durable medical equipment, prosthetics, orthotics, and ... · pdf filedurable medical...

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Crosswalk

Medicare Quality Standards to 2017 Joint Commission Home Care Standards & EPs

Quality Standard

SectionMedicare Quality Standards

Joint Commission

Equivalent NumberJoint Commission Standards and Elements of Performance

LD.01.03.01 Governance is ultimately accountable for the safety and quality of care, treatment, or

services.

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

EP 19

I: Supplier Business Services Requirements

A. Administration

1. The supplier shall 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 necessarily imply that there must be a formal group or committee. The supplier can meet this requirement through various means as long as essential leadership functions occur. An owner can lead an owner-operated business,such as a physician’s office. The supplier may use any form of organization, such as a partnership, sole proprietorship, or corporation.

Depending on the organization’s structure, examples of leadership positions may include the owners, governing body, chief executive officer, and other individuals responsible for managing services provided by the organization.

LD.04.01.11 The organization makes space and equipment available as needed for the provision of

care, treatment, or services.

The organization governs its business so that it obtains and provides appropriate quality equipment, items, and services to patients.

EP 6


A. Administration

2. The supplier shall govern its business so that it obtains and provides appropriate quality equipment, item(s), and service(s) to beneficiaries.

APR.05.01.01 The organization allows The Joint Commission to review the results of external

evaluations from publicly recognized bodies.

When requested, the supplier of medical equipment provides government officials or their authorized agents with copies of reports from licensing, examining, reviewing, or planning bodies.

EP 2

LD.04.01.01 The organization complies with law and regulation.

The organization displays all licenses, certificates, and permits to operate in an area accessible to customers and patients.

EP 10

LD.04.01.11 The organization makes space and equipment available as needed for the provision of


The organization has a physical location.EP 7


A. Administration

3. The supplier shall have a physical location and display all licenses, certificates, and permits to operate. The licenses, certificates and permits must be displayed in an area accessible to customers and patients. The supplier shall provide copies, upon request, to government officials or their authorized agents.

EQ.01.01.01 The organization selects and delivers equipment and supplies.I: Supplier Business Services Requirements

A. Administration

of 29 © 2017 The Joint CommissionOctober 31, 2016


Quality Standard


Joint Commission


The organization provides only durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) and other items that meet applicable Food and Drug Administration regulations and medical device effectiveness and safety standards.

EP 2

EQ.01.03.01 The organization maintains, tests, and inspects the medical equipment it provides to

patients.

The organization obtains from the manufacturer copies of features, warranties, and instructions for each type of non-custom-fabricated item it supplies to patients.

EP 1

4. The supplier shall provide only durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) and other items that meet applicable Food and Drug Administration (FDA) regulations and medical device effectiveness and safety standards. The supplier shall obtain from the manufacturer copies of the features, warranties, and instructions for each type of non-custom fabricated item.

APR.01.03.01 The organization reports any changes in the information provided in the application for

accreditation and any changes made between surveys.

The organization notifies The Joint Commission in writing within 30 days of a change in ownership, control, location, capacity, or services offered. Note 1: When the organization changes ownership, control, location, capacity, or services offered, it may be necessary for The Joint Commission to survey the organization again. If the organization does not provide written notification to The Joint Commission within 30 days of these changes, the organization could lose its accreditation.Note 2: The hospice, home health agency, or DMEPOS supplier is also required to disclose to the Centers for Medicare & Medicaid Services or the Medicare administrative contractor or fiscal intermediary, the addresses of its owners, those with a controlling interest in the organization, or any subcontractor in which the organization directly or indirectly has a 5% or more ownership interest.Note 3: For organizations that elect The Joint Commission Community-Based Palliative Care Certification option: The organization reports any changes in the information provided in the application for certification and any changes made between surveys.

EP 1

LD.04.01.01 The organization complies with law and regulation.

For DMEPOS suppliers serving Medicare beneficiaries: The supplier complies with Medicare statutes, regulations, manuals, program instructions, and contractor policies and articles.

EP 13


A. Administration

5. The supplier shall comply with all Medicare statutes, regulations (including the disclosure of ownership and control information requirements at 42 CFR §420.201 through §420.206), manuals, program instructions, and contractor policies and articles.


A. Administration

6. The supplier shall implement business practices to prevent and control fraud, waste, and abuse by:

LD.04.02.03 Ethical principles guide the organization’s business practices.

The organization implements business practices to prevent and control fraud, waste, and abuse by using procedures that articulate standards of conduct so that the organization complies with applicable law and regulation.

EP 17


A. Administration

• Using procedures that articulate standards of conduct to ensure the organization’s compliance with applicable laws and regulations; and


The organization implements business practices to prevent and control fraud, waste, and abuse by designating one or more individuals in leadership positions to address compliance issues.

EP 18


A. Administration

• Designating one or more individuals in leadership positions to address compliance issues.

LD.04.02.03 Ethical principles guide the organization’s business practices.I: Supplier Business Services Requirements

B. Financial Management



Quality Standard


Joint Commission


For DMEPOS suppliers serving Medicare beneficiaries: The supplier implements financial management practices for accurate accounting and billing to beneficiaries and the Medicare program.

EP 19

The organization’s financial records are accurate, complete, current, and reflect cash- or accrual-based accounting practices.

EP 20

1. The supplier shall implement financial management practices that ensure accurate accounting and billing to beneficiaries and the Medicare program. Financial records shall be accurate, complete, current, and reflect cash or accrual base accounting practices.


The organization maintains accounts that link equipment and items to the patient.EP 21



2. The supplier shall maintain accounts that link equipment and item(s) to the beneficiary and manage revenues and expenses on an ongoing basis, as they relate to beneficiary services, including the following:


The organization manages revenues and expenses on an ongoing basis, as they relate to patient services, including reconciliation of charges to patients for equipment, supplies, and services, with invoices, receipts, and deposits, and by tracking actual revenues and expenses.

EP 22



• Reconciling charges to beneficiaries for equipment, supplies, and services with invoices, receipts, and deposits;

LD.04.01.03 The organization develops an annual operating budget and, when needed, a long-term

capital expenditure plan.

The organization manages revenues and expenses on an ongoing basis as they relate to patient services, including planning to meet the needs of patients and maintain business operations by having an operating budget, as appropriate to the business’ size and scope of services.

EP 13



• Planning to meet the needs of beneficiaries and maintain business operations by having an operating budget, as appropriate to the business’s size and scope of services; and


The organization manages revenues and expenses on an ongoing basis, as they relate to patient services, including reconciliation of charges to patients for equipment, supplies, and services, with invoices, receipts, and deposits, and by tracking actual revenues and expenses.

EP 22



• Having a mechanism to track actual revenues and expenses.


C. Human Resources Management

1. The supplier shall:

HR.01.02.01 The organization defines staff qualifications.

The organization has written policies and job descriptions that specify the following staff requirements specific to the specialized equipment, supplies, and services it provides to patients:- Qualifications- Experience - Applicable certification, registration, or licensure- Training requirements- Continuing education requirements

EP 2

For DMEPOS suppliers serving Medicare beneficiaries: Staff who provide patient care, treatment, or services have the qualifications required by the organization’s job descriptions and policies.

EP 20



• Implement policies and issue job descriptions that specify personnel qualifications, training, certifications/licensures where applicable, experience, and continuing education requirements consistent with the specialized equipment, items, and services it provides to beneficiaries;



Quality Standard


Joint Commission


HR.01.02.05 The organization verifies staff qualifications.

When law or regulation requires care providers to be currently licensed, certified, or registered to practice their professions, the organization both verifies these credentials with the primary source and documents this verification when a provider is hired and when his or her credentials are renewed. (See also HR.01.02.07, EP 2)Note 1: It is acceptable to verify current licensure, certification, or registration with the primary source via a secure electronic communication or by telephone, if this verification is documented. This verification is obtained from the appropriate state licensing or certification board, at the time of hire and at the time of renewal of credentials.Note 2: A primary verification source may designate another agency to communicate credentials information. The designated agency can then be used as a primary source.Note 3: An external organization (for example, a credentials verification organization [CVO]) may be used to verify credentials information. A CVO must meet the CVO guidelines identified in the Glossary.

EP 1

When the organization requires licensure, registration, or certification not required by law and regulation, the organization both verifies these credentials and documents this verification at time of hire and when credentials are renewed. (See also HR.01.02.07, EP 2)

EP 2

HR.01.05.03 Staff participate in ongoing education and training.

Staff participate in ongoing education and training to maintain or increase their competency. Staff participation is documented.

EP 1


Upon request, the organization provides copies of policies, job descriptions, certifications, registrations, and licensures to its accreditation organization and government officials or their authorized agents.

EP 14



• Provide copies of such policies, job descriptions and certifications/licensures (where applicable) upon request to accreditation organizations and government officials or their authorized agents; and



EP 1


EP 2

HR.01.06.01 Staff are competent to perform their responsibilities.

Staff competence is initially assessed and documented as part of orientation.EP 5



• Verify and maintain copies of licenses, registrations, certifications, and competencies for personnel who provide beneficiary services.



Quality Standard


Joint Commission


HR.01.06.01 Staff are competent to perform their responsibilities.

Technical staff are competent to deliver and set up equipment, provide services, and train patients and caregivers.

EP 14



2. Technical personnel shall be competent to deliver and set-up equipment, item(s) and service(s) and train beneficiaries and/or caregiver(s).



EP 1


EP 2

The organization uses the following information from HR.01.02.05, Elements of Performance 1–5, to make decisions about staff job responsibilities:- Required licensure, certification, or registration verification- Required credentials verification- Education and experience verification- Criminal background check- Applicable health screenings

EP 6

HR.01.02.07 The organization determines how staff function within the organization.

Staff who provide patient care, treatment, or services practice within the scope of their license, certification, or registration and as required by law and regulation. (See also HR.01.02.05, EPs 1 and 2)

EP 2



3. Professional personnel shall be licensed, certified, or registered and function within their scope of practice as required by the State standards under which the professional is licensed, certified or registered.


D. Consumer Services

1. When providing equipment, item(s), and service(s) to beneficiaries and/or caregiver(s), the supplier shall:

PC.02.03.01 The organization provides patient education and training based on each patient’s

needs and abilities.I: Supplier Business Services Requirements


• Provide clear, written or pictorial, and oral instructions related to the use, maintenance, infection control practices for, and potential hazards of equipment and/or item(s) as appropriate;



Quality Standard


Joint Commission


The organization provides written and verbal instructions to the patient and/or caregiver about the equipment, supplies, and services provided. The instructions cover the following topics, as appropriate to the equipment, supplies, or services:- Use of the equipment or supplies- Maintenance of the equipment - Potential hazards and safety considerations related to the equipment, supplies, or services Note: Written instructions may include pictures to illustrate the information being provided.

EP 11

EQ.01.01.01 The organization selects and delivers equipment and supplies.

The organization informs the patient of the expected time frames for delivery of medical equipment and supplies.

EP 6



• Provide information regarding expected time frames for receipt of delivered items;


The organization verifies that the patient received the medical equipment and supplies. Verification of delivery is documented.Note: Some examples of methods for verifying delivery include, but are not limited to the following: Contacting the patient to confirm that delivery occurred, providing the patient with a return receipt to complete upon delivery, and retaining a copy of the delivery service’s tracking slip as well as the supplier’s own invoice. Proof of delivery can also be demonstrated by verifying a sample of deliveries and using the data collected for a performance improvement indicator.

EP 12



• Verify that the equipment, item(s), and service(s) were received;

RC.02.01.01 The patient record contains information that reflects the patient's care, treatment, or

services.

For DMEPOS suppliers serving Medicare beneficiaries: The organization documents in the patient record the make and model or any other identifier of the noncustom equipment provided.

EP 23



• Document in the beneficiary’s record the make and model number or any other identifier of any non-custom equipment and/or item(s) provided;

RI.01.02.01 The organization respects the patient's right to participate in decisions about his or her


The organization provides its contact information when the patient receives rental equipment.EP 17

For DMEPOS suppliers serving Medicare beneficiaries: The organization provides the patient with options for renting or purchasing equipment and items.

EP 18



• Provide essential contact information for rental equipment and options for beneficiaries and/or caregiver(s) to rent or purchase equipment and/or item(s), when applicable; and

PC.02.02.05 The organization provides the patient with access to care, treatment, or services during

nonbusiness hours.

The organization provides the patient with information about whom to contact for assistance when the organization is closed.

EP 3

The organization provides the patient with information about normal business hours and how to contact the organization for assistance.

EP 4



• Provide information and telephone number(s) for customer service, regular business hours, after-hours access, equipment and/or item(s) repair, and emergency coverage.

PC.02.01.05 The organization provides interdisciplinary, collaborative care, treatment, or services.I: Supplier Business Services Requirements




Quality Standard


Joint Commission


When the organization cannot provide equipment, items, or services that have been ordered for a patient, it notifies the prescribing practitioner within five calendar days.Note: In rare instances, there may be customized items for which the organization was not notified by the vendor within the five day time frame that the item cannot be provided as specified. The organization is still responsible for notifying the prescribing practitioner, even if it is outside the five day time frame.

EP 172. If the supplier cannot or will not provide the equipment, item(s) or service(s) that are prescribed for a beneficiary, the supplier shall notify the prescribing physician (for purpose of theses standards, we are using this term to include other practitioners who can prescribe DMEPOS under Medicare laws and regulations) or other health care team member(s) promptly within 5 calendar days.

RI.01.07.01 The patient and his or her family have the right to have complaints reviewed by the

organization.

For DMEPOS suppliers serving Medicare beneficiaries: Within five calendar days of receiving a patient’s complaint, the organization notifies the patient by telephone, e-mail, fax, letter, or in person that it has received the complaint and that it is being investigated.

EP 14

For DMEPOS suppliers serving Medicare beneficiaries: Within 14 calendar days of receiving a patient's complaint, the organization provides written notification to the patient of the results of its investigation and its response to those results.

EP 15

For DMEPOS suppliers serving Medicare beneficiaries: The organization maintains documentation of all complaints, copies of investigations, and responses to patients.

EP 16



3. Within 5 calendar days of receiving a beneficiary’s complaint, the supplier shall notify the beneficiary, using either oral, telephone, e-mail, fax, or letter format, that it has received the complaint and is investigating. Within 14 calendar days, the supplier shall provide written notification to the beneficiary of the results of its investigation. The supplier shall maintain documentation of all complaints received, copies of the investigations, and responses to beneficiaries.


E. Performance Management

1. The supplier shall implement a performance management plan that measures: outcomes of consumer services, billing practices, and adverse events. The data collection may target certain aspects of services that have a potential to cause harm or injury; occur frequently (creating a greater than expected number of adjustment(s), repair(s), or replacement(s)); or require significant instruction to assure safe use and benefit of the equipment and/or item(s).



2. At a minimum, each supplier shall measure:

PI.01.01.01 The organization collects data to monitor its performance.

The organization collects data on the following: Patient satisfaction with and complaints about products and services.

EP 17



• Beneficiary satisfaction with and complaints about product(s) and service(s);


The organization collects data on the following: The timeliness of response to patient questions, problems, and concerns.

EP 18



• Timeliness of response to beneficiary question(s), problem(s), and concern(s);


The organization collects data on the following: The impact of the organization's business practices on the adequacy of patient access to equipment, items, services, and information.

EP 19



• Impact of the supplier’s business practices on the adequacy of beneficiary access to equipment, item(s), service(s), and information;



Quality Standard


Joint Commission



For DMEPOS suppliers serving Medicare beneficiaries: The organization collects data on the following: The frequency of billing and coding errors.

EP 20



• Frequency of billing and coding errors (e.g., number of Medicare claims denied, errors the supplier finds in its own records after it has been notified of a claims denial); and


The organization collects data on adverse events involving patients due to inadequate or malfunctioning equipment, supplies, or services (for example, injuries, accidents, signs and symptoms of infection, and hospitalizations).

EP 21



• Adverse events to beneficiaries due to inadequate service(s) or malfunctioning equipment and/or item(s) (e.g., injuries, accidents, signs and symptoms of infection, hospitalizations). This may be identified through follow-up with the prescribing physician, other healthcare team member(s), or the beneficiary and/or caregiver(s).


For DMEPOS suppliers serving Medicare beneficiaries: The organization seeks input from employees, beneficiaries, and referral sources when assessing the quality of its operations and services.

EP 35



3. The supplier shall seek input from employees, customers, and referral sources when assessing the quality of its operations and services.


F. Product Safety


EC.04.01.01 The organization collects information to monitor conditions in the environment.

The organization establishes and implements a process(es) for internally reporting, investigating, and documenting the following:- Injuries to patients, staff, or others within the organization’s facilities- Security incidents involving patients, staff (including staff in the field), or others- Hazardous materials and waste spills and exposures- Fire safety management problems, deficiencies, and failuresNote 1: This bullet on fire safety management is applicable only for inpatient hospice, ambulatory infusion, and facility-based rehabilitation technology.- Equipment management problems, failures, and use errors.- Utility systems management problems, failures, or use errors. Note 2: This bullet on utility systems management is applicable only for inpatient hospice, ambulatory infusion, and facility-based rehabilitation technology.

EP 1


F. Product Safety

• Implement a program that promotes the safe use of equipment and item(s) and minimizes safety risks, infections, and hazards both for its staff and for beneficiaries;

EC.04.01.01 The organization collects information to monitor conditions in the environment.I: Supplier Business Services Requirements

F. Product Safety

• Implement and maintain a plan for identifying, monitoring, and reporting (where indicated) equipment and item(s) failure, repair, and preventive maintenance provided to beneficiaries;



Quality Standard


Joint Commission


The organization establishes and implements a process(es) for internally reporting, investigating, and documenting the following:- Injuries to patients, staff, or others within the organization’s facilities- Security incidents involving patients, staff (including staff in the field), or others- Hazardous materials and waste spills and exposures- Fire safety management problems, deficiencies, and failuresNote 1: This bullet on fire safety management is applicable only for inpatient hospice, ambulatory infusion, and facility-based rehabilitation technology.- Equipment management problems, failures, and use errors.- Utility systems management problems, failures, or use errors. Note 2: This bullet on utility systems management is applicable only for inpatient hospice, ambulatory infusion, and facility-based rehabilitation technology.

EP 1

The organization identifies, reports within the organization, and investigates equipment management problems, failures, and use errors for equipment provided to the patient.

EP 17


patients.

The organization performs basic safety, operation, and function checks and repairs on medical equipment according to the organization’s policy and manufacturers’ guidelines. The organization documents the performance of these checks and repairs.

EP 3

EC.04.01.01 The organization collects information to monitor conditions in the environment.

The organization investigates any incident or injury in which equipment or supplies may have contributed to the incident or injury. Note: The investigation includes all necessary information, pertinent conclusions about what happened, and whether changes in systems or processes are needed. The organization considers possible links between the items and services furnished and the adverse event.

EP 18

For DMEPOS suppliers serving Medicare beneficiaries: When the supplier becomes aware of an incident or injury resulting in a Medicare beneficiary's hospitalization or death, it initiates an investigation within 24 hours.

EP 19

For DMEPOS suppliers serving Medicare beneficiaries: When the supplier becomes aware of an incident or injury that does not result in a Medicare beneficiary's hospitalization or death, it initiates an investigation within 72 hours.

EP 20


F. Product Safety

• Investigate any incident, injury or infection in which DMEPOS may have contributed to the incident, injury or infection, when the supplier becomes aware. The investigation should be initiated within 24 hours after the supplier becomes aware of an incident, injury or infection resulting in a beneficiary’s hospitalization or death. For other occurrences, the supplier shall investigate within 72 hours after being made aware of the incident, injury or infection. The investigation includes all necessary information, pertinent conclusions about what happened, and whether changes in system(s) or processes are needed. The supplier should consider possible links between the equipment, item(s) and service(s) furnished and the adverse event;

EM.02.01.01 The organization has an Emergency Operations Plan.

Note: The organization’s Emergency Operations Plan (EOP) is designed to coordinate

its communications, resources and assets, staff responsibilities, utilities, and patient

clinical and support activities during an emergency (refer to Standards EM.02.02.01,

EM.02.02.03, EM.02.02.07, EM.02.02.09, and EM.02.02.11). Although emergencies have

many causes, the effects on these areas of the organization and the required response

effort may be similar. This "all hazards" approach supports a general response

capability that is sufficiently nimble to address a range of emergencies of different

duration, scale, and cause. For this reason, the plan’s response procedures address

the prioritized emergencies but are also adaptable to other emergencies that the

organization may experience.


F. Product Safety

• Have a contingency plan that enables it to respond to emergencies and disasters or to have arrangements with alternative suppliers in the event that the supplier cannot service its own customers as the result of an emergency or disaster; and



Quality Standard


Joint Commission


The organization has a written Emergency Operations Plan that describes the response procedures to follow when emergencies occur. (See also EM.03.01.03, EP 5 and EP 19)Note 1: The response procedures address the prioritized emergencies but can also be adapted to other emergencies that the organization may experience. Response procedures could include the following: - Maintaining or expanding services- Conserving resources- Curtailing services- Helping patients and families develop a home emergency plan- Educating them about self-care and sources of alternative care in the community- Coordinating home visits from another agency office or alternative care site in the community- Supplementing resources from outside the local community- Curtailing admissions of new patientsNote 2: These expectations do not require the organization to expand services to new patients or evacuate patients from their homes. Organizations that do not provide 24-hour care may plan to close in response to an emergency; their activities may be focused on notification and communication to patients and their families, and strategies for resuming service following an emergency.

EP 2

EM.02.02.03 As part of its Emergency Operations Plan, the organization prepares for how it will

manage resources and assets during emergencies.

The Emergency Operations Plan describes the following: The organization's arrangements with other organizations in the event that it cannot serve its own customers as the result of an emergency.

EP 8


For DMEPOS suppliers serving Medicare beneficiaries: Prior to delivery of equipment or supplies, the organization verifies or authenticates that the equipment and supplies meet the following: - Are not adulterated, counterfeit, or suspected of being counterfeit- Have not been obtained by fraud or deceit- Are branded correctly and labeled for their intended distribution channelsThe verification or authentication of the equipment and supplies is documented.

EP 13


F. Product Safety

• Verify, authenticate, and document the following prior to distributing, dispensing, or delivering products to an end-user:



EP 13


F. Product Safety

- The products are not adulterated, counterfeit, suspected of being counterfeit, and have not been obtained by fraud or deceit; and



EP 13


F. Product Safety

- The products are not misbranded and are appropriately labeled for their intended distribution channels.

IM.02.01.01 The organization protects the privacy of health information.I: Supplier Business Services Requirements

G. Information Management



Quality Standard


Joint Commission


The organization maintains confidential patient records in accordance with privacy and security standards of the Health Insurance Portability and Accountability Act (HIPAA) and other applicable state laws. (See also RI.01.01.01, EP 7)

EP 6

IM.02.01.03 The organization maintains the security and integrity of health information.

The organization maintains secure patient records in accordance with privacy and security standards of the Health Insurance Portability and Accountability Act (HIPAA) and other applicable state laws.

EP 9

RC.01.01.01 The organization maintains complete and accurate patient records.

The organization maintains accurate, pertinent, and accessible patient records, in accordance with law and regulation.

EP 15

The supplier shall maintain accurate, pertinent, accessible, confidential, and secure beneficiary records, in accordance with privacy and security standards of the Health Insurance Portability and Accountability Act (HIPAA) and other applicable Statestandards.

PC.02.01.03 The organization provides care, treatment, or services in accordance with orders or

prescriptions, as required by law and regulation.

For DMEPOS suppliers serving Medicare beneficiaries: The organization provides all medical equipment and supplies to serve a medical purpose covered under the Medicare program and may require the physician to collaborate and coordinate clinical services with other health care professionals (for example, providers of orthotics and prosthetics; occupational, physical, and respiratory therapists; and pedorthists).

EP 10

II. Supplier Product-Specific Service Requirements

Supplier Product-Specific Service Requirements

1. All DMEPOS must serve a medical purpose to be covered under the Medicare program and may require the prescribing physician to collaborate and coordinate clinical services with other healthcare professionals (e.g., orthotists; prosthetists; occupational, physical, respiratory therapists; pedorthists; etc.).


Supplier Product-Specific Service Requirements

2. In addition to the supplier product-specific service requirements in this section, the DMEPOS supplier shall implement the requirements stated in Appendices A through C, as applicable to its business.



The organization consults with the prescribing physician as needed to confirm the physician’s order(s).EP 3

For DMEPOS suppliers serving Medicare beneficiaries: The organization recommends any necessary changes, refinements, or additional evaluations to the prescribed equipment, supplies, and services.

EP 6


A. Intake and Assessment

1. The supplier shall consult with the prescribing physician as needed to confirm the order and to recommend any necessary changes, refinements, or additional evaluations to the prescribed equipment, item(s), and/or service(s).



Beneficiary’s Record


PC.01.03.01 The organization plans the patient’s care.

For DMEPOS suppliers serving Medicare beneficiaries: The organization, in collaboration with the prescribing physician, reviews the patient’s record and incorporates information related to the patient’s condition(s) or to the actual equipment, supplies, or services provided.

EP 29



• Review the beneficiary’s record as appropriate and incorporate any pertinent information, related to the beneficiary’s condition(s) which affect the provision of the DMEPOS and related services, or to the actual equipment, item(s) and service(s) provided, in collaboration with the prescribing physician; and



Quality Standard


Joint Commission


IM.02.01.03 The organization maintains the security and integrity of health information.

The organization protects health information against loss, damage, unauthorized alteration, unintentional change, and accidental destruction.

EP 6


services.

The patient record contains the following clinical information:- Any medications administered, including dose- Any activity restrictions- Any changes in the patient's condition- Any summaries of the patient's care, treatment, or services furnished to the patient’s physician or licensed independent practitioner(s)- The patient's medical history- Any allergies or sensitivities- Any adverse drug reactions- The patient's functional status- Any diet information or any dietary restrictions- Diagnostic and therapeutic tests, procedures, and treatments, and their results- Any specific notes on care, treatment, or services- The patient's response to care, treatment, or services- Any assessments relevant to care, treatment, or services - Physician orders- Any information required by organization policy, in accordance with law and regulation- A list of medications, including dose, frequency, and route of administration for prescription and nonprescription medications, herbal products, and home remedies that relate to the patient's care, treatment, or services- The plan of care- For DMEPOS suppliers serving Medicare beneficiaries: The DMEPOS prescription, any certificates of medical necessity (CMN), and pertinent documentation from the beneficiary's prescribing physician. (See also PC.01.02.01, EP 1; PC.01.03.01, EPs 1 and 23)Note 1: For organizations that provide personal care and support services: The plan of care may be a part of the service agreement or service contract, a list of duties to be carried out by the personal care or support service staff, or another separate document.Note 2: For organizations that provide personal care and support services: The patient record contains the documentation on the list noted above that applies to the care, treatment, or services provided by the personal care and support staff.

EP 2



• The DMEPOS prescription, any certificates of medical necessity (CMNs), and pertinent documentation from the beneficiary’s prescribing physician shall be kept unaltered in the beneficiary’s record.


B. Delivery and Setup



The organization delivers medical equipment and supplies in a time frame that meets the patient’s needs, as agreed upon by the patient or caregiver, organization, and prescribing physician.

EP 8

EQ.01.02.01 The organization safely sets up medical equipment in the patient’s home.

For DMEPOS suppliers serving Medicare beneficiaries: The supplier sets up all medical equipment in the time frame agreed to by the beneficiary or caregiver, the organization, and the prescribing physician.

EP 1



• Deliver and set-up, or coordinate set-up with another supplier, all equipment and item(s) in a timely manner as agreed upon by the beneficiary and/or caregiver, supplier, and prescribing physician;



Quality Standard


Joint Commission


For DMEPOS suppliers serving Medicare beneficiaries: When the supplier coordinates setup of medical equipment with another organization, all equipment is set up in the time frame agreed to by the beneficiary or caregiver, the organization, and the prescribing physician.

EP 2


When setting up medical equipment in the home, the organization does the following: Provides all supplies that are necessary to operate the equipment.

EP 3

When setting up medical equipment in the home, the organization does the following: Adapts, fits, or adjusts the medical equipment to meet the patient’s needs.

EP 6



• Provide all equipment and item(s) that are necessary to operate the equipment or item(s) and perform any further adjustments as applicable;


patients.

For DMEPOS suppliers serving Medicare beneficiaries: The supplier provides or arranges for loaner equipment equivalent to the original equipment during any repair of beneficiary-owned equipment. Note: Loan equipment may be provided free of charge or for a fee.

EP 6



• Provide, or arrange for, loaner equipment equivalent to the original equipment during any repair period except for orthotics and prosthetics; and


The organization selects and delivers medical equipment and supplies to the patient that are consistent with the patient’s known and identified needs, risks, and limitations.

EP 10



The organization confirms that the item delivered to the patient is consistent with the prescribing physician’s order.

EP 11



• Assure that all equipment and item(s) delivered to the beneficiary is consistent with the prescribing physician’s order and identified beneficiary needs, risks, and limitations of which the supplier is aware.


C. Training/Instruction to Beneficiary and/or Caregiver(s)

1. The supplier shall, as applicable:


needs and abilities.

The organization provides or coordinates the provision of instructions related to setup, features, routine use, troubleshooting, cleaning, and maintenance of equipment or supplies it provides.Note: Setup includes preparation of formulas.

EP 12

The organization provides information and instructions about infection control issues related to the equipment and supplies it provides.

EP 13



• Provide, or coordinate the provision of, appropriate information related to the set-up (including preparation of enteral/parenteral nutrients), features, routine use, troubleshooting, cleaning, infection control practices, and maintenance of all equipment and item(s) provided;




EP 13



• Provide relevant information and/or instructions about infection control issues related to the use of all equipment and item(s) provided;



Quality Standard


Joint Commission




For mail-order supplies or equipment: The organization verifies that the patient has received training and written instructions with the initial delivery of the equipment or supplies.

EP 14


services.

The organization documents in the patient record that the patient received training and instructions on the use of items supplied by mail order at the time of their initial delivery.

EP 17



• For initial equipment and/or item(s) provided by mail order delivery: Verify and document in the beneficiary’s record that the beneficiary and/or caregiver(s) has received training and written instructions on the use of the equipment and item(s); and



The organization provides written and verbal instructions to the patient and/or caregiver about the equipment, supplies, and services provided. The instructions cover the following topics, as appropriate to the equipment, supplies, or services:- Use of the equipment or supplies- Maintenance of the equipment - Potential hazards and safety considerations related to the equipment, supplies, or services Note: Written instructions may include pictures to illustrate the information being provided.

EP 11

The organization evaluates the patient’s understanding of the education and training it provided.EP 25



• Ensure that the beneficiary and/or caregiver(s) can use all equipment and item(s) provided safely and effectively in the settings of anticipated use.



The organization tailors education and training materials and techniques to the needs of individual patients or caregivers.

EP 2

The organization tailors education and training materials and techniques to accommodate the patient’s or caregiver’s learning preferences and language. (See also RI.01.01.03, EP 1)

EP 3

The organization provides education and training that is tailored to the risks, complexity, and manufacturers' instructions or specifications for the items being provided.

EP 15



2. Beneficiary and/or caregiver(s) training and instructions shall be commensurate with the risks, complexity, and manufacturer’s instructions and/or specifications for the equipment and item(s). The supplier shall tailor training and instruction materials and approaches to the needs, abilities, learning preferences, and language of the beneficiary and/or caregiver(s).

PC.02.02.01 The organization coordinates the patient’s care, treatment, or services based on the

patient’s needs.

The organization provides follow-up to the patient consistent with the services or equipment provided and recommendations from the physician or health care team.

EP 16


D. Follow-up

The supplier shall provide follow-up services to the beneficiary and/or caregiver(s), consistent with the type(s) of equipment, item(s) and service(s) provided, and recommendations from the prescribing physician or healthcare team member(s).

Appendix A: Respiratory Equipment, Supplies, and Services

1. Respiratory Equipment, Supplies, and Services

1. Respiratory Services encompass the provision of home medical equipment and supplies (described below) that require technical and professional services.



Quality Standard


Joint Commission


PC.02.02.05 The organization provides the patient with access to care, treatment, or services during

nonbusiness hours.

For providers of respiratory equipment, supplies, and services: The organization provides respiratory equipment and services 24 hours a day, 7 days a week, as needed by the patient.

EP 2



2. The supplier shall provide respiratory services 24 hours a day, 7 days a week as needed by the beneficiary and/or caregiver(s).



3. Home medical equipment and supplies covered in this appendix include:• Oxygen concentrators, reservoirs, high-pressure cylinders, oxygen accessories and supplies, and oxygen conserving devices;• Home Invasive Mechanical Ventilators;• Continuous Positive Airway Pressure (CPAP) Devices;• Respiratory Assist Devices (RAD);• Intermittent Positive Pressure Breathing (IPPB) Devices; and• Nebulizers.



Refer to Section II: Supplier Product-Specific Service Requirements.


For DMEPOS suppliers serving Medicare beneficiaries: When delivering respiratory equipment, supplies, and services to Medicare beneficiaries, the supplier complies with all of the following current American Association for Respiratory Care Practice Guidelines: - Oxygen Therapy in the Home or Extended Care Facility- Long Term Invasive Mechanical Ventilation in the Home- Intermittent Positive Pressure Breathing(See also PC.02.03.01, EP 16)

EP 11


For DMEPOS suppliers serving Medicare beneficiaries: When setting up respiratory equipment and supplies for Medicare beneficiaries, the supplier complies with all of the following current American Association for Respiratory Care Practice Guidelines:- Oxygen Therapy in the Home or Extended Care Facility- Long Term Invasive Mechanical Ventilation in the Home- Intermittent Positive Pressure Breathing(See also PC.02.03.01, EP 16)

EP 8


B. Delivery and Set-up

1. In addition to the requirements described in Section II: Supplier Product-Specific Service Requirements, the supplier shall comply with the current version of the American Association for Respiratory Care Practice Guidelines listed below:• Oxygen Therapy in the Home or Extended Care Facility;• Long Term Invasive Mechanical Ventilation in the Home; and• IPPB.


needs and abilities.Appendix A: Respiratory Equipment, Supplies, and Services

C.Training/Instruction to Beneficiary and/or Caregiver(s)



Quality Standard


Joint Commission


For DMEPOS suppliers serving Medicare beneficiaries: The organization provides education and training about respiratory equipment, supplies, and services to patients or caregivers. This training and instruction is consistent with the following current American Association for Respiratory Care Practice Guidelines: - Long Term Invasive Mechanical Ventilation in the Home- Oxygen Therapy in the Home or Extended Care Facility- Intermittent Positive Pressure Breathing- Providing Patient and Caregiver Training- Suctioning of the Patient in the Home(See also EQ.01.01.01, EP 11; EQ.01.02.01, EP 8)

EP 161. In addition to the requirements described in Section II: Supplier Product-Specific Service Requirements, the supplier shall comply and provide training to the beneficiary and/or caregiver(s) consistent with the current version of the American Association for Respiratory Care Practice Guidelines listed below:• Long Term Invasive Mechanical Ventilation in the Home;• Oxygen Therapy in the Home or Extended Care Facility;• IPPB;• Providing Patient and Caregiver Training; and• Suctioning of the Patient in the Home.


D. Follow-up


Appendix B: Manual Wheelchairs, Power Mobility Devices, and Complex

Rehabilitative Wheelchairs and Assistive Technology

I. Manual Wheelchairs

This appendix applies to Manual Wheelchairs, Power Mobility Devices (PMDs), and Complex Rehabilitative Wheelchairs and Assistive Technology. Manual wheelchairs include standard recliners, heavy-duty wheelchairs, standard lightweight wheelchairs, and hemi wheelchairs, armrests, legrests/footplates, anti-tipping devices, and other Medicare approved accessories. PMDs include power wheelchairs and power operated vehicles (POVs) and accessories. Complex Rehabilitative Wheelchairs are Group 2 power wheelchairs with power options, Group 3 and higher power wheelchairs and manual wheelchairs that can accommodate rehabilitative accessories and features (e.g., tilt in space).

PC.01.02.01 The organization assesses and reassesses its patients.

For DMEPOS suppliers serving Medicare beneficiaries: The organization evaluates seating, positioning, and specialty assistive technology to verify that they meet the beneficiary’s needs.

EP 30


services.

For DMEPOS suppliers serving Medicare beneficiaries: The organization documents in the patient record the evaluation of the seating, positioning, and specialty assistive technology to be provided to the beneficiary.

EP 24




A. Intake & Assessment




B. Delivery & Set-up






Quality Standard


Joint Commission








D. Follow-up




EP 30


services.


EP 24



II. Power Mobility Devices


In addition to Section II: Supplier Product-Specific Service Requirements, the supplier shall verify that seating, positioning and specialty assistive technology have been evaluated and documented in the beneficiary’s record.














D. Follow-up




III. Complex Rehabilitative Wheelchairs and Assistive Technology



Quality Standard


Joint Commission


In addition to Section II: Supplier Product-Specific Service Requirements, the suppliershall:

HR.01.01.01 The organization has the necessary staff to support the care, treatment, or services it

provides.

For DMEPOS suppliers serving Medicare beneficiaries: The organization employs (as a W-2 employee) at least one qualified individual per location as a rehabilitation technology supplier (RTS). (See also HR.01.02.01, EP 8)

EP 19




1. Employ (W-2 employee) at least one qualified individual as a Rehabilitative Technology Supplier (RTS) per location.


For DMEPOS suppliers serving Medicare beneficiaries: The organization employs a qualified rehabilitation technology supplier (RTS) that possesses one of the following credentials: Certified Rehabilitative Technology Supplier (CRTS) or Assistive Technology Professional (ATP). (See also HR.01.01.01, EP 19)

EP 8




A qualified RTS is an individual that has one of the following credentials:• Certified Rehabilitative Technology Supplier (CRTS);• Assistive Technology Supplier (ATS) (discontinued 12/31/2008);• Assistive Technology Practitioner (ATP) (discontinued 12/31/2008);• Assistive Technology Professional (AT) (effective 1/1/2009).

HR.01.01.01 The organization has the necessary staff to support the care, treatment, or services it

provides.

For DMEPOS suppliers serving Medicare beneficiaries: The organization determines the number of trained technicians available to serve each location, based on the size and scope of the location’s business. (See also HR.01.02.01, EP 9)

EP 20


For organizations that provide complex rehabilitative wheelchairs and assistive technology: The trained technicians have all of the following:- Factory training from manufacturers of the products the organization supplies- Experience in the field of rehabilitation technologyNote: Experience includes, but is not limited to, on-the-job training or familiarity with rehabilitation patients, products, and services.- For DMEPOS suppliers serving Medicare beneficiaries: Completed at least 10 hours annually of continuing education specific to rehabilitation technology- Ability to program and repair sophisticated electronics associated with power wheelchairs, alternative drive controls, and power seating systems (See also HR.01.01.01, EP 20)

EP 9




2. The RTS shall have at least one or more trained technicians available to service each location appropriately depending on the size and scope of its business. A trained technician is identified by the following:• Factory trained by manufacturers of the products supplied by the company;• Experienced in the field of Rehabilitative Technology, (e.g., on the job training, familiarity with rehabilitative clients, products and services);• Completed at least 10 hours annually of continuing education specific to Rehabilitative Technology; and• Able to program and repair sophisticated electronics associated with power wheelchairs, alternative drive controls, and power seating systems.




3. The RTS shall:

PC.02.01.05 The organization provides interdisciplinary, collaborative care, treatment, or services.

For complex rehabilitation and assistive technology services: The organization coordinates services with the prescribing physician to conduct face-to-face evaluations of the patient in a setting conducive to the patient's condition.

EP 3






Quality Standard


Joint Commission


For complex rehabilitation and assistive technology services: The organization includes information from other health care team members, such as physical therapists, occupational therapists, and the physician, in the delivery of its products.

EP 21• Coordinate services with the prescribing physician to conduct face-to-face evaluations of the beneficiary in an appropriate setting and include input from other members of the health care team (i.e., PT, OT, etc.);


For DMEPOS suppliers serving Medicare beneficiaries: The supplier provides the beneficiary with equipment for trial and simulation, as needed.

EP 5




• Provide the beneficiary with appropriate equipment for trial and simulation, when necessary;


services.

For suppliers of complex rehabilitation and assistive technology services: The organization documents in the patient record all information obtained during the assessment.

EP 18




• Maintain in the beneficiary’s record all of the information obtained during the assessment; and




EP 13




• Implement procedures for assembly and set-up of equipment as well as a process to verify that the final product meets the specifications of the original product recommendation approved by the prescribing physician.




4. If beneficiaries are evaluated in the supplier’s facility, the supplier shall:

EC.02.06.01 The organization establishes and maintains a safe, functional environment.

For complex rehabilitation and assistive technology services: When patients are evaluated in the organization’s facility, the organization provides private, clean, and safe rooms for fittings and evaluations.

EP 3




• Provide the beneficiary private, clean, and safe rooms appropriate for fittings and evaluations; and

EC.02.06.01 The organization establishes and maintains a safe, functional environment.

When patients are evaluated in the organization’s facility, the organization has a repair shop, located either in the facility or in close proximity, for repair, assembly, or modification of products.

EP 16




• Maintain a repair shop located in the facility or in close proximity or easily accessible from another location of the supplier, as well as an area appropriate for assembly and modification of products.

PC.01.02.01 The organization assesses and reassesses its patients.Appendix B: Manual Wheelchairs, Power Mobility Devices, and Complex




Quality Standard


Joint Commission



EP 30


services.


EP 24



In addition to Section II: Supplier Product-Specific Service Requirements, the supplier shall verify that seating, positioning and specialty assistive technology have been evaluated and documented in the beneficiary’s record.














D. Follow-up


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

Custom Fabrication

The supplier shall be trained in a broad range of treatment options to ensure that the item(s) prescribed is/are optimal for the beneficiary’s condition. The provision of custom fabricated or custom fitted devices (i.e., other than off-the-shelf items) requires access to a facility with the equipment necessary to fulfill the supplier’s responsibility to provide follow-up treatment, including modification, adjustment, maintenance and repair of the item(s).

HR.01.02.01 The organization defines staff qualifications.Appendix C: Custom Fabricated and Custom Fitted Orthoses, Prosthetic



Prostheses

Custom Fabrication



Quality Standard


Joint Commission


The organization has written policies and job descriptions that specify the following staff requirements specific to the specialized equipment, supplies, and services it provides to patients:- Qualifications- Experience - Applicable certification, registration, or licensure- Training requirements- Continuing education requirements

EP 2

For DMEPOS suppliers serving Medicare beneficiaries: Staff who provide patient care, treatment, or services have the qualifications required by the organization’s job descriptions and policies.

EP 20

Individuals supplying the item(s) set out in this appendix must possess specialized education, training, and experience in fitting, and certification and/or licensing.




Prostheses

Definitions of Terms

The terms below are used to describe the types of devices referred to in this appendix.




Prostheses

Definitions of Terms



Quality Standard


Joint Commission


1. Custom Fabricated:

A custom fabricated item is one that is individually made for a specific patient. No other patient would be able to use this item. A custom fabricated item is a device which is fabricated based on clinically derived and rectified castings, tracings, measurements, and/or other images (such as x-rays) of the body part. The fabrication may involve using calculations, templates and components. This process requires the use of 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 prior to fitting on the patient.

2. Molded-to-Patient-Model: A particular type of custom fabricated device in which either:a) An impression (usually by means of a plaster, or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; orb) A digital image of the patient's body part is made using computer-aided design-computer aided manufacturing (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 positive model. The device is then individually fabricated and molded over the positive model of the patient.

3. Positive Model of the Patient:a) Molded to patient model is a negative impression taken of the patient's body member and a positive model rectification is constructed; orb) CAD-CAM system, by use of digitizers, transmits surface contour data to software that the practitioner uses to rectify or modify the model on the computer screen. The data depicting the modified shape is electronically transmitted to a commercial milling machine that carves the rectified model; orc) Direct formed model is one in which the patient serves as the positive model. The device is constructed over the model of the patient and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made.

4. Custom Fitted:A prefabricated device, which is manufactured in quantity without a specific patient in mind. The device may or may not be supplied as a kit that requires some assembly and/or fitting and adjustment, or a device that must be trimmed, bent, molded (with or without heat), or otherwise modified by an individual with expertise in customizing the item to fit and be used by a specific patient.

5. Prosthetic Devices:Devices (other than dental) which replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ. This does not require a determination that there is no possibility that the patient’s condition may improve sometime in the future. If the medical record, including the judgment of the attending physician, indicates the condition is of long and indefinite duration, the test of permanence is considered met. (Refer to Section 120 of Chapter 15 of the Medicare Benefit Policy Manual)

6. Orthotic Devices: Rigid and semi-rigid devices used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body.

7. Ocular Prostheses:



Quality Standard


Joint Commission


Custom-fabricated ocular prostheses that replace the globe of the eye or cover the existing unsightly eye as a result of 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, as well as the custom-made ocular prosthesis component that is integrated into an orbital, upper facial, or hemifacial prosthesis.

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

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

10. External Breast Prostheses: Prefabricated or custom fabricated forms, bras, and sleeves.(Refer to Section 120 of Chapter 15 of the Medicare Benefit Policy Manual)

11. Off-The-Shelf Orthoses: Orthoses which requires minimal self adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit the beneficiary. Appendix C does not apply to off-the-shelf orthotics. (Refer to 42

12. Therapeutic Shoes and Inserts: Includes depth or custom-molded shoes along with inserts for individuals with diabetes (Refer to Section 140 of Chapter 15 of the Medicare Benefit Policy Manual)a. Custom-Molded Shoes:• Are constructed over a positive model of the patient’s foot;• Are made from leather or other suitable material of equal quality;• Have removable inserts that can be altered or replaced as the patient’s condition warrants; and• Have some form of shoe closure.b. Depth Shoes:• Have a full length, heel-to-toe filler that, when removed, provides a minimum of 3/16 inch of additional depth used to accommodate custom-molded or customized inserts;• Are made from leather or other suitable material of equal quality;• Have some form of shoe closure; and• Are available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoes according to the American standard last sizing schedule or its equivalent. (The American standard last sizing schedule is the numerical shoe sizing system used for shoes sold in the United States.)c. Inserts:• Are total contact, multiple density, removable inlays that are directly molded to the patient’s foot or a model of the patient’s foot and that are made of a suitable material with regard to the patient’s condition.



Quality Standard


Joint Commission





Prostheses


In addition to Section II: Supplier Product-Specific Service Requirements, the supplier shall:


Based on the patient’s condition and the care, treatment, or services it provides, the organization defines, in writing, which of the following information it collects in the patient’s assessment and reassessment:- Pertinent diagnoses- Pertinent physical findings- Pertinent medical history- Functional status- Psychosocial status- Cultural or religious practices that may affect care- Care the family or support system is capable of and willing to provide- Educational needs, including the abilities, motivation, and readiness to learn- Barriers and safety hazards in the home environment- Any other relevant information that may affect the patient's goals

EP 5

For DMEPOS suppliers serving Medicare beneficiaries: The organization assesses the beneficiary’s need for and use of custom orthotics or prosthetics, previous use of a custom orthotic or prosthetic, results of diagnostic evaluations, and beneficiary expectations.

EP 31


services.

For DMEPOS suppliers serving Medicare beneficiaries: The organization collects pre-treatment photographic documentation when needed for custom orthotics and prosthetics to be provided to the beneficiary.

EP 19




Prostheses


• Assess the beneficiary’s need for and use of the orthoses/prostheses (e.g., comprehensive history, pertinent medical history (including allergies to materials), skin condition, diagnosis, previous use of an orthoses/prostheses, results of diagnostic evaluations, beneficiary expectations, pre-treatment photographic documentation (when appropriate);


For DMEPOS suppliers serving Medicare beneficiaries: The organization determines the appropriate custom orthotic or prosthetic and specifications. The determination is based on the therapeutic benefits the beneficiary hopes to achieve and on the strength, durability, and function needed by the beneficiary for the custom orthotic or prosthetic being considered.

EP 32




Prostheses


• Determine the appropriate orthoses/prostheses and specifications based on beneficiary need for use of the orthoses/prostheses to ensure optimum therapeutic benefits and appropriate strength, durability, and function as required for the beneficiary;



For custom orthotics and prosthetics services: The organization confirms that the implementation plan is consistent with the prescribing physician’s dispensing order and/or the written plan of care and that it is in accordance with Medicare rules.

EP 12




Prostheses




Quality Standard


Joint Commission




The organization tailors education and training materials and techniques to accommodate the patient’s or caregiver’s learning preferences and language. (See also RI.01.01.03, EP 1)

EP 3

• Formulate a treatment plan that is consistent with the prescribing physician’s dispensing order and/or the written plan of care, in accordance with Medicare rules, and consult the physician when appropriate;


For custom orthotics and prosthetics services: The organization performs an in-person diagnosis-specific functional clinical examination for the use of custom orthotics and prosthetics.Note: Such an exam could include sensory function, range of motion, joint stability, skin condition (integrity, color, temperature), presence of edema and wounds, vascularity, pain, manual muscle testing, compliance, cognitive ability, and medical history.

EP 29




Prostheses


• Perform an in person diagnosis-specific functional clinical examination as related to the beneficiary’s use and need of the orthoses/prostheses (e.g., 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);


For custom orthotics and prosthetics services: The organization establishes goals and expected outcomes for the patient. Note: Examples of goals or outcomes include reducing pain, increasing comfort, enhancing function and independence, providing joint stability, preventing deformity, increasing range of motion, addressing cosmetic issues, and promoting healing.

EP 11


For DMEPOS suppliers serving Medicare beneficiaries: The organization solicits feedback from the physician, as necessary, to determine the effectiveness of the device, prosthetic, orthotic, or shoe provided to the patient.

EP 24



For custom orthotics and prosthetics services: The organization asks the patient for comments to determine the effectiveness of the custom orthotics and prosthetics provided. Note: Based on the type of custom orthotic or prosthetic, the patient might be asked about his or her wear schedule or tolerance of the orthotic or prosthetic, comfort, perceived benefits, ability to don and doff, satisfaction with the usefulness and function of the orthotic or prosthetic.

EP 19




Prostheses


• Establish goals and expected outcomes of the beneficiary’s use of the orthoses/prostheses (e.g., reduce pain, increase comfort, enhance function and independence, provide joint stability, prevent deformity, increase range of motion, address cosmetic issues and/or promote healing) with feedback from the beneficiary and/or prescribing physician as necessary to determine the appropriateness of the orthoses/prostheses;


For custom orthotics and prosthetics services: The organization communicates to the prescribing physician the recommended treatment plan and any optional plans, including disclosure of potential risks or benefits involved.

EP 19




Prostheses


• Communicate to the beneficiary and/or caregiver(s), and prescribing physician the recommended treatment plan, including disclosure of potential risk, benefits, precautions, the procedures for repairing, replacing, and/or adjusting the device oritem(s), and the estimated time involved in the process;



Quality Standard


Joint Commission




For custom orthotics and prosthetics services: The organization provides the following instructions to the patient or caregiver:- Use, cleaning, and maintenance instructions- The procedure for repairing, replacing, or adjusting the items, including any risks involved and the estimated time for the repair, replacement, or adjustment process- How to don and doff the custom orthotic or prosthetic, including how to adjust closures for proper fit- How to inspect the skin for pressure areas, redness, irritation, skin breakdown, pain, or edema - How and when to use an interface, such as stockinettes, socks, gloves, or shoes, to accommodate the custom orthotic or prosthetic- How to report any problems related to the custom orthotic or prosthetic to the supplier or prescribing physician Note: Such problems include changes in skin condition, increased pain, increased edema, wound concerns, changes in general health, height and/or weight, and intolerance to wearing the custom orthotic or prosthetic. - How to schedule follow-up appointments as necessary- How to establish a wear schedule based on tolerance of the custom orthotic or prosthetic

EP 17

RI.01.03.01 The organization honors the patient's right to give or withhold informed consent.

For custom orthotics and prosthetics services: The organization informs the patient of the recommended treatment plan.

EP 8

For custom orthotics and prosthetics services: The organization informs the patient about the potential risks, benefits, and precautions of the recommended treatment plan and any optional plans.

EP 10


For custom orthotics and prosthetics services: The organization assesses custom orthotics and prosthetics for structural safety and follows the manufacturer’s guidelines prior to face-to-face fitting or delivery of the product. Note: Considerations might include weight limits, functioning closures, and absence of defects.

EP 3




Prostheses


• Assess the orthoses/prostheses for structural safety and ensure that manufacturer guidelines are followed prior to face-to-face fitting/delivery (e.g., beneficiary weight limits, ensuring that closures work properly and do not demonstrate defects); and



For custom orthotics and prosthetics services: The organization confirms that the implementation plan is consistent with the prescribing physician’s dispensing order and/or the written plan of care and that it is in accordance with Medicare rules.

EP 12




Prostheses


• Ensure the treatment plan is consistent with the prescribing physician’s dispensing order.




Prostheses

B. Delivery and Set-up



Quality Standard


Joint Commission


Not applicable to this appendix.




Prostheses






EP 17




Prostheses


• Provide instructions to the beneficiary and/or caregiver(s) for the specific orthoses, prostheses, or therapeutic shoe/inserts as follows: - How to use, maintain, and clean the orthoses/prostheses (e.g., wearing schedules, therapy, residual limb hygiene, other pertinent instructions); - How to don and doff 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 utilize an appropriate interface (e.g., stockinettes, socks, gloves, shoes) to accommodate the orthoses/prostheses where appropriate; - How to report any problems related to the orthoses/prostheses to the supplier or the prescribing physician if changes are noted (e.g., changes in skin condition, heightened pain, increase in edema, wound concerns, changes in general health, height, weight, or intolerance to wearing the orthoses/prostheses as applicable); - How to schedule follow-up appointments as necessary; and - How to establish an appropriate “wear schedule” and schedule for tolerance of the orthoses/prostheses.



For custom orthotics and prosthetics services: The organization provides instructions to the patient or caregiver about the necessary supplies (for example, adhesives, solvents, and lubricants) needed to attach, maintain, and clean the items. The organization also provides information about how to obtain more of the necessary supplies.

EP 18




Prostheses


• Provide necessary supplies (e.g., adhesives, solvents, lubricants) to attach, maintain, and clean the items, as applicable, and information about how to subsequently obtain necessary supplies; and


patient’s needs.

For custom orthotics and prosthetics services: The organization refers the patient to the physician for treatments or interventions that are beyond the organization’s scope of practice.

EP 13




Prostheses




Quality Standard


Joint Commission


• Refer the beneficiary back to the prescribing physician as necessary for intervention beyond the supplier’s scope of practice.




Prostheses

D. Follow-up



For custom orthotics and prosthetics services: The organization has access, either directly or through another provider, to the equipment needed to modify or adjust custom orthotics and prosthetics.

EP 4




Prostheses

D. Follow-up

• Have access to a facility with the equipment necessary to provide follow-up treatment and fabrication/modification of the specific orthoses/prostheses;




EP 17




Prostheses

D. Follow-up

• Review recommended maintenance with the beneficiary and/or caregiver(s);



For custom orthotics and prosthetics services: The organization asks the patient for comments to determine the effectiveness of the custom orthotics and prosthetics provided. Note: Based on the type of custom orthotic or prosthetic, the patient might be asked about his or her wear schedule or tolerance of the orthotic or prosthetic, comfort, perceived benefits, ability to don and doff, satisfaction with the usefulness and function of the orthotic or prosthetic.

EP 19




Prostheses

D. Follow-up

• Solicit feedback from the beneficiary and/or caregiver and prescribing physician as necessary to determine the effectiveness of the orthoses/prostheses (e.g., wear schedule/tolerance, comfort, perceived benefits/detriments, ability to don and doff, proper usage and function, overall beneficiary satisfaction);



Quality Standard


Joint Commission



Based on the goals established in the patient’s plan of care, staff evaluate the patient’s progress.EP 22

The organization revises plans and goals for care, treatment, or services based on the patient’s needs. (See also RC.02.01.01, EP 2)

EP 23




Prostheses

D. Follow-up

• Review and make changes to the treatment plan based on the beneficiary’s current medical condition;

PC.02.01.01 The organization provides care, treatment, or services for each patient.

The organization provides the patient with care, treatment, or services according to his or her individualized plan of care.

EP 1




Prostheses

D. Follow-up

• Continue to assist the beneficiary until the orthoses/prostheses reaches the optimal level of fit and function consistent with the treatment plan; and


patient’s needs.

The organization provides follow-up to the patient consistent with the services or equipment provided and recommendations from the physician or health care team.

EP 16




Prostheses

D. Follow-up

• Provide appropriate beneficiary follow-up treatment consistent with the types of orthoses/prostheses or therapeutic shoe/inserts provided, the beneficiary’s diagnosis, specific care rendered, and recommendations.



durable medical equipment, prosthetics, orthotics, and ... · pdf filedurable medical...

Documents