Medicare Audit Survival Kit Lower Limb Prosthetics

Dear Valued Customer, The CMS Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have initiated several different types of audits on Prosthetics. As a result, you may receive requests for additional documentation to support your claim. In order to support you directly and help you successfully respond to audit requests, Ottobock has developed an Audit Survival Kit. What is included in the kit: •

Step-by-Step Guide

•

Medicare Coverage Requirements – Explains requirements per medical policy

•

Types of Audits - explains the various audits currently being conducted and what each audit is focused on.

•

Additional Documentation Request - Sample request letter

•

Survival Tips

•

Lower Limb Documentation Guide – Covers all documentation requirements

•

Lower Limb Prosthesis Documentation Checklist – Use to track your documentation

•

Signature Requirements - A comprehensive guide to compliant signatures

•

Documentation Requirements for Replacement of Prosthesis/Components – Reviews Medicare guidelines for replacement.

•

Activity Chart– Use to chart activities and justify product being ordered

Support materials to share with your physician partners •

Physician Documentation Request Fax can be faxed to your referring physicians once they are educated on Medicare documentation requirements for microprocessor knees.

•

Medicare Rules for Changes to the Medical Record Amendments, Corrections and Delayed/Late Entries

•

Lower Limb Prosthesis Physician Documentation Guide can be shared with your referring physicians to educate them on Medicare documentation requirements.

As always, we are available to support your efforts. You can reach us directly by calling Reimbursement Support at 800.328.4058 during regular business hours or by emailing your request to [email protected]. Sincerely, Kimberly Hanson Director of Reimbursement, North America

Customer Service T 800 328 4058 F 800 655 4963 Customer Satisfaction Hotline T 877 627 6583 www.ottobockus.com

Step-by-Step Guide Responding to Medicare Audits Step 1

Send the physician brochure “When Referring your Patient to a Prosthetist” to your referring doctors.

Step 2

See patient at your office: Use Documentation Guide and Activity Chart to complete your documentation.

Step 3

Gather physician (and other) documentation to be sure you have all required documents (use the Documentation Checklist) STOP: Are all of the requirements met? If not, can an addendum or correction be done (see “Medicare Rules for Changes to the Medical Record” in this packet) If not, patient will need to return to the referring physician (or be referred to a new doctor to prescribe the prosthesis).

Step 4

Check each document for compliant signature and date (see attached Medicare signature requirements).

Step 5

Check each page that you will potentially send with the Documentation Request. There must be a patient name, document title and page numbers (for multi-page documents). If information is missing, attach a small label.

Step 6

Prepare documents for submission, so they are ready to send when the Document Request letter arrives. Put documents in the order requested with the Request Letter on top. We suggest including a Table of Contents to help the auditor find the requested information.

Step 7

Submit your claim and wait for the Documentation Request letter (approximately 15 days). Be sure your staff knows the letter is coming. It will come to the address associated with your PTAN number.

Step 8

Submit finished packet to the auditing entity.

Step by Step Guide, Responding to Medicare Audits | Audit Survival Kit | Ottobock

1 of 1

Medicare Coverage Requirements The following 6 items must be documented in the patient’s medical record. The component being ordered must be Medically Necessary. For Medicare medical necessity is determined by the patient’s potential functional ability (potential K-Level). Potential functional ability is based on the reasonable expectations of [both] the “prosthetist and treating physician,” considering factors including, but not limited to:

1. Past History

a. Activities: Was this patient active before the amputation? Was the patient a limited or full community ambulator? Detail the patient’s prior activities to help justify your KLevel determination (see sample activity chart). b. History of prosthetic use: Medicare also requires that there be a complete history of the patient’s prosthetic use. Detail all previous prosthetic components and why they were changed or replaced. How did they work for the patient?

Note: Medicare expects information to be in both the physician and prosthetist’s medical records.

2. Current Condition

a. History and physical examination pertinent to the prosthesis.  History of the Amputation  Physical Examination: Focused on prosthetic prescription  Limitations: Does this patient have a medical condition that might affect his/her ability to ambulate for the long term with the new prosthesis, at the qualifying functional state? If so, there will need to be documentation in the physician’s records that these conditions will not hinder patient’s ability to reach that potential.  Examples (not all inclusive): cardiovascular, pulmonary, neurologic, organ failure, diabetes, spinal problems, etc.  Status of limbs including the residual limb: Unhealed wounds, injuries, arthritis, contractures, phantom pain, etc.

Medicare Coverage Requirements | Audit Survival Kit 1 of 3

Medicare Coverage Requirements 3. The patient's desire to ambulate.

a. Activities: Detail all reasonable activities your patient desires to achieve with the new prosthesis. Why do you think the patient can accomplish these activities? [Use Ottobock’s Activity Chart] b. Desire: Use the word “desire” in the medical record so the auditor can easily find it. Example: “Because this patient was an unlimited K3 ambulator before her amputation and has a strong desire to get back to most of those activities, and she has no medical conditions that will affect her ability to use the new prosthesis, it is anticipated that she will be a strong K3 level ambulator when she receives her new prosthesis. Therefore, I am ordering a microprocessor controlled swing and stance prosthetic knee. This will give her the ability to achieve her daily activities, vary her cadence and navigate uneven terrains when ambulating in the community, without worrying about stumbles or falls.”

Medicare will cover a lower-limb prosthesis when:

4. The prosthesis is prescribed by a physician a. Detailed Written Order (signed prior to billing) b. Dispensing Order (required if item is delivered prior to signature date on the detailed written order)

5. The patient will reach or maintain a defined functional state within a reasonable period of time. a. Defined Functional State: The functional state (K-Level) required for a prosthesis must be discussed in both the physician’s and prosthetist’s medical record. If the patient has not reached the qualifying functional level yet, there must be a reasonable prediction as to when patient will meet that state. Example: “Anticipated time frame for return to unlimited K3 functional level is 3 months. To achieve this, patient will need to attend physical therapy for strengthening and gait training, which she has agreed to.” b. Mobility Aid: Is the patient currently using a mobility aid (cane, crutches, walker, scooter or wheelchair)? If so, we highly recommend that there be a statement/plan in the physician’s medical record as to how long it will take for the patient to ambulate Medicare Coverage Requirements | Audit Survival Kit 2 of 3

Medicare Coverage Requirements without the mobility aid. Medicare does not have a published rule for this, but we have heard of numerous denials. Example 1: “Patient has been using a cane due to her current prosthetic knee malfunctioning. It is anticipated that she will return to unlimited K3 functional level without the use of the cane within a reasonable time. To make sure that she achieves this, I am ordering a physical therapy evaluation.” Example 2: “Patient has been using a cane when engaging in activities which she feels might be unsafe and result in a stumble or fall. It is my professional opinion that she will not need to use a cane with the new microprocessor knee being ordered as it is proven to provide stumble recovery.”

6. The patient is motivated to ambulate.

a. Motivation: The patient’s motivation must be documented in the physician’s medical record. It is best if a form of the word “motivate” is used so the auditor finds the statement easily.

Typical documentation being requested 1. Physician’s order for the item. Include both the dispensing order and the detailed written order. (see Documentation Guide) 2. Information from the medical records that demonstrates coverage criteria (stated above) for the items are met. 3. Factors that justify the selection of the components provided. Every component that you are providing (foot, ankle, knee, socket, etc.) must be discussed in the records. What is the condition of the current component? Can it be repaired? Or is it worn beyond repair? If you are not replacing the component with a similar component, what has changed? (see Replacement Guide) 4. Proof of delivery with name, address and signature of the beneficiary, description the items provided (e.g. narrative description, HCPCS code, HCPCS code narrative, or brand name/model number), date of delivery, and supplier identification. (see Documentation Guide) 5. [Manufacturer] Invoices for the items provided including manufacturer name and model number. 6. Any other pertinent information that would justify payment for the items provided. 7. Advanced Beneficiary Notice (ABN) if one was obtained, must be submitted with the above requested documentation.

Medicare Coverage Requirements | Audit Survival Kit 3 of 3

Types of Audits NEW: Targeted Probe and Educate (TPE) Audits (DME MAC) Focus: Mostly high error rates identified by multiple sources The DME MACs are conducting Pre Payment Review Audits on providers/suppliers who have the highest claim error rates or billing practices that vary significantly from their peers. If selected, the supplier is given three chances to meet Medicare’s criteria.  Notification of Probe Review sent (e.g. topic being reviewed, data reasons for the selection and the process of the review).  20-40 claims audited o Additional documentation request (ADR) letter sent for each claim under audit o Letter states how many days supplier has to submit documents.  Review Results sent when audit complete  If documentation was non-compliant: o Education (one-on-one) offered if there are moderate to high-level of errors. o After 4-6 weeks waiting period DME MAC will review 20-40 claims again. o DME MAC will offer education throughout the process for easily corrected errors. o If errors persist after 3 rounds of audits, the supplier will be referred to CMS for further action.  If documentation is compliant, TPE audit process will stop for at least 12 months.

CERT Audit Contractor Focus: Improper payments made by Medicare DME MACs Randomly selects sample during each reporting period and requests medical records from the health care providers. Reviews claims to see if the claims complied with Medicare coverage, coding, and billing rules, and, if not, the payment adjusted and overpayment/underpayment assessed. CMS and contractors analyze error rate data and develop Error Rate Reduction Plans to reduce improper payments. CERT Documentation Center 1510 East Parham Road Henrico, VA 23228 Fax: 804-261-8100 Customer Service: 443-663-2699 Toll Free: 888-779-7477 Email: https://certprovider.admedcorp.com/ Types of Audits | Audit Survival Kit | Ottobock

1 of 3

Types of Audits Recovery Audit Contractor (RAC) Focus: Improper payments made by Medicare DME MACs (underpayments and overpayments) RACs may look back three years to reopen claims Performant Recovery, Inc. Email: [email protected] Phone: 866-201-0580 Web site: https://performantrac.com/ There are three types of RAC audits: 1.     2.     3.

Complex Review Additional Documentation Request (ADR) sent by RAC o 45-Day Period* starts to submit documentation Review Results sent by RAC when review is completed. o 30-Day Discussion Period* starts (supplier must initiate this) Original Decision Upheld or Original Decision Overturned sent by RAC Demand Letter sent by DME MAC if decision is unfavorable. Semi - Automated review (Potential Errors) Initial Findings sent by RAC o 45-Day Period* starts to submit documentation (not mandatory) Review Results sent by RAC when review is completed. o 30-Day Discussion Period* starts (supplier must initiate this) Original Decision Upheld or Original Decision Overturned sent by RAC Demand Letter sent by DME MAC if decision is unfavorable.

Automated Review (Assumed Errors)  Initial Findings sent by RAC o 30-Day Discussion Period* starts (supplier must initiate this)  Original Decision Upheld or Original Decision Overturned sent by RAC  Demand Letter sent by DME MAC if decision is unfavorable.

* Clock starts on the date of the associated letter (not the received date)

Types of Audits | Audit Survival Kit | Ottobock

2 of 3

Types of Audits Unified Program Integrity (UPICs) and Zone Program Integrity Contractors (ZPICs) Focus: Fraud and abuse (not isolated incorrect payments)  Conducts pre and post-payment review audits o Reviews may be triggered by DME MAC or RA and Government reports identifying vulnerable areas. Identify potential errors and target areas and/or specific providers for possible fraud investigations.

Supplemental Medical Review Specialty Contractor (SMRC) Focus: Vulnerabilities identified by CMS internal data analysis, CERT, or other agencies Conducts pre and post-payment review audits as determined CMS internal data, CERT or other agency. Strategic Health Solutions https://strategichs.com/smrc/  Additional Documentation Request (ADR) sent by SMRC o 45-Day Period* starts to submit documentation  Review Results sent by SMRC when review is completed. o 30-Day Discussion Period* starts (supplier must initiate this)  Original Decision Upheld or Original Decision Overturned sent by SMRC  Demand Letter sent by DME MAC if decision is unfavorable. * Clock starts on the date of the associated letter (not the received date)

Extrapolation CMS auditors are allowed to extrapolate if they identify sustained or high error rate in a sampling, they can estimate an overpayment across all similar claims within a defined period of time and take back all of the money paid to the provider. Guidelines suggest that the error rate should be greater than 50%; however, it can be as low as 10%.

Types of Audits | Audit Survival Kit | Ottobock

3 of 3

Sample Additional Documentation Request (ADR) Letter (Each audit entity has a slightly different ADR letter) We have received your claim for the item(s) listed below. …….. You must respond within 45 days of the date of this letter. Failure to do this may result in partial or complete medical necessity denial of this claim. Thank you for your cooperation. Put this page on the top of your documents, no matter how you send them (electronic, fax, or mail), because it has a bar code on it similar to this, which will match your documentation to the ADR request in Medicare’s computer system. (Do not include a separate Fax Cover Letter) ********************************************************* IMPORTANT PUT THIS PAGE ON TOP OF THE INFORMATION YOU RETURN TO US ******************************************************** Health Insurance Claim Number: Medicare Claim Number: Beneficiary Name: Document Case ID Number: DMS Control Number

Line No

No. of Services

HCPCS Procedure Code

01 02 03

1.0 1.0 1.0

LXXXX RT LXXXX RT LXXXX RT

Use the Document Case ID Number for Electronic Transmissions

Date of Service From June 15, 2017 June 15, 2017 June 15, 2017

Submitted Charge To June 15, 2017 June 15, 2017 June 15, 2017

$ $ $

Provider Number

. . .

This claim has been selected for review because……………………. Please submit copies of the following records……. 1. 2. 3. 4. 5. 6. 7. 8. 9.

Preliminary Dispensing Order Detailed Written Order Proof of Delivery Physician Medical Records (pertinent) Orthotist/Prosthetist Medical Records (pertinent) Justification for each item provided, (include fitting method for orthotics) Reason for Replacement (if applicable) Advanced Beneficiary Notice (ABN) if applicable Other pertinent records

Sample Documentation Request Letter | Audit Survival Kit |Ottobock

1 of 1

Audit Survival Tips 1. Documentation: Request documentation prior to delivery of the device. a) Providers most likely to have information to support your claim: Surgeon Physiatrist Family Practice Neurologist

Physical Therapist/Occupational Therapist IP/OP Rehab Facility Hospital SNF Rehab

b) Types of reports to request: Treatment Plans Operative Reports Diagnostics

Discharge Summaries History and Physicals Progress Notes (least likely to have information)

2. Names, Signatures, Dates: Check each document.  Physician’s Signature should have printed name or attestation (see signature requirements)  Patient’s Name should be on each page  Pages should be numbered  Prosthetist, Orthotist, and staff signatures should have printed name or attestation  Dates should be legible (may need attestation if not)  Content should be legible. If it is not, ask the author to transcribe it and send both copies. 3. Medical Necessity: Make sure that you have documentation to support the medical necessity for each code that you plan to bill, so that you are prepared no matter what the request is for. One medically unnecessary code can jeopardize the entire claim. 4. What to Send: Send only what is requested! 5. Due Date: Educate your staff to watch for audit requests, so the letters do not get misplaced, which could cause you to miss the due date. Letters are generally mailed to the address in which your NPI number is registered to. 6. Cover Letter: Lead the auditor down the path to find the requested information. Only include information pertinent to the request, in the order requested, and included a table of contents with your submission if needed. 7. No Highlighting: Medicare auditors scan your documents, prior to the review. Highlighted information shows up as blacked out and the auditor will not be able to see your most important information. 8. Be Prepared: Have your packet ready to go with copies of the documents attached. Copy and send it out immediately whenever you receive a request for documentation.

Audit Survival Tips | Audit Survival Kit | Ottobock

1 of 2

Audit Survival Tips 9. Packet Order: a. Audit request letter – top b. Table of contents - next c. Documentation arranged in the order stated in the request letter 10. Shipping/Faxing: Each auditor has their rules posted. Send each audit request in a separate batch/envelope. Carefully read the request letter or go onto their web site to find the correct submission information. Use a method that provides proof of delivery (file it). If faxing, keep in mind that the quality of the documents may be reduced, and confirm that all pages of your fax went through (file it). 11. Follow-up: Follow-up after three weeks and make sure they have your

documentation. Most auditors have 60 days or more to review your claim. Medicare has requested that you not send duplicate packets/claims while they are in the review process.

Audit Survival Tips | Audit Survival Kit | Ottobock

2 of 2

Documentation Requirements for LL Prosthetics January 1, 2018

Ottobock has relied upon the CMS guidance and recommendations set forth in this document’s reference section below.

Medicare’s Criteria in a Nutshell Medical necessity for prosthetic components or additions to the prosthesis is based on: 1. The patient’s past history [activities], 2. The patient’s current condition [residual limb and any medical conditions that might affect patient’s ability to use the new prosthesis], and 3. Desire to ambulate. [desire to use the new prosthesis and get back to those previous activities] A lower limb prosthesis is covered when: 4. Prescribed by a physician 5. The member will reach or maintain a defined functional state (K-Level) within a reasonable period of time, and 6. The member is motivated to ambulate Medicare requires that all 6 criteria be documented in the physician’s medical record. Following is a guide: Notes:  Medicare wants to see chart notes reflecting the need for the care (e.g., treatment plan, history and physical, operative report) from the patient’s medical records charted when the patient is being seen (physician’s office, hospital, nursing home, etc.).  To be on the safe side, it is recommended that this information be collected up-front to be sure the physician’s documentation supports the claim.  Each document must be signed and dated, and include the signee’s printed name and credentials. We highly recommend that an Attestation or Signature Log be included when responding to audit requests.  Electronic signature and date is only allowed on electronic documents.

 All documents that support medical necessity must be signed and dated prior to the delivery date.  Each page/chart note must clearly identify the patient.  The amputation side should be clearly and consistently identified.

Physician Documentation: The following information must be included in the ordering physician’s medical records: Recent history and physical examination (focus should be on the amputation, prosthesis, and ambulatory difficulties). a. History of the Injury, Illness, or Condition  Etiology of amputation(s)  Date of amputation  Affected side (s)  Diagnosis b. Physical Examination  Height, weight, recent loss/gain  Cognitive ability to use new prosthesis  Description of the residual limb ( e.g. local and/or phantom pain; wound healing issues; skin irritation, breakdown, infection; limb volume changes or swelling; weight fluctuations; muscle atrophy or contractures; osteoarthritis, or other arthritic conditions of the residual limb joint(s)).  Cardiopulmonary, musculoskeletal, neurological, arm and leg strength, ROM, gait, balance, coordination c. Functional Limitations Describe the nature and extent of limitations on a typical day that might affect the patient’s ability to use/ambulate with the new prosthesis. Note: Any condition identified must be ruled out. Examples:

Lower Limb Prosthesis Documentation Guide | Ottobock

1 of 6

Documentation Requirements for LL Prosthetics January 1, 2018

Cardiopulmonary conditions that might limit the patient’s capacity [e.g. congestive heart failure (CHF), coronary heart disease (CHD), endocarditis, myocarditis, arrhythmias, peripheral arterial (occlusive) disease (PAD/PAOD), chronic venous insufficiency (CVI) with recurring ulcers, lymphedema].  Musculoskeletal conditions (e.g. osteoarthritis sound side leg joints, spinal stenosis, severe low back pain).  Neurological conditions that cause impairments in gait, balance or coordination (e.g. MS, stroke, SCI, Parkinson’s, peripheral nerve lesions, lumbar disc herniation with motor paresis, dementia/Alzheimer’s disease, depression, psychiatric disorders/diseases).  Other comorbidities (e.g. chronic kidney failure, chronic liver failure, cancer with chemotherapy/radiation, general deconditioning). d. Impact of the Limitations: Description of current activities of daily living and how they are impacted by the deficit(s) identified. Is the patient more limited by his/her medical conditions or by the function of the prosthesis? e. Ambulatory Assistance currently used (e.g. cane, walker, wheelchair, care giver). Note: Medicare does not consider a person who permanently uses an ambulatory aid to be functioning at K3 level. If this is a temporary situation, state in your opinion how long it will take for your patient to be back to functioning at K3 level (free of the assistive device). 

Functional Levels (K-Levels) Level 0: Does not have the ability or potential to ambulate (or transfer safely) with or without assistance and a prosthesis does not enhance their quality of life or mobility [ i.e. patient likely will

not be able to ambulate at all].

Level 1: Has the ability or potential to use prosthesis for transfers or ambulation on level surfaces at fixed cadence [i.e. patient likely will be

able to use the prosthesis within his/her dwelling only].

Level 2: Has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs or uneven surfaces

[i.e. patient will likely be able to use prosthesis within his/her dwelling and a limited radius in the community].

Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

[i.e. patient will likely have a prosthetic ability comparable with that of a non-amputated person with no mobility restrictions].

Level 4: Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete. f.

Define the Patient’s Functional State: Describe patient’s functional capabilities in terms of the K-Levels (above) as they relate to the patient’s activities. These should be real activities, such as “walking the dog” and related K-level functions that patient encounters (e.g. long-distance ambulation, obstacles, types of terrain, slopes, stairs, ramps, crowds, public transportation)

Lower Limb Prosthesis Documentation Guide | Ottobock

2 of 6

Documentation Requirements for LL Prosthetics January 1, 2018

Following is what must be in the record:  Patient’s activities prior to amputation  Patient’s current activities  Activities that patient desires to get back to (and has the potential for) using the new prosthesis. Note: If patient was a community ambulator (K3/K4) earlier in life, but not prior to the amputation due to a medical condition (e.g. neuropathy, ulcers, and neuropathic pain) or if patient was never a community ambulator (K3/K4) and now has demonstrated capacity to be one, include why you believe the patient will be a community ambulator with the new prosthesis (e.g. sound limb is asymptomatic, achievements during rehabilitation/physical therapy, diseased limb was the primary cause of the mobility restrictions, etc.). g. Document the Current Prosthesis:  Condition of each component (e.g. socket, knee, pylon, ankle, foot) should be documented.  Reasons for replacement One of the following reasons should be documented for each component being replaced. o Patient’s functional needs have changed o Due to physical changes the component no longer fits o Device is irreparably worn o Device is lost or damaged beyond repair o Cost to repair will be greater than 60% of the cost to purchase a new device.  If the patient’s condition has changed, describe why the current prosthesis is no longer appropriate. (e.g. weight gain/loss, decreased stability, etc.)  If the device was damaged or lost, describe the incident.

h. Previous Prostheses:  Document patient’s past experience with prosthetic components (what has been tried, and the result).  Desire and Motivation: Document patient’s desire to use the new prosthesis and motivation to ambulate. i.

j.

Recommendation for the type of new Prosthesis/ Component(s) and the medical reason for your decision.  The recommendation must be based on patient’s prior activities, current condition, and desire to ambulate. Include a statement as to what your decision is based on.  The Brand name of the prosthetic components is not required. Prognosis: Document patient’s prognosis using the new device, including your opinion as to approximately how long it will take patient to reach the higher K-Level (if applicable).

Dispensing Order  The prosthesis/component may be delivered upon receipt of a dispensing order; however, a signed Detailed Written Order (DWO) must be obtained prior to billing. The DWO can be your dispensing order if signed prior to delivery.  The dispensing order must comply with state prescribing and/or other applicable laws. It is the practitioner’s responsibility to ensure this compliance.  The dispensing order can either be verbal and documented in the patient’s chart OR written by the ordering physician.  For Medicare, there only needs to be one date on the dispensing order. This will be the “order” date.

Lower Limb Prosthesis Documentation Guide | Ottobock

3 of 6

Documentation Requirements for LL Prosthetics January 1, 2018

The following elements must be included in the dispensing prescription: − Patient’s name − Date of order  For written order: use the date of the prescription  For verbal order: use the date the call was received − Description of item − Signature  For written order: Physician’s signature and date , printed name and credential  For verbal order: Printed name of person taking order, signature, date, time.

−

Detailed Written Order (DWO)  The provider may write the detailed order; however, the physician must review and sign it.  Two dates are required on a provider generated DWO (order date and physician’s signature date)  The DWO must be signed & dated by the ordering physician prior to submitting the claim, but could also be the Dispensing Order if signed prior to delivery.  Signature/date stamps are not allowed. The following elements must be included in a “provider generated” DWO: − Order date  Use the date of the dispensing order if you have one.  If you do not already have a dispensing order, use the dated that the DWO is generated by the provider. (today’s date)  The physician’s signature date does not have to match the order date. − Patient’s name on each page

− −

Describe what is being ordered (list all items, options or additional features that will be separately billed or require an upgraded code )  Effective 11/20/2017: You may use one of the following methods: o Narrative description (AK polycentric knee w/friction) o HCPCS code (L5613), o HCPCS code narrative (Addition to lower extremity, endoskeletal system, above knee, knee disarticulation, 4-bar linkage, with friction swing phase control) o Brand name/model number (4R36 Titan polycentric knee joint) *We recommend including brand name and model number for items with multiple codes. Note: Always include RT/LT Physician demographics (printed name, credential, address, phone, NPI) Physician’s handwritten signature and date Note: If this is the only order and the prosthesis will be delivered same day, the physician should include the time of signature to prove that the order was signed prior to delivery.

Prosthetist’s Documentation  Medical records must support that the device is still medically necessary.  Medicare expects that a lost/damaged item would be reported to some authority (e.g. police, homeowners insurance, etc.) and requires that a copy of that report be available. If patient did not report the accident/loss, you will need a signed statement from the patient describing the incident.

Lower Limb Prosthesis Documentation Guide | Ottobock

4 of 6

Documentation Requirements for LL Prosthetics January 1, 2018

a. Functional Evaluation of the patient should corroborate physician’s documentation (see section f. Physician Documentation) − Activities prior to amputation  Activities that patient did in the past and would like to get back to using a new device (e.g. home, work, therapeutic, exercise). − Current activities.  Focus on activities that the new prosthesis will allow that the current prosthesis does not.  Describe difficulties, such as falls, stumbles, not making it across street before light changes, inability to change speed when needed, etc.  How will patient be able to do it better with the new prosthesis? − Potential future activities. If these vary from prior activities, an explanation will be required) b. History of Prosthetic Use − Your records should have a history of each prosthesis patient has used/trialed in the past.  Brand of component  How long did patient use it?  What was the result? c. Current Prosthesis − History of each component being replaced (age, condition, how did it work out?) − Description of the labor involved (e.g. casting, modification, time, tools used, materials used, where was material applied, etc.) − Reason for replacement (e.g. item lost or damaged beyond repair; change in patient’s condition and device no longer fits or does not meet functional needs; item is worn and cannot be repaired or the cost to repair is greater than 60% of the Medicare allowable for a new device).

d. Recommendation for the type and brand of the new prosthesis: − Must be based on physician’s recommendation − Include rationale for your decision − Include medical necessity and justification for each code that will be billed. e. Patient’s motivation and desire to use the new prosthesis (and to ambulate for lower extremity) f. Chart note for each visit with patient with printed name, credential, signature and date on each note. g. Patient’s name on each page.

Proof of Delivery (POD)  NEW A signature date is no longer required; however, if there is one on the form, it must be the date of service on your claim.  If the DWO is signed on same day as the delivery and it is the only order, both documents will need to indicate the time of the signature. Elements to be included on the POD when device is delivered direct to the patient: − Delivery Date − Patient’s name − Address where item is delivered (your office, patient’s home, SNF, etc.) − The quantity delivered for each item − Amputation side for each item, LT/RT − Describe what will be delivered Effective 12/21/2017: You may use one of the following methods: o Narrative description (AK polycentric knee w/friction) o HCPCS code (L5613), o HCPCS code narrative (Addition to lower extremity, endoskeletal system, above knee, knee disarticulation, 4-bar linkage, with friction swing phase control)

Lower Limb Prosthesis Documentation Guide | Ottobock

5 of 6

Documentation Requirements for LL Prosthetics January 1, 2018

−

−

Effective 11/20/17 POD when patient is recently eligible for FFS Medicare and already own a LL prosthesis o Statement that supplier has examined the item, signed by the beneficiary. Statement must meet POD requirements. AND o Supplier attestation that the item meets Medicare requirements.

Beneficiary Authorization −

−

A new authorization is required anytime a new prosthesis/component(s) is provided. In other words, a new authorization is required anytime a new HCPCS code is billed. This authorization should give you: o Permission to submit claims on behalf of beneficiary. o Permission to pay you directly (assigns the benefits to the provider). o Release to authorize the provider to obtain confidential medical information about the beneficiary in order to process the claim.

Example of an Authorization: Name of Beneficiary: HICN: I authorize (supplier)_______ to submit claims to Medicare on my behalf. I request that payment of authorized Medicare benefits be made either to me or on my behalf to (supplier)_____________________ for any services furnished me by that supplier. I authorize any holder of medical information about me to release to (supplier) ________________ and/or the Centers for Medicare & Medicaid Services and its agents any information needed to determine these benefits or the benefits payable for related services. Signature__________________________ Date_____________

Advanced Beneficiary Notice (ABN) if required  NOTE: Medicare does not allow “blanket” ABN’s to be issued. In other words one cannot give an ABN to every patient, in anticipation that Medicare might deny. ABNs are to be used on a case-by-case basis when there is a clear indication that the device will be denied as not medically necessary/not reasonable and necessary. References: • Joint DME MAC. Local Coverage Article: Standard Documentation Requirements for All Claims Submitted to DME MACs (A55426) • CGS & Noridian Supplier Manuals

Lower Limb Prosthesis Documentation Guide | Ottobock

6 of 6

© 2018 Otto Bock HealthCare LP | 01018

Brand name/model number (4R36 Titan polycentric knee joint) *We recommend including brand name and model number for items with multiple codes. Signature and printed name of the patient or designee Note: If designee signs, include the designee’s relationship to the patient and the reason why patient could not sign. This person cannot have any financial connection to the provider. o

Documentation Checklist for LL Prosthetics (add to chart) January 1, 2018 Patient Name: Date: Completed by:

DETAILED WRITTEN ORDER (DWO)

FROM THE PHYSICIAN a.

b.

History of Amputation



Date of Order: • Use dispensing order date if you have one • If not, use date prepared (not physician signature date)



Effective 11/20/17: Narrative description, HCPCS code, HCPCS code narrative, or Brand Name/Model Number.



Etiology of amputations(s)



Physician demographics



Date of amputation(s)





Affected side(s)



Diagnosis

Physician’s hand written signature, date (and time if device will be delivered same day) Meets your state’s requirement for orders Patient name on each page

Physical Examination

 

PROSTHETIST’S DOCUMENTATION



Height, weight, recent loss/gain



Cognitive ability to use new prosthesis



Condition of residual limb



Activities prior to amputation



Cardiopulmonary



Current Activities

 

Musculoskeletal Neurological



Potential future activities



Explanation for the difference (if applicable)



a.

Functional Evaluation

Strength, ROM, gait, balance, coordination

b.

c.

 Limitations (medical conditions that might limit patient’s ability to use new device) & diagnosis causing the symptom.

c.

d.

 Impact of the Limitations (how are ADLs impacted?)



e.

 Ambulatory assistance used and plan to be free of assistive devices (if applicable).



f.

Functional Level 

Patient’s activities prior to amputation



Patient’s current activities



Desired & potential activities using new prosthesis



Explanation for difference

g.

Current Prosthesis

h.

Condition of each component and reason for replacement (must include objective information to support reason)  Prosthetic Components Tried in Past & Result

i.

 Desire and Motivation to Ambulate

j.

 Recommendation for new prosthesis/components • Must be based on prior activities, current condition, and motivation to ambulate. Include statement.  Prognosis using device • Must include the physician’s opinion as to how long it will take patient to reach the functional potential.



k.

  

d.

e. f.

Date of order (date from prescription/date of call)

 

Description of item being dispensed Printed name and signature of Physician or person who took the call. Meets your state’s requirement for orders



Reason for Replacement

Recommendation for type and brand of prosthesis 

Based on physician’s recommendation



Rational for decision



Medical Necessity and Justification for each component

 Patient’s desire and motivation to ambulate and use new prosthesis  Chart note for each visit

Printed name, signature, credential & date on each chart note Signature Log/Attestation  Patient’s name on each page PROOF OF DELIVERY 

Delivery Date



Patient’s Name

 

Delivery Address Effective 12/21/17: Narrative description, HCPCS code, HCPCS code narrative, or Brand Name/Model Number.



Signature and Printed name of signee



Relationship to patient and reason why patient cannot sign

Signature time, if signed on same day as prescription obtained Effective 11/20/17 For newly eligible:  Statement (signed by patient) that supplier has examined item, it meets POD requirements; AND  Supplier attestation item meets Medicare requirements 

signed DWO in possession) Patient’s name

History of components being replaced (age, condition, result) Description of Labor (casting, modification, time, tools, materials & where applied

 

DISPENSING ORDER (required if you dispense before you have a



History of Current components



Printed name, signature , credential & date on each chart note Signature Log/Attestation Patient’s name on each page



 History of Prosthetic use over time (brand, how long used, result)

 

BENEFICIARY AUTHORIZATION ABN IF REQUIRED

LL Prosthetic Checklist 01018 | © 2018 Otto Bock HealthCare LP

1 of 1

Signature Requirements for Documentation Handwritten Signatures Requirement 1. Medicare auditors have been instructed to disregard illegible signatures, unless they are accompanied by a signature log or attestation statement. 2.

Medicare auditors have also been instructed to disregard medical documentation lacking a signature. However, they will allow signature logs or attestation statements as long as the document is not an order.

3.

It is not allowed to add late signatures to a medical record (beyond the short delay that occurs during the transcription process).

4.

If the order has no signature, it will not be considered.

5.

Stamped signatures are not allowed unless the signee has a disability and can prove that he/she is unable to sign due to a disability.

Signature Log 1. A signature log accompanies one set of medical records. 2. Lists the printed name (and credentials) associated with initials or an illegible signature. 3. The signature log can be a separate document (or it can be on the actual page where the initials or illegible signature are used). 4. A signature log may be created at any time. 5. This may include yourself and/or your office staff. Example: Name

Signature

Initial

Date of Signature

John Doe, MD

John Doe, MD

JD

8/31/2012

A. Prosthetist, CPO

A. Prosthetist, CPO

AP

8/31/2012

I.M. Manager

I.M. Manager, Office Manager

IMM

8/31/2012

Signature Requirements | Ottobock 1 of 2

Signature Requirements for Documentation Signature Attestation Statement Example Patient Name:

I.M. Patient

Medicare Number:

555555555A

I, ___________John Doe _________________________, hereby attest that the medical record entry for _________July 1, 2012____________ accurately reflects signatures/notations that I made in my capacity as a(n) _____MD________ when I treated/diagnosed the above listed Medicare beneficiary. I do hereby attest that this information is true, accurate, and complete to the best of my knowledge and I understand that any falsification, omission or concealment of material fact may subject me to administrative, civil, or criminal liability.

John Doe, MD __________________ Signature 08/12/2012 _________________________________ Date

Note: In order to be a valid attestation, it must be signed by the person who authored the medical record entry. It cannot be a partner in the same group practice or other staff member.

Electronic Signature a. A published rule has not been issued for electronic signatures; however, the DME MAC’s recommend that an electronic notation be included. b. Examples of electronic notations (not all inclusive): • •

Electronically signed by: John Doe MD Signed by: John Doe MD

• •

Authenticated by: John Doe MD Approved by: John Doe MD

REFERENCES CGS Jurisdiction C. CMS Signature Requirements. Reviewed Jan. 4, 2016; Noridian Administrative Services Jurisdiction D. Signature Requirements, Nov. 21, 2016 CMS Pub. 100-08, Medicare Program Integrity Manual, Chap. 3-Section 3.3.2.4 Medicare Learning Network. Complying with Medicare Signature Requirements. ICN 905364. Mar. 2016

Signature Requirements | Ottobock 2 of 2

Replacement of Prosthesis or Prosthetic Components Documentation Requirements Correct Prosthesis: The supplier (prosthetist) is responsible to provide the correct prosthesis for the patient. If an incorrect prosthesis is supplied the supplier is obligated to make the situation right (take back the incorrect prosthesis, provide the correct one, and adjust the billing). There is no time limit for this. Repairs and Adjustments are covered when necessary to make the prosthesis or component functional. Manufacturer-Required Maintenance is covered as well. What about the 5-year Useful Lifetime Rule? This rule does not apply to prosthetics. The Social Security Act was amended in 2001 to exclude Prosthetics from the Useful Lifetime Rule, so amputees could get replacements when needed. What is a Replacement? A replacement is the provision of an entirely identical or nearly identical item. If the prosthesis is different, it is considered a new device and no longer covered under the original order.

Rules for Replacement Replacement is covered if the treating physician orders a replacement of the entire prosthesis or major component (socket, knee, foot, etc.) and the replacement falls under one of the following Reasons for Replacement (documented on the order or in the referring physician’s notes). 1) There is a change in the physiological condition of the beneficiary; or 2) There is irreparable wear of the prosthesis/component; or 3) The condition of the prosthesis/component requires repairs, and the cost of such repairs [list price of parts + labor] is greater than 60% of the cost [Medicare allowable] of the replacement prosthesis/component. What Qualifies? The DME MACs have issued further clarification (not all inclusive) on reasons for replacements in their Lower Limb Prosthesis LCDs and Policy Articles: 1) changes in the residual limb; or 2) functional need changes; or 3) wear/tear due to excessive patient weight; or 4) wear/tear due to prosthetic demands of very active amputees; or 5) loss or irreparable damage due to specific accident or natural disaster Documentation Tips Replace Prosthesis | Ottobock

1 of 3

Replacement of Prosthesis or Prosthetic Components Documentation Requirements Tips 1) Take care when describing the current prosthesis in the medical record, so it does not sound like an incorrect prosthesis was provided. 2) Choose one reason (see examples below) for replacing the prosthesis and carefully build a

case to support this in the patient’s medical record. Explain in great detail why the prosthesis is being replaced. While it is required that the status of the current prosthesis be documented, if the patient’s functional need or physiological condition has changed and a different prosthesis is needed, this should be the focus of the documentation.

Documentation Requirements Reason for Replacement

Documentation Requirement

CHANGE IN PATIENT’S CONDITION

Physician:

PHYSIOLOGICAL OR FUNCTIONAL Replace with Identical or Nearly Identical Device

New Detailed Written Order (DWO) is required. The reason for replacement must be on the order (DWO) or in the physician’s medical record. The reason for replacement in this case would be the change that has occurred in the patient’s physiological condition a change in the patient’s functional need.

Note: If device is not identical or nearly identical, see Documentation Checklist, Prosthetist Documentation Guide and Physician Documentation Guide.

Prosthetist:

IRREPARABLE WEAR/TEAR OF THE

Physician:

DEVICE.

Replace with Identical or Nearly Identical Device Note: If device is not identical or nearly identical, see Documentation Checklist, Prosthetist Documentation Guide and Physician Documentation Guide.

Retain documentation of components being replaced, reason for replacement, and description of labor involved; and detailed justification for each component (socket, knee, ankle, foot, etc.) replaced. Proof of Delivery. New Detailed Written Order (DWO) is required. The reason for replacement must be on the order (DWO) or in the physician’s medical record. The reason for the replacement would be “due to wear/tear (e.g. excessive patient weight, prosthetic demands of active amputee, etc.) Prosthetist: Retain documentation of components being replaced, reason for replacement, and description of labor involved; and detailed justification for each component (socket, knee, ankle, foot, etc.) replaced. Proof of Delivery.

Documentation Tips Replace Prosthesis | Ottobock

2 of 3

Replacement of Prosthesis or Prosthetic Components Documentation Requirements Reason for Replacement

Documentation Requirement

WEAR/TEAR OF THE DEVICE OR COMPONENT ; WHEN COST OF REPAIR IS GREATER THAN 60% OF THE COST OF A REPLACEMENT .

Physician:

Replace with Identical or Nearly Identical Device Note: If device is not identical or nearly identical, see Documentation Checklist, Prosthetist Documentation Guide and Physician Documentation Guide.

New Detailed Written Order (DWO) is required. The reason for replacement must be on the order (DWO) or in the physician’s medical record. The reason for the replacement would be “the cost of repair is greater than 60% of the cost of replacement and the reason for wear/tear (e.g. excessive patient weight, prosthetic demands of active amputee, etc.) Prosthetist: Retain documentation of components being replaced, reason for replacement, and description of labor involved; and detailed justification for each component (socket, knee, ankle, foot, etc.) replaced. Proof of Delivery. If replacing an MPK, we suggest having on file a quotation demonstrating repair cost will exceed 60% of replacement cost (i.e. 60% of the total allowable for the new codes being billed).

OR

DEVICE IS LOST OR STOLEN Replace with exact same device as originally ordered.

Physician: New Detailed Written Order (DWO) is required. The reason for replacement must be on the order (DWO) or in the physician’s medical record. In this case, it would be the accident, disaster, or loss. Prosthetist: Proof of loss or damage through documentation such as a police report, picture, or corroborating statement should be submitted with the claim. Describe in medical record that the prosthesis, as originally ordered, still fills the beneficiary's medical needs. Retain documentation of components being replaced, reason for replacement, and description of labor involved. Proof of Delivery.

Reference Medicare DME MAC. Local Coverage Requirements for Standard Documentation for All Claims Submitted

Documentation Tips Replace Prosthesis | Ottobock

3 of 3

©2018 Otto Bock HealthCare LP | 01018

IRREPARABLE DAMAGE DUE TO SPECIFIC A CCIDENT OR NATURAL DISASTER (E.G. FIRE OR FLOOD)

Patient Name: ______________________________ Date: _____________________________________

Activity Chart Potential Daily Activities

List activities that patient has done in the past and would like to get back to using a new device (e.g. home, work, therapeutic, exercise,& leisure). Focus on activities that meet criteria stated in the insurance payer’s coverage policy and activities that the new prosthesis will allow that the current prosthesis does not. Daily Activities (use appropriate K-Level language)

Distance Traveled (use Google Maps)

Can patient do this activity with Current Prosthesis? (Describe difficulties, such as falls, stumbles, not making it across street before light changes, inability to change speed when needed, etc.)

How will patient be able to do it better with the new prosthesis? (What feature does the new prosthesis offer that will help your patient achieve the activity?

Activities Prior to the amputation

Current Activities that patient is struggling with that he/she could better with the new prosthesis.

Potential Future Activities (If these vary from prior activities, an explanation will be required)

LL Prosthesis Activity Chart 01018 | © 2018 Otto Bock HealthCare LP

1 of 1

Fax to:

Fax from:

Company:

Company:

Phone:

Fax:

Patient Name:

Phone:

Fax:

Date of Birth:

No. Pages:

FAX: Documentation Request for a Lower Limb Prosthesis Please be advised the determination of medical necessity for a prosthesis is generally based solely on information in the physician’s records. Therefore we need the following information from your medical records in order to be in compliance and provide a prosthesis to your patient that allows him/her to live a mobile and independent life to the greatest extent possible. •

History of Amputation: Etiology of amputation(s); Date of amputation(s); Side of amputation(s); Diagnosis

•

Physical Examination 1. Weight, Height, Weight Loss/Gain. 2. Cognitive ability to use the use and care for the new prosthesis 3. Condition of residual limb 4. Cardiopulmonary, musculoskeletal, neurological, strength, ROM, gait, balance, coordination Limitations Describe any medical conditions that could potentially interfere with maintaining the selected functional level (e.g., decreased pulmonary reserve, disabling cardiovascular, neuromuscular, peripheral vascular or musculoskeletal conditions). How will these conditions be overcome? Document Medical Necessity: All must be documented 1. Describe patient’s activities prior to amputation in terms of functional capabilities above. What activities does patient want to get back to? These should be real activities such as “walking the dog” and related K-Levels (above) as they relate to the activities. 2. Describe patient’s current ADL and other activities and future potential activities (if different) in terms of the functional capabilities listed above. For future potential, an explanation for the difference (e.g. deconditioned state is reversible by physical training/therapy) is required. 3. Describe patient’s desire and motivation to ambulate with the new prosthesis 4. Treatment plan that includes new prosthetic components appropriate for the selected functional capability Prognosis that includes statement that [in your opinion] patient will reach a defined functional state (K-Level) within a reasonable [specified] amount of time using the new prosthesis. Document any use of Assistive Device(s) Note: Payers may not consider a person who permanently uses ambulatory assistance to be a community ambulator (K3). If this is a temporary situation, your treatment plan should include a plan for being free of the assistive device in a specified amount of time. Document the condition/status of current prosthesis and reason for replacement of each component. If worn/broken, describe the condition of each component that needs to be replaced. If patient’s physical condition or functional needs have changed, describe why prosthesis/component no longer meets his/her needs. Describe Past Experience with Prostheses/Components Describe what has been tried in the past and the results. Recommendation for the new components. Include medical reason for your decision and your opinion as to how long it will take patient to reach the

•

•

• •

•

• •

Functional Capabilities for Lower Extremity [K-Levels]

Level K-0: Does not have the ability/potential to ambulate or transfer safely with/without assistance

Level K-1: Home Ambulator with ability/potential for transfers or ambulation on level surfaces at fixed cadence.

Level K-2: Limited Community Ambulator with ability/potential for ambulation and to traverse low level environmental barriers

Level K-3: Full Community Ambulator with ability/potential for ambulation with variable cadence and to traverse higher level barriers

Level K-4: Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

Please FAX the signed and dated Medical Necessity documents to: _______________________________________________ at (_________)______________________________ PRIVACY NOTICE: The documents accompanying this transmission may contain confidential health information that is legally protected. This information is intended only for the use of the individual or entity named above. The authorized recipient of this information is prohibited from disclosing this information to any other party unless permitted by law or regulation. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of these documents is strictly prohibited. If you have received this information in error, please notify the sender immediately and arrange for the return or destruction of these documents. 45 CFR 164.530 et seq

Medicare Rules for Changes to the Medical Record Amendments, Corrections and Delayed/Late Entries The CMS Program Integrity Manual, instructs the Medicare Auditors to consider all properly written amendments, corrections and late/delayed entries in patient medical records. This means that the physician can add clarification to the medical record after-the-fact if something was missed when the patient was there. However there are specific rules that need to be followed. “All services provided to beneficiaries are expected to be documented in the medical record at the time they are rendered. Occasionally, certain entries related to services provided are not properly documented. In this event, the documentation will need to be amended, corrected, or entered after rendering the service. When making review determinations the MACs, CERT, Recovery Auditors, and ZPICs shall consider all submitted entries that comply with the widely accepted Recordkeeping Principles.” (CMS Program Integrity Manual)

What are Recordkeeping Principles? “Regardless of whether a documentation submission originates from a paper record or an electronic health record, documents submitted to MACs, CERT, Recovery Auditors, and ZPICs containing amendments, corrections or addenda must: • • •

Clearly and permanently identify any amendment, correction or delayed entry as such, and Clearly indicate the date and author of any amendment, correction or delayed entry, and Clearly identify all original content, without deletion” (CGS JC)

Specific Rules for Amendments, Corrections and Late Entries Late Entries “A late entry supplies additional information that was omitted from the original entry. The late entry bears the current date, is added as soon as possible, is written only if the person documenting has total recall of the omitted information and signs the late entry.” (Noridian JE)

Addendums: “An addendum is used to provide information that was not available at the time of the original entry. The addendum should also be timely and bear the current date and reason for the addition or clarification of information being added to the medical record and be signed by the person making the addendum.” (Noridian JE)

[An example would be a lab test not yet available at the time of the exam.] Medicare Rules: Changes to Medical Records 01018 | Ottobock

1 of 3

Medicare Rules for Changes to the Medical Record Amendments, Corrections and Delayed/Late Entries Corrections: “Paper Medical Record •

Use a single line strike through so the original content is still readable, and

•

The author of the alteration must sign and date the revision.

Electronic Health Records (EHR): •

Distinctly identify any amendment, correction or delayed entry, and

•

Provide a reliable means to clearly identify the original content, the modified content, and the date and authorship of each modification of the record.” (CGS JC)

What is Considered Falsified Documentation? “Providers are reminded that deliberate falsification of medical records is a felony offense and is viewed seriously when encountered. Examples of falsifying records include: • • • • • •

Creation of new records when records are requested Back-dating entries Post-dating entries Pre-dating entries Writing over, or Adding to existing documentation (except as described in late entries, addendums and corrections)” (Noridian JE)

“Corrections to the medical record, legally amended, prior to claims submission and/or medical review will be considered in determining the validity of services billed. If these changes appear in the record following payment determination based on medical review, only the original record will be reviewed in determining payment of services billed to Medicare. Appeal of claims denied on the basis of an incomplete record may result in a reversal of the original denial if the information supplied includes pages or components that were part of the original medical record, but were not submitted on the initial review.” (Noridian JE)

Note: In open forums, Medicare has indicated that addendums can only be a clarification (not new information) and should be done within a few days of the visit.

Medicare Rules: Changes to Medical Records 01018 | Ottobock

2 of 3

Medicare Rules for Changes to the Medical Record Amendments, Corrections and Delayed/Late Entries References CMS Program Integrity Manual. 3.3.2.5 Amendments, Corrections and Delayed Entries in Medical Documentation. Rev. 615, Issued: 10-02-15, Effective: 10-02-15, Implementation: 11-02-15. CGS Jurisdiction C. Entries in Medical Records: Amendments, Corrections, and Delayed Entries January 19, 2016. Noridian JE Part B Medical Review. Documentation Guidelines for Amended Medical Records: Amended Medical Records July 16, 2015.

Medicare Rules: Changes to Medical Records 01018 | Ottobock

3 of 3

Lower Limb Prosthesis Physician’s Documentation Guide for Medicare January 1, 2018

Information should be documented in the contemporaneous medical record, being Medicare does not consider letters of medical necessity, orders, templates, or supplier generated forms to be part of the medical record. Medical necessity for a prosthesis/prosthetic component is based on the beneficiary’s “potential” functional ability. Potential functional ability is based on the reasonable expectation of the ordering physician and prosthetist, considering factors including, but not limited to:  The beneficiary’s past history (including prior prosthetic use if applicable); and  The beneficiary’s current condition including the status of the residual limb and the nature and severity of comorbidities; and  The beneficiary’s desire to ambulate.

Clinical assessments of the patient’s rehabilitation potential when considering a prosthesis for a Medicare patient must fall within the following classification levels: Level K0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility. Level K1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator.

LL Prosthesis | Physician’s Documentation Guide for Medicare | Ottobock 1

Lower Limb Prosthesis Physician’s Documentation Guide for Medicare January 1, 2018

Level K2: Has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs or uneven surfaces. Typical of the limited community ambulator. Level K3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. Level K4: Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

Bilateral patients are not held to these classifications; however there must be justification for the prosthetic ordered. Following is what needs to be documented in the physician’s contemporaneous medical record for a microprocessor knee:

History & Physical Examination  Diagnosis related to medical necessity for the prosthesis (=etiology of the amputation)  Date of amputation  Affected side(s) and anatomical level(s)  Recent physical examination relevant to functional deficits. Focus should be on the body systems responsible for the patient’s ambulatory difficulties or impact on the patient’s functional ability. Include the following: o Height and weight, including any recent weight loss or gain o Cardiopulmonary capacity o Musculoskeletal condition, including both arm and leg strength and ROM o Neurological condition, including gait, balance, and coordination

LL Prosthesis | Physician’s Documentation Guide for Medicare | Ottobock 2

Lower Limb Prosthesis Physician’s Documentation Guide for Medicare January 1, 2018

Functional Capabilities  Describe the nature and extent of functional capabilities on a typical day including: o

Patient’s daily activities and functional capabilities prior to the amputation and those activities the patient desires to get back to. 

Describe real activities such as “walking the dog.” Describe activities that require long distance ambulation, changes to walking speed, and obstacles, types of terrain, slopes, stairs, ramps, crowds, public transportation, etc. that patient encountered.



If patient was a community ambulator earlier in life, but not prior to the amputation due to a medical condition (e.g. neuropathy, ulcers, and neuropathic pain) or if patient was never a community ambulator and now has demonstrated capacity to be one, include why you believe the patient will be a community ambulator with the prosthesis/prosthetic component (e.g. sound limb is asymptomatic, achievements during rehabilitation/physical therapy, diseased limb was the primary cause of the mobility restrictions, etc.).

o Describe patient’s current daily activities and how they are impacted by deficit(s) and diagnoses causing the deficits. This could also be a current prosthesis that is not meeting the patient’s needs. o Describe other comorbidities related to functional problems (e.g. neurological, cardiovascular reserve, condition of contralateral limb, fatigue, etc.) and why these conditions will not affect patient’s ability to use the new prosthesis. o Describe any ambulatory assistance (cane, walker, wheelchair, caregiver) currently used with/without the prosthesis. If ordering a level K3+ prosthesis, there needs to be a plan to ambulate without the mobility device within ____ time.

Condition/Status of Current Prosthetic Components  Describe why a new or replacement prosthetic component is needed. Examples: o Current component(s) are worn or broken and cannot be repaired (or the cost to repair will be greater than 60% of the cost to replace the device)

LL Prosthesis | Physician’s Documentation Guide for Medicare | Ottobock 3

Lower Limb Prosthesis Physician’s Documentation Guide for Medicare January 1, 2018

o If patient’s condition has changed, describe why the current prosthesis/component is no longer appropriate. Examples: skin irritation, limb volume change, weight gain/loss, decreased stability. o If patient’s functional level has changed, describe why the current prosthesis/component will not allow patient to achieve the desired K-Level.

Current and Past Prosthetic Use  Describe problems with current prosthesis/component(s) (e.g. frequent falls, inability to navigate non-level terrains that the patient encounters often, etc.).  Describe past experience with prosthesis/components  State your opinion as to why you believe the new prosthesis/component(s) will help your patient regain or maintain function.  State in your opinion how long it will take for the patient to reach the function required for the new prosthesis/component and if physical therapy will be required.

Motivation and Participation  Document that Patient desires to ambulate and is motivated to use the new prosthesis/prosthetic component.

©2017 Otto Bock HealthCare LP ● 05197

 Document that patient is able to cognitively and physically function at a level necessary to use and care for the new prosthesis/prosthetic component  Document that patient is willing and able to participate in training for use of the device.

Prescription  Provide a clear and specific prescription/order for the new prosthesis/prosthetic component(s) with rationale for your decision.  Each component being ordered (socket, knee, ankle, foot) must be included in your assessment.

LL Prosthesis | Physician’s Documentation Guide for Medicare | Ottobock 4

Medicare Audit Survival Kit References for Medicare Documentation Requirements Joint DME MAC. Local Coverage Determination (LCD): Lower Limb Prostheses (L33787) Revision effective January 1, 2018. Joint DME MAC Local Coverage Article: Lower Limb Prostheses - Policy Article (A52496) Revision effective January 1, 2018.

CGS, Region C Medicare Contractor. Supplier Manual: Supplier Documentation Chapter 3. Winter 2018.

Ottobock 800 328 4058 Professionals.ottobockus.com

©2018 Otto Bock HealthCare LP | Medicare Audit Survival Kit | 01308

Joint DME MAC Local Coverage Article: Standard Documentation Requirements for All Claims Submitted to DME MACs (A55426). Revision effective December 21, 2017.