evekhm/cms_iom_500 huggingface dataset:
(Medicare Part D Manual)
 If a beneficiary level point -of-sale opioid claim edit has been implemented, CMS expects the beneficiary to only be able to receive during a transition period the opioid dosage that has been determined to be medically necessary and appropriate, based upon the case management process.  In other words, if a sponsor currently has a beneficiary -level opioid claim edit in place in one of its Part D plans and the beneficiary enrolls in another one of the sponsors plans, or the sponsor has received information from the prior plan from which the beneficiary disenrolled and the sponsor is satisfied that the edit should be continued, the  sponsor may apply the edit during transition.   For new beneficiaries presenting with a prescription that represents ongoing therapy with a non-formulary opioid medication or a formulary opioid medication subject to PA or ST under the new plans utilizatio n management rules, a temporary supply can be provided during transition in accordance with this section, as long as the temporary transition fill does not exceed plan-level limits, cumulative opioid MED edits, or beneficiary -specific limits documented by the previous plan that the current plan also applied.  For non- formulary medications, the safety and dosing should be considered as part of the coverage determination process when such determinations are requested.  30.4.9 - Cost -sharing Considerations  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Starting in 2015, a Part D sponsor must charge cost sharing for a temporary supply of drugs provided under its transition process such that the following conditions are met:    For LIS  enrollees, a sponsor must not charge higher cost sharing for transition supplies than the statutory maximum copayment amounts.    For non- LIS enrollees, a sponsor must charge    The same cost sharing for non- formulary Part D drugs provided during the transition that would apply for non- formulary drugs approved through a formulary exception in accordance with 423.578 (b); and    The same cost sharing for formulary drugs subject to utilization management edits provided during the transition that would apply if the utilization management criteria are met.
(Medicare Part D Manual)
 The same cost sharing for formulary drugs subject to utilization management edits provided during the transition that would apply if the utilization management criteria are met.  30.4.10 - Transition Not ices (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A successful transition process is contingent upon informing enrollees and their health care provider  about their options for ensuring that enrollees medical needs are safely  accommodated within a Part D sponsors formulary.  An enrollee who receives a temporary supply of a non -formulary Part D drug at a network pharmacy might simply assume that, by virtue of filling his or her prescription, that the plan will cover that drug for the remainder of the contract year.  For this reason, sponsors must provide enrollees with appropriate notice regarding their transition process within a reasonable amount of time after providing a temporary supply of non- formulary Part D drugs (includ ing Part D drugs that are on a sponsors formulary but require prior authorization or step therapy under a sponsors utilization management rules).  Part D sponsors will be required to send a written notice, via U.S. First Class mail, to each enrollee who receives a transition fill.  This standard is consistent with CMS requirement that other beneficiary communications, including formulary change notices and explanations of benefits, be sent via U.S. First Class mail.  In addition, this notice must be sent  to each affected enrollee within 3 business days  of adjudication of the temporary transition  fill.  If the enrollee completes his or her transition supply in several fills, the sponsor is required to send notice with the first transition fill only.   CMS b elieves this turnaround is necessary in order to provide an affected enrollee with sufficient time -- especially in light of CMS 30 -day transition fill policy in the retail setting -- to work with his or her prescriber to switch to a therapeutically equivalent drug that is on the plans formulary or to process an exceptions request.  The notice must include the following elements:    That the transition supply provided is temporary;    That the enrollee should work with the sponsor as well as his or her health care provider to satisfy utilization management requirements or to identify appropriate therapeutic alternatives that are on the sponsors formulary;
(Medicare Part D Manual)
 That the transition supply provided is temporary;    That the enrollee should work with the sponsor as well as his or her health care provider to satisfy utilization management requirements or to identify appropriate therapeutic alternatives that are on the sponsors formulary;    That the member has the right to request a formulary exception, the timeframes for processing the except ion, and the member's right to request an appeal if the sponsor issues an unfavorable decision; and    The sponsors procedures for requesting a formulary exception.  CMS provides Part D sponsors with a model transition  letter.  CMS expects that sponsors will make prior authorization or exception request forms available upon request to both enrollees and prescribing physicians and via a variety of mechanisms -- including by mail, fax, email, and on sponsor Web sites.  To the extent that sponsors have the capacity, CMS encourages them to provide any prior authorization or exception request forms a beneficiary will need to effectuate a transition with the transition notice.   CMS strongly encourages point -of-sale notificatio n to enrollees about transition supplies by pharmacists.  CMS has worked with the pharmacy and drug benefit industry, including the National Council for Prescription Drug Programs (NCPDP), to incorporate  a work -around process for using structured payment c oding in the message field of billing transaction responses indicating that a particular fill is a transition supply.  This process is co nsistent with the current NCPDP  standard.  For more information about Standardized Claims Messaging see chapter 14, section 50.5.  30.4.10.1 - Prescriber Notification of Transition Fills  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors must ensure that their transition process includes reasonable efforts to notify prescribers of affected enrollees who receive a transition notice.  CMS believes that prescriber notification  is a means of further strengthening beneficiary protections when dealing with formulary changes or utilization management protocols for necessary medications, be cause the prescriber is in the best position to advise the beneficiary of the benefits or risks of switching to a different medication.
(Medicare Part D Manual)
CMS believes  either of  the following examples constitutes a reasonable effort on the part of Part D sponsors to notify prescribers of affected enrollees who receive a transition notice.  These examples are not exclusive examples of actions that may constitute reasonable efforts:   1) Providing a copy of the written transition notice labeled as the PRESCRIBER COPY directl y to the prescriber of record.  Adding this label to a copy of the transition notice does not require submission of the notice for review and approval by CMS.  The copy may be provided to the prescriber via mail, fax, or electronic means.   2) Notifying the prescriber of record directly of the adjudication of the enrollees transition fill via a phone call, or individualized or batch fax/electronic notification.  This separate communication to the prescriber does not need to be submitted to C MS for review and approval.   CMS expects that plan sponsors will exercise due diligence in sending transition notices/communications to the prescriber of records correct address, whether that entails acquiring contractor support to identify prescribers on Part D claims, contacting the network pharmacy for information on the prescription, or other means.  However, CMS does not expect plan sponsors to verify that the prescriber has received a transition notice/communication.  CMS also recognizes that notific ation of a prescriber who would be expected to have only a transient relationship with the beneficiary, such as a hospital -based physician, would generally not be useful.  30.4.11 - Public Notice of Transition Process (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)
(Medicare Part D Manual)
Part D sponsors must make general information about their transition processes available to beneficiaries in a manner similar to information provided on formularies and benefit design.  It is likely that individuals will base their decision on which prescription drug best meets their needs on a variety of factors.  Having information about a sponsors transition process in plan enrollment materials and Web sites, as well as on the Medicare Prescription Drug Plan Finder,  may reassure beneficiaries that there will be procedures in place to assist them in switching to therapeutic alternatives or in obtaining a formulary exception where appropriate.  It will also serve to educate advocates and other interested third parties  for example, State Medicaid agencies  about sponsor transition processes.  CMS will make plan transition process information available via a required link from the Medicare Prescription Drug Plan Finder to individual sponsor Web sites.  30.5 - Provider and Patient Education  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A Part D sponsor must establish policies and procedures to educate and inform health care providers and enrollees concerning its formulary.  See the marketing guidelines on CMS Web site at http://www.cms.gov/Medicare/Prescription -Drug -Coverage/PrescriptionDrugCovContra/Downloads/MMG_0511.pdf  for more information on acceptable formulary marketing methods.  Chapter 6 - Appendix A  Common Acute Care Home Infusion Drugs   (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  CMS is no longer maintaining this tool and has chosen to remove the table from Appendix A.   Chapter 6  Appendix B  Part D Drugs/Part D Supplementar y Drugs (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  This table provides Part D coverage clarifications for specific products/drugs/drug categories in accordance with statutory and regulatory requirements for Part D drugs.  This is not an exhaustive list but only addresses those products/drugs/drug categories that have been the subject of frequently asked questions.  Specific products not identified in this table should always be evaluated against the statutory and regulatory  definition of a Part D drug before drawing conclusions from this table.  This table does not address Part B versus Part D coverage questions.
(Medicare Part D Manual)
Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  Agents when used for anorexia, weight loss, or weight gain No Prescription drug products being used to treat AIDS wasting and cachexia are not considered agents used for weight gain or agents used for cosmetic purposes, and therefore such products are NOT excluded under such exclusion categories.  Agents when used for cosmetic purposes or hair growth  No Treatments indicated for psoriasis, acne, rosacea, or vitiligo are NOT considered cosmetic.  Agents when used for symptomatic relief of cough and colds  No Cough and cold medications are eligible to meet the definition of a Part D drug in clinically relevant situations other than those of symptomatic relief of  cough and/or colds.  For example, when cough  medications are used to treat a medical condition that causes a cough, such as the use of bronchodilators for the treatment of bronchospasm in asthma, CMS does not consider these cough medications as exclud ed drugs and, therefore, these medications may be 3 Medically Accepted I ndication for purposes of Part D is an FDA labeled indication or an indication supported by citation in either the American Hospital Formulary System (AHFS), or DRUGDEX . Exceptions may be possible when used as part of an anti -cancer chemotherapeutic regim en.                                                   Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  covered under Part D. However, antitussives used to treat cough symptoms, and not the underlying medical condition causing the cough, are excluded from basic Part D coverage regardless of the medical condit ion causing the cough.  Antihistamine/Decongestant Combinations (RX)  Yes, except when being used for symptomatic relief of cough and cold   Barbiturates  Yes Covered for all medically accepted indications as of 2014  Benzodiazepines  Yes Covered for all medically accepted indications as of 2013  Blood glucose testing strips  No NOT directly associated with injection of insulin  Electrolytes/Replenishers:
(Medicare Part D Manual)
*Potassium  Sodium  Calcium  Magnesium  Yes *Potassium Iodide products are excluded from Part D as Iodine products (minerals) because they are not used for potassium supplementation. Erectile (ED) Dysfunction Drugs  No Agents when used for the treatment of sexual or erectile dysfunction, unless such agents are used to treat a condition, other than sexual or er ectile dysfunction, for which the agents have been approved by the FDA .  In addition, ED drugs will meet the definition of a Part D drug when prescribed for medically accepted indications approved by the FDA other than sexual or erectile dysfunction such a s pulmonary hypertension.  However, ED drugs will not meet the definition of a Part D drug when used off -label, even if the off label use is listed in one of the compendia found in section 1927(g)(1)(B)(i) of the Act . Extemporaneous Compounds, including sterile compounding of Yes, but only costs for Part D drug components Dispensing fee may include labor costs associated with mixing a compounded Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  IVs and total parenteral nutrition  may be billed under Part D drug product  that contains at least one Part D drug component
(Medicare Part D Manual)
Part D drug components used solely as vehicles in a compound may be covered under Part D (e.g., D5W, Normal Saline)  Fioricet (Bultalbital, APAP, Caffeine)  Yes See Commercially Available Combination Product Policy  Section 10.3  Fioricet with Codeine  Yes See Commercially Available Combination Product Policy  Section 10.3  Fiorinal (Butalbital, ASA, Caffeine)  Yes See Commercially Available Combination Product Policy  Section 10.3  Fiorinal with Codeine  Yes See Commercially Available Combination Product Policy  Section 10.3  Fosamax plus D  Yes See Commercially Available Combination Product Policy  Section 10.3  Galzin  No  Heparin/Saline Flushes  No See Section 10.6.  Injectable or IV Iron products such as Iron Dextran, Iron Sucrose and Sodium ferric gluconate  No Prescription vitamin/mineral product  Insulin  Yes  Insulin syringes  Yes Covered only for injection of insulin  IV Solutions for hydration therapy  Yes  Lancets  No NOT directly associated with injection of insulin  Less-than-effective DESI Drugs (and those drugs identical, related or similar)  No See Section 10.9  Leucovorin Calcium  Yes  Librax  No Less-than-effective DESI drug  Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  Limbitrol (Amitriptyline/chlordiazepoxide)  Yes See Commercially Available Combination Product Policy  Section 10.3  Lovaza  Yes  Medical foods  No Defined as a food that is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation, and that are not regulated as drugs under section 505 of the Federal Food, Drug, and Cosmetic Act. Megestrol Acetate and Growth Hormone when used for AIDS wasting and cachexia Yes Prescription drug products that otherwise satisfy the definition of Part D drug are Part D drugs when used for AIDS wasting and cachexia if these conditions are "medically accepted" indications, as defined by section 1927(k)(6) of the Social Security Act (SSA), for the particular Part D drug.   Specifically, CMS does not consider
(Medicare Part D Manual)
wasting and cachexia if these conditions are "medically accepted" indications, as defined by section 1927(k)(6) of the Social Security Act (SSA), for the particular Part D drug.   Specifically, CMS does not consider such prescription drug products being used to treat A IDS wasting and cachexia as either agents used for weight gain or agents used for cosmetic purposes, and therefore such products cannot be excluded from the Medicare Prescription Drug Benefit by reference to section 1927(d)(2) of the SSA.  Mephyton  No Prescription vitamin/mineral product  Methadone  Yes, except when indicated for the treatment of opioid dependence  A Part D drug is partially defined 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 Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  because it cannot be dispensed for this purpose upon a prescription at a retail pharmacy.  Nonprescription/Over -the-counter (OTC) drugs 4 No, except insulin and supplies associated with the injection of insulin  Supplies associated with the injection of insulin include syringes, alcohol wipes, insulin pens and pen needles, gauze, and alcohol  PhosLo  Yes  Phytonadione  No Prescription vitamin/mineral product  Polysaccharide Iron Complex  No Prescription vitamin/mineral product  Prescription niacin products  Yes Prescription niacin products are approved by the Food and Drug Administration as safe and effective drugs, are used therapeutically for the treatment of dyslipidemia, and do not serve as nutritional supplements or address a vitamin deficiency.  These products are used at dosages much higher than appropriate for nutritional supplementation.  For these reasons, CMS has concluded that these products should not be considered prescription vitamins for purposes of Part D coverage, and therefore, are not universal ly excluded from coverage under the Medicare prescription drug program.  Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations
(Medicare Part D Manual)
Examples : B vitamins (Folic Acid, Cyanocobalamin)  No  4 Part D plans may include OTC drugs in step therapy protocols as part of their cost effective drug utilization management program.  However, OTC drugs included in these step therapy protocols are considered administrative costs, not Part D drugs.                                                   Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  Vitamin K (phytonadione)  Vitamin D ( ergocalciferol and cholecalciferol)  Zinc (sulfate, acetate)  Iron Iodine  Multivitamin additives for parenteral nutrition  Smoking cessation drugs (OTC)  No  Smoking cessation drugs (RX)  Yes  Sterile Saline/water for Irrigation  Yes  Suboxone, Subutex  Yes  Vitamin D Analogs (Calcitriol, doxercalciferol, and paricalcitol)  Yes NOT considered prescription vitamins     Chapter 6  Appendix C - Summary of Coverage Policy  MEDICARE PART B VERSUS PART D COVERAGE I SSUES  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)   This document is not a statement or promise of coverage, but rather a high level summary of when something may be covered under Parts A, B or D, if all other coverage requirements are met.  Appropriate coverage policies and guidance must be consulted for final coverage determinations.   Introduction
(Medicare Part D Manual)
Introduction   This document provides an overview of outpatient prescription drug coverage policies under Medicare.  Beneficiaries who are inpatients of hospitals or skilled nursing  facilities (SNF) during covered stays may receive drugs as part of their treatment.  Typically, the payment for drugs is bundled into the Medicare Part A payments made to these types of facilities.5  Under the hospice benefit, beneficiaries receive drugs that are medically necessary for symptom control or for pain relief.  In general, references are seen to five major categories of Medicare Part B drug spending:  1. drugs billed by physicians and typically provided in physicians  offices (such as chemother apy drugs); 2. drugs billed by pharmacy suppliers and administered through durable medical equipment (DME), such as respiratory drugs given through a nebulizer; 3. drugs billed by pharmacy suppliers and self -administered by the patient (such as immunosuppr essive drugs and some oral anti -cancer drugs); 4. separately billable drugs provided in hospital outpatient departments; and 5. separately billable End Stage Renal Disease ( ESRD) drugs such as erythropoietin (EPO).  Regional differences in Part B coverage policies for drugs can occur in the absence of a national coverage decision.  A drug for which coverage is available under Part A or Part B, as it is being prescribed and dispensed or administered with respect to the individual, is excluded from the defi nition of a Part D drug and, therefore, cannot be included in Part D basic coverage.   Medicare Part A and Part B Covered Drugs   Part A/B Covered Drugs Set by Statute