Medicare Coverage of Durable Medical Equipment and Other Devices Michelle Velasquez CMS Kansas City RO March 24, 2016
General Coverage Manual Wheelchair Bases Wheelchair Options, Accessories, and Seating Oxygen and Oxygen Equipment Therapeutic Shoes Transcutaneous Electrical Nerve Stimulator (TENS) DME Repairs and Replacements DMEPOS Competitive Bidding Program Advance Beneficiary Notice of Noncoverage (ABN) Program Updates 2
General Coverage 3
General Coverage Criteria All DMEPOS must be: Eligible for a defined Medicare benefit category Reasonable and Necessary Diagnosis or treatment of illness or injury; or Improve the functioning of a malformed body member Meet Medicare guidelines Statutory and regulatory requirements Prescribed by a physician or other qualified medical professional prior to claim submission
Noncovered Items Wigs Hot water bottles Disposable underpads Toilet rails Tub stool or bench Bed board Noncovered items listing: https://med.noridianmedicare.com/web/jddme/t opics/noncovered-items
DME Covered Drugs Oral anticancer Oral antiemetic Nebulizer Immunosuppressive External infusion pump drugs Insulin infusion through pump
Benefit Categories Prosthetic Devices Braces (Orthotics) Surgical Dressings Immunosuppressive Drugs Therapeutic Shoes for Persons with Diabetes Oral Anticancer Drugs Oral Antiemetic Drugs
Fee Schedule Payment Categories Most DMEPOS fall into one of the following categories: Inexpensive or Other Routinely Purchased DME (IRP) Purchase price does not exceed $150 Purchased at least 75% of the time Rental or lump sum purchase Total rental cannot exceed actual purchase price Items Requiring Frequent and Substantial Servicing Rental only Supplies and accessories included Customized Items Individual consideration based on medical need Must be physician prescribed Lump sum payment
Fee Schedule Payment Categories (cont) Prosthetics and Orthotics Lump sum payment Capped Rental Items Paid on monthly rental basis 13 month rental period Item is beneficiary owned after 13 months Capped Rental Purchase Option Complex rehab power wheelchairs only Must give beneficiary option to purchase in first month Oxygen and Oxygen Equipment Rental only 36 month cap
Manual Wheelchair Bases 10
General Coverage Criteria Covered for us in the home if A, B, C, D, and E, and criterion F or G is met: A. Mobility limitation impairing Mobility Related Activity to Daily Living (MRADLs) B. Mobility limitation cannot be sufficiently resolved with cane or walker C. Home provides adequate access between rooms, maneuvering space, and surfaces D. Manual wheelchair (MWC) will improve beneficiary s ability to participate in MRADLs and will use it on a regular basis in the home E. Beneficiary has not expressed an unwillingness to use MWC AND
General Coverage Criteria (cont) F. Beneficiary has sufficient upper extremity function and other physical and mental capabilities needed to safely self-propel MWC in home during typical day OR G. Beneficiary has caregiver available, willing, and able to provide assistance with wheelchair. If the manual wheelchair is only for use outside the home, it will be denied as noncovered.
Manual Wheelchairs Standard Standard Hemi Wheelchair Lightweight Wheelchair High Strength, Lightweight Ultra Lightweight Wheelchair Heavy Duty Wheelchair Extra Heavy Duty Wheelchair Custom Manual Wheelchair Base Pediatric Wheelchair
Indications of Noncoverage Used only outside of home Noncovered Falls under item or service statutorily excluded or does not meet the definition of any Medicare benefit No ABN required Backup wheelchair Not reasonable and necessary Obtain ABN
Wheelchair Options, Accessories, & Seating 15
Basic Criteria Beneficiary has Medicare covered wheelchair Option/Accessory is medically necessary Specific coverage criteria not met, item will deny not reasonable and necessary Accessories must be billed on same claim as wheelchair base When provided on the same date of service
Power Wheelchair Basic Equipment Package Lap or safety belt Battery charger, single mode Complete set of tires and casters Legrests Footrests/foot platform Armrests Any weight specific components required by beneficiary weight capacity Any seat width or depth Any back width Controller and input device
Benificiary Owned Power Operated Wheelchair/Vehicle Medically necessary replacement items covered Must meet coverage criteria
Accessories Must meet specific coverage criteria Examples (list is not all inclusive): Nonstandard seat frame Power tile and/or recline seating systems Electronic interface Anti-rollback devices Non-covered accessories (list is not all inclusive): Option/accessory allowing beneficiary to perform leisure or recreational activities Remote operation Electronic balance
Wheelchair Seating Headrest General Use Seat and/or Back Cushion Skin Protection Seat Cushion Positioning Seat, Back Cushion, and Positioning Accessory Combination Skin Protection and Positioning Custom Fabricated Seat & Back Cushion
Wheelchair Seating Claim Denials Denied as not reasonable or necessary Seat or back cushion provided for transport chair Powered seat cushion Prefabricated seat/positioning back cushion or brand name custom fabricated seat/back cushion No separate payment Solid insert used with seat/back cushion Mounting hardware used for seat/back cushion Back/seat cushion used with rollabout chair Solid support base used with PWC
Oxygen and Oxygen Equipment 22
Coverage Criteria 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 qualified provider or supplier of laboratory services; and 4. Blood gas study performed under specific conditions; and 5. Alternative treatments ineffective
Home Oxygen Conditions where therapy may be covered Severe lung disease Hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy Each patient must receive optimum therapy before longterm home oxygen therapy is ordered Denied as 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
Portable Oxygen Beneficiary must be mobile within the home Qualifying study performed at rest or during exercise Study performed during sleep claim will deny as not reasonable and necessary Separately payable if coverage criteria met Reimbursement is the same regardless of quantity dispensed
Oxygen Payment Rental only for 36 months Months 1-36 Supplier who furnishes equipment in 1 st month must continue for entire 36 mo rental period unless: Beneficiary relocates or elects a new supplier Individual case exceptions by CMS or DME MAC Item becomes subject to competitive bidding Contents, maintenance, supplies and accessories all included in rental allowance Relocation Supplier responsible for providing equipment for remainder of current rental month For subsequent rental months, home supplier encouraged to continue to provide equipment or assist the beneficiary in finding another supplier to take over
Oxygen Payment (cont) Months 37-60 No further payment for remainder of the 5 year reasonable useful lifetime (RUL) Continue providing equipment, supplies, accessories, maintenance during remainder of 5 year RUL New 36-mo rental can only begin if equipment lost, stolen, or irreparably damaged No new 36-mo cap for normal wear and tear, changes of modality, breaks in need or billing or change of suppliers
Maintenance and Service Applies to concentrators and transfilling equipment No M&S payment for gaseous or liquid equipment No separate payment during 36-mo cap M&S billable every 6 months starting 6 months after end of 36-mo cap or end of warranty, whichever is later Supplier must actually make a visit to bill the service Only one M&S payment made regardless of number of visits made during 6 month period
Therapeutic Shoes 29
Coverage Criteria The beneficiary has diabetes mellitus; and The certifying physician has documented in the beneficiary s medical record one or more of the conditions 2a-2f listed in the policy article; and The certifying physician (MD or DO) has completed the Certifying Physician Statement; and Supplier must conduct and document in-person evaluation of the beneficiary prior to selecting items; and Supplier must conduct an objective assessment of the fit of the shoes and inserts and document the results at the time of in-person delivery
Transcutaneous Electrical Nerve Stimulator (TENS) 31
Coverage Criteria Acute post-operative pain Limited to 30 days from day of surgery Denied as not reasonable and necessary for acute pain other than post-operative Chronic pain other than low back pain Chronic, intractable pain other than CLBP Presumed etiology accepted as responding to TENS therapy Must have been present for at least 3 months Other modalities tried and failed (documented in medical records) Chronic low back pain (CLBP) Covered if beneficiary has one of the ICD-9 diagnosis listed on MAC website AND beneficiary is enrolled in approved clinical study
Condition Not Reasonable and Necessary Headache Visceral abdominal pain Pelvic pain Temporomandibular joint (TMJ) pain Not all-inclusive
Supplies Allowance for rental TENS includes all supplies Electrodes Lead wires Batteries Purchased TENS include lead wires and one months supply of Electrodes Conductive paste or gel (if needed) Replacement lead wires Rarely reasonable and necessary more than every 12 months
DME Repairs and Replacements 35
Repairs to Equipment Purchased by Medicare Beneficiary owns equipment Equipment is reasonable and necessary If Medicare paid for base equipment initially, medical necessity for the base equipment has been established Necessity of the repair in the physician or supplier s records
Repairs to Equipment Not Purchased by Medicare Equipment meets definition of a benefit category Reasonable and necessary criteria met Documentation supporting LCD requirements met
Reasons for Denial of Repairs Beneficiary-owned but not paid for by Medicare and equipment does not meet criteria coverage Rented equipment including: Frequent and substantial serviced items Oxygen equipment Capped rental items Rented inexpensive or other routinely purchased Previously denied equipment Beneficiary owned equipment that is under warranty Routine maintenance is not a repair
Replacement Replacement for loss, theft or irreparably damaged Replacement due to reasonable useful lifetime Must be at least 5 years No automatic timeframe Replacement is reasonable and necessary RUL determined when beneficiary received the equipment, not the age of the equipment Similar equipment dispensed due to change in medical condition is not considered replacement
Oxygen Replacement Allowed any time after five year URL New 36 month rental period begins If supplier retains ownership and beneficiary does not elect new equipment no separate payment for accessories or repairs Payment can continue for oxygen contents If supplier transfers title to beneficiary all accessories, maintenance, and repairs are statutorily non-covered Payment can continue for oxygen contents only Requires new physician order and/or CMN
DMEPOS Competitive Bidding Program 41
Program Overview Started in January 2011 for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) in 9 areas of the country (Round 1) In July 2013 The program expanded to more areas (Round 2) The National Mail-Order Program was implemented Contracts awarded to winning suppliers to sell/rent DMEPOS In most cases, only contract suppliers can provide competitively bid DMEPOS Items covered by Medicare does not change
Round 1 Recompete Products 1/1/14-12/31/16 Products Included in Round 1 Recompete Respiratory equipment and related supplies and accessories including Oxygen, oxygen equipment and supplies; Continuous Positive Airway Pressure (CPAP) devices and respiratory assist devices (RADs) and related supplies and accessories; and standard nebulizers Standard mobility equipment and related accessories including Walkers, standard power and manual wheelchairs, scooters, and related accessories General home equipment including Hospital beds and related accessories, group 1 and 2 support surfaces, transcutaneous electrical nerve stimulation (TENS) devices, commode chairs, patient lifts, and seat lifts Enteral nutrients, equipment, and supplies Negative pressure wound therapy pumps and related supplies and accessories External infusion pumps and supplies
Products Included in Round 2* Products Included in Round 2 Oxygen, oxygen equipment, and supplies Enteral nutrients, equipment, and supplies Continuous Positive Airway Pressure (CPAP) devices and Respiratory Assist Devices (RADs), and related supplies and accessories Hospital beds and related accessories Walkers and related accessories Support surfaces (Group 2 mattresses and overlays) Standard (power and manual) wheelchairs, scooters, and related accessories Negative pressure wound therapy pumps and related supplies and accessories *Changes from Round 1 to Round 2 in Bold Italics
Equipment Repair & Replacement For owned medical equipment Any Medicare-enrolled supplier can make necessary repairs For replacement, must use a contract supplier For warranty repairs, follow the warranty rules For rented equipment Repairs are included in rental payment the supplier must fix at no charge
Advance Beneficiary Notice of Noncoverage (ABN) 46
ABN Options Option 1: Beneficiary wants the item and the provider should bill Medicare Provider can ask the patient to pay up front Option 2: The patient wants the item but does not want Medicare billed. The patient will pay for the item out of pocket No appeal rights This may also be used for a voluntary notice (noncovered items)
ABN Options (cont) Option 3: Patient chooses they do not want the item or care in question No appeal rights If the beneficiary cannot or will not make a choice, the notice should be annotated (ex. Beneficiary refused to choose an option
When to Obtain an ABN Medical necessity denials Upgraded items Same/similar equipment Advance Determination of Medicare Coverage (ADMC) denials Invalid or no NSC number Experimental items and services Frequency limited items and services Noncontract supplier furnishes an item included in the DMEPOS CBP for a CBA
ABN Requirements Must clearly identify the particular item or service State that the physician or supplier believes Medicare is likely to deny payment Give the physician or supplier s reason(s) for his/her belief that Medicare is likely to deny payment for the item or service Generic ABNs: Are not acceptable evidence of advance beneficiary notice State denial is possible Statement indicating if Medicare claim is denied, patient will be held responsible Are defective notices and will not protect the physician or supplier from liability 50
Defective Notice An ABN is not acceptable evidence if: The notice is unreadable, illegible, or incomprehensible The beneficiary (or authorized representative) is incapable of understanding due to particular circumstances Given during an emergency Given to the beneficiary under great duress The beneficiary (or authorized representative) is, in any way, coerced or misled by the notifier, by the contents of the notice, and/or by the manner of delivery of the notice The notifier routinely gives this notice to all beneficiaries The notice is a general statement The notice was delivered to the beneficiary (or authorized representative) more than one year before the items or services are furnished 51
Program Updates 52
Prior Authorization of Power Mobility Devices (PMD) Demonstration began September 1, 2012 and ends August 31, 2018. Based on beneficiary s address reported to Social Security Administration Beneficiaries with rep payees are excluded Devices included in demonstration: Suppliers know if PMD is covered before delivery Beneficiaries are notified before PMD is delivered if Medicare will cover
Prior Authorization Process for Certain DMEPOS Items Final rule published December 30, 2015 Addresses questionable utilization and improper payments Does not create new clinical documentation requirements Helps to ensure beneficiaries are not held responsible for the cost of items not eligible for Medicare payment Master list of 135 items Required Prior Authorization List 54
Questions 55