Frequently Asked Question

THE PROCESS FOR APPEALING ON BEHALF OF YOUR PATIENT (THE ENROLLEE)

 Q1. How do I represent my patient in the appeal process?

Q2. The plan has denied my initial request for the prescription and the subsequent appeal to the plan. How do I appeal to MAXIMUS Federal?

Q3. How long will it take for a decision to be issued?

Q4. How can I request an expedited (within 72 hours) appeal?

Q5. Is there an advantage for the prescriber to appeal vs. the enrollee?

Q6. What supporting documentation is required for an exception to the plan’s coverage rules?

Q7. I received a request for a Prescriber Statement from MAXIMUS Federal. Why is additional information required?

COVERAGE ISSUES (EXCLUSIONS, OFF-LABEL COVERAGE, PART B VS D)

Q8. Does Medicare Part D cover drugs that are being used for off-label uses?

Q9. Should I submit peer-reviewed literature to support the off-label use for a drug?

Q10. Does Medicare Part B still cover medications?

Q11. Do I need to request coverage through Medicare Part B before seeking coverage under Medicare Part D?

Q12. Does Medicare Part D cover drugs that have not been approved by the Food and Drug Administration (FDA)?

Q13. Does Medicare Part D cover drugs that are compounded?

Q14. Are there any medications that are specifically excluded under Medicare Part D?

Q15. Where can I obtain information about a Plan’s formulary?

ISSUES AFTER A DECISION FROM MAXIMUS FEDERAL HAS BEEN RENDERED

Q16. What is the next level of appeal after the decision is issued by MAXIMUS Federal Services?

Q17. My request for coverage was approved for the current plan year as an exception to the formulary. Do I need to appeal every year for an exception?

Q18. My request for coverage was approved for the current plan year; however, the plan is not providing coverage of the medication. What can I do?

Q19. Can I appeal on behalf of my customer?

Q20. Does Medicare Part D cover drugs that are being used for off-label uses?

Q21. A medication is currently available and has a NDC number, does that mean it is Food and Drug Administration (FDA) approved?

Q22. Does Medicare Part D cover drugs that are compounded?

Q23. Are Part D covered compounded drugs eligible for a discount through the Coverage Gap Discount Program (CGDP)?

 


THE PROCESS FOR APPEALING ON BEHALF OF YOUR PATIENT (THE ENROLLEE)

Q1. How do I represent my patient in the appeal process?

Answer:

A prescriber appealing beyond the plan level must have a signed Appointment of Representative form or other document authorizing representation from the enrollee. Please note that at the first level review of a plan decision, an enrollee's prescriber may appeal without having an Appointment of Representative (AOR) form filed with the plan.

Please click here for the Appointment of Representative form that may be used to appeal, and closely follow the instructions for completion. An incomplete form cannot be accepted and will delay processing of the appeal.



Q2. The plan has denied my initial request for the prescription and the subsequent appeal to the plan. How do I appeal to MAXIMUS Federal?

Answer:

If you are a properly appointed representative, you may request a standard or expedited reconsideration by filing a signed written request with MAXIMUS Federal Services. You must file the request for reconsideration within 60 calendar days from the date of the notice of the plan’s redetermination, unless the time frame is extended by MAXIMUS Federal for good cause.

A written request may be made using the model Request for Reconsideration form provided by the plan with the redetermination letter. Any other written document may also be submitted as long as it is signed and includes the following:

1.      Enrollee’s name;

2.      Enrollee’s Medicare Claim Number;

3.      Identification of the item for which Reconsideration is requested, e.g., the prescription drug, including dose and quantity;

4.      Name of the authorized representative, if applicable, and documentation of valid appointment; and

5.      Name of the Part D plan that made the determination.

To request a reconsideration of a determination by a Part D plan to deny coverage of a Part D drug that is non-formulary (i.e. is not on the plan's formulary), the prescriber must determine that all covered Part D drugs on any tier of the formulary for treatment of the same condition would not be as effective for the enrollee as the non-formulary drug, would have adverse effects for the enrollee, or both, and provide a written statement to this effect with the appeal request.



Q3. How long will it take for a decision to be issued?

Answer:

Decisions for a valid expedited appeal are generally communicated by MAXIMUS Federal within 72 hours by phone or fax with the written decision letter to follow by mail or fax. Decisions for a standard appeal are mailed or faxed within 7 calendar days. An appeal is not valid if it is lacking an appointment of representative form or an adequate prescriber statement. Processing may be delayed while MAXIMUS Federal attempts to obtain this information from the prescriber.



Q4. How can I request an expedited (within 72 hours) appeal?

Answer:

Expedited appeals can be requested if applying the standard seven (7)-day time frame could seriously jeopardize the enrollee's health or return to maximum function. To request an expedited appeal, indicate on the Reconsideration Request Form or other written request that an “expedited” appeal is requested and include the reason(s) an expedited appeal is necessary.



Q5. Is there an advantage for the prescriber to appeal vs. the enrollee?

Answer:

No. The outcome of the decision is not affected by who initiates the appeal. Regardless of who appeals, a statement from the prescriber is needed to support exception requests. The prescriber’s statement can be submitted by the enrollee. If additional information is needed, MAXIMUS Federal will contact the prescriber by phone or fax.


Q6. What supporting documentation is required for an exception to the plan’s coverage rules?

Answer:

In general, a prescriber’s statement must state why the requested drug is medically necessary by addressing why the plan’s formulary alternatives have been/or may be less effective; or would be more likely to result in an adverse outcome for the enrollee. It is also helpful if the statement addresses the plan’s reason for denial.

Some plans require specific information for a determination of medical necessity. For an explanation of some of the exception requests, please click here. Link to various exception requests


Q7. I received a request for a Prescriber Statement from MAXIMUS Federal. Why is additional information required?

Answer:

MAXIMUS Federal will contact the prescriber as needed by phone or fax for additional information about the diagnosis or formulary alternatives to determine medical necessity. A prescriber’s statement is required to support exception requests.


COVERAGE ISSUES (EXCLUSIONS, OFF-LABEL COVERAGE, PART B VS D)

Q8. Does Medicare Part D cover drugs that are being used for off-label uses?

Answer:

Yes. Certain off-label uses are covered if the definition of a “medically accepted indication” is satisfied. For Part D drugs NOT used in an anticancer chemotherapeutic regimen, a ‘medically accepted indication’ means a use that is:

  • Approved by the FDA; or
  • Supported by citation in one of the specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI) and DRUGDEX.

For Part D drugs used in an anticancer chemotherapeutic regimen, a ‘medically accepted indication’ means a use that is:

  • Approved by the FDA ; or
  • Supported by citation in one of several specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology; or
  • Supported by clinical research that appears in the peer reviewed medical literature, specifically in journals or publications as specified by the Centers for Medicare and Medicaid Services (CMS).

Q9. Should I submit peer-reviewed literature to support the off-label use for a drug?

Answer:

This depends on whether or not the drug is being used in an anticancer chemotherapeutic regimen. Peer reviewed literature cannot be used to support off-label uses of drugs NOT used in an anticancer chemotherapeutic regimen.

For drugs used in an anticancer chemotherapeutic regimen, peer-reviewed medical literature appearing in the regular editions of the regular publications may be used to support an off-label use. Supplement editions privately funded by parties with a vested interest in the recommendations of the authors cannot be used.


Q10. Does Medicare Part B still cover medications?

Answer:

Yes. If a drug is covered under Original Medicare, then the same drug is not eligible to be covered under Medicare Part D. Medicare Part D does not cover any drug for which payment as "prescribed and dispensed or administered" is available for that individual under Parts A or B of Original (or fee-for-service) Medicare. This is true whether or not the individual is actually enrolled in Medicare Part B. Original Medicare does not cover most outpatient prescription drugs. Medicare Part A generally pays for drugs provided to an enrollee during a hospital or skilled nursing facility stay. For more information about Part B vs. Part D coverage, go to Appendix C in the Medicare Prescription Benefit Manual, Chapter 6.


Q11. Do I need to request coverage through Medicare Part B before seeking coverage under Medicare Part D?

Answer:

No. Drug plans may not require beneficiaries to provide a statement from the Part B Medicare Appeals Contractor (MAC) or the Durable Medical Equipment MAC showing that the drug will not be paid for under Part B. However, drug plans may impose prior authorization requirements, even during the transition period, to determine whether the plan should cover a drug under Part D or whether the drug should be covered under Part B.


Q12. Does Medicare Part D cover drugs that have not been approved by the Food and Drug Administration (FDA)?

Answer:

No. In order for a drug to be eligible for coverage under the Medicare Part D, the drug must be:

  • Approved by the Food and Drug Administration (FDA) for safety and effectiveness;
  • Available only by prescription (over-the-counter drugs are not covered);
  • Used and sold in the United States; and
  • Used for a medically accepted indication.

Click here for more information on unapproved drugs marketed in the United States that do not have required FDA approval.


Q13. Does Medicare Part D cover drugs that are compounded?

Answer:

This depends on the components of the compounded medication. A compounded prescription drug product may be covered if it contains at least one FDA approved drug component, although reimbursement is limited to the compounding fees and FDA approved component(s) only. Bulk powders are not FDA approved drug products and therefore are not covered under Part D. A compounded drug must also be prescribed for a "medically accepted indication".


Q14. Are there any medications that are specifically excluded under Medicare Part D?

Answer:

Yes. Medicare Part D excludes certain drugs, classes of drugs or drugs prescribed for certain medical uses. The following is a list of drugs that are excluded from coverage under Medicare Part D. Certain drugs and drug uses  are not subject to the below noted exclusions list.

  • Drugs used for anorexia, weight loss or weight gain;
  • Drugs used to promote fertility;
  • Drugs used for cosmetic purposes or hair growth;
  • Drugs used for the symptomatic relief of cough or cold;
  • Prescription vitamins and mineral products (except prenatal vitamins and fluoride preparations);
  • Nonprescription drugs;
  • Drugs subject to a manufacturer tying arrangement;  
  • Drugs used to treat sexual or erectile dysfunction

A Part D Plan may provide supplemental coverage for excluded drugs, classes of drugs or drug uses if the Plan has contractually opted to provide such coverage as per its subscriber materials (e.g., Evidence of Coverage) and CMS has approved the benefit.

For more information about Part D exclusions, go to Appendix B in the Medicare Prescription Benefit Manual, Chapter 6, which provides additional information on Part D coverage and exclusions.


Q15. Where can I obtain information about a Plan’s formulary?

Answer:

Part D plans must include their current formulary and any applicable quantity limit restrictions, prior authorization criteria and step therapy criteria on their respective website. The formulary should include the tier level and description as well as the quantity limit restrictions. The formulary documents must include all prior authorization and step therapy criteria applied to each formulary drug.


ISSUES AFTER A DECISION FROM MAXIMUS FEDERAL HAS BEEN RENDERED

Q16. What is the next level of appeal after the decision is issued by MAXIMUS Federal Services?

Answer:

The next level of appeal is with an Administrative Law Judge (ALJ). If the enrollee receives an adverse (unfavorable) Reconsideration decision from the Part D QIC, the enrollee or his representative may request a hearing with an ALJ from the Office of Medicare Hearings and Appeals (OMHA). In order to be eligible for an ALJ hearing, the projected value of the denied drug benefit must meet a certain minimum dollar amount established annually by the Secretary of the DHHS.

To request a standard ALJ hearing, the enrollee or representative must make a request in writing within 60 days of the date of the Part D QIC Reconsideration decision. The request must be sent directly to the OMHA office that is identified in the Part D QIC’s Reconsideration decision letter. For standard ALJ hearings, the ALJ must issue a decision, dismissal order, or remand, as appropriate, no later than the end of the 90 calendar day period beginning on the date the request for hearing is received by the OMHA office specified in the Part D QIC’s Reconsideration decision letter, unless the 90 calendar day period has been extended by the ALJ.

If an enrollee or representative is requesting that the hearing be expedited, the enrollee or representative may make the request for an ALJ hearing orally, but only after receipt of the written reconsideration decision letter. A prescribing physician or other prescriber may provide oral or written support for an enrollee's request for expedited review. The request for an expedited ALJ hearing after Reconsideration must be submitted within 60 calendar days from the date the enrollee receives written notice of the Reconsideration, and must be filed with the OMHA office specified in the Part D QIC’s Reconsideration decision letter.

If a request for an ALJ hearing is not filed within the 60 day period, the requestor may ask OMHA for an extension for good cause. A party that requests a good cause extension must do so in writing, and must explain the reason why the request was not filed timely.

For more information, please refer to the OMHA website.


Q17. My request for coverage was approved for the current plan year as an exception to the formulary. Do I need to appeal every year for an exception?

Answer:

A plan may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins.

If a plan decides not to continue coverage under an approved exception into the subsequent plan year for a renewing enrollee, the plan must send a written notice to the enrollee at least 60 days prior to the end of the plan year, unless the plan sent an approval letter to the enrollee when it granted the exception and clearly identified the date that coverage will end in the approval letter.

If a plan is required to send a written notice to the enrollee at least 60 days prior to the end of the plan year or the date coverage ends, the notice must:

•         Explain that the exception will not be extended,

•         Provide the date that coverage will end (e.g., on December 31, 2010),

•         Explain the right to request a new exception once the current exception expires, and

•         Provide instructions for making a new exceptions request.


Q18. My request for coverage was approved for the current plan year; however, the plan is not providing coverage of the medication. What can I do?

Answer:

The Plan must authorize or provide the benefit in dispute in the timeframe specified in the Reconsideration letter. If the Plan does not authorize the benefit within the time specified, call the City CMS Regional Office indicated in the Reconsideration letter.


Q19. Can I appeal on behalf of my customer?

Answer:

Yes, however you must have a signed Appointment of Representative form or other document authorizing representation from the enrollee.

Please click here for the Appointment of Representative form that may be used to appeal, and closely follow the instructions for completion. An incomplete form cannot be accepted and will delay processing of the appeal.


Q20. Does Medicare Part D cover drugs that are being used for off-label uses?

Answer:

Yes. Certain off-label uses are covered if the definition of a “medically accepted indication” is satisfied. For Part D drugs NOT used in an anticancer chemotherapeutic regimen), a ‘medically accepted indication’ means a use that is:

  • Approved by the FDA; or 
  • Supported by citation in one of the specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI) and DRUGDEX.

For Part D drugs used in an anticancer chemotherapeutic regimen, a ‘medically accepted indication’ means a use that is:

  • Approved by the FDA; or
  • Supported by citation in one of several specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology; or
  • Supported by clinical research that appears in the peer reviewed medical literature, specifically in journals or publications as specified by the Centers for Medicare and Medicaid Services (CMS).

Q21.A medication is currently available and has a NDC number, does that mean it is Food and Drug Administration (FDA) approved?  

Answer:

No. Assignment of an NDC number does not in any way denote FDA approval of the product. Neither inclusion in the NDC Directory nor possession of an NDC number is a determination that a product is an FDA-approved drug as defined by the FD&C Act, nor does it denote that a product is covered or eligible for reimbursement by Medicare Part D.


Q22.Does Medicare Part D cover drugs that are compounded?

Answer:

No. This depends on the components of the compounded medication. A compounded prescription drug product may be covered if it contains at least one FDA approved drug component, although reimbursement is limited to the compounding fees and FDA approved component(s) only. Bulk powders are not FDA approved drug products and therefore are not covered under Part D. A compounded drug must also be prescribed for a "medically accepted indication".


Q23.Are Part D covered compounded drugs eligible for a discount through the Coverage Gap Discount Program (CGDP)?

Answer:

No. While a Plan can cover a compounded drug with at least one Part D covered drug, a compounded drug is not eligible for a discount through the CGDP. CMS has determined that because a compounded drug as a whole is not approved under a New Drug Application (NDA) or Biological Licensing Agreement (BLA), a compound does not meet the definition of an applicable drug under the CGDP. Accordingly, Plans will apply the "generic" gap cost-sharing to the Part D drug components of all Part D compounds.

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