Both Medicare and private health insurance plans pay for a large portion or sometimes even all costs associated
with many types of medical equipment used in the home. This type of equipment is referred to as durable medical equipment
or home medical equipment. The guide below will help you understand the Medicare guidelines related to home medical
equipment. Most health insurance plans have similar rules to Medicare, but you should know that all private health
insurance plans vary and the specific rules of your plan may differ from these Medicare guidelines. We accept most of
the major health insurance plans. We would be happy to work with you and your insurance company to help you understand
how your plan works as it relates to home medical equipment needed by you or a loved one. If you have any questions on
insurance coverage or pricing, feel free to contact us. A description of charges is available upon request.
I. Guide to Medicare Coverage
Who qualifies for Medicare benefits?
- Individuals 65 years of age or older
- Individuals under 65 with permanent kidney failure (beginning three
months after dialysis begins), or
- Individuals under 65, permanently disabled and entitled to Social
Security benefits (beginning 24 months after the start of disability
benefits)
The Different Benefits of Traditional Medicare
- Medicare Part A benefits cover hospital stays, home health care and
hospice services
- Medicare Part B benefits cover physician visits, laboratory tests,
ambulance services and home medical equipment
- While oftentimes you do not have to pay a monthly fee to have Part
A benefits, the Part B program requires a monthly premium to stay enrolled.
In 2007 that premium will range between $93.50-161.40 per month depending
on your income. Typically, this amount will be taken from your Social
Security check.
What Can You Expect to Pay?
- Every year, in addition to your monthly premium, you will have to
pay the first $131 of covered expenses out of pocket and then 20 percent
of all approved charges if the provider agrees to accept Medicare payments.
- Unfortunately, your medical equipment provider cannot automatically
waive this 20 percent or your deductible without suffering penalties
from Medicare. They must attempt to collect the coinsurance and deductible
if they are not covered by another insurance plan; however, certain
exceptions can be made if you suffer from qualifying financial hardships.
- If you have a supplemental insurance policy, that plan may pick up
this portion of your responsibility after your supplemental plan’s
deductible has been satisfied.
- If your medical equipment provider does not accept assignment with
Medicare you may be asked to pay the full price up front, but they will
file a claim on your behalf to Medicare. In turn, Medicare will process
the claim and mail you a check to cover a portion of your expenses if
the charges are approved.
Other possible costs:
- Medicare will pay only for items that meet your basic needs as prescribed by a physician. Oftentimes you will find that your provider offers a wide selection of products that vary slightly in appearance or features. You may decide that you prefer the products that offer these additional features. Your provider should give you the option to pay a little extra money to get a product that you really want.
- To take advantage of this opportunity, a new form has been approved by the Centers for Medicare and Medicaid Services (CMS) that allows patients to upgrade to a piece of equipment that they like better than other standard options prescribed by their physician.
- The Advance Beneficiary Notice, or ABN, must detail how the products differ, and requires a signature to indicate that you agree to pay the difference in the retail costs between two similar items. Your provider will typically accept assignment on the standard product and apply that cost toward the purchase of the fancier item, thus requiring less money out of your pocket.
Purpose of ABN
- The Advance Beneficiary Notice also will be used to notify you ahead
of time that Medicare will probably not pay for a certain item or service
in a specific situation, even if Medicare might pay under different
circumstances. The form should be detailed enough that you understand
why Medicare will not pay for the item you are requesting.
- The purpose of the form is to allow you to make an informed decision
about whether or not to receive the item or service knowing that you
may have additional out-of-pocket expenses.
Durable Medical Equipment (DME) Defined
- In order for any item to be covered under Medicare, it typically has to meet the test of durability. Medicare will pay for medical equipment when the item:
- Withstands repeated use (excludes many disposable items such as underpads)
- Is used for a medical purpose (meaning there is a condition which the item will improve)
- Is useless in the absence of illness or injury (thus excluding any item preventive in nature such as bathroom safety items used to prevent injuries)
- Used in the home (which excludes all items that are needed only when leaving the confines of the home setting)
Understanding Assignment (a claim-by-claim contract)
- When a provider 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
$131.00 for 2007.
- If a provider does not accept assignment with Medicare, you will
be responsible for paying the full amount upfront. The provider will
still file a claim on your behalf and any reimbursement made by Medicare
will be paid to you directly. (Providers must still notify you in advance,
using the Advance Beneficiary Notice, if they do not believe Medicare
will pay for your claim.)
Mandatory Submission of Claims
- Every provider is required to submit a claim for covered services within one year from the date of service
The role of the physician with respect to home medical equipment:
- Every item billed to Medicare requires a physician’s order
or a special form called a Certificate of Medical Necessity (CMN), and
sometimes additional documentation will be required.
- Nurse Practitioners, Physician Assistants, Interns, Residents and
Clinical Nurse Specialists can also order medical equipment and sign
CMNs when they are treating a patient.
- All physicians' have the right to refuse to complete documentation
for equipment they did not order, so make sure you consult with your
physician before requesting an item.
Prescriptions Before Delivery:
- For some items, Medicare requires your provider to have completed
documentation (which is more than just a call-in order or a prescription
from your doctor) before they can deliver these items to you:
- Decubitus care (wheelchair cushions and pressure-relieving surfaces
placed on a hospital bed)
- Seat lift mechanisms
- TENS Units (for pain management)
- Power Operated Vehicles/Scooters
- Electric Wheelchairs
- Negative Pressure Wound Therapy
How does Medicare pay for and allow you to use the equipment?
- Typically there are three ways Medicare will pay for a covered item:
- They will purchase it outright, then the equipment belongs to
you,
- They will rent it continuously until it is no longer needed, or
- They will 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.
- After an item has been purchased for you (either outright or after
13 payments), you will be responsible for calling your provider 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.
II. Medicare Coverage for specific types of home medical
equipment
BiPaps/Respiratory Assist Devices
- For a respiratory assist device to be covered, the treating physician
must fully document in your medical record symptoms characteristic of
sleep-associated hypoventilation, such as daytime hypersomnolence, excessive
fatigue, morning headache, cognitive dysfunction, dyspnea, etc.
- A respiratory assist device is covered for those patients with clinical
disorder groups characterized as (I) restrictive thoracic disorders
(i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities),
(II) severe chronic obstructive pulmonary disease (COPD), (III) central
sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA).
- Various tests may need to be performed to establish one of the above
diagnosis groups.
- Three months after starting your therapy, both your physician and
you will be required to respond in writing to questions regarding your
continued use along with how well the machine is treating your condition.
Breast Prostheses
- Breast Prostheses are covered after a radical mastectomy. Medicare
will cover:
- One silicone prosthesis every two years or a mastectomy form
every six months.
- Mastectomy bras are covered as needed.
- There is no coverage for replacement prostheses due to wear and tear
before the listed time frame. However, Medicare will cover replacement
of these items due to:
- Loss
- Irreparable damage, or
- Change in medical condition (e.g. significant weight gain/loss)
- Patients are allowed only one prosthesis per affected side, others
will be denied as not medically necessary even if attempting asymmetry
(need ABN).
- Mastectomy sleeves which are used to control swelling are not covered
in the home setting because they do not meet Medicare’s definition
of a prosthesis; however, it is possible that they may be covered under
the hospital per diem if you request one during your hospital stay.
Cervical Traction
- Cervical traction devices are covered only if both of the criteria below are met:
- The patient has a musculoskeletal or neurologic impairment requiring traction equipment.
- The appropriate use of a home cervical traction device has been demonstrated to the patient and the patient tolerated the selected device.
Commodes
- A commode is only covered when the patient is physically incapable of utilizing regular toilet facilities. For example:
- The patient is confined to a single room, or
- The patient is confined to one level of the home environment and there is no toilet on that level, or
- The patient is confined to the home and there are no toilet facilities in the home.
- Heavy-duty commodes are covered for patients weighing over 300 pounds.
Compression Stockings
- Gradient compression stockings worn below the knee are covered only when used for the treatment of open venous stasis ulcers. They are not covered for the prevention of ulcers, prevention of the reoccurrence of ulcers or treatment of lymphedema without ulcers.
CPAPs
- Continuous Positive Airway Pressure (CPAP) Devices are covered only
for patients with obstructive sleep apnea (OSA).
- You must have an overnight sleep study performed in a sleep laboratory
to establish a qualifying diagnosis. Home and mobile sleep labs/studies
are not accepted for diagnosing this condition.
- Medicare will also pay for replacement masks, cannulas, tubing and
other necessary supplies.
- After your first three months of use, you will be required to verify
if you are benefiting from using the device and how many hours a day
you are using the machine.
Diabetic Supplies
- For diabetics, Medicare covers the glucose monitor, lancets, spring-powered
devices, test strips, control solution and replacement batteries for
the meter.
- Medicare does not cover insulin injections or diabetic pills unless
covered through a Medicare Part D benefit plan.
- Diabetics can obtain up to a three month supply at a time.
- Medicare will approve up to one test per day for non-insulin dependent
diabetics and three tests per day for insulin-dependent diabetics without
additional verification.
- Patients who test above these guidelines are required to be seen
and evaluated by their physician within six months of ordering these
supplies.
- In addition, patients must send their provider evidence of compliant
testing (e.g. a testing log) every six months to continue getting
refills at the higher levels.
- If at any time your testing frequency changes, your physician will
need to give your provider a new prescription.
Glasses
- Medicare covers one complete pair of glasses after the last cataract
surgery. These can include:
- frames
- two lenses
- tint, anti-reflective coating, and/or UV (when the doctor specifically
orders these services for a medical need)
Hospital Beds
- A hospital bed is covered if one or more of the following criteria
(1-4) are met:
- The patient has a medical condition which requires positioning
of the body in ways not feasible with an ordinary bed. Elevation
of the head/upper body less than 30 degrees does not usually require
the use of a hospital bed, or
- The patient requires positioning of the body in ways not feasible
with an ordinary bed in order to alleviate pain, or
- The patient requires the head of the bed to be elevated more
than 30 degrees most of the time due to congestive heart failure,
chronic pulmonary disease, or problems with aspiration. Pillows
or wedges must have been considered and ruled out, or
- The patient requires traction equipment which can only be attached
to a hospital bed.
- Specialty beds that allow the height of the bed to vary are covered
for patients that require this feature to permit transfers to a chair,
wheelchair or standing position.
- A semi-electric bed is covered for a patient that requires frequent
changes in body position and/or has an immediate need for a change in
body position.
- Heavy-duty/extra-wide beds can be covered for patients that 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 provider
usually can apply the cost of the semi-electric bed toward the monthly
rental price of the total electric model by using an Advance Beneficiary
Notice (ABN). You would be responsible to pay the difference in the
retail charges between the two items every month.
Lymphedema Pumps
- Lymphedema Pumps are covered for treatment of true lymphedema as
a result of a:
- Primary Lymphedema resulting from a congenital abnormality of
lymphatic drainage or Milroy’s disease, or
- Secondary lymphedema resulting from the destruction of or damage
to formerly functioning lymphatic channels such as:
- radical surgical procedures with removal of regional groups
of lymph nodes (for example, after radical mastectomy),
- post-radiation fibrosis,
- spread of malignant tumors to regional lymph nodes with lymphatic
obstruction,
- or other causes
- Before you can be prescribed a pump, your physician must monitor
you during a four-week trial period where other treatment options
are tried such as medication, limb elevation and compression garments.
If, at the end of the trial, there is little or no improvement,
a lymphedema pump can be considered.
- The doctor must then document an initial treatment with a pump
and establish that the treatment can be tolerated.
- Lymphedema pumps also are covered for the treatment of chronic venus
insufficiency (CVI).
- Before you can be prescribed a pump for this condition, your
physician must monitor you during a six month trial period where
other treatment options are tried such as medication, limb elevation
and compression garments. If at the end of the trial the stasis
ulcers are still present, a lymphedema pump can be considered.
- The doctor must then document an initial treatment with a pump
and establish that the treatment can be tolerated, that there is
a caregiver available to assist with the treatment in the home,
and then the doctor must prescribe the pressures, frequency, and
duration of prescribed use.
Medicare-covered drugs (other than Medicare Part D coverage)
- As of February 2001, all providers of Medicare-covered drugs are
required to accept assignment on these items.
- Traditional Medicare Part B insurance will cover some nebulizer drugs,
some infused drugs using a pump, specific immunosuppressive drugs, select
oral anti-cancer medications and most parenteral nutrition.
- The Medicare Part D plans may provide additional coverage of other
oral medications, inhalers and similar drugs.
Mobility Products: Canes, Walkers, Wheelchairs, and Scooters
- Essentially the new Mobility Assistive Equipment regulations will
ensure that Medicare funds are used to pay for:
- Mobility needs for daily activities within the home
- Least costly alternative/lowest level of equipment to accomplish
these tasks.
- Most medically appropriate equipment (to meet the needs, not
the wants)
- Medicare requires that your physician and provider evaluate your
needs and expected use of the mobility product you will qualify for.
- They must determine which is the least level of equipment needed
to help you be mobile within your home to accomplish daily activities
by asking the following questions:
- Will a cane or crutches allow you to perform these activities
in the home?
- If not, will a walker allow you to accomplish these activities
in the home?
- If not, is there any type of manual wheelchair that will allow
you to accomplish these activities in the home?
- If not, will a scooter allow you to accomplish these activities
in the home?
- If not, will a power chair allow you to accomplish these activities
in the home?
- Keep in mind if you have another higher level product in mind that
will allow you to do more beyond the confines of the home setting, you
can discuss with your provider the option to upgrade to a higher level
or more comfortable product by paying an additional out of pocket fee
using the Advance Beneficiary Notice (ABN) to select the product you
like best.
- A face-to-face examination with your physician is required prior to
the initial setup of a power chair or scooter.
- Your home must be evaluated to ensure it will accommodate the use
of any mobility product.
Nebulizers
- Nebulizer machines, medications and related accessories are usually
covered for patients with obstructive pulmonary disease, but can also
be covered to deliver specific medications to patients with HIV, CF,
brochiectasis, pneumocystosis, complications of organ transplants, or
for persistent thick or tenacious pulmonary secretions.
- Patients can obtain up to a three month’s supply of nebulizer
medications and accessories at a time.
Non-covered items (partial listing):
- Adult diapers
- Bathroom safety equipment
- Hearing 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
Orthopedic Shoes
- Orthopedic shoes are covered when it is necessary to attach the shoe(s)
to a leg brace.
- However, Medicare will only pay for the shoe(s) attached to the leg
braces.
- Medicare will not pay for matching shoes or for shoes that are needed
for purposes other than for diabetes or leg braces.
Ostomy Supplies
- Ostomy supplies are covered for people with a:
- colostomy
- ileostomy
- urostomy
- Patients can obtain up to a three month’s supply of wafers, pouches, paste and other necessary items at a time.
Oxygen
- Covered for patients with significant hypoxemia in the chronic stable
state when:
- patient has a chronic lung condition or disease or hypoxemia
that might be expected to improve with oxygen therapy, and
- patient’s blood gas levels or oxygen saturation levels
indicate the need for oxygen therapy, and
- alternative treatments have been tried or deemed clinically ineffective.
- Categories/Groups are based on the test results to measure your oxygen:
- I 55≤ mmHg, or 88%≤ saturation
- For these results you must return to your physician 12 months
after the initial visit to continue therapy for lifetime or
until the need is expected to end. Typically, you will not have
to be retested when you return to your physician for the follow-up
visit.
- II 56-59 mmHg, or 89% saturation
- For these results, you must be retested within 3 months of
the first test to continue therapy for lifetime or until the
need is expected to end.
- III ≥60 or ≥90% not medically necessary.
Oxygen will be paid as a rental for the first 36 months. After that
time if you still need the equipment Medicare will no longer make
rental payments on the equipment. If your deductible and copays are
met, the equipment title will transfer to you. Medicare will then
pay for refilling your oxygen cylinders and for repairs and service
of your equipment. Medicare will also separately pay for oxygen accessories
such as tubing, masks and cannulas after the purchase price has been
met.
Parenteral and enteral therapy
- Parenteral therapy requires all or part of the gastrointestinal tract be missing. Nutritional formulas are delivered through a vein.
- Enteral therapy is covered for patients who cannot swallow or take food orally. Nutrition must be delivered through a tube directly into the gastrointestinal tract.
- Medicare will not pay for nutritional formulas that are taken orally.
Patient Lifts
- A lift is covered if transfer between bed and a chair, wheelchair,
or commode requires the assistance of more than one person and, without
the use of a lift, the patient would be bed confined.
- An electric lift mechanism is not covered; because it is considered
a convenience feature. If you prefer to have the electric mechanism,
your provider can usually apply the cost of the manual lift toward the
purchase price of the electric model by using an Advance Beneficiary
Notice (ABN). You would be responsible to pay the difference in the
retail charges between the two items.
Seat Lift Mechanisms
- In order for Medicare to pay for a seat lift mechanism, patients
must be suffering from severe arthritis of the hip or knee, or have
a severe neuromuscular disease. In addition they must be completely
incapable of standing up from any chair, but once standing they can
walk either independently or with the aid of a walker or cane. The physician
must believe that the mechanism will improve, slow down or stop the
deterioration of the patient’s condition.
- Transferring directly into a wheelchair will prevent Medicare from
paying for the device.
- Medicare will only pay for the lift mechanism portion. The chair
portion of the package is not covered, and you will be responsible for
paying the full amount for the furniture component of the chair.
Support Surfaces
- Group 1 products are designed to be placed on top of a standard hospital
or home mattress. They can utilize gel, foam, water or air, and are
covered for patients that are:
- Completely immobile OR
- Have limited mobility with any stage ulcer on the trunk or pelvis
(and one of the following):
- impaired nutritional status
- fecal or urinary incontinence
- altered sensory perception
- compromised circulatory status
- Group 2 products take many forms, but are typically powered pressure
reducing mattresses or overlays. They are covered for patients with
one of three conditions:
- Multiple stage II ulcers on the pelvis or trunk while on a comprehensive
treatment program for at least a month using a Group 1 product,
and at the close of that month, the ulcers worsened or remained
the same. (Monthly follow-up is required by a clinician to ensure
that the treatment program is modified and followed. This product
is only covered while ulcers are still present.) OR
- Large or multiple Stage III or IV ulcers on the trunk or pelvis
(Monthly follow-up is required by a clinician to ensure that the
treatment program is modified and followed. This product is only
covered while ulcers are still present.) OR
- A recent myocutaneous flap or skin graft for an ulcer on the
trunk or pelvis within the last 60 days who were immediately placed
on Group 2 or 3 support surface prior to discharge from the hospital
and the patient has been discharged within last 30 days.
TENS Units
- TENS units are covered for the treatment of chronic intractable pain that has been present for at least three months or more, and in some cases for acute post-operative pain.
- Not all types of pains can be treated with a TENS unit. TENS units have proven ineffective in treating headaches, visceral abdominal pains, pelvic pains, and TMJ pains, and therefore Medicare will not pay for the device when used to treat these conditions.
- For chronic pain sufferers, Medicare will pay for a one or two month trial rental to determine if this device will alleviate the chronic pain. You must return to your physician exactly 30-60 days after initial evaluation to authorize the purchase of this equipment.
- For acute post-operative pain sufferers, Medicare will consider rental payment for a maximum of 30 days. Any duration longer than that will require individual consideration.
Therapeutic Shoes
- Special therapeutic shoes, inserts and modifications can be covered for diabetic patients with the following foot conditions:
- previous amputation of a foot or partial foot
- history of foot ulceration
- peripheral neuropathy with callus formation
- foot deformity
- poor circulation in either foot
Urological Supplies
- Urinary catheters and external urinary collection devices are covered to drain or collect urine for a patient who has permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that patient within 3 months.
III. Medicare Supplier Standards
Below is a summary of the standards Medicare requires of home medical equipment providers. Our company meets or exceeds all of these standards.
- A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements.
- 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.
- An authorized individual (one whose signature is binding) must sign the application for billing privileges.
- 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.
- 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.
- 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.
- A supplier must maintain a physical facility on an appropriate site.
- 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.
- 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 mobile communications devices is prohibited.
- 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.
- A supplier must agree not to initiate telephone contact with beneficiaries, with a few exceptions allowed. This standard prohibits suppliers from calling beneficiaries in order to solicit new business.
- A supplier is responsible for delivery and must instruct beneficiaries on use of Medicare covered items, and maintain proof of delivery.
- A supplier must answer questions and respond to complaints of beneficiaries, and maintain documentation of such contacts.
- 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.
- 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.
- A supplier must disclose these supplier standards to each beneficiary to whom it supplies a Medicare-covered item.
- A supplier must disclose to the government any person having ownership, financial, or control interest in the supplier.
- 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.
- 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.
- Complaint records must include: the name, address, telephone number, a summary of the complaint, and any actions taken to resolve it.
- A supplier must agree to furnish CMS any information required by the Medicare statute and implementing regulations.
- All suppliers of DMEPOS and other items and services must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services for which the supplier is accredited in order for the supplier to receive payment for those specific products and services
- All DMEPOS suppliers must notify their accreditation organization when a new DMEPOS location is opened. The accreditation organization may accredit the new supplier location for 3 months after it is operational without requiring a new site visit.
- All DMEPOS supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare. An accredited supplier may be denied enrollment or their enrollment may be revoked, if CMS determines that they are not in compliance with the DMEPOS quality standards.
- All DMEPOS suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation. If a new product line is added after enrollment, the DMEPOS supplier will be responsible for notifying the accrediting body of the new product so that the DMEPOS supplier can be re-surveyed and accredited for these new products.
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