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Medicare Program Integrity Manual
Chapter 5 – Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS) Items and Services
Having Special DME Review Considerations
Table of Contents (Rev. 11032, 09-30-21)
Transmittals for Chapter 5
5.1 – Home Use of DME, Prosthetics, Orthotics, and Supplies
5.2 – Rules Concerning DMEPOS Orders Prescriptions
5.2.1 – Standard Written Order/ Prescription (SWO) 5.2.2 – Required Elements of a SWO 5.2.3 – Who can complete a SWO 5.2.4 – Timing of the Order/Prescription 5.2.5 - When a New Order/Prescription is Required 5.2.6 - Refills of DMEPOS Items Provided on a Recurring Basis
5.3 – Master List of DMEPOS Items Potentially Subject to a Face- to- Face Encounter
and WOPD and/or Prior Authorization Requirements 5.3.1 – Notification of DMEPOS Item(s) Selected and Included on the Required Face-to-Face Encounter and Written Order Prior To Delivery List
5.4 – Face-to-Face Encounter Definition
5.4.1 – Timing of the Face-to-Face Encounter 5.4.2 – Documentation from the Face-to-Face Encounter 5.4.3 – Suspension of Face-to-Face Encounter and WOPD Requirements
5.5 – Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs)
5.5.1 – Completing a CMN or DIF 5.5.2 – Cover Letters for CMNs 5.5.3 - Reserved for Future Use
5.6 – DME MACs and UPICs Authority to Initiate an Overpayment and/or Civil Monetary Penalty (CMP) When Invalid CMNs or DIFs Are Identified
5.7 - Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and
CMNs
5.8 - Physician Assistant Rules Concerning Orders and CMNs
5.9 - Documentation in the Patient’s Medical Record
5.10 - Supplier Documentation
5.10.1 - Suppliers Documentation for DMEPOS Repair Claims
5.10.2 - Suppliers Documentation for Claims for Replacement of Essential Accessories for Beneficiary-Owned Continuous Positive Airway Pressure (CPAP) and Respiratory Assist Devices (RADs)
5.11 - Evidence of Medical Necessity
5.11.1 - Evidence of Medical Necessity for the Oxygen Claims 5.11.2 - Evidence of Medical Necessity: Wheelchair and Power Operated Vehicle (POV) Claims
5.12 - Period of Medical Necessity - Home Dialysis Equipment
5.13 - Safeguards in Making Monthly Payments
5.13.1 - Reserved for Future Use
5.14 - Pick-up Slips
5.15 - Incurred Expenses for DMEPOS
5.16 - Reserved for Future Use
5.17 - Definitions of Customized DMEPOS
5.18 - Advance Determination of Medical Coverage (ADMC) of Customized DMEPOS
5.18.1 - Items Eligible for ADMC 5.18.2 - Instructions for Submitting ADMC Requests 5.18.3 - Instructions for Processing ADMC Requests 5.18.4 - Affirmative ADMC Decisions 5.18.5 - Negative ADMC Decisions
5.19 - DME MAC Tracking
All claims for DMEPOS items billed to Medicare require a written order/prescription from the treating practitioner as a condition for payment. The required elements of a DMEPOS order/prescription have been codified at 42 CFR 410.38(d)(1) and are listed below.
5.2.2 - Required Elements of a SWO
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
A SWO must contain all of the following elements:
- Beneficiary name or Medicare Beneficiary Identifier (MBI);
- General description of the item. o The description can be either a general description (e.g., wheelchair or hospital bed), a brand name/model number, a HCPCS code, or a HCPCS code narrative; o For equipment – In addition to the description of the base item, the SWO may include all concurrently ordered options, accessories, or additional features that are separately billed or require an upgraded code (List each separately); o For supplies – In addition to the description of the base item, the SWO may include all concurrently ordered supplies that are separately billed Note: If such items are not concurrently ordered, they nonetheless require an order for payment purposes
- Quantity to be dispensed, if applicable;
- Order Date;
- Treating Practitioner Name or National Provider Identifier (NPI); and
- Treating Practitioner Signature.
The elements of the SWO will be evaluated in accordance with Ch. 3, Section 3.3.2.1, which discusses using the totality of the record to verify compliance with required elements.
Note also that while the SWO has a limited number of required order elements, suppliers/providers are permitted to add elements that may provide clarity for issues such as length of need (LON), frequency of use, dosage form/strength, refills frequency, etc. This additional information shall be corroborated by information in the medical record.
Suppliers may also wish to consult state law or regulation since some states may have additional requirements for the elements of an order/prescription (e.g., refill frequency).
5.2.3 –Who can complete a SWO
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
\Statute requires that the treating practitioner who conducts the qualifying face-to-face encounter for Power Mobility Devices (PMDs) also prepare the SWO for the PMD base. For items other than PMDs appearing on the Required Face-to-Face and Written Order Prior to Delivery List, the treating practitioner who conducts the face-to-face encounter does not need to be the prescriber of the DMEPOS items— so long as the prescribing practitioner has knowledge of, and documentation to support (e.g., face-to- face), the condition that requires his or her writing an order/prescription.
For non-PMD items, and PMD separately billed accessories, certain elements of the order/prescription may be completed by someone other than the treating practitioner, so long as the treating practitioner identified in the order, via their name or national provider identifier (NPI), signs the document.
5.2.4 – Timing of the Order/Prescription
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
Written Order Prior to Delivery (WOPD)
For PMDs and other DMEPOS items selected for inclusion on the Required Face-to-Face Encounter and Written Order Prior to Delivery List (See section 5.3.1 below), the SWO must be communicated to the supplier prior to delivery. For items requiring a WOPD, the contractors shall verify that the date of the written order is on or before the date of delivery or on or before the date shipped, the shipping date is used as the date of service. For additional information, see Chapter 4, section 26.1.
Written Orders Prior to Claim Submission:
For DMEPOS items that are not PMDs or otherwise included on the Required Face-to- Face Encounter and Written Order Prior to Delivery List, the SWO must be communicated to the supplier prior to claim submission.
5.2.5 - When a New Order / Prescription is Required
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
A new order/prescription is required:
- For all claims for purchases or initial rentals;
- If there is a change in the DMEPOS order/prescription (e.g., quantity);
- On a regular basis (even if there is no change in the order/prescription) only if it is so specified in the documentation section of a particular medical policy;
- When an item is replaced; and
- When there is a change in the supplier, and the new supplier is unable to obtain a copy of a valid order/prescription for the DMEPOS item from the transferring supplier.
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
Items selected and included in the Required Face-To-Face Encounter and Written Order Prior to Delivery List are published in the Federal Register with no less than 60 days’ notice and posted on CMS’ and its contractors’ websites. Contractors shall include the effective date on their websites. Contractors shall apply the face-to-face encounter and WOPD requirement as a condition of payment for any item appearing on the Required Face-To-Face Encounter and Written Order Prior to Delivery List beginning on the published effective date.
5.4 – Face-to-Face Encounter Definition
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
A face-to-face encounter means an in-person or telehealth encounter between the treating practitioner and the beneficiary. The face-to-face encounter must be used for the purpose of gathering subjective and objective information associated with diagnosing, treating, or managing a clinical condition for which the DMEPOS is ordered. Telehealth encounters used to satisfy the face-to-face requirement must meet the requirements of 42 CFR §§ 410.78 and 414.65 for purposes of DMEPOS coverage.
5.4.1 – Timing of the Face-to-Face Encounter
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
For DMEPOS items appearing on the Required Face-to-Face and Written Order Prior to Delivery List, the treating practitioner must document and communicate to the DMEPOS supplier that the treating practitioner has had a face-to-face encounter with the beneficiary within the 6 months preceding the date of the written order/prescription.
A qualifying face-to-face encounter is required each time there is a new order/prescription for a DMEPOS items on the Required Face-to-Face and Written Order Prior to Delivery List. A single face-to-face encounter may document the clinical conditions necessitating multiple DMEPOS items. In this situation, regardless of whether the DMEPOS items are prescribed on different dates, the single face-to-face encounter may be utilized in support of the multiple items, so long as the encounter date is within 6 months prior to the date of the orders. As always, the supplier is responsible for submitting documentation to support each claim upon request.
The face-to-face requirement codified at 42 CFR 410.38 does not supplant other CMS coverage policies. For example, the National Coverage Determination § 240.2 “Home use of Oxygen” requires a physician examination within a month of starting home oxygen therapy.
5.4.2 – Documentation from the Face-to-Face Encounter
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
A supplier must maintain the SWO and the supporting documentation provided by the treating practitioner and make them available to CMS and its contractors upon request. A supplier must submit additional documentation to CMS or its contractors, upon request, to support and/or substantiate the medical necessity for the DMEPOS.
The face-to-face encounter must support payment and be documented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, progress notes, treatment plans or other sources of information that may be appropriate). The supporting documentation must include subjective and objective beneficiary specific information used for diagnosing, treating, or managing a clinical condition for which the DMEPOS is ordered.
Section 1834(h)(5) of the Act states that for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by orthotists and prosthetists shall be considered part of the individual’s medical record to support documentation created by eligible professionals as described in section 1848(k)(3)(B) of the Social Security Act. Documentation from a face-to-face encounter conducted by a treating practitioner, as well as documentation created by an orthotist or prosthetist, becomes part of the medical records. If the orthotist or prosthetist notes support the documentation created by eligible professionals described in section 1848(k)(3)(B), they can be used together to support medical necessity of an ordered DMEPOS item. In the event the orthotist or prosthetist documentation does not support the documentation created by the eligible professional, payment may be denied.
If a supplier bills for an item listed on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and does not possess documentation of the face-to-face encounter and/or the WOPD, the item will be denied.
5.4.3 – Suspension of Face-to-Face Encounter and WOPD Requirements
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
CMS may suspend the face-to-face encounter and WOPD requirements generally or for a particular item or items at any time and without undertaking rulemaking, except those items for which inclusion on the Required Face-to-Face Encounter and Written Order Prior to Delivery List was statutorily imposed or codified in prior rule making, such as power mobility devices. CMS will post notification of the suspension on the CMS website. Upon direction from CMS, contractors shall post notification of the suspension on their websites and may utilize other communication tools to alert suppliers of the suspension.
However, when the CMN or DIF is submitted electronically and the supplier chooses to maintain a hard copy CMN or DIF, the font may be modified as follows:
o Pitch may vary from 10 characters per inch (cpi) to 17.7 cpi;
o Line spacing must be 6 lines per inch
o Each form must have a minimum 1/4 inch margin on all four sides.
Without exception, these modified hard copy forms must contain identical questions/wording to the CMS forms, in the same sequence, with the same pagination, and identical instructions/definitions printed on the back; and CMN question sets may not be combined.
The CMN can serve as the physician's detailed written order if the narrative description in section C is sufficiently detailed. This would include quantities needed and frequency of replacement for accessories and supplies. For items requiring both a CMN and a written order prior to delivery (e.g., seat lift mechanisms) suppliers may utilize a completed and physician-signed CMN for this purpose. Otherwise, a separate order in addition to a subsequently completed and signed CMN is necessary.
The supplier may not complete the information in section B of the CMN. A supplier who knowingly and willfully completes section B of the form is subject to a civil monetary penalty up to $1,000 for each form or document so distributed. Any supplier who remains in non-compliance after repeated attempts by the contractor to get the supplier into compliance, refer to your RO (for UPICs refer the supplier to the primary GTL or associate GTL and SME) as a potential civil monetary penalty case.
The fee schedule amount, narrative description of the items furnished and the supplier's charge for the medical equipment or supplies being furnished must be completed on a CMN by the supplier prior to it being furnished to the physician. A supplier who knowingly and willfully fails to include this information may be subject to a civil monetary penalty up to $1,000 for each form or document so distributed. Any supplier who remains in non-compliance, after repeated attempts by the contractor to get the supplier into compliance, refer to your RO (for UPICs, refer the supplier to the primary GTL or associate GTL and SME) as a potential civil monetary penalty case.
CMS will not accept any other certifications of medical necessity by other insurers or government agencies.
Suppliers and physician may choose to utilize electronic CMNs (e-CMNs) or electronic DIFs (e-DIFs). E-CMNs or e-DIFS must adhere to all privacy, security, and electronic signature rules and regulations promulgated by CMS and DHHS. Additionally, e-CMNs or e-DIFs must contain identical questions/wording to the CMS forms, in the same sequence, with the same pagination, and identical instructions/definitions as printed on the back of the hardcopy form.
If an item requires a CMN or a DIF and the supplier does not have a faxed, photocopied, original hardcopy, or an electronic signed CMN or DIF in their records when they submit a claim to Medicare, the claim will be denied.
In cases where two or more suppliers merge, the resultant supplier should make all reasonable attempts to secure copies of all active CMNs or DIFs from the supplier(s) purchased. This document should be kept on file by the resultant supplier for future presentation to the DME MACs, and UPICs.
When reviewing claims where the medical record contains a copied, faxed or electronically maintained CMN or DIF (any CMN or DIF created, modified, and stored via electronic means such as commercially available software packages and servers), the DME MACs, or UPICs must accept the copied, faxed or electronic document as fulfilling the requirements for these documents.
When a UPIC is investigating potentially fraudulent behavior by a supplier, it will be the supplier's responsibility to prove the authenticity/validity of the claim(s) under investigation. UPICs may require the supplier to prove the authenticity/validity of the signature on the CMN, DIF, order, or any other questionable portion of the claim(s) under investigation.
Upon request by the DME MACs, UPICs, SMRC or DME RACs, suppliers must provide the CMN or DIF, in a format that the DME MACs, UPICs, SMRC, and DME RACs can accept, in a timely manner. Upon medical review, the DME MACs, UPICs, SMRC, and DME RACs should not deny claims solely because the CMN or DIF is faxed, copied, or electronic. The DME MACs, UPICs, SMRC, and DME RACs may request the supplier to download and print a hard copy of an electronic order, CMN or DIF if the DME MACs, UPICs, SMRC, and DME RACs cannot access it electronically.
For items that require a CMN, and for accessories, supplies, and drugs related to an item requiring a CMN, the CMN may serve as the written order if the narrative description in Section C is sufficiently detailed (as described above). This applies to both hard copy and electronic orders or CMNs. A DIF does not contain a section for a narrative description and is not applicable.
A supplier must have a hard copied, faxed or electronic order, CMN or DIF in their records when they can submit a claim for payment to Medicare. Suppliers must ensure the security and integrity of electronically maintained CMNs or DIFs are in accordance with any regulations published by CMS.
The DME MACs or UPICs need not make any shared system changes to electronically accept e-CMNs or e-DIFS as CMS views e-CMNs or e-DIFs as a transaction between the physician and suppliers. Suppliers must continue to use current systems for transmitting claim information to the DME MAC or UPICs.
The DME MACs should regularly publish an article in their bulletins asking suppliers to remind physicians and suppliers of their responsibility in completing and signing the CMN or DIF. It is the physician’s and supplier’s responsibility to determine both the medical need for, and the utilization of, all health care services. The physician and supplier should ensure that information relating to the beneficiary’s condition is correct. The DME MAC and UPICs should encourage suppliers to include language in their cover letters to remind physicians of their responsibilities.
5.5.3 – Reserved for Future Use
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
5.6 – DME MACs and UPICs Authority to Initiate an Overpayment
and/or Civil Monetary Penalty (CMP) When Invalid CMNs or DIFs Are
Identified
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21)
Section 1862(a)(1)(A) of the Act prohibits Medicare payment for services that are not reasonable and necessary. Section 1833(e) of the Act requires that Medicare be furnished by providers and suppliers "such information as may be necessary in order to determine the amount due.…" These sections provide support that a failure to have a valid CMN or DIF on file or to submit a valid CMN or DIF to the DME MACs or UPICs makes the underlying claim improper because Medicare does not have sufficient information to determine whether the claim is reasonable and necessary. A valid CMN is one in which the treating physician has attested to and signed supporting the medical need for the item, and the appropriate individuals have completed the medical portion of the CMN. A valid DIF is one in which the supplier has attested to and signed supporting the medical need for the item. When the DME MACs and UPICs identify a claim for which a CMN or DIF is not valid, they may deny the claim and/or initiate overpayment action.
If a DME MAC or UPIC identifies a supplier that has a pattern of improperly completing the CMN or DIF, the DME MAC or UPIC may choose to initiate a potential Civil Monetary Penalty (CMP) case against the supplier. The authority for such action is found in §1834(j)(2)(A)(iii) of the Act which states that "any supplier of medical equipment and supplies who knowingly and willfully distributes a CMN in violation of clause (I) or fails to provide the information required under clause (ii) is subject to a civil money penalty in an amount not to exceed $1,000 for each such certificate of medical necessity so distributed." The provisions of §1128A of the Act (other than subsections (a) and (b) shall apply to CMPs penalties under this subparagraph in the same manner as they apply to a penalty or proceeding under §1128(A)(a)) of the Act.
5.7 – Nurse Practitioner or Clinical Nurse Specialist Rules Concerning
Orders and CMNs
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
A nurse practitioner or clinical nurse specialist may give the dispensing order and sign the detailed written order in the following situations:
- They are treating the beneficiary for the condition for which the item is needed;
- They are practicing independently of a physician;
- They bill Medicare for other covered services using their own provider number; and
- They are permitted to do all of the above in the State in which the services are rendered.
A nurse practitioner or clinical nurse specialist may complete Section B and sign Section D of a CMN if they meet all the criteria described above for signing orders.
5.8 – Physician Assistant Rules Concerning Orders and CMNs
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
Physician assistants may provide the dispensing order and write and sign the detailed written order if they satisfy all the following requirements:
- They meet the definition of physician assistant found in §1861(aa)(5)(A) of the Act;
- They are treating the beneficiary for the condition for which the item is needed;
- They are practicing under the supervision of a Doctor of Medicine or Doctor of Osteopathy;
- They have their own NPI; and
- They are permitted to perform services in accordance with State law.
Physician assistants may complete section b and sign section D of a CMN if they meet all the criteria described above for signing orders.
5.9 – Documentation in the Patient’s Medical Record
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21)
For any DMEPOS item to be covered by Medicare, the patient’s medical record must contain sufficient documentation of the patient’s medical condition to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or replacement (if applicable). The information should include the patient’s diagnosis and
Documentation must be maintained in the supplier's files for seven (7) years from date of service. If the provider responds, in writing, that the Medicare qualifying supplier documentation is older than 7 years, and provides proof of continued medical necessity of the item or necessity of the repair, the contractors shall not deny the claim based solely on missing the supporting Medicare qualifying documentation that is over 7 years old.
B. Proof of Delivery
Section 424.57(c)(12) requires suppliers, as part of their standards to be met for enrollment and participation, to maintain proof of delivery documentation in their files. In certain instances, compliance with proof of delivery may be required as a condition of payment, and must be available to the DME MAC, RAC, SMRC, CERT, and UPIC on request. For such items, if the supplier does not have appropriate proof of delivery documentation within the prescribed timeframes, associated claims will be denied and overpayments recouped. We note that non-compliance with supplier standards may also result in revocation from the Medicare program. Suppliers who consistently do not provide documentation to support their services may be referred to the OIG or NSC for investigation and/or imposition of sanctions. If the beneficiary is newly eligible to the Medicare program, the proof of delivery standards require the supplier to obtain a statement, signed and dated by the beneficiary (or beneficiary's designee), that the supplier has examined the item.
Please refer to IOM 100-08. Ch. 4, Section 4.7.3.1 for additional information regarding all proof of delivery requirements.
5.10.1 - Suppliers Documentation for DMEPOS Repair Claims
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
When reviewing DMEPOS claims for repairs, the contractor shall review for continued medical necessity of the item and necessity of the repair. Contractors are not required to determine that the requirements for provision of the DMEPOS item as when it was originally ordered were met. For example, even though a face-to-face encounter is required for the initial provision of certain wheelchairs, it is not needed for the repair of a wheelchair already covered and paid for by Medicare. However, documentation from the treating practitioner that indicates the wheelchair being repaired continues to be medically necessary is required. For this purpose, documentation is considered timely when it is on record in the preceding 12 months, unless otherwise specified in relevant Medicare policy.
In addition, the contractor shall ensure that the supplier’s record includes the nature of the repair required and work performed to restore the item to its functionality to meet the Medicare beneficiary’s medical need.
These instructions do not replace or alter other longstanding instructions related to coverage and payment for reasonable and necessary repairs and maintenance and
servicing of DMEPOS items. Contractors shall continue to adhere to these program policies and procedures. Examples include, but are not limited to, Chapter 15, section 110.2 of the Benefit Policy Manual and Chapter 20, sections 10.2 and 40 of the Claims Processing Manual. Contractors are also reminded that parts and labor covered under a manufacturer or supplier warranty are not to be considered reasonable and necessary under regulation; therefore, contractors shall determine for each claim whether billed parts and labor are covered under a warranty. For reasonable and necessary parts, payment is made on a lump sum basis based on the contractor’s individual consideration of a reasonable payment amount for the part. For reasonable and necessary labor, payment is based on a reasonable fee established by the contractor for labor associated with repairing the item.
5.10.2 - Suppliers Documentation for Claims for Replacement of
Essential Accessories for Beneficiary-Owned Continuous Positive
Airway Pressure (CPAP) and Respiratory Assist Devices (RADs)
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
When reviewing claims for replacement of essential accessories for beneficiary-owned CPAP and RADs, the contractor shall review for continued medical necessity of the DME and necessity of the replacement accessory. Contractors are not required to determine that the requirements for provision of the CPAP and RAD as when it was originally ordered were met. For example, even though a face-to-face encounter is required for the initial provision of the CPAP device, it is not needed for replacement of a CPAP mask for a patient-owned CPAP device covered by Medicare in the past. However, documentation from the treating practitioner that indicates the CPAP or RAD which requires replacement accessories continues to be medically necessary is required. For this purpose, documentation is considered timely when it is on record in the preceding 12 months, unless otherwise specified in relevant Medicare policy.
In addition, the contractor shall ensure that the supplier’s record includes the reason why the accessory(s) need to be replaced to meet the Medicare beneficiary’s medical need. The contractor shall also ensure that the supplier’s record includes the reason why any new accessories (e.g., heated humidifier or heated tubing) need to be furnished to meet the Medicare beneficiary’s medical need. These instructions do not replace or alter other longstanding instructions related to coverage and payment for reasonable and necessary accessories for patient-owned DME. Contractors shall continue to adhere to these program policies and procedures.
5.11 - Evidence of Medical Necessity
(Rev. 10538; Issued: 12-30-20; Effective: 01-01-20; Implementation: 12-29-20)
If replacement supplies are needed for the therapeutic use of purchased DMEPOS, the treating practitioner must specify on the standard written order, or on the CMN, the type of supplies needed, in such a manner that the supplier may calculate the necessary disbursement and assess the continued need for refill with the beneficiary. DME
For an initial claim, the physician must submit a signed certification of medical necessity that includes an oxygen/blood gas lab result. This certification must be corroborated with information in the medical record. A physician signature on the oxygen lab test result is not necessary to corroborate the certification. Instead, the reviewer should consider all submitted records from all of the beneficiary’s healthcare professionals.
Therefore, contractors shall not deny an oxygen or oxygen equipment claim solely because the claim lacks a physician signature on the oxygen lab test result.
5.11.2 - Evidence of Medical Necessity: Wheelchair and Power Operated
Vehicle (POV) Claims
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01- 2020)
The physician or treating practitioner (a physician assistant, nurse practitioner or clinical nurse specialist) must conduct a face-to-face encounter of the beneficiary and write a written order for the power mobility device (PMD). The face-to-face examination and the written order must comply with the instructions found under Required Elements of a SWO, Written Order Prior to Deliver, Face-to-Face Encounter Definitions and Timing of the Face-to-Face Encounter.
The face-to-face examination requirement does not apply when only accessories for power mobility devices are being ordered, nor does it apply for the ordering of replacement PMDs. A replacement PMD would be the same device as previously ordered. However, if a beneficiary has a POV but would like to replace the POV with a power wheelchair, then a face-to-face examination would need to be conducted.
Prior to dispensing a PMD, the DMEPOS supplier must obtain from the physician or treating practitioner who performed the face-to-face examination the written order accompanied by supporting documentation of the beneficiary’s need for the PMD in the home. Pertinent parts from the documentation of the beneficiary’s PMD evaluation may include the history, physical examination, diagnostic tests, summary of findings, diagnoses, and treatment plans. The physician or treating practitioner should select only those parts of the medical record that clearly demonstrate medically necessity for the PMD. The parts of the medical record selected should be sufficient to delineate the history of events that led to the request for the PMD; identify the mobility deficits to be corrected by the PMD; and document that other treatments do not obviate the need for the PMD, that the beneficiary lives in an environment that supports the use of the PMD and that the beneficiary or caregiver is capable of operating the PMD. In most cases, the information recorded at the face-to-face examination will be sufficient. However, there may be some cases where the physician or treating practitioner has treated a patient for an extended period of time and the information recorded at the face-to-face examination refers to previous notes in the medical record. In this instance, those previous notes would also be needed. The physician, treating practitioner or supplier that is a HIPAA covered entity should make sure to remove or edit any materials that may be contained within the medical record that are not necessary to support the order. For example, a
gynecologic report would not be needed in the records submitted for a beneficiary whose clinical need for a PMD is based solely on disability secondary to a stroke.
As defined in the PIM, chapter 3, if data analysis indicates potentially aberrant billing, contractors shall continue to follow the general guidance for performing medical review on claims.
5.12 – Period of Medical Necessity - Home Dialysis Equipment
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21)
Situations may occur causing temporary non-use of equipment:
- Beneficiary requires in-facility treatment for re-stabilization or as a result of some acute condition. The beneficiary is expected to return to home dialysis; - Beneficiary is temporarily without a suitable home dialysis assistant; - Beneficiary is away from home but expects to return; or - Beneficiary is a transplant candidate and is taken off home dialysis preparatory to transplant. (If the transplant cannot occur, or if the transplant is not successful, the patient will very likely resume home dialysis and an evaluation can be made whether it will be within the immediate or foreseeable future.)
Under such circumstances, DME MACs or UPICs determine that medical necessity exists and pay for a period of up to 3 months after the month home dialysis equipment was last used. This does not eliminate the necessity for periodic reevaluation of medical necessity. It provides a tolerance to avoid frequent reevaluation in renal dialysis situations and provides for continuity of payments where economically advantageous.
5.13 - Safeguards in Making Monthly Payments
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21)
The DME MACs and UPICs shall establish appropriate safeguards to assure that payments are not made beyond the last month of medical necessity. They must develop appropriate safeguards to identify and investigate the following:
- Multiple claims for rental of the same or similar equipment from the same supplier within the same rental month (e.g., rental claims with different start dates but within the same rental period); Pub. 100-04, chapter 20, §30. specifically forbids payments for multiple claims for rental of the same or similar equipment from either the same or a different supplier during the same rental month.
- Contraindicated items of rented or purchased equipment;
