base item and all of the options and accessories to be ordered on one SWO?
DME MAC Response: The DME MAC prefer that the base item and all separately billed options and accessories be included on a single SWO; however, CMS final rule CMS-1713-F does allow for separately billed options and accessories to be on a different SWO.

Question 17: The final rule indicates there must be a face-to-face encounter with the treating practitioner within 6 months prior to the SWO being written for PMD. Does the date of the face-to-face encounter mean the day the treating practitioner saw the patient, or could it be the date that the treating practitioner countersigned the licensed/certified medical practitioner (LCMP) evaluation, if later than the treating practitioner's face-to-face encounter?
DME MAC Response: As noted in the question, the final rule CMS-1713-F indicates there must be a qualifying face-to-face encounter with the treating practitioner within six (6) months prior to the SWO being written for PMD. The final rule CMS-1713-F defines a face-to-face encounter as an in-person or telehealth encounter, and defines a treating practitioner as both physicians, defined in section 1861(r)(1) of the Act, and non-physician practitioners (that is, PA, NP, and CNS) defined in section 1861(aa)(5) of the Act. The final rule CMS-1713-F makes no allowance for other dates resetting this timeframe, such as the treating practitioner's co-signature and agreement/disagreement with an LCMP evaluation.

To accommodate the requirements at 42 CFR 410.38, when the treating practitioner sees the beneficiary, regardless of whether a referral to an LCMP is made, that visit date starts the six (6) month timeline for completion of the SWO. If the treating practitioner chooses to refer the beneficiary to an LCMP for a mobility evaluation, the treating physician's co-signature, dating and indicating agreement or disagreement with the LCMP evaluation must occur within this six (6) month timeframe. In cases where the LCMP evaluation is being adopted into the physician's documentation to substantiate the need for the item, the SWO may not be written until the LCMP report is signed, dated and agreement/disagreement indicated.

The PMD LCD-related Policy Article will be updated soon to reflect this updated guidance.

Question 18: Is a qualifying face-to-face encounter required each time a new order/prescription for one of the specified items the Required Face-to-Face Encounter and Written Order Prior to Delivery List?" is ordered.
DME MAC Response: A qualifying face-to-face encounter is required within six (6) months of writing the order for any item on the "Required Face-to-Face Encounter and Written Order Prior to Delivery List." Note that a single face-to-face encounter may document the clinical conditions necessitating multiple DMEPOS items. In this situation, regardless of whether the DMEPOS items are prescribed on different dates, the single face-to-face encounter may be utilized in support of the multiple items, if the encounter date is within 6 months of the orders.

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