CPAP. Respiratory and General DME Mission Do you Accept? /14/2016

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1 Respiratory and General DME Mission Do you Accept? Ronda Buhrmester, CRT O: F: CPAP 1

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3 Top Denial Reasons for PAP Medical record provided did not include documentation of F2F clinical evaluation by treating physician prior to sleep study assessing for OSA WOPD was on a blanket order form that did not allow ordering physician to individualize the equipment & supplies being ordered WOPD for the E0601 were incomplete: missing name, date of receipt, NPI Signature was missing on sleep study Sleep study not interpreted by physician with correct credentials Proof of delivery was not provided or incomplete Diagnostic sleep study not provided Supplier records did not document beneficiary/caregiver received instruction in proper care of device and accessories No documentation of clinical re-evaluation between days after initiating therapy No documentation of adherence to use of PAP device that has been reviewed by treating physician WOPD was missing or incomplete: Detailed description of the items being ordered Prescribing Practitioner's NPI Prescribing practitioner s signature and signature date Date stamp missing Was not received prior to deliver Date of the order Refill Quantity missing 3

4 Written Order Prior to Delivery E0601 and E0470 Requirements: Beneficiary s name Diagnosis Detailed description of item being ordered All billable items listed separately, tailored to the individual needs Pressure settings Frequency of use Length of need Date of order Ordering practitioner s signature and date Ordering practitioner s NPI Make sure to date stamp received on by XYZ supplier Supplies are not a WOPD, just prior to claim submission Ronda Buhrmester Bessie Best, MD Bessie Best, MD 4

5 Example 1 Unacceptable Blanket Order Example 2 Unacceptable Blanket Order Example 3 Acceptable order Does not provide a detailed list of each separately billed item and the replacement instructions are nonspecific Patient: John Doe Start Date: 08/01/2011 Length of Need -Lifetime (99) CPAP Device at 10 cmh20 Heated Humidifier Bi-Pap Equipment (mask, accessories, disposable and reusable filters) - replace as needed Charles Smith August 15,2011 Charles Smith, M.D. Order form lists supplies and accessories in a way that does not allow the physician to pick and choose the specific items being ordered for this beneficiary Patient: John Doe Start Date: 08/01/2011 Length of Need -Lifetime (99) Bi-Pap w/o BU -IPAP 12 cm H 2 0, EPAP 10 CM H 2 0 Heated Humidifier PAP Oral Interface Repl Exhalation Port for PAP Combi Oral/Nasal Mask 1/3 Mo Full Face Mask 1/3 Mo Replacement Face Mask 1/1 Mo Nasal Application Device 1/3 Mo PAP Headgear 1/6 Mo PAP Chinstrap 1/6 Mo PAP Tubing 1/3 Mo PAP Non-disposable Filter 1/6 Mo Humidifier Chamber 1/6 Mo Oral Cushion 2/1 Mo Repl Nasal Pillow Comb Mask 2/1 Mo Replacement Nasal Cushion 2/1 Mo Replacement Nasal Pillows 2/1 Mo PAP Disposable Filter 2/1 Mo Charles Smith August 15,2011 Charles Smith, M.D. Order form lists supplies and accessories in a way that the physician can pick and choose the specific items being ordered for this beneficiary. Note: NPI needs to be on order. Patient: John Doe Start Date: 08/01/2011 Length of Need -Lifetime (99) CPAP Device at 11cmH20 Heated Humidifier Mask -Nasal Pillow 1/3 Mo Mask -Full Face 1/3 Mo Oral Mask Interface 1/3 Mo Nasal Mask cushion 2/1 Mo Full Face Mask Cushion 1/1 Mo Nasal Pillows 2/1 Mo Tubing 1/3 Mo Chinstrap 1/6 Mo Headgear 1/6 Mo Filter, Disposable 2/1 Mo Filter, Non-Disposable 1/6 Mo Humidifier Chamber 1/6 Mo Other Charles Smith August 15,2011 Charles Smith, M.D. NPI: Submit the correct sleep study AND make sure it is signed! PSG Polysomnography. Diagnostic sleep study Indicates if sleep apnea is present, and What type of sleep apnea, or Split Night: Enough data collected to determine that sleep apnea is present Meets guidelines over the minimum 2 ours of recording time, Then goes from a diagnostic study to a titration study in one night Titration Study: Not required Done once diagnosed with sleep apnea Determines appropriate pressure to use on a device to eliminate or reduce apneas and hypopneas Some sleep labs will work for appropriate mask fittings 5

6 Do sleep studies expire? Sleep studies do not expire, however. For an initial study performed for the purposes of a diagnosis, it is preferred that the therapy be initiated within 3 months of the study, but in no case would longer than 12 months be considered! 6

7 Interpreting Sleep Studies For PAP devices with initial date of service on or after , all sleep tests must be interpreted by a physician who holds either: 1. Current certification in Sleep Medicine by the ABSM; or, 2. Current subspecialty certification in Sleep Medicine by a member board of the ABMS; or, 3. Completed residency or fellowship training by ABMS with all requirements for subspecialty certification, until next eligible exam is offered 4. Active staff membership of a sleep center or laboratory accredited by AASM, ACHC or JCAHO Board certification entities: American Board of Sleep Medicine (ABSM) (for those certified prior to 2007) - Certification by ABSM was not time-limited (i.e., lifetime certification) so ABSM still maintains a site with credentials verification information at American Board of Medical Specialties (ABMS) ABMS member boards took over administration of the certifying examination in sleep medicine from ABSM in The ABMS site, also has a credentials verification look-up function. 1. For physicians affiliated with an accredited sleep lab a. American Academy of Sleep Medicine (AASM) accredited sleep lab b. The Joint Commission 2. Board certification entities a. American Board of Sleep Medicine (ABSM) (for those certified prior to 2007) Certification by ABSM was not time limited (i.e., lifetime certification) so ABSM still maintains a site with credentials verification information at b. American Board of Medical Specialties (ABMS) ABMS member boards took over administration of the certifying examination in sleep medicine from ABSM in The ABMS site also has a credentials verification lookup function. c. ABMS member board sites. Each member board of ABMS that is involved in physician training in sleep medicine and administration of a specialty examination in sleep medicine has credentials verification. 7

8 Those specific ABMS member sites are listed below: American Board of Family Medicine 2228 Young Drive Lexington, KY Phone: or Fax: or website: American Board of Internal Medicine 510 Walnut Street Suite 1700 Philadelphia, PA Phone: or Fax: website: American Board of Pediatrics 111 Silver Cedar Court Chapel Hill, NC Phone: Fax: website: Those specific ABMS member sites are listed below: American Board of Psychiatry and Neurology 500 Lake Cook Road, Suite 335 Deerfield, IL Phone: Fax: website: American Board of Otolaryngology 5615 Kirby Drive Suite 600 Houston, Texas Phone: Fax: website: 8

9 Beneficiaries Entering Medicare The beneficiary began using PAP prior to Medicare eligibility and the documentation did not include a F2F evaluation conducted following enrollment in FFS Medicare or the note did not record that the beneficiary had a diagnosis of OSA and continued to use and benefit from PAP therapy. 1. Sleep test prior to FFS Medicare that meets AHI/RDI criteria in effect at the time a replacement PAP and/or accessories are needed, and 2. FTF evaluation following enrollment in FFS Medicare by treating physician that documents: a) Diagnosis of OSA; and b) Beneficiary continues to use the PAP device No requirement for clinical re-evaluation or for objective documentation of adherence to use of the device. Visit has to be done following enrollment to Medicare FFS. Not before, or it will get denied! If the sleep study cannot be obtained because records have been purged, or just not available, then another sleep study needs to be performed. Coverage Beyond 3 Months For PAP Policy E0601 and E0470: Adherence to therapy per criteria Used > 4 hours per night 70% of nights during a consecutive thirty day period anytime during the first three months of initial usage > 21 nights within 30 consecutive days Documentation from treating physician at re-evaluation between 31 st -91 st day after initial therapy must document the following during the visit: OSA symptom improvement Adherence to therapy --What does this mean? Needs to sign the compliance report OR mention in notes Benefiting from therapy **Add KX modifier for month which information is received** 9

10 Replacements follow the F2F ruling Replacement: PAP RUL New F2F evaluation: stating pt benefiting from PAP device and continues to use New detailed written order -- need to be within 6 months and prior to delivery with date received stamp No new sleep study and no new trial period Good to have supplier documentation as to why it needs replaced: such as pt requested, wants a newer version, broken beyond repair Suggest a narrative---new RUL original date of service for E0601 The Why doesn t have to be documented unless it s before the RUL ends. Can include in claim note, that bene requested new machine, or bene requested new machine old outdated, etc. Make sure have original sleep study (diagnostic) that meets current criteria and that original F2F note prior to the initial sleep study UNLESS it s already been purged and not available, then enter a claim note. May have to explain if CERT audits. Apnea-hypopnea index (AHI) = AHI versus RDI Average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device Respiratory effort related arousals (RERAs) are not included in the calculation of the AHI Sleep time can only be measured in a Type I (facility based polysomnogram) or Type II sleep study Respiratory disturbance index (RDI) = Average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device Respiratory effort related arousals (RERAs) are not included in the calculation of the RDI RDI is reported in Type III, Type IV, and other home sleep studies 10

11 Summary of Documentation for PAP Valid Physicians order Good Diagnosis---OSA (G47.33) F2F prior to sleep study Correct Sleep study---diagnostic (PSG) signed Documentation of medical necessity in medical record F2F if needed to meet F2F ruling Completed DWO Proof of delivery Oxygen 11

12 The actual oxygen saturation test indicated on the CMN must be provided Must be supported in the medical record WOPD for E0431 was not prior to delivery Missing WOPD Patient not in a Chronic Stable State at time of study Documentation was not provided to support: alternative treatment measures have been tried or considered and deemed clinically ineffective. the treating physician has determined that the beneficiary has a severe lung disease or hypoxiarelated symptoms that might be expected to improve with oxygen therapy beneficiary being mobile in the home Top Denial Reasons for Oxygen Physicians! Are You Ordering Oxygen For Your Patient? Your medical record documentation determines whether your patient can receive the oxygen equipment and supplies you have prescribed and the amount of the patient's out of pocket expenses. Your medical record documentation must show that other alternative treatments (e.g., medical and physical therapy directed at secretions, bronchospasm and infection) have been tried or considered and deemed clinically ineffective. The documentation must show the patient was seen within 30 days prior to the start of oxygen therapy. The medical record must show the medical condition necessitating the home use of oxygen therapy. The medical record and/or prescription would indicate the oxygen flow rate (e.g., two liters per minute), and the estimation of the frequency (10 minutes per hour), duration of use (12 hours per day) and duration of need (six months). You must specify the type of oxygen delivery system to be used (i.e., portable/stationary concentrator, compressed gas portable/stationary, liquid portable/stationary). Medicare can make payment for home oxygen supplies and equipment when the patient's medical record shows the patient has significant hypoxemia and meets medical documentation, test results, and health conditions as specified in the CMS Internet-Only Manual (IOM) Publication , Section This link will take you to an external website.. 12

13 Continued Physicians! Are You Ordering Oxygen For Your Patient? You must complete and sign Form CMS-484 This link will take you to an external website. (Certificate of Medical Necessity (CMN): Oxygen). However, the CMN itself is not considered part of the medical record. All information included in the CMN must be supported by the contemporaneous medical record. You can find instructions on completing this form in the CMS IOM Publication , Chapter 5 This link will take you to an external website.. The Comprehensive Error Rate Testing (CERT) contractor has identified multiple errors in the claims received for oxygen equipment and supplies. These errors include missing physician clinical records showing the patient's condition and the continued need for oxygen, missing signed and dated order from the physician when changing the oxygen liter flow rate, missing copy of the oxygen saturation testing, and missing treating physician's re-evaluation for recertification CMN. Help your patients and the Medicare program by verifying you have the medical record documentation to support the order and supply of oxygen for your patients. This allows Medicare to pay claims appropriately. Last Updated Jul 20, 2015 Testing Conditions Bene in Chronic Stable State (CSS) OR within 2 days prior to discharge Chronic stable state requires all of the following be met Other forms of treatment have been tried, have not been successful, and O2 is still required Each patient must receive optimal therapy before long-term O2 therapy is ordered Cannot be during a period of acute illness or exacerbation of underlying disease 13

14 How Was Test Performed? At rest and awake - often referred to as "spot or pulse oximetry During exercise requires a series of 3 tests done during a single testing session: At rest, off oxygen - showing a non-qualifying result Exercising, off oxygen showing a qualifying result Exercising, on oxygen showing improvement in test results obtained while exercising off of oxygen ~MUST provide all 3 tests~ During sleep Overnight sleep oximetry May be done in hospital or at home Must be for at minimum 2 hours at or below 88% for total of 5 minutes doesn t have to be continuous ABG (mm HG) Oximetry (% Sat) Group I Notes Group II Additional disease criteria Group III >59 >89 Presumed noncovered Testing Requirements Qualifying test covered under Medicare Part A or B (see below) Test must be performed by provider qualified to bill Medicare: ~Part A provider, Laboratory, IDTF (independent diagnostic testing facility), Physician Most recent blood gas study obtained within 30 days prior to initial date of service If a patient is under a Part A covered stay payment such as hospital, nursing facility, home health, or hospice Meets the qualified provider standard Need to be sure that patient is under a Part A covered payment If the patient is not under the Part A covered payment, then the requirements are not met and qualification would be invalid For example, if a patient is under Part A in nursing facility, Medicare covers the first 100 days, if the patient is under that first 100 days, and qualifies for home oxygen, and then the testing performed in the nursing facility is acceptable. Home Health Part A coverage varies based on diagnosis and plan of care. 14

15 If patient has OSA and needs O2 bled in with PAP, how can the patient get qualified for home oxygen? Use of O2 with PAP Therapy Testing must be done in Chronic Stable State Both oxygen LCD and PAP LCD must be followed OSA sufficiently treated and lung disease unmasked clearly documented that pressure, mask, etc. addressed 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 a. The AHI/RDI reduced to less than or equal to average of 10 events/hour, b. If initial AHI/RDI was less than average of 10 events/hour, the titration shows further reduction in the AHI/RDI 3. Only performed after optimal PAP settings determined 4. Nocturnal oximetry conducted during PSG shows <88% for 5 minutes. 15

16 Pneumonia and O2 There have been several recent discussions of denials for oxygen prescribed for patients coming out of the hospital with a diagnosis of pneumonia. The reasoning is that pneumonia is an acute condition, so the patient is not in a chronic stable state (CSS). It is our understanding that the inpatient discharge from the hospital is the exception to the CSS rule. If a patient has a diagnosis of pneumonia and the physician has ordered discharge from the hospital with oxygen, will this qualify the patient under the oxygen policy? Response: The foundation of Medicare coverage for home oxygen is that the beneficiary must have a chronic lung condition. Therefore, we would not cover home oxygen for someone who needed short-term support strictly due to an acute illness such as pneumonia. However, coverage is available for a beneficiary with an acute exacerbation of a chronic condition IF the qualifying test is done on an inpatient basis within two days of discharge and is the last test prior to discharge. In this situation, coverage is not dependent on the medical records indicating that the acute component has been resolved. Hypoxemia Is It a Covered DX? Hypoxemia alone is not enough it s a symptom Documentation needs to be detailed to show alternative treatments have been tried/considered and ruled out What is causing the hypoxemia? Have other diagnoses been treated prior to O2 therapy? I.E. Pulmonary HTN or restlessness at night are not adequate Question to Physician: Why is oxygen the appropriate treatment? 16

17 Month 61 or after (RUL) Once 61 st month reached, patient is eligible for new equipment, if elects If portable oxygen differs from RUL of stationary, the RUL of the stationary governs the when a new RUL can be initiated No repeat test required, but most recent test and date must be used Medicare will tell you no physician visit is required, but get one anyway to establish continued medical need. Would get a new order as well. New equipment and new intake New CMN required, so a new rental period begins Narrative required on claim using RUL for reason with original date of service Add RA modifier on first month claim If patient elects not to receive new equipment, can transfer ownership of the equipment to the patient make sure patient is aware they will be responsible for accessories and maintenance, and possibly repairs Recent Review on Portable Oxygen Payment Medical records from the treating physician fail to sufficiently document medical necessity o The medical records did not support the beneficiary being mobile in the home o The medical records did not support undetermined lung disease or hypoxia related symptoms that might be expected to improve with oxygen therapy o The medical records did not have blood gas results or oxygen saturation levels that corroborated what was reported on the Certificate of Medical Necessity (CMN) o Blood gas results for at night only Reminder: Please respond to audit and review requests even if you don t have all the proper documentation being requested. This is a supplier standard, #28. 17

18 Written Order Prior to Delivery For all O2 codes except E1390, E1392, and K0738 Must include the following information: Patient s name Narrative of items being ordered (any billable items such as O2 Content) Date of order Liter flow Frequency of use Method of delivery Length of need Ordering practitioner s printed name Ordering practitioner s signature and signature date Ordering practitioner s NPI CMN can serve as DWO if contains all necessary information in section C such as method of delivery and frequency of use O2 Issues I m seeing: 1. CMN Date stamp used for signature date Test results didn t match what is on the CMN Q#2 answered with option 1-patient in CSS as outpatient when patient was an inpatient in hospital 2. Medical Records No mention of medical necessity for oxygen. Had COPD as a Dx but nothing else listed Signature illegible didn t submit attestation statement or signature log 3. No dispensing order for concentrator 4. Portable equipment Didn t mention patient mobile in home in the medical record when portable was ordered No DWO prior to delivery of portable equipment 5. No test results sent with review 18

19 Summary of Documentation for O2 Valid Physicians order Diagnosis needs to be severe lung disease or hypoxia related symptom Qualifying Testing: Done while in CSS or 2 days prior to discharge Documentation of medical necessity in medical record Completed CMN and DWO Is portable ordered make sure documentation includes patient mobile in home Have alternative treatments been tried/considered and rule out Proof of delivery Nebulizers 19

20 Results from Jurisdiction A on E0570 Jurisdiction A: Nov-Jan 2014 = 74% Feb-Apr = 62% May-Aug 2014 = 81% Aug Oct 2014 = 84% Nov Jan 2015 = 76% No response to letter consistently greater than 20% Reason for denials E0570: Results from Jurisdiction A 1. Clinical Documentation Issues: No medical records submitted Insufficient documentation: No payable diagnosis and no mention of need for nebulizer Illegible copy of documentation submitted Physician signature requirements not met: missing signature, no printed name or no log submitted, only printed name, no signature 2. DWO Issues: (was 75% of errors) Missing DWO Invalid DWO: Illegible copy, start date after DOS, physician signature date after claim submitted, missing NPI, no date stamp to show received prior to delivery 3. POD Issues Missing POD Invalid POD: Missing detailed description of item being delivered, missing beneficiary signature 20

21 Medical Record Medical records should include: Beneficiary s diagnosis and prognosis Duration of beneficiary s medical condition Clinical course (worsening or improvement) Nature and extent of functional limitations Other therapeutic interventions, results, past experience with related items Nebulizer WOPD Must include the following information: Patient s name Narrative of items being ordered (any billable items) Date of order, and start date if different than order date Quantity to be dispensed Number of Refills Route of Administration Dosage and concentration of medication, if supplying or applicable Length of need Ordering practitioner s printed name Ordering practitioner s signature and signature date Ordering practitioner s NPI Only need medication listed if supplying BUT need to know the medication to make sure it s approved in LCD 21

22 RAD Devices Initial Coverage Criteria Patient s medical record fully documents symptoms characteristic of sleep associated hypoventilation: Daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc. I. Restrictive thoracic disorders II. Severe chronic obstructive pulmonary disease (COPD) III. Central sleep apnea (CSA) or complex sleep apnea (CompSA) IV. Hypoventilation syndrome 22

23 E0470: Group II: Severe COPD Coverage 1. ABG PaCO 2, while awake and breathing patient s prescribed FiO 2 greater than 52 mm Hg; AND 2. Sleep oximetry demonstrates oxygen saturation of less than or equal to 88 percent for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing at 2 lpm or the patient s prescribed FiO 2 (whichever is higher) (can t be done on RA); AND 3. Prior to initiating therapy, sleep apnea and treatment with CPAP has been considered and ruled out. Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from some form of sleep apnea (Obstructive Sleep Apnea (OSA), CSA and/or Comp SA) Let s Talk About It: COPD-E0470 When does the testing have it be done when patient is inpatient at hospital? Policy doesn t state not specific. Most patient s won t meet criteria upon discharge doesn t mean that they qualify for an NIV So qualify them upon admission, when they are sick---policy isn t specific. That s when they will more than likely meet coverage criteria. 23

24 Severe COPD (E0471) Situation 1 E0471 started anytime after a period of initial use of E0470 if both A and B are met A. ABG PaCO2, while awake and breathing beneficiary s prescribed FIO2, shows that the beneficiary s PaCO2 worsens > 7 mm Hg compared to original result criterion A B. Facility-based PSG demonstrates oxygen saturation < 88% for > 5 minutes nocturnal (minimum recording 2 hours) while using E0470 that is not caused by obstructive upper airway event Severe COPD (E0471) Situation 2 E0471 no sooner than 61 days after initial issue of E0470 both A and B met: A. ABG PaC02 done while awake and breathing beneficiary s prescribed FI02, still remains > to 52 mm Hg, AND B. Sleep oximetry, while breathing with E0470, demonstrates oxygen saturation < 88% for > 5 minutes nocturnal, (minimum recording time of 2 hours) while breathing oxygen at 2 LPM or prescribed FI02, whichever is higher 24

25 Continued coverage beyond the first three months Must be re-evaluated by treating practitioner no sooner than 61st day after initial therapy Documenting that patient is compliant with the device. Compliance is consistently using the machine for at least 4 hours per a 24-hour period Documentation that patient is benefiting from use of the therapy Make sure it s signed and dated by treating practitioner Detailed Written Order Requirements Beneficiary s name Date of order Detailed description of item(s) being ordered such as device, humidity, type of mask, headgear, filters or tubing, or brand name/model number Pressure settings Frequency of use or duration Treating practitioner s printed name and NPI Treating practitioner s signature and date Make sure to use a Date Stamp Received Part of the F2F ruling that was implemented July 1,

26 NIV Basic coverage for Medicare BASIC coverage determination for all audit entities: Must not bill Medicare more than you would any other entity Item must be Medically Necessary for use within the home Medicare will pay for least costly alternative Must provide the item prior to billing 26

27 PIM 5.7- Documentation For any DMEPOS item to be covered by Medicare, the patient s medical record must contain sufficient documentation of the patient s medical condition to substantiate the necessity for the type & quantity of items ordered & for the frequency of use or replacement (if applicable) However, neither a physician s order nor a CMN nor a DIF nor a physician attestation statement by itself provides sufficient documentation of medical necessity, even though it is signed by the treating physician or supplier NOTE - this is now in policies / articles PIM {Program Integrity Manual} on line only National Coverage Determination (280.1) Ventilators Categorized as Frequent & Substantial Servicing Monthly rental includes payment for supplies and accessories Humidifiers are considered accessory; cannot be billed separately Monthly rental includes payment for repair and maintenance Supplier is required to have emergency plan, back up plan in the event primary ventilator breaks down SE1513 released April 23, 2015: Accreditation currently grouped with respiratory moving to own category; 855s will be updated; need to be compliant Oct. 1,

28 Documentation Paint the Picture Generally Covered for Treatment of: Neuromuscular Disorders Thoracic Restrictive Diseases Chronic Respiratory Failure secondary to COPD Medical Record must state: Why the ventilator is medically necessary, and Why a CPAP/BiPAP is insufficient More on Documentation Each disease category are comprised of conditions that can vary from severe and lifethreatening to less serious. May appear to overlap in the RAD LCD, but they are not overlapping specifically COPD Choice of appropriate device based upon severity of the condition RAD is distinguished from ventilation in a patient from whom interruption or failure of respiratory support leads to death The RAD LCD: Conditions listed are not life-threatening conditions where interruption of respiratory support would quickly to serious harm or death Clinical conditions that require intermittent and relatively short durations of respiratory support 28

29 Documentation Repeated hospital admissions due to respiratory failure If a ventilator is used, follow-up visits are documented to show there was a decrease in admissions Remember Medicare pays for least costly alternative, which means a BiPAP or BiPAP S/T needs to be considered and/or ruled out Clinical documentation must be specific to the individual patient s needs Make sure the documentation is very clear and thorough as to why the patient needs a ventilator Detailed Written Order: Patient s name Treating physician s name (printed or typed) Start date of order if start date is different than order date Order for ventilator with description/brand/model/ and settings Any other billable items Physician signature Physician signature date and NPI Length of need Frequency of use 29

30 VENTILATOR- NOINVASIVE vs RAD The CMS National Coverage Determinations Manual (Internet-Only Manual, Publ ) in Chapter 1, Part 4, Section stipulates that ventilators (E0450, E0460-E0464) are covered for the following conditions: Neuromuscular diseases Thoracic restrictive diseases Chronic respiratory failure consequent to COPD Each of these disease categories are comprised of conditions that vary from severe and lifethreatening to less serious Disease groups may appear to overlap conditions described in the RAD LCD - not overlapping Choice of an appropriate device i.e., a ventilator versus a bi-level PAP device based upon the severity of the condition CMS distinguished the use of respiratory product types in a National Coverage Analysis Decision Memo (CAG-00052N) in June 2001 saying that RAD is distinguished from ventilation in a patient for whom interruption or failure of respiratory support leads to death. VENTILATOR- NOINVASIVE vs RAD Continued The conditions described in the RAD LCD determination are not life-threatening conditions where interruption of respiratory support would quickly lead to serious harm or death. These policies describe clinical conditions that require intermittent and relatively short durations of respiratory support. Any type ventilator would not be eligible for reimbursement for any of the conditions described in the RAD LCD even though the ventilator equipment may have the capability of operating in a bi-level PAP (E0470, E0471) mode. Bi-level PAP devices (E0470, E0471) are considered as reasonable and necessary in those clinical scenarios. 30

31 Ventilators Basically.an NIV Not considered reasonable and necessary to treat RAD policy level of conditions Severity of condition determines device required RAD level of conditions are non-life threatening RAD coverage describes conditions requiring intermittent respiratory support From a denial (E0464): More To The Story The submitted documentation does not verify that the severity of the beneficiary s qualifying condition is such that he/she cannot tolerate being off a ventilator for a period of more than minutes. The submitted documentation did not confirm that the severity of the beneficiary s qualifying condition is such that he/she cannot tolerate being off a ventilator for a period of more than approximately 1-2 hours. Response: The DMDs interpretation of the NCD and this article is that a vent is necessary for patients whose life is at risk if they away from the ventilator for as much as two hours. This is why the vents fall into the frequent and substantial servicing category. The supplier has appeal rights if they disagree with the review. Bottom line: You need to have something stating whether it would be life threatening if they discontinued using. This is especially important for nocturnal use only. 31

32 Ventilators CMS announced on Thursday, June 4 th that it has dropped non-invasive vents from the competitive bidding program for Round CMS has made a number of moves to distinguish vents from CPAP and BiPAP devices. In May, it announced it was revising its 855S enrollment application to make vents a separate category. It has also put non-invasive vents under widespread prepayment review In explaining the code changes, CMS stated: Since the Medicare coverage rules for ventilators are the same regardless of what type of ventilator is being used, there is no program need to have codes for different types of ventilators. Therefore, codes E0450, E0460, E0461, E0463, and E0464 will be discontinued effective Dec. 31, New code Exxx1 will be used for ventilators currently described by codes E0450 and E0463, while new code Exxx2 will be used for ventilators currently described by codes E0460, E0461 and E0464. Invasive NIV New Codes: DOS Old code E0463 and allowable $ New code E0465: $ Old code E0464 and allowable $ New Code E0466: $ For all areas, NCBA and CBA 32

33 Release on 8/28/14: Jur. A : E0464 (non-invasive) under prepayment review Documentation must include the following: 1. Physician order for the item 2. Information from the medical record that demonstrates the reasonable and necessary coverage criteria for the item(s) are met. 3. Proof of delivery. Remember This: Vents under Prepayment Review 4. Any other pertinent information that would justify payment for the item(s) provided. 5. Advanced Beneficiary Notice (ABN) if one was obtained, this must be submitted with the above requested documentation. Everyone Needs To Be prepared! Results Are In Error Rate = 90% Primary reasons for Denial = 96% 1. Medical documentation included did not show Neuromuscular disease, thoracic restrictive disease, and chronic respiratory failure secondary to COPD Documentation of disease severity to support without interruption or failure respiratory support leads to death 2. Written Order Prior to Delivery Issues no complete = 27% 3. No response = 9% Reviews will continue for Jurisdiction A 33

34 Jurisdiction D Review E0464 Review announced Dec Results released May 11, 2015 > Error Rate = 57% Top Denial Reasons: 1. Medical record documentation Does not contain timely documentation, within preceding 12 months, to support the continued medical need for therapy. Does not support the patient has qualifying diagnosis to indicate need for ventilator Does not support the requirements for therapy 2. WOPD does not contain valid date stamp or similar Occurring in Jurisdiction B and C! Now performing ADR on E0466 announced January 2016 Continued Use: Continued Use and Continued Medical Need Contact patient regularly to verify they are at home and continue use of the vent---this is a monthly billing, or Obtain progress notes documenting ventilator use Continued Medical Need: A recent order by the treating physician for refills, or A recent change in prescription, or Timely documentation in the medical record showing usage Timely documentation is a record in the preceding 12 months 34

35 Documentation to support medical necessity includes: Valid Physicians order Good Diagnosis Documentation of medical necessity in medical record Ventilator settings Documentation of supplier s back up plan Proof of delivery Hospital Beds 35

36 Results from Jurisdiction D = 73% Top Denial Reasons: Hospital Beds E Documentation submitted does not support the criteria for a semielectric bed 2. Documentation submitted does not support the criteria for a fixed height bed 3. Documentation does not contain a valid date stamp or similar 4. No documentation was received in response to the ADR letter Other Top Denial Reasons J-C o DWO missing date stamp or similar that proved supplier received prior to delivery o Proof of delivery does not contain detailed description of item delivered o DWO missing detailed description of item ordered o DWO missing date of order or start date if different o Item ordered was not consistent with item that supplier billed 36

37 J-B Under Widespread Probe Review Reviewed and results = 70% E0294 hospital bed, semi-electric (head and foot adjustment), without side rails, with mattress E0260 hospital bed, semi-electric (head and foot adjustment), with any type side rails, with mattress E0301 hospital bed, heavy duty, extra wide, with weight capacity greater than 350 pounds, but less than or equal to 600 pounds, with any type side rails, without mattress E0303 hospital bed, heavy duty, extra wide, with weight capacity greater than 350 pounds, but less than or equal to 600 pounds, with any type side rails, with mattress Issues: WOPD did not clearly indicate supplier s date of receipt Lacking medical necessity WOPD was not detailed enough Hospital Beds Normally qualify for fixed height hospital bed (E0250) Has a medical condition which requires positioning of the body in ways not feasible with an ordinary bed, or Requires the head of the bed to be elevated more than 30 degrees most of the time due to CHF, COPD, or problems with aspiration, or Requires positioning of the body in ways not feasible with an ordinary bed in order to alleviate pain, or Requires traction equip. which can only be attached to a hospital bed Semi-electric (E0260)-- Pt. requires frequent changes in body position and/or has immediate need or change in body position. In addition to meeting one of the four criteria above Medicare will not pay for a full electric bed (E0265) Medical Necessity information must be in patient medical records 37

38 Just Some Reminders Refill Requests 38

39 39

40 Request for refill must include: Beneficiary s name Description of each item being requested Date of refill request Consumables (e.g. respiratory medication, urological, ostomy) Quantity of each item the beneficiary still has remaining Non-consumables (e.g. PAP supplies) Functional condition of the item being refilled to demonstrate the cause of the dysfunction that necessitates replacement For example: seal worn out, tubing has holes, filters discolored, etc. Can be a form or in patient s chart notes Watch delivery ticket address: was it delivered or picked up in store Can supply 3 months (90 days) needs a narrative in the claim field Prevention 40

41 Education to staff referral sources beneficiaries Good order intake - CSRs Medical Records Get them and READ THEM! Clinical documentation is important from all sources Use the documentation check off sheets provided by some DME MACs Review medical policies (LCD) and articles Files need to be legible and in order ALL Signatures must be legible DATE STAMP when received Delivery tickets: name-model and serial #s Self Audits are a must do yourself or have outside party Be Proactive Implement written policies, procedures and standards of conduct Conduct effective and on-going training and education Conduct internal monitoring and auditing Respond promptly to detected offenses and develop corrective actions. Demonstrated top-down commitment to compliance Internal compliance programs Increased efficiency Improved internal communication Initiation of immediate and decisive corrective action Weekly meetings brief and to the point You are a team -- you have to work together Work with referrals educate office managers, nurses share denial reports Review claim one more time before submitting 41

42 Proof of Delivery Signed POD required to verify beneficiary received item Requirements: Beneficiary s name Delivery address If beneficiary picks up at store, make sure the delivery ticket as your address on it somewhere to indicate it s a pick-up in the store Detailed description to identify the item(s) being delivered Brand name, serial #, narrative description (HCPCS code not enough) Quantity delivered Date delivered Beneficiary signature and date of signature Supplier signature Don t forget lot numbers for recall purposes Can be signed by: Beneficiary Beneficiary s designee relationship to beneficiary must be noted on delivery slip DATE STAMP REQUIREMENTS Affordable Care Act (ACA) 6407 contains provisions that are applicable to specified items in this policy. 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 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. 42

43 INSUFFICIENT DOCUMENTATION Work with: Office Managers, Social workers, Discharge planners, Nurses Explain the need for the documentation to remain compliant in order for the patient to receive needed equipment Advise physician and their staff that without documentation, Medicare may deny the claim and the patient may be responsible for payment Get the patient involved and explain that they may be liable without physician records Use properly executed ABNs BUT do not use these as a way out COMMON ERRORS- illegible Illegible medical records Illegible physician signatures Signature attestations Signature logs I, [print full name of the physician/practitioner], hereby attest that the medical record entry for [date of service] accurately reflects signatures/notations that I made in my capacity as [insert provider credentials, e.g., M.D.] 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. Stamped signatures Invalid electronic signatures Missing patient identification on multiple pages of medical or supplier records without indication of page numbers If you can t read a note, more than likely no one else can either---ask physician to transcribe note, the nurse is able to transcribe as well have physician sign and date transcription 43

44 Know the ACA 6407 Face to Face Rule Reviewing Today s Challenges May accept a dispensing/verbal order to initiate process, but must get a WOPD Chart notes that indicate medical necessity Any other tests that apply such ABGs, oximetry testing, sleep study, assessments Any other supporting documentation Make sure physician has signed and dated documents, and it s legible Watch delivery dates and date stamp requirements Make sure to get signed medical records, sleep studies, oxygen testing, etc. Besides pre-payment audits, other contractors auditing: Strategic Health Solutions, RAC both post payment Jur A: Jur B: Jur C: Jur D: VGM: Competitive Bid: PDAC: CMS: PECOS: NSC: 44

45 Next Mission to Complete: LIVE CLAIM REVIEWS Are You Ready to Accept the Mission? Mission Possible Completed! What are some takeaways? Ronda Buhrmester, CRT O: F:

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