(Medicare Part D Manual)

ATTACHMENT I   Part B Drugs and Part D Coverage Chart   Drugs are covered under Part B in a variety of settings and under a variety of payment methodologies.   Some drugs are paid on a cost basis or are part of a prospective payment, including: drugs packaged under the outpatient prospective payment system (OPPS); drugs furnished by End-Stage Renal Diseas e (ESRD) facilities and included in Medicares ESRD composite rate; osteoporosis drugs provided by home health agencies under certain conditions; and drugs furnished by: critical access hospitals outpatient departments (CAHs); rural health clinics (RHCs); federally qualified health centers (FQHCs); community mental health centers (CMHCs); and ambulances.    In addition, there are 13 categories of drugs for which separate payment is made under Part B8, including: drugs furnished incident to a physicians se rvice; separately billable ESRD drugs; separately billable drugs provided in hospital outpatient departments; durable medical equipment (DME) supply drugs; drugs covered as supplies; drugs used in immunosuppressive therapy; blood clotting factors; certain vaccines; antigens; parenteral nutrition; certain oral drugs used in cancer treatment; separately billable drugs provided in comprehensive outpatient rehabilitation facilities (CORFs); and intravenous immune globulin provide in the home.9  The following chart groups the various categories of Part B coverage according to the extent to which they present some ambiguity for billing entities and/or Part D sponsors with regard to whether coverage should be under Pa rt B or Part D.  This ambiguity has different implications for stand alone Part D sponsors and for Medicare Advantage -Prescription Drug (MA -PD) Plans (including PACE plans and Section 1876 Cost plans which are treated similarly to MA -PDs).  For stand alone Part D sponsors, the sponsor needs to determine  whether it should make any payment.  For MA -PDs, the MA organization needs to determine whether a payment should be assigned to its Part D spending or to its spending for Part B services.  8 If these drugs are provided as part of a Medicare Part A covered inpatient hospital or skilled nursing facility stay, they are generally bundled  into the Medicare Part A payment to the facility.  The ex ception with regard to inpatient hospital services is clotting factor which is paid separately.  For covered SNF stays certain high cost chemotherapy drugs are billed separately along with preventive injections (e.g., flu shots).  If a beneficiary does not  have Part A coverage, if Part A coverage for the stay has run out or if a stay is non -covered, hospitals and SNFs can be paid for most categories of  Part B covered drugs.  9 Medicare does make separate payment for blood and blood products under Part A and Part B.  Although the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components are regu lated by the FDA, they are not administered in a context that would not be covered under Part A or Part B.  Therefore, generally these products are not Part D drugs.  As a result, they are not included in this discussion.                                                    A.  Situations in which a billing entity would have to decide whether for a given drug to bill Part B or Part D based on characteristics of beneficiary or medical use of the drug.   Relationship between Part B and Part D Coverage  Categ ories of Separately Billable Part B Drugs  Comments  1. The same drug dispensed by a pharmacy may be covered under Part B or Part D depending on the characteristics of the beneficiary.  Drugs used in immunosuppressive therapy for a transplant covered under Medicare.  Pharmacists would bill Part B or the individuals Part D plan based on information received from the individual or the Part D plan.  Part B would be billed if the individual had a Medicare -covered transplant; otherwise, the Part D plan would be billed.  (Part D plan eligibility systems could contain a marker for members who had a Medicare covered transplant.  This information could come from a question included on the Part D sponsors enrollment or coordination of benefit (COB) survey form.)  In determining whether to pay for an immunosuppressive drug under Part D, it would not be appropriate for a Part D sponsor to institute a general policy of requiring a Part B claim rejection, as a substitute for maintaining information on transplant status and paying claims based on that information.  Such a policy would be disruptive to beneficiaries and pharmacies and would unnecessarily increase Part B contractor costs.  Instead a prior authorization requirement would be appropriate.  2. The same drug provid ed by an infusion/DME supplier  may be covered under Part B or Part D depending on the characteristics of the beneficiary or method of administration.  a. Parenteral nutrition or intradialytic parenteral nutrition (IDPN) (for individuals with a non-functioni ng digestive tract).  The supplier would need to know whether the therapy was being provided because of a non- functioning digestive tract.  If so, Part B would be billed.  Otherwise this would be a Part D drug.   It would not be appropriate for Part D sponsors to routinely require a rejection of a claim under Part B before processing a Part D claim.  Such a policy would be disruptive to beneficiaries and pharmacies and would unnecessarily increase Part B contractor costs.  However, if a Part D sponsor had evi dence indicating that a particular claim for parenteral nutrition should be covered under Part B, it would be reasonable to require a rejection by Part B before processing in this case.   b. Infusible DME supply drugs  In general, the supplier would bill Pa rt B if the drug was administered using an infusion pump and bill the Part D plan for infusion using other methods (e.g., IV push).  While professional services and supplies related to the administration of the infused drug are not payable under Part D, some coverage may be available under Part A or B home health benefits, under Medicaid, or from secondary commercial health benefits.   As a rule, drugs infused using an implantable pump would be covered under Part B. Drugs infused in the home using an external pump are covered under Part B if they are included under the local coverage policy of the applicable Medicare DME MAC.  In the case of  a beneficiary in a hospital, or a SNF bed, (1) who does not have Part A coverage, (2) whose Part A coverage for  the stay has run out or  (3) whose stay is non-covered -- infusible DME supply drugs are not covered under Part B because the law limits 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.  In this case, coverage for the drugs would be available under Part D.  (see Attachment II, INFUSION DRUGS , Question 3 for other facilities which cannot be considered a benef iciarys home for DME purposes.)   The fact that coverage is available for a particular drug under Part B with the use of an infusion pump does not mean that coverage under Part D using some other method of administration automatically can be denied.  The re is no Part B coverage in the home for infusion drugs administered without an infusion pump (e.g., IV push).  There is also no Part B coverage in the home for infusion drugs administered with an infusion pump unless the drug is specifically covered under  the local coverage policy of the applicable Medicare DME MAC.  Therefore, determinations about Part D sponsor payment for these other methods of administration and for drugs administered with an infusion pump but not covered by the local DME MAC policy sh ould be based on the question of whether the drug is on the sponsors formulary.   c. Intravenous immune globulin (IVIG) provided in the home for individual with diagnosis of primary immune deficiency disease  The supplier would bill Part B if the diagnosis  is primary immune deficiency disease.  IVIG provided in the home for other diagnoses would be a Part D benefit.  As discussed above, it would not be appropriate, as a general rule, for Part D sponsors to require a rejection of a claim under Part B before processing a Part D claim.  Prior authorization programs could be used to ensure medical necessity in accordance with the Part D sponsors policy.  3. The same drug dispensed by a pharmacy may be covered under Part B or Part D depending on how the drug is used in treatment and the medical condition for which the drug is being prescribed.  a. Certain oral chemotherapy agents used in cancer treatment for which there is an infusible version of the drug.  Pharmacists would need to determine the reason for treatme nt.  If related to cancer treatment, Part B would be billed; otherwise, the Part D plan should be billed.  To the extent that a Part B -covered oral anti -cancer drug has no other medically accepted indication besides cancer treatment, Part D sponsors should not include these drugs on their formularies because of Part B coverage.  For the drugs that have other medically accepted indications, prior authorization programs or other mechanisms to obtain diagnostic information could be used to ensure appropriate p ayment.   b. Oral anti -emetics used in cancer treatment as a full replacement for intravenous treatment.  2. Pharmacists would need to determine the reason for treatment.  If both related to cancer treatment and a full replacement for intravenous administration within 48 hours of cancer treatment, Part B would be billed; otherwise, the Part D plan should be billed.  NOTE:   In order to receive Part B payment, CMS currently requires that the prescribing physician indicate on the prescription that the oral anti -emetic is being used as a full therapeutic replacement for an intravenous anti -emetic drug as part of a  cancer chemotherapeutic regimen.   If based on a prior authorization program or other mechanism to obtain diagnostic information, a Part D sponsor determined that a) a Part B -covered oral anti -emetic was being billed, and b) the drug was being furnished i n the context of cancer treatment for use within 48 hours of cancer treatment, the Part D sponsor should deny payment.  Such drugs dispensed for use after the 48-hour period, or any oral anti -emetic prescribed for conditions other than the effects of cance r treatment, would be Part D drugs.  4) The same vaccine may be covered under Part B or Part D depending on the characteristics of the beneficiary.  Hepatitis B vaccine for individuals at high or intermediate risk.  Physicians would need to determine the lev el of risk of the individual.  If the individual is at high or intermediate risk, Part B would be billed.  For all other individuals, prior authorization programs could be used to ensure appropriate level of risk.  B.  Situation where the form of the drug  determines where it is covered.   Relationship between Part B and Part D Coverage  Categories of Separately Billable Part B Drugs  Comments  The same drug provided by a DME supplier  or a pharmacy may be covered under Part B or Part D depending on its form ( i.e., for use in nebulizer or in metered dose inhaler)  Inhalation DME supply drugs  Certain inhalation drugs are generally covered under Part B when used with a nebulizer in the home.  These drugs would not be covered under Part D for use with a nebulizer.  However, if these drugs were delivered with a metered dose inhaler or other non-nebulized administration, they would be Part D drugs.  In the case of  a beneficiary in a hospital, or a SNF bed, (1) who does not have Part A coverage, (2) whose Part A coverage for the stay has run out or  (3) whose stay is non -covered -- inhalation DME supply drugs are not covered under Part B because the l aw limits 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.  In this case, coverage for the drugs would be  available under Part D.  (See Attachment II, INFUSION DRUGS , Question 3 for other facilities which cannot be considered a beneficiarys home for DME purposes.)   C.  Situations where Part B coverage is in the context of another service.