evekhm/cms_iom_500 huggingface dataset:
(Medicare Part D Manual)
A drug approved or denied through prior authorization constitutes a coverage determination, subject to all applicable coverage determination standards, timelines, and requirements.  However, Part D spons ors should rely upon (1) information included by the physician with the prescription, (2) information communicated by the pharmacist or included with the submitted claim , such as diagnosis information (e.g., to determine whether the prescription is related to a Medicare covered transplant) , (3) information captured by the plan sponsor previously, such as diagnosis information from previous PAs, and (4)  location of administration (e.g., to determine if the prescription is being dispensed for a beneficiary in a nursing home) when available to avoid the need for a separate coverage determination request to obtain the needed information whenever  possible .  Assuming the available information is sufficient to  correctly assign payment to Part A or B or Part D , ther e is no need in such cases to require additional information to be obtained from the physician.  To the extent that the Part D sponsor requires its contracted pharmacies to report the information provided on the prescription to assist in the determination of Part A or B versus Part D coverage, the sponsor should rely on the pharmacists report of appropriate information to appropriately adjudicate the claim under Part D.  For example, for cases in which prednisone is prescribed for a condition other than im munosuppression secondary to a Medicare -covered transplant, and this is either documented  on the prescription, or evident based on the prescribers specialty, a known diagnosis, or concomitant therapies, a sponsor may cover the drug under Part D without se eking further information from the prescribing physician.  This clarification should not be construed to indicate that a Part D sponsor may not impose prior authorization or other procedures to ensure appropriate coverage under the Medicare drug benefit.  Part D sponsors may apply prior authorization to establish appropriate payment under Part A or B or Part D, even if the beneficiary is currently taking the drug.   However, CMS believes that the sponsor will have met appropriate due diligence standards wit hout further contacting a physician if necessary and sufficient information is available , and the contracted pharmacy is able to communicate this information to the sponsor in order to make the coverage determination.  Refer to section 30.2.2.3 for additional guidance on the application of PAs. For
(Medicare Part D Manual)
physician if necessary and sufficient information is available , and the contracted pharmacy is able to communicate this information to the sponsor in order to make the coverage determination.  Refer to section 30.2.2.3 for additional guidance on the application of PAs. For more information on Coverage Determination requirements, see Medicare Prescription Drug Benefit Manual, chapter 18, available at https://www.cms.gov/Medicare/Appeals -and-Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip .
(Medicare Part D Manual)
20.3 - Coverage of Supplemental Drugs Under Enhanced Alternative Coverage  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A Part D sponsor may only include coverage of drugs that would meet the definition of a Part D drug but for the application of section 20.1 (these are known as supplemental drugs, as provided in chapter 5, section 10.2 of this manual) as a supplemental benefit under enhanced alternative coverage.   20.4 - Application of General Exclusion Provisions  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  In accordance with section 1860D -2(e)(3) of the Act,  a Part D sponsor may exclude from qualified prescription drug coverage any Part D drug:    For which payment would not be made if items and services are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the funct ioning of a malformed body member (except for Part D vaccines); or    Which is not prescribed in accordance with the Part D plan.  Such exclusions are coverage determinations or redeterminations pursuant to chapter 18 of this manual, and are subject to appea l.  Unlike other Part D drugs that may be excluded when not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, Part D vaccines may only be excluded when their administration is not reasonable and necessary for the prevention of illness.  30 - Formulary Requirements  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  A Part D sponsor that uses a formulary under its qualified prescription drug coverage must meet requirements for the following:    Pharmacy and Therapeutics committee;   Provision of an adequate formulary;   Transition process;   Limitation on changes in therapeutic classification;  Provision of notice regarding formulary changes;   Limitation of formulary  changes prior to beginning of contract year;   Provider and patient education; and   Formulary changes during the contract year.   30.1 - Pharmacy and Therapeutics (P&T) Committee  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)
(Medicare Part D Manual)
30.1 - Pharmacy and Therapeutics (P&T) Committee  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  A Part D sponsors formulary must be developed and reviewed by a P&T committee that meets specific requirements with respect to:    Membership;   Conflict of interest;  P&T member disclosure to CMS;   Meeting administration;  Formulary management;   Formulary exceptions; and  P&T committee role.   30.1.1 - Membership  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors P&T committee membership must satisfy the following requirements:   P&T committee members must come from various clinical specialties that adequately represent the needs of sponsors enrollees.   A majority of the P&T committee members must be practicing physicians, practicing pharmacists , or both.  CMS defines a practicing physician or pharmacist to be an individual who has an active professional license to practice in the United States or one of its Territories and is currently practicing in the U.S. or one of its Territories.   At least one P&T committee practicing pharmacist and one practicing physician must be an expert in the care of elderly or disabled persons.   At least one P&T committee practicing pharmacist and one practicing physician must be independent and free of conflict with respect to the Part D sponsor and pharmaceutical manufacturers.  Such P&T committee member s may have certain non -employee relationships with pharmaceutical manufacturers (for example consulting, advisory, or research relationships) and still be considered independent and free of conflict provided those relationships do not constitute significant sources of income and they do not otherwise have a conflict of interest that would compromise their independence.  In addition, panel providers in a staff model HMO may be considered independent and free of conflict to the extent that any remuneration re ceived from a Part D sponsor is limited to his or her clinical responsibilities for the care of plan enrollees.   30.1.2 - Conflict of Interest  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  P&T committee members should sign a conflict of interest statement revealing economic or other relationships with entities affected by drug coverage decisions that could influence committee decisions.
(Medicare Part D Manual)
P&T committee members should sign a conflict of interest statement revealing economic or other relationships with entities affected by drug coverage decisions that could influence committee decisions.   30.1.3 - P&T Committee Member Disclosure to CMS  (Rev. 2, Issued:  07- 18-08; Effective/Implementa tion Date:  07 -18-08)  In the event the Part D sponsor has entered into a confidential agreement such that the Pharmacy Benefits Manager (PBM) will not disclose its P&T committee membership to the Part D sponsor, then it is the Part D sponsors responsibil ity to notify CMS that this information will be submitted by the sponsors PBM.  Moreover, the Part D sponsor must ensure that the PBM notifies CMS of the P&T committee membership.  The Part D sponsor maintains ultimate responsibility for adhering to and otherwise fully complying with all terms and conditions of its contract and the sponsor must ensure that the PBM notifies the sponsor that this information has been successfully submitted to CMS.   30.1.4 - Meeting Administration  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07 -18-08)  The Part D sponsors P&T committee should meet on a regular basis, but no less than quarterly.  P&T committee decisions regarding formulary development or revision must be documented in writing.   30.1.5 - Formular y Management  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors P&T committee will consider the following:    The P&T committee must review for clinical appropriateness the practices and policies for formulary management activities, such as prior authorizations, step therapies, quantity limitations, generic substitutions , and other drug utilization activities that affect access.  P&T committee recommendations regarding these activities are advisory only and not binding on the Part D sponsor.   Formulary management decisions must be based on scientific evidence, and may also be based on pharmacoeconomic considerations that achieve appropriate, safe , and cost effective drug therapy.
(Medicare Part D Manual)
 Formulary management decisions must be based on scientific evidence, and may also be based on pharmacoeconomic considerations that achieve appropriate, safe , and cost effective drug therapy.    The P&T committees will be required to establish and document procedures to ensure appropriate drug review and inclusion.  This includes documentation of decisions regarding formulary development and revision and utilization management activities ( 42 CFR 423.120(b)(1)(viii)).  P&T committee recommendations regarding which Part D drugs are placed on a sponsors formulary are binding on the Part D sponsor.   Clinical decisions by the P&T committee should be based on scientific evidence and standards of practice, including peer reviewed medical literature, well -established clinical practice guidelines , and pharmacoeconomic studies, as well as other sources of appropriate information.   Drugs therapeutic advantages in terms of safety and efficacy must be considered when selecting formulary drugs and placing them on formulary tiers.    The P&T committee will make a reasonable effort to review a new FDA approved drug product (or new FDA approved indication) within 90 days of its release onto the market and will make a decision on each new FDA approved drug product (or new FDA approved indication) within 180 days of its release onto the market, or a clinical justification will be provided if th is timeframe is not met.    The P&T committee will evaluate and analyze treatment protocols and procedures related to the sponsors formulary at least annually.    The P&T committee will approve inclusion or exclusion of the therapeutic classes in the formular y on an annual basis.   Part D sponsors that change pharmacy benefit managers ( PBMs ) mid-year are required to continue the existing formulary.  Decisions regarding formulary inclusion made by the previous PBMs P& T committee are binding on the assuming PBM.  CMS will not approve negative formulary change requests for the purpose of aligning an existing formulary with that of a new PBM.   30.1.6 - Formulary Exceptions  (Rev. 2, Issued:  07- 18-08; Effective/Implementat ion Date:  07- 18-08)
(Medicare Part D Manual)
30.1.6 - Formulary Exceptions  (Rev. 2, Issued:  07- 18-08; Effective/Implementat ion Date:  07- 18-08)  P&T committees must review for clinical appropriateness protocols and procedures for the timely use of and access to both formulary and non- formulary drug products.  Part D coverage determinations and appeals information can be found in chapter 18 of this manual.  30.1.7 - P&T Committee Role in Transition  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  At a minimum, a sponsors transition process, the minimum requirements of which are detailed in section 30.4, will address procedures for medical review of non formulary drug requests and, when appropriate, a process for switching new Part D sponsor enroll ees to therapeutically appropriate formulary alternatives failing an affirmative medical necessity determination.  CMS will look to transition process submissions for assurances that a sponsors P&T committee will review and provide recommendations regardi ng the procedures for medical review of non -formulary drug requests.  P&T committee involvement will help ensure that transition decisions appropriately address situations involving enrollees stabilized on drugs that are not on the sponsors formulary (or that are on the formulary but require prior authorization or step therapy under a sponsor's utilization management requirements) and which are known to have risks associated with any changes in the prescribed regimen.   30.2 - Provision of an Adequate Formu lary (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  CMS encourages Part D sponsors to submit formularies similar to those in widespread use today.  CMS will check the formulary to ensure inclusion of a range of drugs in a broad dist ribution of therapeutic categories and classes, in order to satisfy the Medicare Modernization Act (MMA) requirement that a sponsors categorization system does not substantially discourage enrollment by any group of beneficiaries.  CMS will consider the s pecific drugs, tiering and utilization management strategies employed in each formulary.  CMS will identify outliers from common benefit management practices for further evaluation.  Sponsors may be asked to provide written clinical justification for unusu al benefit features that are identified as outliers.
(Medicare Part D Manual)
30.2.1 - Formulary Categories and Classes  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D formularies must include drug categories and classes that cover disease states , consistent with Part D program requirements .  CMS will evaluate 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 Par t D drug choices.   Part D sponsors may use existing classification systems, such as those from U.S. Pharmacopeia (USP) and American Hospital Formulary Service (AHFS), or create their own.  CMS will automatically approve formulary classification  systems tha t are consistent with the USP classification system, available at www.usp.org .  For sponsors that choose to adopt an alternative classification structure, CMS will check the sponsors proposed classification system to determine if it is similar to USP or other commonly used classification systems, such as the AHFS Pharmacologic -Therapeutic Classification (information available at http://www.ahfsdruginformation.com/pt -classification -system.aspx).  Each category or class must include at least two drugs (u nless only one drug is available for a particular category or class, or only two drugs are available but one drug is clinically superior to the other for a particular category or class), regardless of the classification system that is utilized.  The two dr ug minimum requirement must be met through the provision of two chemically distinct drugs.  In other words, Part D sponsors will not meet this requirement by including only two dosage forms or strengths of the same drug, or a brand name drug and its generi c equivalent.  Aside from the inclusion of two drugs in each category or class, multiple strengths and dosage forms should also be available for each covered drug.  This should encompass dosage forms used commonly in long term care ( LTC ) facilities and home infusion.  CMS may require more than two drugs for particular categories or classes if additional drugs present unique and important therapeutic advantages in terms of safety and efficacy, and their absence from the sponsors formulary would substantially discourage enrollment by beneficiaries with certain disease states.
(Medicare Part D Manual)
30.2.1.1 - Application of Existing or New Drugs into the Current Version of the USP Model Guidelines (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  For those formularies that utilize the USP Model Guidelines classification structure, there are several methods to accommodate new Part D drugs that come on to the market during the contract year s between revisions of the Guidelines .  These methods may also be utilized to accommodate existing Part D drugs that have not been classified under the USP Model Guidelines.  CMS expects one of the four options listed below to be used for the above mentioned situations.  1.  Addition of a Par t D drug into an existing USP category or class. In the event that a new Part D drug is approved and is to be added to the formulary, the newly approved Part D drug may fit into the current classification system.  For instance, if a new protease inhibitor is approved, this drug would be added to the formulary in the USP Antivirals category, under the Anti -HIV Agents, Protease Inhibitors class.  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)
(Medicare Part D Manual)
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 .
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
 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.