RETIRED - Frequently Asked Questions - Philips Respironics Respiratory Products Recall - Revised - JA DME

Joint DME MAC Article
Posted July 16, 2021

On June 14, 2021 Philips Respironics announced the voluntary, global recall of an estimated 4 million continuous positive airway pressure (CPAP) devices, bilevel respiratory assist devices (RADs), and ventilators. The situation is quite fluid; consequently, impacted beneficiaries and DME suppliers should check the Philips Respironics website for the most up-to-date information.

Based on questions received by the DME MACs, we have developed the following FAQs:

1. What should DME suppliers and beneficiaries do if they have devices impacted by the voluntary recall?
   Response:
   • For beneficiaries using bilevel RAD and CPAP devices, Philips Respironics recommends discontinuing use of the device and working with the physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.
   • For beneficiaries using life-sustaining mechanical ventilator devices, Philips Respironics recommends not stopping or altering prescribed therapy until talking to the treating practitioner. Philips notes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. If the treating practitioner determines that use of a life-sustaining ventilator should continue, use of an inline bacterial filter is recommended. Beneficiaries should consult with the device's Instructions for Use for guidance on installation of the inline filter.
2. What actions should DME suppliers take, based on the recall information?
   Response: Suppliers of impacted devices should work with their Philips Respironics sales representative to obtain replacement PAP, RAD, or ventilator products for their Medicare beneficiaries. Philips Respironics has a plan in place for DME suppliers to register and receive additional information on the Philips Respironics website.
3. 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. Additional information on the PHE waivers and flexibilities is available in the June 29, 2020 article on the DME MAC websites titled "CMS Issues Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) – COVID-19 Public Health Emergency – Revised."
4. 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.
5. 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 for devices still under the capped rental period 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).
6. 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.
7. 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.
8. Is Medicare Customer Service (1-800-Medicare) aware of the voluntary recall?
   Response: Yes, the DME MACs have made CMS aware of the recall.
9. What impact does the voluntary recall have on New to Medicare patients? Specifically, if the supplier inspects beneficiary-owned equipment that is affected by the recall, is the supplier under any obligation to replace that machine?
   Response: According to the information published by Philips Respironics, beneficiaries are instructed to contact their DME supplier and their treating practitioner. DME suppliers are instructed to work with Philips Respironics directly. With respect to the supplier's obligation to replace the equipment, it depends on who originally paid for the device:
   • If the equipment is beneficiary-owned and the device was paid for by a non-Medicare insurer, the supplier is under no obligation to repair or replace the equipment;
   • If the equipment is beneficiary-owned and the device was paid for by Medicare, the original supplier of the CPAP device must provide a replacement device to the beneficiary at no cost, based on regulations at 42 CFR414.210(e)(4) which states:
     (4) Supplier replacement of beneficiary-owned equipment based on accumulated repair costs. A supplier that transfers title to a capped rental item to a beneficiary in accordance with § 414.229(f)(2) is responsible for furnishing replacement equipment at no cost to the beneficiary or to the Medicare program if the carrier determines that the item furnished by the supplier will not last for the entire reasonable useful lifetime established for the equipment in accordance with § 414.210(f)(1). In making this determination, the carrier may consider whether the accumulated costs of repair exceed 60 percent of the cost to replace the item.
10. What guidance, if any, are the FDA or clinical societies providing to beneficiaries?
    Response: On June 30, 2021 the U.S. Food & Drug Administration (FDA) alerted users of Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The American Academy of Sleep Medicine (AASM) published information on the AASM web site for beneficiaries and treating practitioners. In addition, the American Thoracic Society (ATS) published
    "Recommendations for Sleep and Critical Care Medicine Professionals Regarding Philips Recall Notice."
11. If a beneficiary with a patient-owned recalled device refuses warranty support or chooses to purchase a replacement device out-of-pocket, will the DME MACs honor an executed ABN that holds the beneficiary responsible for replacement equipment (outside of warranty) as same or similar to equipment previously purchased by Medicare?
    Response: The DME MACs will honor a properly executed ABN. The voluntary recall does not modify any of the CMS Reasonable Useful Lifetime (RUL) regulations at 42 CFR 414.210.
12. Will we be able to bill Medicare using HCPCS K0462 if we supply a customer with an alternate unit to use while they are waiting for Philips to repair/replace the unit that is patient owned and it could take several months to get a repair/replacement? Can the DME MACs allow K0462 to be billed for more than one month given the expectation that the repairs will take several months based on the volume?
    Response: Billing a rental unit under HCPCS code K0462 (TEMPORARY REPLACEMENT FOR PATIENT OWNED EQUIPMENT BEING REPAIRED, ANY TYPE) is allowed; however, Suppliers should make every effort to minimize the time that a rental unit is utilized while awaiting repair. This may include working with the treating practitioner to substitute a different brand/model not impacted by the voluntary recall.
    For billing of code K0462, the supplier should enter "Phillips Recall" with the brand/model number impacted and date purchased, along with the manufacturers name, brand/model number of the replacement device in loop 2300 (claim note) and/ or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI X12N, version 5010A1 professional electronic claim format or in Item 19 of the paper claim form.

Philips Respironics notes that they are treating this matter with the highest possible seriousness and are dedicating significant time and resources to address this issue. Due to the evolving nature of the voluntary recall and the potential remedies for the situation, the DME MACs strongly encourage DME suppliers and beneficiaries to consult the Philips Respironics website for the most up-to-date information.

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