INSURANCE COVERAGE FOR THE CHARITÉ®
ARTIFICIAL DISC
THE SURGEON’S GUIDE TO THE APPEALS PROCESS
Provided as a Professional Service of DePuy Spine
The reimbursement material contained in this guide is provided for information
purposes only and represents no statement, promise or guarantee by DePuy Spine,
Inc. concerning levels of reimbursement, payment or charge. Similarly, all codes
are supplied for information purposes only and represent no statement, promise
or guarantee by DePuy Spine, Inc. that these codes will be appropriate or that
reimbursement will be made. Providers are advised to consult their local payer
organization with regard to local reimbursement policies.
Insurance Coverage for the CHARITÉ Artificial Disc
The Surgeon's Guide to the Appeals Process
You may be considering the CHARITÉ® Artificial Disc as an alternative to interbody
spinal fusion for some of your patients with degenerative disc disease (DDD).
Approved by the FDA in October 2004 for single-level DDD, the CHARITÉ Artificial
Disc is the first implant available for total disc replacement in the United States.
Although the the device has been successfully implanted outside the United States
for over 17 years in over 8,000 patients, the CHARITÉ Artificial Disc may be considered
“investigational” by healthcare plans or payers in the United States. As a result,
the initial request for insurance coverage for the implant may be denied.
As a physician with your patient’s best interests in mind, you have the authority,
knowledge, and medical experience necessary to initiate an effective appeal and
reverse a payer’s decision. This guide is designed to provide the information
and tools you need to do just that.
Leading an appeal will require greater involvement on your part, but it’s well
worth the effort. A successful appeal based on the specific medical needs of your
patient can make a real difference in his or her everyday life.
Most healthcare plans take a cautious approach to new technology. A payer may
deny requests for insurance coverage of a new device such as the CHARITÉ Artificial
Disc until the healthcare plan has had an opportunity to conduct its own formal
review of the technology, known as a technology assessment.
A technology assessment can be conducted internally (within the payer’s organization)
or externally (by an independent review firm). Typically, a panel of experts is
identified to review published literature, clinical trial results, costs, appropriate
patient populations, and health outcomes associated with the requested technology
as well as general information about the disease indication.
Members of the panel generally review the materials independently and then form
a collective opinion. Though not binding, this opinion heavily influences a payer’s
decision to provide coverage for new and innovative technology.
If the technology assessment confirms that a device such as the CHARITÉ Artificial
Disc is a safe and effective treatment option for plan members, the process of
obtaining insurance coverage for the device is relatively simple and straightforward
– similar to that required for other payer-approved treatments and procedures.
Until a device is payer-approved, however, you and your patient may need to appeal
for insurance coverage by providing additional information and arguments in
support of the device. The appeals process varies from plan to plan but may involve
as many as 3 parties and 3 levels of appeal.
As you initiate an appeal, keep in mind that any insured patient who is denied
coverage is entitled to have his or her case reviewed. Most payers are regulated
by state and/or federal laws designed to ensure that patients are treated fairly
and equitably. These laws require healthcare plans to act honestly and in good
faith in fulfilling their contractual obligations to their members. Most payers
make every effort to do more than merely fulfill their legal obligations. They
try to reasonably assess the needs of the individuals covered under their plans.
Three parties are frequently involved in appealing a payer’s decision to deny
insurance coverage: you, your patient, and your patient’s employer. Occasionally
a patient advocate or advocacy group may also be helpful in championing the patient’s
case before the healthcare plan.
Your knowledge and experience with the patient makes you the medical expert in
the appeals process. You understand the unique medical needs of your patient;
you are also in the best position to present a convincing case in favor of new
technology such as the CHARITÉ Artificial Disc and overturn a denial of coverage.
Furthermore, through your leadership and partnership with the patient, you can
help empower him or her to participate in the appeals process. You can also identify
situations when it makes sense for the patient’s employer or a patient advocate
or advocacy group to get involved.
As the individual with the most to gain or lose from the healthcare plan’s decision,
your patient should be encouraged to take an active role in the appeals process.
There are a number of ways that your patient can become involved and influence
the outcome of a payer’s decision. These include:
• Obtaining the benefits booklet
or other document containing the healthcare
plan’s guidelines and policies on the appeals
process
• Personally contacting the healthcare plan
to discuss a decision over the phone
• Writing a thoughtful appeal letter that
presents the impact of his or her condition
on daily life and argues against the reasons
for insurance denial
• Asking for advice from the employer who sponsors
the healthcare plan
Most patients acquire healthcare insurance coverage through regular employment.
The employer is considered the plan holder; the employee, the plan subscriber.
Because employers represent large groups of members in the healthcare plan and
can opt to switch plans if members are dissatisfied, employers can have a great
deal of clout in the appeals process.
Patients are likely to find that talking with the employer about a payer’s decision
and involving the Human Resources department in an appeal may prove useful in
reversing a denial of coverage.
Together you, your patient, and your patient’s employer can be a powerful team
in appealing a payer’s decision to deny coverage.
Generally, before a patient undergoes elective surgery, most healthcare plans
require prior authorization of the procedure. For most procedures, your office
staff requests prior authorization by phone. In the case of the CHARITÉ Artificial
Disc, however, you should have your staff submit a letter requesting prior authorization,
also known as a letter of medical necessity.
A letter of medical necessity should include the following information:
• Specific details of the patient’s case history, duration and degree
of illness/injury, and a summary of your
and prior physicians’ clinical experience
with the patient, including previous failed
treatments
• A description of how the patient’s condition
affects his or her ability to work, participate
in activities of daily living, participate
in activities designed to improve his or
her clinical condition (I.e., physical therapy),
sleep, etc.
• A summary of the clinical evidence (i.e., published literature) that supports
the safety and efficacy of the CHARITÉ Artificial Disc as it relates to the patient’s
medical condition
In addition, it is helpful to include a copy of the FDA approval letter for the
device, i.e., the CHARITÉ Artificial Disc, billing code information for the intended
service, and a bibliography of relevant peer-reviewed published literature.
After you submit the letter of medical necessity, you or your office staff should
receive the healthcare plan’s written response, although your patient may receive
a response, too. If the healthcare plan approves your request for prior authorization,
no further action is required.
1st level appeal
If you or your patient receive a communication indicating a denial of coverage,
you should consider initiating a formal appeal. Typically, the communication is
in writing and originates from the designated plan representative who has reviewed
your request. The letter denying coverage should…
• Clearly state
the reason(s) for the decision
• Refer to the healthcare plan provisions
upon which the denial of coverage is based
• Indicate additional written material or
information that can be submitted that might
change the healthcare plan’s decision
• Discuss the procedure for requesting an appeal of
the decision
If the denial letter does not include the information listed above, immediately
submit a written request to the healthcare plan representative for this
information.
If you receive a denial letter with appropriate supporting information, it is
important to take time to gain a thorough understanding of the payer’s reason(s)
for denial of coverage. Try to determine whether the denial involves:
• A medical issue (refusal to authorize surgery)
• An administrative issue (refusal of benefit due to
lack of coverage)
If you or the patient have questions or need further clarification, don’t hesitate
to contact the designated plan representative by phone to discuss the case and
get the answers you need.
Once you understand the reasons for denial of coverage, you and your patient can
initiate an appeal formulated according to the instructions in the benefits booklet
or those received directly from the healthcare plan. Keep in mind that, throughout
the appeals process, reviews of your requests for
coverage must be conducted according to regulations that govern the healthcare
plan, which is overseen by state officials and, ultimately, the state Department
of Insurance (DOI).
During the appeals process, it is important that both you and your patient keep
accurate records of all interactions with the healthcare plan and monitor
the timeliness of the plan’s response.
One common reason for initial denial of insurance coverage is a payer’s lack of
familiarity with a new surgical technology and/or procedure. Especially in the
early stages of physician adoption, insurers may not be aware of all the details
or advantages associated with a new treatment approach.
Throughout the prior authorization and appeals processes, you should plan to educate
the payer and convey the facts about the new technology and/or procedure.
Another common reason for initial denial of insurance coverage is the payer’s
general medical policy, which specifies that the treatment you request is not
reimbursable. Typically, healthcare plans rely heavily on medical policy and apply
it across the board to all members, without regard for individual
circumstances. In this case, your strategy for a 1st
appeal should be to request individual consideration.
A request for individual consideration should be directed to the designated healthcare
plan representative and should ask that the plan reconsider its decision in light
of the patient’s specific medical needs, rather than overall policy. Ideally,
the request should include a letter from you with
appropriate clinical documentation explaining your patient’s medical needs, accompanied
by a letter from your patient that explains why the surgery is necessary from
his or her perspective. (See outline of sample letter.)
If the plan responds with a favorable decision to your request for individual
consideration, the decision will apply only to the patient in question – not to
all members of the plan.
When you submit the 1st appeal or request for individual consideration, be aware
that most healthcare plans follow a definite timeframe for appeals. If you or
your patient fail to meet the timeline, the patient may lose the right to appeal.
Generally, payers make every effort to adhere to their published timeframes. Nonetheless,
it is good to keep track of the expected response date to the appeal. Regardless
of when you receive the decision, the insurer should provide it in writing.
If the plan issues a favorable decision, no further action is required on your
part or on the patient’s part prior to surgery. However, if your patient is denied
insurance coverage again, most healthcare plans offer the opportunity for a 2nd
level appeal.
If a healthcare plan responds to the 1st appeal by denying coverage, the written
communication you receive should contain the following information: the reason(s)
for denial, documentation supporting the decision to deny coverage, an outline
of the next steps in the appeals process, and the appropriate timeframe for the
appeal.
Again, you and your patient should carefully review this information, clarify
any issues with the payer, and then strategize about how to proceed with the 2nd
level appeal.
One common strategy for a 2nd level appeal is to write and request a full and
fair review of your patient’s case. This means that…
• The case should be reviewed
on its own individual merits as well as
the patient’s specific circumstances
• The review should be conducted by an independent
physician who was not involved in the original
decision to deny coverage
• The review should be done school to school; in other words, in the case
of the CHARITÉ Artificial Disc, the physician reviewer, who is usually a consultant
hired by the insurer, should…
– Work in the same specialty
as the patient’s surgeon, i.e., spine
surgery
– Perform procedures of the lumbar spine
– Employ an anterior surgical approach,
i.e., the surgical approach used to implant
the CHARITÉ Artificial Disc
– Routinely treat patients with DDD
In addition, a full and fair review should allow direct discussion between you
and the physician reviewer so that you can present specific facts to the reviewer
about your patient’s case as well as your rationale for treatment.
When requesting a full and fair review, you and your patient should request that
the physician selected to review the case is knowledgeable and thoroughly
trained in the use of the CHARITÉ Artificial Disc. You should know, however,
that the healthcare plan is not obliged to comply with this request.
Another common strategy for a 2nd level appeal is to involve the patient’s employer
and/or a patient advocate or advocacy group. A patient advocate or advocacy group
helps bridge the gap between the patient and the payer. They work on behalf of
the patient, championing the patient’s cause with the healthcare plan.
Patient advocacy groups that can assist with denials of coverage for the CHARITÉ
Artificial Disc include those associated with spine care issues or back pain.
An insurer will usually render a decision on a 2nd level appeal within the timeframe
specified in previous written communication or the benefits booklet. The insurer
should provide written notification if the review takes longer than expected and
should indicate the reason(s) for the delay
as well as the anticipated date for the final
decision.
Throughout the appeals process, you and your patient can help prompt a faster
response by requesting an expedited review and/or following up frequently
with the designated representative of the healthcare plan. However, since
surgery with the CHARITÉ Artificial Disc is an elective procedure, the
payer is not obligated to conduct an expedited review.
In most instances, a denial of coverage for the CHARITÉ Artificial Disc after
a 2nd level appeal will be based on the healthcare plan’s opinion that the device
is still investigational. In other words, the plan believes that the amount or
caliber of long-term data published in U.S. medical journals is insufficient to
adequately document the safety and efficacy of the CHARITÉ Artificial Disc.
Some healthcare plans permit a 3rd level appeal. Third level appeals can occur
as much as 3 months after the initial request for prior authorization. Therefore,
if any new clinical information is available on the technology, such as a new
published clinical study, this material should be included in the appeal.
At this stage of the appeals process, your patient should consider contacting
the state Department of Insurance (DOI). Contact information for the state DOI
can be found in the yellow pages of your phone directory under state government
agencies. You can also source this information from the internet on the state’s
homepage. He or she may qualify for benefits under the Employee Retirement Income
Security Act of 1974 (ERISA) and therefore be eligible to receive coverage for
the CHARITÉ Artificial Disc. The DOI can help determine whether your patient qualifies.
In addition, if your state has a local Office of the Ombudsman, your patient should
get in touch with the office. The Ombudsman can provide additional information
about avenues of appeal available to your patient and may sometimes act as a patient
advocate.
If, after the 3rd level appeal, the healthcare plan continues to deny insurance
coverage, you and your patient have exhausted all channels in the appeals process.
If your patient wishes to further pursue insurance coverage, he or she can consider
legal action.
In your ongoing communication with the healthcare plan, keep in mind that the
appeal is about what is in the best interests of your patient. As the treating
physician, your opinion is crucial in terms of determining which treatment is
medically necessary for your patient. Here are some guidelines to keep in mind
as you go through the appeal process for the CHARITÉ Artificial Disc:
• In all communication, written
or verbal, be sure to identify and refer
to the patient by name to humanize the process
• Clearly state your reasons for disputing
the payer’s decision
• Specifically address each point that the
payer has used to deny your request for
coverage
• Always make your appeal in your own words
• Be sure to refer to the patient’s medical
record and indicate the length of time that
the patient has been in your or another
physician’s care for the particular problem
that you are describing. Discuss the patient’s
medical history, physical exams, clinical
evaluations, and verbal complaints
• Clearly demonstrate that the patient has
failed to respond to all conservative measures
with any consistency or any notable clinical
improvement. Point out that, regardless
of the plan’s decision on coverage, your
patient requires a therapeutic intervention;
in this case, surgery
• Explain that the patient’s treatment options
are limited to surgery involving spinal
fusion or motion-preserving technology.
Point out that spinal fusion is not as appropriate
as motion-preserving technology for this
particular patient with DDD
• Cite the results of specific tests and/or
treatment modalities that have led you to
this decision. Demonstrate how the unique
circumstances of this case make the CHARITÉ
Artificial Disc the treatment of choice
for this particular patient
• Emphasize that, as the treating physician,
your medical opinion regarding what is in
the best interests of your patient should
carry more weight than a chart review conducted
by a well-meaning person who has limited
knowledge of the patient and may not be
familiar with the CHARITÉ Artificial Disc
• Point out that your treatment recommendations
are based on your medical opinion as a highly
qualified spine surgeon, who has been in
practice for a number of years (be sure
to specify the number.) Mention that you
have undergone training specifically focused
on the CHARITÉ Artificial Disc, including
lectures and hands-on surgical technique
• Whenever necessary, be sure to request an opportunity to speak directly with
the physician reviewer assigned to the case
It is not uncommon for your viewpoint and the payer’s viewpoint to be at odds
in the early stages of introducing a technology into your practice. The scenarios
below indicate some of the objections healthcare plans may have to your requests
for coverage for the CHARITÉ Artificial Disc and offer suggestions for ways that
you can respond.
Scenario #1
Payer’s objection: Investigational status of the CHARITÉ Artificial Disc
Your response:
The FDA approved the CHARITÉ Artificial Disc on October 26, 2004, allowing commercial
sales in the United States. The approval was based on the results of a large,
multi-center clinical trial that adhered to the stringent protocol required for
investigational device exemption (IDE) in the United States. The device should
no longer be considered investigational.
Although currently there may be limited medical literature on the CHARITÉ Artificial
Disc, it is important to remember that the time lag between the establishment
of the safety and efficacy of a product and the date when studies appear in peer-reviewed
published literature can be significant.
As a result, acknowledgement of a new technology as an acceptable treatment option
by the medical community is often delayed. Patients should not be penalized because
of this time lag, nor denied access to advanced technology that has proven to
be safe and effective.
(NOTE: You can also refer to peer-reviewed published literature from the IDE study
in the United States, as well as published clinical papers in Europe, to document
the safety and efficacy of the CHARITÉ Artificial Disc. See the bibliography on
page 16.)
Scenario #2
Payer’s objection: Lack of long-term data
Your response:
The first patient in the IDE study on the CHARITÉ Artificial Disc was enrolled
in 2000; the last subject, in April, 2002. Therefore, 5-year data on the device
will first become available in 2007. In the interim, abstracts of data from the
IDE study will be published periodically and updates on
study results will be provided to the FDA annually.
Outside the United States, the CHARITÉ Artificial Disc has had extensive clinical
experience. The device was first made available in Europe and thousands of patients
have undergone surgical implants of the CHARITÉ Artificial Disc.
Currently, European clinical data include both 5- and 10-year follow-up studies
on the device. A study by Lemaire et al reports on results from a 10-year study
in 100 patients in the French journal Rachis. The study is entitled “Clinical
and radiological outcomes with the CHARITÉ
intervertebral disc prosthesis – a minimum 10-year follow up.” Results from the
study indicate that…
• Clinical outcomes are good or excellent in 90% of patients at 10-year
follow-up
• Over 90% of patients have returned to
work
• There have been no subluxation or core
expulsions
• The re-operation rate is only 5%, with a 2% rate
of adjacent segment disc disease
Another study in abstract form by David et al reported successful results in a
9-year follow-up of 147 patients. Printed abstracts from this study can be found
in a supplemental issue of The SpineJournal, 2004(4): 3S-119S.
The same author also reported successful results in a 10 year follow-up
study entitled “Lumbar disc prosthesis: an analysis of long-term complications
for 272 SB CHARITÉ disc prostheses with minimum 10-year follow-up.”
Scenario #3
Payer’s objection: Lack of superiority of the CHARITÉ Artificial Disc vs Anterior
Lumbar Interbody Fusion (ALIF)
Your response:
The IDE clinical trial conducted in the United States evaluated the safety and
efficacy of the CHARITÉ Artificial Disc in a non-inferiority study, which permits
a smaller study population. Because of the size of the patient population, a non-inferiority
study limits superiority claims. Even though a trial may demonstrate outcomes
that show numerical superiority, superiority claims cannot be made.
In the IDE study summary results for the CHARITÉ Artificial Disc, data points
for primary and secondary endpoints are presented for post-operative evaluations
at specific time points: 6 weeks and 3, 6, 12, and 24 months.
Scenario #4
Payer’s objection: Surgery involving ALIF with the BAK ® cage does
not represent the current standard of care for the treatment of DDD.
Your response:
In the 6 years that have transpired between the initial planning stages of the
trial and FDA approval of the CHARITÉ Artificial Disc, additional treatment alternatives
have become available. At the time that the IDE trial for the CHARITÉ Artificial
Disc was planned, the FDA required inclusion
of a control arm. The BAK cage was the only device approved by the FDA for DDD
at that time. Patients should not be penalized for changes in the standard of
care and denied access to a therapeutic intervention that is safe and effective
for the treatment of DDD.
Scenario #5
Payer’s objection: Inadequate criteria for patient selection
Your response:
The CHARITÉ Artificial Disc is intended for use in patients with single-level
DDD at L4-L5 and L5-S1 with no radicular component who have failed non-operative
treatment for at least 6 months. The criteria is appropriate since this group
represents patients whose next therapeutic option would
most likely be lumbar spinal fusion surgery.
The CHARITÉ Artificial Disc offers a treatment option that has the potential to
preserve motion, restore proper disc height, maintain segmental stability, and
re-establish lordotic alignment. As an insurer, the healthcare plan has the power
to encourage appropriate patient selection by
developing medical policy criteria that coincide with FDA-approved labeling. The
plan should adopt this approach to the CHARITÉ Artificial Disc since FDA criteria
clearly define the appropriate patient population.
Scenario #6
Payer’s objection: The CHARITÉ Artificial Disc is being held to a higher standard
than fusion technologies
Your response:
A spine arthroplasty device, particularly one with such an extensive clinical
history outside the United States as the CHARITÉ Artificial Disc, should not be
held to a higher safety standard than other total joint (hip and knee replacement)
or spinal implants available in this country.
Currently, the standard length of study required to document the safety of devices
such as these used to replace knees and hips is 2 years. The IDE study on the
CHARITÉ Artificial Disc in the United States included 2-year follow-up data and
clearly demonstrated the safety and efficacy of the device. This point was originally
made at the FDA Panel Meeting.
The European data on the CHARITÉ Artificial Disc also support the safety, efficacy,
and durability of the device. Studies by Lemaire and David report on outcomes
and complications in a single-arm
case series in a large cohort of patients, with only a small percentage of patients
lost to follow-up. The safety data from these European studies are of particular
interest, because the studies were conducted without a prospective protocol, across
a variety of indications, employing a variety of surgical techniques, and across
diverse patient populations in a clinical practice setting. Regardless of these
variables, when the CHARITÉ Artificial Disc was properly placed and sized, the
implant was associated with few adverse effects.
The commercially available version of the CHARITÉ Artificial Disc has undergone
only minor modifications; therefore, the safety profile seen in the European studies
can reasonably be
extrapolated to the device currently on the market in the United States. The European
data from a clinical practice setting substantiates the U.S. data obtained in
the IDE clinical trial.
Scenario #7
Payer’s objection: Surgeons do not have the ability to perform this new surgical
technique properly
Your response:
DePuy Spine, Inc., the manufacturer of the CHARITÉ Artificial Disc, provides a
thorough training program for both the spine surgeon and the access surgeon. Training
consists of lectures, case reviews, and hands-on laboratory experience. I have
attended this 2-day course. Moreover, before the manufacturer will ship the CHARITÉ
Artificial Disc to the hospital, the surgeon must have completed the entire training
program.
(NOTE: If you have also participated in a mentoring program at any of the 50 Regional
CHARITÉ Artificial Disc Training Centers (RCTC) that discusses patient selection,
patient pre-
and post-operative management, surgical technique, and management of complications,
be sure to mention this fact as well. The list of trained surgeons available at
www.charitedisc.com to verify your participation and specify that the link is
through “Am I a Candidate;” then “Find a CHARITÉ Artificial Disc Surgeon.”)
This outline suggests one method of organizing your appeal letter. Please remember
that you should tell the patient’s story and present your medical conclusions
in your own words.
Re: Request for Reconsideration of a Denial of Coverage [Name of Patient] [Subscriber ID Number]
Dear [Name of representative from healthcare plan]:
Paragraph 1
• State the name of the patient covered under the insurer’s program
• State the date of the denial
• State that the technology requested is the CHARITÉ
Artificial Disc
Paragraph 2
• State the length of time that you have had [name of patient] in
your care
• State that [name of patient] has a diagnosis
consistent with the indications for the
CHARITÉ Artificial Disc
• Explain that all other conservative treatments or previous surgeries employed
in an attempt to treat [name of patient] have failed
Paragraph 3
• State that, after discussion with [name of patient], it is your
opinion that the most appropriate treatment
option is total disc replacement with the
CHARITÉ Artificial Disc
• Emphasize that this recommendation is not made
lightly, given the nature of the planned surgery
Paragraph 4
• Point out that the CHARITÉ Artificial Disc has
extensive clinical experience behind it, noting:
– The FDA approval of the device in October, 2004
– The worldwide literature available on
the device and disc arthroplasty (refer
to the bibliography and the
scenarios)
– The large number of patients in the
United States – approximately 1,000 as
of February, 2005 – who have already received
the CHARITÉ Artificial Disc
– The positive outcomes reported in the randomized, multi-center IDE study in
the United States; a low complication rate and high patient satisfaction
• Refer to any personal experience you have had performing this surgery, and to
your CHARITÉ Artificial Disc training
Paragraph 5
• State that the manufacturer reports that a growing number of insurance
companies are now developing medical policies
favoring the use of total disc arthroplasty
for the treatment of DDD
• Most importantly, emphasize that [name of patient] meets the inclusion/exclusion
criteria for the CHARITÉ Artificial Disc that are detailed in the Indications
For Use in the product labeling
Paragraph 6
• Mention the goals of surgery with the CHARITÉ Artificial Disc:
to maintain motion of the spinal segment,
restore proper disc height, maintain segmental
stability, and re-establish lordotic angle
• Restate your position that [name of patient] is an excellent candidate for this
surgery and you support his or her request for an appeal of denial of coverage
Paragraph 7
• State that you believe that this case should be reviewed based
on individual patient consideration and
not on medical policy
• Request a full and fair review and a school-to-school review with the opportunity
to discuss the case directly with the reviewer
Paragraph 8
• Conclude by stating that you trust that [name of payer] will grant
an approval of this surgery so that together
you can provide the best possible care to
[name of patient]
• Add that, given the duration of [name of patient]’s condition and his or her
present level of discomfort, you look forward to a timely reply
Sincerely,
[Physician name and signature]
Enclosures:
• Copy of letter of appeal from [name of patient]
• Supporting clinical literature
– Provide more details about the technology and clinical documentation
to dispute any objections
– Submit a “request for individual consideration,”
based on the merits of the case and the
needs of your particular patient
– Contact the insurer’s designated representative by
phone to ask questions or clarify any issues
• If the plan approves, no further action is required
2nd level appeal
• If the insurer does not approve the 1st appeal, you and the patient
should write another letter to the insurer
• Potential strategies:
– Request a “full and fair review” by a physician not previously involved
in the case
– Ask that the review be conducted “school
to school”
– Request that the physician reviewer
be knowledgeable about the CHARITÉ Artificial
Disc
– Request an opportunity to discuss the
case with the physician reviewer
– Work closely with the patient to get
the patient’s employer involved in the
appeal
– Alternatively, involve a patient advocate or
advocacy group in the appeal
• If the plan approves, no further action is
required
3rd level appeal
• If the insurer continues to deny coverage, you and your patient
will need to write a final letter to the
insurer and appropriate state agencies,
such as the DOI or Office of the Ombudsman
• Potential strategies:
– Investigate whether the patient qualifies under ERISA
– Initiate patient advocacy by contacting
all appropriate local and state agencies
– Contact the patient’s employer to find out whether the employer is willing to
contact the payer and act as a patient advocate. (NOTE: You can offer to provide
return-to-work data and data to help increase the employer’s willingness to participate
in the appeal)
Post 3rd level appeal
• If the 3rd level appeal proves unsuccessful, you and your patient have exhausted
all steps in the appeals process. The patient can consider legal action
Appeals process: the process by which
you seek to overcome a healthcare plan’s denial
of insurance coverage for a medical technology
or procedure that your doctor believes is
necessary.
DOI: Department of Insurance. A department
within the federal or state government that
oversees the functions of all healthcare plans
and is the ultimate authority in the appeals
process. Contact information for the Department
of Insurance can be found in the yellow pages
under state agencies.
ERISA: the Employee Retirement Income
Security Act of 1974. A federal program that
provides benefits for eligible patients and
procedures that might not be covered by private
healthcare plans. The Department of Insurance
can assist you in determining whether you
qualify for benefits under ERISA.
Full and fair review: a review of a
denial of health insurance benefits that is
conducted by a physician who was not involved
in your insurer’s original decision to deny
coverage. Typically the physician reviewer
has the same specialty as your physician.
During the review, your case is examined on
its individual merits and your specific circumstances.
Letter of medical necessity: written
by your surgeon, this letter argues that the
requested surgery is necessary medically for
you. Generally, the letter includes details
about the surgery and a history of your case,
a description of how your condition affects
your life, and published literature that supports
the safety and efficacy of the new technology
or procedure you are requesting.
Medical policy: reimbursement guidelines
and procedures that govern all members of
a healthcare plan.
Office of the Ombudsman: a government
office available in certain states only. The
Ombudsman can assist you in the appeals process
by suggesting additional avenues for appeal
and acting as a patient advocate. To determine
if your state has an Ombudsman, contact the
Division of Consumer Affairs.
Patient advocate: an individual or
group that champions your case before the
healthcare plan and helps bridge the gap between
you and your insurer. Patient advocates can
be effective in helping to overturn a denial
of insurance coverage. A partial listing of
advocacy groups is found on the back cover
of this guide.
Patient benefits booklet: distributed
by the healthcare plan to its members, the
booklet usually contains detailed information
regarding the plan’s policies, benefits, and
procedures for appealing denial of insurance
coverage.
Prior authorization: a request for
approval of a specific medical service, typically
an elective procedure. The process involves
either verbal or written communication between
your doctor and the insurer regarding the
type of service to be performed, the reason
for service, your medical history, and documentation
of the success of the service. In the case
of the CHARITÉ Artificial Disc, a letter requesting
prior authorization should be submitted by
your doctor to your insurer.
School-to-school review: in this type
of review, an insurer hires a physician as
a consultant to evaluate your appeal. The
physician generally works in the same specialty
as your doctor, performs identical types of
procedures, and has experience in treating
other patients with the same condition. Therefore,
he or she is especially qualified to review
your case. In the case of a CHARITÉ Artificial
Disc review the physician should be a surgeon
who performs complex spine surgery.
1. Blumenthal et al. “Prospective study evaluating total disc replacement; preliminary
result.” J Spinal Disord Tech. 2003 Oct;16(5):450-4.
2. Geisler F et al. “Neurological complications of lumbar artificial disc replacement
and comparison of clinical results with those related to lumbar arthrodesis in
the literature: results of a multi-center prospective randomized investigational
device exemption study of CHARITÉ intervertebral disc.” J Neurosurg (Spine
2) 1:143-154. September 2004. Invited Submission from the Joint Section Meeting
on Disorders of the Spine and Peripheral Nerves, March 2004.
3. Hochschuler SH et al. “Artificial disc: preliminary results of a prospective
study in the United States.” Eur Spine J. 2002 Oct;11:Suppl 2:S106-10.
4. Kim WJ et al. “Treatment of juxtafusional degeneration with artificial disc
replacement (ADR): preliminary results of an ongoing prospective study.” Spine.
2003;28 Suppl:390-7.
5. Lemaire JP et al. “Intervertebral disc prosthesis. Results and prospects for
the year 2000.” Clin Orthop. 1997 Apr;(337):64-67.
6. Lemaire JP. “SB CHARITÉ intervertebral disc prosthesis: biomechanical, clinical
and radiological correlations with a series of 100 cases over a follow-up of more
than 10 years,” Rachis. 2002;14(4):271-85 [French].
7. McAfee P et al. “SB CHARITÉ Disc Replacement: report of 60 prospective randomized
cases in a U.S. Center.” J Spinal Disord Tech. 2003 Aug;16(4): 424-33.
8. McAfee P et al. “Experimental design of total disk replacement – experience
with a prospective randomized study of the SB CHARITÉ.” Spine 2003 Oct
15;28(20):S153-62.
Biomechanical Papers
1. Cunningham BW et al. “Biomechanical evaluation of total disc replacement arthroplasty:
an in vitro human cadaveric model.” Spine. 2003;28 Suppl:412-7.
2. Cunningham BW et al. “General principles of total disc replacement arthroplasty:
seventeen cases in a nonhuman primate model.” Spine. 2003 Oct15;28(20):S118-24.
3. Gillet P. “The fate of the adjacent motion segments after lumbar fusion.” J
Spinal Disord Tech. 2003 Aug;16(4):338-45.
4. Hallab N, Link HD, McAfee PC. “Biomaterial optimization in total disc arthroplasty.”
Spine. 2003 Oct 15;l28(20): S1139-52.
Pending Publication
In Print
1. David. “Revision of a CHARITÉ artificial disc 9.5 years in vivo to a new CHARITÉ
artificial disc: case report and explant analysis.” EuroSpin J.
In Review
2. Blumenthal et al. “A Prospective, Randomized, Multi-Center FDA IDE Study of
Lumbar Total Disc Replacement with the CHARITÉ® Artificial Disc vs. Lumbar Fusion:
Part I - Evaluation of Clinical Outcomes.” Spine.
3. McAfee et al. “A Prospective, Randomized, Multi-Center FDA IDE Study of Lumbar
Total Disc Replacement with the CHARITÉ® Artificial Disc vs. Lumbar Fusion: Part
II - Evaluation of Radiographic Outcomes and Correlation of Surgical Technique
Accuracy with Clinical Outcomes.” Spine.
Pending Submission
4. Holt et al. “Complications of Artificial Disc
Replacement.” IDE Study Data. Spine.
5. McAfee et al. “Revisions and Re-operations for Artificial Disc Replacement.”
IDE Study Data. Spine.
6. Regan et al. “Evaluation of the Learning Curve for Artificial Disc Replacement.”
IDE Study Data. Spine.
ABSTRACTS
The following abstracts were presented at the 19th Annual NASS Meeting, October
2004.The printed abstracts can be found in a supplemental issue of The
Spine Journal, 4 (2004) 3S-119S.
1. Blumenthal S, M.D. et al. “Prospective randomized comparison of total disc
replacement to fusion in a 24-month follow-up FDA-regulated study.”
2. McAfee P, M.D. et al. “A prospective randomized FDA study of the Charité disc
replacement – a radiographic outcomes analysis of 276 consecutive patients.”
3. Regan J, M.D. et al. “Charité artificial disc replacement evaluation of the
learning curve and complications in a multicenter prospective randomized controlled
FDA IDE trial.”
4. Tortolani P, M.D. et al. “The incidence of heterotopic ossification in total
disk replacements: a prospective randomized FDA study in 257 consecutive patients.”
5. Lemaire J P, M.D., et al. “Clinical and radiological outcomes with the Charité
intervertebral disc prosthesis – minimum 10-year follow-up.”
6. Scott-Young M, MBBS. “Revision strategies for total lumbar disc replacement.”
7. David T, M.D. et al. “Lumbar disc prosthesis: an analysis of longterm complications
for 272 SB Charité disc prostheses with minimum 10-year follow-up.”
8. Pimenta L, M.D. et al. “Multiple replacement levels with Charité lumbar artificial
disc: 12 months follow-up correct sagittal and coronal alignment.”
The following abstracts have been presented at past society meetings.
9. Hochschuler et al. “Comparison of Return to Work Following Total Disc Arthroplasty
vs. Fusion: A Prospective Randomized Study.” SAS 2004.
10. Cannas et al. “Disc replacement – report on 82 SB CHARITÉ III disc prosthesis
in 75 patients.” ISSLS 2004.
11. David. “Lumbar Disc Prosthesis: Five Years Follow-up Study on 96 patients.”
NASS 2000.
12. David. “Lumbar Disc Prosthesis: Five Years Follow-up Study on 147 Patients
with 163 SB Charité Prosthesis.” EuroSpine 2003.
13. Lemaire JP et al. “Clinical and radiological outcomes with the CHARITÉ intervertebral
disc prosthesis: minimum 10 year follow-up.” IMAST/NASS 2004.
14. McAfee P et al. “The importance of surgical volume as a predictor of outcomes
with spinal surgery – a prospective randomized multicenter trial of 276 patients
undergoing lumbar disk replacement.” IMAST 2004.
PRESENTATIONS
Spine Arthroplasty Society, Vienna Austria: May 4-7, 2004
1. Blumenthal S. “Randomized controlled trial on the CHARITÉ Artificial Disc vs.
fusion for single level lumbar degenerative disc disease: A two year follow-up
study.”
• Results from the U.S. IDE study indicate CHARITÉ Artificial
Disc replacement restores disc height, restores
and maintains range of motion, and leads
to significantly higher rates of patient
satisfaction compared to ALIF with BAK cage
and autograft.
• Patients with CHARITÉ Artificial Disc replacement showed clinically significant
improvement in pain and function at six-months compared to patients with BAK ALIF.
2. Guyer R. “Range of motion analysis of the lumbar spine after total disc replacement:
a prospective two-year follow-up study.”
• In a subset of 53 patients from the U.S. IDE study, range of motion returned
to near normal pre-operative levels at 3 months and was maintained at 2 years.
3. Hochschuler S et al. “Comparison on return to work following total disc arthroplasty
vs. fusion: a prospective randomized study.”
• A report of results for patients enrolled in the CHARITÉ Artificial Disc IDE
study and the ProDisc IDE study at one site showed patients with total disc replacement
returned to work faster than patients with either ALIF or 360º fusion.
4. McAfee P. et al. “A prospective randomized FDA study of the CHARITÉ Artificial
Disc replacement – a correlation of surgically accurate technique with clinical
outcomes in 276 consecutive patients.”
• Radiographs for 276 patients with CHARITÉ Artificial Disc replacement
in the U.S. IDE study were analyzed for
proper placement of the prosthesis. Of those,
83% had ideal placement, 11% had sub-optimal
placement and 6% had poor placement.
• A correlation was shown between ideal
placement and good clinical outcomes, and
poor placement and less than favorable clinical
outcomes.
• The zone of the ideal placement of the CHARITÉ Artificial Disc is large and
forgiving in both the AP and lateral planes (+10mm) as would be expected with
an unconstrained device.
5. Moumene M, Geisler F. “Effect of artificial disc placement on facet loading:
unconstrained vs. semi-constrained.”
• Finite element analysis shows
CHARITÉ Artificial Disc replacement reduced
facet loading by 50% compared to the intact
segment while ProDisc increase facet loading
by 10%.
• An unconstrained design is less sensitive to placement than a semi-constrained
design due to better representation of the floating center of rotation.
6. Sachs B et al. “Comparison of complications associated with total disc replacement
versus lumbar fusion at two-year follow."
• A report of results
for patients enrolled in the CHARITÉ Artificial
Disc IDE study and ProDisc IDE study at
one site showed total disc replacement had
a lower incidence of persistent post-operative
radiculopathy than either ALIF or 360º fusion.
• The complication rate is similar for total disc
replacement and lumbar fusion.
7. Tortolani PJ et al. “The incidence of heterotopic ossification in total disc
replacement.”
• In 257 patients with CHARITÉ Artificial Disc replacement
in the U.S. IDE study, 4.3% exhibited radiographic
signs of heterotopic ossification which
did not affect clinical outcomes or range
of motion.
• Incidence of heterotopic ossification in CHARITÉ Disc patients is low compared
to 43% in total hip replacement.
AANS/CNS, San Diego, CA. March 18, 2004: Section on Disorders of the Spine
8. Geisler F. “CHARITÉ Artificial Disc Results Submitted to FDA.” Study results
suggest that CHARITÉ Artificial Disc has a significant positive effect on pain,
functionality and range of motion after back surgery.
Indications
DISCLAIMER: This information can assist the
surgeon’s business staff and hospital personnel
responsible for billing, coding, and contracting
in their negotiations with third party payers
for coverage and reimbursement for the CHARITÉ
Artificial Disc. It is also intended to assist
third party payers when reviewing the CHARITÉ
Artificial Disc for medical policy coverage
and provider payments. DePuy Spine is pleased
to share this information and trusts that
the material will be a valuable resource to
your organization.
WARNING: In the USA, this product has labeling
limitations. See package insert for complete
information.
CAUTION: Federal (USA) Law restricts this
device to sale by or on the order of a physician
(or properly licensed practitioner) who has
appropriate training or experience.
DePuy Spine is a joint venture with Biedermann
Motech GmbH. DEPUY SPINE™, the DePuy Spine™
logo and CHARITÉ® are all trademarks of DePuy
Spine, Inc.
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