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MEDICARE DMEPOS SUPPLIER STANDARDS
Note: This is an abbreviated version of the supplier standards every Medicare DMEPOS supplier must meet in order to obtain and retain their billing privileges. These standard , in their entirety, are listed in 42 C.F.R.424.57(c)
1. A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements.2. A supplier must provide complete and accurate information on the DMEPOS supplier application. Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days.
3. A supplier must have an authorized individual (whose signature is binding) sign the enrollment application for billing privileges.
4. A supplier must fill orders from its own inventory, or contract with other companies for the purchase of items necessary to fill orders. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or any other Federal procurement or non-procurement programs.
5. A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped rental equipment.
A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law, and repair or replace free of charge Medicare covered items that are under warranty.
7. A supplier must maintain a physical facility on an appropriate site and must maintain a visible sign with posted hours of operation. The location must be accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.
8. A supplier must permit CMS or its agents to conduct on-site inspections to ascertain the supplier’s compliance with these standards
9. A supplier must maintain a primary business telephone listed under the name of die business in a local directory or a toll free number available through directory assistance. The exclusive use of a beeper, answering machine, answering service or cell phone during posted business hours is prohibited.
10. A supplier must have comprehensive liability insurance in the amount of at least $300,000 that covers both the supplier's place of business and all customers and employees of the supplier. If the supplier manufactures its own items, this insurance must also cover product liability and completed operations.
11. A supplier is prohibited from direct solicitation to Medicare beneficiaries. For complete details on this prohibition see 42 CFR § 424.57 (c) (11).
12. A supplier is responsible for delivery of and must instruct beneficiaries on the use of Medicare covered item and maintain proof of delivery and beneficiary
13. A supplier must answer questions and respond io complaints of beneficiaries, and maintain documentation of such contacts.
14. A supplier must maintain and replace at no charge or repair cost either directly; or through a service contract with another company, any Medicare covered red items it has rented to beneficiaries.
15. A supplier must accept returns of substandard (less than full quality for the particular item) or unsuitable items (inappropriate for tire beneficiary at the time it was fitted and rented or sold) from beneficiaries.
16. A supplier must disclose these standards to each beneficiary it supplies a Medicare-covered item.
17. A supplier must disclose any person having ownership, financial, or control interest in the supplier.
18. A supplier must not convey or reassign a supplier number, i.e., the supplier may not sell or allow another entity to use its Medicare billing number.
19. A supplier must have a complaint resolution protocol establish to address beneficiary complaints that relate to these standards. A record of these complaints must be maintained at the physical facility.
20. Complaint records must include: the name, address, telephone number and health insurance claim number of the beneficiary, a summary of the complaint, and any actions take to resolve it.
21. A supplier must agree to furnish CMS any information required by the Medicare statute and regulations.
22. All suppliers must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services, for which the supplier is accredited in order for the supplier to receive payment for those specific products and services (except for certain exempt pharmaceuticals).
23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.
24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare.
25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.
26. A supplier must meet the surety bond requirements specified in 42 CFR § 424.57 (d).
27. A supplier must obtain oxygen from a state-licensed oxygen supplier.
28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 CFR § 424.5 t6(f).
29. A supplier is prohibited from sharing a practice location with other Medicare provides and suppliers.
30. A supplier-must remain open to the public for a minimum of 30 hours per week except physicians (as defined in section 1848(j)
(3) of the Act) or physical and occupational therapists or a DMEPOS supplier working with custom made orthotics and prosthetics
MEDICARE DMEPOS SUPPLIER STANDARDS
DMEPOS suppliers have tile option to disclose the following statement to satisfy the requirement outlined in Supplier Standard 16 in lien of providing a copy of the standards to the beneficiary.The products and/or services provided to you by ( supplier legal business name or DBA) are subject to the supplier standards contained in the Federal regulations shown at 42 Code of Federal Regulations Section 424.57(c). These standards concern business professional and operational matters (e.g. honoring warranties and hours of operation). The frill text of these standards can be obtained at http://www.ecfr.gov. Upon request we will furnish you a written copy of the standards.
Plan of Service for Patient Needs
Approved by: ACHC
Original approval date: 06/01/2021
Date revised:
ACHC Standard: DRX5-3A
The organization expects that most services will be requested by the patient’s primary care physician or specialist or hospital attending physician. In the event that a patient requests care/service on their own then an evaluation will be performed to determine their eligibility, level of care and support needs. A care plan would then be put into place for the patient. The plan of care would be appropriate and as stated in Standard DRX5-2CR the physician would become involved at this point.
CMS Quality Standards
When supplying equipment, items, and services to patients and caregivers, we will:
- Give clear instructions on using and maintaining equipment
- Let you know when the equipment will be delivered, if applicable, and document proof-of-delivery
- Record the equipment’s make and model onto your record
- Give contact information for renting and purchasing the equipment
- Give contact information for regular and after-hours repairs and emergencies
- Notify the prescriber within 5 days if we cannot supply the equipment
- Notify the patient within 5 days of our receipt of a complaint and that we are investigating
- Notify the patient within 14 days the results of the complaint investigation
- Keep documentation of complaints, investigations, and responses to the patient
- We will confirm the order with the physician and keep them posted to any changes needed
- Keep detailed records on the patient chart with regard to CMN’s, prescriptions, face-to-face encounters with the physician, physical assessments and telephone logs
- Upon delivery we will set-up and make adjustments as needed, provide loaner equipment while original is under repair, and ensure the equipment meets the physician orders and the patient’s needs.
When available we will leave written instructions, or oral communication, preferably in English, to the patient/caregiver regarding use, maintenance, cleaning, and disinfecting the equipment.
Our goal is that the patient knows how to use the equipment and understands everything about it when we leave. They are always welcome to call the pharmacy with any questions.
We will offer the patient/caregiver follow-up services, consistent with the equipment, items, and services given, and the prescribing physician recommendations.
Process of Patient Education of Community Retail Services/Products
Approved by: ACHC
Original approval date: 06/01/2021
Date(s) revised:
ACHC Standard: DRX5-5CR
Written and/or verbal instructions will be provided to the patient at the initiation of service and will be specific to the product or service provided. These instructions will include manufacturer's guidelines on safe use, care (and maintenance if required), and hazards of use of any product or service we render.
These instructions will be offered by the pharmacist on duty.
Acceptance and/or refusal of instructions will become a part of the patient file.
Request for Refills
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX5-8A
We do not supply services that are not specifically requested by the patient or their physician. This means that the patient, their caregiver, or their physician must contact the pharmacy to request a refill of DMEPOS supplies—we do not auto-refill these products.
When the refill was requested, how much quantity was requested and who requested the refill will be documented on the patient record.
Process for the Evaluation of the Patient’s Needs
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX5-2CR
A pharmacist or appropriately trained pharmacy technician will initially evaluate the eligibility, service and support needs of the patient. The patient’s physician will then be contacted to confirm and/or address the recommendations of the evaluation, if required.
The evaluation will include such things as the requested needed supplies, the physician order, diagnosis, physician name, length of need, any special patient needs, and how to contact the pharmacy in case of emergency.
Policies and Procedures Regarding Recalled Products
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX7-7CR
When we receive recall notices either from the manufacturer, wholesaler, or a governmental agency the organization will respond immediately. On medical products such as wheelchairs, walkers, nebulizers and ostomy/enteral nutrition pumps the manufacturer and serial number will be recorded on the patient profile. On prescription drugs a recall typically is only to the retail level and of course we would check our stock and pull any affected products. If it goes to a patient level recall we would be able to review who received a particular manufacturers’ product and contact them with instructions on how to return or to safely dispose of the drug.
If there is an external report of a defect in one of our products by the patient or their caregiver we will respond immediately and attempt to remedy or replace if necessary. The patient’s physician will be notified regarding any defect or recall.
Securing Patient Confidential Protected Health Information (PHI)
And Electronic Protected Health Information (EPHI)
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX2-5A
The patient has the right to a confidential record. The organization ensures this right by way of policies and procedures designed to secure patient information.
Protected Health Information (PHI) is health data created, received, stored, or transmitted by HIPPA- covered entities and their business associates in relation to the provision of healthcare, healthcare operations and payment for healthcare services. This information may be received electronically, by telephone, fax or verbally.
Only the pharmacist on duty may release PHI or confidential information. Conditions/persons that allow release of PHI would include a request from the patient’s primary care physician, a request from a hospital where the patient is being treated, and from other healthcare providers attending to the patient. The patient themself may also request their PHI.
Patients must sign a release before any PHI may be given to anyone. This release will also include what kind of PHI may be released and to whom.
Patient records will be secured electronically by the pharmacy software vendor. This software is password protected and only medical pharmacy personnel have access to this information.
PHI may be released to legal authorities only upon a warrant or subpoena.
The medical pharmacy personnel will log out of the computer system if they are not working at the workstation, i.e., bathroom break, lunch break or leaving for the day.
Signed confidentiality statements will be maintained in the personnel file. These policies/procedures will be abided by daily and reviewed annually by the pharmacist-in-charge.
The individual contacting the patient for the first time will provide written information and will discuss confidentiality/privacy of patient-specific information as included in the Patient Rights and Responsibilities statement. Documentation of receipt of confidentiality information is maintained in the patient record. Patient records contain signed release of information statements when the organization bills a third-party payor or shares information with others outside the organization as required by HIPPA and other applicable laws and regulations.
In accordance with the provisions of the HITECH Act, any breaches to confidentiality of patient PHI must be investigated and the affected individuals must be notified that their health information was breached.
Patient Rights and Responsibilities
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX2-2CR
Southeast Community Pharmacy Statement of Patient Rights and Responsibilities
- • Be informed, in advance of the care/service being provided and their financial responsibility
- • Receive information on the products that we will provide and specific limitations on those services
- • Have one’s property and person treated with respect, consideration and recognition of patient dignity and individuality
- • Be able to identify delivery personnel through proper identification
- • Be free from mistreatment, neglect, or verbal, mental, sexual, or physical abuse, including injuries of unknown source and misappropriation of patient property.
- • Voice grievances/complaints regarding treatment or care, lack of respect of property, or recommend changes in policy, personnel or service without restraint, interference, coercion, discrimination or reprisal
- • Having grievances/complaints regarding products that are (or fail to be) furnished investigated
- • Confidentiality/privacy of all information contained in the patient record and of Protected Health Information (PHI)
- • Be advised on our policies/procedures regarding disclosure of clinical records
- • Receive appropriate product without discrimination in accordance with physician orders
- • Referrals by us to any other provider are always at no cost and without any kickback
- • Be fully informed of one’s responsibilities
This Statement of Patient Rights and Responsibilities will be reviewed upon a new hire and annually thereafter and made a part of the worker’s personnel file. This statement will be updated if/when State or Federal changes are made. We truly want the patient or patient’s caregiver to fully understand their rights and responsibilities and to exercise them. This statement will always be available in written format and may also be found on our website in the ‘About Us’ section. We will document receipt of this statement onto the patient’s record.
Meeting Patient Needs During a Crisis or Disaster
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX7-4A
In an attempt to furnish needed medical supplies to patients during an emergency, which for our area typically would be hurricanes, we would do our utmost to see that they do not run out of supplies. For our organization this would relate mainly to ostomy/urological supplies and enteral nutrition products.
We would want to be prepared for loss of electricity for a number of days following a hurricane, which itself lasts ten to fifteen hours. Knowing that a storm is coming would allow us to contact our patients to make sure that they have enough supplies and this is normally three to five days in advance.
Cell phones are our primary method of communication with personnel to keep them informed of the situation at the store and to determine if they are needed on site during the event. Since we live on a peninsula oftentimes the state directs traffic only out of our area and not into it. Therefore, we would contact our patients who would possibly need ostomy/urological supplies or enteral nutrition products and get them in advance of the storm.
Regarding “911” EMS services, we have cell phones and a land line at the pharmacy. If these are not available, then us and everyone else effected by the storm would be incommunicado for a time.
These procedures will be reviewed annually by all personnel.
How the Patient May Report Complaints/Grievances
The patient has the right to voice grievances/complaints regarding treatment of care that is (or fails to be) furnished and lack of respect of property by anyone who is furnishing care/service on behalf of the organization, and must not be subjected to discrimination or reprisal for doing so.
The organization ensures this right and investigates all grievances/complaints. In light of this standard the following will apply:
- • The appropriate person to be notified will be the pharmacist on duty
- • We request that a grievance/complaint be reported within 2 business days
- • We will investigate and respond within 2 business days of receiving the patient report
- • A patient may report in person or by telephone, email or fax
- • A review and evaluation of the collected information will be conducted
- • Communication with the patient regarding questions, more information, etc will be done, preferably in person but may be performed via telephone, fax or email
- • Documentation of all activities involved with the grievance/complaint, investigation, analysis and resolution will be maintained. The outcomes and a summary report will be maintained and will be included in the annual Performance Improvement report
- • Personnel are oriented and familiar with the patient grievance/complaint policies and procedures
Statement of Patient Financial Responsibility
Approved By: ACHC
Original Approval Date: 06/01/2021
Date(s) Revised:
ACHC Standard: DRX3-4B
We will inform the patient of their financial responsibility prior to or at the time of delivery of the service or equipment. If there is a change in payment information, we let the patient know as soon as possible but no later than 30 days after we become aware of the change. We will inform all Medicare and Medicaid patients as to whether assignment is accepted or not. We will verify insurance coverage, including deductibles and copays, to the best of our ability. This will also include an Advance Beneficiary Notice of Non-coverage.
