(Medicare Part D Manual)

Question 1 -  Can claims submitted by a pharmacy for inhalation drugs delivered through metered -dose inhalers be denied based on Part B coverage of inhalation drugs used with a nebulizer?   Answer 1   No.  Since there currently is no coverage under Part B for inhalation drugs delivered through metered- dose inhalers and dispensed by a pharmacy, these drugs would be covered under Part D.  Question 2  Does Part B cover inhalation drugs used with a nebulizer  in the case of  a beneficiary in a hosp ital or SNF bed who does not have Part A coverage, whose Part A coverage for the stay has run out or whose stay is non -covered?   Answer 2   No, inhalation drugs used with a nebulizer  are not covered under Part B under those circumstances because the law li mits coverage under Part Bs DME benefit to those items that are furnished for use in a patients home, and specifies that a hospital or SNF cannot be considered the beneficiarys home for this purpose.  (See list above ( INFUSION DRUGS , Question 3) for other facilities which cannot be considered a beneficiarys home for DME purposes.  VACCINES   Question 1  Are all vaccines covered under Part D?   Answer 1   No.  There are a number of vaccines that remain covered under Part B.  For instance, pneumococcal  and influenza vaccines are not covered under Part D because of Part B coverage.  Hepatitis B vaccine is covered under Part B for individuals at high or intermediate risk; for all other individuals, it would be covered under a Part D benefit.  Part B also covers certain vaccines reasonable and necessary for the treatment of an illness or injury.  All other currently available vaccines and all future preventative vaccines could be covered under Part D.  Question 2  - If a Part D sponsor determines through a p rior authorization program that a hepatitis B vaccine is going to be administered by a physician can the Part D sponsor deny the claim based on Part B coverage in the setting?  Answer 2   No.  Since the Part B benefit for hepatitis B vaccine is separate fr om the incident to benefit, the determination about whether it is a Part D drug depends solely on characteristics of the beneficiary.  However, if the Part D sponsor determines based on Medicare Part B guidelines that the individual is at high or medium risk for hepatitis B, the claim should be denied.  For all other individuals, the vaccine would be a Part D drug.   Question 3 -  Medicare Part B covers hepatitis B vaccine for high and intermediate risk groups if ordered by a doctor of medicine or osteopa thy, how are these groups defined?   Answer 3  The high risk groups for whom vaccination is covered include:   Individuals with End stage renal disease (ESRD);   Individuals with hemophilia who received Factor VIII or IX concentrates;   Clients of institutions for individuals for the mentally handicapped;   Persons who live in the same household as a hepatitis B Virus (HBV) carrier;   Homosexual men;   Illicit injectable drug abusers   Intermediate risk groups include:   Staff in institutions for the mentally handicapped; and   Workers in health care professions who have frequent contact with blood or blood-derived body fluids during routine work.   ANTIGENS   Question 1  If a pharmacy submits a claim for antigens should a Part D sponsor make payment?  Answer 1   No.  Antigens are covered only under Part B.   BLOOD CLOTTING FACTORS   Question 1  If a pharmacy submits a claim for blood clotting factors should a Part D sponsor make payment?   Answer 1   No.  Blood clotting fact ors are covered under Part A and Part B.  Chapter 6  Appendix C - Summary of Coverage Policy   ATTACHMENT III   Web sites for Part B Coverage Information   Pub. 100 -04, Medicare Claims Processing Manual  http://www.cms.gov/Regulations -and-Guidance/Guidance/Manuals/Internet -Only -Manuals -IOMs -Items/C MS018912.html?DLPage=1&DLSort=0&DLSortDir=ascending  Pub. 100 -02, Medicare Benefit Policy Manual   http://www.cms.gov/Regulations -and-Guidance/Guidance/Manuals/Internet -Only -Manuals -IOMs -Items/CMS012673.html?DLPage=1&DLSort=0&DLSortDir=ascending  Medicare Coverage Database  http://www.cms.hhs.gov /mcd/search.asp   A/B MAC and DME MAC contact information  http://www.cms.hhs.gov/apps/contacts /   Chapter 6 - Appendix D   (Rev. 10, Issued: 02- 19-10, Effective/Implementation Date: 03- 01-10)  The Most Commonly Prescribed Drug Classes for the Medicare Population   3- HYDROXY - 3- METHYLGLUTARYL COENZYME A (HMG COA) REDUCTASE INHIBITORS  HORMONAL AGENTS, STIMULANT/ REPLACEMENT/ MODIFYING (THYROID)  5 ALPHA - REDUCTASE INHIBITORS  INSULIN, INTERMEDIATE - ACTING  ADENOSINE DIPHOSPHATE P2Y12 INHIBITORS  INSULIN, LONG - ACTING  ALPHA 1 - ADRENERGIC BLOCKING AGENTS  INSULIN, SHORT - ACTING  ALPHA - ADRENERGIC AGONISTS  LAXATIVES  ALPHA - ADRENERGIC AGONISTS, OPHTHALMIC  LEUKOTRIENE RECEPTOR ANTAGONISTS  ANGIOTENSIN II RECEPTOR ANTAGONISTS  LINCOMYCIN ANTIBACTERIALS  ANGIOTENSIN - CONVERTING ENZYME (ACE) INHIBITORS  LOCAL ANESTHETICS  ANTI - INFLAMMATORIES, INHALED CORTICOSTEROIDS  LOOP DIURETICS  ANTIARRHYTHMICS - CLASS IA/ II/ III/ IV  LTC DRUGS - AMINO DERIVATIVE PENICILLINS (CHEWABLE)  ANTICHOLINERGICS  LTC DRUGS - AMINO DERIVATIVE PENICILLINS (ORAL LIQUID)  ANTICOAGULANTS  LTC DRUGS - ANTIEMETICS (SUPPOSITORY)  ANTIDEPRESSANTS, OTHER  LTC DRUGS - BRONCHODILATORS, SYMPATHOMIMETIC (SHORT - ACTING SOLUTION)  ANTIEMETICS  LTC DRUGS - HISTAMINE2 (H2) BLOCKING AGENTS (ORAL LIQUID)  ANTIHERPETIC AGENTS  LTC DRUGS - LOOP DIURETICS (ORAL LIQUID)  ANTISPASMODICS, GASTROINTESTINAL  LTC DRUGS - MACROLIDES (ORAL LIQUID)  ANTISPASMODICS, URINARY  LTC DRUGS - NONSTEROIDAL ANTI - INFLAMMATORY DRUGS (ORAL LIQUID)  ANTISPASTICITY AGENTS  MACROLIDES  ANXIOLYTICS  MISCELLANEOUS ANTIBACTERIALS  ATYPICALS  NICOTINIC ACID  AZOLE ANTIFUNGALS, ORAL  NITROFURAN ANTIBACTERIALS  BETA - ADRENERGIC BLOCKING AGENTS WITH VASODILATING PROPERTIES  NONSELECTIVE BETA - ADRENERGIC BLOCKING AGENTS  BETA - ADRENERGIC BLOCKING AGENTS, OPHTHALMIC  NONSTEROIDAL ANTI - INFLAMMATORY DRUGS  BETA - LACTAM, PENICILLINS  OPHTHALMIC AMINOGLYCOSIDES  BIGUANIDES  OPHTHALMIC ANTI - ALLERGY AGENTS    BIPOLAR AGENTS  OPHTHALMIC PROSTAGLANDIN AND PROSTAMIDE ANALOGS  BISPHOSPHONATES, ORAL  OPIOID ANALGESICS, LONG - ACTING  BOWEL PREPARATION PRODUCTS  OPIOID ANALGESICS, SHORT - ACTING  BRONCHODILATORS, ANTICHOLINERGIC  OPIOID ANALGESICS, SHORT - ACTING WITH APAP  BRONCHODILATORS, SYMPATHOMIMETIC (LONG - ACTING)  PHOSPHODIESTERASE III/ ADENOSINE UPTAKE INHIBITORS  BRONCHODILATORS, SYMPATHOMIMETIC (SHORT - ACTING)  POLYENE ANTIFUNGALS  CALCIUM CHANNEL BLOCKING AGENTS (NON - DIHYDROPYRIDINES)  POTASSIUM SUPPLEMENTS  CALCIUM CHANNEL MODIFYING AGENTS  POTASSIUM - SPARING DIURETICS  CARDIOSELECTIVE BETA - ADRENERGIC BLOCKING AGENTS  PROGESTINS  CARDIOVASCULAR AGENTS, OTHER  PROTECTANTS, GASTROINTESTINAL  CEPHALOSPORIN ANTIBACTERIALS, 1ST GENERATION  PROTON PUMP INHIBITORS  CEPHALOSPORIN ANTIBACTERIALS, 2ND GENERATION  QUINOLONES  CHOLESTEROL ABSORPTION INHIBITORS  SEDATIVES/ HYPNOTICS  CHOLINESTERASE INHIBITORS  SELECTIVE ESTROGEN RECEPTOR MODIFIERS  DIHYDROPYRIDINES  SEROTONIN/ NOREPINEPHRINE REUPTAKE INHIBITORS  DOPAMINE AGONISTS, NONERGOT  SKELETAL MUSCLE RELAXANTS  DOPAMINE PRECURSORS  SMOKING CESSATION AGENTS  ESTROGENS  SODIUM CHANNEL INHIBITORS  FIBRATES  SULFONAMIDES  GAMMA - AMINOBUTYRIC ACID (GABA) AUGMENTING AGENTS  SULFONYLUREAS  GLUCOCORTICOIDS, OPHTHALMIC  TETRACYCLINES  GLUCOCORTICOIDS - SYSTEMIC  THIAZIDE DIURETICS  GLUCOCORTICOIDS - TOPICAL - MEDIUM POTENCY  THIAZOLIDINEDIONES  GLUCOCORTICOIDS -TOPICAL -HIGH POTENCY  TRICYCLICS  GLUTAMATE PATHWAY MODIFIERS  VASODILATORS, DIRECT - ACTING ARTERIAL  GLUTAMATE REDUCING AGENTS  VASODILATORS, DIRECT - ACTING ARTERIAL/ VENOUS  HISTAMINE1 (H1) BLOCKING AGENTS, MILDLY/ NON - SEDATING  XANTHINE OXIDASE INHIBITORS  HISTAMINE2 (H2) BLOCKING AGENTS       Chapter 6 - Appendix E  Sample Transition Supply Scenarios and Eligibility  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A Part D sponsor must provide for an appropriate transition process for certain enrollees who are prescribed Part D drugs that are non- formulary in order to promote continuity of c are and avoid interruptions in drug therapy while a switch to a therapeutically equivalent medication or the completion of an exception request to maintain coverage of an existing drug based on medical necessity reasons can be effectuated .  See Sections 30.4  30.4.11 for additional guidance.  Coverage Year 1  Coverage Year 2  Transition Eligible?  Sponsor A  Plan ABC (on formulary)   Sponsor A  Plan ABC (on formulary)  No No change in formulary   Sponsor A  Plan ABC (non- formulary and/or new UM criteria)  Yes Negative change; potential interruption of coverage  Sponsor A  Plan EFG (on formulary)  No No change in formulary   Sponsor A  Plan EFG (non- formulary and/or UM criteria)  Yes Non- formulary change; potential interruption of coverage  Sponsor B  Plan JKL (on formulary)  No No interruption of coverage   Sponsor B  Plan JKL (non- formulary and/or UM criteria)  Yes Non- formulary change; potential interruption of coverage  Sponsor A  Plan  DEF (non-formulary)  [filled  under exception]  Any Sponsor  Any Plan  (on formulary)   No No interruption of coverage   Sponsor A  Plan DEF (non- formulary)   Yes Plans may approve an exception or transition to a formulary item prior to the new contract year  Sponsor A  Plan DEF (on formulary, with UM criteria)   Yes Plans may approve an exception or transition to a formulary item prior to the new contract year  Sponsor B  Plan MNO (non -formulary and/or UM criteria)  Yes Potential interruption of coverage     Transmittals Issued for this Chapter