RETIRED - CMS Issues Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) - COVID-19 Public Health Emergency - Revised - JA DME

Joint DME MAC Publication
Posted June 3, 2022

On April 6, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment (CMS-1744-IFC), establishing that certain requirements for face-to-face/in-person encounters will not apply during the COVID-19 public health emergency. In addition, CMS-1744-IFC stated that the chief medical officer or the equivalent individual of a facility may authorize a physician of a different specialty than specified in a national coverage determination (NCD) or local coverage determination (LCD) to perform a service, procedure, or portion of a procedure. The chief medical officer or equivalent may also authorize a different practitioner type than the one specified in the NCD or LCD to perform the service or procedure. In addition, CMS-1744-IFC finalized on an interim basis that CMS would not enforce various clinical indications of coverage found in specific NCDs, LCDs, and related policy articles. These interim final policies are effective for claims with dates of service on or after March 1, 2020 and for the duration of the COVID-19 Public Health Emergency (PHE). It is in the best interest of patients, health care professionals and suppliers to limit face-to-face encounters and avoid exposure of vulnerable Medicare beneficiaries to COVID-19. Furthermore, CMS believes that it is possible that patients receiving services for respiratory-related indications will be required to receive care in unexpected settings, including the home. This may be necessary as COVID-19 and other patients are shifted across healthcare settings to accommodate an increase in patient volume.

A subsequent CMS interim final rule with comment, CMS-5531-IFC, was put on display at the Office of the Federal Register on May 1, 2020, scheduled to be published on May 8, 2020. This IFC clarified that reasonable and necessary statutory requirements in section 1862(a)(1) of the Social Security Act are not being waived due to the COVID-19 PHE. CMS-5531-IFC additionally instructs that, unless expressly permitted by statute, items and services must be medically reasonable and necessary, and that the medical records must document the medical necessity of the item(s) and/or service(s) billed.

Finally, on an interim basis, CMS-5531-IFC expanded non-enforcement of clinical indications of coverage for therapeutic continuous glucose monitors (CGMs).

Face-To-Face/In-Person Encounters

For the duration of this PHE for the COVID-19 PHE, it is in the best interest of patients, health care professionals and suppliers to limit face-to-face encounters and avoid exposure of vulnerable Medicare beneficiaries to COVID-19. Therefore, on an interim basis, we are finalizing that to the extent an NCD or LCD (including policy articles) would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services, those requirements would not apply during the COVID-19 PHE.

Exception: Note that the IFCs do not apply to Power Mobility Devices (PMDs) where the face-to-face encounter with the ordering practitioner is mandated by Medicare statute at section 1834(a)(1)(E)(iv) of the Social Security Act, as codified in 42 CFR § 410.38. The regulation already permits the use of telehealth in accordance with Medicare guidelines. CMS has extended flexibilities to permit a broader use of telehealth services, locations, provider types and technologies during the COVID-19 PHE.

Exception: Note that CMS Quality Standards Appendices, incorporated by reference in the DMEPOS Supplier Standards at 42 CFR §424.57 continue to apply during the COVID-19 PHE. The CMS-1744-IFC only addressed requirements in NCDs, LCDs and related articles.

Clinical Indications for Coverage

Effective for claims with dates of service on or after March 1, 2020 and for the duration of this COVID-19 PHE, clinical indications for coverage found in respiratory, infusion pump, and therapeutic continuous glucose monitor NCDs or LCDs will not be enforced. These NCDs and LCDs include:

• Home Oxygen (NCD 240.2)
• Infusion Pumps (NCD 280.14)
• Continuous Positive Airway Pressure for Obstructive Sleep Apnea (NCD 240.4)
• Intrapulmonary Percussive Ventilator (NCD 240.5)
• Durable Medical Equipment Reference List (NCD 280.1) - Only clinical indications for ventilators are not enforced
• Oxygen and Oxygen Equipment (L33797)
• Positive Airway Pressure Devices for the Treatment of Obstructive Sleep Apnea (L33718)
• Oral Appliances for the Treatment of Obstructive Sleep Apnea (L33611)
• Respiratory Assist Devices (L33800)
• Mechanical In-exsufflation Devices (L33795)
• High Frequency Chest Wall Oscillation (L33785)
• Nebulizers (L33370)
• Suction Pumps (L33612) - Only clinical indications for respiratory suction pumps (E0600) are not enforced
• Glucose Monitors (L33822) - Only clinical indications for Therapeutic Continuous Glucose Monitors (CGM) are not enforced
• External Infusion Pumps (L33794)

Treating practitioners and suppliers must still:

• Provide a standard written order (SWO) for all items. For PMDs, the treating practitioner must document and communicate to the DMEPOS supplier that the treating practitioner has had a face-to-face encounter with the beneficiary within the 6 months preceding the date of the written order/prescription, per section 1834(a)(1)(E)(iv) of the Act;
• Ensure that the items or services are reasonable and necessary;
• Continue documenting the medical necessity for all services. Accordingly, the medical record must be sufficient to support payment for the services billed (that is, the services were actually provided, were provided at the level billed, and were medically necessary);
• Make documentation available, upon request.

This enforcement discretion will only apply during the COVID-19 PHE. At the conclusion of the COVID-19 PHE, the DME MACs will return to enforcement of the clinical indications for coverage.

Requirements for Consultations or Services Furnished by or Supervised by a Particular Medical Practitioner or Specialist

Effective for claims with dates of service on or after March 1, 2020 and for the duration of the COVID-19 PHE, to the extent NCDs and LCDs require a specific practitioner type or physician specialty to furnish a service, procedure or any portion thereof, the chief medical officer or equivalent of the facility can authorize another physician specialty or other practitioner type to meet those requirements. Additionally, to the extent NCDs and LCDs require a physician or physician specialty to supervise other practitioners, professionals or qualified personnel, the chief medical officer of the facility can authorize that such supervision requirements do not apply during the COVID-19 PHE.

Claim Instructions

Suppliers should continue to use the appropriate modifiers, including the KX and/or CG modifier where applicable, for all HCPCS codes included in the NCDs and LCDs listed above. In addition, the CR modifier (CATASTROPHE/DISASTER RELATED) should be added to the HCPCS code(s) billed. Finally, suppliers are instructed to enter "COVID-19" in the NTE 2400 (line note) or NTE 2300 (claim note) segments of the American National Standard Institute (ANSI X12) format or field 390-BM of the National Council for Prescription Drug Program (NCPDP) format. These abbreviations may also be used in Item 19 of the CMS-1500 claim form.

In addition, to ensure that the requirements of the Durable Medical Equipment benefit are met, and that claims payment will be made correctly, if the external infusion pump is still in the capped rental period, drug(s) administered with the external infusion pump should be billed on the same claim as the pump.

CMN and DIF Instructions - Oxygen (Form CMS 484.3) and External Infusion Pumps (Form 10125)

CMS-1744-IFC stated that CMS would exercise enforcement discretion for clinical indications of coverage for the oxygen NCDs and LCDs during the PHE. Numerous fields on the Certificate of Medical Necessity (CMN) for oxygen are directly related to the clinical indications. After carefully reviewing the CMN and the related claims processing issues that would result from having missing information or having clinical information for which the form was intended, CMS has determined that requirements for a CMN for oxygen claims will not be enforced during the COVID-19 PHE. The same concerns that apply to the oxygen CMN also apply to the External Infusion Pump (EIPs) DIF; therefore, the requirements for a DIF for EIP claims will also not be enforced. Suppliers should follow the guidance in the Claim Instruction section above for oxygen and EIP claims.

There is no requirement to submit a CMN or DIF during the PHE for oxygen or EIPs. If CMNs or DIFs are not submitted, suppliers must use the CR modifier and COVID-19 narrative for any oxygen or EIP claims submitted during the COVID PHE. CMNs or DIFs are not required regardless of the diagnosis or etiology necessitating the use of the CMN-related or DIF-related DME. Use of the CR modifier and COVID-19 narrative simply reflects that the claim was submitted during the COVID PHE.

ICD-10 Codes

For claims associated with the treatment of COVID-19-related illness, suppliers and providers should use the following ICD-10 codes on all claims for DMEPOS:

For claims with dates of service on or after April 1, 2020, suppliers and providers should enter ICD-10 code U07.1 (COVID-19) on the claim.

For claims associated with non-COVID-19-related illness, suppliers and providers should indicate on the claim the appropriate ICD-10 code, coded to the highest level of specificity.

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