evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
Covered drugs also include those prescription drugs, such as prednisone, that are used in conjunction with immunosuppressive drugs as part of a therapeutic regimen reflected in FDA approved labeling for immunosuppressive drugs.  Therefore, antibiotics, hypertensives, and other drugs that are not directly related to rejection are not covered.  The FDA has identified and approved for marketing the following specifically labeled immunosuppressive drugs.  They are:   Sandimmune (cyclosporine), Sandoz Pharmaceutical;  Imuran (azathioprine), Burroughs Wellcome;  Atgam (antithymocyte globulin), Upjohn;  Orthoclone OKT3 (Muromonab- CD3), Ortho Pharmaceutical;  Prograf (tacrolimus), Fujisawa USA, Inc;  Celicept (mycophenolate mefetil, Roche Laboratories;  Daclizumab (Zenapax);  Cyclophosphamide (Cytoxan);  Prednisone; and  Prednosolone.  The CMS expects contractors to keep informed of FDA additions to the list of the immunosuppressive drugs.  50.5.2 - Erythropoietin (EPO)  (Rev. 1, 10- 01-03) A3-3112.4.B.4, HO -230.4.B.4  The statute provides that EPO is covered for the treatment of anemia for patients with chronic renal failure who are on dialysis.  Coverage is available regardless of whether the drug is administered by the patient or the patients caregiver.  EPO is a bio logically engineered protein which stimulates the bone marrow to make new red blood cells.  NOTE:   Non -ESRD patients who are receiving EPO to treat anemia induced by other conditions such as chemotherapy or the drug zidovudine (commonly called AZT) must meet the coverage requirements in 50 .  EPO is covered for the treatment of anemia for patients with chronic renal failure who are on dialysis when:   It is administered in the renal dialysis facility; or    It is self -administered in the home by any dialysis patient (or patient caregiver) who is determined competent to use the drug and meets the other conditions detailed below.
(Medicare Benefit Policy Manual)
 It is self -administered in the home by any dialysis patient (or patient caregiver) who is determined competent to use the drug and meets the other conditions detailed below.  NOTE:   Payment may not be made for EPO under the incident to provision when EPO is administered in the renal dialysis facility.   Also, in the office setting, reimbursement will be made for the administration charge only for non- ESRD patients receiving EPO.  50.5.2.1 - Requirements for Medicare Coverage for EPO  (Rev. 1, 10-01-03) B3-2049.5  Medicare covers EPO and items related to its administration for dialysis patients who use EPO in the home when the following conditions are met:  A.  Patient Care Plan  A dialysis patient who uses EPO in the home must have a current care plan (a copy of which must be maintained by the designated backup facility for Method II patients) for monitoring home use of EPO that includes the following:  1. Review of diet and fluid intake for aberrations as indicated by hyperkalemia and elevated blood pressure secondary to volume overload;  2. Review of medications to ensure adequate provision of supplemental iron;  3. Ongoing evaluations of hematocrit and iron stores;  4. Reevaluation of the dialysis prescription taking into account the patients increased appetite and red blood cell volume;  5. Method for physician and facility (including backup facility for Method II patients) follow-up on blood tests and a mechanism (such as a patient log) for keeping the physician informed of the results;  6. Training of the patient to identify the signs and symptoms of hypotension and hypertension; and  7. The decrease or discontinuance of EPO if hypertension is uncontrollable.  B.  Patient Selection   The dialysis facility, or the physician responsible for all dialysis- related services furnished to the patient, must make a comprehensive assessment that includes the following:  1. Preselection Monitoring   The patients hematocrit (or hemoglobin), serum iron, transferrin saturation, serum ferritin, and blood pressure must be measured.  2 Conditions the Patient Must Meet   The assessment must find that the patient meets the following conditions:  a. Is a dialysis patient;  b. Has a hematocrit (or comparable hemoglobin level) that is as follows:
(Medicare Benefit Policy Manual)
The assessment must find that the patient meets the following conditions:  a. Is a dialysis patient;  b. Has a hematocrit (or comparable hemoglobin level) that is as follows:   For a patient who is initiating EPO treatment, no higher than 30 percent unless there is medical documentation showing the need for EPO despite a hematocrit (or comparable hemoglobin level) higher than 30 percent.  Patients with severe angina, severe pulmonary distress, or severe hypotension may require EPO to prevent adverse symptoms even if they have higher hematocrit or hemoglobin level s.   For a patient who has been receiving EPO from the facility or the physician, between 30 and 36 percent.   c. Is under the care of:    A physician who is responsible for all dialysis -related services and who prescribes the EPO and follows the drug labeling instructions when monitoring the EPO home therapy; and    A renal dialysis facility that establishes the plan of care and monitors the progress of the home EPO therapy.   3. The assessment must find that the patient or a caregiver meets the following conditions:    Is trained by the facility to inject EPO and is capable of carrying out the procedure;    Is capable of reading and understanding the drug labeling; and    Is trained in, and capable of observing, aseptic techniques.  4. Care and Storage of Drug  The assessment must find that EPO can be stored in the patients residence under refrigeration and that the patient is aware of the potential hazard of a childs having access to the drug and syringes.   C.  Responsibilities of Physician or Dialysis Facility   The patients physician or dialysis facility must:    Develop a protocol that follows the drug label instructions;    Make the protocol available to the patient to ensure safe and effective home use of EPO;    Through the amounts prescribed, ensure that the drug on hand at any time does not exceed a 2- month supply;    Maintain adequate records to allow quality assurance for review by the Network and State Survey Agencies. For Method II patients, current records must be provided to and maintained by the designated backup facility; and   The dialysis facility must submit claims for EPO, if the facility provides it.
(Medicare Benefit Policy Manual)
 The dialysis facility must submit claims for EPO, if the facility provides it.   See the Medicare Claims Processing Manual, Chapter 11, End Stage Renal Disease, for instructions for billing and processing claims for EPO under Method 1 and Method 2.  Note that hematocrit readings are required on claims.  It is expected that the ESRD f acility or hospital outpatient department will maintain the following information in each patients medical record to permit the review of the medical necessity of EPO.   1. Diagnostic coding;  2. Most recent creatinine prior to initiation of EPO therapy;  3. Date of most recent creatinine prior to initiation of EPO therapy;  4. Most recent hematocrit (HCT) prior to initiation of EPO therapy;  5. Date of most recent hematocrit (HCT) prior to initiation of EPO therapy;  6. Dosage in units/kg;  7. Weight in kgs; and 8. Number of units administered.   50.5.2.2 - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use  (Rev. 1, 10- 01-03) PM-AB-99-59, Dated 8/1/99  This instruction pertains exclusively to the preoperative surgical indication of the drug Procrit, in which it is administered to specific patients prior to surgery to reduce risk of transfusion.  It does not affect Medicare policies related to other Food and Drug Administration (FDA) approved uses of Procrit.  It is not a national coverage decision .  Procrit as Preventive Service   The A/B MAC (B) may determine that Procrit is covered for individuals who:   1. Are undergoing hip or knee surgery   2. Have an anemia with a hemoglobin between 10 and 13 mg/dL;   3. Are not a candidate for autologous blood transfusion;   4. Are expected to lose more than 2 units of blood; and  5. Have had a workup so that their anemia appears to be that of chronic disease.  The preoperative use of Procrit may be afforded to these individuals when A/B MACs (B), exercising their discretion, determine that this treatment is reasonable and necessary.  In other cases, Procrit is considered a preventive service and therefore not covered.
(Medicare Benefit Policy Manual)
50.5.3 - Oral Anti -Cancer Drugs  (Rev. 1, 10- 01-03) A3-3112.4.B.5, HO -230.4.B.5  Effective January 1, 1994, Medicare Part B coverage is extended to include oral anti -cancer drugs that are prescribed as anti -cancer chemotherapeutic agents providing they have the same active ingredients and are used for the same indications as anti -cancer chemotherapeutic agents which would be covered if they were not self -administered and they were furnished incident to a physicians service as drugs and biologicals.  For an oral anti -cancer drug to be covered under Part B, it must:    Be prescribed by a physician or other practitioner licensed under State law to prescribe such drugs as anti-cancer chemotherapeutic agents;    Be a drug or biological that has been approved by the Food and Drug Administration (FDA);    Have the same active ingredients as a non -self-administrable anti- cancer chemotherapeutic drug or biological that is covered when furnished incident to a physicians service.  The oral anti -cancer drug and the non- self-administrable drug must have the same  chemical/generic name as indicated by the FDAs Approved Drug Products (Orange Book), Physicians Desk Reference (PDR), or an authoritative drug compendium;    Be used for the same indications, including unlabeled uses, as the non- self-administrable version of the drug; and    Be reasonable and necessary for the individual patient.  50.5.4 - Oral Anti -Nausea (Anti-Emetic) Drugs  (Rev. 185, Issued: 04- 15-14, Effective: 05 -29-13, Implementation: 07- 07-14)
(Medicare Benefit Policy Manual)
50.5.4 - Oral Anti -Nausea (Anti-Emetic) Drugs  (Rev. 185, Issued: 04- 15-14, Effective: 05 -29-13, Implementation: 07- 07-14)  Effective January 1, 1998, Medicare also covers self -administered anti- emetics, which are necessary for the administration and absorption of the anti -neoplastic chemotherapeutic agents when a high likelihood of vomiting exists.  The anti -emetic drug is cov ered as a necessary means for administration of the anti -neoplastic chemotherapeutic agents.  Oral drugs prescribed for use with the primary drug, which enhance the anti-neoplastic effect of the primary drug or permit the patient to tolerate the primary an ti-neoplastic drug in higher doses for longer periods, are not covered.  Self -administered anti- emetics to reduce the side effects of nausea and vomiting brought on by the primary drug are not included beyond the administration necessary to achieve drug absorption.  Section 1861(s)(2) of the Social Security Act extends coverage to oral anti -emetic drugs that are used as full replacement for intravenous dosage forms of a cancer regimen under the following conditions:    Coverage is provided only for oral drugs approved by the Food and Drug Administration (FDA) for use as anti -emetics;    The oral anti -emetic must either be administered by the treating physician or in accordance with a written order from the physician as part of a cancer chemotherapy regimen;    Oral anti -emetic drugs administered with a particular chemotherapy treatment must be initiated within 2 hours of the administration of the chemotherapeutic agent and may be continued for a period not to exceed 48 hours from that time;    The oral anti -emetic drugs provided must be used as a full therapeutic replacement for the intravenous anti -emetic drugs that would have otherwise been administered at the time of the chemotherapy treatment.   Only drugs pursuant to a physicians order at the time of the chemotherapy treatment qualify for this benefit.  The dispensed number of dosage units may not exceed a loading dose administered within two hours of the treatment, plus a supply of additional dosage units not to exceed 48 hours of therapy.
(Medicare Benefit Policy Manual)
Oral drugs that are not approved by the FDA for use as anti -emetics and which are used by treating physicians adjunctively in a manner incidental to cancer chemotherapy are not covered by this benefit and are not reimbursable within the scope of this benef it.  It is recognized that a limited number of patients will fail on oral anti- emetic drugs. Intravenous anti -emetics may be covered (subject to the rules of medical necessity) when furnished to patients who fail on oral anti-emetic therapy.   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.
(Medicare Benefit Policy Manual)
 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)
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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:
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
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.