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Health Care Professional's Fact Sheet on Prescription Drug Coverage Determinations and Exceptions, Appeals & Grievances


Prescribing Physician’s Role in Coverage Determinations and Exceptions, Appeals & Grievances Processes

The enrollee, enrolee’s physician and/or enrollee’ appointed representative can file a coverage determination (including tiering exception or formulary exception). The adjudication timeframe begins when the plan sponsor receives the physician’s supporting statement.

CMS provides dedicated help for physicians through email at [email protected].


Short Decision Making Timeframes

CMS has directed every prescription drug plan to respond to requests without delay. Plans must communicate decisions on initial coverage determinations no later than 24 hours after receiving an expedited request, or 72 hours after receiving a standard request. If a prescribing physician requests a coverage determination on behalf of an enrollee, the physician also will receive notice of the decision from the plan. Coverage determinations include decisions on formulary and tiering exception requests. If the plan fails to meet the timeframe, the case goes to an independent review entity under contract with CMS for a decision on the case. The independent review entity is commonly referred to as the Part D qualified independent contractor (Part D QIC).

Please keep the 24 and 72 hour timeframe in mind when filing a request. Should the carrier/plan need to contact you for more information and your office is closed (i.e. weekends, holidays) the request will most likely be denied and you or your patient will need to file an appeal. Therefore, fully complete the request documentation and give a telephone number where that will be answered during the 24 or 72 hour time period.




Requests Made by Prescribing Physicians

A coverage determination can be requested by a Part D plan enrollee, by an appointed representative or the prescribing physician on behalf of the enrollee. A prescribing physician can also request an expedited redetermination (first level of appeal) on behalf of the enrollee. Prescribing physicians cannot request a standard redetermination (first level of appeal) or a reconsideration (second level of appeal), unless they are the enrollee's appointed representative. Form CMS-1696 (Appointment Of Representative) or an equivalent writing can be used to appoint a representative.




Prescribing Physician Supporting Statements

Prescribing physicians have an important role in the exceptions process. Whenever an enrollee requests a formulary or tiering exception, the prescribing physician must provide the Part D plan with an oral or written statement to support the exception request. Formulary exception requests include requests for exceptions to cost utilization management tools, such as step therapy or dose restrictions. The plan’s timeframe for making a decision on an exception request does not begin until the prescribing physician’s supporting statement is received by the plan. Anyone can go to our coverage determination site at: www.cms.hhs.gov/center/provider.asp to get contact numbers for the plans to facilitate the submission of the supporting statement.




Enrollee’s Appeal Rights

If an enrollee doesn’t agree with the initial coverage determination made by the plan, the enrollee has the right to appeal the coverage determination. As noted above, the prescribing physician can ask for an expedited first level appeal (redetermination) on behalf of the enrollee. The following chart describes the steps and the time limits of the process. For expedited redeterminations, a Part D plan must give the enrollee (and prescribing physician involved, as appropriate) notice of its decision no later than 72 hours after receiving the request. Decisions on standard redeterminations must be communicated to the enrollee in writing no later than 7 days after receiving the request. If a plan issues an adverse redetermination, the enrollee will receive a notice that includes information on how to request a reconsideration by the Part D QIC.




CMS Medicare Part D Appeals Process Flowchart

Medicare Prescription Drug (Part D)
Coverage Determination*/Appeals Process
Standard Process
72 hour time limit**
Expedited Process
24 hour time limit**
Coverage Determination
60 days to file a request for redetermination
PDP/MA-PD
Standard Redetermination
7 day time limit
PDP/MA-PD
Expedited Redetermination
72 hour time limit
First Appeal
Level
60 days to file a request for reconsideration
Part D Independent Review Entity (IRE) or QIC
Standard Redetermination
7 day time limit
Part D Independent Review Entity (IRE) or QIC
Expedited Redetermination
72 hour time limit
Second Appeal Level
see PDP & MA-PD QIC/IRE address/fax below
60 days to file
Office of Medicare Hearings and Appeals
Administrative Law Judge (ALJ) Hearing
Standard Decision
Amount in Controversy (AIC) >$130***
90 day time limit
Office of Medicare Hearings and Appeals
Administrative Law Judge (ALJ) Hearing
Expedited Decision
Amount in Controversy (AIC) >$130***
10 day time limit
Third Appeal Level
60 days to file
Medicare Appeals Council
Standard Decision
90 day time limit
Medicare Appeals Council
Expedited Decision
10 day time limit
Fourth Appeal Level
60 days to file
Federal District Court
Amount in Controversy (AIC) > $1,300***
Fifth Appeal Level


Notes:

The IRE/QIC handling both Drug Benefit and Late Enrollment Penalty Reconsiderations is determined based on your initial and follow-up appeals dates:

As noted on the C2C Innovative Solutions, Inc. website (c2cinc.com),
"Effective February 1, 2021, C2C Innovative Solutions, Inc. (C2C), is the Part D QIC; therefore, [C2C is] adjudicating new reconsideration requests received on and after February 1, 2021. There will be a short period in which both C2C and Maximus, the outgoing QIC, are processing reconsiderations. Maximus will continue posting effectuation, case file submission information, and appeals received/decided for reconsideration requests received on or before January 31, 2021 and reopening requests for drug benefit appeals received on or before March 31, 2021 and reopening requests for LEP appeals received on or before April 16, 2021. PDP and MA-PDP Plans should return case files to Maximus, when Maximus has requested the case file."
Mailing and Fax for Second Level Appeals QIC/IRE:

For All Drug Benefit (PDP & MA-PD)
Reconsiderations
:


C2C Innovative Solutions, Inc.:
via U.S. Postal Service (USPS):
C2C Innovative Solutions, Inc.
Part D Drug Reconsiderations
P.O. Box 44166
Jacksonville, FL 32231-4166

via UPS / FedEx ONLY:
C2C Innovative Solutions, Inc.
Part D Drug Reconsiderations
301 W. Bay St., Suite 600
Jacksonville, FL 32202

Telephone for Enrollees Only: (833) 919-0198 (Toll Free)
Fax for Enrollees Only - Expedited Appeals: (833) 710-0579 (Toll Free)
Fax for Enrollees Only - Standard Appeals:(833) 710-0580 (Toll Free)

For more information:
C2C Appeal Instructions and links

MAXIMUS Federal Services:

MAXIMUS Federal Services
Medicare Part D QIC
860 Cross Keys Office Park
Fairport, NY 14450

Fax numbers: (585) 425-5390
Toll free fax: (866) 825-9507
Customer Service: 585-425-5300
Toll Free Customer Service:
877-456-5302

For Late Enrollment Penalty (LEP) Reconsiderations:

C2C Innovative Solutions, Inc.:
via U.S. Postal Service (USPS):
C2C Innovative Solutions, Inc.
Part D LEP Reconsiderations
P.O. Box 44165
Jacksonville, FL 32231-4165

via UPS / FedEx ONLY:
C2C Innovative Solutions, Inc.
Part D LEP Reconsiderations
301 W. Bay St., Suite 600
Jacksonville, FL 32202

Telephone for Enrollees Only: (833) 919-0198 (Toll Free)
Fax for Enrollees Only:(833) 946-1912 (Toll Free)


For more information:
C2C Appeal Instructions and links

MAXIMUS Federal Services:

MAXIMUS Federal Services
Medicare Part D QIC
P.O. Box 991
Victor, NY 14564-0991

Fax numbers: (585) 869-3320
Toll free fax: (866) 589-5241
Customer Service: 585-425-5300
Toll Free Customer Service: 877-456-5302


AIC: Amount in Controversy -- AIC must be greater than $130 for third level appeals and AIC must be greater than $1,300 for Judicial Review
ALJ: Administrative Law Judge -- third level appeals
IRE: Independent Review Entity also known as a Qualified Independent Contractor (QIC) -- second level appeals
MA-PD: Medicare Advantage plan with Prescription Drug (Part D) benefits
PDP: Prescription Drug plan (drug only benefits -- no health benefits)
QIC: Qualified Independent Contractor also known as an Independent Review Entity (IRE) -- second level appeals

*A request for a coverage determination includes a request for a tiering exception or a formulary exception. A request for a coverage determination may be filed by the enrollee, the enrollee’s appointed representative or the enrollee’s physician or other prescriber.

**The adjudication timeframes generally begin when the request is received by the plan sponsor. However, if the request involves an exception request, the adjudication timeframe begins when the plan sponsor receives the physician’s supporting statement.

***The AIC requirement for an ALJ hearing and Federal District Court is adjusted annually in accordance with the medical care component of the consumer price index. The chart reflects the amounts for calendar year (CY) 2011.