(Medicare Part D Manual)

Question 6  Since Part B covers parenteral nutrition under certain circumstances, should Part D sponsors deny these claims?   Answer 6   It depends.  Part B coverage for parenteral nutrition is limited to individuals with a non-functi oning digestive tract.  So if parenteral nutrition is being provided based on this condition, the claim should be denied.  For all other medically accepted indications, coverage would be under Part D.  Prior authorization programs could be used to ensure a ppropriate payment.  As a general policy, it would not be appropriate to require a rejection of a claim under Part B before processing a Part D claim.  However, if a Part D sponsor had a reasonable basis for assuming that a particular claim would be covere d under Part B, it could require a rejection by Part B before processing.   ORAL ANTI -CANCER DRUGS   Question 1 -  With regard to oral anti -neoplastics, we understand that if they have an IV form, they are covered under Part B.  It is our thinking then, that we could exclude those that are used solely for cancer under this premise since they would be covered under Part B.  Answer 1  Yes. Part D sponsors should not include on their formularies the oral anti -cancer agents covered by Part B whose only medically accepted indication is as an anti -cancer agent.  They should always deny claims for these drugs.  For the drugs that have other medically accepted indications, Part D sponsors should deny claims for these drugs when used for cancer treatment but when these  drugs are used for other indications they would be Part D drugs.  The use of the drug could be determined through a prior authorization program.  ORAL ANTI -EMETICS   Question 1 -  Do pharmacies bill oral anti -emetics under Part B or Part D?   Answer 1  - It depends.  Before billing either Part B or Part D, pharmacists would need to determine the reason for treatment.  If it is related to cancer treatment and is a full replacement for intravenous administration within 48 hours of cancer treatment, Part B would be billed; otherwise, Part D should be billed.10  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 intrav enous anti -emetic drug as part of a cancer chemotherapeutic regimen.  If (based on a prior authorization program) a Part D sponsor determines that a Part B -covered oral anti -emetic drug is being billed, and that the drug is being furnished in the context of cancer treatment for use within 48 hours of such treatment, the Part D sponsor should deny payment since coverage is available under Part B.  Such drugs dispensed for use after the 48- hour period, or any oral anti -emetic prescribed for conditions other than treatment of the effects of cancer treatment, would be Part D drugs.  IMMUNOSUPPRESSANTS   Question 1  - Do pharmacies bill oral immunosuppressants under Part B or Part D?   10 There may be some local A/B MAC contractor variance regarding the 48 hour interval for the oral anti -emetics granisetron and dolasetron.  Part D sponsors should contact their local A/B MAC contractor for more information regarding these drugs.                                                   Answer 1  - It depends. Pharmacists would bill Part B or the individuals Part D plan based on information received from the individual or sources substantiating the patients transplant.  Part B would be billed if the individual had a Medicare covered transplant; otherwise, the Part D plan would be billed.  INJECTABLES   Question 1 -  Can claims submitted by pharmacies for injectable drugs be denied based on Part B coverage in a physician office incident to a physician service?  Answer 1   No.  The exclusion from t he definition of a Part D drug of drugs covered under Parts A or B is based on whether coverage is available under Part A or Part B for the drug as it is being prescribed and dispensed or administered with respect to the individual.  Thus, the same drug may be covered under different circumstances under both programs.  As a result, coverage cannot generally be determined based solely on the drug itself.   The fact that an injectable is covered under Part B in a physicians office or hospital outpatient department or other provider setting does not mean that these drugs should be excluded from the Part D sponsors formularies, or that a Part D sponsor can deny a claim from a pharmacy based on availability of Part B coverage in a physicians office.  If, howe ver, a member submits an out -of-network claim for an injectable drug administered in -office from a physicians supply, and this drug is covered in that setting by the Part B contractor for that area, such a claim should be denied by the Part D sponsor base d on Part B coverage.  (Of course, an MA -PD plan would not deny such a claim, but rather pay it under the A/B benefit.)   Question 2 -  An injectable drug that a Medicare contractor considers to be usually not self -administrable (e.g., injectable chemotherap y drugs) can only be covered under Part B as incident to a physician service if it is obtained by a physician and administered as part of a physician service. Can Part D sponsors require prior authorization for these medications when dispensed by a pharm acy?  If the sponsor determines that the drug will be administered in a physician office, can the sponsor deny the claim because the practice of the patient taking the drug to the physicians office for administration is unsafe and because coverage is avai lable under Part B if the physician obtained and administered the drug?   Answer 2 -  Part D sponsors determine the scope of their own prior authorization programs subject to CMS review to ensure that such programs have a sound medical basis and do not discr iminate against beneficiaries with certain medical conditions.   To the extent that a sponsors prior authorization program applies to injectables and infusables that would be covered under Part B as incident to a physicians service, and the sponsor determines based on medical literature that there exist serious safety concerns such that it would go against accepted medical practice for a particular injectable or infusable to be dispensed directly to a member, the claim can be denied as not "reasonable."  Thus, the dispensing of that particular drug to that member may be excluded by the Part D sponsor under Section 1862(a)(1)(A) of the Social Security Act as applied to Part D under 1860D -2(e)(3)(A) of the Act.  This same safety concern would not exist, how ever, if the claim for the drug was being submitted by an infusion supplier.  Safety -based reasonableness determinations will need to be made on a case -by-case basis, since circumstances will vary.  In general, there are very few instances when an injectab le or infusable drug could not be reasonably dispensed directly to the patient.  All drugs are in some sense hazardous.  This is not a unique characteristic of injectables and infusables.  Some situations that would present safety concerns in dispensing di rectly to a patient who is transporting the drug to a physicians office for administration include:    The drug itself presents a bona fide public safety hazard (e.g., highly radioactive substance or an environmentally hazardous chemotherapeutic agent) that  requires chain of custody handling to ensure use of appropriate equipment (i.e., safety hood) or persons of special qualifications.    The drug requires special handling to preserve biologic activity and the patient is incapable or unwilling to do so.  (For  instance, a vaccine that must be kept frozen could be a problem if the patient had to transport it a long distance in summer heat.)    The patient presents a high risk of diversion or inappropriate use.  (For instance, giving a heroin addict a vial of morphine.)    The patient has demonstrated unreliability, aversion, or unwillingness in transporting drugs to his doctors office.  (For instance, with respect to dispensing injectable psychiatric meds.)   In the absence of a serious safety concern based on the individual situation, however, there is no basis for denying a prescription presented at a pharmacy based on the availability of Part B coverage in another setting (e.g., physician office).  Finally, it is CMS understanding that the practice of brown -bagging drugs is opposed by medical societies.  CMS continues to urge them to reinforce this message with their members.   Question 3  Most Medicare Advantage plans treat most non -self-injectables as a medical benefit.  Do they have to treat them as a Part D  benefit?   Answer 3 -  If an injectable drug is covered under Part B in a provider or physician office setting, it will continue to be covered under Part B in those settings.  If an injectable drug is not covered in a provider setting (e.g., determined by t he contractor to be usually self -administered), then it will need to be covered under Part D.  In addition, claims for non- Part-B-covered injectables whether usually self -administered or not, when dispensed and submitted by pharmacists could be covered und er Part D.  However, Part D plans could establish medical necessity criteria for limiting coverage of injectable drugs in physician offices.   Question 4 -  What are Part D sponsors to do if their region includes multiple A/B MAC contractor areas and these contractors have differing policies with regard to injectable drugs?   Answer 4  A Part D sponsor will have to modify its coverage based on the variation in Part B coverage across contractor areas within its region.  That is, assume that there are two contr actor areas within a Part D sponsors region, Contractor A and Contractor B.  Further assume that Contractor A covers injectable X when furnished in a physician office but Contractor B does not.  As a result of this difference in Part B coverage, injectabl e X is a Part D drug when furnished in a physician office for members residing in Contractor Bs area, but not in Contractor As area.  In either area, injectable X would be covered under Part D if dispensed by a pharmacy.   For MA -PD plans, rules for selec ting local coverage determinations apply.  That is, if a local MA plans service area includes more than one contractor area, the plan may seek approval from CMS to apply uniformly to all of the plans enrollees local coverage policies that are the most beneficial to enrollees.  Regional MA plans can select a set of local coverage policies to apply uniformly to their enrollees without CMS pre -approval.  In either case, if the selected contractor covers injectable X, the MA -PD would treat injectable X as a b asic A/B benefit.  If the selected contractor does not cover injectable X, the MA -PD would treat it as a Part D drug.   Question 5 What about new injectable drugs?   Answer 5  - As new injectables are approved by the FDA, Part B contractors or CMS would continue to make coverage decisions regarding drugs provided incident to a physicians service based on whether the drug is not usually self -administered.  Injectables not covered under Part B as incident to a physicians service would become Part D drugs.  However, there is no requirement for Part D sponsors to provide coverage of non- Part-B-covered drugs in the physician office setting if the drugs can be safely self -administered and there is no medical necessity for administration in that setting.   INHALAT ION DRUGS   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?