Distribution Policies

1. Program Overview

The 30-Day Mask Guarantee is designed to support patient comfort, optimize clinical outcomes, and allow providers to trial mask solutions with confidence. This program applies to eligible masks dispensed through authorized channels and is intended to function as a structured clinical trial period rather than a no questions asked return.

2. Eligibility

• The guarantee applies to masks dispensed to patients within participating clinics or providers.
• The mask must be fitted and issued by a trained clinician or staff member.
• The program is limited to one guarantee claim per patient, per mask category, unless otherwise approved.

3. Trial Period

The 30-day period begins on the date the mask is dispensed to the patient. All claims must be submitted within 30 calendar days of this date. Claims submitted outside this window may not be accepted.

4. Clinical Fit and Selection Requirements

Participating providers are expected to follow a structured fitting process. This includes, at minimum:

• Assessment of patient needs such as breathing patterns, pressure requirements, facial features, and comfort preferences.
• Selection of appropriate mask type and size using available sizing tools where applicable.
• Initial education on mask use, adjustment, and care.

Claims may be denied if there is insufficient evidence that appropriate fitting and selection protocols were followed.

5. Patient Trial and Monitoring

Providers are expected to support the patient during the initial usage period. This includes:

• Review of early experience within the first several nights of use.
• Addressing issues such as leaks, discomfort, or skin irritation.
• Making reasonable adjustments, including strap fitting, cushion sizing, or comfort settings where applicable.

The intent of the guarantee is to encourage troubleshooting and optimization prior to return.

6. Data Collection and Submission

All guarantee claims must include completion of the required feedback form. This will include:

• Mask type and size dispensed.
• Summary of patient experience, including comfort and fit.
• Primary reason for return or exchange.
• Confirmation of troubleshooting steps taken.

Where available, providers are encouraged to include usage and therapy data to support continuous product improvement. Incomplete submissions may result in delayed processing or denial of the claim.

7. Return and Exchange Criteria

Masks may be returned or exchanged under this program for reasons including, but not limited to:

• Persistent leak issues that cannot be resolved through adjustment.
• Patient discomfort or intolerance.
• Sizing or fit concerns.
• Skin irritation or pressure related issues.

Yuwell/HME Distribution reserves the right to request the return of any Mask Guarantee claim mask. Returned products must comply with hygiene and safety guidelines and may be subject to inspection.

8. Program Limitations

• The guarantee applies only to eligible products and does not extend to accessories or replacement components unless specified.
• Products returned under this program may not be resold.

9. Operational Considerations

• Providers are responsible for maintaining accurate records of mask fittings, patient education, and follow up activities.
• Timely submission of claims and supporting documentation is required for reimbursement or credit.
• The manufacturer reserves the right to audit submissions to ensure compliance with program requirements.

10. Program Intent, Integrity and Misuse

This program is intended to support appropriate clinical use, patient satisfaction, and continuous product improvement. Participation is expected to align with reasonable clinical practices and good faith use of the guarantee.

Return activity will be periodically reviewed across participating providers. Clinics with return rates that significantly exceed program averages, or that demonstrate consistent patterns outside of expected clinical norms, may be identified as outliers and subject to further review.

In situations where misuse, overutilization, or non-standard application of the program is identified, the manufacturer reserves the right to take appropriate action. This may include, but is not limited to, limiting the number of eligible returns, requiring additional documentation, modifying program eligibility, or suspending or removing participation in the program.

The manufacturer retains sole discretion in determining what constitutes excessive or patterned returns, considering factors such as volume, product mix, patient population, and documented clinical practices.

12. Modifications

The manufacturer reserves the right to modify or discontinue the program at any time. Updates will be communicated to participating providers in advance where possible.