Insurance
Coverage for the CHARITÉ® Artificial Disc
A Patient
Guide to the Appeals Process
Provided as a
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
A Patient Guide to the Appeals Process
If your doctor has recommended that you have
a total disc replacement with the CHARITÉ
Artificial Disc, you may find that your healthcare
plan refuses insurance coverage for the device
the first time around.
Don’t be alarmed if this happens. It’s quite
common for insurers to deny coverage for a
new technology – even a device with as much
clinical experience as the CHARITÉ Artificial
Disc.
Although it has been used for more than 15
years in over 10,000 surgeries worldwide and
recently received FDA approval for use in
the United States, the CHARITÉ Artificial
Disc may be considered “investigational” by
many healthcare plans. Therefore, they may
deny coverage until they have a chance to
conduct their own technology assessment.
This cautious policy is meant to be in your
best interest. However, if you are denied
coverage for the CHARITÉ Artificial Disc and
your doctor believes that the device can make
a significant difference in your life, you
can “appeal” the insurer’s decision to deny
coverage.
Since the appeals process varies from plan
to plan and often involves a number of steps,
it may seem overwhelming at first. However,
don’t be intimidated. This guide provides
the information and tools you need to understand
the process and pursue an appeal.
Throughout the process, keep in mind that,
by working closely with your doctor and remaining
consistent, insistent, and polite in all dealings
with your insurer, you have the best chance
of working through the appeal.
A healthcare plan may sponsor
a panel of experts to review all of the important
information about a new technology. This includes
background information, published articles
in medical journals, efficacy and safety results
from clinical studies, and reported costs
and outcomes. Typically, the panel members
review this information independently, then
form a collective decision. Although the
collective decision about the technology is not binding,
it strongly influences the insurer’s decision
whether to provide coverage for a new device.
If your insurer’s technology assessment confirms
that the CHARITÉ Artificial Disc is safe and
effective for its members, then getting insurance
coverage can be relatively simple and straightforward.
Until a decision is made for all people covered
by a particular insurer, requests for coverage
will be denied. You and your doctor will need
to appeal the decision to deny coverage by
providing additional information to support
your individual case.
If you are considering an appeal, keep
in mind that, if your insurer denies coverage
for a new technology that you have requested,
you are entitled to have your case reviewed.
Most payers are regulated by state and/or
federal laws designed to ensure that patients
are treated fairly. These laws require healthcare
plans to act honestly and in good faith in
fulfilling their obligations to members.
Three parties are frequently involved in appealing
an insurer’s decision to deny coverage: you,
your doctor, and your employer. Occasionally,
a patient advocate or advocacy group may also
help champion your case before the healthcare
plan. Since your doctor has the most medical
knowledge and experience with your case, be
sure to rely on his or her advice throughout
the process.
Together, you, your doctor, and your employer
can be a powerful team in appealing an insurer’s
decision to deny coverage.
Since you have the most to gain or lose from
an insurer’s decision, it’s important that
you take an active role in the appeals process.
You can work to help influence the decision
by…
• Learning all about the process used by your
specific healthcare plan. The procedures may
be explained in the patient benefits booklets
distributed by your healthcare plan, or you
can request a description of the process from
your insurer in writing
• Personally contacting your designated healthcare
plan representative by phone to discuss a
decision or follow up on details of the appeals
process
• Writing a thoughtful appeal letter that
describes the impact of your condition on
your daily activities as well as its impact
on any physical therapy program that you are
involved in
• Asking for advice from your employer, specifically,
an individual in the Human Resources department,
who can help resolve any questions you may
have about your healthcare benefits and explain
how the benefits apply to you
• Keeping a regular log of your contacts with
the insurance company including next steps
and follow-up
• Holding yourself and the insurance company
to all timelines outlined in the appeal procedure
During the appeals process, it is important
that both you and your doctor keep accurate
and detailed records of all interactions with
the healthcare plan and monitor the timeliness
of the plan’s response. (See
sample form)
Generally, before you undergo an elective
surgery (surgery you choose to have performed),
most doctors’ offices need a prior authorization
, or approval,
to ensure that the surgery will be covered
under the plan. For the CHARITÉ Artificial
Disc, your doctor will need to request prior
authorization in writing, through a letter
of medical necessity.
In the letter, your doctor should discuss
all of the details about your case and your
medical history, summarize results of clinical
studies that demonstrate why the surgery is
appropriate for you, explain how you can benefit
from the surgery, and why this surgery is
the best treatment option for you.
Typically, your doctor will receive the response
from your healthcare plan, although you may
receive a response, too. If the healthcare
plan approves your request for prior authorization,
no further action is required. If you receive
a letter indicating denial of coverage, you
and your doctor should consider an appeal.
Each healthcare plan has its own specific
appeals process, so be sure to speak to your
insurer first to learn about all of the steps
and timelines involved. In addition, make
sure that you have a copy of the plan’s guidelines
for an appeal in writing.
If your physician has submitted a letter requesting
prior authorization for surgery and you are
denied coverage, you can appeal to have your
request reconsidered. Your doctor may supply
additional details about the surgery to the
insurer or request that your case is considered
individually – not according to the plan’s
usual medical policies. This is known as a
request for individual consideration.
Your doctor’s letter should be accompanied
by a letter from you explaining your condition,
why you need the surgery, and why you believe
that you are entitled to the surgery under
the terms of your insurance plan.
If your insurer reconsiders your case and
still denies coverage, your doctor can write
to the insurer to ask for a full and fair
review of your request. In this case,
an independent physician, one not involved
in the original decision and not employed
by the healthcare plan, evaluates your case.
In the best case scenario, the physician will
have the same medical specialty as your treating
physician. This is known as a school to
school review. In a school to school review,
your doctor should request to speak with the
reviewing physician. This will give your doctor
the opportunity to discuss your case directly
with the reviewer.
When asking for a full and fair review,
you and your doctor can request that the physician
selected to review your case is knowledgeable
and thoroughly trained specifically in the
use of the CHARITÉ Artificial Disc. You should
know, however, that the healthcare plan is
not obliged to comply with this request.
You may
also want to get your employer involved at this
stage, or to engage a patient advocate or advocacy
group. Their influence can encourage your
insurer to pay special attention to your case.
They can also insure that you are treated
fairly and in accordance with the appeal procedure
outlined by your health insurance plan.
If coverage is denied after a full and fair
review, you and your doctor can appeal to
an outside organization, such as a local government
agency, to evaluate your case. For example,
the Insurance Commission within your home
state may be able to take action to influence
your insurer’s decision.
You may also want to contact your state Department
of Insurance (DOI) to find out whether you
are eligible for insurance benefits under
ERISA, the Employee Retirement Income Security
Act of 1974. This program may be able to provide
the coverage you need.
Another strategy is to contact the Division
of Consumer Affairs or the local Office of
the Ombudsman, if there is one in your state.
The Ombudsman can provide information about
other avenues of appeal available to you and
may even agree to act as an advocate for you.
A search on your home state’s Internet page
can provide a wealth of information on how
to contact the office of the ombudsman.
Look up listings under managed care, consumer
protection, or healthcare commissions to locate
your ombudsman or an equivalent representative.
Local libraries can also provide free internet
services and assist in the search for an ombudsman
or patient advocacy group in your area. Government
agencies for healthcare information for consumers
may also be helpful, and they can be found
in the yellow pages of your phone directory
under state agencies or in the pages with
a blue border that list government agencies.
After you submit your 3rd level appeal, you
and your doctor have exhausted all channels
in the appeals process. If your healthcare
plan denies coverage and you wish to pursue
the matter any further, you may want to consider
legal action.
Throughout the appeals process, you and
your doctor can help prompt a faster response
by requesting an expedited review of your
case and/or following up frequently with your
designated representative of the healthcare
plan. However, since surgery with the CHARITÉ
Artificial Disc is an elective procedure,
the insurer is not obligated to conduct an
expedited review.
There are a number of steps you can take to
keep your appeal moving forward. The following
are a few suggestions:
• Before beginning the appeals process, inquire
about your insurer’s requirements concerning
the selection of healthcare providers and
hospitals and the need for physician referrals.
• Pay attention to the timelines identified
in the appeals process. If you fail to meet
a timeline, you may lose your right to appeal.
Hold your insurer to the timelines as well.
• Note the name of the individual who signed
the first letter of denial of insurance coverage.
Use that person or another individual that
the plan designates as the point of contact
for your next level appeal.
• Stay in frequent contact with the designated
representative of your insurer to make sure
that your appeal is moving along.
• Involve your surgeon in the appeals process.
Ask your doctor to write a letter supporting
your appeal. Also ask him or her to contact
the insurer directly to speak with the person
who denied coverage, as well as the Medical
Director or Case Manager involved.
• Always make sure you
understand each next step in the appeals
process. Don’t hesitate to discuss these steps
with your insurer.
• Involve your employer. The employer is considered
the insurance plan holder, whereas the employee
is the plan subscriber. In some instances,
the employer has control over the benefits
and covered services.
• Keep a record of all
contacts
with your healthcare plan. Note the date and time
of your call or letter, the tone of
the interaction, the topics discussed, any next steps with
their due dates, and the outcome of
the call or correspondence. Record names, titles, departments, and
phone numbers (See sample form below
and/or on page 18 of the downloadable pdf
file).
• Contact your local Division of Consumer
Affairs or the Office of the Ombudsman to
assist in your appeal and make sure that you
understand each step in the appeals process.
By following the guidelines
below, you can
create a strong appeal letter. You will
find suggested outlines for the content of 2
appeal letters in the Appendix that follows below
and/or on pages 12-15 of the downloadable pdf
file. As you write your letter, keep the
following points in mind:
• Write in a friendly, informative manner.
Explain your condition and the impact it has
had on your life, why you need the surgery,
and why you feel that you are entitled to
the surgery under the terms of your insurance
plan.
• Always make your appeal in your own words.
Refrain from using catch phrases or standard
wording.
• Try to determine whether the denial of
coverage involves a healthcare provider issue(i.e., inadequate
authorization of services) or an administrative
issue(lack of coverage for specific services).
Then address the issue in your letter, stating
clearly what you want to appeal and why. Concentrate
on the facts and refer back to the specific
points raised by the insurer in the denial
letter you have received.
• Include the name of your doctor, the scheduled
date for your surgery, your insurance ID number,
an insurance claim number, if available, and
any other identifying information. Also include
information about how the insurer can get
in touch with you – phone and fax numbers,
e-mail addresses, etc.
• Work closely with your doctor on all insurer-directed
communication.
• End each letter with the timeframe in which
you expect a response, based on the insurer’s
own written guidelines. Make sure your healthcare
plan follows up within the timeline established
for the appeals process.
• Send your appeal letter by certified mail,
return receipt requested. Keep a copy of the
appeal, delivery receipt, and a record of
all correspondence (written or verbal) for
your files.
• Provide a copy of the letter to your surgeon
and your employer’s Human Resources department.
• A written appeal requires a response from
your insurer. After sending an appeal letter,
you should receive notice from the healthcare
plan that your appeal has been received. If
you do not receive this notice, contact the
plan to make sure your appeal has been delivered
to the appropriate individual. Refer to the
return receipt during your conversation.
This outline suggests one method of organizing
your appeal letter. Please remember that you
should tell your story in your own words.
[Date]
[Name of Representative from Insurance Company]
[Insurance Company Name]
[Insurance Address]
[City, State, Zip]
Re: Request for Reconsideration of a Denial
of Coverage
[Your Name]
[Type of Insurance]
[Group Number/Policy Number]
[Subscriber ID Number]
Dear [Name of designated representative of
insurance company]:
Paragraph
1
• State that you wish to appeal the plan’s
denial of coverage for the CHARITÉ Artificial
Disc.
• Indicate the date of the letter of denial.
• State that you understand that the healthcare
plan has determined that the CHARITÉ Artificial
Disc is an investigational device.
Paragraph
2
• Mention the condition that you have been
diagnosed with and the date of the diagnosis.
• Describe your condition, the various treatments
you have tried and the impact of the condition
on your life and on your family.
•
Explain that your
doctor believes that you are a good candidate
for surgery with the CHARITÉ Artificial Disc, that
the CHARITÉ Artificial Disc is the
best treatment for you, and that he
or she ```believes that you will significantly
benefit from it.
• Add that your doctor has submitted a letter
of medical necessity that includes an overview
of your medical history and diagnosis, a discussion
of how the CHARITÉ Artificial Disc will be
used to correct your condition, and his or
her rationale for the surgery.
Paragraph
3
• Point out that the CHARITÉ Artificial Disc
has been approved by the FDA and has been
demonstrated to be safe and effective.
• Mention that your doctor is well trained
in this surgery.
• Ask that the insurer reconsider the earlier
decision and allow coverage for the CHARITÉ
Artificial Disc for your case.
• Offer to have your surgeon provide any additional
information that is necessary regarding your
medical history or the CHARITÉ Artificial
Disc.
•
Thank the insurer for taking the time to review
your letter .
• Conclude by indicating that you look forward
to hearing from the insurer by [date].
This outline suggests one method of organizing
your appeal letter. Please remember that you
should tell the your story in your own words.
[Date]
[Name of Representative from Insurance Company]
[Insurance Company Name]
[Insurance Address]
[City, State, Zip]
Re: Request for Reconsideration of a Denial
of Coverage
[Your Name]
[Type of Insurance]
[Group Number/Policy Number]
[Subscriber ID Number]
Dear [Name of designated representative of
insurance company]:
Paragraph
1
• State that you wish to appeal the plan’s
denial of coverage for the surgery to implant
the CHARITÉ Artificial Disc.
• Mention that this surgery has been recommended
by your doctor[specify physician’s name].
• Explain that your doctor and others have
treated your symptoms for some time without
any real improvement.
• List your symptoms and limitations.
• Describe how your symptoms have prevented
you from participating in your normal activities
(i.e., working, taking care of your home,
your family, other responsibilities).
Paragraph
2
• Mention that your doctor has discussed all
of your options with you.
• Indicate that you believe that the option
with the greatest chance to help you is the
CHARITÉ Artificial Disc.
• Note that your doctor has advised you that
the surgery is medically necessary.
• Point out that you continue to have symptoms
and disabilities, despite having been treated
with medications [list which ones], therapy
[specify physical or chiropractic], devices
[specify adaptive devices or braces, if used]
and surgery [specify what procedure, if performed].
Paragraph
3
• State that you understand your rights to
appeal the plan decision to deny surgery.
• Request that your appeal be reviewed by
a physician in a specialty similar to your
doctor’s, a surgeon who is trained in complex
spine surgery.
•
Note that you are aware of the insurer’s timeline
for reviewing the appeal [specify the
number of days] .
Paragraph
4
• State that you have asked your doctor to
assist in the review process by providing
the insurer with more medical information
and data on the surgery.
• Request that your doctor speak directly
with the reviewer, physician to physician,
to discuss your case in a consultative manner.
Paragraph
5
• Conclude by stating that you look forward
to a timely review and a favorable outcome.
• Restate the fact that you need this surgery
in order to improve your life and your ability
to function.
– Ask your doctor to provide
more details about the technology and clinical
documentation to argue against the idea
that the device is investigational
– Ask your doctor to submit a “request for
individual consideration,” based on the
merits of your case and your specific needs
– Urge your doctor to 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 your 1st
appeal, you and your doctor will need to write
another letter to the insurer
• Potential strategies:
– Request a “full and fair review”
by a physician not previously involved in
your case
– Ask that the review be conducted “school
to school”, meaning it is done by a spine
surgeon knowledgeable in complex spine surgeries
– Request that the physician reviewer be
knowledgeable about the CHARITÉ Artificial
Disc
– Ask your doctor to discuss the case with
the physician reviewer
– Try to get your employer involved in the
appeal
– 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 doctor will need to write another
letter to the insurer
• Potential strategies:
– You and your doctor can investigate
whether you qualify for benefits under ERISA
– Contact local and state agencies that
can help advise you and “lobby” for your
case, i.e., the Office of the Ombudsman
– Ask a representative of your employer
(i.e., someone from Human Resources) to
contact your insurer and act as your advocate
Post 3rd
level appeal
• If the 3rd level appeal proves unsuccessful,
you have exhausted all steps in the appeals
process. At this point you may wish to consider
legal action
YOUR NAME: _________________________________
TYPE OF INSURANCE: _________________________________
MEMBER/GROUP NUMBER: _________________________________
APPEALS CASE NUMBER: _________________________________
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 medically necessary 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 prior to the
procedure being performed. 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.
List of Attorneys General by state: http://www.naag.org/ag/full_ag_table.php.
Search for health care unit. An appeals and
grievance process should be defined – complaint
forms may be available to download.
The CHARITÉ® Artificial
Disc is indicated for spinal arthroplasty
in skeletally mature patients with degenerative
disc disease (DDD) at one level from L4-S1.
DDD is defined as discogenic back pain with
degeneration of the disc confirmed by patient
history and radiographic studies. These DDD
patients should have no more than 3mm of spondylolisthesis
at the involved level. Patients receiving
the CHARITÉ Artificial Disc should have failed
at least six months of conservative treatment
prior to implantation of the CHARITÉ Artificial
Disc.
LIMITED WARRANTY AND DISCLAIMER: DePuy
Spine products are sold with a limited warranty
to the original purchaser against defects
in workmanship and materials. Any other express
or implied warranties, including warranties
of merchantability or fitness, are hereby
disclaimed.
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.
Download this
entire Guide - PDF File (374
Kb)
A Patient
Guide to the Appeals Process: Appendices ONLY - Microsoft Word File (40 Kb)
