Philips recall: Noridian provides guidance

WASHINGTON – Noridian Healthcare Solutions has posted FAQs for Jurisdictions A and D on the impact of the Philips recall on coverage and billing for Medicare beneficiaries, AAHomecare has reported. 

Among the questions in the FAQ: 

• How should DME suppliers address the situation with Medicare beneficiaries who are in the first 90-days adherence metric in the PAP and RAD Local Coverage Determinations (LCDs)? 
• Response: During the Public Health Emergency (PHE), CMS has instructed the DME MACs to not enforce clinical indications of coverage for the types of respiratory devices involved in the voluntary recall. Services must still be reasonable and necessary. 
• Once a beneficiary gets the new replacement equipment, do they have to restart the 90-day adherence trial? Or do they just pick it up where they left off? 
• Response: The beneficiary has the option to restart the 90-day adherence trial or they may resume meeting the adherence metric where they left off. The supplier should notate their records if the recall impacted the beneficiary’s adherence timeline. 
• What should DME suppliers do if a beneficiary wishes to return their Philips Respironics product that is impacted by the voluntary recall? 
• Response: Suppliers are reminded that the CMS Supplier Standards (42 CFR 424.57) apply to this situation, specifically Standard #15 – [Suppliers] Must accept returns from beneficiaries of substandard (less than full quality for the particular item or unsuitable items, inappropriate for the beneficiary at the time it was fitted and rented or sold). 
• If beneficiaries choose not to continue PAP, RAD or ventilator use until their equipment has been replaced, how does that affect the supplier as far as Medicare standards? Are they required to provide temporary replacement equipment? 
• Response: If a DME supplier continues to bill for PAP, RAD, or ventilators, they are required to provide the equipment for which they’re billing. 
• If a beneficiary chooses to wait for new equipment, does the DME supplier stop billing for rental? Is it a break in service that they simply pickup when the new equipment is provided? 
• Response: Yes, the DME supplier must stop billing, and resumption of billing would occur with the next unbilled rental month. There is no break in service because the requirements for a new capped rental billing are not met. CMS defines a 60-plus consecutive day interruption as a period including two full rental months plus whatever days are remaining in the rental month during which the need ends. In addition to the timing requirement, there must also be a change in medical necessity, defined as a resolution of the condition that created the first period of medical necessity and the subsequent development of a second event that creates a new period of medical necessity. In the voluntary recall situation, there is no change in medical necessity as a result of the recall; therefore, there is no break in service and no new capped rental. 

AAHomecare said on Friday that it planned to provide additional perspective on the guidance this week. 

Philips announced the recall of certain Bi-Level CPAP, CPAP and mechanical ventilator devices on June 14 to address identified potential health risks related to the polyester-based polyurethan sound abatement foam component in these devices.