Covered by Medicare Billing Guide for EMEND Billing Guide for by guy22

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									          Covered by
           Medicare




Billing Guide
for EMEND
Billing Guide for EMEND
This billing guide has been prepared by Merck & Co., Inc., to help
answer billing and reimbursement questions that may arise when
you are prescribing EMEND® (aprepitant) .
Inside you will find details about new Medicare coverage of EMEND
for appropriate patients,1 as well as sample billing forms for both
outpatient clinics and office-based physicians. To help ensure that all
eligible patients may receive EMEND, an explanation of services
provided by the ACT Program— Accessing Coverage Today for
EMEND— is also provided.
Your Merck representative may have information about local
Medicare and managed care organization coverage of EMEND.
When available, such information can be found in the clear pocket
at the back of this guide.
Finally, an overview of antiemetic guidelines is included for your
information and convenience.2,3


EMEND, in combination with other antiemetic agents, is indicated
for prevention of:
• Acute and delayed nausea and vomiting associated with initial
  and repeat courses of highly emetogenic cancer chemotherapy,
  including high-dose cisplatin.
• Nausea and vomiting associated with initial and repeat courses
  of moderately emetogenic cancer chemotherapy.


This information is current as of March 2006. Confirm all coding and
billing information with individual third-party payers because policies
may differ. The codes provided in this resource serve only as a guide,
and their use does not guarantee payment. It is the responsibility of
each provider to ensure that the billing and coding for all services and
products are appropriate and correct.




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
Table of Contents
National Coverage Decision for EMEND . . . . . . . . . . . . . . . . . . . . . . .2


Medicare Part B and Part D Coverage . . . . . . . . . . . . . . . . . . . . . . . . .4


Outpatient Billing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6


Office-Based Billing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8


The ACT Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10


USP Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14


Antiemetic Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16


Local Formulary Coverage Information . . . . . . . . . . . . . . . . . . . . . . . 17



Selected Important Risk Information
EMEND is a moderate CYP3A4 inhibitor. EMEND should not be used
concurrently with pimozide, terfenadine, astemizole, or cisapride.
Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by
aprepitant could result in elevated plasma concentrations of these
drugs, potentially causing serious or life-threatening reactions.




                                                                                                    1
National Coverage Decision
for EMEND
Medicare Part B Coverage of Oral Antiemetics
Medicare Part B covers oral antiemetics that are used as a full
therapeutic replacement for an intravenous (IV) antiemetic regimen
that otherwise would have been administered at the time of
chemotherapy treatment. Medicare-covered oral antiemetics are
administered within 2 hours before and 48 hours after the
administration of the chemotherapy drug.



Selected Important Risk Information
EMEND should be used with caution in patients receiving
concomitant medicinal products, including chemotherapy
agents, that are primarily metabolized through CYP3A4.
Inhibition of CYP3A4 by aprepitant could result in elevated
plasma concentrations of these concomitant medicinal products.
The effect of EMEND on the pharmacokinetics of orally
administered CYP3A4 substrates is expected to be greater
than the effect of EMEND on the pharmacokinetics of
intravenously administered CYP3A4 substrates.
Because a small number of patients in clinical studies received the
CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular
caution and careful monitoring are advised in patients receiving these
agents or other chemotherapy agents metabolized primarily by
CYP3A4 that were not studied.




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
2
                                                                            National Coverage Decision
Medicare Part B Coverage of EMEND
Effective April 4, 2005, Medicare Part B covers EMEND for
chemotherapy-induced nausea and vomiting when used in combination
with an oral 5-HT3 receptor antagonist and oral dexamethasone. Coverage
is defined for patients receiving 1 or more of the following anticancer
chemotherapeutic agents:
• carmustine             • dacarbazine          • doxorubicin
• cisplatin              • mechlorethamine      • epirubicin
• cyclophosphamide       • streptozocin         • lomustine
Please refer to the Decision Memo for Aprepitant for Chemotherapy-Induced
Emesis (CAG-00248N) at http://new.cms.hhs.gov/mcd/viewncd.asp?ncd_id
=110.18&ncd_version=1&basket=ncd%3A110%2E18%3A1%3AAprepitant
+for+Chemotherapy%2DInduced+Emesis.

EMEND Is Now Also Covered by Medicare Part D
Effective January 1, 2006, EMEND is covered by both Medicare
Part B and Part D.1 Coverage depends on the regimen with which
EMEND is dispensed and is subject to plan formulary. Please refer
to the Decision Memo for Aprepitant for Chemotherapy-Induced
Emesis (CAG-00248N) at http://new.cms.hhs.gov/
MedlearnMattersArticles/downloads/MM3831.pdf.




                                                                       3
 EMEND—Approved by Medicare
 for Part B and Part D Coverage
 The table below explains Medicare Part B and Part D coverage for EMEND.


             Medicare Part B                       Medicare Part D

     EMEND is prescribed with an oral        Covers medical uses of EMEND that
     5-HT3 receptor antagonist and oral      are not covered by Part B.
     dexamethasone.
     Covers oral antiemetics that are
     • Used as a full therapeutic
       replacement for an IV antiemetic
       that otherwise would have been
       administered at the time of
       chemotherapy treatment.
     • Administered within 2 hours before
       and 48 hours after administration
       of the chemotherapy drug.
     • Prescribed for a patient receiving
       1 or more of the following
       anticancer chemotherapeutic
       agents: carmustine, cisplatin,
       cyclophosphamide, dacarbazine,
       mechlorethamine, streptozocin,
       doxorubicin, epirubicin, lomustine.
                                             Claims should be billed to the
     Claims should be billed to the          appropriate Medicare prescription
     appropriate DMERC or DME MAC.*          drug plan (PDP).

*DME MACs (Durable Medical Equipment Medicare Administrative Contractors) will
 replace DMERCs (Durable Medical Equipment Regional Carriers) on July 1, 2006.
 Before that date, please submit claims to the appropriate DMERC. After that date,
 claims must be submitted to the appropriate DME MAC.

 Selected Important Risk Information
 The most frequent adverse events reported in clinical trials of EMEND
 for highly emetogenic chemotherapy were asthenia/fatigue (17.8%),
 nausea (12.7%), hiccups (10.8%), constipation (10.3%), diarrhea (10.3%),
 and anorexia (10.1%).
 The most frequent adverse events reported in clinical trials of EMEND
 for moderately emetogenic chemotherapy were alopecia (24.0%),
 fatigue (21.9%), headache (16.4%), constipation (12.3%), neutropenia
 (8.9%), dyspepsia (8.4%), stomatitis (5.3%), hot flush (3.0%), and
 pharyngolaryngeal pain (3.0%).
 4
Writing a Prescription for EMEND for Appropriate Patients
To ensure accurate documentation for the use of EMEND, please
use the prescription sticker available from your Merck representative,
or document the antiemetic and chemotherapy regimen on the
prescription. An example is provided below:


        Medicare Part B                     OR       Medicare Part D
    Aprepitant was prescribed                    Aprepitant was not prescribed in
    • In combination with an oral                accordance with the Medicare
      5-HT3 receptor antagonist and              Part B coverage guidelines found
      oral dexamethasone                         in the National Coverage
       AND                                       Decision for Aprepitant.




                                                                                        Medicare Part B and Part D
    • For a patient receiving 1 or
      more of the following
      anticancer chemotherapeutic
      agents: carmustine, cisplatin,
      cyclophosphamide,
      dacarbazine,mechlorethamine,
      streptozocin, doxorubicin,
      epirubicin, or lomustine

If the patient’s claim is reimbursable under Medicare Part B,
please instruct him or her to find a local DMERC or DME MAC
pharmacy or supplier
• By visiting the CMS† website,
  http://www.medicare.gov/Supplier/Home.asp
• By calling the ACT program — Accessing Coverage Today
  for EMEND — the reimbursement and patient support
  program sponsored by Merck & Co., Inc., at
  1-866-EMEND-Rx (1-866-363-6379)




Centers for Medicare & Medicaid Services.
†



Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
                                                                                    5
                                                             ®
 Outpatient Billing for EMEND (aprepitant)
 Hospital outpatient clinics that dispense EMEND and other
 oral antiemetics to their patients for prechemotherapy and
 postchemotherapy treatment of nausea and vomiting may bill
 Medicare Part B for the covered drugs on the UB-92 (CMS-1450)
 claim form.
 Please note that effective July 1, 2006, there is a new policy on
 hospital outpatient billing for take-home oral antiemetics (CMS
 Manual System, Pub 100-04, Medicare Claims Processing Manual,
 Transmittal 840: http://www.cms.hhs.gov/transmittals/downloads/
 R840CP .pdf).
 An update for the hospital outpatient billing for EMEND will be
 available before July 1, 2006, and may be obtained from your
 Merck representative.

 Coding for EMEND
                                                      HCPCS           Number of
                             Revenue     HCPCS*     Description,         HCPCS
        How Supplied                                 Including
                              Code        Code    Standard Billing     Standard
                                                        Unit          Billing Units
          Trifold pack         636
     containing one 125-mg    (drugs                Aprepitant,       57 per trifold
          capsule and        requiring   J8501         oral,              pack
      two 80-mg capsules     detailed                per 5 mg        (285 mg/5 mg)
       NDC 0006-3862-03       coding)
                               636
       80-mg capsules         (drugs                Aprepitant,      16 per capsule
       NDC 0006-0461-30      requiring   J8501         oral,         (80 mg/5 mg)
       NDC 0006-0461-05      detailed                per 5 mg
                              coding)
                               636
      125-mg capsules         (drugs                Aprepitant,      25 per capsule
      NDC 0006-0462-30       requiring    J8501        oral,         (125 mg/5 mg)
      NDC 0006-0462-05       detailed                per 5 mg
                              coding)



*HCPCS=Healthcare Common Procedure Coding System.


 EMEND is given for 3 days as part of a regimen that includes a
 corticosteroid and a 5-HT3 receptor antagonist. The recommended
 dosage of EMEND is 125 mg orally 1 hour before chemotherapy
 treatment (Day 1) and 80 mg once daily in the morning on Days 2 and 3.


 Before prescribing EMEND, please read the
 Prescribing Information enclosed in the back pocket.
 6
Sample UB-92 Form for Hospital Outpatient
Clinic Billing
                                                                FL 46: Days or Units
                                                        The quantity of drug per capsule
                                                          is converted into billing units,
                                                         and the number of billing units
       FL 42: Revenue Code                                     is entered in FL 46.
    Enter Revenue Code 636                             Because J8501 describes EMEND
(drugs requiring detailed coding)                    per 5 mg, a trifold pack containing one
 on the lines on which EMEND                            125-mg capsule and two 80-mg
   and the other covered oral                              capsules = 57 billing units.
     antiemetics are listed.

                                             JXXXX          1        xxx.xx

                                             JXXXX          1        xxx.xx

 636       Drugs requiring detailed coding   J8501         57

 335       Chemotherapy                      CXXXX          1

 335       Chemotherapy                      CXXXX
                                                           FL 44: HCPCS
                                                         J8501 is the HCPCS
                                                          code for EMEND.




  xxx.xx         xxx.xx
                                                                                                   Outpatient Billing




For more information, contact ACT, the reimbursement and patient
support program for EMEND sponsored by Merck & Co., Inc.,
at 1-866-EMEND-Rx (1-866-363-6379).
Contact your local Medicare carrier for further information.

                                                                                               7
Office-Based Billing
                       ®
for EMEND (aprepitant)
Coding for EMEND
Office-based physicians who dispense EMEND and other oral
antiemetics to their patients for prechemotherapy and postchemotherapy
prevention of nausea and vomiting may bill Medicare Part B for the
covered drugs. CMS-1500 claim forms for oral drugs are filed to a
DMERC or DME MAC rather than your local Part B carrier. You must have
a DMERC or DME MAC supplier number to file claims for your region.
Contact the National Supplier Clearinghouse at 1-866-238-9652 or visit the
website below for more information about obtaining a supplier number:
http://www.pgba.com/palmetto/Providers.nsf/Home/Providers+
National+Supplier+Clearinghouse+Home?OpenDocument

                                    HCPCS Description,
                            HCPCS      Including           Number of HCPCS
        How Supplied
                             Code       Standard         Standard Billing Units
                                       Billing Unit
         Trifold pack
    containing one 125-mg            Aprepitant, oral,    57 per trifold pack
         capsule and        J8501
                                        per 5 mg           (285 mg/5 mg)
     two 80-mg capsules
      NDC 0006-3862-03

      80-mg capsules
                                     Aprepitant, oral,      16 per capsule
      NDC 0006-0461-30      J8501
                                        per 5 mg            (80 mg/5 mg)
      NDC 0006-0461-05


      125-mg capsules
                                     Aprepitant, oral,     25 per capsule
      NDC 0006-0462-30      J8501
                                        per 5 mg           (125 mg/5 mg)
      NDC 0006-0462-05



Selected Important Risk Information
The efficacy of hormonal contraceptives may be reduced during
coadministration with EMEND and for 28 days after the last dose of EMEND.
Alternative or backup methods of contraception should be used during
treatment with EMEND and for 1 month after the last dose of EMEND.
Coadministration of EMEND with warfarin may result in a clinically
significant decrease in international normalized ratio (INR) of prothrombin
time. In patients on chronic warfarin therapy, the INR should be closely
monitored in the 2-week period, particularly at 7 to 10 days, following
initiation of the 3-day regimen of EMEND with each chemotherapy cycle.
Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
8
                                                                              Office-Based Billing
Sample CMS-1500 Form for DMERC Billing by
Office-Based Dispensing Physicians




                                        Field 24G: Days or Units
                                     The quantity of drug per capsule
                                       is converted into billing units,
                                      and the number of billing units
                                           is entered in Field 24G.
                                         Because J8501 describes
        Field 24D:                      EMEND per 5 mg, a trifold
                                       pack containing one 125-mg
 J8501 is the HCPCS code                  capsule and two 80-mg
        for EMEND.                      capsules = 57 billing units.




For more information, contact ACT, the reimbursement and patient
support program for EMEND sponsored by Merck & Co., Inc., at
1-866-EMEND-Rx (1-866-363-6379).
Contact your local Medicare carrier for further information.




                                                                          9
The ACT Program
ACT is a 2-part program specifically designed to assist insured
patients with insurance reimbursement issues, and to provide
product support for those qualified individuals lacking coverage
for EMEND® (aprepitant). Reimbursement Support Services and
Patient Assistance are both provided.
• Reimbursement Support Services: A free support program that is
  committed to helping with questions related to insurance coverage
  for EMEND
• Patient Assistance: Provides EMEND free of charge to eligible
  patients who do not have insurance coverage
When you call the toll-free number, 1-866-EMEND-Rx (1-866-363-6379),
an ACT Reimbursement Specialist will assist you. These specially
trained representatives will help answer questions related to
insurance coverage for EMEND and will process applications for
patient assistance.




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
10
Reimbursement Support Services
• Personalized support—the same Reimbursement Specialist
  dedicated to each case throughout the entire process
• Complete insurance benefit investigation
• Patient advocacy throughout the prior-authorization process
• Support of the patient by initiating the appeals process on his
  or her behalf
• Assistance with the medical-necessity process
• Assistance with a comprehensive search for alternate reimbursement




                                                                                The ACT Program
  resources and enrollment assistance for qualified patients (eg, state
  and federal assistance programs)
• Coordination of patient’s receipt of EMEND from in-network pharmacy
• Assessment of patient’s qualification for patient assistance,
  and processing accordingly

Contacting ACT for Reimbursement Assistance
The ACT Program for EMEND can be accessed by calling
1-866-EMEND-Rx (1-866-363-6379) to speak to a dedicated
Reimbursement Specialist.
• Speak live to a Reimbursement Specialist, Monday through Friday,
  8 AM to 8 PM ET.
• Leave a confidential message for the dedicated Reimbursement
  Specialist 24 hours a day.
• If you are calling with an insurance question, please be prepared
  to provide personal coverage information, such as insurance
  policy number, name of policy holder, group number, and patient
  information. The patient’s personal identifying information will be
  available to RxCrossroads, the administrator of this program, but
  will not be disclosed to anyone else, except as required by law.




                                                ACT
                                                Accessing Coverage Today
                                                for EMEND® (aprepitant)

                                                                           11
ACT Patient Assistance
An ACT Reimbursement Specialist will help patients apply for patient
assistance, which provides EMEND® (aprepitant) to eligible patients
without insurance coverage.
• Convenient: Patients can apply 1 of 3 ways—phone, fax, or mail.
• Easy: Just complete a simple 1-page application.
• Fast response: EMEND can be shipped directly to the patient’s
  home within 48 to 72 hours of receipt of application, unless the
  prescription for EMEND has to be sent to the physician’s office.
• Refills available: A single application covers 1 prescription
  and refills for up to 12 months.
Patient assistance is available for patients who have:
• No insurance
• Insurance, but no prescription coverage
• Been denied access into a federally funded or state-funded
  assistance program

Contacting ACT for Patient Assistance
The ACT Reimbursement Specialist will accept applications
for patient assistance:
• Over the phone: 1-866-EMEND-Rx (1-866-363-6379)
• Via fax: 1-866-EMEND-Tx (1-866-363-6389)
     — When faxing the completed application, promptly enclose
       the signed original application in the self-addressed postage-paid
       envelope provided and place in the mail. Signed original
       applications must be received for all patients who receive
       EMEND through the Patient Assistance Program. Product
       will not be delayed to qualified patients for the first shipment;
       however, subsequent refill shipments will not be shipped until
       the original signed application has been received.
• Via mail: ACT
            PO Box 18979
            Louisville, KY 40261-0979




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
12
Qualifying for ACT Patient Assistance
1. Household net income
2. Geographic location of the patient
3. Number of people in the household
4. Household out-of-pocket medical expenses (that are deducted
   from net income)

Other Important Information
EMEND, distributed through the ACT Program for EMEND, is free
of charge to all eligible patients. Merck & Co., Inc., is not associated
with any individuals or organizations that may charge patients a fee
to assist them in completing applications for our program. If patients
contact someone for assistance in completing the application, these
individuals or organizations are acting independently of Merck, have
no affiliation with Merck, and do not have the consent of Merck.
While Merck will make every effort to grant assistance, Merck cannot
guarantee you product patient assistance. Merck reserves the right to
change or discontinue the program at any time.




                                                 ACT
                                                 Accessing Coverage Today
                                                 for EMEND® (aprepitant)

                                                                            13
USP Guidelines
Updates for Benefit Year 2007
Under the Medicare Modernization Act, the United States
Pharmacopeia (USP) is required to develop and update a formulary
template, the USP Model Guidelines Version 2.0, for use by Medicare
Part D Plans in developing their formularies. These guidelines
are voluntary.
The Therapeutic Category for Antiemetics (No. 28) has been updated
in the most recent version of the guidelines with further distinctions
according to drug class and mechanism of action. In Version 1.0, only
5-HT3 receptor antagonists and “other” antiemetics were listed
as Formulary Key Drug Types. However, Version 2.0 now includes
NK1 receptor antagonists as a separate Formulary Key Drug Type
for benefit year 2007.

Selected Important Risk Information
EMEND is a moderate CYP3A4 inhibitor. EMEND should not be used
concurrently with pimozide, terfenadine, astemizole, or cisapride.
Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by
aprepitant could result in elevated plasma concentrations of these
drugs, potentially causing serious or life-threatening reactions.




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
14
Sample USP Model Guidelines Version 2.0 and
Formulary Key Drug Types




                                                NK1 receptor
                                                antagonists
        No. 28                                 included as a
      Antiemetics                             Formulary Key
                                                 Drug Type




                                                               USP Guidelines




                                                         15
Antiemetic Guidelines
Several national and international guideline groups include EMEND
as part of a standard antiemetic regimen for select patients.

National Comprehensive Cancer Network (NCCN)
NCCN guidelines include aprepitant as part of standard antiemetic
therapy for:
• Patients receiving highly emetogenic chemotherapy
• Patients receiving a combination of anthracycline
  and cyclophosphamide
• Select patients receiving other moderately
  emetogenic chemotherapies
Please refer to NCCN guidelines for more information regarding
NCCN recommendations.2



Multinational Association for Supportive Care
in Cancer (MASCC)
MASCC recommends a regimen including EMEND for first-line
prevention of CINV in patients receiving3:
• Highly emetogenic chemotherapy
• A combination of anthracycline plus cyclophosphamide



Selected Important Risk Information
In clinical trials, EMEND has been shown to increase the AUC of
dexamethasone, a CYP3A4 substrate, by 2.2-fold on Days 1 and 5.
Therefore, the dexamethasone dose administered in the regimen
with EMEND was reduced by approximately 50% as compared
with the standard-therapy group to achieve similar exposures of
dexamethasone. See PRECAUTIONS, Drug Interactions, in the
Prescribing Information for additional information on dose adjustment
for methylprednisolone when coadministered with EMEND.




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
16
Local Formulary Coverage and
Reimbursement Updates
In the pocket facing this page, you may find information about local
Medicare and managed care carriers that cover EMEND and/or
reimbursement updates.
For more information, contact ACT, the reimbursement and patient
support program about reimbursement for EMEND sponsored by
Merck & Co., Inc., at 1-866-EMEND-Rx.
In addition, you can contact your local Medicare carrier for further
information on Medicare Part B.



Selected Important Risk Information
Chronic continuous use of EMEND for prevention of nausea and
vomiting is not recommended because it has not been studied and
because the drug interaction profile may change during chronic
continuous use.




                                                                            Antiemetic Guidelines/
                                                                               Local Coverage




                                                                       17
References: 1. Centers for Medicare & Medicaid Services. Decision memo for aprepitant for
chemotherapy-induced emesis (CAG-00248N). Available at: http://www.cms.hhs.gov/mcd/view
decisionmemo.asp?id=133. Accessed February 1, 2006. 2. National Comprehensive Cancer
Network. Clinical practice guidelines in oncology—v.2.2006: antiemesis. Available at:
http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf. Accessed April 26, 2006.
                     ,
3. Gralla RJ, Roila F Tonato M, for the Multinational Association for Supportive Care in Cancer.
Antiemetic guidelines consensus. Slides presented at: Perugia International Cancer Conference VII:
Consensus Conference on Antiemetic Therapy; March 29–31, 2004; Perugia, Italy. Last updated
September 1, 2005.




Before prescribing EMEND, please read the
Prescribing Information enclosed in the back pocket.
18

								
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