(Medicare Benefit Policy Manual)

More than one oral anti emetic drug may be prescribed and may be covered for concurrent use if needed to fully replace the intravenous drugs that otherwise would be given.  See the Medicare National Coverage Determinations Manual, Publication 100-03, Chapter 1, Section 110.18, for detailed coverage criteria.  50.5.5 - Hemophilia Clotting Factors  (Rev. 1, 10-01-03) A3-3112.4.B.2, HO-230.4.B.2  Section 1861(s)(2)(I) of the Act provides Medicare coverage of blood clotting factors for hemophilia patients competent to use such factors to control bleeding without medical supervision, and items related to the administration of such factors.  Hemophilia, a blood disorder characterized by prolonged coagulation time, is caused by deficiency of a factor in plasma necessary for blood to clot.  For purposes of Medicare Part B coverage, hemophilia encompasses the following conditions:   Factor VIII deficiency (classic hemophilia);    Factor IX deficiency (also termed plasma thromboplastin component (PTC) or Christmas factor deficiency); and    Von Willebrands disease.  Claims for blood clotting factors for hemophilia patients with these diagnoses may be covered if the patient is competent to use such factors without medical supervision.  The amount of clotting factors determined to be necessary to have on hand and thus covered under this provision is based on the historical utilization pattern or profile developed by the contractor for each patient.  It is expected that the treating source , e.g., a family physician or comprehensive hemophilia diagnostic and treatment center, have such information.  From this data, the contractor is able to anticipate and make reasonable projections concerning the quantity of clotting factors the patient wil l need over a specific period of time.  Unanticipated occurrences involving extraordinary events, such as automobile accidents or inpatient hospital stays, will change this base line data and should be appropriately considered.  In addition, changes in a p atients medical needs over a period of time require adjustments in the profile.   50.6  Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home  (Rev. 12352, Issued: 11 -08-23, Effective: 01 -01-24, Implementation: 01 -02-24)  The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency diseases in the home (ICD-10- CM codes  G11.3, D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.82, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, or D83.9 if only an unspecified diagnosis is necessary). The Act defines intravenous immune globulin as an approved pooled plasma derivative for the treatment of primary immune deficiency disease. It is covered under this benefit when  the patient has  a diagnosed primary  immune  deficiency  disease,  it is administered  in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration  of the derivative in the patients  home is medically  appropriate. For coverage of IVIG under this benefit, it is not necessary for the derivative to be administered through a piece of durable medical equipment. Division FF, section 4134 of the Consolidated Appropriation Act, 2023 mandated that CMS establish a permanent, bundled payment for items and services related to administration of IVIG in a patients home. The permanent, bundled home IVIG items and services payment is effective for home IVIG infusions furnished on or after January 1, 2024. Payment for these items and services is required to be a separate bundled payment made to a durable medical equipment supplier for all items an d services furnished in the home during a calendar day. It is up to the provider to determine the services and supplies that are appropriate and necessary to administer the IVIG for each individual. This may or may not include the use of a pump; however, a  pump is not covered under the home IVIG items and services payment.   60 - Services and Supplies Furnished Incident To  a Physicians/NPPs Professional Service   (Rev. 12425; Issued: 12-21- 23: Effective: 01 -01-24; Implementation: 01-02-24)     B3-2050    A - Noninstitutional Setting    For purposes of this section a noninstitutional setting means all settings other than a hospital or skilled nursing facility    Medicare pays for services and supplies (including drug and biologicals which are not usually self-administered) that are furnished incident to a physicians or other practitioners services, are commonly included in the physicians or practitioners bills, and for which payment is not made under a separate benefit category listed in  1861(s)  of the Act. A/B MACs (A) and (B) must not apply incident to requirements to services having their own benefit category. Rather, these services should meet the requirements of their own benefit category. For example, diagnostic tests are covered under 1861 (s)(3) of the Act and are subject to their own coverage requirements. Depending on the particular tests, the supervision requirement for diagnostic tests or other services may be more or less stringent than supervision requirements for services and supplies furnished incident to physicians or other practitioners services. Diagnostic tests need not also meet the incident to requirement in this section. Likewise, pneumococcal, influenza, and hepatitis B vaccines are covered under 1861(s)(10) of the Act and need not also meet incident to requirements. (Physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives, clinical psychologists, clinical social workers, physical therapists and occupational therapists all have their own benefit categories and may provide services without direct physician supervision and bill directly for these services. When their services are provided as auxiliary personnel (see under direct physician supervision, they may be covered as incident to s ervices, in which case the incident to requirements would apply.    For purposes of this section, physician means physician or other practitioner (physician, physician assistant, nurse practitioner, clinical nurse specialist, nurse midwife,  and clinical psychologist) authorized by the Act to receive payment for services i ncident to his or her own services.    To be covered incident to the services of a physician or other practitioner, services and supplies must be:     An integral, although incidental, part of the physicians professional service (see 60.1);      Commonly rendered without charge or included in the physicians bill (see 60.1A);     Of a type that are commonly furnished in physicians offices or clinics (see 60.1A);     Furnished by the physician or by auxiliary personnel under the physicians direct supervision (see 60.1B).    B - Institutional Setting    Hospital services incident to physicians or other practitioners services rendered to outpatients (including drugs and biologicals which are not usually self-administered by the patient), and partial hospitalization and intensive outpatient services incid ent to such services may also be covered.    The hospitals A/B MAC (A) makes payment for these services under Part B to a hospital.                                                                                                                                   60.1 - Incident To Physicians Professional Services  (Rev. 1, 10-01-03) B3-2050.1  Incident to a physicians professional services means that the services or supplies are furnished as an integral, although incidental, part of the physicians personal professional services in the course of diagnosis or treatment of an injury or illness.  A - Commonly Furnished in Physicians Offices   Services and supplies commonly furnished in physicians offices are covered under the incident to provision.  Where supplies are clearly of a type a physician is not expected to have on hand in his/her office or where services are of a type not considered medically appropriate to provide in the office setting, they would not be covered under the incident to provision.  Supplies usually furnished by the physician in the course of performing his/her services, e.g., gauze, ointments, bandages, and oxygen, are also covered.  Charges for such services and supplies must be included in the physicians bills.  (See 50 regarding coverage of drugs and biologicals under this provision.)  To be covered, supplies, including drugs and biologicals, must represent an expense to the physician or legal entity billing fir he services or supplies.  For example, where a patient purchases a drug and the physician administers it, the cost of the drug is not covered.  However, the administration of the drug, regardless of the source, is a service that represents an expense to the physician. Therefore, administration of the drug is payable if the drug would have been covered if the physician purchased it.  B - Direct Personal Supervision   Coverage of services and supplies incident to the professional services of a physician in private practice is limited to situations in which there is direct physician supervision of auxiliary personnel.  Auxiliary personnel means any individual who is acting under the supervision of a physician, regardless of whether the individual is an employee, leased employee, or independent contractor of the physician, or of the legal entity that employs or contracts with the physician. Likewise, the supervising physician may be an employee, leased employee or independent contractor of the legal entity billing and receiving payment for the services or supplies.   However, the physician personally furnishing the services or supplies or supervising the auxiliary personnel furnishing the services or supplies must have a relationship with the legal entity billing and receiving payment for the services or supplies that satisfies the requirements for valid reassignment. As with the physicians personal professional services, the patients financial liability for the incident to services or supplies is to the physician or other legal entity billing and receiving payment for the services or supplies. Therefore, the incident to services or supplies must represent an expense incurred by the physician or legal entity billing for the services or supplies.  Thus, where a physician supervises auxiliary personnel to assist him/her in rendering services to patients and includes the charges for their services in his/her own bills, the services of such personnel are considered incident to the physicians service if there is a physicians service rendered to which the services of such personnel are an incidental part and there is direct supervision by the physician.  This does not mean, however, that to be considered incident to, each occasion of service by auxiliary personnel (or the furnishing of a supply) need also always be the occasion of the actual rendition of a personal professional service by the physician. Such a service or supply could be considered to be incident to when furnished during a course of treatment where the physician performs an initial service and subsequent services of a frequency which reflect his/her active participation in and management of the course of treatment. (However, the direct supervision requirement must still be met with respect to every nonphysician service.)  Direct supervision in the office setting does not mean that the physician must be present in the same room with his or her aide. However, the physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the aide is performing services.   If auxiliary personnel perform services outside the office setting, e.g., in a patients home or in an institution (other than hospital or SNF), their services are covered incident to a physicians service only if there is direct supervision by the physician. For example, if a nurse accompanied the physician on house calls and administered an injection, the nurses services are covered. If the same nurse made the calls alone and administered the injection, the services are not covered (even when billed by t he physician) since the physician is not providing direct supervision. Services provided by auxiliary personnel in an institution (e.g., nursing, or convalescent home) present a special problem in determining whether direct physician supervision exists. The availability of the physician by telephone and the presence of the physician somewhere in the institution does not constitute direct supervision. (See 70.3 of the Medicare National Coverage Determinations Manual for instructions used if a physician maintains an office in an institution.) For hospital patients and for SNF patients who are in a Medicare covered stay, there is no Medicare Part B coverage of the services of physician -employed auxiliary personnel as services incident to physicians services u nder 1861(s)(2)(A) of the Act . Such services can be covered only under the hospital or SNF benefit and payment for such services can be made to only the hospital or SNF by a A/B MAC (A) .  (See 80 concerning physician supervision of technicians performing diagnostic x- ray procedures in a physicians office.)   60.2 - Services of Nonphysician Personnel Furnished Incident To Physicians Services  (Rev. 1, 10-01-03) B3-2050.2  In addition to coverage being available for the services of such auxiliary personnel as nurses, technicians, and therapists when furnished incident to the professional services of a physician (as discussed in 60.1), a physician may also have the services of certain nonphysician practitioners covered as services incident to a physicians professional services.  These nonphysician practitioners, who are being licensed by the States under various programs to assist or act in the place of the physician, include, for example, certified nurse midwives, clinical psychologists, clinical social workers, physician assistants, nurse practitioners, and clinical nurse specialists.  (See 150 through 200 for coverage instructions for various allied health/nonphysician practitioners services.)