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DMEPOS Quality Standards

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Face-to-Face Requirement

A practitioner (physician, physician assistant, nurse practitioner, or clinical nurse specialist) must conduct and document a face-to-face encounter with the Medicare patient within 6 months before issuing a standard written order (SWO) or prescription for certain DMEPOS items. A practitioner must be sure to gather all information to show that diagnosing, treating, or managing the patient’s condition requires the item. The supplier must maintain the written order/prescription and supporting documentation provided by the treating practitioner.

A face-to-face encounter is an in-person or telehealth encounter between a practitioner and the patient. If practitioners use telehealth, they must meet the telehealth service requirements to get paid.

Master List

We require that some DMEPOS meet extra criteria before we cover them. The Master List has all DMEPOS items that may require providers or suppliers to meet more payment requirements.

DMEPOS suppliers must meet CMS DMEPOS Quality Standards under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and become accredited to get and keep Medicare billing privileges unless they’re exempt from accreditation requirements. Getting all staff to understand the quality standards will help you, as a supplier, meet these standards and get accredited.

This tool outlines the quality standards, explains certain DMEPOS item requirements, and has resources for more information.

 

The DMEPOS Quality Standards have 2 sections and 3 appendixes:

Section I: Supplier Business Services 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 setup, patient or caregiver training and instruction, and follow-up.

Appendixes describe specific DMEPOS items and services requirements:

  • Appendix A: Respiratory equipment, supplies, and services
  • Appendix B: Manual wheelchairs, power mobility devices, and complex rehabilitative wheelchairs and assistive technology
  • Appendix C: Custom-fabricated and custom-fitted orthoses; prosthetic devices; external breast prostheses; therapeutic shoes and inserts (and their accessories and supplies); and custom-made somatic, ocular, and facial prostheses

Want More Information?

We’ve summarized the DMEPOS Quality Standards. For more information on a topic, click the More Information link. The Glossary link in Appendix C also expands to define terms used. Hover your cursor over dotted underlined words to see more information.

Tip:

Additional information about dotted underlined words.

Section I: Supplier Business Services Requirements

A. Administration

  • Have 1 or more people who perform leadership functions
  • Manage your business to get and supply quality equipment and items
  • Have a physical location and display all licenses, certificates, and permits to operate
  • Supply only DMEPOS and other items that meet applicable standards
  • Comply with all Medicare laws, regulations, and guidance
  • Implement business practices that prevent fraud, waste, and abuse
 
  • Suppliers must must have 1 or more people performing leadership functions with the authority, responsibility, and accountability to direct the organization and its key activities and operations. Leadership doesn’t necessarily mean a formal group or committee; the supplier can meet this requirement in different ways. An owner can lead a business they operate, like a practitioner’s office. Suppliers may use any organizational structure, like a partnership, sole proprietorship, or corporation. Depending on the organization’s structure, leadership positions may include the owners, a governing body, the chief executive officer (CEO), and other people managing organizational services.
  • Suppliers must get and supply patients with equipment, items, and services of appropriate quality.
  • Suppliers must have a physical location and display all licenses, certificates, and operating permits in an area available to customers and patients. Upon request, suppliers must provide copies to government officials or their authorized agents.
  • Suppliers must provide only DMEPOS and other items that meet applicable FDA regulations and medical device effectiveness and safety standards. Suppliers must obtain from the manufacturer copies of the feature specifications, warranties, and instructions for each type of non-custom item.
  • Suppliers must comply with all Medicare statutes, regulations (including the disclosure of ownership and control information requirements in 42 CFR 420.201–420.206), manuals, program instructions, and contractor policies and articles. 42 CFR 411.355 discusses general exceptions to the referral prohibition that are related to both ownership or investment and compensation.
  • Suppliers must implement business practices to prevent and control fraud, waste, and abuse by:
    • Adhering to procedures and conduct that make sure the organization complies with applicable laws and regulations
    • Assigning 1 or more company leaders to address compliance issues

Tip:

One person or several (for example, the owner, governing body, or CEO) can meet leadership requirements. Leaders confirm compliance with standards, laws, and regulations and are responsible for all business operations. They relay all rules, policies, and procedures to the staff and contractors. An organizational chart should show that the leaders have the legal authority to make all decisions and are accountable for those decisions.

Create a Compliance Program

Establish business practices that make sure your organization complies with laws and regulations. Choose 1 person with the knowledge, skills, and education to manage compliance issues and be responsible for organizational compliance (typically a risk management or compliance officer).

For help with developing a compliance plan, read the Office of Inspector General’s Compliance Program Guidance for the DMEPOS Industry notice.

 

B. Financial Management

  • Use financial management practices that ensure accurate accounting and billing practices
  • Keep accounts that link equipment, items, and services to the patient

Suppliers must:

  • Use financial management practices that ensure accurate accounting and billing to patients and the Medicare program. Keep accurate, complete, and current financial records that 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:
      • Not billing before you get the prescription
      • Using correct modifiers and codes
    • Produce periodic financial statements
  • Keep accounts that link equipment, items, and services to the patient and regularly manage patient service revenues and expenses. This includes:
    • Reconciling charges to patients for equipment, supplies, and services with bills, receipts, and deposits
    • Planning to meet patient needs and maintain business operations by using a budget appropriate to the business’s size and scope of services
    • Tracking actual revenues and expenses

C. Human Resources Management

  • Have policies and job descriptions stating personnel qualifications and other requirements
  • Provide documentation to accrediting organizations and government officials or their authorized agents upon request
  • Verify and keep copies of licenses and all documentation for personnel
  • Hire competent technical personnel to provide equipment, items, and services to patients and train patients and caregivers
  • Hire professional personnel who work within their scope of practice
  • Suppliers must:
    • Issue policies and job descriptions stating personnel qualifications and required training, certifications or licensures (where applicable), experience, and continuing education for specialized equipment, items, and services they offer patients
    • Provide copies of these policies, job descriptions, and certifications or licensures (where applicable) to accreditation organizations and government officials or their authorized agents when requested
    • Verify and keep copies of licenses, registrations, certifications, and proof of competency for personnel delivering patient services
  • Technical personnel must be competent to deliver and set up equipment, items, and services and to train patients and caregivers
  • Professional personnel must be licensed, certified, or registered and act within their scope of practice as required by state standards
 

Human Resources Management

  • Evaluate and document employee and contractor performance
  • Document compliance with all applicable health requirements (for example, tuberculosis, hepatitis B virus, or drug screening as required by state law)
  • Document contractor compliance and accreditation for contractual relationships
  • Include educational requirements in job descriptions
  • Instruct employees on duties and Occupational Safety and Health Administration (OSHA) requirements
  • Perform state-required background checks for applicable personnel
  • Use the System for Award Management (SAM) website and the Office of Inspector General (OIG) website to verify that all employees and contractors can participate in federal health care programs
  • Verify all professional licenses and certificates—including commercial driver’s licenses for van drivers, if necessary—through the appropriate website

Note: Get more information on vehicle regulations at Transportation.gov. DMEPOS suppliers must comply with local business licenses, fire codes, and transportation regulations. Contact your local agency or administration for information.

D. Consumer Services

  • Provide clear instructions on using and maintaining equipment and items
  • Inform the patient of when you’ll deliver the equipment, items, or services
  • Verify the patient received the equipment, items, or services and document proof of delivery
  • Record the make, model, and serial number of the equipment or item in the patient’s record
  • Provide equipment rental contact and purchasing information
  • Provide contact information for regular and after-hours repairs or emergencies
  • Notify the prescribing practitioner within 5 days if you can’t supply the equipment, items, or services
  • Notify the patient within 5 days that you received their complaint and are investigating it
  • Notify the patient of investigation results within 14 days of the complaint
  • Keep documentation of complaints, investigations, and patient responses
  • When providing equipment, items, and services to patients and caregivers, suppliers must:
    • Provide clear (written, pictorial, or verbal) instructions about infection control practices for, and potential hazards of, equipment or items, as appropriate
    • Provide information about items’ expected delivery timeframes
    • Verify that the patient received the equipment, items, and services and maintain proof of delivery documentation in the patient’s record
    • Document in the patient’s record the make, model, and serial number or other identifier of non-custom equipment or items delivered
    • Provide essential contact information for renting and purchasing equipment and discuss patient and caregiver options, when applicable
    • Provide information and phone numbers for customer service, regular business hours, after-hours access, equipment or item repair, and emergency coverage (patients must be able to contact their supplier 24 hours a day, 7 days a week)
  • If a supplier can’t or won’t offer the prescribed equipment, items, or services, they must notify the prescribing physician or other health care team members within 5 calendar days (for these standards, prescribing physicians include other practitioners who can prescribe DMEPOS under Medicare laws and regulations).
  • Within 5 calendar days of getting a patient complaint, suppliers must notify the patient that they received the complaint and are investigating. Suppliers can notify patients in person or by phone, email, fax, or letter.
  • Within 14 calendar days, suppliers must notify patients in writing of the investigation results. Suppliers must keep documentation of all complaints received, investigations, and patient responses.

E. Performance Management

  • Measure outcomes of consumer services, billing practices, and adverse events outcomes
  • Seek input from employees, customers, and referral sources on service quality
  • Suppliers must use a performance management plan that measures outcomes of consumer services, billing practices, and adverse events. Data collection may target services that could cause harm or injury, occur frequently (creating more adjustments, repairs, or replacements than expected), or require significant training to ensure safe equipment or item use and 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, power mobility devices)
    • Response timeliness
  • At a minimum, suppliers must measure:
    • Patient product and service satisfaction and complaints.
    • Response timeliness to patient questions, problems, and concerns.
    • Impact of business practices 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 records).
    • Patient adverse events due to inadequate services or malfunctioning equipment or items (for example, injuries, accidents, infection signs and symptoms, and hospitalizations). Follow up with the prescribing practitioner, other health care team members, the patient, and caregivers who identify the events.
  • Suppliers 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

  • Have a safety program
  • Have a plan to identify, monitor, and report equipment failure
  • Investigate DMEPOS-related incidents, injuries, or infections
  • Develop a contingency plan to meet customer needs in an emergency or disaster
  • Verify and document that products are genuine and not damaged

Suppliers must:

  • Have a program that promotes safe equipment and item use and minimizes staff and patient safety risks, infections, and hazards
  • Implement and maintain a plan for identifying, monitoring, and reporting equipment and item failure, repair, and preventive maintenance
  • Investigate any use-related DMEPOS incident, injury, or infection when the supplier becomes aware of it:
    • Suppliers must initiate an investigation within 24 hours after they become aware of an incident, injury, or infection resulting in a patient’s hospitalization or death. For other occurrences, the suppliers must investigate within 72 hours after being made aware of the incident, injury, or infection.
    • Investigations must include all necessary information and all relevant conclusions about what happened and whether the supplier needs to change systems or processes. Consider possible links between the adverse event and the equipment, items, and services provided. Check the OSHA requirements for injury reporting under the Medical Device Reporting regulation.
  • Have a contingency plan to respond to emergencies and disasters or help arrange for alternative suppliers if the supplier can’t serve its customers

    Tip:

    Make sure the contingency plan is specific to the geographic area and considers:

    • Communications
    • Data storage
    • Patient care and services
    • Risk assessment
  • Before providing products to the end user, verify, authenticate, and document the following:
    • The products aren’t compromised, damaged, counterfeit, suspected counterfeit, or acquired by fraud or deceit
    • The products aren’t misbranded and are appropriately labeled for their intended distribution channels

Equipment Maintenance Plan

The maintenance plan must list all inventory, including equipment and supplies that are discontinued, obsolete, or not patient-ready. Separate the clean and dirty equipment and supplies and log completed repairs.

Track or log all equipment by model, serial, or other identifying number to ensure that recalled equipment can be located and stolen equipment can be identified. Provide evidence that you maintain all equipment. Log refrigeration equipment calibration and temperature checks.

G. Information Management

Suppliers must keep accurate, relevant, accessible, confidential, and secure patient records as required by the Health Insurance Portability and Accountability Act (HIPAA) privacy and security standards and other applicable state standards.

Accreditation & Patient Records Review

The accreditation organization will review a minimum of 5 patient records as part of the accreditation survey process. The patient records can’t include:

  • Mock files
  • Fictional patients
  • Simulated documentation
  • Templates

Back Up Your Information Daily

Design information management systems that consider:

  • Back-up methods
  • Multiple media formats (for example, electronic, fax, and paper)
  • Preparation for natural disasters
  • Suitability of marketing materials (for example, the information should be translated into languages appropriate for the target population and not be misleading)

Evaluate the effectiveness of information management systems when they’re in place.

Section II: Supplier Product-Specific Service Requirements

All Medicare-covered DMEPOS must serve a medical purpose and may require the prescribing practitioner to coordinate clinical services with other Medicare providers (for example, orthotists; prosthetists; pedorthists; and occupational, physical, and respiratory therapists).

DMEPOS suppliers must meet this section’s supplier product-specific service requirements and follow the requirements in appendixes A–C as they apply to the supplier’s business.

A. Intake & Assessment

  • Communicate with the practitioner to confirm orders and any changes
  • Review the patient’s record and document relevant information
  • Keep unaltered DMEPOS order/prescriptions in the patient’s record
 

Suppliers must:

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

The patient’s record must support medical necessity, including:

  • Face-to-face encounter records
  • Patient history
  • Physical exam notes
  • Diagnostic tests
  • Summary of findings
  • Progress notes
  • Treatment plans
  • Prescriptions
  • Practitioner and patient phone communication logs

B. Delivery & Setup

  • Deliver and set up equipment, items, and services timely
  • Provide all necessary equipment and items and make any adjustments
  • Deliver loaner equipment while the original is under repair (except in the case of orthotics and prosthetics)
  • Make sure equipment, items, and services are consistent with the prescribing practitioner’s order and the patient’s needs

Suppliers must:

  • Deliver and set up, or coordinate with another supplier to set up, all equipment and items timely as agreed to by the patient, caregiver, supplier, and prescribing practitioner
  • Provide all necessary equipment and items and make any further adjustments if applicable
  • Deliver or arrange for loaner equipment equal to the original equipment during a repair period (except for orthotics and prosthetics)
  • Make sure all equipment and items delivered to the patient meet the prescribing practitioner’s order and identified patient needs, risks, and limitations
  • Make sure equipment delivery personnel are knowledgeable about the equipment
 

C. Patient and Caregiver Training & Instruction

  • Provide or coordinate training and written instruction on equipment and item setup, features, use, and maintenance
  • Make sure training relates to risks, manufacturer’s instructions, and patient need
  • Verify and document training and instructions for mail-delivered items
  • Make sure patients and caregivers can safely use the equipment and items
  • Provide infection control information

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

  • As applicable, suppliers must:
    • Deliver or coordinate providing appropriate information about setup, features, routine use, troubleshooting, cleaning, infection control practices, and maintenance for all equipment and items, including how to prepare enteral or parenteral nutrients.
    • Verify and document in the patient’s record that they trained the patient or caregiver and gave written instructions on how to safely use the initial equipment or items delivered by mail order and that the patient and caregiver understood the instructions. Include the date, time, and signature of the person providing the services.
    • Make sure patients and caregivers can use all equipment and items safely and effectively in their expected settings of use.
  • Patient and caregiver training must fit with equipment and item risks, complexity, and manufacturer instructions and specifications. Suppliers must tailor training and instructional materials and approaches to meet patient and caregiver needs, abilities, and learning and language preferences.

D. Follow-Up

Suppliers must offer patient and caregiver follow-up services consistent with the equipment, items, and services provided and with the recommendations from the prescribing practitioner or other health care team members.

 

Appendix A: Respiratory Equipment, Supplies & Services

  • Respiratory services described here include offering home medical equipment and supplies that require technical and professional services
  • Suppliers must offer respiratory services 24 hours a day, 7 days a week
  • Home medical equipment and supplies covered in this appendix include:

A. Intake & Assessment

All Section II. A. Intake & Assessment requirements

B. Delivery & Setup

All Section II. B. Delivery & Setup requirements, plus compliance with the current version of the American Association for Respiratory Care clinical practice guidelines listed here:

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

C. Patient and Caregiver Training & Instruction

All Section II. C. Patient and Caregiver Training & Instruction requirements, plus patient and caregiver training consistent with the current version of the American Association for Respiratory Care clinical practice guidelines listed here:

 
  • Long-Term Invasive Mechanical Ventilation in the Home
  • Oxygen Therapy in the Home or Alternate Site Health Care Facility
  • Intermittent Positive Pressure Breathing
  • Providing Patient and Caregiver Training
  • Suctioning of the patient in the home

D. Follow-Up

All Section II. D. Follow-Up requirements



Appendix B: Manual Wheelchairs, Power Mobility Devices & 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.

Complex rehabilitative wheelchairs include Group 2 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, Power Mobility Devices & Complex Rehabilitative Wheelchairs and Assistive Technology Requirements
FunctionManual Wheelchairs, Power Mobility Devices & Complex Rehabilitative Wheelchairs and Assistive Technology* Requirements
Intake & AssessmentAll Section II. A. Intake & Assessment requirements, plus the supplier must evaluate and document seating, positioning, and specialty assistive technology in the patient’s record
Delivery & SetupAll Section II. B. Delivery & Setup requirements
Patient and Caregiver Training & InstructionAll Section II. C. Patient and Caregiver Training & Instruction requirements
Follow-UpAll Section II. D. Follow-Up requirements

* Additional Complex Rehabilitative Wheelchairs and Assistive Technology Requirements

All requirements in the table, plus:

  • Employ at least 1 qualified rehabilitative technology supplier (RTS) per location
  • Employ at least 1 trained technician per location
  • Have a repair and modification area in or near your facility
  • Provide patients with private, clean, and safe fitting and evaluation rooms

The RTS:

  • Coordinates services with the prescribing practitioner
  • Carries out assembly and setup procedures and validates setup
  • Keeps patient records provided at assessment
  • Gives the patient necessary trial and simulation equipment

All requirements in the table, plus:

  • Suppliers must employ at least 1 qualified RTS, with W-2 employee status, per location. A qualified RTS is someone with 1 of these credentials:
    • Assistive technology professional (ATP)
    • Certified rehabilitative technology supplier (CRTS)
  • The RTS must have 1 or more trained technicians available to appropriately service each location, depending on business size and scope. A trained technician:
    • Is trained by the manufacturers on the products they supply
    • Has experience in rehabilitative technology (including on-the-job training and familiarity with rehabilitative clients, products, and services)
    • Completes at least 10 continuing education hours related to rehabilitative technology annually
    • Can program and repair sophisticated electronics associated with power wheelchairs, alternative drive controls, and power seating systems
  • The RTS must:
    • Coordinate services with the prescribing physician to evaluate the patient face-to-face in an appropriate setting and include input from other health care team members (for example, physical and occupational therapists)
    • When necessary, supply patients with appropriate trial and simulation equipment
    • Record and keep all patient assessment information
    • Implement assembly and equipment setup procedures and verify that the final product meets the prescribing practitioner’s original product specifications
    •  
  • If suppliers evaluate patients in their facility, they must:
    • Provide patients with private, clean, and safe fitting and evaluation rooms
    • Maintain a repair shop in or near the facility, or easily accessible from another of the supplier’s locations, as well as an area appropriate for product assembly and modification


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

Suppliers must train in a broad range of treatment options to make sure they can provide the best items for the patient’s condition.

Offering custom-fabricated or -fitted devices requires that the supplier has access to a facility to provide follow-up treatment, including modification, adjustment, maintenance, and item repair.

People supplying the items identified in this appendix must:

  • Be certified and/or licensed
  • Have specialized education, training, and fitting experience

Glossary

These terms describe the types of devices in this appendix. The Medicare Benefit Policy Manual, Chapter 15 and 42 CFR 414.402 have more information about these terms.

Custom-Fabricated Custom-fabricated items are individually made for a specific patient, and no other patient can use them. You custom-fabricate a device on clinically derived and rectified castings, tracings, measurements, and other body part images, like X-rays.

Fabricating may involve calculations, templates, and components. This process both:

  • Uses basic materials, including, but not limited to, plastic, metal, leather, uncut or unshaped cloth sheets, bars, or other basic forms
  • Involves substantial work, like 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; a person 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, or item molding; installing add-on components; or item assembly.

Custom-Molded Shoes Custom-molded shoes are constructed over a positive model of the patient’s foot and made from leather or other suitable, equal-quality material. They have removable inserts you can alter or replace as the patient’s condition warrants and some form of shoe closure.

Depth Shoes

  • Have a full length, heel-to-toe filler that, when removed, provides a minimum of 3/16 of an inch of additional depth to accommodate custom-molded or customized inserts
  • Are made from leather or other suitable, equal-quality material
  • Have some form of shoe closure
  • Are available in full and half sizes with a minimum of 3 widths and the sole 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 restoration of auricular, nasal, mid-facial, orbital (including ocular), upper facial, hemifacial, partial facial, nasal septal, and other face areas disfigured by traumatic injury, disease, ablative surgery, or congenital malformation

Inserts Total-contact, multiple-density, removable inlays that are:

  • Directly molded to the patient’s foot or a model of the patient’s foot or directly carved from a patient-specific, rectified model
  • Made of a material suitable for the patient’s condition

Minimal Self-Adjustment 42 CFR 414.402 defines minimal self-adjustment as an adjustment the patient, patient’s caretaker, or device supplier can do without needing a certified orthotist (in other words, a person certified by the American Board for Certification in Orthotics and Prosthetics or the Board for Orthotics/Prosthetist Certification) or a person with specialized training.

 

Molded-to-Patient-Model Molded-to-patient-model:

  • Is 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 creating the final product.
  • Uses computer-aided design and computer-aided manufacturing (CAD-CAM) software that creates a digital image of the patient’s body part. This technology uses specialized probes, digitizers, and scanners that create a computerized positive model and direct milling equipment to carve a positive model. You then fabricate and mold the individual device over the positive patient model.
  • Includes digitally created diabetic therapeutic shoe inserts you create using the patient’s body part and CAD-CAM systems software. This technology uses specialized probes, digitizers, and scanners to 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, 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 custom-made ocular prosthesis components that are integrated into orbital, upper facial, or hemifacial prostheses.

Off-the-Shelf (OTS) Orthoses OTS prefabricated orthotic items need minimal self-adjustment for appropriate use, and suppliers don’t need expertise in trimming, bending, molding, assembling, or customizing them to fit the patient. Appendix C doesn’t apply to OTS orthotics.

Orthotic Devices Orthotic devices are rigid and semirigid devices used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured body part.

Positive Molded to the Patient 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 software uses digitizers to collect surface contour data, which 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 fit the patient. You check the completed custom fabrication and make all necessary adjustments.

For diabetic therapeutic shoe inserts, CAD-CAM software uses a digitizer to collect surface contour data, which 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 (other than dental 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. We don’t need to determine if the patient’s condition may improve in the future. The device passes the test of permanence when the patient’s medical condition, in the attending practitioner’s opinion, is of long and indefinite duration.

 

Somatic Prostheses Custom-fabricated somatic prostheses replace areas of the human body that aren’t included under definitions of facial and ocular prosthetics but need visual and functional integration. Typical somatic prosthetics replace fingers, thumbs, partial hands, hands, and toes disfigured by traumatic injury, disease, ablative surgery, or congenital malformation.

Specialized Training People specially trained to provide custom fitting services to patients with a medical need for orthotics include physicians, treating practitioners (physician assistants, nurse practitioners, or clinical nurse specialists), occupational therapists, and physical therapists, all of whom must comply with all applicable federal and state licensure and regulatory requirements.

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

 

A. Intake & Assessment

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

  • Look at the patient’s need for, and use of, the orthoses or prostheses
  • Determine the appropriate orthosis or prosthesis specifications
  • Perform an in-person, diagnosis-specific functional clinical exam
  • Establish patient goals and expected outcomes
  • Formulate a treatment plan consistent with the prescribing practitioner’s order
  • Communicate the recommended treatment plan to the patient and stakeholders
  • Make sure the orthoses or prostheses are structurally safe
  • Follow manufacturer guidelines

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, review the patient’s comprehensive history and relevant medical history, including material allergies, skin condition, diagnosis, previous use of orthoses or prostheses, diagnostic evaluation results, patient expectations, and pretreatment photographic documentation when appropriate)
  • Determine the appropriate orthoses or prostheses and specifications based on the patient’s need for optimum therapeutic benefits and appropriate strength, durability, and function
  • Create a treatment plan that follows the prescribing practitioner’s dispensing order and the written plan of care according to Medicare rules, and consult the practitioner when appropriate
  • Complete an in-person, diagnosis-specific functional clinical exam of the patient’s use and need for the orthoses or prostheses (considering, for example, sensory function, range of motion, joint stability, skin condition (integrity, color, and temperature), presence of edema or wounds, vascularity, pain, manual muscle testing, compliance, cognitive ability, and medical history)
  • Determine appropriate patient outcomes (for example, reducing pain, increasing comfort, enhancing function and independence, providing joint stability, preventing deformity, increasing range of motion, addressing cosmetic issues, and promoting healing), using patient and prescribing practitioner feedback as necessary
  • Communicate to patients, caregivers, and prescribing practitioners the:
    • Recommended treatment plan, including disclosing potential risks, benefits, and precautions
    • Procedures for repairing, replacing, and adjusting the device or items
    • Estimated processing time
  • Look at the structural safety of the orthoses or prostheses and make sure you follow manufacturer guidelines (for example, patient weight limits, making sure closures work properly and have no defects) before a face-to-face encounter for fitting and delivery
 

B. Delivery & Setup

Not applicable to this appendix

C. Patient and Caregiver Training & Instruction

All Section II. C. Patient and Caregiver Training & Instruction requirements, plus:

  • Provide instructions for specific orthoses, prostheses, or therapeutic shoes and inserts
  • Provide supplies for attaching, maintaining, and cleaning items
  • Refer patients to prescribers for help beyond the supplier’s scope of practice

All Section II. C. Patient and Caregiver Training & Instruction requirements, plus suppliers must:

  • Instruct patients and caregivers on the specific orthoses, prostheses, or therapeutic shoes or inserts, including how to:
    • Use, maintain, and clean the orthoses or prostheses (for example, discussing wearing schedules, therapy, residual limb hygiene, and other relevant instructions)
    • Put on and remove the orthoses or prostheses, including how to adjust closures for proper fit
    • Inspect the skin for pressure areas, redness, irritation, skin breakdown, pain, or edema
    • Use an appropriate interface as a layer between the patient’s skin and the orthoses or prostheses (for example, stockinettes, socks, gloves, shoes)
    • Report orthosis or prosthesis problems (for example, changes in skin condition; heightened pain; increase in edema; wound concerns; changes in general health, height, or weight; or orthosis or prosthesis wearing intolerance) to the supplier or prescribing practitioner
    • Schedule follow-up appointments as necessary
    • Establish an appropriate wear schedule for tolerance of the orthoses or prostheses
  • Provide necessary supplies (for example, adhesives, solvents, lubricants) for attaching, maintaining, and cleaning the items, and provide information about how to get more supplies
  • Refer the patient to the prescribing practitioner as necessary for help beyond the supplier’s scope of practice

D. Follow-Up

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

  • Have access to a facility for follow-up services
  • Provide follow-up treatment consistent with the type of orthoses or prostheses
  • Review recommended maintenance with the patient
  • Get patient and stakeholder feedback on the DMEPOS effectiveness
  • Review and adjust the treatment plan as necessary
  • Help patients get the best level of fit and function of the orthoses or prostheses
 

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

  • Have access to a facility with the equipment necessary to provide follow-up treatment and fabrication or modification of specific orthoses or prostheses
  • Review recommended maintenance with patients and caregivers
  • Get feedback from patients, caregivers, and prescribing practitioners as necessary (for example, wear schedule and tolerance, comfort, perceived benefits and detriments, ability to put on and remove, proper use and functioning, overall patient satisfaction) to determine the orthoses’ or prostheses’ effectiveness
  • Review and update the treatment plan based on the patient’s current medical condition
  • Continue helping the patient until the orthoses or prostheses reaches the optimal level of fit and function consistent with the treatment plan
  • Provide patient follow-up treatment as appropriate for the types of orthoses, prostheses, or therapeutic shoes and inserts provided; the patient’s diagnosis; the care delivered; and recommendations given
 

DMEPOS Accreditation Organizations

Supplier Standards & Quality Standards

National Provider Enrollment (NPE) contractors (east and west) process Medicare enrollment applications for DMEPOS suppliers to make sure they meet all supplier standards and enrollment requirements.

Suppliers must comply with all applicable supplier standards and regulatory requirements to enroll in Medicare and keep their Medicare billing privileges.

CMS-approved AOs use the quality standards to accredit suppliers. The NPE contractors and AOs are completely independent, so compliance with 1 entity doesn’t guarantee compliance with the other.

To enroll in Medicare and keep Medicare billing privileges, all DMEPOS suppliers (except for exempt professionals and other specified persons) must comply with the Medicare Program’s supplier standards and quality standards and be accredited. We allow CMS-approved DMEPOS accreditation organizations (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 and enteral nutrition
  • Transfusion medicine and prosthetic devices
  • Prosthetics and orthotics

Suppliers can contact the AOs directly for accreditation information.

 

Resources

Applicable Regulations & Guidance

DMEPOS Resources



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