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DMEPOS Quality Standards

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Together we can advance health equity and help eliminate health disparities for all minority and underserved groups. Find resources and more from the CMS Office of Minority Health:

Face-to-Face Requirement

A practitioner (physician, physician assistant, nurse practitioner, or clinical nurse specialist) must document a face-to-face encounter with a Medicare patient within the 6 months before the Standard Written Order (SWO) for certain DMEPOS items.

A face-to-face encounter is an in-person or telehealth encounter between you and the patient. If you use telehealth for the encounter, you must meet the telehealth services requirements to get paid.

Master List

We require some DMEPOS meet extra criteria before they’re covered. In 2020, we created a library called the Master List that has all DMEPOS items that may require providers or suppliers to meet more payment requirements.

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must meet CMS DMEPOS Quality Standards under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and become accredited to get or keep Medicare billing privileges unless they’re exempt. Involving all staff in understanding the DMEPOS Quality Standards process will help you meet them and get accredited.

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

 

The DMEPOS Quality Standards have 2 sections and 3 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, patient and or caregiver training and instruction, and follow-up.

Appendices describe specific DMEPOS items and services requirements:

  • Appendix A: Respiratory Equipment, Supplies, & Services
  • Appendix B: Manual Wheelchairs, Power Mobility Devices (PMDs), & Complex Rehabilitative Wheelchairs with Assistive Technology
  • 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

Want More Information?

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

Tip:

Additional information about dotted underlined words.

Section I: Supplier Business Service Requirements

A. Administration

 
  • Suppliers must must have 1 or more individuals perform leadership functions with the authority, responsibility, and accountability to direct the organization and its key activities and operations.
    • Leadership doesn’t mean a formal group or committee; the supplier can meet this requirement in different ways. An owner can lead an owner-operated business, like a practitioner’s office. Suppliers may use any organizational structure, 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 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.

  • Suppliers must manage their business to get and supply appropriate quality patient equipment, items, and services.
  • 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.
  • Supplier must offer only DMEPOS and other items that meet applicable FDA regulations and medical device effectiveness and safety standards. Manufacturers must provide suppliers copies of features, warranties, and instructions for each item type not custom fabricated.
  • Suppliers must comply with all Medicare statutes, regulations (including the disclosure of ownership and control information requirements at 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 related to both ownership or investment and compensation.
  • Supplier 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 1 or more company leaders to address compliance issues

Create a Compliance Program

Establish business practices ensuring compliance 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 developing a compliance plan, go to the Office of Inspector General Compliance Program Guidance for DMEPOS.

 

B. Financial Management

  • Suppliers must use financial management practices that ensure accurate accounting and billing. Keep accurate, complete, 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:
      • Don’t bill before you get the prescription
      • Use correct modifiers and codes
    • Produce periodic financial statements
  • Suppliers must keep accounts that link equipment and item(s) to the patient and manage patient service revenues and expenses regularly, including:
    • 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

  • Suppliers must:
    • Issue policies and job descriptions stating personnel qualifications, training, certifications and or licensures (where applicable), experience, and continuing education requirements for specialized equipment, items, and services they offer patients
    • Provide copies of these policies, job descriptions, and certifications and or licensures (where applicable) to accreditation organizations and government officials or their authorized agents when requested
    • Verify and keep license, registration, certification, and competency copies for personnel delivering patient services
    • Have competent technical personnel to deliver and set up equipment, item(s) and service(s), and train patients and caregivers
  • Professional personnel must act within their scope of practice as required by state standards and be licensed, certified, or registered
 

Human Resources Management

  • Do 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
  • Do state-required background checks
  • Verify all employees and contractors can participate in federal health care programs via 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

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

  • When supplying equipment, items, and services to patients and caregivers, suppliers must:
    • Provide clear, written or pictorial, and verbal instructions about using, maintaining, infection control practices for, and potential hazards of, equipment and or items, as appropriate
    • Provide information about items’ expected delivery time frames
    • 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
    • Provide essential contact information for renting and purchasing equipment and patient and caregiver options, when applicable
    • Provide information and phone number(s) for customer service, regular business hours, after-hours access, equipment and 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 they have 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 complaint documentation, investigation copies, and patient responses.

E. Performance Management

  • Suppliers must use a performance management plan that measures consumer services, billing practices, and adverse events outcomes. Data collection may target services with potential to cause harm or injury, occurring frequently (creating more adjustments, repairs, or replacements than expected), or services requiring significant training to ensure safe equipment use and or item 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)
    • Response timeliness
  • At a minimum, suppliers must measure:
    • Patient product and service satisfaction and complaints
    • Response timeliness to patient questions, problems, and concerns
    • 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 records after we deny claims)
    • Patient adverse events due to inadequate services or malfunctioning equipment and 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 it
  • 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

Suppliers 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 noted).
  • Investigate any DMEPOS incident, injury, or infection related to use when you become aware of it. Suppliers must begin an 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 doesn’t result in hospitalization or death, suppliers must begin investigating within 72 hours after notification. Investigations must include all necessary information, relevant 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. Check the OSHA requirements for injury reporting under the Medical Device Reporting regulation.
  • Have a contingency plan that enables response to emergencies and disasters or to arrange for alternative supplier(s) if the supplier can’t serve their customers.

    Tip:

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

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

Equipment Maintenance Plan

The maintenance plan should include 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. Show evidence you maintain all equipment. Log refrigerated equipment calibration and temperature checks.

G. Information Management

Suppliers must keep accurate, relevant, accessible, confidential, and secure patient records, required by the Health Insurance Portability and Accountability Act (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 practitioner to coordinate clinical services with other Medicare providers (for example, orthotists, prosthetists, occupational, physical, respiratory therapists, pedorthists, etc.).

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

A. Intake & Assessment

 

Suppliers must:

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

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

  • CMNs
  • Face-to-face encounter records
  • Physical assessments
  • Prescriptions
  • Practitioner and patient phone communication logs

B. Delivery & Set-Up

Suppliers must:

  • Deliver and set up all equipment and items timely as agreed by the patient, caregiver, supplier, and prescribing practitioner 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 patient equipment and items delivered meet the prescribing practitioner’s order and the supplier’s aware of identified patient needs, risks, and limitations

Deliver the scheduled equipment on time. Ensure knowledgeable equipment delivery personnel.

 

C. Patient & Caregiver Training & Instruction

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

  • As applicable, suppliers 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 or parenteral nutrients
    • Provide infection control information and or instructions about all equipment and items
    • For initial equipment and or items delivered by mail order, verify and document in the patient’s record you trained the patient and caregiver and gave written instructions on how to use the equipment and items, including the date, time, and person providing the services signature
    • Ensure patients and caregivers can use all equipment and items safely and effectively in their anticipated settings
  • Patient and caregiver training must fit with equipment and items risks, complexity, and manufacturer instructions and or specifications. Suppliers must change training and instructional materials and approaches according to patient and caregiver needs, abilities, learning preferences, and language.

D. Follow-Up

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

 

Appendix A: Respiratory Equipment, Supplies, & Services

  • Respiratory services described here include offering home medical equipment and supplies that need technical and professional services
  • Suppliers must offer respiratory services 24 hours a day, 7 days a week as needed by patients and caregivers
  • 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 here:

  • IPPB Devices
  • Long-Term Invasive Mechanical Ventilation in the Home
  • Oxygen Therapy in the Home or Alternate Site Health Care Facility

C. Patient & Caregiver Training & Instruction

All Section II. C. Patient & 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:

 
  • IPPB Devices
  • Long-Term Invasive Mechanical Ventilation in the Home
  • Oxygen Therapy in the Home or Alternate Site Health Care Facility
  • Providing 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, Power Mobility Devices, & Complex Rehabilitative Wheelchairs with 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 place).

Manual Wheelchairs, Power Mobility Devices, & Complex Rehabilitative Wheelchairs with Assistive Technology Requirements
FunctionManual Wheelchairs, Power Mobility Devices, & Complex Rehabilitative Wheelchairs with 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 & Caregiver Training & InstructionAll Section II. C. Patient & Caregiver Training & Instruction requirements
Follow-UpAll Section II. D. Follow-Up requirements

*Additional Complex Rehabilitative Wheelchairs with Assistive Technology Requirements

All requirements in the table above, plus:

  • Employ at least 1 certified Rehabilitative Technology Supplier (RTS) per location
  • Employ at least 1 trained tech per location
  • Have a repair and modification area in or near your facility
  • Provide patients private, clean, and safe fitting and evaluation rooms

The RTS:

  • Coordinates services with the prescribing practitioner
  • Carries out assembly and set-up procedures, and validates set-up
  • Keeps patient records information provided at assessment
  • Provides the patient necessary trial and simulation equipment

All requirements in the table above, plus:

  • Suppliers must employ at least 1 RTS qualified, W-2 employee per location. A qualified RTS is someone with 1 of these credentials:
    • Assistive Technology Professional (ATP)
    • Certified Rehabilitative Technology Supplier (CRTS)
  • RTS must have at least 1 or more trained technicians to appropriately service each location depending on the business’s size and scope. A trained technician:
    • Is able to program and repair sophisticated power wheelchairs, alternative drive controls, and power seating systems electronics
    • Completes at least 10 continuing education hours annually related 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 they supply
  • RTS must:
    • Coordinate and do patient and prescribing practitioner face-to-face encounters in an appropriate setting and include input from other health care team members (that is, physical therapist, occupational therapist)
    • Implement assembly and equipment set-up procedures, and verify the final product meets the prescribing practitioner’s original product recommendation specifications
    • Record and keep all patient assessment information
    • When necessary, supply patients with appropriate trial and simulation equipment
  •  
  • If suppliers evaluate patients 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
    • Provide patients private, clean, and safe fitting and evaluation rooms

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 get training in a broad range of treatment options to ensure the best items for the patient’s condition.

Offering custom-fabricated or custom-fitted devices requires facility access to provide 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

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

Custom-Fabricated Custom-fabricated items are individually made for a specific patient. No other patient can use them. You fabricate a custom-fabricated device on clinically derived and rectified castings, tracings, measurements, and or other body part images, like X-rays. Fabricating may involve calculations, templates, and components. This process uses basic materials including, but not limited to, plastic, metal, leather, or uncut or unshaped cloth 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, provides 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 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 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, patient’s caretaker, or device supplier can do without needing certified orthotist services (that is, an individual certified by the American Board for Certification in Orthotics and Prosthetics or the Board for Orthotics/Prosthetist Certification) or an individual 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 crafting the final product.
  • Computer-Aided Design and Computer-Aided Manufacturing (CAD-CAM) 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.
  • Digitally created diabetic therapeutic shoe inserts, you create using the patient’s body part and 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 suppliers don’t need expertise in trimming, bending, molding, assembling, or customizing to fit the individual. Appendix C doesn’t apply to OTS orthotics. 42 CFR 414.402 has more information.

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 software 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, CAD-CAM software 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 (other than dental) 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 a determination that there’s no possibility the patient’s condition may improve in the future. The device passes the performance test when the attending practitioner’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 provide 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 & Inserts These include depth or custom-molded shoes and 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, relevant medical history [including material allergies], skin condition, diagnosis, previous use of an orthoses or prostheses, diagnostic evaluation results, patient expectations, and pre-treatment 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 consistently follows the prescribing practitioner’s dispensing order and or the written plan of care according to Medicare rules, and consult the practitioner when appropriate
  • Does an in-person, diagnosis-specific functional clinical exam of the patient’s use and need for the orthoses or 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, provide joint stability, prevent deformity, increase range of motion, address cosmetic issues, and or promote healing) using patient and or prescribing practitioner feedback as necessary
  • Communicate to patients, caregivers, and prescribing practitioners the recommended treatment plan, including disclosure of potential risks, benefits, precautions, procedures for repairing, replacing, and or adjusting the device or items, and the estimated process time
  • Look at the structural safety of orthoses or prostheses and ensure you follow manufacturer guidelines before a face-to-face encounter for fitting and delivery (for example, patient weight limits, making sure that closures work properly and have no defects)
  • Ensure the treatment plan consistently follows the prescribing practitioner’s dispensing order
 

B. Delivery & Set-Up

Not applicable to this appendix.

C. Patient & Caregiver Training & Instruction

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

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

  • Instruct patients and or caregivers on the specific orthoses, prostheses, or therapeutic shoes or inserts:
    • How to use, maintain, and clean the orthoses or prostheses (for example, wearing schedules, therapy, residual limb hygiene, other relevant instructions)
    • How to put on and remove the orthoses or 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 or prostheses, where appropriate
    • How to report orthoses or prostheses problems to the supplier or prescribing practitioner (for example, changes in skin condition, heightened pain, increase in edema, wound concerns, changes in general health, height, weight, or orthoses or prostheses wearing intolerance as applicable)
    • How to schedule follow-up appointments as necessary
    • How to establish an appropriate wear schedule and schedule for tolerance of the orthoses or prostheses
  • Provide necessary supplies (for example, adhesives, solvents, lubricants) to attach, maintain, and clean the items, and information about how to get necessary 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:

 

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 specific orthoses or prostheses fabrication or modification
  • Review recommended maintenance with patients and caregivers
  • Get feedback from patients, caregivers, and prescribing practitioners as necessary to decide the orthoses or prostheses effectiveness (for example, wear schedule and tolerance, comfort, perceived benefits and 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 or prostheses reach the best level of fit and function consistent with the treatment plan
  • Provide appropriate patient follow-up treatment consistent with the types of orthoses or prostheses or therapeutic shoe and inserts provided, the patient’s diagnosis, specific care delivered, and recommendations
 

DMEPOS Supplier Accreditation Organizations (AOs)

Supplier Standards and Quality Standards

Suppliers must comply with the current standards to get and 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 1 entity doesn’t guarantee compliance with the other.

To enroll or keep Medicare billing privileges, all DMEPOS suppliers (except for exempt 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 and enteral nutrition
  • Transfusion medicine and prosthetic devices
  • Prosthetics and orthotics

Suppliers can contact the AOs directly for accreditation information.

 

Resources

Applicable Regulations and Guidance

DMEPOS Resources



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