Statement of
Medical Necessity
Get set for submission
To ensure prompt processing, ask yourself the following
questions prior to submission:
Did you ll out the entire form?
Did you include the patient’s premorbid and current weights?
Did you select a diagnosis?
Did you select a dose?
Did you specify details for injection training?
Select "Register Only" to enroll your patients for services that include a dedicated
case manager, assistance programs, 24/7 phone support for product-related questions,
and in-home or in-office injection training.
©2019 EMD Serono, Inc. All rights reserved.
EMD Serono is a business of Merck KGaA, Darmstadt, Germany
US/SER/0419/0032
4. Rx AND STATEMENT OF
MEDICAL NECESSITY
STATEMENT OF MEDICAL NECESSITY
Complete and fax.
Note that some plans may require 3-6 months of clinical notes.
Make sure to complete entire form before submitting.
1. PATIENT INFORMATION
2. DIAGNOSIS INFORMATION
To be completed and signed by prescriber.
Phone: 1-877-714-AXIS (2947)
Fax: 866-823-9554
Patient Name
DOB / / Male Female
Street Address
City State Zip
Preferred Phone # Email
Okay to Leave Detailed Message: Daytime Evening
INSURANCE INFORMATION
Primary Insurance
Insurance ID Payer Phone #
> IMPORTANT: Attach a copy, front and back, of patient’s insurance card
PATIENT MEDICAL HISTORY
Active malignancy (other than Kaposi’s Sarcoma)? Yes No
Describe Date / /
HAART/Antiretroviral therapy
Yes No
Describe Date / /
Adequate oral nutritional intake?
Yes No
Trial with appetite stimulant? Megace
®
Marinol
®
Other
Describe Date / /
TREATMENT WITH TESTOSTERONE OR ANABOLIC STEROIDS
Therapy Tried
Testosterone
Therapy Name
Response to Therapy Date / /
Anabolic Steroids
Therapy Name
Response to Therapy Date / /
Other
Therapy Name
Response to Therapy Date / /
IF PATIENT IS NOT A CANDIDATE FOR ANABOLICS, STATE REASON
Elevated liver function enzymes / impaired liver function
Elevated triglycerides or cholesterol
Other
Prescriber Name
Office/Clinic/Institution
Street Address
City
State Zip
Phone #
Fax #
Tax ID #
Medicaid #
NPI #
OFFICE CONTACT
Name
Phone Email
PRESCRIPTION
Serostim
®
4-mg, multi dose 7-vial pack
5-mg 7-vial pack
6-mg 7-vial pack
Prescribed dose
mg per day for 28 days refills
No Substitutions / Dispense as Written
RECONSTITUTION AND ADMINISTRATION
29G, 1⁄ 2˝ needles, 3-cc syringe, with 20G, 1˝ needles
for reconstitution
30G, 1⁄ 2˝ needles, 3-cc syringe, with 20G, 1˝ needles
for reconstitution
Select reconstitution volume
0.5 mL 1.0 mL
Injection training to be conducted by EMD Serono
Yes No
Training location
Prescriber Office Home / Other Web-based
Yes No HIV-associated Wasting
Premorbid Weight
Date / /
Current Weight
Date / /
Weight Loss History
Date
Weight
DIAGNOSED BY THE FOLLOWING
1. Weight Loss
Unintentional weight loss of
% in months.
2. BMI
Current BMI Date / /
3. PRESCRIBER INFO
PRESCRIBER CERTIFICATION
I certify that the prescribed therapy is medically necessary,
that the information in this Statement of Medical Necessity
is accurate to the best of my knowledge, and that I am aware
of the risks and benefits associated with use of Serostim
®
.
I authorize EMD Serono (1) to provide any information on this
form to the insurer of the named patient and (2) to forward the
above prescription, by fax or by other mode of delivery, to the
chosen pharmacy.
Prescriber's Name:
Date: / /
Prescriber's Signature:
Pharmacy Name
Pharmacy Address
Pharmacy Fax
ICD10: R64, B20, B22.2
Register Only
This section must be completed in entirety in order for the case to be processed.
Include supporting documentation.
Response to previous course of Serostim
®
therapy (if applicable)
3. Other Signs of
HIV-associated Wasting
click to sign
signature
click to edit
PATIENT AUTHORIZATION
Phone: 1-877-714-AXIS (2947)
Fax: 866-823-9554
Patient Name: ____________________________________
Date of Birth: ____________________________________
Home Phone #: ____________________________________
AUTHORIZATION TO USE AND DISCLOSE HEALTH
AND OTHER PERSONAL INFORMATION
I authorize my physician and their staff to disclose my health
and other personal information, including, but not limited to, the
information on my completed Statement of Medical Necessity
form and, if eligible, the application for EMD Seronos Patient
Assistance Program and any confidential HIV-related information,
if applicable, including HIV test results, to EMD Serono, Inc. and
its agents and representatives (collectively “EMD Serono”) so
that EMD Serono may use and further disclose my information
to healthcare providers, pharmacies, insurance companies,
prescription drug plans, and other third-party payers (collectively,
Third Parties”) in order to:
(1) facilitate the filling of my prescription for and the delivery and
administration of Serostim
®
;
(2) assist me in obtaining insurance coverage for Serostim
®
;
(3) contact me by mail, e-mail, and/or telephone to enroll me in,
and administer, programs that provide Serostim
®
support
services;
(4) including to determine my eligibility to participate in the Patient
Assistance Program, and, if eligible, to verify the accuracy
of the information I provide in my application for the Patient
Assistance Program;
(5) provide me with free educational information and materials;
(6) conduct surveys to measure my satisfaction with patient
support services; and
(7) for such other purposes as may be required or permitted by
applicable law.
I further authorize the Third Parties to disclose health and other
personal information about me in their possession to EMD Serono
in order to assist EMD Serono in accomplishing the purposes
described above.
I understand that, once my information is disclosed pursuant
to this authorization, it may no longer be protected by federal
privacy laws (the Health Insurance Portability and Accountability
Act). However, I understand that EMD Serono will not release my
information to any party, except as provided in this authorization or
as permitted by applicable law, without first obtaining my (or my
authorized representative’s) separate written consent.
I understand that I may refuse to sign this authorization and
that such refusal will not affect my ability to receive Serostim
®
,
but, if eligible, it will limit my ability to participate in the Patient
Assistance Program.
I understand that this authorization will remain in effect for ten
years from the date of my signature, unless I revoke it earlier
by contacting EMD Serono in writing at One Technology Place,
Rockland, MA 02370.
If I revoke this authorization, EMD Serono will stop using and
disclosing my information as soon as possible, but the revocation
will not affect prior use or disclosure of my information in reliance
on this authorization.
I understand that the services provided by EMD Serono that are
described in this authorization can be changed at any time, without
prior notification.
I understand that certain Third Parties may receive compensation
in exchange for their disclosure of my information to EMD Serono.
I also understand that I have the right to receive a copy of this
authorization.
Patient Name (please print)
Signature of Patient (or personal representative)
Date / /
Authority/Relationship of Personal Representative to Sign on
behalf of Patient (if applicable)
Street Address:
________________________________________
City: _____________________ State: _________
Zip: ________________________________________
©2019 EMD Serono, Inc. All rights reserved.
EMD Serono is a business of Merck KGaA, Darmstadt, Germany
US/SER/0419/0032
Phone: 1-877-714-AXIS (2947)
Fax: 866-823-9554
The AXIS Center
®
offers patient support through assistance with prior authorizations,
appeals, financial support, injection training, and addressing patient questions.
1. Contact the AXIS Center
®
at 1-877-714-AXIS (2947).
2. Fax completed SMN to 866-823-9554.
3. Receive confirmation of receipt within 24 hours.
If you do not receive conrmation,
contact the AXIS Center
®
.
Select "Register Only" to enroll your patients for services that include a dedicated
case manager, assistance programs, 24/7 phone support for product-related questions,
and in-home or in-office injection training.