(Medicare Program Integrity Manual)

 Be eligible for a defined Medicare benefit category,    Be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functi oning of a malformed body member, and    Meet all other applicable Medicare coverage, coding and payment requirements.  Contractors shall communicate to the submitter (and beneficiary upon request) their prior authorization decision and the assigned unique t racking number (UTN), which indicates that the submitter requested a prior authorization, for corresponding claim submissions.   For certain prior authorization programs, the requirement to prior authorize is a condition of payment, as further described in the sections below.  Absent any explicit CMS instruction to the contrary, submitters may correct identified issues with their prior authorization request(s) and resubmit their request(s) for prior authorization without restriction.  Contractors shall conduct prior authorization reviews within the timeframes defined by CMS in the corresponding prior authorization program operational instruction(s).  The prior authorization process is further described in following sections.  B.  Condition of Payment   Contractors shall determine if the requirement to prior authorize a particular item or service is a condition of payment, as specified in the individual operational instruction(s).  If prior authorization is a condition of payment, claims submitted without  an indication that the submitter made a prior authorization request (i.e., UTN) shall be denied upon receipt.   C.  Outreach and Education  Contractors shall educate stakeholders each time a new prior authorization program is launched for  a particular item or service, the requisite information and timeframes for prior authorization submissions, and the vehicle(s) for submitting such information to the contractor for assessment.  Contractors shall make sure submitters are aware of the timeframes for contract ors to render prior authorization decisions, for each individual prior authorization program.  Each prior authorization program will have an associated Operational Guide and will be available on the CMS website.  Contractors shall, at a minimum, provide public access to agency -developed prior authorization operational guides, by posting the link(s) on their website.   Contractors shall hold group or individualized training sessions, as appropriate, to notify the stakeholders of upcoming prior authorization programs and to make sure there is ongoing understanding of the specific requirements for those applicable prior authorization programs.  D.  Prior Authorization Submission   Contractors shall assess the information/documentation included in the prior author ization submission for completeness.  Requisite information for individualized prior authorization programs will be included in the operational guides, and shall be available on the CMS website.   Requisite information may include, but is not limited to:   Beneficiary Information (i.e., name, Medicare beneficiary identifier, date of birth)    Physician/Practitioner Information (i.e., name, provider identification number, address)    Supplier Information (i.e., name, national supplier clearinghouse (NSC) number, identification number, address)    Documentation from the medical record to support the medical necessity of the item or service, and    Any other relevant documents as deemed necessary by the contractor to process the prior authorization.   E.  Prior Authorization Decisions   Contractors shall notify the submitter if their prior authorization submission results in a provisional affirmative, or non- affirmative decision.    A provisional affirmative decision is a preliminary finding that a future claim subm itted to Medicare for the item or service likely meets Medicares coverage, coding, and payment requirements.   A non- affirmative decision is a finding that the submitted information/documentation does not meet Medicares coverage, coding, and payment requi rements, and if a claim associated with the prior authorization is submitted for payment, it would not be paid.  Contractors shall provide notification of the reason(s) for the non -affirmation, if a request is non -affirmative, to the submitter.  If a prior  authorization request receives a non -affirmative decision, the prior authorization request can be resubmitted an unlimited number of times, unless otherwise specified.  Contractors shall send detailed decision letters to submitters.  As appropriate for the given prior authorization program, contractors shall send detailed decision letters to other stakeholders (e.g., beneficiaries) using their official address on file.  In addition, there may be certain prior authorization programs that require the contrac tors to notify the appropriate entity by other means, such as telephone.  If a claim is submitted for payment without an affirmative prior authorization decision on file, contractors shall use their existing processes to either suspend claims for additiona l review or to process claims as denials, based on each individualized prior authorization program, as detailed in the operational instruction.   F.  Expedited Request   For certain items or services, delays in receipt of a prior authorization decision could jeopardize the life or health of the beneficiary.  Contractors shall, for such items or services, expedite their decisions based on the operational instruction.  If the claim processing systems would unavoidably delay the delivery of the UTN in an expedit ed fashion, contractors shall nonetheless render an affirmative or non- affirmative decision to the submitter within the mandated, expedited timeframe.  Contractors shall alert the submitter that the decision is being provided as expediently as possible, so that the item or service may be provided, but that the submitter should hold their claim and not submit it until such time as the UTN is received (in order to avoid a claims payment denial).   3.10.1 - Prior Authorization Program for Certain DMEPOS  (Rev. 937; Issued: 01- 31-20; Effective: 03 -02-20; Implementation: 03 -02-20)  A prior authorization program for certain DMEPOS items that are frequently subject to unnecessary utilization is described in 42 CFR 405 and 414.234.  Among other things, these sections establish a Master List of certain DMEPOS items meeting inclusion criteria and potentially subject to prior authorization.  CMS will select Healthcare Common Procedure Coding System (HCPCS) codes from the Prior Authorization Master List that shall require prior authorization, at its discretion.  In selecting HCPCS codes, C MS may consider factors such as geographic location, item utilization or cost, system capabilities, emerging trends, vulnerabilities identified in official agency reports, or other analysis, and may implement prior authorization nationally or locally.  The Prior Authorization Master List is the list of DMEPOS items that have been identified using the inclusion criteria described in 42 CFR 414.234.  The Master List can be found on the CMS website.  The Required Prior Authorization List is the items selected from the Prior Authorization Master List to be implemented in the Prior Authorization Program.  The Required Prior Authorization List can be found on the CMS website, and will be updated as additional codes are selected for prior authorization.   CMS may el ect to exempt suppliers from prior authorization program upon demonstration of compliance with Medicare coverage, coding, and payment rules.  The CMS may suspend prior authorization requirements generally or for a particular item or items at any time and w ithout undertaking rulemaking.  CMS provides notification of the suspension of the prior authorization requirements via (i) Federal Register notice; and (ii) Posting on the CMS prior authorization Web site.  3.10.1.1- Voluntary Prior Authorization (PA) for DMEPOS Accessories   (Rev: 12056; Issued: 05 -25-23; Effective: 06 -26-23; Implementation: 06-26-23)  The 2019 ESRD and DMEPOS final rule (84 Fed. Reg. 60648 (Nov. 8, 2019)) permits CMS to develop a program to allow suppliers to voluntarily include certain accessories on prior authorization requests submitted for items on the Required Prior Authorization List. These accessories may receive a prior authorization decision for operational simplicity, even if the accessory itself is not on the Required Prior Authorization List. Voluntarily submitting a prior authorization request for accessories does not create a condition of payment and is not mandatory.  Prior authorization requests for accessories must include a corresponding item on the Required Prior Authorization List; otherwise, the prior authorization request for the accessory will be rejected. Accessories submitted on a prior authorization request where the corresponding item on the Required Prior Authorization List is non- affirmed will also be non- affirmed.   The list of DME items that require prior authorization can be found on  Required Prior Authorization List , and the list of selected accessories that can be voluntarily added to prior authorization requests can be found on the Voluntary Prior Authorization List . The Required Prior Authorization List and the Voluntary Prior Authori zation List will be updated as additional codes are selected.  For more information, please see the CMS DMEPOS Prior Authorization website.  3.10.2 - Prior Authorization Process for Certain Hospital Outpatient Department (OPD) Services  (Rev. 937; Issued: 01-31- 20; Effective: 03 -02-20; Implementation: 03 -02-20)  A prior authorization process for certain hospital OPD services is described in 42 CFR 419.80 through 419.89 as a method for controlling unnecessary increases in the volume of covered services.  These sections establish requirements for the submission of a prior authorization request (PAR), the timeframes for the review of a PAR, and the process for CMS to exempt providers from prior authorization requirements.    The li st of hospital OPD services requiring prior authorization will be updated through formal notice -and-comment rulemaking.  Technical updates to the list of services, such as changes to the name of the service or the HCPCS code, will be published on the CMS w ebsite.   The CMS may elect to exempt a provider from this prior authorization process upon a providers demonstration of compliance with Medicare coverage, coding, and payment rules after semiannual assessments.  Providers must reach a prior authorization provisional affirmation threshold of 90 percent or greater to be eligible for exemption.  The CMS may suspend the outpatient department services prior authorization process requirements generally or for a particular service(s) at any time by issuing notification on the CMS website.                                       Transmittals Issued for this Chapter   Rev #  Issue Date  Subject  Impl Date  CR#  R12056PI  05/25/2023  Update to Chapt er 3 of Publication (Pub.) 100-08 (Program Integrity Manual (PIM)) for the Voluntary Prior Authorization (PA) Process for Durable Medical Equipment, Prosthetics, Orthotics, Supplies (DMEPOS) Accessories