What a DMEPOS Policy and Procedure Manual Has to Cover

A DMEPOS policy and procedure manual is not a CMS form, and no regulation prescribes its table of contents. It exists because the requirements surveyors apply are written as things the supplier "shall implement," and the only way to show a surveyor that a requirement is implemented consistently is a written policy plus records that prove staff follow it. The sources that set the content are the CMS DMEPOS Quality Standards (final, effective August 12, 2024) and the 30 supplier standards in 42 CFR 424.57(c). Each accrediting organization layers its own standards on top, crosswalked to the CMS version, so ask yours for its standards before you finalize anything.

Below is the outline we build from, with the source for each part.

Which policies cover leadership and compliance?

• Organization and leadership. Who directs the business, with authority and accountability. The Quality Standards allow an owner to lead an owner-operated business; the manual should name the roles anyway (Section I.A.1).
• Compliance program. Written standards of conduct and a designated leader who handles compliance issues, aimed at preventing fraud, waste and abuse (I.A.6).
• Licenses and display. How licenses, certificates and permits are obtained, renewed and displayed, and who provides copies to officials on request (I.A.3; supplier standard 1). Link this to a renewal calendar so a lapsed state license never surprises you.
• Medicare program rules. Commitment to Medicare statutes, regulations, manuals and contractor policies, including ownership disclosure (I.A.5; standard 17).
• Change reporting. Who reports changes to the enrollment contractor and the accrediting organization, and the 30-day deadline (standard 2; see the 30-day rule).
• Telephone contact. The ban on unsolicited calls to beneficiaries and its three exceptions (standard 11). Marketing staff and vendors need this in writing.
• Excluded parties. Screening contractors and vendors so you never contract with an excluded entity (standard 4).

Which financial and human resources policies are required?

• Financial management. Accurate accounting and billing; accounts that link equipment to the beneficiary; reconciling charges with invoices, receipts and deposits; an operating budget appropriate to the business; tracking revenue and expenses (I.B).
• Job descriptions and qualifications. For each role, qualifications, training, certifications or licenses, experience and continuing education (I.C.1).
• Credential verification. Verifying and keeping copies of licenses, registrations, certifications and competencies for staff who serve beneficiaries (I.C.1).
• Competency of technical staff to deliver, set up and train (I.C.2), and professionals working within their state scope of practice (I.C.3).

What do the consumer service policies need to say?

• Instructions to beneficiaries. Written or pictorial and oral instructions on use, maintenance, infection control and hazards; expected delivery time frames; verifying receipt; recording the make and model; rental contacts and rent-or-purchase options; customer service, after-hours, repair and emergency numbers (I.D.1; standards 5 and 12).
• Orders you cannot fill. Notifying the prescriber within 5 calendar days (I.D.2).
• Complaints. Acknowledgment within 5 calendar days and written results within 14 calendar days (I.D.3), plus the complaint resolution protocol and log contents from standards 19 and 20: beneficiary name, address, phone and claim number, a summary, the date received, who received it, actions taken, and who decided not to investigate and why.
• Disclosure of the supplier standards to every beneficiary (standard 16).
• Warranties, repairs and returns. Honoring warranties without charge, maintaining and repairing rented items, loaner equipment during repairs except for orthotics and prosthetics, and accepting returns of substandard or unsuitable items (standards 6, 14 and 15; Section II.B).

Which quality and safety policies do surveyors test against records?

• Performance management plan. At minimum, measures of beneficiary satisfaction and complaints, response timeliness, access, billing and coding error frequency, and adverse events, with input from employees, customers and referral sources (I.E).
• Product safety. A program for safe use, infection control and hazards; tracking equipment failure, repair and preventive maintenance; incident investigation within 24 hours for hospitalization or death and 72 hours otherwise (I.F).
• Emergency and disaster contingency plan, or arrangements with alternative suppliers (I.F).
• Product integrity. Verifying before delivery that products are not adulterated, counterfeit or misbranded and are labeled for their channel (I.F).
• Records and privacy. Accurate, confidential, secure beneficiary records consistent with HIPAA and state law (I.G), and keeping ordering and referring documentation for 7 years from the date of service (standard 28; 42 CFR 424.516(f)).

What goes in the intake, delivery and follow-up policies?

• Intake. Consulting the prescriber to confirm the order; reviewing the beneficiary's record; keeping the prescription, certificates of medical necessity and prescriber documentation unaltered (II.A).
• Delivery and setup. Timely delivery and setup; everything needed to operate the item; delivery consistent with the order and the beneficiary's known needs and risks (II.B); proof of delivery (standard 12).
• Training. Instruction tailored to the beneficiary's abilities and language, and for initial items sent by mail order, documented training and written instructions (II.C).
• Follow-up consistent with the equipment and the prescriber's recommendations (II.D).

Billing documentation sits beside these policies. Our sister company, White Glove Medical Billing, handles DME claims; enrollment and accreditation are ours.

Do product lines need their own sections?

If you supply them, yes. Respiratory suppliers need 24-hour, 7-day service and procedures following the named American Association for Respiratory Care guidelines (Appendix A). Complex rehabilitative wheelchair suppliers need policies for the employed rehabilitative technology supplier, trained technicians, face-to-face evaluations coordinated with the prescriber, and verification that the final product matches the recommendation (Appendix B). Custom orthotics, prosthetics and related items have their own appendix (Appendix C). Accreditation scope is product-specific under 42 CFR 424.57(c)(22), so a policy for a product you do not sell is clutter, and a missing policy for one you do sell is a deficiency.

Why do template manuals fail surveys?

1. They describe a different business. A manual that promises 24-hour respiratory service from a brace-only supplier, or names positions you do not have, tells the surveyor nobody read it.
2. Practice does not match the paper. Surveyors interview staff and pull at least 5 real patient records. A 14-day complaint policy with a log showing 30-day responses is worse than no policy.
3. No evidence of training. Staff sign-offs and competency checklists are the bridge between policy and practice.
4. They go stale. The 2026 rule changed survey frequency, new-location surveys and ownership changes. A manual that still describes a three-year cycle or a 90-day grace period for new locations is out of date.

How do we build a manual that fits your business?

Accreditation Readiness ($2,495, see pricing) includes a manual written for your actual products, staff and locations, mapped to the Quality Standards and your accreditor's crosswalk, with training sign-offs, logs and file templates for real patients, followed by a mock survey. Annual Survey Readiness ($1,200 per year) keeps it current as rules change. See preparing for an unannounced survey for how surveyors test it.