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

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.