evekhm/cms_iom_500 huggingface dataset:
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
 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 .
(Medicare Part D Manual)
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:
(Medicare Part D Manual)
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)
(Medicare Part D Manual)
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.   Steering of physicians or beneficiaries to a sponsors and/or PBMs own mail order pharmacy.  Steering of physicians  or beneficiaries to a sponsors and/or PBMs own specialty pharmacy for any drugs which are not restricted to select pharmacies based on manufacturer or FDA distribution limitations.   30.2.3 - Long -term Care Accessibility  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07 -18-08)
(Medicare Part D Manual)
30.2.3 - Long -term Care Accessibility  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07 -18-08)  Part D sponsors will be required to provide medically necessary prescription drug treatments for enrollees in the general Medicare population, as well as  those enrollees who reside in LTC  facilities.  For example,  it is CMS expectation that sponsors provide coverage of dosage forms of drugs that are widely utilized in the LTC setting, such as unit dose products and liquid, chewable, and parenteral preparations.  Further, while nebulized solutions may not be  requir ed on all formularies, CMS  would expect sponsors to also cover these dosage forms under circumstances in which Part B coverage is not available.  When determining days supplies for residents in LTC facilities, Part D sponsors should follow industry best pr actices and allow for at least 31 days per fi ll.  30.2.4 - Specialty Tiers  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Regulations at 42 CFR 423.578(a)(7) allow Part D sponsors to exempt a formulary tier, in which it places very high cost and unique items, from tiered cost -sharing exceptions.  In order to ensure that a Part D sponsor does not substantially discourage enrollment by specific patient populations reliant upon these medications, CMS will only approve specialty tiers within formularies and benefit designs that comply with the following:    Only one tier is designated a specialty tier exempt from cost- sharing exceptions.    Cost-sharing associated with  the specialty tier is limited to 25% after the standard deductible and before the initial coverage limit (or up to 33%  for sponsors with decreased or no deductible under alternative prescription drug coverage designs).  When applying a reduced deductible,  sponsors are limited to the maximum specialty coinsurance levels as defined each year in the Bid User Manual.  The deductible applied to the non- specialty tiers may not exceed the deductible that is applied to the specialty tier.
(Medicare Part D Manual)
 Only Part D drugs with s ponsor negotiated prices that exceed the dollar -per-month amount established by CMS in the annual Call Letter may be placed in the specialty tier.  CMS will apply an upfront evaluation across all plans for drugs that exceed the dollar -per-month threshold a nd are intended for inclusion in the specialty tier.    If not all drugs (including all strengths) within a category or class meet the criteria for inclusion in the specialty tier, the sponsor must ensure that placement of the remaining drugs among the other  tiers of the formulary does not substantially discourage enrollment.   Part D sponsors will need to evaluate the negotiated prices at the drug product strength, package size, and formulation level in order to determine appropriate inclusion of the drug in the Part D plans specialty tier.  In addition to cost calculations, CMS considers claims history in reviewing the placement of drugs on Part D sponsors specialty tiers.  Except for newly approved drugs for which Part D sponsors would have little or no cl aims data, CMS will approve specialty tiers that only include drugs when their claims data demonstrates that the majority of the fills exceed the specialty tier cost criteria.  Part D sponsors should be prepared to provide CMS with the applicable claims data during the formulary review process  if requested .  Also, if  a Part D drug product is available in multiple strengths, package sizes , and formulations, CMS will only allow inclusion on the specialty tier of those strengths, package sizes , and formulations that would reasonably exceed t he dollar -per-month threshold.  Part D sponsors must evaluate the long acting nature of some drug formulations and calculate the monthly cost across the drug's full duration of action in considering possible specialty tier placement .  For example, if the specialty tier threshold was $600 dollars, a long acting formulation with a plan negotiated price of $900 dollars that lasts for 3 months would not be eligible for the plan's specialty tier since the monthly cost is only $300 dollars.   30.2.5 - Protected Classes (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)
(Medicare Part D Manual)
30.2.5 - Protected Classes (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsor formularies must include all or substantially all drugs in the immunosuppressant  (for prophylaxis of organ transplant rejection),  antidepressant, antipsychotic, anticonvulsant, antiretroviral, and antineoplastic classes.  CMS instituted this policy because it was necessary to ensure that Medicare beneficiaries reliant upon these drugs would not be substantially discourage d from enrolling in certain Part D plans, as well as to mitigate the risks and complications associated with an interruption of therapy for these vulnerable populations.   Formularies must include substantially all drugs in these six categories that are FDA  approved by the last CMS specified HPMS formulary upload date for the upcoming contract year.  New drugs or newly approved uses for drugs within the six classes that come onto the market after the CMS specified formulary upload date will be subject to an ex pedited P&T  committee review.  The expedited review process requires P&T committees to make a decision within 90 days, rather than the normal 180- day requirement.  At the end of the 90 day period, these drugs must be added to Part D plan formularies.  Substantially all in this context means that all drugs and unique dosage forms in these categories are expected to be included in sponsor formularies, with the following exceptions:    multi- source brands of the identical molecular structure ;  extended release products when the immediate -release product is included ;  products that have the same active ingredient or moiety ; and  dosage forms that do not provide a unique route of administration (e.g., tablets and capsules versus tablets and transdermals) ;
(Medicare Part D Manual)
Part D sponsors may not implement PA or ST requirements  that are intended to steer beneficiaries to preferred alternatives within these classes for enrollees who are currently taking a drug.  This prohibition applies to those beneficiaries already enrolled in t he plan as well as new enrollees who were actively taking drugs in any of the six classes of clinical concern prior to enrollment into the plan.  If a sponsor cannot determine at the point of sale whether  an enrollee is currently taking a drug  (e.g., new e nrollee filling a prescription for the first time), the sponsor shall treat such enrollee as currently taking the drug.   For HIV/AIDS drugs, utilization management tools such as prior authorization and step therapy are generally not employed in widely used, best practice formulary models.  Part D sponsors may conduct consultations with physicians regarding treatment options and outcomes in all cases.   See also sections 30.2.2.2, 30.2.2.3, 30.4.3, and 30.4.8 of this chapter for additional guidance on utilization management and transition fill guidance specific to protected class drugs.  30.2.6 - Submission of Multiple Formularies  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  CMS recognizes that sponsors may wish to submit mor e than one formulary in order to offer enhanced access to Part D drugs.  CMS has the responsibility to ensure that there are meaningful differences between multiple formulary submissions from one organization to reduce confusion amongst beneficiaries.  CMS  may request that sponsors withdraw a formulary in which no meaningful differences can be demonstrated.   For guidance on submitting formularies for employer group waiver plans, see chapter 12, section 20.14, of this manual.  30.2.7 - Formulary Performance and Content Review  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Regardless of the classification system chosen, CMS will review and approve drug lists that are consistent with best practice formularies currently in widespread  use today.  The current formulary requirements are subject to change and/or revision.   CMS reviews  formulary drug lists with respect to the following areas :
(Medicare Part D Manual)
CMS reviews  formulary drug lists with respect to the following areas :   CMS evaluates the sufficiency of a Part D sponsors formulary categories and classes in conjunction with the formulary drug list to ensure that the formulary provides access to an acceptable range of Part D drug choices.    Consistent with 42 CFR 423.120 (b)(2)(i), each formulary is reviewed for inclusion of at least two Part D drugs for each category and class submitted on the formulary file (except as noted in 423.120 (b)(ii)).    CMS will review tier placement to ensure that the formulary does not substantially discourage enrollment of certain beneficiaries.  When developing their formulary tier structure, sponsors should utilize standard industry practices.  Tier 1 should be considered the lowest cost -sharing tier available to beneficiaries.  Any subsequent tiers within the formulary structure will be higher cost- sharing tiers in ascending order , except that  plans may assign a low  cost share to Tier 5 or 6 when assigned as a Select Care tier.  For example, drugs in Tier 3 will have a higher cost -share for beneficiaries than drugs in Tier 2.  Best practices in existing formularies and preferred drug lists generally place drugs in a less preferable position only when drugs that are therapeutically similar (i.e., drugs that provide similar treatment outcomes) are in more preferable positions on the formulary.  The CMS review will focus on identifying drug categories that may substantia lly discourage enrollment of certain beneficiaries by placing drugs in non- preferred tiers in the absence of commonly used therapeutically similar drugs in more preferred positions.
(Medicare Part D Manual)
 CMS will analyze formularies to determine whether appropriate access is a fforded to drugs or drug classes addressed in widely accepted treatment guidelines which are indicative of general best practice.  Examples of these may include asthma, diabetes, chronic stable angina, atrial fibrillation, heart failure, thrombosis, lipid disorders, hypertension, chronic obstructive pulmonary disease, dementia, depression, bipolar disorder, schizophrenia, benign prostatic hyperplasia, osteoporosis, migraine, gastroesophageal reflux disease, epilepsy, Parkinsons disease, end stage renal dis ease, hepatitis, tuberculosis, community acquired pneumonia, rheumatoid arthritis, multiple sclerosis and HIV .  Part D sponsors should be aware of treatment guidelines impacting those enrollees residing in LTC facilities, such as CDCs annual Morbidity and Mortality Weekly Report (MMWR) on prevention and control of influenza.  This list of conditions does not represent an exhaustive list, but merely serves as another check in the review proces s.   CMS will analyze the availability of the most commonly prescr ibed drug classes for the Medicare population (Appendix D).  This list is derived from Part D claims data.  The drugs identified will be expanded to the class level and used in the formulary review process.  CMS understands that sponsors  will not provide i dentical coverage of these drug classes, and CMS review will focus on ensuring that sponsors present a balanced formulary.  These drug classes will cover common diseases and conditions, and will allow CMS to ensure that sponsors are covering the most wide ly used medications, or therapeutically similar medications, for the most common conditions.    CMS will review all Part D sponsors formularies to ensure they contain all commercially available vaccines (unless excluded due to available reimbursement under Part B, e.g., influenza or pneumococcal vaccines , or if a commercially available vaccine manufacturer does not participate in the coverage gap discount program ).  Sponsors will only be allowed to use drug utilization management tools to:   o Assess the necessity of vaccines that are less commonly administered in the Medicare population, such as anthrax and yellow fever vaccines;   o Facilitate use of vaccines in line with Advisory Committee on Immunization Practices (ACIP) recommendations; and
(Medicare Part D Manual)
o Assess the necessity of vaccines that are less commonly administered in the Medicare population, such as anthrax and yellow fever vaccines;   o Facilitate use of vaccines in line with Advisory Committee on Immunization Practices (ACIP) recommendations; and   o Evaluate potential  reimbursement of those vaccines that could be covered under Part B when directly related to the treatment of an injury or direct exposure to a disease or condition (e.g., tetanus).    UM restrictions will also be evaluated as part of the formulary content r eview.  In addition to ensuring that the use of these tools are consistent with industry best practices, CMS will also compare all sponsors formulary submissions to analyze the comparative use of UM tools.  When outliers are identified, CMS will request a clinical justification that supports the use of the submitted edits.  All formularies will be evaluated using the criteria above in this section.  Outliers for each area of review will be further evaluated by CMS to determine whether the outlier is deemed  potentially discriminatory.  Examples of this may include a lack of appropriate drug classes to treat certain diseases, a lack of sufficient drugs in a therapeutic class,  inappropriate tier placement that would discriminate against a group of beneficiarie s, or missing drugs that could discourage certain types of beneficiaries from enrolling in the plan.  If any of the outliers appear to create problems of access, sponsors will have the opportunity to present reasonable clinical justification s.  30.2.8 - Formulary Submission Timeline  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors that fail to meet formulary submission and re -submission deadlines during the formulary approval process may face a CMS determination that CMS cannot approve their Part D bids.  For most Part D sponsors, a failure to obtain bid approvals will result in the termination of their Part D sponsor or MA organization contracts effective at the end of the existing contract year.  In the case of an initial Part D sponsor or MA organization contract applicant, CMS would decline to enter into a contract with the organization.