Oxygen Documentation
Requirements
Presented by Noridian Medicare Provider Outreach
and Education - DME and Part B
September 2015
DISCLAIMER
•
This information release is the property of Noridian Healthcare
Solutions, LLC. It may be freely distributed in its entirety but may
not be modified, sold for profit or used in commercial documents.
•
The information is provided “as is” without any expressed or implied
warranty. While all information in this document is believed to be
correct at the time of writing, this document is for educational
purposes only and does not purport to provide legal advice.
•
All models, methodologies and guidelines are undergoing
continuous improvement and modification by Noridian and CMS.
The most current edition of the information contained in this release
can be found on the Noridian website at
http://www.noridianmedicare.com and the CMS website at
http://www.cms.gov
•
The identification of an organization or product in this information
does not imply any form of endorsement.
•
CPT codes, descriptors, and other data only are copyright 2015
American Medical Association. All rights reserved. Applicable
FARS/DFARS apply.
September 2015
2
Acronyms
•
•
•
•
•
•
•
•
•
ABG: Arterial Blood Gas
ABN: Advance Beneficiary
Notice of Noncoverage
CBA: Competitive Bidding Area
CEDI: Common Electronic Data
Interchange
CERT: Comprehensive Error
Rate Testing
CMS: Center for Medicare &
Medicaid Services
CO: Contractual Obligation
DMECS: Durable Medical
Equipment Coding System
DME MAC: Durable Medical
Equipment Medicare
Administrative Contractor
September 2015
•
•
•
•
•
•
•
•
•
•
DMEPOS: Durable Medical
Equipment Prosthetics Orthotics
and Supplies
HCPCS: Healthcare Common
Procedure Coding System
HHA: Home Health Agency
HICN: Heath Insurance Claim
Number
HMO: Health Maintenance
Organization
IDTF: Independent Diagnostic
Testing Facility
IOM: Internet Only Manual
IVR: Interactive Voice Response
(system)
LCD: Local Coverage
Determination
LON: Length of Need
3
Acronyms (2)
•
•
•
•
•
•
•
•
•
•
•
•
LPM: Liters per minute
LTOT: Long Term Oxygen
Therapy
mm Hg: Millimeters of Mercury
M&S: Maintenance and Service
MLN: Medicare Learning Network
NCD: National Coverage
Determination
NSC: National Supplier
Clearinghouse
PA: Policy Article
PHI: Protected Heath Information
PIM: Program Integrity Manual
POD: Proof of delivery
•
•
•
•
•
•
•
•
•
•
PR: Patient Responsibility
PTAN: Provider Transaction
Access Number
RA: Remittance Advice
RA: Recovery Auditor
RUL: Reasonable Useful Lifetime
SAT: Oxygen Saturation
SNF: Skilled Nursing Facility
SOF: Signature on File
TIN: Taxpayer Identification
Number
ZPIC: Zone Program Integrity
Contractor
https://med.noridianmedicare.com/web/jddme/help/acronyms-glossary
• www.cms.gov/apps/acronyms
September 2015
4
Objective
• To provide clarity for both physician offices and
Durable Medical Equipment (DME) suppliers on
the documentation requirements for their
Medicare patients who require home oxygen
therapy.
September 2015
5
Agenda
• Coverage Criteria
• Testing Requirements
• Certificate of Medical Necessity
• General Documentation
• Relocation and Travel
• Comprehensive Error Rate Testing (CERT)
• Reminders and Resources
September 2015
6
Coverage Criteria
National Coverage Determination (240.2)
Local Coverage Determination (L11457)
Policy Article (A33677)
Covered Home Oxygen Therapy
1. Severe lung disease or hypoxia related
symptoms; and
2. Beneficiary’s blood gas study meets specific
criteria; and
3. Blood gas study performed by physician or a
qualified provider or supplier of laboratory
services; and
4. Blood gas study performed under specific
conditions; and
5. Alternative treatments ineffective
September 2015
8
FAQ
• Q: Could you expand on what constitutes
alternative treatments?
A: This can include a note/list showing other
medications prescribed to treat the beneficiary's
respiratory illness or other evidence that the
physician considered alternative treatments
before prescribing oxygen therapy.
– Many disease conditions have standard treatment
regimens associated with them. This would depend
upon the disease being treated.
September 2015
9
Home Oxygen – Not
Reasonable and Necessary
• Angina pectoris in the absence of hypoxemia
• Dyspnea without cor pumonale or evidence of
hypoxemia
• Severe peripheral vascular disease in absence
of systemic hypoxemia
• Terminal illnesses that do not affect respiratory
system
September 2015
10
Group I
• ABG at or below 55 mm Hg or SAT at or below
88%
1.
2.
3.
4.
At rest, or
During exercise (3 tests)
During sleep (at least 5 min)
During sleep (signs of hypoxemia)
• Decrease in ABG more than 10 mm Hg or a decrease in SAT
more than 5% from baseline for at least 5 minutes taken
during sleep
• Initial coverage limited to 12 months
September 2015
11
Group II
• ABG between 56 – 59 mm Hg or SAT at 89%
– Same testing requirements as Group I
• AND beneficiary has one of following conditions:
– Dependent edema, suggesting congestive heart
failure; or
– Pulmonary hypertension or cor pulmonale; or
– Erythrocythemia with a hematocrit greater than 56%
• Initial coverage limited to 3 months
September 2015
12
Testing Requirements
Blood Gas Study
• Qualifying test covered under Medicare
• Part A or B
• Test must be performed by provider qualified to
bill Medicare:
–
–
–
–
Part A Provider
Laboratory
Independent Diagnostic Testing Facility (IDTF)
Physician
• Test cannot be performed by:
– Supplier
September 2015
14
Testing
• Types of qualifying tests:
– Arterial blood gas (ABG) – below 60 mm Hg
– Blood oxygen saturation (SAT) – below 90%
– Most recent study prior to CMN initial date (w/in 30 days)
• Study can be performed:
– At rest
– During sleep
– During exercise
• Can be formal exercise or exertion while performing daily
activities
• Three separate readings must be taken
• Record reading taken during exercise breathing room air on
CMN
September 2015
15
Sleep Oximetry Studies
• Oximeter must be:
– Stand-alone overnight pulse oximetry
– Tamper proof
– Capable of downloading data that allows documentation of
duration of O2 desaturation below specified value
• Home based overnight oximetry tests
– Performed under direction of Medicare enrolled IDTF
– Can be delivered by supplier or shipping entity if:
• Ordered by physician
• Test results accessible only by IDTF
• Lowest saturation reported on CMN
– Lowest recorded during 5 minute qualifying period
– 5 minute period does not have to be continuous
September 2015
16
Overnight Oximetry,
OSA AND PSG
• Testing must be done in Chronic Stable State
• Both oxygen LCD and PAP LCD must be
followed
• OSA sufficiently treated and lung disease
unmasked
September 2015
17
Overnight Oximetry,
OSA AND PSG (2)
• Overnight oximetry during home sleep test not
eligible to be used for oxygen qualification.
• Testing may only occur during a Titration Study
and
1. Minimum 2 hours
2. During titration specific reduction in AHI/RDI criteria
met
3. Only performed after optimal PAP settings
determined
4. Nocturnal oximetry conducted during PSG shows
<88% for 5 minutes.
September 2015
18
Inpatient vs.
Outpatient Testing
• Blood gas study performed
– Inpatient hospital stay, 2 days prior to discharge
• Last test prior to discharge
– Outpatient, while beneficiary is in a chronic stable
condition
• Not during acute illness or exacerbation of underlying disease
September 2015
19
Certificate of Medical Necessity
(CMN)
Initial CMN
1. First claim to DME MAC
– Testing and physician evaluation within 30 days of
initial date
2. Break in need during 36 month rental period
– Testing and physician evaluation within 30 days of
initial date
3. Replacement due to RUL
– No new testing or new physician visit required
4. Replacement due to irreparable damage, theft,
or loss of the originally dispensed equipment
– No new testing or new physician visit required
September 2015
21
Recertification
5. Group I patients – 12 months after initial
– Most recent qualifying test prior to 13th month
6. Group II patients – 3 months after initial
– Most recent qualifying test between 61st – 90th day
• Other requirements for 6 and 7:
– Re-evaluation within 90 days prior to recertification
– Above criteria not met, but use continues, coverage
resumes when requirements are met
• Recertification for replacement equipment:
– Same timeframes apply
– Repeat testing and re-evaluation not required
– Use most recent qualifying value and test date
September 2015
22
Revised CMN
7. Change in flow rate category
a. Less than 1 liter per minute (LPM)
b. 1-4 LPM
c. Greater than 4 LPM
8. Length of need expired
9. Portable added to stationary
10. Stationary added to portable
11. New treating physician - oxygen order is the
same
12. New supplier does not have the prior CMN
 Revised CMN does not change recertification schedule
September 2015
23
Other CMN Notes
• CMN Sections B and D completed by physician
– Signature and date stamps are not acceptable for use
on CMNs and DIFs
– Form CMS-484 (09/05):
www.noridianmedicare.com/dme/forms/docs/cms484.pdf
• Misc. changes not requiring new CMN or testing
– Flow rate changes but remains in same category
– Change of modality
– New written order is required though
September 2015
24
Making Changes to a CMN
• Two options
– Draw line through error
• Treating physician must initial and date correction
• Must have similar capability for electronic CMN
– Complete new CMN
• Whiteout not acceptable
www.noridianmedicare.com/dme/forms/cmn_dif_forms.html
September 2015
25
Certificate of Medical Necessity
www.noridianmedicare.com/dme/news/manual/docs/chapter4.pdf
September 2015
26
Oxygen CMN Section A
Supplier completes
September 2015
27
Oxygen CMN Section B
Physician completes
September 2015
28
Oxygen CMN Sections C & D
Supplier completes
Physician completes
September 2015
29
Documentation
Authorized to Order
• Treating MD or DO
• Nurse Practitioner or
Clinical Nurse Specialist
– Treating beneficiary for
condition for which item is
needed
– Practicing independently of
physician
– Bill Medicare for other
covered services using
own NPI
– Permitted to do in state
where services are
rendered
September 2015
• Physician Assistant (PA)
– Meet definition of physician
assistant found in Section
1861(aa)(5)(A) of Social
Security Act
– Treating beneficiary for
condition for which item is
needed
– Practice under supervision
of MD or DO
– Have own NPI
– Permitted to perform
services in accordance with
state law
31
Implementation vs. Enforcement
Affordable Care Act Section 6407
• Implementation Date
– For all requirements
– July 1, 2013
• Enforcement Date
– For WOPD requirements
• Date of Service (DOS) January 1, 2014
– For F2F requirements
• To be announced by CMS in 2014
September 2015
32
FAQ
• Q: Do these requirements replace any existing
F2F requirements that may already exist in a
particular medical policy?
• A: No. Suppliers are expected to comply with
both these requirements of MM8304 and the
ACA in addition to the existing requirements
within each individual medical policy.
September 2015
33
Face-to-Face Evaluation
• Face-to-Face Documentation
– Beneficiary was evaluated and/or treated for a
condition supporting the DME ordered
– All Medicare coverage and documentation
requirements for DMEPOS apply
• F2F Evaluation must take place within 6 months
prior to the date on the written order (oxygen 30
day requirement supersedes)
• Must be received by supplier prior to delivery of
DME
– Date stamp (or equivalent) upon receipt
September 2015
34
FAQ
• Question: Does the ordering physician have to
be the same physician that conducts the face-toface evaluation?
• Answer: No. The physician that signs the WOPD
does not have to be the same physician that
conducts the face-to-face evaluation.
September 2015
35
Written Order Prior to Delivery
(WOPD)
• Basic elements
– 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 NPI
• Only needed for those items that require a face-to-face per
MM8304-Revised
September 2015
36
WOPD: Additional Elements
Items Provided on a Periodic Basis
•
•
•
•
•
•
•
Item(s) to be dispensed
Dosage or concentration, if applicable
Route of administration
Frequency of use
Duration of infusion, if applicable
Quantity to be dispensed
Number of refills
September 2015
37
Acceptable Detailed Written Order
• May be completed by someone other than
physician
– Treating physician must review, sign and date
• Acceptable orders
–
–
–
–
Fax
Photocopy
Electronic
Original pen and ink
• CMN can serve as the WOPD if sufficiently
detailed
September 2015
38
WOPD Update 8/28/2014
• Errors identified on WOPD prior to delivery
– WOPD may be properly amended (Program Integrity
Manual, Publ., 100-08, Chapter 3, Section 3.3.2.5) or
– New WOPD may be created and sent to physician for
signature and date
• Errors identified on WOPD after delivery
– Prior to claim submission, original supplier may
recover delivered item(s), obtain WOPD and redeliver
– After claim submission, original suppler can recover
items and new supplier must complete transaction
after complying with all requirements
September 2015
39
Mix of Items Ordered
• Special attention should be given to items
ordered
• Specifically related to Oxygen
– Do require WOPD per MM8304
• E 0424, E0431, E0433, E0434, E0439, E0441, E0442,
E0443, E0444
– Do Not require WOPD per MM8304
• E1390, E1392
September 2015
40
Preliminary/Dispensing Order
• E1390/E1392 for O2
may be dispensed
based on verbal/
preliminary order
• E1390/E1392
provided based on a
dispensing order must
be followed up with a
completed detailed
written order
September 2015
Description
of Item
Beneficiary’s
Name
Signature
Physician’s
Name
Date of
Order
41
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
September 2015
42
Continued Need
• Continued medical need justifies the item
remains reasonable and necessary
– Documentation justifying continued medical need
includes:
•
•
•
•
September 2015
A recent order by the treating physician for refills
A recent change in prescription
A properly completed CMN or DIF with the LON specified
Timely documentation in the medical record showing usage
43
Medical Records
IOM Program Integrity Manual (100-08, Chapter 5)
*Must
September 2015
be available upon request
44
Relocation and Travel
Relocation and Travel
• Months 1-36:
– Supplier responsible for providing equipment for
remainder of current rental month
– For subsequent rentals months, home supplier
encouraged to continue to provide equipment or
assist the beneficiary in finding another supplier to
take over
• Months 37-60:
– Home supplier required to provide or make
arrangements for another supplier to provide
equipment and all related items/services
• Beneficiary responsible for airline oxygen
services and services provided outside the
United States
September 2015
46
• CMS allows for replacement of oxygen
equipment in cases where a supplier exits the
business
− Oxygen equipment considered lost
− New 36 month rental period for new supplier
− New RUL for new supplier
•http://www.cms.gov/Outreach-andEducation/Outreach/FFSProvPartProg/Downloads/2014
-05-22-Enews.pdf
September 2015
47
Comprehensive Error Rate
Testing (CERT)
Top Ranking Policies
#1
http://www.cms.gov/Research-Statistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-Compliance-Programs/CERT/CERT-ReportsItems/Downloads/AppendicesMedicareFee-forService2014ImproperPaymentsReport.pdf?agree=yes&next=Accept
September 2015
49
CERT Documentation Contractor
Requests provider documentation sent to:
Livanta
CERT Documentation Contractor (CDC)
9090 Junction Drive, Suite 9
Annapolis Junction, MD 20701
Phone: 888-779-7477
Fax: 240-568-6222
www.certprovider.com
September 2015
50
CERT Review Contractor
Reviews documentation sent from Livanta:
AdvanceMed
CERT Review Contractor (CRC)
1530 E Parham Road
Richmond, VA 23228
September 2015
51
Documentation Concerns
• Physician authentication
• Physician order must be present
• Billed service covered by a NCD or LCD
– Meet all aspects of coverage
• Covered diagnosis code
– Does not guarantee payment on post payment review
• Medical records
– Critical to support medical necessity for all DME items
September 2015
52
Relevant Medical Records
• Examples of relevant medical records include:
– Physician medical notes
– Non-physician clinical notes
– Non-physician clinical evaluations
September 2015
53
Supplemental Documentation
• Other types of information not sufficient by
themselves to document coverage criteria
– Even if signed or initialed by treating physician
– Not considered part of patient’s medical record
• Will be given consideration if corroborated by
medical record
– Applies to documents created before delivery of
item(s)
September 2015
54
Examples of Supplemental
Documentation
• Forms (either narrative or check-off) devised by
supplier and completed, signed and dated by
physician
• Summaries of patient’s medical condition
prepared by supplier or physician
• Forms (either narrative or check-off) developed
by suppliers and completed by patient or
caregiver
September 2015
55
Signature Compliance
• Ordering practitioner must be clearly identified in
records
– First name/last name/credentials/date
• If illegible, must also type/print name
• Review Purposes
– Medicare requires that services provided/ordered be
authenticated by the author.
• Method used must be hand written or electronic
– Stamp signatures are not acceptable
• MLN 6698 - Signature Guidelines for Medical
Review Purposes
September 2015
56
Common CERT Oxygen Errors
Missing clinical records to support
condition
Missing order
Missing evidence of qualifying
testing for CMN
Missing re-evaluation within 90
days of recertification CMN
September 2015
57
Combating CERT Errors
•
•
•
•
•
•
Consistent intake process
Internal audit process
Review Medicare requirements (LCDs and PAs)
Educate staff on how to respond to CERT
Submit complete and legible records
DME MAC Browse by DMEPOS Category
– Select oxygen
– https://med.noridianmedicare.com/web/jddme/policies
/lcd/active/oxygen-and-oxygen-equipment
September 2015
58
In Summary:
• DME suppliers need physician community to
successfully assist beneficiaries in payment of
their claims
• Orders must be complete and clearly notate
what is needed for your patient
• Medical records must be specific to each
individual beneficiary
– Detailed description of condition
– Ongoing monitoring
September 2015
59
Reminders and Resources
DME Resources
• LCD/Policy Article
– https://med.noridianmedicare.com/web/jddme/policies/lcd
/active
• Supplier Manual
– https://med.noridianmedicare.com/web/jddme/education/
supplier-manual
• “Dear Physician” letters
– https://med.noridianmedicare.com/web/jddme/policies/
physician-resources
• Documentation Checklist
– https://med.noridianmedicare.com/web/jddme/policies/
documentation-checklists
September 2015
61
Newest DME Physician Resource
• Physicians! Are you ordering oxygen for your
patient?
• https://med.noridianmedicare.com/web/jddme/ar
ticle-detail/-/view/2230715/physicians-are-youordering-oxygen-for-your-patient• Published July 20, 2015
September 2015
62
Paper Claim Submitters
• ICD-9 / ICD-10 indicator below required with claims
dated 10/1/2015 or after
– If indicator left blank, claim denies
– Resubmit claim with single digit (between the
vertical/dotted lines)
• With indicator 9 for ICD-9 or a 0 (zero) for ICD-10 diagnoses
– Enter the ICD indicator as a single digit between
the vertical, dotted lines
September 2015
63
Noridian Likes Website Feedback!
•Provide constructive/complimentary
feedback to continue Noridian website
growth and improvement
September 2015
64
Reminders
• Attend entire workshop to earn CEU(s)
• Take short polling survey
– Pops up after closing out of webinar
• CEU & Presentation PDF emailed within 3 days
– Earn 1.0 CEU today
• Q/A section
– Type to all panelists, not host
• Pertinent Q/As relevant to presentation posted to
Noridian website around 30 business days
September 2015
65
Thank you for attending!
DME and Part B