(Medicare Part D Manual)

2.  Placement of a Part D drug into an Other class. In the current USP Model Guidelines, USP listed an Other class under various categories.  Should a new Part D drug receive approval that cannot be placed into an existing class, and the particular USP category contains an Other class, the new drug may be placed into the Other class.   3.  Addition of a new cla ss under an existing category.  If a new Part D drug is approved that does not fit into an existing class, but is appropriate for a particular category, then a new class may be displayed under an existing category.  This method would also apply to formularies that utilize AHFS or another classification structure.   4.  Miscellaneous Therapeutic Agents. If an existing or newly approved Part D drug does not fit into any existing category, a Miscellaneous Therapeutic Agents category may be displayed on the formulary.   30.2.2 - Formulary Benefit Management Tools  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  CMS will look to existing best practices to check that Part D sponsors use of prior authorization, step therapy, and quantity  limits is consistent with such practices.  CMS will look to current industry standards as well as appropriate guidelines that might be found from expert organizations and to the use of such standards in existing drug sponsors that are widely used by senio rs and people with disabilities.  CMS will ensure that sponsors use of such tools is consistent with best practices.  CMS will also compare formularies among the applicants to analyze the comparative use of practices such as prior authorization, step ther apy, and quantity limits.  In cases where a sponsor may fall outside of best practices, the sponsor will be asked to provide a reasonable justification for its practices.   CMS expectation is that formulary benefit management tools will be used in Part D f ormularies consistent with the way they are applied in existing formulary systems.   A POS edit that is triggered based on approved formulary criteria or other allowable CMS restriction does not constitute a coverage determination unless the plan treats the presentation of a prescription as a request for a coverage determination.  However, a plan that approves or denies a drug through application of such criteria has made a coverage determination that is subject to all applicable coverage determination standards, timelines, and requirements outlined in chapter 18 of this manual, available at https://www.cms.gov/Medicare/Appeals -and-Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip .  In addition, in accordance with chapter 18 of this manual , when a prescription cannot be filled as written under the Part D benefit and the issue is not resolved at the POS, the network pharmacy must deliver written notice to the enrollee explaining their right to request a coverage determination, including an exception, from the plan.  Regardless of whether the plan approves the request, a pharmacist may decide not to dispense a prescription based on the information obtained in a safety edit and/or on his or her professional judgment pur suant to professional standards of practice.  30.2.2.1 - Utilization Management Edits Requiring CMS Submission and Approval (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  CMS requires Part D sponsors to submit utilization management requirements  applied at point of sale ( POS), such as prior authorization (PA) , step therapy (ST), and quantity limits  (QL) not based upon the FDAs maximum daily dose limits, as part of their Health Plan Management System (HPMS) formulary submis sion.  Sponsors must perform adequate oversight of their PBMs and other delegated entities to verify that they are complying with all CMS requirements and not causing beneficiary harm due to impermissible delayed or denied access to Part D drugs.  A plan may  decide that it is reasonable in certain circumstances to accept information from pharmacists, such as in making A or B versus D determinations  (see section 20.2.2) .  CMS encourages sponsors to test the adjudication of their approved formularies  and UM edits  in advance and during the plan year to help identify errors.  In addition, sponsors should routinely review rejected claims to assist in the timely identification of discrepancies between the CMS approved benefit and what is being adjudicated at POS.  There are three types of POS edits2:   Hard reject : stop s the pharmacy from processing a claim unless or until an override is  entered or  authorized by a plan representative.    Soft reject : stop s the pharmacy from processing a claim unless or until a pharma cist-submitted drug utilization review (DUR)/prospective payment system (PPS) code  is entered.  It is important to distinguish that soft edits that have been overridden by the pharmacist cannot later be overturned by the plan.   Message only alerts: do not stop a claim from processing, but provide important clinical and/or coverage information to the pharmacy.  Prior Authorization and Step Therapy Edits  With respect to PAs and STs, sponsors must clearly submit all requirements as part of the respective HPMS files.  For example, CMS expects that, with rare exceptions, the sponsors approval of a PA or ST for one strength of a drug for a beneficiary will apply to all strengths.  If the criteria are not submitted to and approved by CMS at a dose -specific level, sponsors must not implement dose -level requirements because this causes undue burden for the benefici ary, pharmacy, and prescriber.  Additionally, CMS expects that the Part D sponsor will submit all components of the PA, such as a requirement for laborator y tests and/or other medical procedure s before coverage of a drug will be authorized. For more detailed information on applying PA edits, see section 30.2.2.3.  Quantity Limit Edits  While QLs that allow for the dispensing of a given drug up to the FDA -approved maximum daily dose do not need to be submitted to CMS, any QLs enforced below the FDA -approved maximum dose or below the days supply entered in the Part D benefit package (PBP) must be included in the HPMS formulary submission for CMS review and approval.  QL edits may be applied across a plan or applied to a subset population (such as a specific age range for which a drug may be high risk or contraindicated)  when clinically appropriate.  QL edits may be enforced as maximum daily dose or as quantity -over-time limits, consistent with how they were included in the formulary submission.  High Cost Edits  Part D sponsors may also utilize a POS high cost edit as a component of their comprehensive fraud, waste & abuse program.  The use of this edit must not inappropriately restrict access to Part D drugs. CMS expects high cost edits:    To be res olvable in real time at the POS   Not be invoked repetitively for the same drug and dosage dispensed by the same pharmacy or after a favorable coverage determinati on.  2 Section 12.3 DUR/PPS -Generated Rejections. Telecommunication Version D and Above Questions, Answers, and Editorial Updates. May 2014. National Council for Prescription Drug Programs. Version 26.0.                                                   Once a high cost edit is addressed, should other CMS- approved or other safety edits apply, these edits must also be addressed.  Opioid Specific Safety Edits  Sponsors may apply QLs to opioids even though there is no clearly defined FDA maximum dose in the approved labeling.  O verutilization may trigg er a plan- level POS edit, which  is implemented by a plan after case management and advance written notice, in accordance with the opioid overutilization guidance available at https://www.cms.gov/Medicare/Prescription-Drug -Coverage/PrescriptionDrugCovContra/RxUtilization.html .  Sponsors are also encouraged to implement plan- level POS edits based  upon cumulative morphine equivalent dose ( MED ) across the opioid class.  To do so, plans will need to submit QLs for all individual opioids based upon equivalent MED as part of the HPMS formulary submission for CMS review , unless a lower plan- level (non -cumulative) edit has been approved for a specific opioid.  In addition to the HPMS formulary submission reflecting these MED edits, plan sponsors are expected to  submit detailed operational information in advance of the formulary submission deadline.  The d ocumentation should contain at a minimum the MED level being utilized, and a written description of the mechanics of the programs, such as the days in excess of a cumulat ive level that would trigger the edit, and the mechanism by which the edits would be r esolved.   In the event a beneficiary- level POS edit is more limited than a plan- level POS edit, the beneficiary -specific edit should be applied.  Utilization management requirements for non- formulary opioid prescriptions should be addressed as part of the coverage determination process.  See section 30.4.8 for additional guidance on edits applied during the transition period.  Chapter 7 of this manual contains more information on drug utilization management tools.  30.2.2.2 - Utilization Management Edits Not Requiring CMS Submission and Approval  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  CMS considers safety edits to prevent dispensing of unsafe dosing of drugs  to be part of the concurrent DUR requirements for all Part D dr ugs.  CMS does not require Part D sponsors to submit POS safety related edits as part of their HPMS formulary submission, even if they are implemented as hard edits ( with the exception of opioid specific edits, as defined in section 30.2.2.1).  These edits  are typically applied at the point -of-sale or point -of-distribution and assist the pharmacist in identifying and/or preventi ng inappropriate drug therapy.  These utilization review edits include the following:    Screening for potential drug therapy problems due to therapeutic duplication;   Age/gender -related contraindications;   Over -utilization (e.g., early refill) and underutilization;   Drug -drug interactions;   Incorrect drug dosage or duration of drug therapy (e.g., doses above FDA maximum approved dos ing);   Drug -allergy contraindications;   Clinical Abuse/Misuse   Safety edits, including on protected class drugs and controlled substances, can be implemented without submission to or approval by CMS for duplicative therapy or when labeling clearly indicates  the dispensing as unsafe , duplicative, or contraindicated.  Edits based upon precautions in the label, as opposed to contraindications or doses that exceed those supported by the label, must be submitted to CMS for approval.  T hese safety controls at POS should not be suppressed during beneficiaries transition pe riods (see s ection 30.4.8-  Edits for Transition Fills).   CMS specifically expects all sponsors to consider the cumulative acetaminophen (APAP) content of combination opioid analgesics and implement plan -level edits in their systems to prevent the dispensing of unsafe daily doses of APAP (greater than 4 grams/day as recommended by the FDA).  At a minimum, CMS expects Part D sponsors to implement soft plan- level safety edits at POS to reduce cumulati ve APAP overutilization among enrollees.  Sponsors P&T committees should develop the specifications for plan- level POS edits to prevent cumulative APAP overutilization based upon their own enrollee data, while minimizing false positives by accounting for known exceptions, such as reasonable early refills.  P&T committees may consider a mix of plan- level soft edits designed to compel the pharmacists clinical evaluation of APAP usage and hard edits to prevent APAP doses at and above amounts for which there would be no reasonable medical or dispensing explanation.  30.2.2.3  Application of Prior Authorization  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D s ponsors should consistently utilize PA  for those drugs with the highest likelihood of non-Part D covered uses, based on the following definitions :   High likelihood that coverage is available under Parts A or B (versus D) for the drug as prescribed and dispensed or administered, as discussed in section 20.2 of this chapter,   High likelihood that the drug is excluded from Part D coverage (e.g., a drug or drug class or its m edical use that is excluded from coverage or otherwise restricted under Part D as defined in section 1927(d)(2) of the Act), or    High likelihood of use for non- medically accepted indications as defined in section 1860D -2(E)(4) of the Act (see section 10.6).   CMS  recognize s that sponsors utilize standard PA forms to facilitate the collection of information necessary to fulfill the PA.  However, CMS  has identified several non- allowable practices that cannot be included on prior authorization forms, examples of which are provided below:    Requirements more restrictive than CMS -approved prior authorization criteria.   Limited Access or Step Therapy restrictions not consistent with the CMS- approved formulary.   Quantity Limits inconsistent with FDA maximum dosi ng or not consistent with the CMS-approved formulary.   Prior Authorization criteria not submitted for HPMS approved formulary medications.