(Medicare Part D Manual)

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.  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;    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.   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)  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.   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: