(Medicare Benefit Policy Manual)

A/B MACs (A) and (B) will make the determination of reasonable and necessary with respect to the medical appropriateness of a drug to treat the patients condition.  MACs will continue to make the determination of whether the intravenous or injection form of a drug is appropriate as opposed to the oral form.  MACs will also continue to make the determination as to whether a physicians office visit was reasonable and necessary.  However, MACs should not make a determination of whether it was reasonable and necessary for the patient to choose to have his or her drug administered in the physicians office or outpatient hospital setting.  That is, while a physicians office visit may not be reasonable and necessary in a specific situation, in such a case an injection service would be payable.   L.  Reporting Requirements   Each A/B MAC (A), (B), or (HHH), or DME MACs must report to CMS its complete list of injectable drugs that the A/B MACs (A), (B), or (HHH), or DME MACs has determined are excluded when furnished incident to a physicians service on the basis that the drug is usually self -administered.  The CMS expects that A/B MACs (A), (B), and (HHH), and DME MACs will review injectable drugs on a rolling basis and update their list of excluded drugs as it is developed and no less frequently than annually.  For example, A/B MACs (A), (B), and (HHH), and DME MACs  should not wait to publish this list until every drug has been reviewed.  A/B MACs (A), (B), and (HHH), and DME MACs  must enter their self -administered drug exclusion list to the Medicare Coverage Database (MCD).  This database can be accessed at www.cms.hhs.gov/mcd. See Pub.100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3, Policies and Guidelines Applied During Review,  for instructions on submitting these lists to the MCD.   M.  Drugs Treated as Hospital Outpatient Supplies   In certain circumstances, Medicare pays for drugs that may be considered usually self-administered by the patient when such drugs function as supplies.  This is the case when the drugs provided are an integral component of a procedure or are directly related to it, i.e., when they facilitate the performance of or recovery from a particular procedure.  Except for the applicable copayment, hospita ls may not bill beneficiaries for these types of drugs because their costs, as supplies, are packaged into the payment for the procedure with which they are used.  Listed below are examples of when drugs are treated as supplies and hospitals should bill Medicare for the drug as a supply and should not separately bill the beneficiary.   Sedatives administered to a patient while he or she is in the preoperative area being prepared for a procedure.    Mydriatic drops instilled into the eye to dilate the pupils, anti -inflammatory drops, antibiotic drops/ointments, and ocular hypotensives that are administered to a patient immediately before, during, or immediately following an ophthalmic procedure.  This  does not refer to the patients eye drops that the patient uses pre -and postoperatively.   Barium or low osmolar contrast media provided integral to a diagnostic imaging procedure.    Topical solution used with photodynamic therapy furnished at the hospital to treat nonhyperkeratotic actinic keratosis lesions of the face or scalp.    Antibiotic ointments such as bacitracin, placed on a wound or surgical incision at the completion of a procedure.   The following are examples of when a drug is not directly related or integral to a procedure, and does not facilitate the performance of or recovery from a procedure.  Therefore the drug is not considered a packaged supply.  In many of these cases the drug itself is the treatment instead of being integral or directly related to the procedure, or facilitating the performance of or recovery from a particular procedure.    Drugs given to a patient for his or her continued use at home after leaving the hospital.   Oral pain medication given to an outpatient who develops a headache while receiving chemotherapy administration treatment.    Daily routine insulin or hypertension medication given preoperatively to a patient.   A fentanyl patch or oral pain medication such as hydrocodone, given to an outpatient presenting with pain.   A laxative suppository for constipation while the patient waits to receive an unrelated X -ray.  These two lists of examples may serve to guide hospitals in deciding which drugs are supplies packaged as a part of a procedure, and thus may be billed under Part B.  Hospitals should follow CMS guidance for billing drugs that are packaged and paid as supplies, reporting coded and uncoded drugs with their charges under the revenue code associated with the cost center under which the hospital accumulates the costs for the drugs.  50.3 - Incident To Requirements  (Rev. 1, 10- 01-03) B3-2049.3  In order to  meet all the general requirements for coverage under the incident -to provision, an FDA approved drug or biological must:    Be of a form that is not usually self -administered;    Must be furnished by a physician; and   Must be administered by the physician, or by auxiliary personnel employed by the physician and under the physicians personal supervision.  The charge, if any, for the drug or biological must be included in the physicians bill, and the cost of the drug or biological must represent an expense to the physician.  Drugs and biologicals furnished by other health professionals may also meet these requirements. (See 170, 180, 190 and 200 for specific instructions.)  Whole blood is a biological, which cannot be self-administered and is covered when furnished incident to a physicians services.  Payment may also be made for blood fractions if all coverage requirements are satisfied and the blood deductible has been met.  50.4 - Reasonableness and Necessity  (Rev. 1, 10-01-03) B3-2049.4  50.4.1 - Approved Use of Drug  (Rev. 1, 10-01-03) B3-2049.4  Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. (See the Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 20.)  Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling.  Therefore, the program may pay for the use of an FDA approved drug or biological, if:   It was injected on or after the date of the FDAs approval;   It is reasonable and necessary for the individual patient; and   All other applicable coverage requirements are met.   The A/B MAC (A), (B), or (HHH), or DME MAC will deny coverage for drugs and biologicals, which have not received final marketing approval by the FDA unless it receives instructions from CMS to the contrary.  For specific guidelines on coverage of Group C cancer drugs, see the Medi care National Coverage Determinations Manual.   If there is reason to question whether the FDA has approved a drug or biological for marketing, the MAC must obtain satisfactory evidence of FDAs approval.  Acceptable evidence includes:   A copy of the FDAs letter to the drugs manufacturer approving the new drug application (NDA);   A listing of the drug or biological in the FDAs Approved Drug Products or FDA Drug and Device Product Approvals;   A copy of the manufacturers package insert, approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it; or   Information from the FDAs Web site.   When necessary, the regional office (RO) may be able to help in obtaining information.  50.4.2 - Unlabeled Use of Drug  (Rev. 1, 10-01-03) B3-2049.3  An unlabeled use of a drug is a use that is not included as an indication on the drugs label as approved by the FDA.  FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the A/B MAC (B) determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepte d standards of medical practice.  In the case of drugs used in an anti -cancer chemotherapeutic regimen, unlabeled uses are covered for a medically accepted indication as defined in 50.5.  These decisions are made by the MAC on a case- by-case basis.   50.4.3 - Examples of Not Reasonable and Necessary  (Rev. 1, 10- 01-03) B3-2049.4  Determinations as to whether medication is reasonable and necessary for an individual patient should be made on the same basis as all other such determinations (i.e., with the advice of medical consultants and with reference to accepted standards of medical practice and the medical circumstances of the individual case).  The following guidelines identify three categories with specific examples of situations in which medications would not be reasonable and necessary according to accepted standards of medical  practice:   1.  Not for Particular Illness   Medications given for a purpose other than the treatment of a particular condition, illness, or injury are not covered (except for certain immunizations).  Charges for medications, e.g., vitamins, given simply for the general good and welfare of the patient and not as accepted therapies for a particular illness are excluded from coverage.   2.  Injection Method Not Indicated   Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration.  For example, the accepted standard of medical practice for the treatment of certain diseases is to initiate therapy with parenteral penicillin and to complete therapy with oral penicillin.  A/B MACs (B) exclude the entire charge for penicillin injections given after the initiation  of therapy if oral penicillin is indicated unless there are special medical circumstances that justify additional injections.   3.  Excessive Medications   Medications administered for treatment of a disease and which exceed the frequency or duration of injections indicated by accepted standards of medical practice are not covered.  For example, the accepted standard of medical practice in the maintenance treatment of pernicious anemia is one vitamin B -12 injection per month.  A/B MACs (B) exclude the entire charge for injections given in excess of this frequency unless there are special medical circumstances that justify additional injections.   A/B MACs (B) will supplement the guidelines as necessary with guidelines concerning appropriate use of specific injections in other situations.  They will use the guidelines to screen out questionable cases for special review, further development, or denia l when the injection billed for would not be reasonable and necessary.  They will coordinate any type of drug treatment review with the Quality Improvement Organization (QIO).   If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the A/B MAC (B) or DME MAC excludes the entire charge (i.e., for both the drug and its administration).  Also, A/B MACs (B) exclude from payment any charges for other services (such as office visits) which were primarily for the purpose of administering a noncovered injection (i.e., an injection that is not reasonable and necessary for the diagnosis or treatment of an illness or injury).  50.4.4 - Payment for Antigens and Immunizations  (Rev. 1, 10- 01-03)  50.4.4.1 - Antigens  (Rev. 186, Issued: 04- 16-14, Effective: 01 -01 01, Implementation: 05 -12-14)  Payment may be made for a reasonable supply of antigens that have been prepared for a particular patient if: (1) the antigens are prepared by a physician who is a doctor of medicine or osteopathy, and (2) the physician who prepared the antigens has examine d the patient and has determined a plan of treatment and a dosage regimen.   Antigens must be administered in accordance with the plan of treatment and by a doctor of medicine or osteopathy or by a properly instructed person (who could be the patient) under the supervision of the doctor.  The associations of allergists that CMS con sulted advised that a reasonable supply of antigens is considered to be not more than a 12- month supply of antigens that has been prepared for a particular patient at any one time.  The purpose of the reasonable supply limitation is to assure that the anti gens retain their potency and effectiveness over the period in which they are to be administered to the patient.  (See 20.2 and 50.2.)   50.4.4.2 - Immunizations (Rev.  11905; Issued:03-  16-23; Effective:10 -19-22; Implementation: 04 -17-23)