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Both Medicare and private health insurance plans pay for a large portion or sometimes even all costs associated with many types of medical equipment. The guide below will help you better understand the Medicare guidelines related to home medical equipment. Most health insurance plans have similar rules to Medicare, but you should know that all private health insurance plans vary and the specific rules of your plan may differ form these Medicare quidelines. We accept most of the major health insurance plans. We would be happy to work with you and your insurance company to help you understand how your plan works as it relates to home medical equipment needed by you or a loved one. If you have any questions on what your insurance may or may not cover, please give us a call and we will gladly assist you.
Medicare Coverage Information
 
Physician Resources
Physician Documentation Requirements-Blood Glucose Strips and Lancets
Physician Letter-Medical Records
Physician Letter-PWC/POV
Physician Letter-PAP Devices
Physician Letter-Therapeutic Shoes
 
Documentation Checklists
 
Documentation to Support Coverage
 
 
I.Guide to Medicare Coverage.
Who qualifes for Medicare Benefits?
-Individuals 65 years of age or older
-Individuals under 65 with permanent kidney failure (beginning three months after dialysis begins, or
-Individuals under 65, permanently disabled and entitled to Social Security benefits (beginning 24 months after the start of disability benefits)
The different benefits of traditional Medicare
-Medicare Part A benefits cover hospital stays, home health care and hospice services.
-Medicare Part B benefits cover physician visits, laboratory tests, ambulance services and home medical equipment
-While often times you do not have to pay a monthly fee to have part A benefits, the Part B program requires a montly premium to stay enrolled. In 2008 that premium will range between $96.40 and $238.40 per month depending on your income. Typically, this amount will be taken from your social security check.
What can you expect to pay?
-Every year, in addition to your monthly premium, you will have to pay the first $135 of covered expenses out of pocket and then 20 percent of all approved charges if the provider cannot automatically waive this 20 percent or your deductible without suffering penalties from Medicare. Your provider must attempt to collect the coinsurance and deductible if those charges are not covered by another insurance plan; however, certain exceptions can be made if you suffer from qualifying financial hardships.
-If you have a supplemental insurance policy, that plan may pick up this portion of your responsibility after your supplemental plan's deductible has been satisfied
-If your medical equipment provder does not accept assignment with Medicare your may be asked to pay the full price up front, but they will file a claim on your behalf to Medicare. In turn, Medicare will process the claim and mail you a check to cover a portion of your expenses if the charges are approved.
Durable medical Equipment (DME) Defined
-In order for any item to be covered under Medicare, it typically has to meet the test of durability. Medicare will pay for medical equipment when the item:
-Withstands repeated use (excludes many disposable items such as underpads)
-Is used for a medical purpose (meaning there is an underlying condition which the item should improve)
-Is useless in the absence of illness or injury (thus excluding any item preventative in nature such as bathroom safety items used to prevent injuries)
-Used in the home (which excludes all items that are needed only when leaving the confines of the home setting)
The role of the physician with respect to home medical equipment:
-Every item billed to Medicare requires a physician's order or a special form called a Certificate of Medical Necessity (CMN), and sometimes additional documentation will be required.
-Nurse practitioners, physician assistants, interns, residents and clinical nurse specialists can also order medical equipment and sign CMN's when they are treating a patient.
-All physicians have the right to refuse to complete documentation for equipment they did not order, so make sure you consult with your physician before requesting an item from a provider.
Prescriptions Before Delivery:
-For some items, Medicare requires your provider to have completed documentation (which is more than just a call-in order or a prescription form from your doctor) before these items can be delivered to you:
-Decubitus care (wheelchair cushions and pressure-relieving surfaces placed on a hospital bed.)
-Seat lift mechanisms
-TENS units (for pain management)
-Power Operated Vehicles/Scooters
-Electric or Power wheelchairs
-Negative pressure wound therapy (wound vacs)
How does Medicare pay for and allow you to use the equipment?
1. Typically there are four ways Medicare will pay for covered item:
-purchase it outright; then the equipment belongs to you,
-Rent it continuously until it is no longer needed, or
-consider it a "capped" rental in which Medicare will rent the item for a total of 13 months and consider the item purchased after having made 13 payments
     -Medicare will not allow you to purchase these items outright (even if you think you will need it for a long period of time).
     -This is to allow you to spread out your coinsurane instead of paying in one lump sum.
     -It also protects the Medicare program from paying too much should your needs change earlier than expected.
If you have oxygen therapy, Medicare will make rental payments for a total of 36 months during which time this fee covers all service, accessories, and oxygen contents.
     -Beyond the 36 months, Medicare will limit payments for a replacement accessories, and allows a small fee for montly content and to check the equipment every six months.
2. After an item has been purchased for you, you will be responsible for calling your provider any time that item needs to be serviced or repaired. When necessary, Medicare will pay for a portion of repairs, labor, replacement parts, and for temporary loaner equipment to use during the time your product is in for servicing. All of this is contingent on the fact that you still need the item at the time of repair and continue to meed Medicare's coverage criteria for the item being repaired.
 
-For a respiratory assist device to be covered, the treating physician must fully document in your medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning heaedaches, cognitive dysfunction, dyspnea, etc.
-A respiratory assist device is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e. progressive neuromuscular disease or severe thoracic cage abnormalities),(II)severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA)
-Various tests may need to be performed to establish one of the above diagnosis groups.
-Three months after your therapy is begun, both your physician and you will be required to respond in writing to questions regarding your continued use along with how well the machine is treating your condition.
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Breast Prostheses are covered after a radical mastectomy. Medicare will cover:
   -One silicone prostheses every two years or a mastectomy form every six months.
   -Mastectomy bras are covered as needed.
There is no coverage for replacement prostheses due to wear and tear before the specified time frames. However, Medicare will cover replacement of these items due to:
-Loss
-Irreparable damage, or
-Change in medical condition (e.g. significant weight gain/loss)
Patients are allowed only one prosthesis per affected side; others will be denied as not medically necessary even if attempting symmetry (an ABN should be provided in this circumstance).
Mastectomy sleeves which are used to control swelling are not covered in the home setting because they do not meet Medicare's definition of a prosthesis; however, it is possible that they may be covered under the hospital per diem if you request one during your hospital stay.
Cervical traction devices are covered only if both of the criteria below are met:
  1. the patient has a musculoskeletal or neurologic impairement requiring traction equipment.
  2. the appropriate use of a home cervical traction device has been demonstrated to the patient and the patient tolerated the selected device.
A commode is only covered when the patientis physically incapable of utilizing regular toilet facilities. For example:
1. The patient is confined to a single room, or
2. The patient is confined to one level of the home environment and there is no toilet on that level, or
3. The patient is confined to the home and there is no toilet facilities in the home.
Heavy-duty commodes are covered for patients weighing over 300 pounds.
Gradient compression stockings worn below the knee are covered only when used for the treatment of open venous stasis ulcers. They are not covered for the prevention of ulcers, prevention of the reoccurrence of ulcers or treatment of lymphedema without ulcers.
-Continuous Positive Airway Pressure (CPAP) Devices are covered only for patients with obstructive sleep apnea (OSA).
-Patients must have an overnight sleep study performed in sleep laboratory to establish a qualifying diagnosis. In March of 2008, home sleep testing was approved as an acceptable means of diagnosing this condition when your physician deems this testing is appropriate.
Medicare will also pay for replacement masks, cannulas, tubing and other necessary supplies.
After the first three months of use, you will be required to verify if you are benefiting from using the device and how any hours a day you are using the machine.
-For diabetics, Medicare covers the glucose monitor, lancets, spring-powered lancing devices, test strips, control solution, and replacement batteries for the meter.
-Medicare does not cover insulin injections or diabetic pills unless covered through a Medicare Part D benefit Plan.
-Diabetics can obtain up to a three-month supply at a time.
-Medicare will approve up to one test per day for non-insulin-dependent diabetics and three tests per day for insulin-dependent diabetics without additional verification.
    -Patients who test above these guidelines are required to be seen and evaluated by their physician within six months of ordering these supplies.
    -In addition, patients must send their provider evidence of compliant testing (e.g. a testing log) every six months to continue getting refills at the higher levels.
-If at anytime your testing frequency changes, your physician will need to give your provider a new prescription.
A hospital bed is covered if one or more of the following criteria (1-4) are met:
1. The patient has a medical condition which requires positioning of the body in ways not feasible with an ordinary bed. Elevation of the head/upper body less than 30 degrees does not usually require the use of a hospital bed, or
2. The patient requires positioning of the body in ways not feasible with an ordinary bed in order to alleviate pain, or
3. The patient requires the head of the bed to be elevated more than 30 degrees most of the time due to congestive heart failure, chronic pulmonary disease, or problems with aspiration. Pillows or wedges must have been considered and ruled out, or
4. The patient requires traction equipment whcih can only be attached to a hospital bed.
Specialty beds that allow the height of the bed to vary are covered for patients that require this feature to permit transfers to a chair, wheelchair, or standing position.
A semi-electric bed is covered for a patient who requires frequent changes in body position and/or has an immediate need for a change in body position.
Heavy-Duty/Extra-wide beds can be covered for patients who weight over 350 pounds.
The total electric bed is not covered because it is considered a convenience feature. If the patient prefers to have the total electric feature, the provider usually can apply the cost of the semi-electric bed toward the monthly rental price of the total electric model by using an Advance Beneficiary Notice (ABN). The patient would be responsible to pay the difference in the retail charges betweent he two items every month.
-Lymphedema Pumps are covered for treatment of true lymphedema as a result of a:
      -Primary Lymphedema resulting from a congenital abnormality of lymphatic drainage or Milroy's disease, or
      -Secondary lymphedema resulting fromt he destruction of or damage to formerly functioning lymphatic channels such as:
     -radical surgical procedures with removal or regional groups or lymph nodes (for example, after radical mastectomy),
     -post-radiation fibrosis,
     -spread of malignant tumors to regional lymph nodes with lymphatic obstruction,
     -or other causes
-Before you can be prescribed a pump, your physician must monitor you during a four week trial periord where other treatment options are tried such as medication, limb elevation and compression garments. If, at the end of the trial, there is little or no improvement, a lymphedema pump can be considered.
-The doctor must then document an initial treatment with a pump and establish that the treatment can be tolerated.
Lymphedema pumps also are covered for the treatment of chronic venus insufficiency (CVI).
-Before you can be prescribed a pump for this condition, your physician must monitor you during a six month trial period where toher treatment options are tried such as medication, limb elevation and compression garments. If at the end of the trial the stasis ulcers are still present, a lymphedema pump can be considered.
The doctor must then document an initial treatment with a pump and establish that the treatmetn can be tolerated, that there is a caregiver available to assist with the treatment in the home, and then the doctor must prescribe the pressures, frequency, and duration of prescribed use.
-Essentially the new Mobility Assistive Equipment regulations will ensure that Medicare funds are used to pay for:
    -mobility needs for daily activities within the home
    -least costly alternative/lowest level of equipment to accomplish these tasks.
    -Most medically appropriate equipment (to meet the needs, not the wants)
-Medicare requires that your physician and provider evaluate your needs and expected use of the mobility product you will qualify for.
-They must determine which is the least level of equipment needed to help you be mobile within your home to accomplish daily activities by asking the following quesitons:
-Will a cane or crutches allow you to perform these activities in the home?
-If not, will a walker allow you to accomplish these activities in the home?
-If not, is there any type of manual wheelchair that will allow you to accomplish these activities in the home?
-If not, will a scooter allow you to accomplish these activities in the home?
-If not, will a power chair allow you to accomplish these activities in the home?
Keep in mind if you have another higher level product in mind that will allow you to do more beyond the confines of the home setting, you can discuss with your provider the option to upgrade to a higher level or more comfortable product by paying an additional out of pocket fee using the Advance Beneficiary Notice (ABN) to select the product you like best.
-A face-to-face examination with your physician is required prior to the initial setup of a power chair or scooter.
-Your home must be evaluated to ensure it will accommodate the use of any mobility product.
Nebulizer machines, medications, and related accessories are usually covered for patients with obstructive pulmonary disease, but can also be covered to deliver specific medications to patients with HIV, CF, brochiectasis, pneumocystosis, complications of organ transplants, or for persistent thick or tenacious pulmonary secretions.
Patients can obtain up to a three month's supply of nebulizer medications and accessories at a time.
-Orthopedic shoes are covered when it is necessary to attach the shoe(s) to a leg brace.
-However, Medicare will only pay for the shoe(s) attached to the leg braces.
-Medicare will not pay for matching shoes or for shoes that are needed for purposes other than for diabetes or leg braces.
Ostomy supplies are covered for people with a:
-colostomy
-ileostomy
-urostomy
Patients can obtain up to a three month's supply of wafers, pouches, paste, and other necessary items at a time.
-Covered for patients with significant hypoxemia that might be expected to improve with oxygen therapy, and
-patient's blood gas levels or oxygen saturation levels indicate the need for oxygen therapy, and
-alternative treatments have been tried or deemed clinically ineffective.
Categories/Groups are based on the test results to measure your oxygen:
I.  55°‹ mmHg, or 88%°‹ saturation
    -For these results you must return to your physician 12 months after the initial visit to continue therapy for lifetime or until the need is expected to end. Typically, you will not have to be retested when you return to your physician for the follow-up visit.
II. 56-59 mmHg, or 89% saturation
    -For these results, you must be retested within 3 months of the first test to continue therapy for lifetime or until the need is expected to end.
III. °›60 or °›90% not medically necessary.
Oxygen will be paid as a rental for the first 36 months. After that time if you still need the equipment Medicare will no longer make rental payments on the equipment. If your deductible and copays are met, the equipment title will transfer to you. Medicare will then pay for refilling your oxygen cylinders and for repairs and service of your equipment. Medicare will also seperately pay for oxygen accessories such as tubing, masks, and cannulas after the purchase price has been met.
-A lift is covered if transfer between bed and a chair, wheelchair, or commode requires the assistance of more than one person and, without the use of a lift, the patient would be bed confined.
-An electric lift mechanism is not covered because it is considered a convenience feature. IF you prefer to have the electric mechanism, your provider can usually apply the cost of the manual lift toward the purchase price of the electric model by using an Advance Beneficiary Notice (ABN). You would be responsible to pay the difference in the retail charges between two items.
In order for Medicare to pay for a seat lift mechanism, patients must be suffering from severe arthritis of the hip or knee, or have a severe neuromuscular disease. In addition they must be completely incapable of standing up from any chair, but once standing they can walk either independently or with the aid of a walker or cane. The physician must believe that the mechanism will improve, slow down, or stop the deterioration of the patient's condition.
Transferring directly into a wheelchair will prevent Medicare from paying for the device.
Medicare will only pay for the lift mechanism portion. The chair portion of the package is not covered, and you will be responsible for paying the full amount for the furniture component of the chair.
Group 1 products are designed to be placed on top of a standard hospital or home mattress. They can utilize gel, foam, water, or air, and are covered for patients who are:
-completely immobile OR
-have limited mobility with any stage ulcer on the trunk or pelvis (and one of the following):
   -impaired nutritional status
   -fecal or urinary incontinence
   -altered sensory perception
   -compromised circulatory status
Group 2 products take many forms, but are typically powered pressure reducing mattresses or overlays. They are covered for patients with one of three condtions:
-Multiple stage II ulcers on the pelvis or trunk while on a comprehensive treatment program for atleast a month using a Group 1 product, and at the close of that month, the ulcers worsened or remained the same. (Monthly follow-up is required by a clinician to ensure that the treatment program is modified and followed. This product is only covered while ulcers are still present.)
-Large or multiple stage III or IV ulcer on the trunk or pelvis (Montly follow-up is required by a clinician to ensure that the treatment program is modified and followed. This product is only covered while ulcers are still present.)
-A recent myocutaneous flap or skin graft for an ulcer on the trunk or pelvis within the last 60 days who were immediately placed on Group 2 or 3 support surface prior to discharge from the hospital and the patient has been discharged within last 30 days.
-TENS units are covered for the treatment of chronic intractable pain that has been present for atleast three months or more, and in some cases for acute post-operative pain.
-Not all types of pains can be tolerated with a TENS unit. TENS units have proven ineffective in treating headaches. visceral abdominal pains, pelvic pains, and TMJ pains, and therefore Medicare will not pay for the device when used to treat these conditions.
-For chronic pain sufferes, Medicare will pay for a one or two month trial rental to determine if this device will alleviate the chronic pain. You must return to your physician exactly 30-60 days after initial evaluation to authorize the purchase of this equipment.
-For acute post-operative pain sufferers, Medicare will consider rental payment for a maximum of 30 days. Any duration longer than that will require individual consideration.
-Special therapeutic shoes, inserts, and modifications can be covered for diabetic patients with the following foot conditions:
      -previous amputation of a foot or partial foot
      -history of foot ulceration
      -peripheral neuropathy with callus formation
      -foot deformity
      -poor circulation in either foot
Urinary catheters and external urinary collection devices are covered to drain or collect urine for a patient who has permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that patient within 3 months.
Medicare will cover the cost of one pair of therapeutic shoes (diabetic shoes) and inserts for people with diabetes if you have a medical need for them. To ensure that Medicare pays for your shoes, you must follow the steps below:
-Your treating doctor must complete a certificate of medical necessity for the therapeutic shoes and document the need in your medical records. So, do not order anything until you have visited your doctor
-The Shoes and Inserts must be prescribed by a podiatrist, orthotist, prosthetist, or pedorthist.
-The order must be received by us before medicare is billed so we have it on file.
-If you receive Medicare through a Medicare Advantage Plan (like HMO,PPO) it is likely you will have to follow the plan's steps for approval and purchase. Make a point of calling your plan's customer service number and ask about their steps for coverage of diabetic shoes.
Medicare will cover one of the following per calender year:
-One pair of custom-molded shoes, including the inserts provided with the shoes, and two additional pairs of inserts or;
-One pair of extra depth shoes and three pairs of heat molded inserts or;
-One pair of extra depth shoes and three pairs of custom molded inserts taken from a cast impression of your feet.
Medicare will not cover deluxe features: a deluxe feature is one that does not contribute to the shoe's therapeutic function-for example, a custome style, color or custom material.
How do I qualify for the Coverage of Diabetic Shoes?
You must be covered under Part B of Medicare and all three of the following conditons are met:
1. You have diabetes and;
2. You have one or more of the following conditions:
-Loss of one foot or part of a foot
-Amputation of toe or partial toe of either foot
-History of sores on your feet
-History of pre-ulcerative calluses of either foot
-Nerve damage in your feet and calluses on either foot
-Deformity of either foot (for example, hammertoe or bunions)
-Poor circulation in either foot.
3. Your doctor has certified your need in writing that states:
-You meet the criteria for the shoes
-The doctor is treating you under a comprehensive plan of care for diabetes
-The exact reasons you need the therapeutic shoes (any customization, inserts, etc).
Remember
-Only an M.D. or D.O. can sign the certification statement; a podiatrist may not write the prescription for the shoes
-You also need a new order for the replacement of any shoe
-A copy of the certification statement and prescription must be kept on file by your supplier
-A new certification statement will be required for shoes, inserts or modifications each year they are purchased.
How much you pay will depend on whether or not you have Part B coverage and where you buy your shoes. However, if you are enrolled in Medicare Part B these general rules apply:
-After you have paid your yearly deductible, you will pay 20% of the approved Medicare amount for the shoes and inserts.
-You will pay less if you buy from a supplier who accepts assignment. If you receive your medicare through a Medicare Advantage Health Plan,  you may owe little to nothing depending on the plan with which you have signed up and your benefits with the plan. If you have Supplemental Medigap insurance, you might owe little to no money for your shoes.
Medicare Requirements for Durable Medical Equipment
Medicare has specific requirements about what is and what is not covered under the DME guidelines. To qualify as durable medical equipment and thus be covered by Medicare, the item must meet the following qualifications:
-The item must be primarily for medical use. To qualify for use of a motorized scooters. You must be unable to walk.
-The item must be necessary for your use in the home, apartmetn, home of a relative, or an assisted living facility. A hospital or nursing home that provides you with Medicare-covered care does not qualify as your "home", but a long-term care facility may. To use the scooter as an example again, Medicare would cover a power-operated scooter if you needed it to get around inside your home, but it would not pay for it if you wanted it maily to shop or run errands.
-You must have a certificate of medical necessity(CMN), which is different than a prescription. The CMN is a special form that authorizes the use of certain physician-prescribed equipment, such as oxygen concentrators and wheelchairs, and is often required to support the prescription. Not every piece of durable medical equipment requires a CMN. Medicare-certified suppliers know which items require a CMN and will coordinate with your physician's office to acquire all the required documentation.
-The item must be able to withstand repeated use. Thus disposable or short-lived items such as diapers or support house do not qualify. However, lancets and test strips used by people who have diabetes are covered, even though they are once-time use items.
-The item must be useful only in the presence of illness or injury.
Equipment that is covered by Medicare
-Prosthetics: devices that replace part of all of an internal organ or its function, such as artificial limbs, eyes, and legs. It also includes items for nutrition therapy, such as food pumps and intravenous poles
-Orthotics: braces for the back, neck, arm, and leg
-Lancets and test strips to test blood sugar levels (eventhough they are not durable and are discarded after one use, they are still covered)
-Respiratory equipment: respirators, oxygen concentrator, oxygen tanks, nebulizers, inhalers, continuous positive airway pressure (CPAP; if diagnosed with obstructive sleep apnea)
-Canes, Walkers
-Hospital beds
-Bed Pans (if confined to a bed), bedside commodes
-Catheters, ostomy supplies
Which Equipment is Not Covered
-Adult diapers, incontinet pads, and other supplies for incontinence
-Hearing aids and dentures
-Bandages and surgical stockings
-Chair lifts, stairway elevators
-Posture chairs
-Room heaters, electric air cleaners, humidifiers
-Grab bars
-Irrigation kits
-Rubber gloves
-Diathermy machines
-Raised toilet seats
-Telephone alert systems
-Insulin and syringes
Medicare Requirements for Wheelchairs and Scooters
For Medicare to cover any of the wheelchairs and scooters your doctor must state that you need this equipment because of your medical condition. Medicare will pay 80% of the Medicare-approved amount, after you've met the Part B deductible. You pay 20% of the Medicare -approved amount.
For you to be eligible for any device known as "mobility assistive equipment"(MAE) which includes canes,crutches,walkers,manual wheelchairs,power wheelchairs, and scooters, the item must be needed in your home.
To get MAE, you must meet the following requirements:
-Have a health condition where you need help with activities of daily living like bathing, dressing, getting in or out of the bed or chair, moving around, or using the bathroom.
-Be able to safely operate and get on and off the wheelchair or scooter
-Have good vision
-Be mentally able to safely use a scooter, or have someone with you who can make sure the device is used correctly and safely.
The equipment also must be useful within the physical layout of your home (it must not be too big for your home or blocked by things in it's path.)
Manual Wheelchair
Rolling Chair/Geri-chair
You may need a rolling chair if you need more support than a wheelchair can give. These chairs have small wheels, that must be atleast 5 inches in diameter. The rolling chair must be designed to meet your needs due to illness or other impairment.
Power-Operated Vehicle/Scooter
You may need a power-operated scooter if you can't use a cane or walker or operate a manual wheelchair.
Power Wheelchair
You may need a motorized wheelchair if you can't use a manual wheelchair in your home, or if you don't qualify for a power-operated scooter because you arent strong enough to sit up or to work the scooter controls safely in your home.
Before you get either a power wheelchair or scooter, you must meet with a doctor who can explain to Medicare (in the form of an order) why you need the device. The doctor also must be able to tell Medicare that you can operate it safely.
Remember, you must have a medical need for Medicare to cover a power wheelchair or scooter. Medicare won't cover this equipment if it will be used mainly for leisure or recreational activities, or if it's only needed to move around outside your home.
Note: You have the choice of either renting or buying a power wheelchair or scooter. If you don't need a power wheelchair or scooter on a long-term basis, you may want to rent the equipment to reduce your out-of-pocket costs. Talk to your supplier to find out more about this option.
Below is a summary of the standards Medicare requires of home medical equipment providers. Our company meets or exceeds all of these standards.

1.       A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements.

2.       A supplier must provide complete and accurate information on the DMEPOS supplier application. Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days.

3.       An authorized individual (one whose signature is binding) must sign the application for billing privileges.

4.       A supplier must fill orders from its own inventory, or must contract with other companies for the purchase of items necessary to fill the order. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or from any other Federal procurement or non-procurement programs.

5.       A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped rental equipment.

6.       A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law, and repair or replace free of charge Medicare covered items that are under warranty.

7.       A supplier must maintain a physical facility on an appropriate site.

8.       A supplier must permit CMS (formerly HCFA), or its agents to conduct on-site inspections to ascertain the supplierís compliance with these standards. The supplier location must be accessible to beneficiaries during reasonable business hours, and must maintain a visible sign and posted hours of operation.

9.       A supplier must maintain a primary business telephone listed under the name of the business in a local directory or a toll free number available through directory assistance. The exclusive use of a beeper, answering machine or cell phone is prohibited.

10.    A supplier must have comprehensive liability insurance in the amount of at least $300,000 that covers both the supplierís place of business and all customers and employees of the supplier. If the supplier manufactures its own items, this insurance must also cover product liability and completed operations.

11.    A supplier must agree not to initiate telephone contact with beneficiaries, with a few exceptions allowed. This standard prohibits suppliers from calling beneficiaries in order to solicit new business.

12.    A supplier is responsible for delivery and must instruct beneficiaries on use of Medicare covered items, and maintain proof of delivery.

13.    A supplier must answer questions and respond to complaints of beneficiaries, and maintain documentation of such contacts.

14.    A supplier must maintain and replace at no charge or repair directly, or through a service contract with another company, Medicare-covered items it has rented to beneficiaries.

15.    A supplier must accept returns of substandard (less than full quality for the particular item) or unsuitable items (inappropriate for the beneficiary at the time it was fitted and rented or sold) from beneficiaries.

16.    A supplier must disclose these supplier standards to each beneficiary to whom it supplies a Medicare-covered item.

17.    A supplier must disclose to the government any person having ownership, financial, or control interest in the supplier.

18.    A supplier must not convey or reassign a supplier number, i.e., the supplier may not sell or allow another entity to use its Medicare billing number.

19.    A supplier must have a complaint resolution protocol established to address beneficiary complaints that relate to these standards. A record of these complaints must be maintained at the physical facility.

20.    Complaint records must include: the name, address, telephone number, and health insurance claim number of the beneficiary, a summary of the complaint, and any actions taken to resolve it.

21.    A supplier must agree to furnish CMS (formerly HCFA) any information required by the Medicare statute and implementing regulations.

22.    All suppliers of DMEPOS and other items and services must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services, for which the supplier is accredited in order for the supplier to receive payment for those specific products and services.

23.    All DMEPOS suppliers must notify their accreditation organization when a new DMEPOS location is opened. The accreditation organization may accredit the supplier location for three months after it is operational without requiring a new site visit.

24.    All DMEPOS supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill the Medicare. An accredited supplier may be denied enrollment or their enrollment may be revoked, if CMS determines that they are not in compliance with the DMEPOS quality standards.

25.    All DMEPOS suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation. If a new product line is added after enrollment, the DMEPOS supplier will be responsible for notifying the accrediting body of the new product so that the DMEPOS supplier can be re-surveyed and accredited for these new products.

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