Important Patient Information

1. A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements.
2. A supplier must provide complete and accurate information on the DMEPOS supplier application. Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days.
3. A supplier must have an authorized individual (whose signature is binding) sign the enrollment application for billing privileges.
4. A supplier must fill orders from its own inventory or contract with other companies for the purchase of items necessary to fill orders. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or any other Federal procurement or non-procurement programs.
5. A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment and of the purchase option for capped rental equipment.
6. A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law and repair or replace free of charge Medicare covered items that are under warranty.
7. A supplier must maintain a physical facility on an appropriate site and must maintain a visible sign with posted hours of operation. The location must be accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.
8. A supplier must permit CMS or its agents to conduct on-site inspections to ascertain the supplier’s compliance with these standards.
9. A supplier must maintain a primary business telephone listed under the name of the business in a local directory or a toll-free number available through directory assistance. The exclusive use of a beeper, answering machine, answering service, or cell phone during posted business hours is prohibited.
10. A supplier must have comprehensive liability insurance in the amount of at least $300,000 that covers both the supplier’s place of business and all customers and employees of the supplier. If the supplier manufactures its own items, this insurance must also cover product liability and completed operations.
11. A supplier is prohibited from direct solicitation to Medicare beneficiaries. For complete details on this prohibition, see 42 CFR § 424.57 (11).
12. A supplier is responsible for the delivery of and must instruct beneficiaries on the use of Medicare covered items and maintain proof of delivery and beneficiary instruction.
13. A supplier must answer questions and respond to complaints of beneficiaries and maintain documentation of such contacts.
14. A supplier must maintain and replace at no charge or repair cost either directly or through a service contract with another company any Medicare-covered items it has rented to beneficiaries.
15. A supplier must accept returns 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) from beneficiaries.
16. A supplier must disclose these standards to each beneficiary it supplies a Medicare-covered item.
17. A supplier must disclose any person having ownership, financial, or control interest in the supplier.
18. A supplier must not convey or reassign a supplier number; i.e., the supplier may not sell or allow another entity to use its Medicare billing number.
19. A supplier must have a complaint resolution protocol established to address beneficiary complaints that relate to these standards. A record of these complaints must be maintained at the physical facility.
20. Complaint records must include: the name, address, telephone number, and health insurance claim number of the beneficiary, a summary of the complaint, and any actions taken to resolve it.
21. A supplier must agree to furnish CMS any information required by the Medicare statute and regulations.
22. All suppliers must be accredited by a CMS-approved accreditation organization to receive and retain a supplier billing number. The accreditation must indicate the specific products and services for which the supplier is accredited in order for the supplier to receive payment for those specific products and services (except for certain exempt pharmaceuticals).
23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.
24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited to bill Medicare.
25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.
26. A supplier must meet the surety bond requirements specified in 42 CFR § 424.57 (d).
27. A supplier must obtain oxygen from a state-licensed oxygen supplier.
28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 CFR § 424.516(f).
29. A supplier is prohibited from sharing a practice location with other Medicare providers and suppliers.
30. A supplier must remain open to the public for a minimum of 30 hours per week except physicians (as defined in section 1848(j) (3) of the Act) or physical and occupational therapists or a DMEPOS supplier working with custom made orthotics and prosthetics.

DMEPOS suppliers have the option to disclose the following statement to satisfy the requirement outlined in Supplier Standard 16 in lieu of providing a copy of the standards to the beneficiary.

The products and/or services provided to you by (supplier legal business name or DBA) are subject to the supplier standards contained in the Federal regulations shown at 42 Code of Federal Regulations Section 424.57(c). These standards concern business professional and operational matters (e.g. honoring warranties and hours of operation). The full text of these standards can be obtained at http://www.ecfr.gov. Upon request we will furnish you a written copy of the standards.

Enovis Notice of Privacy Practices

This notice describes how medical information about you may be used and disclosed and how you can get access to this information. Please review it carefully.

DJO, LLC, Surgi-Care, Inc., Ortho Pros Express, Inc., and other direct or indirect DMEPOS supplier subsidiaries of Enovis Corporation (collectively known as “Enovis”), are committed to protecting your privacy and understand the importance of safeguarding your medical information. We are required by federal law to maintain the privacy of health information that identifies you or that could be used to identify you (known as “Protected Health Information” or “PHI”). We also are required to provide you with this Notice of Privacy Practices, which explains our legal duties and privacy practices, as well as your rights, with respect to PHI that we collect and maintain. Enovis is required by federal law to abide by this Notice. However, we reserve the right to change the privacy practices described in this Notice and make the new practices effective for all PHI that we maintain. Should we make such a change, you may obtain a revised Notice by contacting our office at Enovis, Attn: Corporate Compliance, Privacy Officer, 5919 Sea Otter Place, Suite 200, Carlsbad, CA 92010, and requesting a revised copy be sent in the mail or by accessing our website at www.enovis.com.

Uses and Disclosures of Protected Health Information

A. Routine Uses and Disclosures of Protected Health Information

We are permitted under federal law to use and disclose PHI, without your written authorization, for certain routine uses and disclosures, such as those made for treatment, payment, and the operation of our business. The following are examples of the types of routine uses and disclosures of PHI that we are permitted to make. While this list is not exhaustive, it should give you an idea of the routine uses and disclosures we are permitted to make.

• For Treatment: We will use and disclose your PHI to provide, coordinate, or manage your treatment. For example, we will disclose your PHI, as necessary, to the physician that referred you to us.
• For Payment: Your PHI will be used, as needed, to obtain payment for the health care products and/or services we provide to you. For example, we may tell your health plan about an orthosis/brace you will receive to determine whether your plan will cover the orthosis/brace.
• For Health Care Operations: We may use or disclose your PHI in order to support the business activities of Enovis. These activities include, but are not limited to, quality assessment, employee review, legal services, licensing, and conducting or arranging for other business activities.
• Treatment Alternatives: We may use or disclose your PHI or contact you to provide you with information about treatment alternatives or other health-related benefits and services that may be of interest to you.
• Sale of the Business: If we decide to sell, transfer or merge all or part of our business to or with another entity, we may share your PHI with the new owners.

B. Uses and Disclosures That May Be Made Without Your Authorization or Opportunity to Object

We may use or disclose your PHI in the following situations without your authorization or providing you the opportunity to object.

• Required by the Secretary of Health and Human Services: We may be required to disclose your PHI to the Secretary of Health and Human Services to investigate or determine our compliance with the requirements of the final rule on Standards for Privacy of Individually Identifiable Health Information.
• Required By Law: We may use or disclose your PHI to the extent that the use or disclosure is otherwise required by federal, state, or local law.
• Public Health: We may disclose your PHI for public health activities, such as disclosures to a public health authority or other government agency that is permitted by law to collect or receive the information (e.g., the Food and Drug Administration).
• Health Oversight: We may disclose PHI to a health oversight agency for activities authorized by law, such as audits, investigations, and inspections. Oversight agencies include government agencies that oversee the health care system, government benefit programs, other government regulatory programs, and civil rights laws.
• Abuse or Neglect: If you have been a victim of abuse, neglect, or domestic violence, we may disclose your PHI to a government agency authorized to receive such information. In addition, we may disclose your PHI to a public health authority that is authorized by law to receive reports of child abuse or neglect.
• Judicial and Administrative Proceedings: We may disclose your PHI in response to an order of a court or administrative tribunal (to the extent such disclosure is expressly authorized), and, in certain conditions, in response to a subpoena, discovery request, or other lawful process.
• Law Enforcement: We may disclose your PHI, so long as applicable legal requirements are met, for law enforcement purposes, such as providing information to the police about the victim of a crime.
• Coroners and Funeral Directors: We may disclose your PHI to a coroner, medical examiner, or funeral director if it is needed to perform their legally authorized duties.
• Organ Donation: If you are an organ donor, we may disclose your PHI to organ procurement organizations as necessary to facilitate organ donation or transplantation.
• Research: Under certain circumstances, we may disclose your PHI to researchers when their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your PHI.
• Serious Threat to Health or Safety: We may disclose your PHI if we believe it is necessary to prevent a serious and imminent threat to public health or safety and it is to someone we reasonably believe is able to prevent or lessen the threat.
• Specialized Government Functions: When the appropriate conditions apply, may disclose PHI for purposes related to military or national security concerns, such as for the purpose of a determination by the Department of Veterans Affairs of your eligibility for benefits.
• Workers’ Compensation: We may disclose your PHI as necessary to comply with workers’ compensation laws and other similar programs.
• Inmates: We may use or disclose your PHI if you are an inmate of a correctional facility and we created or received your PHI in the course of providing products and/or care to you.

C. Uses and Disclosures That May Be Made Either With Your Agreement or the Opportunity to Object

Unless you object, we may disclose to a member of your family, a relative, a close friend or any other person you identify, orally or in writing, your PHI that directly relates to that person’s involvement in your health care. If you are unable to agree or object to such disclosure, we may disclose such information, as necessary, if we determine that it is in your best interest to disclose such information, based on our professional judgment. We may use or disclose your PHI to notify or assist in notifying a family member, personal representative, or any other person that is responsible for your care of your location or general condition.

D. Uses and Disclosures of Protected Health Information Based Upon Your Written Authorization

• Marketing: We must obtain your written authorization to use and disclose your PHI for most marketing purposes.
• Sale of PHI: We must obtain your written authorization for any disclosure of your PHI which constitutes a sale of PHI.
• Other Uses: Other uses and disclosures of your PHI, not described above, will be made only with your written authorization. You may revoke your authorization, at any time, in writing, except to the extent that we have taken action in reliance on the authorization.

Your Rights Regarding Health Information About You

You have certain rights regarding your PHI, which are explained below. You may exercise these srights by submitting a request in writing to our Privacy Officer.

A. You have the right to inspect and copy your PHI. If you would like to see or copy your PHI that is contained in a designated record set (e.g., medical and billing records), we are required to provide you access to such PHI for inspection and copying within 30 days after receipt of your request (60 days if the information is stored off-site). We may charge you a reasonable fee to cover duplication, mailing, and other costs incurred by us in complying with your request. In addition, there are situations where we may deny your request for access to your PHI. For example, we may deny your request if we believe the disclosure will endanger your life or that of another person. Depending on the circumstances of the denial, you may have a right to have this decision reviewed.

B. You have the right to request a restriction of your PHI. This means you may ask us not to use or disclose any part of your PHI for purposes of treatment, payment, or health care operations. You may also request that any part of your PHI not be disclosed to family members or friends who may be involved in your care or for notification purposes as described in this Notice. Your request must state the specific restriction requested and to whom you want the restriction to apply. We are not required to agree to a restriction that you may request. If we agree to the requested restriction, we may not use or disclose your PHI in violation of that restriction unless it is needed to provide emergency treatment. However, we must agree not to disclose your PHI to your health plan if the disclosure is for payment or health care operations and relates to a health care item or service which you paid for in full out of pocket.

C. You have the right to request to receive confidential communications from us by alternative means or at an alternative location. We will accommodate reasonable requests. We may also condition this accommodation by asking you for information as to how payment will be handled or specification of an alternative address or other method of contact.

D. You have the right to amend your PHI. This means you may request an amendment of your PHI in our records that is contained in a designated record set (e.g., medical and billing records) for as long as we maintain the PHI. We will respond to your request within 60 days (with up to a 30-day extension, if needed). We may deny your request if, for example, we determine that your PHI is accurate and complete. If we deny your request, we will send you a written explanation and allow you to submit a written statement of disagreement.

E. You have the right to receive an accounting of certain disclosures that we have made of your PHI. You have the right to receive an accounting of certain disclosures we have made, if any, of your PHI. This right only applies to disclosures for purposes other than treatment, payment or health care operations as described in this Notice. It also excludes disclosures we may have made to you, your family members or friends involved in your care. The right to receive this information is subject to certain exceptions, restrictions and limitations. You must specify a time period, which may not be longer than 6 years and cannot include any date before April 14, 2003. You may request a shorter timeframe. You have the right to one free request within any 12-month period, but we may charge you for any additional requests in the same 12-month period. We will notify you about any such charges, and you are free to withdraw or modify your request in writing before any charges are incurred.

F. You have the right to obtain a paper copy of this notice from us.

G. You have the right to be notified if you are affected by a breach of unsecured PHI.

H. You have the right to opt out of receiving fundraising communications from us. We may contact you for fundraising purposes. You have the right to opt out of receiving these communications.

Complaints

If you believe that we have violated your privacy rights, you may file a complaint with us by notifying our Privacy Officer in writing at the following address:

ENOVIS
5919 Sea Otter Place, Suite 200
Carlsbad, CA 92010
Attn: Corporate Compliance, Privacy Officer
Email: Corporate.Compliance@enovis.com

We will not retaliate against you in any way for filing a complaint.

You may also report your complaint to the Secretary of Health and Human Services, Office of Civil Rights by calling 877-696-6775 or by sending a formal, written complaint to the address below:

U.S. Department of Health & Human Services
Office of Civil Rights
200 Independence Avenue, S.W.
Washington, D.C., 20201

This notice is effective on January 1, 2024.