CERT Nebulizer Errors - CGS Medicare · 3.0mg total – 1 vial 558 mg total/month – 186 vials**...

DME CERT Outreach and Education Task Force

National Nebulizer Webinar, Summer 2015

Revised September 3, 2015 © 2015 Copyright.

CERT Nebulizer Errors:

The DME CERT Outreach and

Education Task Force Responds

Nebulizer Policy

CERT Errors

Nebulizer CERT Errors -

Detailed Written Orders

No detailed written orders were submitted

The detailed written orders were written after the date of service

The detailed written order did not include a date stamp or equivalent

indicating when the supplier received the document (ACA 6407)

The detailed written orders did not include detailed description of the

items to be provided to the beneficiary

The detailed written orders were incomplete

• Missing quantity to dispense

• Missing dosage concentration

• Missing number of refills



Medical Records/Continued Need

No medical records were submitted

The medical record did not support medical necessity for the

inhalation medication or the nebulizer

The face-to-face encounter was not within six months of detailed

written orders (ACA 6407)

The face-to-face encounter did not include a date stamp or equivalent

indicating when the supplier received the document (ACA 6407)

No indication that inhalation medication was part of the practitioner’s

treatment plan for the beneficiary

No proof of continued need submitted



Proof of Delivery/Continued Use

No proof of delivery documents were submitted

The proof of delivery was missing the detailed description of the items

The quantities on the proof of delivery did not match the quantities or

units of service billed to the Medicare program


Nebulizer Policy

Requirements -

Physician’s Orders for

the Nebulizer Equipment


Must be signed/dated by physician

• Must be legible

Faxed, photocopied, electronic, or pen & ink orders are acceptable for

claim submission

Must be kept on file by supplier

Signature and Date stamps are not acceptable on orders

• Exception: Rehabilitation Act of 1973 in the case of an author with a

physical disability



The Detailed Written Order (DWO) must include:

Beneficiary’s name

Physician’s Name

Date of the order and the start date, if start date is different from the

date of the order

Detailed description of the item

The prescribing practitioner’s National Provider Identifier (NPI)

• E0570, E0575, E0580, E0585, K0730

The signature of the ordering practitioner

Signature date



A new order is required:

Change of supplier

Change in the item(s), frequency of use, or amount prescribed

Change in the length of need or a previously established length of

need expires

State law requires periodic prescription renewal

On a regular basis, if specified in the documentation section of a

particular medical policy

When an item is replaced


Face-to-Face Exam

Effective July 1, 2013

The face-to-face encounter conducted by the physician, PA, NP, or

CNS must document that the beneficiary was evaluated and/or

treated for a condition that supports the item(s) of DME ordered

Remember that all Medicare coverage and documentation

requirements for DMEPOS also apply

• Refer to the Jurisdictional DME MAC LCD for more information


Face-to-Face Exam

The face-to-face examination with the beneficiary must be conducted

within the six (6) months prior to the date of the prescription

The face-to-face examination must document that the beneficiary

was evaluated and/or treated for a condition that supports the

need for the item(s) of DME ordered but doesn’t need to specify

the item(s) ordered

The prescriber must provide a copy of the face-to-face examination

and the prescription for the item(s) to the DMEPOS supplier before

the item(s) can be delivered


When is a New Face-to-Face

and Order Required?

A face-to-face examination is required each time a new order for one

of the specified items is necessary based on Medicare guidelines

• A new prescription is required by Medicare:

– For all claims for purchases or initial rentals

– When there is a change in the prescription for the accessory, supply, drug, etc.

– If a Local Coverage Determination (LCD) requires periodic prescription renewal

(i.e., policy requires a new prescription on a scheduled or periodic basis)

– When an item is replaced

– When there is a change in the supplier


Timing Requirements

There are specific date and timing requirements:

The date of the face-to-face examination must be on or before the

date of the written order (prescription) and may be no older than

six (6) months prior to the prescription date

The date of the face-to-face examination must be on or before the

date of delivery for the item(s) prescribed

The date of the written order must be on or before the date of delivery

The DMEPOS supplier must have documentation of both the face-to-

face visit and the completed WOPD in their file prior to the delivery of

these items


Date Stamps

A date stamp (or similar) is required which clearly indicates the

supplier’s date of receipt of both the face-to-face record and the

completed WOPD

• A fax header can be used if it contains sufficient information to prove the

documents were received by the supplier prior to delivery

It is recommended that both documents be separately date-stamped

to avoid any confusion


Corrections and Amendments

to Face-to-Face and WOPD

Prior to Delivery of Equipment

If errors in the face-to-face visit documentation or WOPD are

identified the supplier has two options:

• The supplier may request that the treating physician amend the face-to-face

visit notes or the WOPD, whichever is applicable, following the guidance in

the Program Integrity Manual Pub.100-08, Chapter 3, Section 3.3.2.5, or

• A new face-to-face examination may be conducted

and/or a new WOPD may be created


Corrections and Amendments

to Face-to-Face and WOPD

After Delivery of Equipment

If errors in the face-to-face visit documentation or WOPD are

identified the following rules apply:

• Prior to Claim Submission: The original supplier may recover the delivered

item(s), obtain a compliant, complete WOPD and/or face-to-face visit notes

that describe a medical condition for which the DME is being prescribed,

whichever is applicable, and then re-deliver the item(s) to the beneficiary; or

• After Claim Submission: The original supplier can recover their items

and a new supplier must complete the transaction after complying with

all requirements


Detailed Written Order -

Example 1

• Detailed Written Order Requirements

• Beneficiary's name

• Physician's name

• Date of the order and the start date, if

start date is different from the date of the

order

• Detailed description of the item(s)

• Physician signature and signature date

• Physician’s NPI


Detailed Written Order - Example 2

Invalid The detailed written order

requirements:

Beneficiary's name

Physician's name

Date of the order and the start date, if start

date is different from the date of the order

Detailed description of the item(s)

Physician signature and signature date

Physician’s NPI


Detailed Written Order -

Example 3

Date of service on claim is

07/05/2015

WOPD was written after date of

delivery


Nebulizer Policy

Requirements -

Physician’s Orders for

Inhalation Medication

Items Provided on a

Periodic Basis Requirements

Item(s) to be dispensed

Dosage or concentration, if applicable

Route of administration

Frequency of use

• detailed instructions for use and specific amounts to be dispensed

Duration of infusion, if applicable

Quantity to be dispensed

Number of refills


Allowances


Drug Name HCPCS

Unit of Service (UOS) Maximum/Month Maximum

UOS/Month

Acetylcysteine J7608 Per 1 gram 74 grams/month 74

Albuterol J7611, J7613 Per 1 mg 465 mg/month** 465

Albuterol/Ipratropium combination J7620 Up to 2.5 mg albuterol

and 0.5 mg of ipratropium –

3.0mg total – 1 vial

558 mg total/month –

186 vials**

186

Arformoterol J7605 15 mcg 930 mcg/month 62

Budesonide J7626 Up to 0.5 mg – 1 vial 31 mg/month 62

Cromolyn sodium J7631 Per 10 mg 2480 mg/month 248

Dornase alpha J7639 Per 1 mg 78 mg/month 78

Formoterol J7606 20 mcg 1240 mcg/month 62

Ipratropium bromide J7644 Per 1 mg 93 mg/month 93

Levalbuterol J7612, J7614 Per 0.5 mg 232.5 mg/month** 465

Metaproterenol J7669 Per 10 mg 2800 mg/month** 280

Pentamidine J2545 Per 300 mg 300 mg/month 1

Treprostinil J7686 1.74 mg – 1 ampule/vial 31 ampules/vials month 31

Sterile saline or water A4216, A4218 10 ml – 1 unit 560 ml/month 56

Distilled water, sterile water, or sterile

saline in large volume nebulizer

A4217, A7018 500 ml 18,000 ml –

18 liters/month

36

Dates on DWOs and WOPDs

Order date

• The date is pulled from the dispensing order

• Required on all DWOs/WOPDs

Start date

• If ordering physician specifies a different date than the order date

Signature date

• Someone other than the physician may complete the detailed description of the item.

However, the treating physician must review the detailed description and personally

sign and date the order to indicate agreement. – CMS IOM Publication 100-08,

Medicare Program Integrity Manual, Chapter 8, Section 5.2.3

Majority of DWOs/WOPDs require an order date and a signature date

since suppliers typically complete the DWO/WOPD


Acceptable Formats for Orders

Verbal

Written

• Photocopy

• Facsimile image

• Electronically maintained

• Original “pen-and-ink” document

– Other payers may require hard copy


Physician Signatures

Medicare requires a legible identifier for services provided/ordered

Handwritten or electronic signatures are acceptable

Stamped signatures and signature dates are not acceptable

If a signature is missing the order is invalid


Handwritten Signatures

Illegible signature with printed physician name and credentials

Acceptable, signature requirement met


Signature Logs

Should include

• Physician printed name

• Physician signature

• Physician initials

• Credentials and NPI (encouraged)

Provide in audit situation


Electronic Signatures

Some examples of acceptable notations of electronic signatures

(not all inclusive list)


– Electronically signed by

– Authenticated by

– Approved by

– Completed by

– Finalized by

– Signed by

– Validated by

– Sealed by

Order Changes

CMS IOM Publication 100-08, Chapter 5, Section 5.3.1

• Physician must line through error

• Initial, and

• Date the correction

If not noted, the supplier should obtain a new order


When Is A New Order Required?

There is a change of supplier

There is a change in the item(s), frequency of use, or amount

prescribed

There is a change in the length of need or a previously established

length of need expires

State law requires a prescription renewal

On a regular basis (even if there is no change in the order) only

if it is so specified in the documentation section of a particular

medical policy


Example DWO for Inhalation

Medication


Nebulizer Policy

Requirements –

Medical Records

and Continued Need

LCD Coverage Criteria

Small volume nebulizer (A7003-A7005) and compressor (E0570) are

covered to administer inhalation solutions in the following situations:

• Albuterol, arformoterol, budesonide, cromolyn, formoterol, ipratropium,

levalbuterol or metaproterenol for management of obstructive pulmonary

disease (ICD-9 491.0-508.9)

• Dornase alpha for cystic fibrosis patients (ICD-9 277.02)

• Tobramycin for patients with cystic fibrosis or bronchiectasis

(ICD-9 277.02, 494.0, 494.1, 748.61, or 011.50-011.56)

• Pentamidine for patients with HIV, pneumocystosis, or complications of

organ transplants (ICD-9 042, 136.3 or 996.80 - 996.89)

• Acetylcysteine for persistent thick or tenacious

pulmonary secretions (ICD-9 480.0 – 508.9 or 786.4)



Large volume nebulizer (A7007,A7017) compressor (E0565,

E0572) and water or saline (A4217 or A7018) are covered:

When used to deliver humidity to patients with thick, tenacious

secretions who has one of the following conditions:

• Cystic fibrosis (ICD-9 277.02),

• Bronchiectasis (ICD-9 494.0, 494.1, 011.50-011.56 or 748.61),

• A tracheostomy (ICD-9 V44.0 or V55.0), or

• A tracheobronchial stent (ICD-9 519.19)



The necessity for the nebulizer equipment is based on the medical

need for inhalation medication

If the inhalation medication used with the nebulizer are not covered,

the nebulizer, compressor, and accessories will be not be covered and

denied as not reasonable and necessary

The LCD contains maximum monthly quantities of the inhalation

medications

• Any quantities ordered above these maximums must be supported in the

medical record


Medical Record Documentation

Supplier-produced records, even if signed by the ordering physician,

and attestation letters (e.g. letters of medical necessity) are deemed

not to be part of a medical record for Medicare payment purposes.

Templates and forms, including CMS Certificates of Medical

Necessity, are subject to corroboration with information in the

medical record.

Information contained directly in the contemporaneous medical record

is the source required to justify payment except as noted elsewhere

for prescriptions and CMNs.


Initial Need Documentation

Initial justification for medical need is established at the time items are

first ordered

Medical records demonstrating the items are reasonable and

necessary are created just prior to, or at the time of, the creation of

the initial prescription

Entries in the medical record must have been created prior to, or at

the time of, the initial date of service to establish whether the initial

reimbursement was justified based on the applicable coverage policy


Continued Need Documentation

In addition to initial justification documentation, for ongoing

supplies and rental DME items, there must be information in the

medical record to support items continue to be used and remains

reasonable and necessary

Information used to justify continued medical need must be timely for

the date of service under review


Continued Need Documentation

Any of the following may serve as documentation justifying continued

medical need:

• A recent order by the treating physician for refills

• A recent change in prescription

• A properly completed CMN or DIF with an appropriate length

of need specified

• Timely documentation in the medical record showing usage of items

Timely documentation is a record in the preceding 12 months unless

otherwise specified in the applicable policy


Nebulizer Policy

Requirements –

Continued Use and

Delivery Documentation


Continued Use

Continued use describes ongoing utilization by a beneficiary

Must be periodically documented to confirm item continues to be used

• Acceptable continued use documentation:

– Beneficiary’s medical records or

– Supplier records

Suppliers must discontinue billing if the item is no longer being used


Proof of Delivery (POD)

Supplier Standard 12

Signed POD required to verify beneficiary received DMEPOS item

Confirms correct coding of item(s) billed

Must be available upon request

• If not provided, claim denied, overpayment requested

• If no documentation provided on consistent basis, may be referred to Office

of Inspector General (OIG)

Maintain documentation for seven years


Method 1- Direct Delivery

Delivery directly to a beneficiary by a supplier

The POD record must include:


• Delivery address

• Sufficiently detailed description to identify the item(s) being delivered (e.g.,

brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Beneficiary (or designee) signature

Date of service = Date of delivery


Method 2 – Deliver/Shipping

Service

Delivery to beneficiary via shipping service

The POD record must include:


• Delivery address

• Delivery service's package ID number, supplier invoice number or

alternative method that links the supplier's delivery documents with the

delivery service's records

• Detailed description identifying item(s) being delivered

• Quantity delivered

• Date delivered

• Evidence of delivery

Date of service = shipping date Revised September 3, 2015 © 2015 Copyright.

Method 3 – Delivery to Nursing

facility

Delivery to a nursing facility on the beneficiary’s behalf

The POD record is based on delivery via method 1 (direct delivery) or

method 2 (shipping service)

Documentation from the nursing facility


POD Exception:

Anticipation of Discharge

Delivery to Facility

Delivered for the purpose of

fitting/training

2 days prior to discharge

from hospital or nursing

facility

DOS=Discharge Date

POS=12 (Beneficiary’s

Home)

Delivery to Home

2 days prior to discharge

from hospital or nursing

facility

DOS=Discharge Date

POS=12 (Beneficiary’s

Home)


POD Exception:

Part A Covered Inpatient Stay

May not be billed to DME MAC:

• Drugs or other DMEPOS used by the beneficiary prior to discharge

– For purposes other than training and/or fitting

• Surgical Dressings, Urological Supplies or Ostomy Supplies provided by

facility

– These items are payable to the facility under Part A Medicare

Applies to beneficiaries in:

• Hospitals

• Skilled nursing facilities (POS=31)

• Nursing facilities (POS=32)


POD: Beneficiaries Entering

Medicare

Statement of DMEPOS item(s) in beneficiary’s possession must

include:

• Date of delivery

• Information that supplier examined item

• Information that the item(s) meet Medicare requirements

• Signed and dated by beneficiary or designee

Rented items

• RUL begins first day of first rental month

Date of service

• Match signature date of beneficiary or designee


Proof of Delivery Signature

Proof of delivery can be signed by:

Beneficiary

Beneficiary’s designee

• Relationship to beneficiary must be noted on delivery slip

Proof of delivery cannot be signed by:

Suppliers

Employees of suppliers

Anyone with financial interest in delivery of item

*Required only for direct delivery method, shipping service uses tracking mechanism


Questions?


Thank you!

Thank you for participating in this

DME CERT Outreach and Education

Task Force presentation.


Disclaimer

The DME CERT Outreach and Education Task Force consists of representatives from each of the DME

MACs and is independent from the CMS CERT Team and CERT Contractors, who are responsible for

the calculation of the Medicare Fee-for-Service Improper payment rate.

The DME CERT Outreach and Education Task Force has produced this material as an informational

reference for providers furnishing services in our contract jurisdictions. The DME CERT Outreach and

Education Task Force employees, agents, and staff make no representation, warranty, or guarantee that

this compilation of Medicare information is error-free and will bear no responsibility or liability for the

results or consequences of the use of this material. Although every reasonable effort has been made to

assure the accuracy of the information within these pages at the time of publication, the Medicare

program is constantly changing, and it is the responsibility of each provider to remain abreast of the

Medicare program requirements. Any regulations, policies and/or guidelines cited in this publication are

subject to change without further notice. Current Medicare regulations can be found on the Centers for

Medicare & Medicaid Services (CMS) website at http://www.cms.gov.

CMS prohibits education activities or training from recording of any kind.


http://www.cms.gov/

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CERT Nebulizer Errors - CGS Medicare · 3.0mg total – 1 vial 558 mg total/month – 186 vials**...

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