evekhm/cms_iom_500 huggingface dataset:
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
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.   Relationship b etween Part B and Part D Coverage  Categories of Separately Billable Part B Drugs  Comments  The same drug dispensed by a pharma cy is covered under Part B if provided as part of a service in a provider setting, physicians office or home. 1. Drugs furnished incident to a physician service  2. Separately billable ESRD drugs  3. Separately billable drugs in HOPDs  4. Separately billable drugs in CORFs  5. Drugs packaged under the OPPS 6. Drugs furnished by ESRD facilities and included in Medicares ESRD composite rate  7. Osteoporosis drugs provided by home health agencies under certain conditions  Generally, if a beneficiary present s at a pharmacy with a scri pt it would be a Part D drug.  The availability of Part B coverage in a provider setting or physicians office should not result in a refusal of coverage under Part D for drugs dispensed by a pharmacy.  This is the case because coverage is not available under Part B as the drug is being prescribed and dispensed or administered with respect to the individual.  Thus, for example, while Part B covers certain injectables provided incident to a physician services, injectables disp ensed by a pharmacy are not being furnished by a physician and would be Part D drugs.
(Medicare Part D Manual)
Part D sponsors should deny claims submitted by members for Part B -covered injectables if they are administered in a physician office from a physicians supply.   Part D sponsors can subject injectables and infusables that would be covered under Part B as incident to a physician service, to a prior authorization program.  To the extent that the sponsor determines based on medical literature that there exist seriou s 8. Drugs furnished by CAHs outpatient departments  9. Drugs furnished by RHCs  10. Drugs furnished by FQHCs  11. Drugs furnished by CMHCs  12. Drugs furnished by ambulances.   safety concerns such that it would go against accepted medical practice for a particular injectable or infusable to be dispensed directly to an enrollee, the claim can be denied as not "reasonable."   Safety -based reasonableness determinations will need t o be made on a case- by-case basis, since circumstances will vary.  In general, however, there are very few instances when an injectable or infusable drug could not be reasonably dispensed directly to the patient.   D.  Completely unambiguous situations.   Relationship between Part B and Part D Coverage  Categories of Separately Billable Part B Drugs  Comments  1) Unique drugs never dispensed by a pharmacy.  Non-DME drugs covered as supplies (including radiopharmaceuticals (both diagnostic and therapeutic) and low osmolar contrast media.)   This category of drugs is those used for diagnostic or therapeutic purposes in a provider or physician office setting.  CMS would assume that these drugs are not dispensed by pharmacies.  2) Drugs that would not be covered under Part D because of Part B coverage.  1. Blood clotting factors  2. Antigens  Pneumococcal and influenza vaccines  These categories would not be a Part D benefit and should not be included on a Part D sponsors formulary.  Chapter 6  Appendix  C - Summary of Coverage Policy   ATTACHMENT II  Part B v. Part D Drug Qs and As  EXCLUSIONS RELATED T O MEDICARE COVERAGE UNDER PART A OR PART B   Question 1  Should Part D sponsors deny claims for drugs covered under Part A or Part B of Medicare?
(Medicare Part D Manual)
ATTACHMENT II  Part B v. Part D Drug Qs and As  EXCLUSIONS RELATED T O MEDICARE COVERAGE UNDER PART A OR PART B   Question 1  Should Part D sponsors deny claims for drugs covered under Part A or Part B of Medicare?   Answer 1  Drugs, or uses of drugs, for which coverage is available under Part A or Part B are excluded from the definition of a Part D drug and, therefore, cannot be included in Part D basic coverage.  Unlike the list of supplementary drugs, these drugs, or uses of drugs, cannot be included in supplemental coverage.   There are two important considerations in determining whether a claim to Part D can be denied based on the availability of coverage under Part A or Part B of Medicare.    First, the exclusion fr om the definition of a Part D drug for 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 and coverage generally cannot be determined based solely on the drug itself.  Since most Part B drug coverage is available in a provider setting or physicians office rather than as drug s dispensed by pharmacists, there are very limited situations when a drug claim submitted by a pharmacy should be denied based on the availability of coverage under Part A or Part B.    Second, to the extent a drug could be covered under part B as prescribed and dispensed or administered, Part D sponsors should view coverage as available under Part B regardless of whether or not an individual is actually enrolled in Part B.   Question 2  Can a Part D sponsor require that coverage be denied under Part A or Part B before making payment under Part D?   Answer 2  Generally, no.  In limited instances, prior authorization programs may be necessary to determine whether the diagnosis of the individual or the particular use of a drug is consistent with Part D covera ge, but it would not be appropriate to routinely require a denial from Part A or Part B before making payment in lieu of prior authorization.  Such a policy would be disruptive to beneficiaries and pharmacies and would unnecessarily increase Part B contrac tor costs.
(Medicare Part D Manual)
Question 3 -  What happens if a Part D sponsor makes payment for a drug and later determines that the drug was covered under Part B as prescribed and dispensed or administered?   Answer 3 -  If the drug as prescribed and dispensed or administered was covered under Part B on that day, the payment by the Part D sponsor would have been in error and it should seek recovery from the billing entity, which should bill Part B instead.   Question 4 -  In the case of a newly approved drug that may be covered u nder one of the Part B benefit categories, can a Part D sponsor defer a coverage decision until Part B makes a decision?  Answer 4 -  No.  Once a drug is approved by the FDA it is a Part D drug.  While it is not automatically a covered Part D drug, that is,  it may not be included on a Part D sponsors formulary, a member could request coverage on a n exception basis.   For Medicare Part B coverage, a determination has to be made as to whether the approved drug fits in a benefit category (e.g., a drug covered as a supply of an external infusion pump used at home).  In the vast majority of cases these determinations are delegated to the individual contractors.  If a drug has a Medicare Part B benefit category and the drug is being prescribed and dispensed or adm inistered as covered under Part B, the drug is no longer a Part D drug.   Question 5 -  How will Part D sponsors determine whether a drug is covered under Part B?   Answer 5 -  First, it is important to keep in mind that in most cases Part B drug coverage should not impact payment decisions by Part D sponsors since Part B coverage is generally in a provider setting or physician's office rather than for drugs dispensed at a pharm acy.  Payment for a particular drug can be denied only if there is Part B coverage as the drug is prescribed and dispensed or administered.  The fact that a claim is received for a drug that is sometimes covered by Part B is not a basis for denial since th e Part D sponsor would have to determine whether the drug is being prescribed and dispensed or administered on the basis under which Part B coverage is available.  This will generally involve interaction between the Part D sponsor and the Medicare Part B c ontractor with jurisdiction in that geographic area for that drug.
(Medicare Part D Manual)
With regard to new drugs, as decisions are made nationally or by individual A/B MAC contractors, this information will be available on the CMS and contractor Web sites.  INFUSION DRUGS   Question 1 -  Since Part B covers infusion drugs in the home, can a Part D sponsor reject any claim for home infusion?   Answer 1  No.  Part B coverage is generally limited to a number of drugs that require the use of an infusion pump in the home.  Any agents  administered in the home via IV drip or push injection would be covered under Part D.  This could include the same drugs that are covered under Part B when furnished through the use of an infusion pump.  Question 2  Does Part B cover drugs that require an external infusion pump in the case of  a beneficiary in a hospital 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, drugs that require an external infusion pump ar e not covered under Part B under those circumstances 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.  Question 3 -  What other facilities cannot be considered the beneficiarys home under the law for purposes of receiving the Medicare DME benefit?   Answer 3   In addition to a hospital, a SNF or a distinct part SNF, the following facil ities cannot be considered a home for purposes of receiving the Medicare DME benefit:    a nursing home that is dually -certified as both a Medicare SNF and a Medicaid nursing facility (NF);   a Medicaid -only NF that primarily furnishes skilled  care;   a non- participating nursing home (i.e., neither Medicare or Medicaid) that provides primarily skilled  care; and   an institution which has a distinct part SNF and which also primarily furnishes skilled care.   Question 4 -  If the infusion services are furnished in an o utpatient provider setting, can a Part D sponsor deny a claim?
(Medicare Part D Manual)
Question 4 -  If the infusion services are furnished in an o utpatient provider setting, can a Part D sponsor deny a claim?   Answer 4   Yes.  If a physician office or hospital outpatient department bill for infusion administered in those settings, the claim should always be denied because of coverage in those settings under Part B.  Question 5  Since Part B covers intravenous immune globulin (IVIG) provided in the home, should a Part D sponsor deny claims for this drug?   Answer 5   It depends.  Part B coverage for IVIG in the home is for individuals whose diag nosis is primary immune deficiency disease.  Part D would provide coverage for IVIG in the home for all other medically accepted indications.  Prior authorization requirements could be used to ensure appropriate payment in accordance with the Part D sponsors medical necessity criteria.  It would not be appropriate 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.  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.
(Medicare Part D Manual)
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?
(Medicare Part D Manual)
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.)
(Medicare Part D Manual)
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: