evekhm/cms_iom_500 huggingface dataset:
(General Information, Eligibility, and Entitlement Manual)
Fee-for-Service Contractor Transition Handbooks  07/02/2007 5446 R43GI  03/30/2007 Clarification in Testing Instructions for Definition of Local Components  07/02/2007 5395 R38GI  05/26/2006 Files Maintenance Program Update to the Internet -Only Manual (IOM)  06/26/2006 5055 R34GI  01/06/2006 Change Management Process -- Electronic Change Infor mation Management Portal (eChimp)  01/03/2006 4092 R33GI  12/30/2005 Change Management Process -- Electronic Change Information Management Portal (eChimp)  01/03/2006 4092 R30GI  10/28/2005 Initiate STC testing of the MCS for RRB and HIGLAS  04/03/2006 4150 R26GI  07/22/2005 Implement Ne w Medicare Plan ID and Carrier Number for the Single Testing Contractor (STC)  10/03/2005 3978 R25GI  07/15/2005 Next Generation Desktop (NGD) Testing Requirements  08/15/2005 3493 R24GI  05/27/2005 2005 Scheduled Release for July Updates to Software Programs and Pricing/Coding Files  06/27/2005 3865 R23GI  05/06/2005 Procedures for Modifying Shared Systems Edits and Capturing Audit Trail Data  10/03/2005 3862 R17GI  02/25/2005 Review of Contractor Implementation of Change Requests (Replacement for expired CR 944)  03/01/2005 2884 R16GI  01/28/2005 Standard Terminology for Claims Processing Systems  04/04/2005 3596 R15GI  01/21/2005 Review of Contractor Implementation of Change Requests (Replacement for expired CR 944)  03/01/2005 2884 R08GI  07/30/2004 Establish Standard Terminology for Medicare Shared Systems  01/03/2005 3086 R06GI  05/2//2004  CMS Policy for Testing Quarterly Release of the Medicare Shared Systems and the CWF  08/01/2004 3011 R05GI  05/07/2004 Initial Publication of Chapter  N/A 2765 Back to top of Chapter
(Medicare Part D Manual)
Medicare Prescription Drug Benefit Manual   Chapter 6  Part D Drugs and Formulary Requirements    Table of Contents  (Rev. 1 8, 01- 15-16)
(Medicare Part D Manual)
Transmittals for Chapter 6 10 - Definition of a Part D Drug  10.1 -  General  10.2 -  Covered Part D Drug 10.3 -  Commercially Available Combination Products  10.4 -  Extemporaneous Compounds  10.5 -  Medical Supplies Associated with the Delivery of Insulin  10.6 -  Medically -Accepted In dication  10.6.1 -  Retrospective Determination of a Medically -Accepted Indication  10.7 -  Drugs  Purchased in Another Country  10.8 -  Drugs Used to Treat Opioid Dependence  10.9 -  DESI Drugs  10.10 -  Over -the-Counter Products (OTCs)  10.11 -  Common Home Infusion Drugs  10.12 -  Bundling of Home Infusion Drugs Under a Part C Supplemental Benefit  10.13 -  Inhaler Supplies  10.14 -  Vaccine A dministration  10.14.1 -  Elements of Vaccine Administration  10.14.2 -  Establishment of Multiple Vaccine Administration Fees  10.14.3 -  Other Vaccine Administration Considerations  20 - Part D Exclusions  20.1 -  Excluded Categories  20.2 -  Drugs Covered Under Medicare Part A or B  20.2.1 -  Exhausted Part A Benefits  20.2.2 -  Part D Sponsor Due Diligence in Prior Authorization of Part A or  B Versus Part D Coverage Determination  20.3 -  Coverage of Supplemental Drugs Under Enhanced Alternative Coverage  20.4 -  Application of General Exclusion Provisions  30 - Formulary Requirements  30.1 -  Pharmacy and Therapeutics (P&T) Committee  30.1.1 -  Membership  30.1.2 -  Conflict o f Interest  30.1.3 -  P&T Committee Member Disclosure to CMS  30.1.4 -  Meeting Administration  30.1.5 -  Formulary Management  30.1.6 -  Formulary Exceptions  30.1.7 -  P&T Committee Role in Transition  30.2 -  Provision of an Adequate Formulary  30.2.1 -  Formulary Categories and Classes  30.2.1.1 -  Application of Existing or New Drugs into the Current Version of the USP Model Guidelines  30.2.2 -  Formulary Benefit Management Tools  30.2.2.1 -  Utilization Management Edits Requiring CMS Submission and Approval  30.2.2.2  Utilization Management Edits Not Requiring CMS Submission and Approval  30.2.2.3  Application of Prior Authorization  30.2.3 -  Long -term Care Accessibility  30.2.4 -  Specialty Tiers
(Medicare Part D Manual)
 Utilization Management Edits Not Requiring CMS Submission and Approval  30.2.2.3  Application of Prior Authorization  30.2.3 -  Long -term Care Accessibility  30.2.4 -  Specialty Tiers  30.2.5 -  Protected Classes  30.2.6 -  Submission of Multiple Formularies  30.2.7 -  Formulary Performance and Content Review  30.2.8 -  Formulary Submission Timeline  30.3 -  Formulary Changes  30.3.1 -  Limitation on Changes in Therapeutic Classification  30.3.2 -  Limitation of Formulary Changes Prior to Beginning of Contract Year  30.3.3 -  Midyear Formulary Changes  30.3.3.1 -  Policy Regarding Formulary Changes  30.3.3.2 -  Formulary Maintenance Changes  30.3.3.3 -  Non -maintenance (Other) Formulary Changes  30.3.4 -  Provision of Notice Regarding Formulary Changes  30.3.4.1 -  Beneficiary Notice Requirements  30.3.4.2 -  Notice for Other Entities  30.3.4.3 -  Provision of Noti ce Regarding Formulary Changes Subsequent to Removal from the Market  30.3.4.4 -  Notice Requirements for Pending Formulary Changes  30.3.5 -  Formulary Change Notice in Advance of Upcoming Contract Year  30.4 -  Transition  30.4.1 -  Transition Requirements  30.4.2 -  General Transition Process  30.4.3 -  New Prescriptions Versus Ongoing Drug Therapy  30.4.4 -  Transition Timeframes and Transition Supply  30.4.4.1 -  Timeframe and Transition Supply  in the Retail Setting  30.4.4.2 -  Timeframe and Transition Supply  in the Long Term Care Setting  30.4.4.3 -  Transition Extension 30.4.5 -  Transition Across Contract Years  30.4.6 -  Emergency Supply for Current Enrol lees in the LTC Setting  30.4.7 -  Level of Care Changes  30.4.8 -  Edits for Transition Fills  30.4.9 -  Cost -sharing Considerations  30.4.10 -  Transition Notices  30.4.10.1 -  Prescriber Notification of Transition Fills  30.4.11 -  Public Notice of Transition Process  30.5 -  Provider and Patient Education Appendix A -  Common Acute Care Home Infusion Drugs  Appendix B -  Part D Drugs/Supplemental Drugs Summary Table  Appendix C -  Medicare Part B versus Part D Coverage Issues  Appendix D -  The Most
(Medicare Part D Manual)
Public Notice of Transition Process  30.5 -  Provider and Patient Education Appendix A -  Common Acute Care Home Infusion Drugs  Appendix B -  Part D Drugs/Supplemental Drugs Summary Table  Appendix C -  Medicare Part B versus Part D Coverage Issues  Appendix D -  The Most Commonly Prescribed Drug Classes for the Medicare Population  Appendix E  Sample Transition Supply Scenarios and Eligibility  10 - Definition of a Part D Drug  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)
(Medicare Part D Manual)
Part D drugs are defined in Title XVIII of the Social Security Act (the Act) and in the regulations (42 CFR 423.100).  Part D sponsors are responsible for making appropriate coverage determinations and ensuring that covered Part D drugs meet the requirements in this section.   10.1 - General  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Subject to the exclusions specified in section 20 of this chapter, a Part D drug means the following , if used for a medically -accepted indication as defined by section 1927(k)(6) of the Act:   A drug that may be dispensed only upon a prescription that is described in sections 1927(k)(2)(A)(i) through (iii) of the Act;    A biological product described in sections 1927(k)(2)(B)(i) through (ii i) of the Act;   Insulin described in section 1927(k)(2)(C) of the Act;    Medical supplies associated with the delivery of insulin;    A vaccine licensed under section 351 of the Public Health Service Act and its administration.   The Centers for Medicare & Medicaid Services ( CMS ) considers it best practice for Part D sponsors to consider the proper listing of a drug product with the Food and Drug Administration (FDA ) as a prerequisite for making a Part D drug coverage determination.  The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed.  Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.   The FDAs Comprehensive NDC Structured Product Labeling Data Elements file (NSDE) is used as a source of NDC information for Medicare Part D Formulary Reference File and prescription drug event ( PDE ) editing. The NSDE file can be found at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm
(Medicare Part D Manual)
CMS interprets dispensed only upon a prescription as meaning a drug that is recognized by the FDA as a prescribed drug requiring Rx only on its label per section 503(b)(4) of the Federal Food, Drug , and Cosmetic (FD&C)  Act.  Additionally, Part D sponsors must recognize a physicians authority to delegate prescribing where authorized by State law.  Generally, in retail pharmacy, standing orders and protocols are methods used by physicians to delegate and define their prescribing authority to non- physicia n providers such as pharmacists.  Standing orders are typically pre -approved documents for a specific drug or vaccine, contain a set of required clinical criteria and permit administration of the drug without physician examination, as long as the required clinical criteria are met.  A protocol is similar to a standing order but is generally broader in scope and may include multiple drugs and extensive clinical criteria.  A Part D sponsor may only provide benefits for Part D drugs that require a prescription if those drugs are dispensed upon a valid prescription, as  required by  423.104(h).  10.2 - Covered Part D Drug  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A covered Part D drug is a Part D drug that is included in a Part D sponsors formulary, or treated as being included in a Part D plans formulary as a result of a coverage determ ination or appeal under 42 CFR  423.566, 423.580, and  423.600, and obtained at a network pharmacy or an out -of-network pharmacy in accordance with 42 CFR  423.124 .  For the applicable drugs of a manufacturer to be covered under Part D, the  manufacturer must participate in the Medicare Coverage Gap Discount Program.  An applicable drug is a Part D drug that is approved under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or a biologics licens e application under section 351 of the Public Health Service Act (other than a product licensed under subsection (k) of such Act).  Thus the definition of applicable drugs excludes biological products approved under the abbreviated licensure pathway (biosi milars).
(Medicare Part D Manual)
10.3 - Commercially Available Combination Products (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Only those combination products approved and regulated in their combination form by the FDA as a drug, vaccine, insulin, or biological product, as described in paragraph (i), (ii), (iii), or (v) of the Part D drug definition at 423.100 are eligible for Part D coverage.  This requirement for FDA approval applies to commercially available combination products meant for broad distribution.  Extemporaneously compounded prescription drug products (addressed separately in this chapter in section 10.4 as well as in 423.120 (d)) are not affected by this  requirement.  Approved commercially available combination products include those w ith multiple active ingredients combined in a single drug product and those  products with multiple drugs that  remain separate but are co-packaged together and intended for dispensing as a single entity .  10.4 - Extemporaneous Compounds  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Compounded prescription drug products can contain: (1) all Part D drug product components; (2) some Part D drug product components; or (3) no Part D drug product components.  As defined in 423.120(d), only compounds that contain at least one ingredient that independently meets the definition of a Part D drug, and that do not contain any ingredients covered under Part B as prescribed and dispensed or administered, may be covered under Part D.  Only costs associated with those components that satisfy the definition of a Part D drug are allowable costs under Part D because the compounded products as a whole do not satisfy the definition of a Part D drug.
(Medicare Part D Manual)
For a Part D compound to be considered on -formulary, all ingredients that independently meet the definition of a Part D drug must be considered on- formulary.  B ulk powders  (i.e., Active Pharmaceutical Ingredients for compounding)  do not satisfy the definition of a Part D drug and are not covered by Part D.  For any non- Part D ingredient of the Part D compound, the Part D sponsors contract with the pharmacy must prohibit balance billing the beneficiary for the cost of any such ingredients.  Sponsors treat ing compounds as non- formulary products should be applying the cost sharing associated with an exceptions tier, regardless of whether the compound contains brand name or generic products.  For a Part D compound considered off -formulary, transition rules apply such that all ingredients that independently meet the definition of a Part D drug must become payable in the event of a transition fill and be covered if an exception under 423.578(b) is approved for coverage of the compound.  The labor costs associated with mixing a compounded product that contains at least one Part D drug component can be included in the dispensing fee (as defined in 42 CFR 423.100).  For compounds containing all generic products, the generic cost -sharing should be applied.  If a compound contains any brand name p roducts, the Part D sponsor may apply the higher brand name cost -sharing to the entire compound.  For low income subsidy (LIS) beneficiaries the copayment amount is based on whether the most expensive ingredient that independently meets the definition of a  Part D drug in the Part D compound is a generic or brand name drug.   10.5 - Medical Supplies Associated with the Delivery of Insulin  (Rev. 2; Issued:  07- 18-08; Effective/Implementation Date:  07 -18-08)  Medical supplies directly associated with delivering insulin to the body, including syringes, needles, alcohol swabs, gauze, and insulin injection delivery devices not otherwise covered under Medicare Part B, such as insulin pens, pen supplies, and needle -free syringes , can satisfy the definition of a Part D drug.  However, test strips, lancets and needle disposal systems are not considered medical supplies directly associated with the delivery of insulin for purposes of coverage under Part D.
(Medicare Part D Manual)
Insulin syringes equipped with a safe needle device, i n their entirety (syringe and device), are also Part D drugs and should be managed like any other Part D drug the sponsor places on its formulary.  Part D sponsors must make safety enabled insulin syringes available on their formularies for all of their in stitutionalized beneficiaries.   10.6 - Medically -Accepted Indication  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Section 1860D -2(e)(4) of the Act defines   medically -accepted indication, in part by reference to section 1927(k)(6) of the Act, to any use of a covered Part D drug which is approved under the Federal Food, Drug, and Cosmetic Act , or the use of which is supported by one or more c itations included or approved for inclusion in any of the compendia described in section 1927(g)(1)(B)(i) of the Act.  The recognized compendia are:  I. American Hospital Formulary Service Drug Information,  and II. DRUGDEX  Information System.   The definit ion of medically accepted indication also means, in the case of a covered Part D drug used in an anticancer chemotherapeutic regimen, the definition of medically accepted indication in section 1861(t)(2)(B) of the Act.  Thus, Part D sponsors will be requir ed to thoroughly understand and apply Part Bs definition of an anti -cancer chemotherapeutic regimen, utilize Part B compendia, and consider peer reviewed medical literature when necessary.  Pub. 100- 02, Medicare Benefit Policy Manual , chapter 15, s ection 50.4.5 (http://www.cms.gov/Regulations -and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf ) will be the authoritative guidance for Part D sponsors in their consideration of medically -accepted indications for Part D anti -cancer chemotherapeutic claims.
(Medicare Part D Manual)
Part D sponsors are responsible for ensuring that covered Part D drugs are prescribed for medi cally -accepted indications using the tools and data available to them to make such determinations.  Part D sponsors must reference all CMS recognized compendia to determine whether there are any supportive citations, prior to determining that a drug is not  being used for a medically -accepted indication.  Part D sponsors may rely on utilization management policies and procedures , approved by CMS where required (see section 30.2.2.1), to make such determinations .  Dispensing pharmacists  are not required to contact each prescriber to verify a prescription is being used for a medically -accepted indication.  Also,  medically -accepted indication refers to the diagnosis or condition for which a drug is being prescribed, not the dose being prescribed for such indicat ion.  Part D sponsors may have dose limitations based on FDA labeling, but an enrollee may request (and be granted) an exception to a dose restriction through the formulary exception process based on medical necessity criteria.   Additionally a Part D drug must be used for a medically -accepted indication that facilitates the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines).  Consequently, if a drug works on medical equipment or devices and is not used for a medically -accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug.  For example, a heparin flush is not used to treat a patient for a medically -accepted indication, but rather to dissolve possible blood clots around an infusion line.  Therefore, heparins use in this instance is not therapeutic but is, instead, necessary to make durable medical equipment work.  Heparin would therefore not be a Part D drug when used in a heparin fl ush.
(Medicare Part D Manual)
Utilization management edits should be applied to drugs that are likely to be used for indications that are excluded from Part D coverage or that are not medically accepted in the sponsors experience or as directed by CMS.  While CMS would not expec t edits to be universally applied to check whether every drug or most drugs are being used for medically -accepted indications, Part D sponsors remain responsible for ensuring that Part D drugs are only covered when used for medically -accepted indications.  Therefore, a ll Part D s ponsors should consistently utilize prior authorization (PA ) for those drugs with the highest likelihood of non- Part D covered uses, as detailed in section 30.2.2.3 unless  plans are able to reliably use tools other than PA to determine appropriate coverage for the drug.    10.6.1 - Retrospective Determination of a Medically -Accepted Indication  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors may retrospectively identify and confirm  either as part of their retrospective review programs required under 42 CFR 423.153, or incident to another utilization management review  that a dispensed drug , including when dispensed as a transition fill, was not prescribed for a medically -accepted indication for a particular individual (see the example below, in which this occurred because a dosage issue resulted in the case being flagged).   Example:   An individual receives a prescription and takes the  drug within a common dosing regimen (i.e., one tablet daily).  Several months later, that individuals physician writes a new prescription for an increased dosage of that drug.  The second prescription triggers a quantity limit claim edit (for example, ba sed on safety limits) .  As a result, the individuals physician requests a coverage determination from the plan and submits evidence to support an exception to the quantity limit.  Based on that evidence, the Part D sponsor makes a determination that the drug was not prescribed for a medically -accepted indication.
(Medicare Part D Manual)
When it was not reasonable to expect a Part D sponsor to require prior authorization to ensure a drug is being used for an accepted medical indication, CMS would not expect the sponsor to recover  payments made to pharmacies or attempt to obtain reimbursement from enrollees.  However, w hen retrospective review of point of sale claims adjudication determines that a drug was dispensed for a non- medically -accepted indication, the PDE should be deleted and accumulators adjusted.  (Sponsors should additionally reference all applicable PDE guidance  and, when applicable, guidance in the Prescription Drug Benefit Manual, chapter 18  Part D Enrollee Grievances, Coverage Determinations, and Appeals,  regardi ng required notices for coverage determinations, available at https://www.cms.gov/Medicare/Appeals -and-Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip ).  10.7 - Drugs Purchased in Another Country  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors must exclude Part D drugs from qualified prescription drug coverage if they are not sold in the United States.  In addition, Part D sponsors may only pay for drugs that satisfy the definition of Part D drug.  In general, such definition requires FDA approval for sale in the United States.  Therefore, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus it is considered to be unapproved.   In the event of a drug shortage, in order to ensure access to critically needed drugs in conjunction with the actions taken by the FDA, CMS will accept PDE submissions with national drug codes for foreign versions of Part D drugs, imported under the FDAs exercise of its enforcement discretion.  PDE allowances will be limited to the specific drug p roduct(s), conditions, and the duration of the shortage as specified by the FDA.  Such products cannot be discounted under the Medicare Coverage Gap Discount Program.  10.8 - Drugs Used to Treat Opioid Dependence  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)
(Medicare Part D Manual)
Part D sponsors must include coverage for Part D drugs, either by formulary inclusion or via an exception, when medically necessary for the treatment of opioid dependence.  Coverage is not limited to single entity products such as Subutex, but must include combination products that are Part D drugs when medically necessary (e.g., Suboxone).  For any new enrollees, CMS requires sponsors to have a transition policy to prevent any unintended interruptions in pharmacologic treatment with Part D drugs during their transition into the benefit.  This transition policy, along with CMS non- formulary exceptions/appeals requirements, should ensure that all Medicare enrollees have timely access to their medically necessary Part D drug  therapies for opioid dependence.   A Part D drug is defined, in part, as a drug that may be dispensed only upon a prescription.  Consequently, methadone is not a Part D drug when used for treatment of opioid dependence because it cannot be dispensed for this purpose upon a prescription at a retail pharmacy.  (NOTE:   Methadone is a Part D drug when used for pain).  State Medicaid Programs may continue to include the costs of methadone in their bundled payment to qualified drug treatment clinics or hospital s that dispense methadone for opioid dependence.   10.9 - DESI Drugs  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)