Exception and Appeals Process

Exception & Appeals Process Information

Each payer follows a different process when filing exceptions and appeals. Here’s a helpful guide to share with your patients:

How to Request an Exception or Appeal a Decision From Your Prescription Drug Plan

Uniform Prescription Drug Prior Authorization Request Forms & Notification Requirements for Health Plans

Some health plans in select states must use their state's Uniform Prior Authorization request form. Please contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining prior authorization forms.

Click here to see if your state is included:

Uniform Prior Authorization Information for Select States

The information below provides a summary of each payer's general exceptions and appeals process, which may pertain to services as well as to drugs and products. Some payers provide additional and specific exceptions and appeals information in the individual drug formularies. For this information, refer to the specific formulary.

Third-party reimbursement is affected by many factors. The content provided is for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult with your payer organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

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For Medicare, AARP Medicare Plans (UnitedHealthcare) have an exception process to request a coverage determination for prescription drugs which is submitted by either the patient or the patient's representative, such as a provider. Drug formularies, prior authorization and other prescribing criteria are available on the Web site so that the provider and patient may be aware of any limitations or restrictions on coverage by reviewing the available materials. If the coverage determination/precertification is not approved, then either the patient or the provider may proceed through an appeals or redetermination process. Instructions for filing appeals are detailed on the Medicare Coverage Determinations and Appeals page.

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Aetna has a multilevel Dispute and Appeals process that depends in part on which type of plan the patient has, and in which state the patient resides. The Aetna Web site has instructions with contact information for providers and providers may use a provider area for online submissions. The form for medical exception of drugs is accessible by selecting Rx Medical Exception/Precertification Request Form.

For Medicare, Aetna has a formal Precertification or Exception Process in place for requesting a coverage determination which is submitted by either the patient or the provider. Drug clinical policies are available on the Web site so that the provider may be aware of any limitations or restrictions on coverage by reviewing the available policy materials. If the coverage determination/precertification is not approved, then either the patient or the provider may proceed through an appeals or redetermination process.

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The Anthem Web site has a Forms library with a link to the Specialty Pharmacy exception form. An online submission form to request a formulary addition is available. Drug-specific prior authorizations forms may be found by using the search feature on the Rx Prior Authorizations page. The search results may return a Clinical Criteria document as well. Appeals and grievances may be handled using the steps listed on the Complaints, Grievance, and Appeals page for California members. Forms are available in multiple languages. The patient or an authorized representative, such as a provider, can file a grievance/appeal with Anthem Blue Cross by calling the customer service number on the back of the patient's card, or by mailing a completed grievance/appeal form or by submitting an online grievance/appeal form. To appoint a representative, the patient may call the customer service number on the back of the patient's card to acquire an authorization form.

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Anthem Blue Cross Blue Shield has a provider area linkable from the home page of their Web site. Providers can then select the applicable state from the pulldown menu. Prior Authorization forms, Medical Policies and Clinical Guidelines are available from the navigation link drop down menus which detail medical necessity criteria for specific drugs. The Provider Disputes and Appeals and the Member Grievances, Appeals and Exceptions Information page details the multilevel exceptions and appeals process. The member, his/her representative, or a provider may use this process once an adverse determination review such as a precertification/preauthorization has been made. The provider may submit appeals orally, in writing, or electronically with supporting documentation.

For Medicare, the provider may submit a Medicare Provider Coverage Determination Form to request drug coverage and then, if appropriate when following an adverse determination, may file an appeal. Appeal processing information and forms are located on the Medicare Appeals and Grievances page.

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Arkansas Blue Cross and Blue Shield has the Formulary Exception and Appeal Request forms available on the Forms for Providers page. Providers may also contact the payer with questions regarding prescription drug coverage by phone at 1-800-863-5561.

Arkansas Blue Cross and Blue Shield Medicare providers can access forms that should be used when requesting drug coverage by selecting the appropriate plan in the Medicare Part D section that links to the formulary benefit manager page. The resulting information page has both a formulary search tool for drugs and a link for the Formulary Exception online request form.

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For commercial plans of Blue Cross of Idaho, providers are requested to review available Commercial Medical Policies for information on drugs or drug classes and submit an initial Commercial Prior Authorization form or Specific Drug Prior Authorization form with supporting medical necessity documentation. A Formulary Exception Request form is also available online for specific plans. If a request results in a denial, the provider may then appeal the adverse decision through a one- or two-level process described in Provider Inquiry and Appeals Process.

For Blue Cross of Idaho Medicare plans, the process of submitting a drug coverage determination and appealing an adverse determination is outlined in the Medicare Exception Process area.

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For Blue Cross and Blue Shield of Alabama commercial plans, call 1-800-216-9920 for general provider pharmacy inquiries. For pharmacy reviews, providers may call the pharmacy review representative at 1-800-206-1048.

For Medicare plans, Blue Cross and Blue Shield of Alabama has posted forms and instructions on its Web site detailing its Medicare Complaints and Appeals process. Drug pharmacy policies are available on the Web site for review. The patient or his/her representative, such as a provider, may apply for a coverage determination on the basis of requesting coverage for a drug not on the formulary, changing a restriction to a drug's coverage, changing coverage for a drug's cost basis, or appealing a previously denied process.

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For Medicare, Blue Cross Blue Shield of Arizona has Pharmacy Policies in the provider area that can be found by selecting the appropriate health plan. Detailed appeals information can be found in the member's area. The Medicare Complaints and Appeals page gives detailed information about requesting coverage decisions and making an appeal. These processes can be done for both medical care and prescription drugs. On the Forms & Materials page, there are two separate forms for the provider and member when requesting a drug prior authorization form. The form for the provider is called Pharmacy Prior Authorization Request and the form for the member is called Prescription Drug Determination form. Both of these downloadable forms may be submitted via fax using the contact information provided in the forms.

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The Blue Cross and Blue Shield of Florida Web site has posted formularies under Medication Guide for both commercial and Medicare plans. For commercial plans, available prior authorization/exception forms are based on the type of authorization being requested as detailed on the Prescription Drug Forms page. Pharmacy Medical Policies are also available.

For Medicare, select the Medicare drug plan from the Prescription Drug Coverage Determination Criteria and Forms page and click through the approval page to exit the payer's Web site and enter the pharmacy benefit manager's Web site. Drug coverage requests and limitation variances are discussed. Coverage determination and redetermination (appeals) process, contact information and forms are available and may be submitted by the provider.

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Blue Cross and Blue Shield of Illinois commercial plans have separate Claim Review and Appeal processes depending on the type of claim issue to be resolved. The appeals process is used to request a reconsideration review after a denial by the payer's medical management. A provider may then initiate the appeals process by phone or in writing and follow the request with supporting documentation. The member or authorized representative, such as a provider or facility, may request a specific member appeal such as clinical appeal made by a physician, a nonclinical appeal by a nonmedical appeals committee, or an urgent/expedited appeal based on the circumstances of the appeal.

For Medicare, the appeal process is outlined in the Medicare Coverage Determination and Redetermination page. The provider may submit a Medicare Provider Coverage Determination Form for coverage or submit a request for a Formulary Exception for coverage of a not-on-formulary (not covered) drug or submit a request for a drug to be covered at a lower tier, if available for the member's benefit plan. Then, if appropriate when following an adverse determination, the provider may file an Appeal/Redetermination Form by following the Appeal Instructions that are also provided on a separate page.

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Blue Cross and Blue Shield of Kansas has a Professional Provider page which links to forms, predetermination/prior authorization documents and medical policies. A provider Contact Information page for appeals, benefits and predeterminations is also available.

For Medicare, Blue Cross and Blue Shield of Kansas has an Grievances, Appeals and Exceptions Information page. Members or his/her representative, such as a provider, may submit a Medicare Coverage Determination Request Form to handle drug coverage requests using the Customer Service page for contact information. If the coverage determination request results in a denial, an appeal may be requested using the Redetermination (Appeal) Form provided with supporting documentation.

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Blue Cross and Blue Shield of Kansas City providers may contact the payer for exceptions and appeals information or use the Provider Log-in page information to contact the payer.

For Medicare, the payer has an Information on the Grievances, Appeals and Exceptions Processes page. The Coverage Determination Request Form is used to request a formulary exception. If an adverse determination is made, an appeal may be filed using the Request for Redetermination of Medicare Prescription Drug Denial form and submitting it using the contact information found on the form.

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Blue Cross Blue Shield of Michigan has a Resolving Problems area for commercial plans that addresses benefit inquiries and, if needed, the grievance and appeal process following an adverse benefit decision. The member or provider may initiate an inquiry using the contact information located on the member's ID card, Explanation of Benefits documents or information provided on the Contact Us page. For an appeal process, information is provided on internal and external review processes and depends on the type of member coverage.

For Medicare, the Appeals, Complaints and Coverage Decisions page states that initially a coverage determination is submitted by either the patient or the provider to request a coverage benefit. If denied, then an appeal or coverage redetermination may be filed according to the process on the Decision Appeals page using the detailed instructions.

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Formulary exceptions are handled by completing the Minnesota Uniform Form for Prior Authorization Request and Formulary Exceptions, which is linkable to the Prior authorization and formulary exception form section of the Forms page on the Blue Cross and Blue Shield of Minnesota Web site. Also available is a link to the pharmacy benefit provider Web site for exceptions and appeals information.

For Medicare, Blue Cross and Blue Shield of Minnesota uses a regional Web site, MedicareBlue Solutions, for Medicare Part D coverage information. Use the Documents page to access the formularies, prior authorization criteria, and forms for formulary exceptions, coverage determinations and redeterminations (appeals). There is additional information on the Coverage Determinations page for exceptions, grievances and appeals.

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  • Documents
  • Coverage Determinations

For BlueCross BlueShield of Mississippi, providers may call for precertification or for questions about prior authorization requirements for medications using the Contact Information page. The Prescription Drug Benefit Appeal is an online form to start an appeal process. The Provider Forms page has links for online submissions of prescription drug prior authorizations and appeals.

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Blue Cross and Blue Shield of Montana commercial plans have pharmacy policies, prior authorization criteria and online prior authorization requests on the Provider Forms And Documents page. In the event of a denial, the provider may follow the instructions on the Claim Review And Appeal page.

The Blue Cross and Blue Shield of Montana Medicare Part D prescription drug plan is linkable on the Medicare Plans page under the Compare Plans area. Use the MedicareBlue Rx link to access the payer's Medicare Part D regional Web site, MedicareBlue Solutions, for Medicare Part D coverage information for both group and individual plans. Select the Documents link below to access the formularies, prior authorization criteria, and forms for formulary exceptions, coverage determinations and redeterminations (appeals).

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  • MedicareBlue Solutions Formulary Search
  • Documents

For commercial plans, Blue Cross and Blue Shield of Nebraska has a downloadable Appeal/Reconsideration Request Form available for providers. Drug policies, prior authorization forms and the formularies are accessible in the Pharmacy Management area.

For Medicare, Blue Cross and Blue Shield of Nebraska has a Medicare Part D information page which can be used to access a regional Web site, MedicareBlue Solutions, for prescription drug coverage information. Select the Documents link to access the formularies, prior authorization criteria, and forms for formulary exceptions, coverage determinations and redeterminations (appeals). Click on the Coverage Determinations/Exceptions, Grievances and Appeals link to access the Exception and Appeals form and instructions.

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  • Documents
  • Coverage Determinations/Exceptions, Grievances and Appeals

For Blue Cross and Blue Shield of New Mexico's commercial plans, providers may refer to the Pharmacy Program and the Medical Review Drugs and Criteria pages available online that detail medical necessity, formulary criteria and prior authorization for specific drugs. An Appeal Request Form is available for providers.

For Medicare, Blue Cross and Blue Shield of New Mexico members may submit a Drug Coverage Determination Form to the contact provided on the Coverage Determination and Redetermination page. Determinations for drug coverage may be based on payment or provisions made by the payer such as requesting a formulary exception or removing a limitation regarding the drug. The Medicare Formulary or Tier Exception Form is available online. Instructions for filing the determination or subsequent appeal form are discussed in the Request for Redetermination of Medicare Prescription Drug Denial document.

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Blue Cross and Blue Shield of North Carolina has a two-level appeal process described on its Provider Appeals pages for Level I and Level II appeals. Level I appeals may be used to appeal denials of medical necessity or preauthorization requests. There is an Appeals: Frequently Asked Questions page with answers for members and providers about the levels. The Level I Appeal form is accessible from Forms and Documentation. Level II appeals are available to providers if the Level I appeal is denied. Level II appeals may be used for appeals due to medical necessity.

Blue Cross and Blue Shield of North Carolina Medicare providers may review the drug formularies, prior authorization and limitations to determine if a drug determination is required. For redeterminations, the payer has Level I and II Medicare appeal processes that the provider may subsequently submit on the basis of medical necessity. The provider may submit supporting documentation along with the Medicare forms appropriate for each level of appeal.

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For Commercial plans, there is a provider link on the top of the main entry page which leads to the provider area of the Blue Cross Blue Shield of North Dakota Web site. Use the Provider Service tab or link below to navigate to the Forms & Documents page where Dispensing Limit Override, Coverage Exception and Step Therapy forms are accessible under the Pharmacy section. Medical policies are located by using the navigation link to the Policies & Approvals page. Scroll down the page and click on the Drugs link in the main content area of the page for the listing of Medical Policy by drug.

For Medicare, Blue Cross Blue Shield of North Dakota uses a regional Web site, MedicareBlue Solutions, for Medicare Part D coverage information. Use the Documents page to access the formularies, prior authorization criteria, and forms for formulary exceptions, coverage determinations and redeterminations (appeals).

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  • Documents
  • Coverage Determinations/Exceptions, Grievances and Appeals
  • Coverage Determination Form
  • Request for Redetermination of Medicare Prescription Drug Denial

The Blue Cross Blue Shield Northern Plains Alliance includes the states of Iowa, Minnesota, Montana, Nebraska, North Dakota, South Dakota, and Wyoming. The 7 states under this plan can be accessed from the links below for detailed information about the different Medicare plans and forms to use for coverage determinations, exceptions and appeals.

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  • Coverage Determinations/Exceptions, Grievances and Appeals
  • MedicareBlue Solutions Formulary Search

For commercial plans, Blue Cross and Blue Shield of Oklahoma has common prescription coverage topics on the Frequently Asked Questions page. For appeals, a Review Request Form is also available from the Health Care Provider Forms page.

For Medicare, Blue Cross and Blue Shield of Oklahoma formularies include information on prior authorization, dispensing limitations or step therapy. Quantity limit or step therapy exception forms are located on the Utilization Management page. Drug Coverage Determination information and forms are available on the payer's site. Determinations for drug coverage may be based on payment or provisions made by the payer such as requesting a formulary exception or removing a limitation regarding the drug.

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The Blue Cross & Blue Shield of Rhode Island Commercial Formulary page has forms available for quantity limit, copay and formulary exceptions. Providers may contact the payer directly for appeals information.

For Medicare, coverage determinations and redetermination (appeal) forms are linkable from the Medicare Formulary page. For a prescription drug coverage exception, an initial Coverage Determination Request is submitted for review as described on the Medicare Part D Coverage Decisions and Appeals Information page. If an adverse coverage determination results, then an Appeal or Coverage Redetermination may be filed. The appeal may be filed by the patient or the patient's representative such as a physician.

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BlueCross BlueShield of South Carolina has an Exception Request form for formulary exceptions on its Web site. There is also a Provider Appeals Guidelines page that provides a general overview of the exception and appeals process. Appeals are handled in a two-step process based on the physician obtaining written permission to represent the patient on his/her behalf and then by submitting a Medical Review Request form. The basis for an appeal varies and is limited; however, one application that can be made is on the basis of medical necessity. The Medical Review Request form must be attached to documents showing the medical necessity of the requested coverage. The Medical Review Request form may be submitted either by mail or fax to the contacts listed directly on the bottom of the form.

For Medicare, BlueCross BlueShield of South Carolina has formulary exception information within the specific Part D comprehensive formulary plan documentation which advises contacting the payer directly at 1-888-645-6025 or (TTY/TDD) 1-888-645-6023. Exceptions requests, supported by a provider, may be considered for formulary, tiering and utilization restrictions based on medical effectiveness or adverse medical effects.

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For commercial plans, BlueCross BlueShield of Texas provides a pharmacy Override Request which the provider may use to apply for a pharmacy coverage benefit. Contact the payer directly for questions regarding a coverage denial.

For Medicare, BlueCross BlueShield of Texas has an exception process in place for requesting a Coverage Determination which can be used to request coverage for a drug not on its formulary or, in limited cases, lower the cost-sharing tier for a drug. The physician must support the request with additional supporting documentation. If the coverage determination is not approved, then the patient or his/her representative, such as the provider, may proceed through an Appeals or Redetermination process.

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For commercial plans, information about benefit coverage, exceptions and appeals is available by calling 1-800-442-2376. The Pharmacy guide has formulary and prior authorization information for providers.

For Medicare, Blue Cross Blue Shield of Wyoming uses a regional Web site, MedicareBlue Solutions, for Medicare Part D coverage information. Select the Documents link to access the formularies, prior authorization criteria, and forms for formulary exceptions, coverage determinations and redeterminations (appeals).

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  • MedicareBlue Solutions Formulary Search
  • Coverage Determinations

Capital BlueCross providers can request exception information from CVS Caremark by calling 1-800-585-5794 or fax requests to 1-888-836-0730. On the payer's Web site, there is a Physician Log-in page for providers for online submissions. Appeals may be filed by the patient or the patient's representative. Detailed information is available on the payer's Web site in the Certificate of Coverage documents for the patient's plan.

For Medicare, Medicare Part D drug coverage determinations and redeterminations are available online by selecting from the links under the patient plans in the Grievances & Appeals section of the Forms & Updates page. Benefit and prescription drug information are also linkable from the Forms & Updates page.

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CareFirst BlueCross BlueShield has contact information for provider inquiries regarding patient coverage in its Provider Quick Reference Guides. The Provider Inquiry Resolution Form may be used to submit inquiries regarding coverage review rejections and to submit additional supporting materials for medical necessity. There is also a plan-specific Frequently Asked Questions which has pharmacy and appeals information.

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For Central California Alliance for Health prior authorization questions, call the Alliance Pharmacy Department at 1-831-430-5507. A Prescription Drug Prior Authorization Request form is available online. To file an appeal in the case of an adverse coverage decision, call the payer directly at 1-800-700-3874, extension 5505, or the Grievance Coordinator at 1-800-700-3874, extension 5525.

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Cigna has an Appeal Policy & Procedures for Health Care Professionals page that has information on a single level appeal process for a denied authorization. Forms are provided on the Claim Adjust & Appeal Guidelines page for a benefit limitation or exclusion. Benefit inquiries or appeals information is located on the Healthcare Appeals & Grievances page.

For Medicare, Cigna has an appeals process for both standard and expedited appeals which may be submitted by the patient, an appointed representative or the provider following an adverse coverage decision. A Coverage Determination Request Form is available and may be used to request coverage for a drug that is not covered or to alter a limitation relating the drug's coverage. If a Notice of Denial has not been received, the Coverage Determination Request Form should be submitted first. The Appeals Form, a request for a redetermination of coverage, is submitted by mail or fax to the contact information on the form following an adverse coverage decision.

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Community Health Choice has a provider area that has links to Provider Tools. A provider log-in is available to access the linked provider information. Appeals information appears in the pharmacy benefit manager's (Navitus Health Solutions) Pharmacy Manual which is located on the Web site. Appeals and benefit complaints can be handled by calling Navitus Customer Care at 866-333-2757. A written appeal may be filed if Customer Care is unable to resolve the benefit complaint. The appeal can be mailed to:

Navitus Health Solutions
Attn Appeals Department
PO Box 999
Appleton, WI 54912-0999

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Questions about the CommunityCare pharmacy benefits can be resolved by calling 1-877-293-8628.

For Medicare, the Grievances, Coverage Decisions and Appeals page has information on Medicare coverage decisions and appeals processes. Both the Medicare Part D Coverage Determination Request and Medicare Redetermination/Appeal forms are available online.

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For commercial plans, providers may refer to the state-specific provider area Document Library for Provider Reconsideration and Appeals forms and information. The Document Library page for Iowa is linked below, as an example.

For Medicare, Coventry Health Care has an appeals process for prescription drugs that may be used following a negative review of a preauthorization or coverage determination request. The member may use the contact information on the payer's ID card or in the Evidence of Coverage to submit an appeal or redetermination request. Both a Coverage Determination and a Coverage Redetermination request form are available on the Web site. For plan-specific information, refer to the particular Coventry Health Care Web site that has state-plan information for the patient's state.

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For the CVS Caremark commercial formulary, contact the payer using the information on the Pharmacy Help Desk page for exceptions and appeals information. Prescription drug prior authorization information and forms are available online.

For CVS Caremark Silverscript, Medicare coverage determination for a drug can be requested for several reasons including to ask that a drug be covered that is not on the drug list, to waive a restriction regarding the drug's coverage, to request that a drug's cost-sharing tier be lowered or to request a prior approval of a drug that has limitations for coverage. A patient or his/her physician or representative may submit a coverage determination request. An appeals process is also in place if a negative coverage determination results.

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For commercial plans, Dean Health Plan's Web site has a provider Forms & Resources page that links to an Exception to Coverage Request form.

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EmblemHealth has a provider Pharmacy Services page which addresses documentation and criteria for obtaining prior authorization as well as dispute resolution if an appeal is requested following a denial.

For Medicare, there is a Dispute Resolution process for providers and members to follow once a written adverse determination is made. The initial adverse determination includes instructions for the member or the member's representative, such as a provider, to file an appeal or grievance for both regular and expedited appeals. A reconsideration may be made later by the provider if the original appeal did not include the provider's input. An external appeal may be made to the New York State Department of Insurance once a Final Adverse Determination is made by the payer. The member or his/her representative, such as a provider, may request a Medicare Coverage Determination to handle drug coverage requests due to medical necessity, formulary exception requests, exception requests from a tier structure, amounts of cost sharing, prior authorization, or utilization management. After a denial, redetermination may be requested in writing with supporting documentation provided by the physician. Both regular and expedited processes are detailed.

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The patient or an authorized representative, such as a provider, can file a grievance/appeal with Empire BlueCross BlueShield by calling the customer service number on the back of the patient's card, or by mailing a completed grievance/appeal form or by submitting an online grievance form. There is a Medical Necessity Appeals page on the payer's Web site that has more information. When appointing a representative, the patient must call the customer service number on the back of the patient's card to acquire an authorization form. A provider may also request a Formulary Addition using the online form.

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The EnvisionRxPlus Web site has a Grievance, Coverage Determination and Appeals page which details the process. An exception or coverage determination may be requested to cover a drug not on the formulary, to request a waiver for the coverage restrictions for a drug, or to submit a request for a drug to be covered at a lower tier, if available for the member's benefit plan. Both standard and expedited decisions are available for a coverage determination request which may be submitted online or mailed to the payer. Drug determination requests may be sent to the address on the form, submitted online or faxed to the payer. In case of denial, an appeal or Request for Redetermination form may be submitted.

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Excellus BlueCross BlueShield appeals are initiated by either the patient or the provider. Requests can be made to cover a nonformulary drug, lower the cost-sharing tier, or to waive a drug's limitations. Drug limitations are found on the provider Drug Policies page. The process starts with an initial coverage determination for a formulary exception and progresses through several levels of appeals, if necessary. For commercial plans, the Appeals Process can be found in the Participating Provider Manual which is available with a provider login.

Medicare Part D exceptions and appeals are handled in a formal multilevel process detailed on the Web site on the Grievances & Appeals page. The initial decision by the payer is considered the coverage determination and an appeal or Request for Reconsideration Form may be filed within a limited timeframe.

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For Medicare, Geisinger Health Plan has an Exceptions and Appeals Information page that details the coverage determination, exception and appeal process. An exception may be requested to cover a nonformulary drug, to request a tier change or waive a drug's coverage restrictions. If the coverage determination results in a denial, a standard or expedited appeal may be filed.

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For Commercial plans, Group Health Cooperative has appeal process information and forms on the Coverage and Claim Appeals page. There is a formal internal appeals process for review of member coverage and disputes that includes both first level appeal process and an optional second-level review. There is a downloadable appeal form that a member can mail or fax and an online submission form available as well.

For Medicare, formulary exception requests may be made to cover a nonformulary drug or waive a drug's coverage restrictions. The exception may be filed by the member or the member's representative, such as a provider. Information and contact information is located on the Exceptions, Appeals, and Grievances page. The Medicare Provider Coverage Determination Form is available online. If a coverage determination request is denied, an appeal or redetermination may be submitted using the Request for Redetermination of Medicare Prescription Drug Denial Form.

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For commercial plans, Gundersen Health Plan has a Pharmacy Benefits page that has commercial formulary information. From the Pharmacy Benefits page, select the specific formulary for information on how to submit a formulary exception request. Exceptions can be requested to provide coverage for drugs not on the formulary, to waive coverage restrictions or limits for drug utilization, or to request a higher level of coverage for a drug.

Gundersen Health Plan has a Medicare appeal/coverage determination process to handle drug coverage provisions or decisions such as a nonformulary exception, co-payment reduction, reversal in a coverage reduction or stoppage, or changing a limitation relating to the drug coverage. The appeals process is discussed and contact information is provided on the Medicare Part D Initial Decisions, Appeals And Grievances page for both standard and expedited decisions. Either the member or the member's representative, such as a provider, may make the request. If a negative coverage decision is made, a further appeals process is available.

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Harvard Pilgrim Health Care has commercial plan appeal information for both members and providers linkable on the Appeal page in its Web site. There is a downloadable Provider Appeal form online, and instructions are in the Provider Appeal Overview document. The Provider Manual has documentation requirements and the specified timeframe for the appeals process. A multi-level appeal process is available for providers and may be made for several specified reasons including denial of preauthorization request. Providers may appeal a denial decision by following the downloadable instructions on the Provider Appeals Overview and submitting a Provider Appeal form to the contact information provided in the instructions.

For Medicare Part D, instructions for Medicare formulary exception processes are located in the Evidence of Coverage for the member benefit plan. Members or providers may select the Members link from the home page and then Medicare Options from the subsequent page. The Evidence of Coverage documentation is found by locating the member's formulary using specific member information and using the online search feature on the Medicare Options page. Follow the links for Find a Medicare Part D prescription drug plan and enter the member's information. Each plan has a downloadable Evidence of Coverage document which discusses the usage of the Medicare Prescription Drug Coverage Determination Form. Exceptions may be filed for several reasons, such as to request a drug that is not covered, to reduce the co-pay on a drug that is nonpreferred, or to remove a limitation on a drug such as a quantity limit. An appeal may be filed by the patient or an appointed representative, such as a physician, in the case of an adverse coverage determination.

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For Medicare, Health Net has appeals information under its state-based Appeals and Grievances pages. Appeals may be filed once a benefit determination or decision has been made by Health Net. The appeal may be initiated by letter or submitted with a Request for Reconsideration Form linkable from the Appeals and Grievances page which may be submitted by using the contact information on the Appeals and Grievances page. For plan-specific information, refer to the particular state Web site that has plan information for the patient's state.

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Health Plan of San Joaquin has prior authorization forms and an exception and appeals form on the Forms & Documents page. A Provider Dispute Resolution form allows for exception requests based on medical necessity or utilization management. Providers may contact the payer directly using the information on the Contact Us page.

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HealthNow New York has a Provider Login page that participating physicians can use to review coverage and benefits and check the status of documentation such as drug prior authorizations and appeals. For exceptions, the patient, or an appointed representative, such as a physician, may file the Prior Approval/Non-Formulary Medication Request Form or a subsequent Request for Appeal Form in the case of a prescription coverage request denial.

For Medicare, HealthNow New York has a Medicare Resource Center in their Web site that provides payer contact information and plan specific links to Exceptions and Appeals pages that have detailed drug coverage decisions and how to file an appeal.

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The HealthPlus of Michigan provider may file a formal written appeal within a limited time frame using the information provided on the Appeal Process page. A Pharmacy Prior Authorization/Exception Request form is available online. The HealthPlus Pharmacy Department can also be contacted at 1-810-720-2758 for questions on drug formularies, prior authorization criteria and prior authorization request forms.

For Medicare, HealthPlus of Michigan has a pharmacy Drug Exception Process for medications that are dependent on a coverage determination. The form Request For Medicare Prescription Drug Coverage Determination is available via a linkable PDF or the provider may use an online submission form. In addition, physicians or members may contact HealthPlus by telephone at 1-800-332-9161, or by fax at 1-810-720-2757. In the event of an adverse coverage benefit determination, an appeal may be filed using the Request for Redetermination of Medicare Prescription Drug Denial form along with the Request for Reconsideration form.

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Midwest Health Plan providers can request a drug prior authorization by faxing a completed Request for Prior Authorization form with supporting documents to 1-248-540-9811 or by calling 1-248-540-6686. Formulary exceptions for drugs not included in the approved drug list can be requested by faxing a Pharmacy Exception Request form to the payer at 1-313-429-5230. There is also an Exception Request Policy which explains the process and requirements for an exception. If an adverse decision is made, the provider and member will be notified in writing and an appeal may then be filed within a limited time frame from the date of the denial notice. Request an appeal or call for additional information from Customer Service at 1-800-654-2200.

For Medicare, providers can call 1-888-654-0706 about plan benefits or coverage. The coverage determination and redetermination forms are located on the Forms page. The Provider Appeals section of the Provider Manual has appeals process instructions should the provider disagree with a utilization management decision.

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For commercial Highmark Blue Cross Blue Shield plans, an appeal may be filed on the patient's behalf following an an adverse drug coverage determination. Provider-initiated appeals information may be found in the provider manual: Procedural Guide for Providers. Benefit appeals may be filed by phone or in writing. Contact information is provided in the manual.

For Medicare, Highmark Blue Cross Blue Shield has a document called Summary of the Highmark's Grievance and Coverage Determination (Exceptions) Process that details the initial coverage determination requests and redeterminations/appeals process, which may follow an initial adverse determination decision.

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Highmark now covers the 13-county northeastern and north central Pennsylvania region formerly covered by Blue Cross of Northeastern Pennsylvania. Commercial plans and restrictions about coverage are noted in the formulary itself. If a drug is not approved, providers may initiate an appeal with some limitations on the member's behalf. These limitations are discussed in the Primary Care Physician Policy & Procedure Manual, Section E: Appeals.

Medicare members and providers may refer to the drug formularies for coverage and limitations. For exceptions, providers may submit a Prescription Drug Medication Exception Request form. A Request for Redetermination of Medicare Prescription Drug Denial may be submitted following an adverse determination once a Medicare Coverage Determination has been filed and denied.

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For commercial plans, physicians may request a prior authorization or a medical exception for drug coverage using the contact information and Humana forms on the Provider Prior Authorization for Pharmacy Drugs page.

For Medicare, members or his/her representatives, such as a provider, may submit a Medicare Coverage Determination Request Form to handle drug coverage requests online or by phone or fax. Physicians are requested to use the contact information, and forms are available on the Medicare Drug Coverage Determination page. If the coverage determination request results in a denial, a Request for Redetermination of Medicare Prescription Drug Denial may be filed using the form provided with supporting documentation.

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Independence Blue Cross has a Policies & Guidelines area of its Web site that has links to pharmacy information such as formulary, prior authorization, drug and medical policies. Under the Tools and Resources navigation menu is a link to a Forms page that has the Nonformulary Exception Request Form which may be used to request drug coverage. If a denial results, a provider may file an appeal on the patient's behalf by faxing additional supporting documentation according to the For Providers: Frequently Asked Questions page information.

For Medicare, there is an Organization Determination, Appeals, and Grievances page that describes requirements for prior authorization, coverage determination, and appeals. There are also downloadable forms to submit these requests.

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For Commercial coverage, there is a Provider Drug Formularies page which links to the individual plan formulary documents. In these documents, formulary exceptions are discussed and there is an exception form linkable from the Frequently Used Forms page. The Request for Formulary Exception can be completed and sent to the contact information provided on the form by email or fax.

Medicare has a Prescription Coverage page which provides detailed information about co-pay, formularies and other prescription drug information. The Request for Formulary Exception form can be used to request a coverage determination or an exception for drug utilization. Information regarding Complaints and Appeals discusses the right to make a complaint about medical services and to request a drug coverage redetermination in the event of an adverse determination.

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Employer Health Programs, Priority Partners Plans and US Family Health Plan

Formulary exceptions, such as a request to waive a quantity limit, may be requested on the basis of medical necessity and are handled by the prior authorization process. Use the prior authorization form below for the relevant plan and submit the form to the contact information located in the form. Supporting documentation is requested. In the case of a denial, formulary appeals may be made on a standard or expedited basis. The appeal must be filed within a limited timeframe as noted and may be filed online. Payer appeal response timeline charts are linkable on the Claims & Appeals Information page.

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Medical Mutual of Ohio has a provider information area that has resources and tools for providers including a Prescription Management page. A provider Prior Approval list has pharmacy information as well as a link to the Prior Authorization Form. Providers may use the information on the Contact Us page for exception and appeals process inquiries.

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Reference URL(s) (Copy and paste URL(s) into browser window.)

  • Provider Area
  • Prescription Management
  • Prior Approval List
  • Prior Authorization Form
  • Contact Us

For MetroPlus Health Plan prior authorizations, exceptions and appeals information, visit the Forms page or contact the payer at 1-877-433-7643. Similarly, for specialty guideline management, contact the payer's pharmacy benefit manager at 1-866-814-5506. A Formulary Exception/Prior Authorization Request Form is available online.

For Medicare, there is a Prescription Drug Information page on its Web site that explains the drug exception process. The exception process may be used to request coverage for a nonformulary drug, request tier changes or to waive a drug utilization guideline. In the case of an adverse determination, a standard appeals may be requested by submitting the Prescription Drug Coverage Redetermination Form to the contact information listed on the form. An expedited appeal may be made by calling the payer at 1-866-986-0356.

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Optima Health has prior authorization and exception forms on its Web site for providers. Exceptions may be requested on the basis of medical necessity or to ask for a drug restriction waiver. The provider may contact the payer using the Contact Us for Providers page or utilize the Provider Login area for more information.

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Neighborhood Health Plan has appeal information in its Provider Manual. Providers can file an appeal or a review for a denial including the appropriate supporting documents with provider appeals department. The appeal must be filed within a limited time frame of the Explanation of Payment date on which the original claim was processed. Mail the completed Request for Claim Review form to the address below or fax the form to 1-617-772-5511.

Neighborhood Health Plan
Provider Appeals Department
253 Summer Street
Boston, MA 02210

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Premera Blue Cross has information on prior authorizations, medical policies and the formulary exception process on the Drugs Requiring Approval page. Appeals may be submitted by either the physician or the member patient. Plan specific drug coverage is located on the Rx Search page. Contact information for the payer regarding drug coverage is located under Pharmacy Services on the Provider Contacts page.

For Medicare, the Part D Pharmacy Resources page has links to the formulary and a discussion on the various types of formulary exceptions that may be filed. Exception forms and frequently asked questions may be found on the Appeals & Grievances pages under the Part D Coverage Determinations, Exceptions, Appeals and Grievances section.

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For Presbyterian Healthcare Services plans, formulary exceptions may be made on the basis of coverage for a non-formulary drug, or to waive coverage restrictions on a drug. Either the patient or the patient's appointed representative, such as a physician, may make the coverage exception request. More information is available on the Appeals, Grievance, and Exception Process page.

The appeals, grievance and exception process for Medicare is described in detail on the payer's What are Appeals and Grievances page. There are several types of appeals available such as standard or expedited. An initial appeal can be started by contacting Presbyterian directly at 1-505-923-6060 or submitting a written appeal to the address on the payer's Web site.

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For Providence Health & Services formulary exceptions, contact the payer directly at 1-800-466-6642 or by fax at 1-616-942-8206.

For Medicare, the payer's Web site provides the detailed appeal information on the Medical Appeals, Determination and Grievance Processes page. An organization or coverage decision or an appeal can be requested by the member, provider or a patient's representative by calling 1-503-574-8000 or 1-800-603-2340 or submitting a written request using the contact information on the payer's Web site.

Reference URL(s) (Copy and paste URL(s) into browser window.)

  • Providence Health & Services
  • Contact Us
  • Pharmacy Resources
  • Medical Appeals, Determination and Grievance Processes

Regence BlueCross BlueShield has provider drug information in the Pharmacy area of its Web site, which links to its formulary information and medical policies. Nonformulary drug coverage determinations are handled via submission of a Prior Authorization Form. Formulary exception requests can be made by accessing the Instructions to Request an Exception link which goes to the payer's pharmacy benefit manager site. An online exception request form is available. Requests for an appeal due to an adverse determination are in the state-specific provider area: Administrative Manual: Medical Provider Appeals.

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Reference URL(s) (Copy and paste URL(s) into browser window.)

  • Pharmacy
  • Administrative Manual: Medical Provider Appeals

For commercial plans, AvMed Health Plans has exception information on its Web site in the Medication Exception Request Form. If the exception request results in a denial, appeal requests can be initiated by calling 1-800-346-0231 within a limited time frame. A Provider Request for Claim Review/Appeal Form is available.

For Medicare plans exception requests are handled by the coverage determination process. Exception and appeals process information can be found on its Web site in the Provider Appeal Process and Appeals - Part D Prescription Drugs documents. For Medicare drug prior authorizations, providers may fax a completed request form with supporting documentation to AvMed at 1-305-671-0189. In case of an adverse determination, the physician can request a review or appeal by faxing a completed Provider Request for Claim Review/Appeal to 1-800-452-3847 or mail form to the AvMed address listed above.

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For commercial plans, UnitedHealthcare has many online resources for providers that include Medical & Drug Policies and Coverage Determination Guidelines which the provider may use to review for medical necessity criteria. Information on regulations regarding appeals for insurers is in its Appeals Standards documentation. Drug coverage, prior authorization or benefit inquiry information is located within the physician login area.

For Medicare, UnitedHealthcare has a Coverage Determinations, Appeals and Grievances page with information on the basis for an appeal and on the appeals process. The process information includes applying for a coverage determination or an appeal. A Level I appeal or redetermination for patients or his/her representatives may be filed if there is an initial adverse coverage determination. The Level I appeal may be filed in writing when supporting documentation and contact information is provided. Further appeals beyond Level I are also discussed.

Reference URL(s) (Copy and paste URL(s) into browser window.)

  • UnitedHealthcare Home page
  • Medical & Drug Policies and Coverage Determination Guidelines
  • Appeal Standards
  • Coverage Determinations, Appeals and Grievances
  • Appeal/Coverage Redetermination

Unity Health Plans Insurance Corporation has a provider area on its Web site that includes pharmacy information such as prescription drug prior authorization forms. A provider login area is also available. Providers may use the information on the Contact Us page for further inquiries by phone, mail or an online email system.

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For Univera Healthcare exceptions, there is a prescription drug Prior Authorization and Step Therapy information page and an exception form for quantity limits on its Web site. For appeals, the provider may contact the payer directly at 1-800-499-1275.

For Medicare, the member or his/her representative, such as a provider, may request a Medicare Coverage Determination to handle drug coverage requests or formulary exception requests by phone, fax or in writing. If this results in a denial, an appeal or redetermination may be requested in writing or by fax. Contact information is provided on the Grievance and Appeals page. Both regular and expedited processes are detailed and supporting documentation provided by the physician may be required.

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Wellmark Blue Cross and Blue Shield has a Provider Drug Information area that has the Wellmark drug list and formulary exception request form. The Formulary Exception Form may be faxed to Pharmacy Operations. The fax number is listed on the form. Information about the provider Appeals Process is also available. The provider area of its Web site also states that physicians may request an initial medical necessity determination using a Provider Prior Authorization form for medications.

For Medicare, Wellmark Blue Cross and Blue Shield uses a regional Web site, MedicareBlue Solutions, for Medicare Part D coverage information. Select the Documents link to access the formularies, prior authorization criteria, and forms for formulary exceptions, coverage determinations and redeterminations. The Coverage Determinations page has information on the exception and appeals process.

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  • MedicareBlue Solutions Formulary Search
  • Coverage Determinations

R2

INDICATIONS
Anemia Due to Chronic Kidney Disease

PROCRIT® is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.

Anemia Due to Zidovudine in HIV-infected Patients

PROCRIT® is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

Anemia Due to Chemotherapy in Patients With Cancer

PROCRIT® is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

PROCRIT® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT® is not indicated for patients who are willing to donate autologous blood preoperatively.

PROCRIT® has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT® is not indicated for use:

  • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure or in whom the anemia can be managed by transfusion.
  • In patients scheduled for surgery who are willing to donate autologous blood.
  • In patients undergoing cardiac or vascular surgery.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
Important Safety Information For PROCRIT®

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
  • Use the lowest PROCRIT® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery:
Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.

(See WARNINGS AND PRECAUTIONS: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism, and WARNINGS AND PRECAUTIONS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

Contraindications

PROCRIT® is contraindicated in patients with:

  • Uncontrolled hypertension
  • Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT® or other erythropoietin protein drugs
  • Serious allergic reactions to PROCRIT®

PROCRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated in:

  • Neonates, infants, pregnant women, and lactating women. When therapy with PROCRIT® is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol.

Additional Important Safety Information

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

  • In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), PROCRIT® and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
  • Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials of patients with cancer, PROCRIT® and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer

  • ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

Hypertension

  • PROCRIT® is contraindicated in patients with uncontrolled hypertension. Following initiation and titration of PROCRIT®, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving PROCRIT®.
  • Appropriately control hypertension prior to initiation of and during treatment with PROCRIT®. Reduce or withhold PROCRIT® if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.

Seizures

  • PROCRIT® increases the risk of seizures in patients with CKD. During the first several months following initiation of PROCRIT®, monitor patients closely for premonitory neurologic symptoms. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency.

Lack or Loss of Hemoglobin Response to PROCRIT®

  • For lack or loss of hemoglobin response to PROCRIT®, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to PROCRIT® therapy.

Pure Red Cell Aplasia

  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with PROCRIT®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which PROCRIT® is not approved).

  • If severe anemia and low reticulocyte count develop during treatment with PROCRIT®, withhold PROCRIT® and evaluate patients for neutralizing antibodies to erythropoietin. Contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) to perform assays for binding and neutralizing antibodies. Permanently discontinue PROCRIT® in patients who develop PRCA following treatment with PROCRIT® or other erythropoietin protein drugs. Do not switch patients to other ESAs.

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with PROCRIT®. Immediately and permanently discontinue PROCRIT® and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs.

Severe Cutaneous Reactions

  • Blistering and skin exfoliation reactions, including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including PROCRIT® ) in the postmarketing setting. Discontinue PROCRIT® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative

  • PROCRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women. In addition, do not mix PROCRIT® with bacteriostatic saline (which also contains benzyl alcohol) when administering PROCRIT® to these patient populations.

  • Serious and fatal reactions, including “gasping syndrome,” can occur in neonates and infants treated with benzyl alcohol–preserved drugs, including PROCRIT® multiple-dose vials. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively. PROCRIT® multiple-dose vials contain 11 mg of benzyl alcohol per mL. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Risk of Infectious Diseases Due to Albumin (Human) Content

  • PROCRIT® contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Dialysis Management

  • Patients may require adjustments in their dialysis prescriptions after initiation of PROCRIT®. Patients receiving PROCRIT® may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.

Anemia in Patients with Chronic Kidney Disease

  • In adult patients not on dialysis:
    • Consider initiating PROCRIT® treatment only when the hemoglobin level is less than 10 g/dL and:
      • The patient’s rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and
      • Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
    • If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of PROCRIT®, and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions.
  • In adult patients on dialysis:
    • Initiate PROCRIT® treatment when the hemoglobin level is less than 10 g/dL.
    • If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of PROCRIT®.
  • In pediatric patients:
    • Initiate PROCRIT® treatment only when the hemoglobin level is less than 10 g/dL.
    • If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of PROCRIT®.
  • When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
    • Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
    • If the hemoglobin rises rapidly (e.g. more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT® by 25% or more as needed to reduce rapid responses.
    • For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
    • For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT® dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue PROCRIT® if responsiveness does not improve.
  • Adverse reactions in ≥5% of PROCRIT®-treated adult patients not on dialysis in clinical studies were hypertension and arthralgia.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection.

Anemia Due to Chemotherapy in Patients with Cancer

  • PROCRIT® is not indicated for use in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • PROCRIT® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • PROCRIT® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
  • Initiate PROCRIT® in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
  • Use the lowest dose of PROCRIT® necessary to avoid RBC transfusions.
  • Reduce dose by 25% if:
    • Hemoglobin increases greater than 1 g/dL in any 2-week period or
    • Hemoglobin reaches a level needed to avoid RBC transfusion.
  • Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.

Surgery/Perisurgery

  • PROCRIT® is not indicated for use in patients scheduled for surgery who are willing to donate autologous blood.
  • PROCRIT® is not indicated for use in patients undergoing cardiac or vascular surgery.
  • Deep venous thrombosis prophylaxis is recommended during PROCRIT® therapy.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.

Anemia Due to Zidovudine in Patients with HIV infection

  • Withhold PROCRIT® if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
  • Discontinue PROCRIT® if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation.

Please see full Prescribing Information, including Boxed WARNINGS.

080071-171019