The Centers for Medicare and Medicaid Services (“CMS”) has added a new face-to-face encounter requirement related to the ordering of certain Durable Medical Equipment (“DME”) items in the Medicare Program Revisions to Payment Policies under the Physician Fee Schedule Final Rule that was published in November, 2012 (the “Final Rule”). For covered DME items requiring a written order, physicians must document that a face-to-face encounter with the beneficiary occurred within six (6) months before the written order. The new rule is effective for all covered DME items ordered on or after July 1, 2013. The rule does not apply retrospectively to DME orders prior to July 1, 2013. CMS is not implementing a requirement for a face-to-face encounter for prosthetic devices, orthotics, and prosthetics that require a written order, at this time, and deferred to future rule-making to address this area.

Under the proposed rule, the face-to-face encounter was required to occur either within 90 days before or 30 days after the date the order was written. Those time frames were changed in the Final Rule, and the face-to-face encounter must occur within six months before the order is written. The face-to-face encounter requirement does not replace or supersede the requirements for the Certificate of Medical Necessity. Both may be completed at the same time.

Physician assistants, clinical nurse specialists, and nurse practitioners are authorized to conduct the face-to-face encounter and to order DME within their scope of practice. However, the physician must document the face-to-face encounter that is performed by the physician assistants, clinical nurse specialists, and nurse practitioners. When the beneficiary has been discharged from the hospital, another face-to-face encounter is not required to be documented, if the treating physician who performed the face-to-face encounter in the hospital orders the DME within six months after the date of discharge.

During the face-to-face encounter, the physician, physician assistant, nurse practitioner, or certified nurse specialist must evaluate the beneficiary, conduct a needs assessment, or treat the beneficiary for the medical condition that supports the need for each covered item of DME. This information should be included in the beneficiary’s medical record, along with the identity of the practitioner who performs the face-to-face assessment. Any encounter that is covered as an “incident to” service does not satisfy the requirements for the face-to-face encounter.

The face-to-face encounter may be accomplished through a telehealth encounter, provided all Medicare requirements for telehealth have been met. A single face-to-face encounter, including a telehealth encounter, can support the need for multiple covered items of DME, as long as it is documented in the medical record that the beneficiary was evaluated or treated for a condition that supports the need for each covered item during the specified time frame.

CMS recognized the need for a standard accepted practice to document the face-to-face encounter when performed by the physician assistant, clinical nurse specialist, or nurse practitioner and provided guidance on how to accomplish this in the Final Rule. The physician must sign or co-sign the pertinent portion of the medical record indicating the occurrence of the face-to-face encounter for the date of the encounter. The physician’s signature on the pertinent portion of the medical record documents that the beneficiary was evaluated or treated for a condition relevant to an item of DME on that date of service. The physician’s signature provides evidence that the physician reviewed the relevant documentation to support that a face-to-face encounter occurred for that date of service. A signed order for the DME alone will not satisfy the requirement that the physician sign or co-sign the relevant portion of the medical record.

When the physician conducts the face-to-face encounter himself or herself, there is no need for a separate certification by the physician that the encounter occurred. In that case, the submission of the pertinent portion of the medical record documented by the physician would be sufficient to document that the face-to-face encounter occurred.

The face-to-face encounter is a condition of payment for the supplier, and the supplier must make the information available to CMS upon request. CMS did not require a particular method of transmitting notice to the supplier that the face-to-face encounter occurred. Also, CMS indicated it would not require the physician to provide a copy of the face-to-face documentation to the beneficiary, as suggested in the proposed rule.

The final rule makes it clear that, for items that do not require a written order before delivery, suppliers are allowed to dispense DME based upon a verbal order. However, the supplier must have the written order before submitting the claim for payment. For items that require a written order prior to delivery, the supplier must have the written order with the face-to-face documentation prior to delivery when submitting a claim for payment.

A valid written order for DME must include, at a minimum: 1) the beneficiary’s name; 2) the item of DME ordered; 3) the prescribing practitioner NPI; 4) the signature of the prescribing practitioner; and 5) the date of the order. CMS removed the requirement that orders for covered DME include a diagnosis and “necessary and proper usage instructions”, as those would be overly burdensome, considering the large number of covered DME items and the many diagnoses and usage instructions for each one. However, CMS cautioned that the related diagnoses should be documented in the beneficiary’s medical record. CMS also expects that the “necessary and proper usage instructions” would be provided to the beneficiary or to the care giver to ensure proper usage of the item.

With regard to the amount of necessary clinical information required to demonstrate all coverage and coding requirements were met, CMS referred to the NCDs and LCDs that address many of the items. The documentation requirements in the Final Rule are in addition to any requirements in the NCDs or LCDs that may require a face-to-face encounter. CMS issued a caution about the use of templates for documentation, particularly those that provide limited options or space for collection of information, such as those that utilize a “check the box” system, and discouraged the use of these types of templates.

The list of Specified Covered Items for which a face-to-face encounter is required was published with the Final Rule. The Specified Covered Items meet at least one of the following criteria: 1) items that currently require a written order prior to delivery per instructions in the Program Integrity Manual; 2) items that cost more than $1,000.00; 3) items that CMS believes are particularly susceptible to fraud, waste and abuse, based on recommendations from the DME Medicare Administrative Contractors; and 4) items determined by CMS to be vulnerable to fraud, waste and abuse based on reports of the HHS OIG, Government Accountability Office, or other oversight entities.

CMS removed from the list any items where regulations specifically state that face-to-face encounter is not necessary (such as for power wheelchair accessories). Also, the new face-to-face encounter requirement does not apply to power mobility devices, as the existing regulation requires a 45-day face-to-face encounter for that DME item. The 45-day requirement has not been superseded by the new Final Rule.

In recognition of the burden associated with the requirement that the physician document the face-to-face encounter has occurred between a physician assistant, certified nursing specialist, or nurse practitioner, CMS will establish a payment for a new HCPCS code. CPT Code G0454 will be used to compensate the physician who documents that the face-to-face encounter has been performed by a physician assistant, certified nursing specialist, or nurse practitioner. The new G-code will become effective when the provisions in the regulation become effective on July 1, 2013. The physician can receive payment for only one G-code for documenting the face-to-face encounter occurred, even if multiple written orders for covered DME items originate from the same visit.

CMS believes the existing Evaluation and Management (E&M) codes are sufficient for practitioners furnishing face-to-face encounters. CMS stated that only a physician who does not bill an associated E&M code for the beneficiary would be eligible to use the G-code. However, CMS clarified that physicians may still bill for an E&M service that is clearly unrelated to the patient’s need for, and documentation of, the DME authorization.