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 I. Guide to Medicare Coverage

Who qualifies 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 oftentimes you do not have to pay a monthly fee to have Part A benefits, the Part B program requires a monthly 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 agrees to accept Medicare payments.
• Unfortunately, your medical equipment 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 provider does not accept assignment with Medicare you 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.

Other possible costs:

• Medicare will pay only for items that meet your basic needs. Oftentimes you will find that your provider offers a wide selection of products that vary slightly in appearance or features. You may decide that you prefer the products that offer these additional features. Your provider should give you the option to allow you to privately pay a little extra money to get the product that you really want.
• To take advantage of this opportunity, a new form has been approved by the Centers for Medicare and Medicaid Services (CMS) that allows patients to upgrade to a piece of equipment that they like better than other standard options for which they may otherwise qualify.
• The Advance Beneficiary Notice, or ABN, must detail how the products differ, and requires a signature to indicate that you agree to pay the difference in the retail costs between two similar items. Your provider will typically accept assignment on the standard product and apply that cost toward the purchase of the fancier item, thus requiring less money out of your pocket.

Purpose of ABN

• The Advance Beneficiary Notice also will be used to notify you ahead of time that Medicare will probably not pay for a certain item or service in a specific situation, even if Medicare might pay under different circumstances. The form should be detailed enough that you understand why Medicare will probably not pay for the item you are requesting.
• The purpose of the form is to allow you to make an informed decision about whether or not to receive the item or service knowing that you may have additional out-of-pocket expenses.

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 preventive 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)

Understanding Assignment (a claim-by-claim contract)

• When providers accept assignment, they are agreeing to accept Medicare’s approved amount as payment in full.
• You will be responsible for 20 percent of that approved amount. This is called your coinsurance.
• You also will be responsible for the annual deductible, which is $135.00 for 2008.
• If a provider does not accept assignment with Medicare, you will be responsible for paying the full amount upfront. The provider will still file a claim on your behalf and any reimbursement made by Medicare will be paid to you directly. (Providers must still notify you in advance, using the Advance Beneficiary Notice, if they do not believe Medicare will pay for your claim.)

Mandatory Submission of Claims

• Every provider is required to submit a claim for covered services within one year from the date of service

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 CMNs 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 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 a 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 coinsurance 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 to replacement of accessories, and allows a small fee for monthly 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 meet Medicare’s coverage criteria for the item being repaired.

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II. Medicare Coverage for specific types of home medical equipment

BiPaps/Respiratory Assist Devices

• 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 headaches, 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 diseases 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.

Breast Prostheses

• Breast Prostheses are covered after a radical mastectomy. Medicare will cover:
  • One silicone prosthesis 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

• Cervical traction devices are covered only if both of the criteria below are met:
  1. The patient has a musculoskeletal or neurologic impairment 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.

Commodes

• A commode is only covered when the patient is 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 are no toilet facilities in the home.
• Heavy-duty commodes are covered for patients weighing over 300 pounds.

Compression Stockings

• 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.

CPAPs

• 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 a 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 many hours a day you are using the machine.

Diabetic Supplies

• 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 any time your testing frequency changes, your physician will need to give your provider a new prescription.

Glasses

• Medicare covers one complete pair of glasses after the last cataract surgery. These can include:
  • frames
  • two lenses
  • tint, anti-reflective coating, and/or UV (when the doctor specifically orders these services for a medical need)

Hospital Beds

• 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 which 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 weigh 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 between the two items every month.

Lymphedema Pumps

• 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 from the destruction of or damage to formerly functioning lymphatic channels such as:
    • radical surgical procedures with removal of regional groups of 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 period 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 other 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 treatment 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.

Medicare-covered drugs (other than Medicare Part D coverage)

• As of February, 2001, all providers of Medicare-covered drugs are required to accept assignment on these items.
• Traditional Medicare Part B insurance will cover some nebulizer drugs, some infused drugs using a pump, specific immunosuppressive drugs, select oral anti-cancer medications and most parenteral nutrition.
• The Medicare Part D plans may provide additional coverage of other oral medications, inhalers and similar drugs.

Mobility Products: Canes, Walkers, Wheelchairs, and Scooters

• 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 questions:
  • 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.

Nebulizers

• 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.

Non-covered items (partial listing):

• Adult diapers
• Bathroom safety equipment
• Hearing aids
• Syringes/needles
• Van lifts or ramps
• Exercise equipment
• Humidifiers/Air Purifiers
• Raised toilet seats
• Massage devices
• Stair lifts
• Emergency communicators
• Low Vision aids
• Grab bars

Orthopedic Shoes

• 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

• 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.

Oxygen

• Covered for patients with significant hypoxemia in the chronic stable state when:
  • patient has a chronic lung condition or disease or 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 separately pay for oxygen accessories such as tubing, masks, and cannulas after the purchase price has been met.

Parenteral and enteral therapy

• Parenteral therapy requires all or part of the gastrointestinal tract be missing. Nutritional formulas are delivered through a vein.
• Enteral therapy is covered for patients who cannot swallow or take food orally. Nutrition must be delivered through a tube directly into the gastrointestinal tract.
• Medicare will not pay for nutritional formulas that are taken orally.

Patient Lifts

• 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 the two items.

Seat Lift Mechanisms

• 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.

Support Surfaces

• 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 conditions:
  • Multiple stage II ulcers on the pelvis or trunk while on a comprehensive treatment program for at least 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.) OR
  • Large or multiple Stage III or IV ulcers on the trunk or pelvis (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.) OR
  • 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

• TENS units are covered for the treatment of chronic intractable pain that has been present for at least three months or more, and in some cases for acute post-operative pain.
• Not all types of pains can be treated 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 sufferers, 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.

Therapeutic Shoes

• 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

Urological Supplies

• 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.

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III. Medicare Supplier Standards

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 supplier’s 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 supplier’s 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.

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