(Medicare Benefit Policy Manual)

If the hospital engages the services of a nurse anesthetist or other nonphysician anesthetist (either on a salary or fee- for-service basis) under arrangements which provide for billing to be made by the hospital, the cost of the service when provided to an inpatient could be covered under Part A.  (See the Medicare Claims Processing Manual for more information.)  20.2 - Medical Social Services to Meet the Patient's Medically Related Social Needs  (Rev. 1, 10-01-03) A3-3101.2.B, HO-210.2.B  Medical social services are services which contribute meaningfully to the treatment of a patient's condition.  Such services include, but are not limited to:   Assessment of the social and emotional factors related to the patient's illness, need for care, r esponse to treatment, and adjustment to care in the facility;    Appropriate action to obtain case work services to assist in resolving problems in these areas; and    Assessment of the relationship of the patient's medical and nursing requirements to their h ome situation, financial resources, and the community resources available to them in making the decision regarding their discharge.  30 - Drugs and Biologicals  (Rev. 1, 10-01-03) A3-3101.3, HO-210.3  Drugs and biologicals for use in the hospital, which are ordinarily furnished by the hospital for the care and treatment of inpatients, are covered.  Three basic requirements must be met for a drug or biological furnished by a hospital to be a covered hospital service:   1. The drug or biological must represent a c ost to the institution in rendering services to the beneficiary;   2. The drug or biological must meet the statutory definition.  Under the statute, payment may be made for a drug or biological only where it is included, or approved for inclusion, in the latest official edition of the United States Pharmacopoeia -National Formulary (USP -NF), the United States Pharmacopoeia Drug Information (USP DI), or the American Dental Association (ADA) Guide to Dental Therapeutics, except for those drugs and biologicals unfavorably evaluated in the ADA Guide to Dental Therapeutics.  Combination drugs are also included in the definition of drugs if the combination itself or all of the therapeutic ingredients of the combination are included, or approved for inclusion, in a ny of the above drug compendia.  Drugs and biologicals are considered approved for inclusion in a compendium if approved under the established procedure by the professional organization responsible for revision of the compendium; or be approved by the phar macy and drug therapeutics or equivalent committee of the medical staff of the hospital for use in the hospital; and   3. Use of the drug or biological must be safe and effective and otherwise reasonable and necessary as specified in the Medicare Benefit Polic y Manual, Chapter 15, Covered Medical and Other Health Services, 50.   Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this last requirement when used for indications specified in the labeling.  Therefore, use of an FDA -approved drug or biological is covered if:   It was administered on or after the date of the FDA's approval;   It is reasonable and necessary for the individual patient; and    All other applicable coverag e requirements are met.   Drugs and biologicals, which have not received final marketing approval by the FDA, are not covered unless CMS instructs the A/B MAC (A) to the contrary.  However, FDA-approved drugs are used for indications other than those specified on the labeling.  As long as the FDA has not specified such use as nonapproved, coverage is determined taking into consideration the generally accepted medical practice in the community.  For example, the labeling of certain chemotherapeutic drugs indicates their use in the therapy of specified types of cancer.  However, based on experience and empirical evidence, physicians may prescribe these drugs for a wider range of cancer treatments than what is indicated in the labeling.  Local medical review policy may or may not grant coverage, depending on the circumstances.  Determinations as to whether use of a drug or biological is reasonable and necessary for an individual patient are the responsibility of the Quality Improvement Organization (QIO), if this  is part of the review for a PPS acute care admission.  However, if this is an excluded service claim being reviewed by the A/B MAC (A), the A/B MAC (A) reviews and makes a determination, unless it cannot and needs to refer it to the QIO for an initial determination.   A hospital stay solely for the purpose of use of a drug or biological that is determined not reasonable and necessary is not covered.  30.1 - Drugs Included in the Drug Compendia  (Rev. 1, 10-01-03) A3-3101.2.A, HO-210.3.A  Medicare covers only  those drugs and biologicals included, or approved for inclusion, in the latest official edition or revision of the compendia as previously listed.  Where a drug is excluded from coverage because it is unfavorably evaluated in either the AMA Drug Evaluatio ns or Accepted Dental Therapeutics, the exclusion applies to all uses for which the drug or biological was so unfavorably evaluated.  Drugs and biologicals are considered "approved for inclusion" in a compendium if approved under the procedure established by the professional organization responsible for revision of the compendium.  30.2 - Approval by Pharmacy and Drug Therapeutics Committee  (Rev. 1, 10-01-03) A3-3101.3.B, HO-210.3.B  A pharmacy and drug therapeutics or equivalent committee is a medical staff committee that confers with the hospital pharmacist in the formulation of policies pertaining to drugs.  Drugs and biologicals approved for use in the hospital by such a committee are covered only if the committee develops and maintains a formulary or li st of drugs accepted for use in the hospital.  The committee need not function exclusively as a pharmacy and drug therapeutics committee but may also carry on other medical staff functions.  Drugs and biologicals are considered approved for use in the hospital if selected for inclusion in the hospital drug list of formulary under the procedure of the committee established for that purpose.  Express approval is required; the fact that a drug or biological has not been specifically determined to be unacceptab le for use in the hospital does not constitute approval.  Drugs and biologicals are covered if approved for general use in the hospital, or if approved for use by a particular patient or group of patients.  Approval by a pharmacy and drug therapeutics comm ittee is an alternative to approval for inclusion of the drug or biological in an approved drug compendium (see 30.1 above); such approval does not preclude the need for a determination of medical necessity.  An investigat ional drug is not considered to meet the reasonable and necessary test since its efficacy has not yet been established.   The decision of individual hospitals should not transcend the determinations of the Food and Drug Administration and Public Health Service in respect to the safety and effectiveness of drugs.  Therefore, even if approved by an appropriate hospital committee, the reasonable cost of an investigational or other nonapproved drug or biological (e.g., Laetrile) cannot be reimbursed.  This exclusion from payment applies whether or not the drug or biological is administered during the course of an otherwise covered hospital stay, since payment may not be made for items and services that are not reasonable and necessary.  A hospital stay solely for the purpose of administering a drug or biological that is not reasonable and necessary, including an investigational drug or biological, is not covered and the drug or biological itself is not covered.  30.3 - Combination Drugs  (Rev. 1, 10-01-03) A3-3101.3.C, HO-210-3.C  Combination drugs are covered if the combination itself or all of the therapeutic ingredients of the combination are included, or approved for inclusion, in any of the designated drug compendia.  Any combination drug approved for use in the hospital by the pharmacy and drug therapeutics or equivalent committee is covered.   30.4 - Drugs Specially Ordered for Inpatients  (Rev. 1, 10-01-03) A3-3101.3.D, HO-210.3.D  Coverage is not limited to drugs and biologicals routinely stocked by the hospital; a drug or biological not stocked by the hospital, which the hospital obtains for the patient from an outside source, such as a community pharmacy, can also be covered.  Drugs and biologicals not included in the drug list or formulary maintained b y the hospital's pharmacy and drug therapeutics committee may be covered if the hospital has a policy which permits such drugs to be furnished to a patient at the special request of a physician.  However, in order to be covered, such drugs and biologicals must be included, or approved for inclusion, in one of the designated drug compendia.  (In addition, a combination drug, or all of its therapeutic ingredients, would have to be included or approved for inclusion in one of the compendia.)  30.5 - Drugs for Use Outside the Hospital  (Rev. 1, 10-01-03) A3-3101.3.E, HO-210.3.E  Drugs and biologicals furnished by a hospital to an inpatient for use outside the hospital are, in general, not covered as inpatient hospital services.  However, if the drug or biological is deemed medically necessary to permit or facilitate the patient's departure from the hospital, and a limited supply is required until the patient can obtain a continuing supply, the limited supply of the drug or biological is covered as an inpatient hospital service.   40 - Supplies, Appliances, and Equipment  (Rev. 1, 10-01-03) A3-3101.4, HO-210.4  Supplies, appliances, and equipment, which are ordinarily furnished by the hospital for the care and treatment of the beneficiary solely during the inpatient h ospital stay, are covered inpatient hospital services.   Under certain circumstances, supplies, appliances, and equipment used during the beneficiary's inpatient stay are covered under Part A even though the supplies, appliances and equipment leave the hospital with the patient upon discharge.  These are circumstances in which it would be unreasonable or impossible from a medical standpoint to limit the patient's use of the item to the periods during which the individual is an inpatient.  Examples of items c overed under this rule are:   Items permanently installed in or attached to the patient's body while an inpatient, such as cardiac valves, cardiac pacemakers, and artificial limbs; and    Items which are temporarily installed in or attached to the patient's body while an inpatient, and which are also necessary to permit or facilitate the patient's release from the hospital, such as tracheotomy or drainage tubes.  Hospital admission packs containing primarily toilet articles, such as soap, toothbrushes, toothpaste, and combs, are covered under Part A if routinely furnished by the hospital to all its inpatients.  If not routinely furnished to all patients, the packs are not covered.  In that situation, the hospital may charge beneficiaries for the pack, but only if they request it with knowledge of what they are requesting and what the charge to them will be.   Supplies, appliances, and equipment furnished to an inpatient for use only outside the hospital are not, in general, covered as inpatient hospital services.  However, a temporary or disposable item, which is medically necessary to permit or facilitate the patient's departure from the hospital and is required until the patient can obtain a continuing supply, is covered as an inpatient hospital service.  Oxygen furnished to hospital inpatients is covered under Part A as an inpatient supply.  50 - Other Diagnostic or Therapeutic Items or Services  (Rev. 1, 10-01-03) A3-3101.5, HO-210.5  Other diagnostic or therapeutic items or services ordinarily furnished inpa tients by the hospital or by others under arrangements made by the hospital are covered.  This category of covered services encompasses items and services not otherwise specifically listed as covered inpatient hospital services.  (See the Medicare Benefit Policy Manual, Chapter 15,  Covered Medical and Other Health Services.)   Such services to hospital inpatients may be covered under Part A even when furnished off the hospital premises.  For example, diagnostic or therapeutic services of an audiologist off the hospital premises are covered if billed for by the hospital under arrangements (see Pub 100- 01, the Medicare General Information, Eligibility, and Entitlement Manual, Chapter 5, 10.3, for further information concerning under arrangements), if the services are furnished at a speech and hearing center, and if the audiologist meets the qualifications for an audiologist:   Is licensed if applicable by the State in which practicing; and    Is eligible for a certification of clinical competence in audiology granted by the American Speech and Hearing Association; or   Meets the education requirements for certification and is in the process of accumulating the supervised experience required for certification.   50.1 - Therapeutic Items  (Rev. 1, 10-01-03) A3-3101.5.A, HO-210.5  Therapeutic items, which are covered when ordinarily furnished by the hospital to its inpatients, or when ordinarily furnished to hospital inpatients by others under arrangements with them made by the hospital, include but are not limited to  the following:   Surgical dressings, and splints, casts, and other devices used for the reduction of fractures and dislocations;   Prosthetic devices (other than dental) which replace all or part of an internal body organ (including contiguous tissue) or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ; and