Medicare Guide

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 (you only have to pay money when you use the services), the Part B program requires a monthly premium to stay enrolled (even if you do not use the services). In 2018 that premium could be around $134 per month (but could be less) depending on your income. Typically, this amount will be taken from your Social Security check.
• Medicare Part C is coverage offered through various insurance companies that offer Medicare Advantage Plans.  These plans are offered as an alternative to Medicare Part B.  Medicare Advantage Plans cover the same benefits as your Part B plan but often have limited provider networks and may require authorization for services prior to making payment. Premiums and deductibles vary by plan. Some plans offer perks like gym memberships as a participation benefit.
• Medicare Part D offers optional program benefits that cover prescription drugs.
• For more information about your benefits or making coverage decisions, you can visit the official website for Medicare benefits at www.medicare.gov.

What Can You Expect to Pay for Medicare Part B Services?

• In 2018, in addition to your monthly premium, you will have to pay the first $183 of covered expenses out-of-pocket for Part B services, and then 20 percent of all approved charges if the supplier agrees to accept Medicare payments.
• Unfortunately, your medical equipment supplier cannot automatically waive this 20 percent or your deductible without suffering penalties from Medicare. They 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 meet qualifying financial hardships established by your supplier.
• 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 supplier 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 supplier 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 supplier 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 you to upgrade to a piece of equipment that you like better than the other standard option you may otherwise qualify for.  This form is known as the Advance Beneficiary Notice or ABN.
• The ABN form that your supplier completes for you 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 supplier 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 of Non-Coverage will also 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 (which 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 (which excludes any item that is 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 a supplier accepts 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 $183.00 for 2018.
• If you have chosen to receive an upgraded, fancier product than what Medicare typically covers, you will also be responsible for any additional amounts disclosed on the Advance Beneficiary Notice that identifies the additional features and fees that you have approved.
• If a supplier does not accept assignment with Medicare, you will be responsible for paying the full amount upfront. The supplier will still file a claim on your behalf and any reimbursement made by Medicare will be paid to you directly. (Suppliers must still notify you in advance, using the Advance Beneficiary Notice, when they do not believe Medicare will pay for your claim.)

Mandatory Submission of Claims

• Every supplier is required to submit a claim for covered services within one year from the date of service. However, if the item is never covered by Medicare, your supplier is not obligated to submit a claim.

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 such as copies of office visit notes from prior visits with your physician or healthcare provider or copies of test results relevant to the prescription of your medical equipment.
• Nurse Practitioners, Physician Assistants, Interns, Residents and Clinical Nurse Specialists can also order medical equipment and sign CMNs when they are treating you.
• All physicians and healthcare providers have the right to refuse to complete documentation for equipment they did not order, so make sure you consult with your physician or healthcare provider about your need for medical equipment or supplies before requesting an item from a supplier.
• For every new item prescribed by your physician or healthcare provider, you should have a recent office visit that documents the reasons for ordering the equipment and products.  Most items require you to have an in-person office visit with your doctor or healthcare provider to discuss the need and justification for the prescription of medical equipment (and even replacement equipment) before a supplier can fill those orders.

Prescriptions before Delivery:

• For some items, Medicare requires your supplier to have completed documentation (which is more than just a call-in order or a prescription from your doctor or healthcare provider) before they can deliver these items to you:
  • Decubitus care (wheelchair cushions, pressure-relieving surfaces placed on a hospital bed and air-fluidized beds)
  • Seat lift mechanisms
  • TENS Units (for pain management)
  • Power Operated Vehicles/Scooters
  • Electric or Power Wheelchairs and related options and accessories
  • Negative Pressure Wound Therapy (wound vacs)
• The list of items that require an office visit and written order before delivery has been expanded due to new provisions of the Affordable Care Act to include all items that cost more than $1000, and commonly prescribed items such as oxygen, hospital beds, wheelchairs and more. There are over 150 products across multiple product categories that are affected.   Your supplier will be able to tell you if the item ordered by your doctor or healthcare provider is subject to these additional requirements.
• Your supplier cannot deliver these products to you without a compliant written order from your doctor or healthcare provider. They cannot provide services and get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

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 and accessories.
     • Beyond the 36 months (for a period of two additional years), Medicare will limit payments to a small fee for monthly gas or liquid contents, where applicable, and a limited service fee to check the equipment every six months.
2. After an item has been purchased for you, you will be responsible for calling your supplier anytime 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.

What is competitive bidding?

In many parts of the country, a new program called Competitive Bidding will require you to obtain certain medical equipment from specific, Medicare-contracted suppliers in order for Medicare to pay. Not all products are subject to competitive bidding in the same area.  If you are located in a city where the program is in effect, you will need to obtain some or all of the following items from a contracted supplier:

• Oxygen, oxygen equipment, and supplies
• Standard power wheelchairs, scooters, and related accessories
• Enteral nutrition, 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 1 and Group 2 mattresses and overlays)
• Manual Wheelchairs and accessories
• Mail-order and local home delivery of diabetic supplies
• Nebulizers
• Home infusion therapy including insulin pumps and supplies
• TENS Units and supplies
• Patient Lifts
• Commodes
• Seat Lift Chairs
• Negative Pressure Wound Therapy Devices and related supplies and accessories

Competitive Bidding areas are designated based on the zip code of your permanent residence on file with Social Security. To find out if your zip code is affected by Competitive Bidding, call 1-800-MEDICARE (1-800-4227). You may also visit Medicare.gov and lookup suppliers in your area by zip code (a notice will appear if your area is subject to Competitive Bidding). If medical equipment is marked with a yellow/orange star, it will need to be provided by a contracted supplier (also marked with an orange star).  Throughout this guide, products that are potentially impacted by the competitive bidding program will be designated with a double asterisk **.  Your provider can assist you with answering your questions about competitive bidding and can address whether or not they have been contracted to provide the services you need if subject to competitive bid.

Medicare Supplier Standards

Below is a summary of the standards Medicare requires of home medical equipment suppliers. As an approved Medicare provider, 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 and cannot contract with an individual or entity to provide licensed services.

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. This standard requires that the location is accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.

8. A supplier must permit CMS, 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, answering service or cell phone during posted business hours 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 contacting a Medicare beneficiary based on a physician’s oral order unless an exception applies.

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 any information required by the Medicare statute and implementing regulations.

22. All suppliers 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 of those specific products and services (except for certain exempt pharmaceuticals). Implementation Date - October 1, 2009

23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.

24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare.

25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.

26. Must meet the surety bond requirements specified in 42 C.F.R. 424.57(c). Implementation date- May 4, 2009

27. A supplier must obtain oxygen from a state- licensed oxygen supplier.

28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 C.F.R. 424.516(f).

29. DMEPOS suppliers are prohibited from sharing a practice location with certain other Medicare providers and suppliers.

30. DMEPOS suppliers must remain open to the public for a minimum of 30 hours per week with certain exceptions.

Medicare Coverage for Specific Types of Home Medical Equipment

BiLevel Devices/Respiratory Assist Devices**

• For a respiratory assist device to be covered, the treating physician or healthcare provider 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 if you have a clinical disorder characterized as
  • (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities),
  • (II) severe chronic obstructive pulmonary disease (COPD), or
  • (III) central sleep apnea (CSA) or Complex Sleep Apnea (CompSA),
  • (IV) hypoventilation syndrome

• If you are diagnosed with Obstructive Sleep Apnea, see the coverage criteria for Positive Airway Pressure Devices below.

• Various tests may need to be performed to establish one of the above clinical disorders.
• Three months after starting your therapy you must return to your doctor or healthcare provider for a follow-up to confirm the machine is benefitting you and that you are regularly using the device. 
  • This must be documented in your doctor or healthcare provider’s notes from that office visit.  Your physician or healthcare provider will be required to respond in writing to questions regarding your continued use along with how well the machine is treating your condition.
  • If you are not using your machine for an average of four hours per night per 24 hour period at the time you meet with your doctor or healthcare provider, then you may be held responsible (via an Advance Beneficiary Notice) to pay for the rental until you meet this requirement. 
• BiLevel Devices are considered to be capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a compliant written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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.
  • As an alternative, Medicare can cover a nipple prosthesis every three 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)
• You are allowed only one prosthesis per affected side, others will be denied as not medically necessary even if attempting asymmetry (an Advance Beneficiary Notice 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.
• A mastectomy bra is covered if the pocket of the bra is used to hold a covered prosthesis or mastectomy form.

Cervical Traction

• Cervical traction devices are covered only if both of the criteria below are met:
  1. You have a musculoskeletal or neurologic impairment requiring traction equipment.
  2. The appropriate use of a home cervical traction device has been demonstrated to you and you are able to tolerate the selected device.

Commodes**

• A commode is only covered when you are physically incapable of utilizing regular toilet facilities. For example:
  1. You are confined to a single room, or
  2. You are confined to one level of the home environment and there is no toilet on that level, or
  3. You are confined to the home and there are no toilet facilities in the home.
• Heavy-duty commodes are covered if you weigh over 300 pounds.
• Commodes with detachable arms are covered if your body configuration requires extra width, or if the arms are needed to transfer in and out of the chair.
• Raised toilet seats that are used to position hand bars over a regular toilet are not covered by Medicare.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 reimbursed by Medicare for the prevention of ulcers, prevention of the reoccurrence of ulcers, treatment of lymphedema or swelling without ulcers.

Positive Airway Pressure Devices (CPAPs and Bi-Level Devices for Obstructive Sleep Apnea)**

Continuous Positive Airway Pressure (CPAP) Devices are covered only if you have Obstructive Sleep Apnea (OSA).

• Medicare requires that you first meet with your physician or healthcare provider to discuss your symptoms and risk factors for Obstructive Sleep Apnea.
• After meeting with your doctor or healthcare provider, you must then have an overnight sleep study performed in a sleep laboratory or through a special, in-home sleep test to establish a qualifying diagnosis of Obstructive Sleep Apnea.
• Your doctor or healthcare provider may then prescribe a CPAP to treat your obstructive sleep apnea.  Medicare will initially cover a three month trial of this equipment.  Medicare will also pay for replacement masks, tubing and other necessary supplies as prescribed by your doctor or healthcare provider.
• If during your sleep study (or during your trial period) the CPAP device is not working for you, or if you cannot tolerate the CPAP machine, your doctor or healthcare provider may prescribe a different device called a Bi-Level or a Respiratory Assist Device, and Medicare can consider this for coverage as well. 
• 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.  Per Medicare, a follow-up face-to-face visit with your physician or healthcare provider is required to document an improvement of your symptoms no sooner than 31 days and no later than 91 days from the set-up date.  Data is typically downloaded from your sleep equipment and must be provided to your doctor or healthcare provider during this follow-up visit to document that the machine has been used consistently for at least 4 hours per night on 70% of nights during a 30-day consecutive period.
• Talk with your supplier if you are having problems adjusting to the therapy or using the equipment every night.  There are a lot of variations that can make the therapy more comfortable for you.
• CPAPs and Bi-Levels are considered capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 of testing materials 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 of need.
  • If you test above these guidelines, you are required to be seen and evaluated by your physician or healthcare provider within six months prior to receiving your initial supplies from your supplier.
  • In addition, you must send your supplier evidence of compliant testing (e.g. a testing log or notes from your physician) every six months to continue getting refills at the higher levels.
• If at any time your testing frequency changes, your physician or healthcare provider will need to give your supplier a new prescription.
• Medicare began a namail orderl order program in July of 2013 that requires you to get your diabetic supplies through one of approximately 20, nationally contracted suppliers for all testing supplies delivered to your home.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier may not be able to deliver your glucometer to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Glasses

• Medicare covers one complete pair of glasses, after the last cataract surgery with intra-ocular lens replacement. The Medicare benefit includes a frame and two lenses.  As an alternative, a pair of contact lenses can be covered in lieu of glasses. 
• Medicare beneficiaries that have a condition called aphakia (patients who born without an intra-ocular lens, or who have had the lens removed and not replaced), Medicare will cover glasses, and/or contacts as often as is medically necessary.
• When specifically prescribed for a medical condition documented in your medical chart, Medicare may also cover tint, anti-reflective coating, and/or UV protection.

Hospital Beds**

• A hospital bed is covered if you have visited your doctor or healthcare provider and during an office visit your doctor or healthcare provider documents in your chart that one or more of the following criteria (1-4) are met:
  1. You have 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. You require positioning of the body in ways not feasible with an ordinary bed in order to alleviate pain, or
  3. You require 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. You require traction equipment which can only be attached to a hospital bed.
• Specialty beds that allow the height of the bed to be adjusted are covered if you require this feature to permit transfers to a chair, wheelchair or standing position.
• A semi-electric bed is covered if your medical condition requires frequent changes in body position and/or you have an immediate need for a change in body position.
• Heavy-duty/extra-wide beds can be covered if you weigh over 350 pounds.
• The total electric bed is not covered because it is considered a convenience feature. If you prefer to have the total electric feature, your supplier usually can apply the cost of the qualifying hospital bed toward the monthly rental price of the total electric model. You will need to sign an Advance Beneficiary Notice (ABN) and will be responsible to pay the difference in the retail charges between the two items every month.
• Hospital beds are a capped rental item, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Lymphedema Pumps

• Compression Pumps are not reimbursed by Medicare for the treatment of peripheral artery disease or the prevention of venous thrombosis (blood clots).
• Lymphedema Pumps are covered for treatment of true lymphedema as a result of:
  • Primary Lymphedema which is an inherited disorder that occurs on its own such as Milroy’s disease, congenital lymphedema due to lymphatic aplasia or hypoplasia, lymphedema praecox, lymphedema tarda, and similar disorders.  (This is a relatively uncommon, chronic condition), or
  • Secondary lymphedema which is much more common and results from the destruction of or damage to formerly functioning lymphatic channels that may result from:
    • radical surgical procedures with removal of regional groups of lymph nodes (for example, after radical mastectomy),
    • radiation therapy,
    • trauma
    • obstruction caused by tumors,
    • lymphatic filariasis (typically found in developing countries)
    • Chronic Venous Insufficiency (CVI) which results in compression produced by the leakage of fluids from the venous system in the lower extremities (legs and feet),
      • This condition also presents with hyperpigmentation, stasis dermatitis, chronic edema and venous ulcers. 
      • The incidence of lymphedema from CVI is not well established.
      • However, Medicare has established guidelines for CVI with one or more venous stasis ulcers.
  • When lymphedema extends into the chest, trunk or abdomen, a specialty pump can be considered.
  • Before you can be prescribed a pump, your physician or healthcare provider must monitor you during a minimum, four-week trial period for lymphedema and six week trial for CVI with ulcers. 
    • During the trial your doctor or healthcare provider must document the results of other treatment options including limb elevation, regular exercise, compression bandage systems or compression garments, dietary adjustments, and the use of diuretic and similar medications as applicable.
    • Your doctor or healthcare provider should document pre and post measurements in your chart notes as each conservative treatment is evaluated. 
    • If, during the trial there is any improvement using these other methods, Medicare will not approve a pump.
    • Medicare will only consider reimbursing for the pump when you have been unresponsive to the conservative treatment and there is no significant improvement over the required trial period (the most recent four or six weeks).
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this product to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

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

• All suppliers of Medicare-covered drugs are required to accept assignment on these items.
• Very few medications are covered under your Part B benefit.  Traditional Medicare Part B insurance will cover some nebulizer drugs, some infused drugs that require the use of 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**

• Medicare policy on mobility products requires that that Medicare funds are only used to pay for:
  • Mobility needs for daily activities within the home
  • The lowest level of equipment required to accomplish these tasks.
  • The most medically appropriate equipment (that meets your needs, not your wants)
• Medicare requires that your physician or healthcare provider and supplier evaluate your needs and expected use of the mobility product to determine which item 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 supplier 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).
• Your home must be evaluated to ensure it will accommodate the use of any mobility product.

• A face-to-face examination with your physician or healthcare provider to specifically discuss your mobility limitations and need for mobility is required prior to the initial setup of a power chair, scooter or manual wheelchair.
• In some cases for custom manual chairs and power mobility items you may also be asked to see a physical therapist or occupational therapist to determine the best fit and equipment selection.
• The majority of all manual and power wheelchairs are considered capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Nebulizers**

• Nebulizer machines, medications and related accessories are usually covered if you have obstructive pulmonary disease, but can also be covered to deliver specific medications if you have HIV, Cystic Fibrosis, bronchiectasis, pneumocystosis, complications of organ transplants, or for persistent thick or tenacious pulmonary secretions.
• You may obtain up to a three month’s supply of nebulizer medications and accessories at a time as long as you continue to regularly use the medications through your machine.
• If at any time you stop using your medications, please notify your supplier.
• Nebulizer machines are considered to be capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• When at home, you may receive up to a 3-month supply of nebulizer accessories at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Non-covered items (partial listing):

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

Orthopedic Shoes

• Orthopedic shoes are covered when it is necessary to attach the shoe(s) to a leg brace.
• Medicare will only pay for the shoe(s) attached to the leg brace(s).
• 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, or
  • urostomy
• You may obtain up to a three month’s supply of wafers, pouches, paste and other necessary items as needed.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

Oxygen**

• Your doctor or healthcare provider must start with an office visit to discuss your symptoms before ordering any testing.  If your symptoms are indicative of a chronic lung condition or other disease that requires long term oxygen therapy, Medicare will likely cover oxygen when the test results meet the coverage criteria outlined below.
• Oxygen is not covered for acute illnesses like pneumonia or for exacerbations of an underlying disease, because this is considered a temporary, acute or unstable condition. 
• Oxygen is covered if you have significant hypoxemia in a chronic stable state when:
  • You have a severe lung disease or hypoxemia that might be expected to improve with oxygen therapy, and
  • Your blood gas levels or oxygen saturation levels indicate the need for oxygen therapy, and
  • Your oxygen study was performed by a physician, qualified lab, other qualified provider and
  • Alternative treatments have been tried or deemed clinically ineffective.
• Categories/Groups of oxygen therapy are based on the test results to measure your oxygen.  There are two types of tests that can be used for this purpose.  An Arterial Blood Gas (ABG) test is an invasive procedure which provides detailed information and a direct measurement of oxygen in arterial blood (from an artery).  ABG test results are reported in millimeters of mercury (mmHg).  A saturation test (SAT) is a non-invasive procedure that indirectly measures oxygen saturation using a sensor typically placed on the ear or finger.  SAT test results are reported in percentages (%).
  • Group I Criteria: mmHG ≤ 55, or saturation ≤ 88%
    • For these results you must return to your physician or healthcare provider between 9-12 months after the initial visit to discuss whether your oxygen therapy should continue for lifetime or for a shorter period if the need is expected to end. Typically, you will not have to be retested when you return to your physician or healthcare provider for the follow-up visit.
  • Group II Criteria: 56-59 mmHg, or 89% saturation
    • For these results, you must return for another office visit with your physician or healthcare provider to discuss your oxygen therapy and for these borderline results you will also have to be retested within 3 months of the first test to continue therapy for lifetime or until the need is expected to end.
  • Group III Criteria: mmHg ≥ 60 or saturation ≥ 90% is considered to be not medically necessary.
• Note on nocturnal oxygen therapy:  If you only require the use of oxygen during the nighttime, your doctor should rule out obstructive sleep apnea as a cause for the hypoxemia symptoms you may be experiencing.  If obstructive sleep apnea is a potential factor, Medicare will not cover oxygen therapy until you have officially had the sleep apnea diagnosed and treated.  When obstructive sleep apnea is a factor, testing for oxygen can only begin after the apneas are controlled with appropriate positive airway therapy using a CPAP or Bi-PAP.  When obstructive sleep apnea is a factor, you can only be tested in a facility (not in your home).
• 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. However, if equipment is still necessary, your supplier will continue to provide the equipment to you for an additional 24 months. During this two year service period, Medicare will pay your supplier for refilling your oxygen cylinders (if you have gas or liquid systems) and for a semi-annual maintenance fee.
• After 60 months of service through Medicare your supplier is not obligated to continue service, but you may choose to receive new equipment and Medicare will begin paying for your equipment rental again.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Parenteral and Enteral therapy**

• Parenteral therapy requires all or part of the gastrointestinal tract to be missing. Nutritional formulas are delivered through a vein.
• Enteral therapy is covered if you 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.
• Specialty nutrition/formulations can be covered if you have unique nutrient needs or specific disease conditions which are well documented in your physician’s or healthcare provider’s records.  In most cases you may have to try standard formulas and document that they are unsuccessful before Medicare will consider the specialty nutrition.
• You must have nearly depleted the supplies on hand to be eligible for additional product.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Patient Lifts**

• A lift is covered if transfer between a bed and a chair, wheelchair, or commode requires the assistance of more than one person and, without the use of a lift, you 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 supplier can usually apply the cost of the manual lift toward the purchase price of the electric model. You will need to sign an Advance Beneficiary Notice (ABN) and would be responsible to pay the difference in the retail charges between the two items on a monthly basis.
• Patient lifts are considered to be capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider.  Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Seat Lift Mechanisms**

• In order for Medicare to pay for a seat lift mechanism, you must be suffering from severe arthritis of the hip or knee, or have a severe neuromuscular disease. In addition you must be completely incapable of standing up from any chair, but once standing can walk either independently or with the aid of a walker or cane. The physician or healthcare provider must believe that the mechanism will improve, slow down or stop the deterioration of your 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.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order. 
• Your supplier cannot deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider.  Your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Support Surfaces**

• Group 1 products are designed to be placed on the top of standard hospital bed or home mattresses. They can utilize gel, foam, water or air, and are covered if you are:
  • Completely immobile OR
  • Have limited mobility or 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 if you have 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 surgery for an ulcer on the trunk or pelvis within the last 60 days where you were immediately placed on Group 2 or 3 support surface prior to discharge from the hospital and you have been discharged within the last 30 days.
• A physician or healthcare provider must make monthly assessments as to whether continued use of the equipment is required.  Sometimes your physician or healthcare provider may order a home healthcare nurse to come visit you to make these assessments.
• Medicare will only pay for the rental of a Group 2 product until your ulcers completely heal.  If your ulcers have healed you must return the equipment to your supplier or make arrangements to pay for future monthly rentals privately using an Advance Beneficiary Notice (ABN) document.
• Group 3 products are air-fluidized beds and are only covered if you meet ALL of the following conditions:
  • A stage III or stage IV pressure ulcer, and
  • Are bedridden or chair bound as the result of limited mobility, and
  • In the absence of an air-fluidized bed would require institutionalization, and
  • An alternate course of conservative treatment has been tried for at least one month without improvement of the wound, and
  • All other alternative equipment has been considered and ruled out.
• A physician or healthcare provider must assess and evaluate you after completion of a course of conservative therapy within one month prior to ordering the Group 3 support surface.
• A trained adult caregiver must be available to assist you. Medicare does not cover the cost of hiring a caregiver, or for structural modifications to your home to accommodate this equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver these products to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 pain can be treated with a TENS unit. Medicare will not pay for the device or supplies when used to treat conditions where the units have been proven ineffective.  These include:
  • headaches,
  • visceral abdominal pain,
  • pelvic pain,
  • TMJ pain, and
  • lower back pain (except for individuals participating in an approved clinical trial)  
• For chronic pain sufferers that have had persistent pain for three or more months in duration, Medicare will pay for a one or two month trial rental to determine if this device will help or alleviate the chronic pain. You must return to your physician or healthcare provider 30-60 days after your initial evaluation to discuss how the therapy is working and 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 Medicare will deny as not medically necessary.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver this product to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 or pre-ulcerative calluses
  • peripheral neuropathy with callus formation
  • foot deformity
  • poor circulation in either foot
• You must have an office visit with your physician or healthcare provider within six months of receiving new shoes to discuss and document your diabetes management and why you need these special shoes.  This office visit must be repeated each time you wish to obtain replacement shoes.
• Only a physician treating your diabetes can certify your diabetic condition and complications that require specialty shoes. 
• Your healthcare practitioner or a podiatrist may further evaluate your feet and order the shoes.
• When providing you with shoes, your supplier must perform an in-person evaluation of your foot/feet, and they must verify that your shoes fit properly.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

Urological Supplies

• Urinary catheters and external urinary collection devices are covered to drain or collect urine if you have permanent urinary incontinence or permanent urinary retention. Permanent incontinence and retention are defined as a condition that is not expected to be medically or surgically corrected within 3 months.
• A maximum of six catheters may be used per day (up to 200 per month), unless it is determined that a higher number is medically necessary by your physician or healthcare provider, and these unique circumstances are specifically documented in your medical records.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

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 (you only have to pay money when you use the services), the Part B program requires a monthly premium to stay enrolled (even if you do not use the services). In 2018 that premium will be between $134 per month or higher depending on your income. Typically, this amount will be taken from your Social Security check.
• Medicare Part C is coverage offered through various insurance companies that offer Medicare Advantage Plans.  These plans are offered as an alternative to Medicare Part B.  Medicare Advantage Plans cover the same benefits as your Part B plan but often have limited provider networks and may require authorization for services prior to making payment. Premiums and deductibles vary by plan. Some plans offer perks like gym memberships as a participation benefit.
• Medicare Part D offers optional program benefits that cover prescription drugs.
• For more information about your benefits or making coverage decisions, you can visit the official website for Medicare benefits at www.medicare.gov.

What Can You Expect to Pay?

• In 2018, in addition to your monthly premium, you will have to pay the first $183 of covered expenses out-of-pocket for Part B services, and then 20 percent of all approved charges if the supplier agrees to accept Medicare payments.
• Unfortunately, your medical equipment supplier cannot automatically waive this 20 percent or your deductible without suffering penalties from Medicare. They 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 meet qualifying financial hardships established by your supplier.
• 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 supplier 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 supplier 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 supplier 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 you to upgrade to a piece of equipment that you like better than the other standard option you may otherwise qualify for.  This form is known as the Advance Beneficiary Notice or ABN.
• The ABN form that your supplier completes for you must detail how the products differ and require a signature to indicate that you agree to pay the difference in the retail costs between two similar items. Your supplier 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 of Non-Coverage will also 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), Orthotics and Prosthetics 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 (which 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 (which excludes any item that is 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)
• An orthotic simply put is a brace. Covered Braces are defined as rigid or semi-rigid devices that are used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body. There are many products that fall into this category including knee braces, ankle and foot braces (such as walking boots) and back braces just to name a few.
• A prosthesis is a device that is intended to replace all or part of an internal body organ or to replace all or part of the function of a permanently immobile or malfunctioning internal body part.  There are a number of items that fall within the prosthetic category including artificial arms and legs, breast prostheses, eye prostheses, parenteral and enteral nutrition, and ostomy supplies. Glasses and contacts for patients with aphakia or pseudophakia are also covered under this category.

Understanding Assignment (a claim-by-claim contract)

• When a supplier accepts 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 $183 in 2018.
• If you have chosen to receive an upgraded, fancier product than what Medicare typically covers, you will also be responsible for any additional amounts disclosed on the Advance Beneficiary Notice that identifies the additional features and fees that you have approved.
• If a supplier does not accept assignment with Medicare, you will be responsible for paying the full amount upfront. The supplier will still file a claim on your behalf and any reimbursement made by Medicare will be paid to you directly. (Suppliers must still notify you in advance, using the Advance Beneficiary Notice, when they do not believe Medicare will pay for your claim.)

Mandatory Submission of Claims

• Every supplier is required to submit a claim for covered services within one year from the date of service. However, if the item is never covered by Medicare, your supplier is not obligated to submit a claim.

The role of the physician with respect to home medical equipment, prosthetics and orthotics:

• 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 such as copies of office visit notes from prior visits with your physician or healthcare provider or copies of test results relevant to the prescription of your medical equipment.
• Nurse Practitioners, Physician Assistants, Interns, Residents and Clinical Nurse Specialists can also order medical equipment and sign CMNs when they are treating you.
• All physicians and healthcare providers have the right to refuse to complete documentation for equipment they did not order, so make sure you consult with your physician or healthcare provider about your need for medical equipment or supplies before requesting an item from a supplier.
• For every new item prescribed by your physician or healthcare provider, you should have a recent office visit that documents the reasons for ordering the equipment and products.  Most items require you to have an in-person office visit with your doctor or healthcare provider to discuss the need and justification for the prescription of medical equipment (and even replacement equipment) before a supplier can fill those orders.

Prescriptions before Delivery:

• The list of items that require an office visit and written order before delivery has been expanded due to new provisions of the Affordable Care Act to include all items that cost more than $1000, and commonly prescribed items such as oxygen, hospital beds, wheelchairs and more. There are over 150 products across multiple product categories that are affected.   Your supplier will be able to tell you if the item ordered by your doctor or healthcare provider is subject to these additional requirements.
• Your supplier cannot deliver these products to you without a compliant written order from your doctor or healthcare provider. They cannot provide services and get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• At this time Prosthetic and Orthotic items are not subject to the Face-to-Face rule that mandates a detailed written order prior to delivery, however, every item does require a detailed written order from your doctor or healthcare provider prior to billing.

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 (generally orthotic and prosthetic items are purchased),
   • 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 and accessories.
     • Beyond the 36 months (for a period of two additional years), Medicare will limit payments to a small fee for monthly gas or liquid contents, where applicable, and a limited service fee to check the equipment every six months.
2. After an item has been purchased for you, you will be responsible for calling your supplier anytime 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.

What is competitive bidding?

In many parts of the country, a new program called Competitive Bidding will require you to obtain certain medical equipment, product, and supplies from specific, Medicare-contracted suppliers in order for Medicare to pay. Not all products are subject to competitive bidding in the same area.  If you are located in a city where the program is in effect, you will need to obtain some or all of the following items from a contracted supplier:

• Oxygen, oxygen equipment, and supplies
• Standard power wheelchairs, scooters, and related accessories
• Enteral nutrition, 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 1 and Group 2 mattresses and overlays)
• Manual Wheelchairs and accessories
• Mail-order and local home delivery of diabetic supplies
• Nebulizers
• Home infusion therapy including insulin pumps and supplies
• TENS Units and supplies
• Patient Lifts
• Commodes
• Seat Lift Chairs
• Negative Pressure Wound Therapy Devices and related supplies and accessories

Competitive Bidding areas are designated based on the zip code of your permanent residence on file with Social Security. To find out if your zip code is affected by Competitive Bidding, call 1-800-MEDICARE (1-800-4227). You may also visit Medicare.gov and lookup suppliers in your area by zip code (a notice will appear in your area is subject to Competitive Bidding). If a product or item is marked with a yellow/orange star, it will need to be provided by a contracted supplier (also marked with an orange star).  Throughout this guide, products that are potentially impacted by the competitive bidding program will be designated with a double asterisk **.  Your provider can assist you with answering your questions about competitive bidding and can address whether or not they have been contracted to provide the services you need if subject to competitive bid.

Medicare Coverage for Prosthetics and Orthotics

Prosthetics:

Additional Prostheses other than those listed below may be covered by Medicare. Talk to your supplier for specific details or questions regarding those items.

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.
  • As an alternative, Medicare can cover a nipple prosthesis every three months.
  • Mastectomy bras are covered as needed, but not on an automatic basis.
• 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)
• You are allowed only one prosthesis per affected side, others will be denied as not medically necessary even if attempting asymmetry (an Advance Beneficiary Notice 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 prosthesis; however, it is possible that they may be covered under the hospital per diem if you request one during your hospital stay.
• A mastectomy bra is covered if the pocket of the bra is used to hold a covered prosthesis or mastectomy form.

Eye Prostheses

• Eye prostheses are covered by Medicare if you have an absence or shrinkage of an eye due to birth defect, trauma or surgical removal.
• Medicare will also cover polishing and resurfacing of the prosthesis twice annually.
• Medicare will cover a one-time enlargement or reduction of your prosthesis when medically necessary.  Speak with your physician or healthcare provider if there is a medical need to have your prosthesis resized beyond the one time allowance.
• Your prosthesis may be eligible for replacement after five years under the Medicare benefit, talk with your supplier for details
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider, nor can they get the documentation at a later date because if they do, Medicare cannot make payment for those products to you or your supplier.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

Facial Prostheses

• Facial prostheses are covered by Medicare if you have a loss or absence of facial tissue due to disease, trauma, surgery or birth defect.
• Facial prostheses can replace all or part of the face and can include:
  • Nasal prosthesis – removable superficial prosthesis which restores all or part of the nose and may include the nasal septum.
  • Mid-facial prosthesis – removable superficial prosthesis which restores part or all of the nose and significant adjacent facial tissue/structures, but does not include the eye orbit or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek, upper lip, or forehead.
  • Orbital prosthesis - removable superficial prosthesis, which restores the eyelids and the hard and soft tissue of the orbit. It may also include the eyebrow.
  • Upper facial prosthesis - removable superficial prosthesis, which restores the orbit and significant adjacent facial tissue/structures, but does not include the nose or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek or forehead. This code does not include the eye prosthesis. 
  • Hemi-facial prosthesis - removable superficial prosthesis, which restores part or all of the nose and the orbit plus significant adjacent facial tissue/structures, but does not include any intraoral maxillary component. This code does not include the eye prosthesis.
  • Auricular prosthesis - removable superficial prosthesis, which restores all or part of the ear.
  • Partial facial prosthesis - removable superficial prosthesis which restores a portion of the face but does not specifically involve the nose, orbit, or ear.
  • Nasal septal prosthesis - removable prosthesis, which occludes a hole in the nasal septum but does not include superficial nasal tissue.
• Medicare will not cover skin care products that are related to the use of the prosthesis including cosmetics, skin cream, cleansers, etc.
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider, nor can they get the documentation at a later date because if they do, Medicare cannot make payment for those products to you or your supplier.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• Your physician and prosthetist will best determine the type of prosthesis that is necessary for your condition. If you would prefer a prosthesis that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the item that you want.

Glasses

• Medicare covers one complete pair of glasses, after the last cataract surgery with intra-ocular lens replacement. The Medicare benefit includes a frame and two lenses.  As an alternative, a pair of contact lenses can be covered in lieu of glasses.
• Medicare beneficiaries that have a condition called aphakia (patients who are born without an intraocular lens, or who have had the lens removed and not replaced), are eligible for glasses, and/or contacts as often as is medically necessary.
• When specifically prescribed for a medical condition documented in your medical chart, Medicare may also cover additional medically necessary features such as tint, anti-reflective coating, and/or UV.

Lower Limb Prostheses

• Lower Limb Prostheses include those designed to replace feet, knees, ankles, hips or sockets and are covered when:
  • You will reach or maintain a desired functional state within a reasonable time frame; and
  • You are motivated to walk.
• Medicare coverage is considered based on an assessment of your potential functional abilities as determined by your physician and prosthetist. To determine your functional level, your physician and prosthetist will consider:
  • Your past history (including the use of prior prostheses, if applicable),
  • Your current condition including the status of the residual limb, as well as any other medical problems you may have, and
  • Your desire to walk.
• Lower Limb Prostheses can be custom fabricated for you or provided off the shelf and custom fitted to address your individual needs. Custom fabricated items are created specifically to suit your individual needs and tend to be more expensive. Off the shelf prostheses can be bought “as is” and then customized for an individual fit. 
• Your physician and prosthetist will best determine the type of prosthesis that is necessary for your condition. If you would prefer a prosthesis that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the item that you want.

Non-covered items (partial listing)

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

Ostomy Supplies

• Ostomy supplies are covered for people with a:
  • colostomy,
  • ileostomy, or
  • urostomy
• You may obtain up to a three month’s supply of wafers, pouches, paste and other necessary items as needed.
• You must have nearly depleted the supplies on hand to be eligible for additional product.

Parenteral and Enteral Therapy**

• Parenteral therapy requires all or part of the gastrointestinal tract to be missing. Nutritional formulas are delivered through a vein.
• Enteral therapy is covered if you 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.
• Specialty nutrition/formulas can be covered if you have unique nutritional needs or specific disease conditions which are well documented in your physician’s or healthcare provider’s records.  In most cases, you may have to try standard formulas and document that they are unsuccessful before Medicare will consider the specialty nutrition.
• You must have nearly depleted the supplies on hand to be eligible for additional product.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 or pre-ulcerative calluses
  • peripheral neuropathy with callus formation
  • foot deformity
  • poor circulation in either foot
• You must have an office visit with your physician or healthcare provider within six months of receiving new shoes to discuss and document your diabetes management and why you need these special shoes.  This office visit must be repeated each time you wish to obtain replacement shoes.
• Only a physician treating your diabetes can certify your diabetic condition and complications that require specialty shoes. 
• Your healthcare practitioner or a podiatrist may further evaluate your feet and order the shoes.
• When providing you with shoes, your supplier must perform an in-person evaluation of your foot/feet, and they must verify that your shoes fit properly.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

Urological Supplies

• Urinary catheters and external urinary collection devices are covered to drain or collect urine if you have permanent urinary incontinence or permanent urinary retention. Permanent incontinence and retention are defined as a condition that is not expected to be medically or surgically corrected within 3 months.
• A maximum of six catheters may be used per day (up to 200 per month), unless it is determined that a higher number is medically necessary by your physician or healthcare provider, and these unique circumstances are specifically documented in your medical records.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

Vacuum Erection Devices (VEDs)

• Vacuum Erection Devices (VEDs) are no longer covered by Medicare for the treatment of erectile dysfunction.
• As of July 1, 2015, the Achieving a Better Life Experience (ABLE) Act of 2014 mandated that Medicare discontinue coverage of these devices to mirror the non-coverage policies of the Medicare Part D program for erectile medication.

Orthotics:

Ankle-Foot Orthoses (Braces)

• Ankle-Foot Braces are covered for patients that:
  • are able to walk,
  • need the ankle or foot to be stabilized due to a weakness or deformity, and
  • have the potential to benefit functionally from the use of the brace to do more than could be accomplished without a brace.
• In order for Medicare to cover an ankle-foot brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine your need for the brace.
• Ankle-Foot Braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.
• Not all products that fall within this category are eligible for Medicare payment. For an Ankle-Foot Brace to be covered by Medicare, the condition/injury must also qualify. Medicare does not pay for braces used primarily for comfort or prevention purposes.
•  Your physician will best determine the type of brace that is necessary to treat your condition.  If you would prefer a brace that has features above and beyond what you medically need, (such as warmth, circulation support, additional comfort features, etc.) you may be asked to complete an Advanced Beneficiary Notice and pay out of pocket for the brace that you want.

Arm Supports and Slings

• Arm Support and Slings are generally made of cloth-like material and therefore do not meet the definition of a brace. These items are not payable under the Durable Medical Equipment benefit of your Medicare policy.  However, these items are billable by your physician when incident to an office visit and likely can be obtained directly from your physician.

Clavicle/Shoulder Orthoses (Braces)

• Clavicle/Shoulder braces are covered for patients that need:
  • stabilization of the clavicle or shoulder because of a weakness or deformity,
  • to restrict movement of the clavicle or shoulder due to injury or disease, or
  • to limit movement during recovery from a surgical procedure on the clavicle or shoulder.
• In order for Medicare to cover a clavicle/shoulder brace, you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit from its use. 
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Clavicle/Shoulder braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Elbow Orthoses (Braces)

• Elbow braces are covered for patients that need:
  • Stabilization of the elbow because of a weakness or deformity,
  • To restrict movement of the elbow joint due to an injury or disease, or
  • to limit movement during recovery from a surgical procedure on the elbow.
• In order for Medicare to cover an elbow brace, you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit from its use. 
• Elbow braces can be very basic or have additional features. Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Elbow braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Knee Orthoses (Braces)

• Knee braces are covered for patients that:
  • are able to walk;
  • require the knee to be stabilized because of a weakness or deformity of the knee,
  • had a recent injury to the knee, or
  • had a recent surgical procedure on the knee such as a knee joint replacement.
• In order for Medicare to cover payment for a knee brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine your need for the brace.
• Knee braces can be very basic or have additional features such as Velcro straps, flexible support joints or additional padding for comfort.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Knee braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.
• Knee braces should be expected to last 1-2 years, depending on the type of brace being prescribed.

Knee-Ankle-Foot Orthoses (Braces)

• Knee-Ankle-Foot Braces are covered for patients that:
  • are able to walk,
  • have a weakness or deformity of the foot and ankle and need additional stability for the knee, and
  • have the potential to benefit functionally from the use of the brace.
• In order for Medicare to provide payment for a Knee-Ankle-Foot brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine your need for the brace.
• Knee-Ankle-Foot Braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.
• Not all products that fall within this category are eligible for Medicare payment. For a Knee- Ankle-Foot Brace to be covered by Medicare the condition it is being used to treat must qualify.
• Your physician will best determine the type of brace that is necessary to treat your condition.  If you would prefer a brace that has features above and beyond what you medically need, (such as warmth, circulation support, additional comfort features, etc.) you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.

Cervical  Orthoses (Neck Braces)

• Neck braces are covered for patients that need:
  • stabilization because of a weakness or deformity of the neck,
  • to restrict movement of the neck due to an injury or disease, or
  • to limit movement during recovery from a surgical procedure on the neck.
• In order for Medicare to cover payment for a neck brace you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit functionally from its use.  
• Neck braces can be very basic or have additional features.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Neck braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Orthopedic Shoes

• Orthopedic shoes are covered when it is necessary to attach the shoe(s) to a leg brace.
• Medicare will only pay for the shoe(s) attached to the leg brace(s).
• Medicare will not pay for matching shoes or for shoes that are needed for purposes other than diabetes or leg braces.

Spinal Orthoses (Back Braces)

• Back braces are covered:
  • When it is medically necessary to reduce pain by restricting upper body movement, or
  • to aid in the healing process after injury or a surgical procedure, or
  • to support weak, spinal muscles or a deformed spine
• In order for Medicare to provide payment for a Back brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit functionally from its use.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• In order for a back brace to be payable by Medicare it must be made primarily of non-elastic material such as canvas, cotton, nylon etc. or have a rigid posterior panel.
• Back braces that are primarily made of elastic material will not be covered under the Medicare program. These items do not meet the definition of a brace as they are not rigid or semi-rigid and Medicare will not pay for these braces.

Wrist and Forearm Orthoses (Braces)

• Wrist and Forearm braces are covered for patients that need:
  • stabilization of the wrist or forearm because of a weakness or deformity,
  • to restrict movement of the wrist or forearm due to an injury or disease, or
  • to limit movement during recovery from a surgical procedure on the wrist or forearm  (such as a joint replacement).
• In order for Medicare to cover payment for a wrist or forearm brace, you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit functionally from its use.
• Wrist or forearm braces can be very basic or have additional features.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Wrist and forearm braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Medicare Supplier Standards

Below is a summary of the standards Medicare requires of home medical equipment suppliers. 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 and cannot contract with an individual or entity to provide licensed services.

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. This standard requires that the location is accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.

8. A supplier must permit CMS, 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, answering service or cell phone during posted business hours 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 contacting a Medicare beneficiary based on a physician’s oral order unless an exception applies.

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 any information required by the Medicare statute and implementing regulations.

22. All suppliers 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 of those specific products and services (except for certain exempt pharmaceuticals).

23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.

24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare.

25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.

26. Must meet the surety bond requirements specified in 42 C.F.R. 424.57(c).

27. A supplier must obtain oxygen from a state- licensed oxygen supplier.

28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 C.F.R. 424.516(f).

29. DMEPOS suppliers are prohibited from sharing a practice location with certain other Medicare providers and suppliers.

DMEPOS suppliers must remain open to the public for a minimum of 30 hours per week with certain exceptions.

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 (you only have to pay money when you use the services), the Part B program requires a monthly premium to stay enrolled (even if you do not use the services). In 2018 that premium will be $134 per month or higher depending on your income. Typically, this amount will be taken from your Social Security check.
• Medicare Part C is coverage offered through various insurance companies that offer Medicare Advantage Plans.  These plans are offered as an alternative to Medicare Part B.  Medicare Advantage Plans cover the same benefits as your Part B plan but often have limited provider networks and may require authorization for services prior to making payment. Premiums and deductibles vary by plan. Some plans offer perks like gym memberships as a participation benefit.
• Medicare Part D offers optional program benefits that cover prescription drugs.
• For more information about your benefits or making coverage decisions, you can visit the official website for Medicare benefits at www.medicare.gov.

What Can You Expect to Pay for Medicare Part B Services?

• In 2018, in addition to your monthly premium, you will have to pay the first $183 of covered expenses out-of-pocket for Part B services, and then 20 percent of all approved charges if the supplier agrees to accept Medicare payments.
• Unfortunately, your medical equipment supplier cannot automatically waive this 20 percent or your deductible without suffering penalties from Medicare. They 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 meet qualifying financial hardships established by your supplier.
• 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 supplier 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 supplier 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 supplier 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 you to upgrade to a piece of equipment that you like better than the other standard option you may otherwise qualify for.  This form is known as the Advance Beneficiary Notice or ABN.
• The ABN form that your supplier completes for you 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 supplier 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 of Non Coverage will also 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 (which 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 (which excludes any item that is 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 a supplier accepts 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 $183 for 2018.
• If you have chosen to receive an upgraded, fancier product than what Medicare typically covers, you will also be responsible for any additional amounts disclosed on the Advance Beneficiary Notice that identifies the additional features and fees that you have approved.
• If a supplier does not accept assignment with Medicare, you will be responsible for paying the full amount upfront. The supplier will still file a claim on your behalf and any reimbursement made by Medicare will be paid to you directly. (Suppliers must still notify you in advance, using the Advance Beneficiary Notice, when they do not believe Medicare will pay for your claim.)

Mandatory Submission of Claims

• Every supplier is required to submit a claim for covered services within one year from the date of service. However if the item is never covered by Medicare, your supplier is not obligated to submit a claim.

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 such as copies of office visit notes from prior visits with your physician or healthcare provider or copies of test results relevant to the prescription of your medical equipment.
• Nurse Practitioners, Physician Assistants, Interns, Residents and Clinical Nurse Specialists can also order medical equipment and sign CMNs when they are treating you.
• All physicians and healthcare providers have the right to refuse to complete documentation for equipment they did not order, so make sure you consult with your physician or healthcare provider about your need for medical equipment or supplies before requesting an item from a supplier.
• For every new item prescribed by your physician or healthcare provider, you should have a recent office visit that documents the reasons for ordering the equipment and products.  Most items require you to have an in-person office visit with your doctor or healthcare provider to discuss the need and justification for the prescription of medical equipment (and even replacement equipment) before a supplier can fill those orders.

Prescriptions before Delivery:

• For some items, Medicare requires your supplier to have completed documentation (which is more than just a call-in order or a prescription from your doctor or healthcare provider) before they can deliver these items to you:
  • Decubitus care (wheelchair cushions, pressure-relieving surfaces placed on a hospital bed and air-fluidized beds)
  • Seat lift mechanisms
  • TENS Units (for pain management)
  • Power Operated Vehicles/Scooters
  • Electric or Power Wheelchairs and related options and accessories
  • Negative Pressure Wound Therapy (wound vacs)
• The list of items that require an office visit and written order before delivery has been expanded due to new provisions of the Affordable Care Act to include all items that cost more than $1000, and commonly prescribed items such as oxygen, hospital beds, wheelchairs and more. There are over 150 products across multiple product categories that are affected.   Your supplier will be able to tell you if the item ordered by your doctor or healthcare provider is subject to these additional requirements.
• Your supplier cannot deliver these products to you without a compliant written order from your doctor or healthcare provider. They cannot provide services and get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

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 and accessories.
     • Beyond the 36 months (for a period of two additional years), Medicare will limit payments to a small fee for monthly gas or liquid contents, where applicable, and a limited service fee to check the equipment every six months.
2. After an item has been purchased for you, you will be responsible for calling your supplier anytime 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.

What is competitive bidding?

In many parts of the country, a new program called Competitive Bidding will require you to obtain certain medical equipment from specific, Medicare-contracted suppliers in order for Medicare to pay. Not all products are subject to competitive bidding in the same area.  If you are located in a city where the program is in effect, you will need to obtain some or all of the following items from a contracted supplier:

• Oxygen, oxygen equipment, and supplies
• Standard power wheelchairs, scooters, and related accessories
• Enteral nutrition, 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 1 and Group 2 mattresses and overlays)
• Manual Wheelchairs and accessories
• Mail-order and local home delivery of diabetic supplies
• Nebulizers
• Home infusion therapy including insulin pumps and supplies
• TENS Units and supplies
• Patient Lifts
• Commodes
• Seat Lift Chairs
• Negative Pressure Wound Therapy Devices and related supplies and accessories

Competitive Bidding areas are designated based on the zip code of your permanent residence on file with Social Security. To find out if your zip code is affected by Competitive Bidding, call 1-800-MEDICARE (1-800-4227). You may also visit Medicare.gov and lookup suppliers in your area by zip code (a notice will appear if your area is subject to Competitive Bidding). If medical equipment is marked with a yellow/orange star, it will need to be provided by a contracted supplier (also marked with an orange star).  Throughout this guide, products that are potentially impacted by the competitive bidding program will be designated with a double asterisk **.  Your provider can assist you with answering your questions about competitive bidding and can address whether or not they have been contracted to provide the services you need if subject to competitive bid.

Medicare Coverage for Prosthetics and Orthotics

Prosthetics:

Additional Prostheses other than those listed below may be covered by Medicare. Talk to your supplier for specific details or questions regarding those items.

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.
  • As an alternative, Medicare can cover a nipple prosthesis every three months.
  • Mastectomy bras are covered as needed, but not on an automatic basis.
• 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)
• You are allowed only one prosthesis per affected side, others will be denied as not medically necessary even if attempting asymmetry (an Advance Beneficiary Notice 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 prosthesis; however, it is possible that they may be covered under the hospital per diem if you request one during your hospital stay.
• A mastectomy bra is covered if the pocket of the bra is used to hold a covered prosthesis or mastectomy form.

Eye Prostheses

• Eye prostheses are covered by Medicare if you have an absence or shrinkage of an eye due to birth defect, trauma or surgical removal.
• Medicare will also cover polishing and resurfacing of the prosthesis twice annually.
• Medicare will cover a one-time enlargement or reduction of your prosthesis when medically necessary.  Speak with your physician or healthcare provider if there is a medical need to have your prosthesis resized beyond the one time allowance.
• Your prosthesis may be eligible for replacement after five years under the Medicare benefit, talk with your supplier for details
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider, nor can they get the documentation at a later date because if they do, Medicare cannot make payment for those products to you or your supplier.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

Facial Prostheses

• Facial prostheses are covered by Medicare if you have a loss or absence of facial tissue due to disease, trauma, surgery or birth defect.
• Facial prostheses can replace all or part of the face and can include:
  • Nasal prosthesis – removable superficial prosthesis which restores all or part of the nose and may include the nasal septum.
  • Mid-facial prosthesis – removable superficial prosthesis which restores part or all of the nose and significant adjacent facial tissue/structures, but does not include the eye orbit or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek, upper lip, or forehead.
  • Orbital prosthesis - removable superficial prosthesis, which restores the eyelids and the hard and soft tissue of the orbit. It may also include the eyebrow.
  • Upper facial prosthesis - removable superficial prosthesis, which restores the orbit and significant adjacent facial tissue/structures, but does not include the nose or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek or forehead. This code does not include the eye prosthesis. 
  • Hemi-facial prosthesis - removable superficial prosthesis, which restores part or all of the nose and the orbit plus significant adjacent facial tissue/structures, but does not include any intraoral maxillary component. This code does not include the eye prosthesis.
  • Auricular prosthesis - removable superficial prosthesis, which restores all or part of the ear.
  • Partial facial prosthesis - removable superficial prosthesis which restores a portion of the face but does not specifically involve the nose, orbit, or ear.
  • Nasal septal prosthesis - removable prosthesis, which occludes a hole in the nasal septum but does not include superficial nasal tissue.
• Medicare will not cover skin care products that are related to the use of the prosthesis including cosmetics, skin cream, cleansers, etc.
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider, nor can they get the documentation at a later date because if they do, Medicare cannot make payment for those products to you or your supplier.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• Your physician and prosthetist will best determine the type of prosthesis that is necessary for your condition. If you would prefer a prosthesis that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the item that you want.

Glasses

• Medicare covers one complete pair of glasses, after the last cataract surgery with intra-ocular lens replacement. The Medicare benefit includes a frame and two lenses.  As an alternative, a pair of contact lenses can be covered in lieu of glasses.
• Medicare beneficiaries that have a condition called aphakia (patients who are born without an intra-ocular lens, or who have had the lens removed and not replaced), are eligible for glasses, and/or contacts as often as is medically necessary.
• When specifically prescribed for a medical condition documented in your medical chart, Medicare may also cover additional medically necessary features such as tint, anti-reflective coating, and/or UV.

Lower Limb Prostheses

• Lower Limb Prostheses include those designed to replace feet, knees, ankles, hips or sockets and are covered when:
  • You will reach or maintain a desired functional state within a reasonable time frame; and
  • You are motivated to walk.
• Medicare coverage is considered based on assessment of your potential functional abilities as determined by your physician and prosthetist. To determine your functional level, your physician and prosthetist will consider:
  • Your past history (including the use of prior prostheses, if applicable),
  • Your current condition including the status of the residual limb, as well as any other medical problems you may have, and
  • Your desire to walk.
• Lower Limb Prostheses can be custom fabricated for you or provided off the shelf and custom fitted to address your individual needs. Custom fabricated items are created specifically to suit your individual needs and tend to be more expensive. Off the shelf prostheses can be bought “as is” and then customized for an individual fit. 
• Your physician and prosthetist will best determine the type of prosthesis that is necessary for your condition. If you would prefer a prosthesis that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the item that you want.

Non-covered items (partial listing)

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

Ostomy Supplies

• Ostomy supplies are covered for people with a:
  • colostomy,
  • ileostomy, or
  • urostomy
• You may obtain up to a three month’s supply of wafers, pouches, paste and other necessary items as needed.
• You must have nearly depleted the supplies on hand to be eligible for additional product.

Parenteral and Enteral Therapy**

• Parenteral therapy requires all or part of the gastrointestinal tract to be missing. Nutritional formulas are delivered through a vein.
• Enteral therapy is covered if you 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.
• Specialty nutrition/formulas can be covered if you have unique nutritional needs or specific disease conditions which are well documented in your physician’s or healthcare provider’s records.  In most cases, you may have to try standard formulas and document that they are unsuccessful before Medicare will consider the specialty nutrition.
• You must have nearly depleted the supplies on hand to be eligible for additional product.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 or pre-ulcerative calluses
  • peripheral neuropathy with callus formation
  • foot deformity
  • poor circulation in either foot
• You must have an office visit with your physician or healthcare provider within six months of receiving new shoes to discuss and document your diabetes management and why you need these special shoes.  This office visit must be repeated each time you wish to obtain replacement shoes.
• Only a physician treating your diabetes can certify your diabetic condition and complications that require specialty shoes. 
• Your healthcare practitioner or a podiatrist may further evaluate your feet and order the shoes.
• When providing you with shoes, your supplier must perform an in-person evaluation of your foot/feet, and they must verify that your shoes fit properly.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

Urological Supplies

• Urinary catheters and external urinary collection devices are covered to drain or collect urine if you have permanent urinary incontinence or permanent urinary retention. Permanent incontinence and retention are defined as a condition that is not expected to be medically or surgically corrected within 3 months.
• A maximum of six catheters may be used per day (up to 200 per month), unless it is determined that a higher number is medically necessary by your physician or healthcare provider, and these unique circumstances are specifically documented in your medical records.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

Vacuum Erection Devices (VEDs)

• Vacuum Erection Devices (VEDs) are no longer covered by Medicare for the treatment of erectile dysfunction.
• As of July 1, 2015, the Achieving a Better Life Experience (ABLE) Act of 2014 mandated that Medicare discontinue coverage of these devices to mirror the non-coverage policies of the Medicare Part D program for erectile medication.

Orthotics:

Ankle-Foot Orthoses (Braces)

• Ankle-Foot Braces are covered for patients that:
  • are able to walk,
  • need the ankle or foot to be stabilized due to a weakness or deformity, and
  • have the potential to benefit functionally from the use of the brace to do more than could be accomplished without a brace.
• In order for Medicare to cover an ankle-foot brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine your need for the brace.
• Ankle-Foot Braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.
• Not all products that fall within this category are eligible for Medicare payment. For an Ankle-Foot Brace to be covered by Medicare, the condition/injury must also qualify. Medicare does not pay for braces used primarily for comfort or prevention purposes.
•  Your physician will best determine the type of brace that is necessary to treat your condition.  If you would prefer a brace that has features above and beyond what you medically need, (such as warmth, circulation support, additional comfort features, etc.) you may be asked to complete an Advanced Beneficiary Notice and pay out of pocket for the brace that you want.

Arm Supports and Slings

• Arm Support and Slings are generally made of cloth-like material and therefore do not meet the definition of a brace. These items are not payable under the Durable Medical Equipment benefit of your Medicare policy.  However, these items are billable by your physician when incident to an office visit and likely can be obtained directly from your physician.

Clavicle/Shoulder Orthoses (Braces)

• Clavicle/Shoulder braces are covered for patients that need:
  • stabilization of the clavicle or shoulder because of a weakness or deformity,
  • to restrict movement of the clavicle or shoulder due to injury or disease, or
  • to limit movement during recovery from a surgical procedure on the clavicle or shoulder.
• In order for Medicare to cover a clavicle/shoulder brace, you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit from its use. 
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Clavicle/Shoulder braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Elbow Orthoses (Braces)

• Elbow braces are covered for patients that need:
  • Stabilization of the elbow because of a weakness or deformity,
  • To restrict movement of the elbow joint due to an injury or disease, or
  • to limit movement during recovery from a surgical procedure on the elbow.
• In order for Medicare to cover an elbow brace, you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit from its use. 
• Elbow braces can be very basic or have additional features. Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Elbow braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Knee Orthoses (Braces)

• Knee braces are covered for patients that:
  • are able to walk;
  • require the knee to be stabilized because of a weakness or deformity of the knee,
  • had a recent injury to the knee, or
  • had a recent surgical procedure on the knee such as a knee joint replacement.
• In order for Medicare to cover payment for a knee brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine your need for the brace.
• Knee braces can be very basic or have additional features such as Velcro straps, flexible support joints or additional padding for comfort.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Knee braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.
• Knee braces should be expected to last 1-2 years, depending on the type of brace being prescribed.

Knee-Ankle-Foot Orthoses (Braces)

• Knee-Ankle-Foot Braces are covered for patients that:
  • are able to walk,
  • have a weakness or deformity of the foot and ankle and need additional stability for the knee, and
  • have the potential to benefit functionally from the use of the brace.
• In order for Medicare to provide payment for a Knee-Ankle-Foot brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine your need for the brace.
• Knee-Ankle-Foot Braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.
• Not all products that fall within this category are eligible for Medicare payment. For a Knee- Ankle-Foot Brace to be covered by Medicare the condition it is being used to treat must qualify.
• Your physician will best determine the type of brace that is necessary to treat your condition.  If you would prefer a brace that has features above and beyond what you medically need, (such as warmth, circulation support, additional comfort features, etc.) you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.

Cervical  Orthoses (Neck Braces)

• Neck braces are covered for patients that need:
  • stabilization because of a weakness or deformity of the neck,
  • to restrict movement of the neck due to an injury or disease, or
  • to limit movement during recovery from a surgical procedure on the neck.
• In order for Medicare to cover payment for a neck brace you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit functionally from its use.  
• Neck braces can be very basic or have additional features.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Neck braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Orthopedic Shoes

• Orthopedic shoes are covered when it is necessary to attach the shoe(s) to a leg brace.
• Medicare will only pay for the shoe(s) attached to the leg brace(s).
• Medicare will not pay for matching shoes or for shoes that are needed for purposes other than diabetes or leg braces.

Spinal Orthoses (Back Braces)

• Back braces are covered:
  • When it is medically necessary to reduce pain by restricting upper body movement, or
  • to aid in the healing process after injury or a surgical procedure, or
  • to support weak, spinal muscles or a deformed spine
• In order for Medicare to provide payment for a Back brace, you must have one of the above conditions and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit functionally from its use.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• In order for a back brace to be payable by Medicare it must be made primarily of non-elastic material such as canvas, cotton, nylon etc. or have a rigid posterior panel.
• Back braces that are primarily made of elastic material will not be covered under the Medicare program. These items do not meet the definition of a brace as they are not rigid or semi-rigid and Medicare will not pay for these braces.

Wrist and Forearm Orthoses (Braces)

• Wrist and Forearm braces are covered for patients that need:
  • stabilization of the wrist or forearm because of a weakness or deformity,
  • to restrict movement of the wrist or forearm due to an injury or disease, or
  • to limit movement during recovery from a surgical procedure on the wrist or forearm  (such as a joint replacement).
• In order for Medicare to cover payment for a wrist or forearm brace, you must meet one of the above criteria and also have undergone a face-to-face visit with your physician to examine and document your need for the brace and your ability to benefit functionally from its use.
• Wrist or forearm braces can be very basic or have additional features.
• Your physician will best determine the type of brace that is necessary to treat your condition. If you would prefer a brace that has features above and beyond what you medically need, you may be asked to complete an Advanced Beneficiary Notice and pay out-of-pocket for the brace that you want.
• Wrist and forearm braces can be Custom Fitted or provided Off-the-Shelf.
  • Custom Fitted braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require fitting by a certified orthotist, and
    • require substantial modification at the time of the fitting to ensure a proper fit.
  • Off-the-Shelf braces are manufactured devices that:
    • may be supplied as a kit that requires some assembly,
    • require minimal adjustment by you as the beneficiary for a proper fit, and
    • do not require a certified orthotist to ensure the best possible fit.

Medicare Coverage for Specific Types of Home Medical Equipment

BiLevel Devices/Respiratory Assist Devices**

• For a respiratory assist device to be covered, the treating physician or healthcare provider 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 if you have a clinical disorder characterized as
  • (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities),
  • (II) severe chronic obstructive pulmonary disease (COPD), or
  • (III) central sleep apnea (CSA) or Complex Sleep Apnea (CompSA),
  • (IV) hypoventilation syndrome

• If you are diagnosed with Obstructive Sleep Apnea, see the coverage criteria for Positive Airway Pressure Devices below.

• Various tests may need to be performed to establish one of the above clinical disorders.
• Three months after starting your therapy you must return to your doctor or healthcare provider for a follow-up to confirm the machine is benefitting you and that you are regularly using the device. 
  • This must be documented in your doctor or healthcare provider’s notes from that office visit.  Your physician or healthcare provider will be required to respond in writing to questions regarding your continued use along with how well the machine is treating your condition.
  • If you are not using your machine for an average of four hours per night per 24 hour period at the time you meet with your doctor or healthcare provider, then you may be held responsible (via an Advance Beneficiary Notice) to pay for the rental until you meet this requirement. 
• BiLevel Devices are considered to be capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a compliant written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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.
  • As an alternative, Medicare can cover a nipple prosthesis every three 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)
• You are allowed only one prosthesis per affected side, others will be denied as not medically necessary even if attempting asymmetry (an Advance Beneficiary Notice 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.
• A mastectomy bra is covered if the pocket of the bra is used to hold a covered prosthesis or mastectomy form.

Cervical Traction

• Cervical traction devices are covered only if both of the criteria below are met:
  1. You have a musculoskeletal or neurologic impairment requiring traction equipment.
  2. The appropriate use of a home cervical traction device has been demonstrated to you and you are able to tolerate the selected device.

Commodes**

• A commode is only covered when you are physically incapable of utilizing regular toilet facilities. For example:
  1. You are confined to a single room, or
  2. You are confined to one level of the home environment and there is no toilet on that level, or
  3. You are confined to the home and there are no toilet facilities in the home.
• Heavy-duty commodes are covered if you weigh over 300 pounds.
• Commodes with detachable arms are covered if your body configuration requires extra width, or if the arms are needed to transfer in and out of the chair.
• Raised toilet seats that are used to position hand bars over a regular toilet are not covered by Medicare.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 reimbursed by Medicare for the prevention of ulcers, prevention of the reoccurrence of ulcers, treatment of lymphedema or swelling without ulcers.

Positive Airway Pressure Devices (CPAPs and Bi-Level Devices for Obstructive Sleep Apnea)**

Continuous Positive Airway Pressure (CPAP) Devices are covered only if you have Obstructive Sleep Apnea (OSA).

• Medicare requires that you first meet with your physician or healthcare provider to discuss your symptoms and risk factors for Obstructive Sleep Apnea.
• After meeting with your doctor or healthcare provider, you must then have an overnight sleep study performed in a sleep laboratory or through a special, in-home sleep test to establish a qualifying diagnosis of Obstructive Sleep Apnea.
• Your doctor or healthcare provider may then prescribe a CPAP to treat your obstructive sleep apnea.  Medicare will initially cover a three month trial of this equipment.  Medicare will also pay for replacement masks, tubing and other necessary supplies as prescribed by your doctor or healthcare provider.
• If during your sleep study (or during your trial period) the CPAP device is not working for you, or if you cannot tolerate the CPAP machine, your doctor or healthcare provider mmay prescribe a different device called a Bi-Level or a Respiratory Assist Device, and Medicare can consider this for coverage as well. 
• 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.  Per Medicare, a follow-up face-to-face visit with your physician or healthcare provider is required to document an improvement of your symptoms no sooner than 31 days and no later than 91 days from the set-up date.  Data is typically downloaded from your sleep equipment and must be provided to your doctor or healthcare provider during this follow-up visit to document that the machine has been used consistently for at least 4 hours per night on 70% of nights during a 30-day consecutive period.
• Talk with your supplier if you are having problems adjusting to the therapy or using the equipment every night.  There are a lot of variations that can make the therapy more comfortable for you.
• CPAPs and Bi-Levels are considered capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 of testing materials 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 of need.
  • If you test above these guidelines, you are required to be seen and evaluated by your physician or healthcare provider within six months prior to receiving your initial supplies from your supplier.
  • In addition, you must send your supplier evidence of compliant testing (e.g. a testing log or notes from your physician) every six months to continue getting refills at the higher levels.
• If at any time your testing frequency changes, your physician or healthcare provider will need to give your supplier a new prescription.
• Medicare began a national mail order program in July of 2013 that requires you to get your diabetic supplies through one of approximately 20, nationally contracted suppliers for all testing supplies delivered to your home.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier may not be able to deliver your glucometer to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Glasses

• Medicare covers one complete pair of glasses, after the last cataract surgery with intra-ocular lens replacement. The Medicare benefit includes a frame and two lenses.  As an alternative, a pair of contact lenses can be covered in lieu of glasses. 
• Medicare beneficiaries that have a condition called aphakia (patients who born without an intra-ocular lens, or who have had the lens removed and not replaced), Medicare will cover glasses, and/or contacts as often as is medically necessary.
• When specifically prescribed for a medical condition documented in your medical chart, Medicare may also cover tint, anti-reflective coating, and/or UV protection.

Hospital Beds**

• A hospital bed is covered if you have visited your doctor or healthcare provider and during an office visit your doctor or healthcare provider documents in your chart that one or more of the following criteria (1-4) are met:
  1. You have 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. You require positioning of the body in ways not feasible with an ordinary bed in order to alleviate pain, or
  3. You require 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. You require traction equipment which can only be attached to a hospital bed.
• Specialty beds that allow the height of the bed to be adjusted are covered if you require this feature to permit transfers to a chair, wheelchair or standing position.
• A semi-electric bed is covered if your medical condition requires frequent changes in body position and/or you have an immediate need for a change in body position.
• Heavy-duty/extra-wide beds can be covered if you weigh over 350 pounds.
• The total electric bed is not covered because it is considered a convenience feature. If you prefer to have the total electric feature, your supplier usually can apply the cost of the qualifying hospital bed toward the monthly rental price of the total electric model. You will need to sign an Advance Beneficiary Notice (ABN) and will be responsible to pay the difference in the retail charges between the two items every month.
• Hospital beds are a capped rental item, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Lymphedema Pumps

• Compression Pumps are not reimbursed by Medicare for the treatment of peripheral artery disease or the prevention of venous thrombosis (blood clots).
• Lymphedema Pumps are covered for treatment of true lymphedema as a result of:
  • Primary Lymphedema which is an inherited disorder that occurs on its own such as Milroy’s disease, congenital lymphedema due to lymphatic aplasia or hypoplasia, lymphedema praecox, lymphedema tarda, and similar disorders.  (This is a relatively uncommon, chronic condition), or
  • Secondary lymphedema which is much more common and results from the destruction of or damage to formerly functioning lymphatic channels that may result from:
    • radical surgical procedures with removal of regional groups of lymph nodes (for example, after radical mastectomy),
    • radiation therapy,
    • trauma
    • obstruction caused by tumors,
    • lymphatic filariasis (typically found in developing countries)
    • Chronic Venous Insufficiency (CVI) which results in compression produced by the leakage of fluids from the venous system in the lower extremities (legs and feet),
      • This condition also presents with hyperpigmentation, stasis dermatitis, chronic edema and venous ulcers. 
      • The incidence of lymphedema from CVI is not well established.
      • However, Medicare has established guidelines for CVI with one or more venous stasis ulcers.
  • When lymphedema extends into the chest, trunk or abdomen, a specialty pump can be considered.
  • Before you can be prescribed a pump, your physician or healthcare provider must monitor you during a minimum, four-week trial period for lymphedema and six week trial for CVI with ulcers. 
    • During the trial your doctor or healthcare provider must document the results of other treatment options including limb elevation, regular exercise, compression bandage systems or compression garments, dietary adjustments, and the use of diuretic and similar medications as applicable.
    • Your doctor or healthcare provider should document pre and post measurements in your chart notes as each conservative treatment is evaluated. 
    • If, during the trial there is any improvement using these other methods, Medicare will not approve a pump.
    • Medicare will only consider reimbursing for the pump when you have been unresponsive to the conservative treatment and there is no significant improvement over the required trial period (the most recent four or six weeks).
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this product to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

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

• All suppliers of Medicare-covered drugs are required to accept assignment on these items.
• Very few medications are covered under your Part B benefit.  Traditional Medicare Part B insurance will cover some nebulizer drugs, some infused drugs that require the use of 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**

• Medicare policy on mobility products requires that that Medicare funds are only used to pay for:
  • Mobility needs for daily activities within the home
  • The lowest level of equipment required to accomplish these tasks.
  • The most medically appropriate equipment (that meets your needs, not your wants)
• Medicare requires that your physician or healthcare provider and supplier evaluate your needs and expected use of the mobility product to determine which item 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 supplier 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).
• Your home must be evaluated to ensure it will accommodate the use of any mobility product.

• A face-to-face examination with your physician or healthcare provider to specifically discuss your mobility limitations and need for mobility is required prior to the initial setup of a power chair, scooter or manual wheelchair.
• In some cases for custom manual chairs and power mobility items you may also be asked to see a physical therapist or occupational therapist to determine the best fit and equipment selection.
• The majority of all manual and power wheelchairs are considered capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Nebulizers**

• Nebulizer machines, medications and related accessories are usually covered if you have obstructive pulmonary disease, but can also be covered to deliver specific medications if you have HIV, Cystic Fibrosis, bronchiectasis, pneumocystosis, complications of organ transplants, or for persistent thick or tenacious pulmonary secretions.
• You may obtain up to a three month’s supply of nebulizer medications and accessories at a time as long as you continue to regularly use the medications through your machine.
• If at any time you stop using your medications, please notify your supplier.
• Nebulizer machines are considered to be capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
• When at home, you may receive up to a 3-month supply of nebulizer accessories at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Non-covered items (partial listing):

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

Orthopedic Shoes

• Orthopedic shoes are covered when it is necessary to attach the shoe(s) to a leg brace.
• Medicare will only pay for the shoe(s) attached to the leg brace(s).
• 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, or
  • urostomy
• You may obtain up to a three month’s supply of wafers, pouches, paste and other necessary items as needed.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

Oxygen**

• Your doctor or healthcare provider must start with an office visit to discuss your symptoms before ordering any testing.  If your symptoms are indicative of a chronic lung condition or other disease that requires long term oxygen therapy, Medicare will likely cover oxygen when the test results meet the coverage criteria outlined below.
• Oxygen is not covered for acute illnesses like pneumonia or for exacerbations of an underlying disease, because this is considered a temporary, acute or unstable condition. 
• Oxygen is covered if you have significant hypoxemia in a chronic stable state when:
  • You have a severe lung disease or hypoxemia that might be expected to improve with oxygen therapy, and
  • Your blood gas levels or oxygen saturation levels indicate the need for oxygen therapy, and
  • Your oxygen study was performed by a physician, qualified lab, other qualified provider and
  • Alternative treatments have been tried or deemed clinically ineffective.
• Categories/Groups of oxygen therapy are based on the test results to measure your oxygen.  There are two types of tests that can be used for this purpose.  An Arterial Blood Gas (ABG) test is an invasive procedure which provides detailed information and a direct measurement of oxygen in arterial blood (from an artery).  ABG test results are reported in millimeters of mercury (mmHg).  A saturation test (SAT) is a non-invasive procedure that indirectly measures oxygen saturation using a sensor typically placed on the ear or finger.  SAT test results are reported in percentages (%).
  • Group I Criteria: mmHG ≤ 55, or saturation ≤ 88%
    • For these results you must return to your physician or healthcare provider between 9-12 months after the initial visit to discuss whether your oxygen therapy should continue for lifetime or for a shorter period if the need is expected to end. Typically, you will not have to be retested when you return to your physician or healthcare provider for the follow-up visit.
  • Group II Criteria: 56-59 mmHg, or 89% saturation
    • For these results, you must return for another office visit with your physician or healthcare provider to discuss your oxygen therapy and for these borderline results you will also have to be retested within 3 months of the first test to continue therapy for lifetime or until the need is expected to end.
  • Group III Criteria: mmHg ≥ 60 or saturation ≥ 90% is considered to be not medically necessary.
• Note on nocturnal oxygen therapy:  If you only require the use of oxygen during the nighttime, your doctor should rule out obstructive sleep apnea as a cause for the hypoxemia symptoms you may be experiencing.  If obstructive sleep apnea is a potential factor, Medicare will not cover oxygen therapy until you have officially had the sleep apnea diagnosed and treated.  When obstructive sleep apnea is a factor, testing for oxygen can only begin after the apneas are controlled with appropriate positive airway therapy using a CPAP or Bi-PAP.  When obstructive sleep apnea is a factor, you can only be tested in a facility (not in your home).
• 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. However, if equipment is still necessary, your supplier will continue to provide the equipment to you for an additional 24 months. During this two year service period, Medicare will pay your supplier for refilling your oxygen cylinders (if you have gas or liquid systems) and for a semi-annual maintenance fee.
• After 60 months of service through Medicare your supplier is not obligated to continue service, but you may choose to receive new equipment and Medicare will begin paying for your equipment rental again.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Parenteral and Enteral therapy**

• Parenteral therapy requires all or part of the gastrointestinal tract to be missing. Nutritional formulas are delivered through a vein.
• Enteral therapy is covered if you 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.
• Specialty nutrition/formulations can be covered if you have unique nutrient needs or specific disease conditions which are well documented in your physician’s or healthcare provider’s records.  In most cases you may have to try standard formulas and document that they are unsuccessful before Medicare will consider the specialty nutrition.
• You must have nearly depleted the supplies on hand to be eligible for additional product.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Patient Lifts**

• A lift is covered if transfer between a bed and a chair, wheelchair, or commode requires the assistance of more than one person and, without the use of a lift, you 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 supplier can usually apply the cost of the manual lift toward the purchase price of the electric model. You will need to sign an Advance Beneficiary Notice (ABN) and would be responsible to pay the difference in the retail charges between the two items on a monthly basis.
• Patient lifts are considered to be capped rental items, and that means they cannot be purchased outright.  You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Depending on which product is ordered, your supplier may not be able deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider.  Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Seat Lift Mechanisms**

• In order for Medicare to pay for a seat lift mechanism, you must be suffering from severe arthritis of the hip or knee, or have a severe neuromuscular disease. In addition you must be completely incapable of standing up from any chair, but once standing can walk either independently or with the aid of a walker or cane. The physician or healthcare provider must believe that the mechanism will improve, slow down or stop the deterioration of your 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.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order. 
• Your supplier cannot deliver this equipment to you without a written order or certificate of medical necessity from your doctor or healthcare provider.  Your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

Support Surfaces**

• Group 1 products are designed to be placed on top of standard hospital bed or home mattresses. They can utilize gel, foam, water or air, and are covered if you are:
  • Completely immobile OR
  • Have limited mobility or 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 if you have 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 surgery for an ulcer on the trunk or pelvis within the last 60 days where you were immediately placed on Group 2 or 3 support surface prior to discharge from the hospital and you have been discharged within the last 30 days.
• A physician or healthcare provider must make monthly assessments as to whether continued use of the equipment is required.  Sometimes your physician or healthcare provider may order a home healthcare nurse to come visit you to make these assessments.
• Medicare will only pay for the rental of a Group 2 product until your ulcers completely heal.  If your ulcers have healed you must return the equipment to your supplier or make arrangements to pay for future monthly rentals privately using an Advance Beneficiary Notice (ABN) document.
• Group 3 products are air-fluidized beds and are only covered if you meet ALL of the following conditions:
  • A stage III or stage IV pressure ulcer, and
  • Are bedridden or chair bound as the result of limited mobility, and
  • In the absence of an air-fluidized bed would require institutionalization, and
  • An alternate course of conservative treatment has been tried for at least one month without improvement of the wound, and
  • All other alternative equipment has been considered and ruled out.
• A physician or healthcare provider must assess and evaluate you after completion of a course of conservative therapy within one month prior to ordering the Group 3 support surface.
• A trained adult caregiver must be available to assist you. Medicare does not cover the cost of hiring a caregiver, or for structural modifications to your home to accommodate this equipment.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver these products to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 pain can be treated with a TENS unit. Medicare will not pay for the device or supplies when used to treat conditions where the units have been proven ineffective.  These include:
  • headaches,
  • visceral abdominal pain,
  • pelvic pain,
  • TMJ pain, and
  • lower back pain (except for individuals participating in an approved clinical trial)  
• For chronic pain sufferers that have had persistent pain for three or more months in duration, Medicare will pay for a one or two month trial rental to determine if this device will help or alleviate the chronic pain. You must return to your physician or healthcare provider 30-60 days after your initial evaluation to discuss how the therapy is working and 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 Medicare will deny as not medically necessary.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver this product to you without a written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

** Some or all of the products in this category may be subject to competitive bidding depending on where you live.  Ask your supplier for details.

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 or pre-ulcerative calluses
  • peripheral neuropathy with callus formation
  • foot deformity
  • poor circulation in either foot
• You must have an office visit with your physician or healthcare provider within six months of receiving new shoes to discuss and document your diabetes management and why you need these special shoes.  This office visit must be repeated each time you wish to obtain replacement shoes.
• Only a physician treating your diabetes can certify your diabetic condition and complications that require specialty shoes. 
• Your healthcare practitioner or a podiatrist may further evaluate your feet and order the shoes.
• When providing you with shoes, your supplier must perform an in-person evaluation of your foot/feet, and they must verify that your shoes fit properly.
• Newly established requirements of the Affordable Care Act require a specific office visit with your physician or healthcare practitioner to assess and document your need for this equipment take place and must then issue a compliant written order.
• Your supplier cannot deliver this product to you without a written order from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery.  So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.

Urological Supplies

• Urinary catheters and external urinary collection devices are covered to drain or collect urine if you have permanent urinary incontinence or permanent urinary retention. Permanent incontinence and retention are defined as a condition that is not expected to be medically or surgically corrected within 3 months.
• A maximum of six catheters may be used per day (up to 200 per month), unless it is determined that a higher number is medically necessary by your physician or healthcare provider, and these unique circumstances are specifically documented in your medical records.
• When at home, you may receive up to a 3-month supply at one time.
• You must have nearly depleted the supplies on hand to be eligible for additional products.

Medicare Supplier Standards

Below is a summary of the standards Medicare requires of home medical equipment suppliers. As an approved Medicare provider, 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 and cannot contract with an individual or entity to provide licensed services.

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. This standard requires that the location is accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.

8. A supplier must permit CMS, 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, answering service or cell phone during posted business hours 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 contacting a Medicare beneficiary based on a physician’s oral order unless an exception applies.

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 any information required by the Medicare statute and implementing regulations.

22. All suppliers 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 of those specific products and services (except for certain exempt pharmaceuticals). Implementation Date - October 1, 2009

23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.

24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare.

25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.

26. Must meet the surety bond requirements specified in 42 C.F.R. 424.57(c). Implementation date- May 4, 2009

27. A supplier must obtain oxygen from a state- licensed oxygen supplier.

28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 C.F.R. 424.516(f).

29. DMEPOS suppliers are prohibited from sharing a practice location with certain other Medicare providers and suppliers.

30. DMEPOS suppliers must remain open to the public for a minimum of 30 hours per week with certain exceptions.