Frequently Asked Questions

MA-PD/PDP Plans

Frequently Asked Questions

Question 1
What documentation must a Part D plan include when submitting a drug appeal case file to the Part D QIC?
Answer 1:
The Case File Transmittal Form is required and the Case Narrative Form is strongly recommended. The information requested on these forms has been carefully considered and approved by the Centers for Medicare & Medicaid Services (CMS) as necessary for case processing. These forms are the Part D plan’s main working tools for submitting case files to the Part D QIC.

The Case File Transmittal form identifies the procedural and evidentiary exhibits that a Part D plan may be required to submit with a case file depending on the drug benefit in dispute. These exhibits are listed on Page 3 of the Case File Transmittal Form. For more information regarding these exhibits, please refer to the C2C Part D QIC Reconsideration Procedures Manual.

If the Part D plan requires further assistance with identifying the exhibits that should be presented with a case file, they should contact the Plan Liaison at the Part D QIC for assistance at MedicarePartDAppeals@c2cinc.com.

Part D Prescription Drug Case Transmittal Form (PDF)

Part D Prescription Drug Case Narrative Form (PDF)

Question 2
How should Part D plans send drug case files and related correspondence to the Part D QIC?
Answer 2:
Plans may submit case files electronically via the QIC Appeals Portal: https://www.c2cinc.com/Appellant-Signup

Benefits of using the C2C Innovative Solutions QIC Appeals Portal are:

Secure login and submission (permits plans to securely transmit appeals case files)
Online appeal case file submission forms (eliminating paper forms)
Immediate confirmation of submission (including a confirmation number)
Ability to upload and submit files electronically (eliminating mailing and shipping costs, faxing and CDs)

Fax:
Fax for Part D Plan Expedited Appeals	(904) 539-4093
Fax for Part D Plan Standard Appeals	(904) 539-4097
Fax for Part D Plan Auto-Forwarded Appeals	(904) 539-4099
UPS / FedEx ONLY: C2C Innovative Solutions, Inc. Part D QIC 301 W. Bay St., Suite 1110 Jacksonville, FL 32202	United States Postal Service (USPS): C2C Innovative Solutions, Inc. Part D Drug Reconsiderations P.O. Box 44166 Jacksonville, FL 32231-4166

Question 3
When can I expect to receive a Part D QIC reconsideration decision?
Answer 3:
Decisions for valid expedited appeals are generally faxed to the Part D plan within 72 hours. Decisions for standard appeals are generally faxed within seven calendar days. For standard reconsideration requests involving payment for services already furnished, the Part D plan must notify the enrollee of its reconsideration in writing no later than 14 calendar days from the date it receives the request for a standard retrospective reconsideration. Processing may be delayed if an appeal is brought by a representative and is lacking an Appointment of Representative (AOR) form or other applicable representation documents. Likewise, if a prescriber statement is required to process the appeal and is either lacking or is inadequate, processing may be delayed while the Part D QIC attempts to obtain this information. We allow 14 days for a response for representation documentation and for prescriber information.

Question 4
How can a Part D plan ensure the Part D QIC has the correct plan contact information for requesting case files?
Answer 4:
Part D plans are responsible for communicating all contact information, including changes to the Part D QIC. Part D plans must complete a Plan Contact Form. This information includes the Part D plan’s name, plan contract number, fax number, phone number, address and main point of contact for both Drug Benefit and LEP appeals, respectively, as well as a Reporting Contact. With the inclusion of new Part D plans each year, it is imperative that the Part D QIC receives the plan’s preferred contact information. This information is logged into a database and used for requesting case files and for general communication. If contact information has changed, fax or email an updated Plan Contact Form to the Plan Liaison as soon as possible at MedicarePartDAppeals@c2cinc.com.

Part D Plan Contact Form (PDF)

Question 5
Why are Part D plans required to include the Evidence of Coverage (EOC) with each drug appeal case file submission?
Answer 5:
CMS mandates that Part D plans provide the entire EOC and formulary for the reconsideration process, especially since these documents are required for further levels of appeal with the Office of Medicare Hearings and Appeals (OMHA) and the Medicare Appeals Council (MAC). Currently CMS strongly recommends that Part D plans provide the Part D QIC with the EOC and formulary information via CD. Part D plans are encouraged to review the pertinent evidentiary and procedural documentation on Page 3 of the Case File Transmittal Form for the information the Part D QIC uses to efficiently render meaningful decisions for enrollees.

Question 6
How should a Part D plan notify the Part D QIC regarding multiple auto-forwarded appeals?
Answer 6:
If the volume of auto-forwarded appeal files exceeds 20 or more appeals at one time, please notify the Plan Liaison directly at MedicarePartDAppeals@c2cinc.com.

Question 7
What documents should Part D plans send to the Part D QIC based on untimely or missed timeframe determinations?
Answer 7:
For appeals involving untimely or auto-forwarded case files, Part D plans must include the following information:

Enrollee’s name
Enrollee’s Medicare Number
Identification of the item for which reconsideration is requested, e.g., the prescription drug, including dose and quantity
Name of the authorized representative, if applicable, and documentation of valid appointment
Name and contact information of the prescriber
Name of the Part D plan that made the determination

Please note that it is crucial for Part D plans to send a copy of the case file, even though the case file may be incomplete, since the Part D QIC is obligated to render a determination on the enrollee’s request. The Part D plan should explain why it was not able to timely complete the determination, and should identify missing information and any outstanding information requests. The plan should also provide information needed to the QIC to process the appeal, such as prescriber contact information, plan formulary documents and utilization management policies, as applicable, and subscriber materials detailing the benefits offered. Please refer to §6.1 of the C2C Part D QIC Reconsideration Procedures Manual for direction on requirements for auto-forwarded case files.

Question 8
What if the Part D plan has approved the drug(s) but the time frame was missed for timely notification of the approval?
Answer 8:
The Part D plan must auto-forward the case file to the Part D QIC. The approval notices along with the case file must be submitted and indicate on the Case Narrative Form that coverage is being provided. It is also imperative that a screen print or authorization page/approval notice be included with each case file as proof of coverage.

Please include the following details on the Case Narrative Form:

The drug(s) at issue, including brand/generic name, dose and quantity requested
The actual dates of coverage that were approved

Question 9
Why is it important to include the correct Part D plan contract number and plan ID number with each case file?
Answer 9:
The correct Part D plan contract number and plan ID number for the enrollee are critical to accurate processing of the reconsideration decision. Many reconsideration decisions issued by the Part D QIC consider language in the EOC and/or the formulary status of the drug at issue. The Part D plan contract number and plan ID allow the Part D QIC to confirm that the correct EOC and formulary are in the record. The Part D QIC requires the correct plan documentation in the case record to perform a meaningful substantive review of an appeal.

Question 10
Why does the Part D QIC require a Medicare Number for case processing rather than the Part D plan member identification number?
Answer 10:
The full Medicare Number must be provided on each submission from Part D plans in the correct section on the Case File Transmittal Form. The Medicare Number is the unique identifier issued from Medicare. The Part D QIC cannot use internal member identification numbers, since these numbers are plan-specific and do not allow for tracking of enrollees in the Medicare database.

Question 11
Where do Part D plans send completed Notices of Effectuation?
Answer 11:
Part D plans may send completed Notices of Effectuation through the C2C Portal or by fax:
C2C Portal: https://www.c2cinc.com/Appellant-Signup
Fax Number: (904) 539-4101

Question 12
What documentation should a Part D plan include when submitting an LEP case file to the Part D QIC?
Answer 12:
The LEP Case File Transmittal Form and Case Narrative Form must be fully completed and submitted to the Part D QIC by mail or fax within 14 calendar days after receiving the case file request. These two forms should be submitted with every case file. Note that the information requested on these forms has been carefully considered and approved by CMS for LEP appeal processing. Plans are encouraged to use the QIC Portal to submit LEP documentation at https://www.c2cinc.com/Appellant-Signup.

The LEP Case File Transmittal Form identifies the procedural and evidentiary exhibits that a Part D plan may be required to submit with a case file. For more information regarding these exhibits, please refer to the C2C Part D QIC Reconsideration Procedures Manual.

If the Part D plan requires further assistance with identifying the exhibits that should be submitted with a case file, they should contact the Plan Liaison at MedicarePartDAppeals@c2cinc.com.

Late Enrollment Penalty Case Transmittal Form (PDF)

Question 13
Where should Part D plans send LEP case files and related correspondence to the Part D QIC?
Answer 13:
Plans may submit case files electronically via the QIC Appeals Portal: https://www.c2cinc.com//Appellant-Signup

Benefits of using the C2C Innovative Solutions QIC Appeals Portal are:

Secure login and submission (permits plans to securely transmit appeals case files)
Online appeal case file submission forms (eliminating paper forms)
Immediate confirmation of submission (including a confirmation number)
Ability to upload and submit files electronically (eliminating mailing and shipping costs, faxing, and CDs).

Fax:

Plan LEP Appeals (Case Files & Documentation)

(904) 539-4072

UPS / FedEx ONLY:

C2C Innovative Solutions, Inc.
Part D QIC
301 W. Bay St., Suite 1110
Jacksonville, FL 32202

United States Postal Service (USPS):

C2C Innovative Solutions, Inc.
Part D Drug Reconsiderations
P.O. Box 44166
Jacksonville, FL 32231-4166

Question 14
Is the Part D plan required to submit an LEP case file to the Part D QIC for an enrollee who is no longer a plan member?
Answer 14:
Yes. If the Part D QIC requests a case file for an enrollee who is no longer a plan member, that Part D plan is required to submit a case file to the Part D QIC within 14 calendar days after receiving the Case File Request Form.

Question 15
How should a Part D plan respond to a Case File Request from the Part D QIC if it has no applicable documentation regarding an appeal?
Answer 15:
If the Part D plan has no documentation regarding the LEP, the Part D plan shall return the Case File Transmittal Form to the Part D QIC within 14 calendar days after receiving the Case File Request Form, acknowledge that the documentation requested is unavailable and explain the reason(s) why.

Question 16
Is the Part D plan required to submit a case file to the Part D QIC if the plan has rescinded the LEP?
Answer 16:
The Part D plan is required to return the Case File Request Form to the Part D QIC within 14 calendar days after receiving the Part D QIC’s Case File Request Form, indicating that the LEP has been rescinded. However, the Part D plan is not required to forward a completed case file containing procedural and evidentiary documentation when an LEP has been rescinded. The Part D plan shall also indicate the following on the LEP Case File Transmittal Form:

Date the LEP was rescinded
Date the enrollee was notified that the Late Enrollment Penalty was rescinded

Question 17
Is the Part D plan required to submit a case file to the Part D QIC if the enrollee was not assessed an LEP?
Answer 17:
The Part D plan is required to return the Case File Request Form within 14 calendar days after receiving the Case File Request Form, indicating that the enrollee was not assessed an LEP.

Question 18
How should a Part D plan proceed when submitting an LEP case file beyond the fourteen-day submission deadline?
Answer 18:
The Part D plan should make its best effort to submit a completed LEP case file by mail or fax within 14 calendar days after receiving the Case File Request Form. In the event that the Part D plan cannot meet this timeframe, the Part D QIC will accept case file submissions that are beyond the submission deadline. Late case file submissions will also be recorded in the Medicare Appeals System (MAS) and reported to CMS. However, Part D plans should be aware that that the Part D QIC may have already reached a decision when the Part D plan submits a late case file.

Question 19
When will the Part D plan receive notification of the LEP appeal decision?
Answer 19:
The Part D QIC strives to notify the appellant and the Part D plan of the final decision as soon as possible, usually within 90 days of receipt of the appeal request. LEP appeals could have a 14 calendar day extension as described in §2.30 of the C2C Reconsideration Manual. However, in certain circumstances the appeal may be processed within a shorter time frame. Generally, the Part D plan will receive a copy of the final decision letter by fax.

Question 20
How should a Part D plan proceed if it disagrees with the LEP final decision?
Answer 20:
The LEP appeal decision issued by the Part D QIC is final and not subject to further appeal. However, if the Part D plan disagrees with the final decision, it may request reopening of the LEP reconsideration decision. The Part D plan should submit a detailed written request for reopening within 180 days from the date of the LEP reconsideration decision. The Part D QIC will only reopen an LEP appeal for the following reasons:

To correct an error
If fraud is suspected
If there is new information that might change the decision and this information was not previously available

The Part D plan is required to comply with the LEP reconsideration decision until an LEP reopening decision is issued by the Part D QIC.

Question 21
When should the Part D plan select “YES” to the question in the case file submission to the Part D QIC “Is this enrollee deemed ‘at-risk’”?
Answer 21:
This should only be selected when the appeal is for an At-Risk Determination as defined by 42 Code of Federal Regulations (CFR) Section 423.100.

Part D Drug Management Program Policy Guidance (PDF)

Question 22
What should the Part D plan do if it receives a case file request from the Part D QIC for an appeal that an initial coverage determination (CD) and/or redetermination (RD) were not issued?
Answer 22:
The Part D QIC needs to track and report these cases. Please submit the case file and indicate there was no CD/RD. When selecting the representative option, Part D plans should select “NO” indicating the representative is not valid if you do not have documentation indicating otherwise.

Question 23
Why would the Part D QIC accept an FDA labeled orphan drug designation as a medically accepted indication?
Answer 23:
Under Medicare rules, a positive citation is required within a Medicare approved compendia to support that a drug is prescribed for a medically accepted indication. If the Food and Drug Administration (FDA) has granted orphan drug designation to a drug to treat a particular condition then that designation appears within an approved compendia and is therefore a medically accepted indication for the drug. The Part D QIC is the Independent Review Entity and as such cannot provide interpretative guidance to plans.

Question 24
What information was provided in the prescriber statement received by the Part D QIC that explained why the Part D plan’s formulary alternatives would likely not be as effective as the drug requested?
Answer 24:
The Part D QIC is unable to provide the specific information contained within the prescriber statement. If the Part D plan feels that the decision needs to be reopened, the Part D plan can specifically request a reopening.

Question 25
What does the Part D plan do if it believes the Part D QIC’s reconsideration decision is erroneous and/or should be modified due to new and material information not previously available or known?
Answer 25:
When a Part D plan believes that the Part D QIC reconsideration decision is erroneous and/or should be modified due to new and material information not previously available or known, the Part D plan may submit a written or verbal statement to the Part D QIC that sets forth this information. If the Part D plan alleges error as a basis for reopening, the Part D plan should clearly describe its rationale for concluding that the reconsideration decision is erroneous on the face of the evidence. If the Part D plan alleges new and material information as a basis for reopening, the Part D plan should clearly identify the new information it has received, explain why the information was not previously available, and explain how the new information may modify the reconsideration decision.

The Part D QIC will evaluate the written or verbal statement submitted by the Part D plan and determine if there is good cause for reopening review. If the Part D QIC does not find good cause for reopening, the Part D QIC will notify the Part D plan about its decision not to reopen. If the Part D QIC does find good cause for reopening, the Part D QIC will reopen on its own motion and process the request.

A Part D plan request for reopening, whether granted by the Part D QIC or not, does not stay the date of the Part D plan’s compliance obligation. When submitting the reopening request, please clearly state on the transmittal form to the Part D QIC that this is a request for reopening.