In response to the declaration of a Public Health Emergency (“PHE”) in the spring of 2020, CMS issued two interim final rules (“Interim Rules”) that waive or relax certain requirements for suppliers and physicians in conjunction with the documentation required for DMEPOS.

Proof of Delivery Signature
For claims with a date of service during the PHE, CMS has waived the patient signature requirement for proof of delivery when items are delivered directly to the patient by the supplier. Nevertheless, the supplier should document the correct delivery date and that a signature could not be obtained because of COVID-19.

Face-to-Face/In-Person Requirements
The Interim Rules waive the requirements in the NCDs/LCDs and related articles for a face-to-face or in-person encounter for evaluations, assessments, certifications, or other implied face-to-face services for dates of service on or after March 1, 2020, for the duration of the PHE. Other requirements, such as the Supplier Standards, identified in 42 CFR § 424.57 and the related Quality Standards Appendices, continue to apply during the PHE.

Clinical Indications for Respiratory Coverage
For all claims with a date of service on or after March 1, 2020, and through the duration of the PHE, CMS has waived the enforcement of clinical indications for coverage under certain NCDs and LCDs. This waiver includes the following equipment for respiratory conditions:

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

Under the Interim Rules, the treating practitioner and supplier must still (i) provide a Standard Written Order for all items; (ii) ensure the items/services are reasonable and necessary; (iii) document the medical necessity for all items/services; (iv) document that items/services were actually provided; and (v) make documentation available upon request.

Use of CR Modifier and Claim Instructions
For all claims affected by the PHE, the DME MACs have instructed the supplier to add the CR modifier (catastrophe/disaster related) to the claim and enter “COVID-19” in the NTE 2400 (line note) or NTE 2300 (claim note) segments of the ANSI X12 format or field 390-BF of the NCPDP format. These abbreviations may also be used in Item 19 of the CMS-1500 claim form.

Additionally, the DME MACs have instructed suppliers to continue to bill the KX and/or CG modifiers for the following respiratory equipment LCDs so long as a Standard Written Order is on file for the item and the medical record supports that the item is reasonable and necessary: (i) Oral Appliances for the Treatment of Obstructive Sleep Apnea (L33611); (ii) Nebulizers (L33370); (iii) Oxygen and Oxygen Equipment (L33797); (iv) High Frequency Chest Wall Oscillation (L33785); (v) Positive Airway Pressure Devices for the Treatment of Obstructive Sleep Apnea (L33718); (vi) Mechanical In-exsufflation Devices (L33795); and (vii) Respiratory Assist Devices (L33800).

Conclusion
While CMS and the DME MACs have implemented relaxed requirements during the PHE, the enforcement discretion will only apply for the duration of the PHE. The DME MACs have stated that they will return to enforcement of the clinical and documentation requirements at the conclusion of the PHE.

Cara C. Bachenheimer, JD, is an attorney with the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas, where she heads up the firm’s Government Affairs Practice. Ms. Bachenheimer’s practice focuses on federal lobbying activities with Congress, the Administration, and federal regulatory agencies, such as CMS, FDA, IRS, and FAA. She can be reached at (806) 345-6321 or cbachenheimer@bf-law.com.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or jbaird@bf-law.com.