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DMEPOS QUALITY STANDARDS

Note: We revised this product with the following content updates:
  • No substantive changes

Introduction

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must meet the Centers for Medicare & Medicaid Services (CMS) DMEPOS Quality Standards under the Medicare Modernization Act of 2003 (MMA).

Face-to-Face Requirement

A physician must document when they or a physician assistant, nurse practitioner, or clinical nurse specialist had a face-to-face encounter with a Medicare patient in the 6 months before the written order for certain DME items. For more information on the face-to-face encounter requirement, refer to MLN Matters® Article MM8304.

DMEPOS suppliers must comply with the DMEPOS Quality Standards and become accredited to get or keep Medicare billing privileges, unless exempted. Understanding the DMEPOS Quality Standards and involving all staff in the process will help you meet them and get accreditation.

This tool outlines the standards, explains specific requirements for some DMEPOS items, and has resources for more information.

 

The DMEPOS Quality Standards have two sections and three appendices:

  • Section I: Supplier Business Service Requirements focuses on administration, financial management, human resources management, consumer services, performance management, product safety, and information management
  • Section II: Supplier Product-Specific Service Requirements focuses on intake and assessment, delivery and set-up, training/instruction, and follow-up
  • Appendices describe requirements for specific types of DMEPOS items and services:
    • Appendix A: Respiratory Equipment, Supplies, and Services
    • Appendix B: Manual Wheelchairs, Power Mobility Devices (PMDs), and Complex Rehabilitative Wheelchairs and Assistive Technology
    • Appendix C: Custom-Fabricated and Custom-Fitted Orthoses, Prosthetic Devices, External Breast Prostheses, Therapeutic Shoes, Inserts, Accessories, and Supplies; and Custom-Made Somatic, Ocular, and Facial Prostheses

Want More Information?

We’ve summarized the DMEPOS Quality Standards requirements for DMEPOS suppliers. For more information on a topic, click the “More information…” link. The glossary in Appendix C also expands. When you see dotted underlined words, hover over them for more information.

Tip:

Tips additional information about dotted underlined words.

Section I: Supplier Business Service Requirements

A. Administration

 

1. The supplier must have one or more individuals who perform leadership functions with the authority, responsibility, and accountability to direct the organization and its key activities and operations.

  • The term “leadership” does not mean a formal group or committee. As long as essential leadership functions happen, the supplier can use different ways to meet this requirement. An owner can lead an owner-operated business, like a physician’s office. The supplier may use any form of organization, like a partnership, sole proprietorship, or corporation.
  • Depending on the organization’s structure, examples of leadership positions may include the owners, a governing body, the Chief Executive Officer (CEO), and other individuals responsible for managing organizational services.

Tip:

One person or several can meet leadership requirements (for example, the owner, governing body, or CEO). The leadership confirms compliance with standards, laws, and regulations and is responsible for all business operations. The leadership relays all rules, policies, and procedures to the staff and contractors. An organizational chart should show the leadership has the legal authority to make all decisions and is accountable for those decisions.

2. The supplier must manage their business to get and supply appropriate quality patient equipment, items, and services.

FDA Reporting Requirements

For more information, refer to the FDA reporting requirements webpage.

3. The supplier must have a physical location and display all licenses, certificates, and operating permits in an area available to customers and patients. Upon request, the supplier must give copies to government officials or their authorized agents.

4. The supplier must offer only DMEPOS and other items that meet applicable FDA regulations and medical device effectiveness and safety standards. The manufacturer must give the supplier copies of the features, warranties, and instructions for each type of item not custom fabricated.

5. The supplier must comply with all Medicare statutes, regulations (including the disclosure of ownership and control information requirements at 42 Code of Federal Regulations [CFR] § 420.201–420.206), manuals, program instructions, and contractor policies and articles.

6. The supplier’s business practices must prevent and control fraud, waste, and abuse by:

  • Using procedures and conduct that ensure the organization’s compliance with applicable laws and regulations
  • Assigning one or more company leaders to address compliance issues

Create a Compliance Program

Establish business practices ensuring compliance with laws and regulations. Choose one person with the knowledge, skills, and education to manage compliance issues and be accountable for compliance in this position (typically a risk management or compliance officer).

For help developing a compliance plan, refer to the OIG Compliance Program Guidance for DMEPOS.

 

B. Financial Management

1. The supplier must use financial management practices that ensure accurate accounting and billing. You must keep accurate, complete, current financial records and reflect cash- or accrual-based accounting practices.

Tip:

  • Account for any Advance Beneficiary Notices of Non-coverage (ABNs) issued for upgrades
  • Develop a method for tracking actual revenues and expenses
  • Develop an operating budget
  • Practice proper billing practices, including:
    • Do not bill before you get the prescription
    • Use correct modifiers and codes
  • Produce periodic financial statements

2. The supplier must keep accounts that link equipment and item(s) to the patient and manage revenues and expenses regularly, related to patient services, including the following:

  • Link charges to patient equipment, supplies, and services with bills, receipts, and deposits
  • Plan to meet patient needs and maintain business operations by using a budget appropriate to the business’ size and scope of services
  • Use a system to track actual revenues and expenses

C. Human Resources Management

1. The supplier must have:

  • Policies and issue job descriptions stating personnel qualifications, training, certifications/licensures where applicable, experience, and continuing education requirements for specialized equipment, items, and services they offer patients
  • Give copies of these policies, job descriptions, and certifications/licensures (where applicable) when requested to accreditation organizations and government officials or their authorized agents
  • Verify and keep license, registration, certification, and competency copies for personnel who deliver patient services

2. Competent technical personnel to deliver and set up equipment, item(s), and service(s), and train patients and caregivers.

3. Professional personnel must act within their scope of practice as required by State standards where the professional is licensed, certified, or registered.

 

Human Resources Management

  • Conduct employee and contractor performance evaluations
  • Document compliance with all applicable health requirements (for example, tuberculosis [TB], hepatitis B virus [HBV], or drug screening State law requires)
  • Document contractor compliance and accreditation for contractual relationships
  • Include job description educational requirements
  • Instruct employees on duties and Occupational Safety & Health Administration (OSHA) requirements
  • Perform State-required background checks
  • Verify all employees and contractors can participate in Federal health care programs at the System for Award Management (SAM) website
  • Verify all professional licenses and certificates through the appropriate website, including Commercial Driver’s Licenses (CDLs) for van drivers, if necessary

D. Consumer Services

1. When supplying equipment, items, and services to patients and caregivers, the supplier must:

  • Give clear, written or pictorial, and oral instructions about using, maintaining, infection control practices for, and potential hazards of, equipment and/or items as appropriate
  • Give information about expected time frames for item delivery
  • Verify equipment, items, and services delivery
  • Document the make and model number or other identifier of any non-custom equipment and/or items delivered in the patient’s record
  • Give essential contact information for renting and purchasing equipment and patient and caregiver options, when applicable
  • Give information and telephone number(s) for customer service, regular business hours, after-hours access, equipment and/or item repair, and emergency coverage
 

2. If the supplier cannot or will not offer the equipment, items, or services prescribed for a patient, the supplier must notify the prescribing physician or other health care team members within 5 calendar days (for these standards, “prescribing physician” includes other practitioners who can prescribe DMEPOS under Medicare laws and regulations).

Customer Service

Patients must be able to contact their supplier 24 hours a day, 7 days a week.

3. Within 5 calendar days of getting a patient complaint, the supplier must notify the patient they have the complaint and are investigating. The supplier can notify the patient orally or by telephone, email, fax, or letter. Within 14 calendar days, the supplier must notify the patient in writing of the investigation results. The supplier must keep complaints documentation, investigation copies, and patient responses.

E. Performance Management

1. The supplier must use a performance management plan that measures consumer services, billing practices, and adverse events outcomes. The data collection may target services with potential to cause harm or injury; occur frequently (creating a greater than expected number of adjustments, repairs, or replacements); or require significant training to assure safe use of equipment and/or items benefit.

Tip:

When designing outcomes measures, target:

  • Adverse events
  • Patient service satisfaction
  • Billing practices
  • Consumer services
  • Items or services that are:
    • High risk (for example, complex rehabilitation or ventilators)
    • High volume (for example, diabetic supplies)
    • Problem-prone (for example, PMDs)
  • Timeliness of response

2. At a minimum, each supplier must measure:

  • Patient products and services satisfaction and complaints
  • Response timeliness to patient questions, problems, and concerns
  • Supplier’s business practices impact on patient access to equipment, items, services, and information
  • Billing and coding error frequency (for example, number of Medicare claims denied, errors the supplier finds in their own records after claims denial notification)
  • Patient adverse events due to inadequate services or malfunctioning equipment and/or items (for example, injuries, accidents, signs and symptoms of infection, and hospitalizations). Follow-up with the prescribing physician, other health care team members, the patient, and caregivers who identify it.

3. The supplier must get input from employees, customers, and referral sources when assessing operation and service quality.

Tip:

Get input from all customers, including referral sources.

 

F. Product Safety

The supplier must:

  • Have a program that promotes safe equipment and item use and minimizes staff and patient safety risks, infections, and hazards
  • Use and maintain a plan for identifying, monitoring, and reporting equipment and item failure, repair, and preventive maintenance (where indicated)
  • Investigate any DMEPOS incident, injury, or infection related to use when you become aware of it. The supplier must begin the investigation within 24 hours after they become aware of an incident, injury, or infection resulting in a patient’s hospitalization or death. If the incident, injury, or infection does not result in hospitalization or death, the supplier must begin investigating within 72 hours after notification. The investigation must include all necessary information, pertinent conclusions about what happened, and if you need to change systems or processes. Consider possible links between the equipment, items, and services and the adverse event.

    Tip:

    When investigating an incident, injury, or infection, check the OSHA requirements for injury reporting under the Medical Device Reporting regulation.

  • Use a contingency plan that enables response to emergencies and disasters or to arrange for alternative suppliers if the supplier cannot service their customers

    Tip:

    Make sure the contingency plan is specific for the geographical area and considers:

    • Communications
    • Data storage
    • Patient care/services
    • Risk assessment
  • Verify, authenticate, and document the following before delivering products to an end-user:
    • The product is not compromised or damaged, counterfeit, suspected counterfeit, and not acquired by fraud or deceit
    • The product is not misbranded and appropriately labeled for its intended distribution channels

Equipment Maintenance Plan

The maintenance plan should encompass all inventory, including discontinued, obsolete, or supplies not patient ready. Separate the clean and dirty supplies, and log completed repairs.

Keep a tracking system or log of all your equipment by model, serial, or other identifying number to ensure recalled equipment location and identify theft instances. Show evidence you maintain all equipment. Log refrigerated equipment calibration and temperature checks.

G. Information Management

The supplier must keep accurate, pertinent, accessible, confidential, and secure patient records required by the HIPAA privacy and security standards and other applicable State standards.

Back up Your Information Daily

Design information management systems considering:

  • Back-up methods
  • Multiple media formats (for example, electronic, fax, and paper)
  • Natural disasters
  • Marketing materials suitability (that is, translated into languages appropriate for the target population and not misleading)

Evaluate the information management system effectiveness when in place.

Section II: Supplier Product-Specific Service Requirements

All Medicare-covered DMEPOS must have a medical purpose and may require the prescribing physician to coordinate clinical services with other health care professionals (for example, orthotists, prosthetists, occupational, physical, and respiratory therapists, and pedorthists).

DMEPOS suppliers must meet the supplier product-specific service requirements in this section and follow the requirements in Appendices A through C, as they apply to their business.

A. Intake & Assessment

 

The supplier must:

  • Communicate with the prescribing physician to confirm the order and recommend necessary changes, refinements, or additional evaluations to the prescribed equipment, items, and/or services
  • Review the patient’s record as appropriate and work with the prescribing physician to include important information about the patient’s condition(s) affecting the DMEPOS and related services, or to the actual equipment, items, and services
  • Keep the patient’s prescribing physician’s unaltered DMEPOS prescription, CMNs, and important documentation in the patient’s record

The patient’s record must contain information that helps determine medical necessity, including:

  • CMNs
  • Face-to-face encounter records
  • Physical assessments
  • Prescriptions
  • Physician and patient telephone communication logs

B. Delivery & Set-Up

The supplier must:

  • Deliver and set up all equipment and items in a timely manner as agreed to by the patient, caregiver, supplier, and prescribing physician or coordinate set-up with another supplier
  • Deliver all equipment and items and make further applicable adjustments
  • Deliver loaner equipment equal to the original equipment during a repair period or arrange for it (except for orthotics and prosthetics)
  • Ensure all equipment and items delivered to the patient meet the prescribing physician’s order and the supplier is aware of identified patient needs, risks, and limitations

Deliver the equipment in the time scheduled. The delivery person must be knowledgeable about the equipment.

 

C. Patient and Caregiver Training/Instruction

Give the patient and caregiver written equipment instructions. Change the instructions according to the patient and caregiver ability, needs, learning preferences, and primary language. Document you delivered the instructions and the patient and caregiver understood them. Make sure the patient and caregiver know how to safely use the equipment.

1. As applicable, the supplier must:

  • Deliver or coordinate appropriate information about set-up, features, routine use, troubleshooting, cleaning, infection control practices, and all equipment and items maintenance, including how to prepare enteral/parenteral nutrients
  • Give infection control issues information and/or instructions about all equipment and items
  • For initial equipment and/or items delivered by mail order, verify and document the patient’s record that you trained the patient and caregiver and gave written instructions on how to use the equipment and items
  • Ensure the patient and caregivers can use all equipment and items safely and effectively in their anticipated settings

2. The patient’s and caregivers’ training must correspond with the equipment and items risks, complexity, and manufacturer’s instructions and/or specifications. The supplier must change training and instructional materials and approaches according to the patient and caregiver needs, abilities, learning preferences, and language.

D. Follow-Up

The supplier must offer patient and caregiver follow-up services, consistent with the equipment, items, and services given, and prescribing physician or other health care team member recommendations.

Patient Record

Document all training and communication in the patient’s record, including the date, time, and person giving the service’s signature.

 

Appendix A: Respiratory Equipment, Supplies, and Services

1. Respiratory services described below include offering home medical equipment and supplies that need technical and professional services.

2. The supplier must offer respiratory services 24 hours a day, 7 days a week as needed by the patient and caregivers.

3. Home medical equipment and supplies covered in this appendix include:

  • Continuous Positive Airway Pressure (CPAP) devices
  • Home invasive mechanical ventilators
  • Intermittent Positive Pressure Breathing (IPPB) devices
  • Nebulizers
  • Oxygen concentrators, reservoirs, high-pressure cylinders, oxygen accessories and supplies, and oxygen conserving devices
  • Respiratory Assist Devices (RADs)

A. Intake & Assessment

All Section II.A. Intake & Assessment requirements.

B. Delivery & Set-Up

All Section II.B. Delivery & Set-Up requirements, plus compliance with the current version of the American Association for Respiratory Care Clinical Practice Guidelines listed below:

  • Intermittent Positive Pressure Breathing
  • Long-Term Invasive Mechanical Ventilation in the Home
  • Oxygen Therapy in the Home or Alternate Site Health Care Facility

C. Patient and Caregiver Training/Instruction

All Section II.C. Patient and Caregivers Training/Instructions requirements, plus patient and caregiver training consistent with the current version of the American Association for Respiratory Care Clinical Practice Guidelines listed below:

 
  • Intermittent Positive Pressure Breathing
  • Long-Term Invasive Mechanical Ventilation in the Home
  • Oxygen Therapy in the Home or Alternate Site Health Care Facility
  • Supplying Patient and Caregiver Training
  • Endotracheal Suctioning of Mechanically Ventilated Patients With Artificial Airways

D. Follow-Up

All Section II.D. Follow-Up requirements.

Appendix B: Manual Wheelchairs, PMDs, and Complex Rehabilitative Wheelchairs and Assistive Technology

Manual wheelchairs include standard recliners; heavy-duty wheelchairs, standard lightweight wheelchairs, hemi wheelchairs; armrests, leg rests, or footplates; anti-tipping devices; and other Medicare-approved accessories.

Power Mobility Devices (PMDs) include power wheelchairs and Power Operated Vehicles (POVs) and accessories.

Group 2 is complex rehabilitative power wheelchairs with power options, Group 3 power wheelchairs, and manual wheelchairs that accommodate rehabilitative accessories and features (for example, tilt in space).

Manual Wheelchairs, PMDs, and Complex Rehabilitative Wheelchairs and Assistive Technology Requirements
FunctionManual Wheelchairs, PMDs, and Complex Rehabilitative Wheelchairs and Assistive Technology* Requirements
Intake & AssessmentAll Section II.A. Intake & Assessment requirements, plus the supplier must verify they evaluated and documented seating, positioning, and specialty assistive technology in the patient’s record.
Delivery & Set-UpAll Section II.B. Delivery & Setup requirements
Patient and Caregiver Training/InstructionAll Section II.C. Training/Instruction for the Patient and any Caregivers requirements
Follow-UpAll Section II.D. Follow-Up requirements

*Additional Complex Rehabilitative Wheelchairs and Assistive Technology Requirements

All requirements in the table above, plus:

1. Employ at least one certified Rehabilitative Technology Supplier (RTS) per location

2. Employ at least one trained tech per location

3. Have a repair and modification area in or near your facility

4. Give the patient an appropriate, private, safe fitting and evaluation room


The RTS:

1. Coordinates services with the prescribing physician

2. Carries out assembly and set-up procedures, and validates set-up

3. Keeps patient records information given at assessment

4. Gives the patient necessary trial and simulation equipment

Along with the requirements in the table above, the supplier must:

1. Employ at least one RTS qualified, W-2 employee per location. A qualified RTS is someone with one of the following credentials:

  • Assistive Technology Professional (ATP)
  • Certified Rehabilitative Technology Supplier (CRTS)

2. The RTS must have at least one or more trained technicians to appropriately service each location depending on the size and scope of the business. A trained technician:

  • Is able to program and repair sophisticated power wheelchairs, alternative drive controls, and power seating systems electronics
  • Completed at least 10 continuing education hours annually specific to rehabilitative technology
  • Is experienced in rehabilitative technology (for example, on-the-job training, familiarity with rehabilitative clients, products, and services)
  • Is trained by the manufacturers on the products supplied by the company

3. The RTS must:

  • Coordinate and conduct patient and prescribing physician face-to-face encounters in an appropriate setting and include input from other members of the health care team (that is, physical therapist, occupational therapist)
  • Implement assembly and equipment set-up procedures, and verify the final product meets the prescribing physician’s original product recommendation specifications
  • Record and keep all the patient assessment information
  • When necessary, supply the patient with appropriate trial and simulation equipment
 

4. If the supplier evaluates the patient in their facility, they must:

  • Maintain a repair shop and an area appropriate for product assembly and modification in or near the facility, or within easy access to another supplier
  • Give the patient private, clean, and safe fitting and evaluation rooms

Appendix C: Custom-Fabricated and Custom-Fitted Orthoses, Prosthetic Devices, External Breast Prostheses, Therapeutic Shoes, Inserts, Accessories, and Supplies; Custom-Made Somatic, Ocular, and Facial Prostheses

Suppliers must get training in a broad range of treatment options ensuring the best items for the patient’s condition.

Offering custom-fabricated or custom-fitted devices requires facility access to give follow-up treatment, including modification, adjustment, maintenance, and item repair, except off-the-shelf (OTS) items.

Individuals supplying the items identified in this appendix must have certification, and/or licensing, and specialized education, training, and fitting experience.

Glossary for this section

These terms describe the types of devices in this appendix. For more information about these terms, refer to the Medicare Benefit Policy Manual, Chapter 15 or 42 CFR § 414.402.

Custom-Fabricated A custom-fabricated item is individually made for a specific patient. No other patient can use this item. You fabricate a custom-fabricated device on clinically derived and rectified castings, tracings, measurements, and/or other body part images, such as X-rays. Fabricating may involve calculations, templates, and components. This process uses basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of uncut or unshaped sheets, bars, or other basic forms, and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, and finishing before a patient fitting.

 

Custom-Fitted Custom-fitted orthotics are prefabricated devices. You or a manufacturer may supply them as a kit that requires assembly. They all require fitting and adjustment (for example, an individual with modifying expertise must trim it, bend it, mold it [with or without heat], or otherwise modify it for a specific patient). A patient’s custom-fitted orthotic requires item modification for an individualized fit. Modifications must involve altering the item beyond simple adjustments made by bending, trimming, and/or item molding, installing add-on components, or item assembly.

Custom-Molded Shoes

  • Constructed over a positive model of the patient’s foot
  • Made from leather or other suitable, equal quality material
  • Have removable inserts you can alter or replace as the patient’s condition warrants
  • Have some form of shoe closure

Depth Shoes

  • Have a full length, heel-to-toe filler that when removed, gives a minimum of 3/16 inch of additional depth to accommodate custom-molded or customized inserts
  • Made from leather or other suitable, equal quality material
  • Have some form of shoe closure
  • Available in full and half sizes with a minimum of three widths so the sole is graded to the size and width of the upper portions of the shoes according to the American standard last sizing schedule (the U.S. numerical shoe sizing system) or its equivalent

External Breast Prostheses Prefabricated or custom-fabricated forms, bras, and sleeves

Facial Prostheses Custom-fabricated prosthetic face restoration including auricular, nasal, mid-facial, orbital (including ocular), upper facial, hemifacial, partial facial, nasal septal, and other face areas disfigured by traumatic injury, disease, and/or ablative surgery, or congenital malformation

Inserts

  • Total contact, multiple density, removable inlays.
  • Directly molded to the patient’s foot or model of the patient’s foot or directly carved from a patient-specific, rectified model
  • Made of a suitable material for the patient’s condition

Minimal Self-Adjustment 42 CFR § 414.402 defines minimal self-adjustment as an adjustment the patient, caretaker for the patient, or device supplier can perform without needing certified orthotist services (that is, an individual certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotics/Prosthetist Certification) or an individual with specialized training.

 

Molded-to-Patient-Model Molded-to-Patient-Model is defined as:

  • Creating a specific body part impression (for example, a foam box impression, a plaster or fiberglass cast) directly on the patient and using it to make a positive model of the body part when crafting the final product.
  • Computer-Aided Design–Computer-Aided Manufacturing (CAD-CAM) systems software creates a digital image of the patient’s body part. This technology includes specialized probes, digitizers, and scanners that create a computerized positive model that uses direct milling equipment to carve a positive model. You fabricate and mold the device individually over the positive patient model.
  • For therapeutic shoe inserts for diabetics, you digitally create the patient’s body part using CAD-CAM systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a patient-specific insert.

Ocular Prostheses Custom-fabricated ocular prostheses replace the globe of the eye or cover the existing eye resulting from traumatic injury, disease, and/or ablative surgery, or congenital malformation. Custom-made eye prostheses include conformers, scleral shells, and ocular prostheses that fit within the natural socket tissue and eyelids, and the custom-made ocular prosthesis component integrated into an orbital, upper facial, or hemifacial prosthesis.

Off-The-Shelf Off-the-shelf (OTS) prefabricated orthotics items need minimal self-adjustment for appropriate use and need no expertise in trimming, bending, molding, assembling, or customizing to fit the individual. Appendix C does not apply to OTS orthotics.

Orthotic Devices Orthotic devices are rigid and semi-rigid devices used for supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured body part.

Positive Patient Model

  • Molded-to-patient-model is a negative impression taken of the patient’s body member and used to make a positive model rectification.
  • CAD-CAM system uses digitizers to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the modified shape goes to a commercial milling machine that carves the rectified model.
  • The patient serves as the positive model in a direct formed model. You construct the device over the patient’s model, and then fabricate it to the patient. The supplier checks the completed custom fabrication and makes all necessary adjustments.
  • For diabetic therapeutic shoe inserts, a CAD-CAM system uses a digitizer to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the rectified model goes to a commercial milling machine that carves the patient-specific insert.

Prosthetic Devices Prosthetic devices replace all or part of an internal body organ (including contiguous tissue) or replace all or part of the permanently inoperative or malfunctioning internal body organ’s function, except dental. Medicare does not need a determination of no possibility the patient’s condition may improve in the future. The device passes the performance test when the attending physician’s opinion and patient’s medical condition are long and of indefinite duration.

 

Somatic Prostheses Custom-fabricated somatic prostheses replace areas of the human body not included under definitions of facial and ocular prosthetics but need visual and functional integration. Somatic prosthetics typically include finger, thumb, partial hand, hand, and toe disfigured by traumatic injury, disease, and/or ablative surgery, or congenital malformation.

Specialized Training Individuals specially trained to give custom fitting services to patients with a medical need for orthotics, include: a physician, a treating practitioner (a physician assistant, nurse practitioner, or clinical nurse specialist), an occupational therapist, or physical therapist who complies with all applicable Federal and State licensure and regulatory requirements.

Therapeutic Shoes and Inserts These include depth or custom-molded shoes along with inserts for individuals with diabetes.

 

A. Intake & Assessment

All Section II.A. Intake & Assessments requirements plus:

All Section II.A. Intake & Assessment requirements plus the supplier must:

  • Review the patient’s need for and use of the orthoses or prostheses (for example, reviewing the patient’s comprehensive history, pertinent medical history [including material allergies], skin condition, diagnosis, previous use of an orthoses/prostheses, results of diagnostic evaluations, patient expectations, and pre-treatment photographic documentation [when appropriate])
  • Determine the appropriate orthoses/prostheses and specifications based on the patient’s need for optimum therapeutic benefits and appropriate strength, durability, and function
  • Create a treatment plan that consistently follows the prescribing physician’s dispensing order and/or the written plan of care according to Medicare rules, and consult the physician when appropriate
  • Perform an in-person, diagnosis-specific functional clinical examination of the patient’s use and need for the orthoses/prostheses (for example, sensory function, range of motion, joint stability, skin condition [integrity, color, and temperature], presence of edema and/or wounds, vascularity, pain, manual muscle testing, compliance, cognitive ability, and medical history)
  • Determine appropriate patient outcomes (for example, reduce pain, increase comfort, enhance function and independence, give joint stability, prevent deformity, increase range of motion, address cosmetic issues, and/or promote healing) using patient and/or prescribing physician feedback as necessary
  • Communicate to the patient, caregivers, and prescribing physician the recommended treatment plan, including disclosure of potential risk, benefits, precautions, the procedures for repairing, replacing, and/or adjusting the device or items, and the estimated process time
  • Look at the structural safety of orthoses/prostheses and ensure you follow manufacturer guidelines before a face-to-face encounter for fitting/delivery (for example, patient weight limits, making sure that closures work properly and have no defects)
  • Ensure the treatment plan consistently follows the prescribing physician’s dispensing order
 

B. Delivery & Set-Up

Not applicable to this appendix.

C. Patient and Caregivers Training/Instruction

All Section II.C. Training/Instructions requirements, plus:

All Section II.C. Training/Instructions requirements, plus the supplier must:

  • Instruct the patient and/or caregiver(s) on the specific orthoses, prostheses, or therapeutic shoes/inserts as follows:
    • How to use, maintain, and clean the orthoses/prostheses (for example, wearing schedules, therapy, residual limb hygiene, other pertinent instructions)
    • How to put on and remove the orthoses/prostheses, including how to adjust closures for proper fit
    • How to inspect the skin for pressure areas, redness, irritation, skin breakdown, pain, or edema
    • How to use an appropriate interface (for example, stockinettes, socks, gloves, shoes) to help the orthoses/prostheses where appropriate
    • How to report orthoses/prostheses problems to the supplier or the prescribing physician (for example, changes in skin condition, heightened pain, increase in edema, wound concerns, changes in general health, height, weight, or orthoses/prostheses wearing intolerance as applicable)
    • How to schedule follow-up appointments as necessary
    • How to establish an appropriate “wear schedule”
  • Give necessary supplies (for example, adhesives, solvents, lubricants) to attach, maintain, and clean the items, and information about how to subsequently get necessary supplies
  • Refer the patient back to the prescribing physician as necessary for help beyond the supplier’s scope of practice

D. Follow-Up

All Section II.D. Follow-Up requirements, plus:

 

All Section II.D. Follow-Up requirements, plus the supplier must:

  • Have access to a facility with the equipment necessary to give follow-up treatment and specific orthoses/prostheses fabrication/modification
  • Review recommended maintenance with the patient and caregivers
  • Get feedback from the patient, caregivers, and prescribing physician as necessary to determine the orthoses/prostheses effectiveness (for example, wear schedule/tolerance, comfort, perceived benefits/detriments, ability to put on and remove, proper use and function, overall patient satisfaction)
  • Review and make changes to the treatment plan based on the patient’s current medical condition
  • Continue helping the patient until the orthoses/prostheses reach the best level of fit and function consistent with the treatment plan
  • Give appropriate patient follow-up treatment consistent with the types of orthoses/prostheses or therapeutic shoe/inserts given, the patient’s diagnosis, specific care delivered, and recommendations
 

Accreditation Organizations (AOs) for DMEPOS Suppliers

Supplier Standards and Quality Standards

Suppliers must comply with the current standards to get and/or keep Medicare billing privileges through the National Supplier Clearinghouse (NSC). The government publishes supplier standards in 42 CFR § 424.57(c).

CMS-approved AOs use quality standards guidelines. To get accredited, suppliers must comply with them.

The NSC and the AOs are completely independent. Compliance with one entity does not guarantee compliance with the other.

To enroll or keep Medicare billing privileges, all DMEPOS suppliers (except for exempted professionals and other specified persons) must comply with the Medicare Program’s Supplier and Quality Standards to become accredited. CMS allows AOs to accredit DMEPOS suppliers who meet Medicare Part B DMEPOS Quality Standards. The accreditation requirement applies to suppliers of:

  • Durable medical equipment
  • Medical supplies
  • Home dialysis supplies and equipment
  • Therapeutic shoes
  • Parenteral/enteral nutrition
  • Transfusion medicine and prosthetic devices
  • Prosthetics and orthotics

Suppliers can contact the AOs directly for accreditation information using this AO list.

 

Key Takeaways

  • DMEPOS suppliers must comply with the DMEPOS Quality Standards and become accredited to get or keep Medicare billing privileges, unless exempted.
  • DMEPOS Supplier Business Service Requirements focus on administration, financial management, human resources management, consumer services, performance management, product safety, and information management.
  • Supplier Product-Specific Service Requirements focus on intake and assessment, delivery and set-up, training/instruction, and follow-up.
  • The Appendices describe specific types of DMEPOS items and service requirements.
 

Resources

Applicable Regulations and Guidance

Coverage Determinations

Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) in the Medicare Coverage Database

Enrollment Standards

42 CFR § 424.57

Internet-Only Manuals (IOMs)

CMS.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs

IOM chapters with important information for DMEPOS suppliers:

  • Medicare Benefit Policy Manual
    • Chapter 15 discusses coverage of some DMEPOS items and services
  • Medicare Claims Processing Manual
    • Chapter 20 discusses DMEPOS
    • Chapter 30 discusses financial liability protections, including proper use of the Advance Beneficiary Notice of Non-coverage (ABN)
  • Medicare Program Integrity Manual
    • Chapter 5 discusses special considerations for DME medical claims review, including information on prescriptions, orders, and documentation

Occupational Safety & Health Administration (OSHA)

Regulations on infection control, fire and safety, and local fire codes

State Law

DMEPOS suppliers must comply with local business licenses, fire codes, and transportation regulations. Contact your local agency or administration for information.

U.S. Department of Transportation

Follow regulations applicable to vehicles



DMEPOS Resources

CMS Resources

DME Center

DMEPOS Accreditation

DMEPOS Competitive Bidding

DMEPOS Information for Pharmacies


DMEPOS Supplier Enrollment

Become a Medicare Provider or Supplier

Enroll as a DMEPOS Supplier

Form CMS-855S

DMEPOS Supplier Standards


U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG)

OIG.hhs.gov


DME Medicare Administrative Contractors (DME MACs) Contact Information

Go.CMS.gov/MAC-website-list


National Supplier Clearinghouse (NSC)

PalmettoGBA.com/nsc


Other Resources

American Association for Respiratory Care (AARC) Clinical Practice Guidelines

American Orthotic & Prosthetic Association (AOPA)

Claim Adjustment Reason Codes (CARCs) and Remittance Advice Remark Codes (RARCs)

Common Electronic Data Interchange (CEDI)

DME Pricing Data Analysis and Coding (PDAC)

International Classification of Diseases


Physician Self-Referral Law (Stark Law) Considerations for DMEPOS Suppliers

42 CFR § 411.355

Physician Self-Referral

“Physician Self-Referral Law” Provider Compliance Training Video



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