(Medicare National Coverage Determinations Manual)

If State law does not preclude a home health aide from prefilling insulin syringes, but the home health agency chooses to send a nurse to perform only this task, the visit is reimbursed as if made by a home health aide.   NOTE:  As indicated, to qualify for home health benefits, a patient must require skilled nursing services on an intermittent basis or physical therapy or speech -language pathology.  If a beneficiary does not qualify for home health benefits but only needs someone to prefill syringes with the correct dosage of insulin, then no program payment can be made.   Cross -reference:   The Medicare Benefit Policy Manual, Chapter 7, Home Health Services, 20, 30, 30.2.2 and, 50.  290.2 - Home Health Nurses Visits to Patients Requiring Heparin Injections  (Rev. 1, 10- 03-03) CIM 90 -2  Professional medical advice indicates that subcutaneous injections of low dose heparin can be, under certain circumstances, medically accepted therapy for the treatment of recurrent deep venous thrombosis, recurrent pulmonary emboli, and other conditions r equiring long term anticoagulation.  The usual drug of choice for these conditions is warfarin.  Heparin may be substituted for warfarin in circumstances such as demonstrated warfarin sensitivity.  Heparin is now the drug of choice for anticoagulation duri ng pregnancy.   Medicare payment may be made for serial visits by the home health nurse to teach the patient or the caring person to give subcutaneous injections of low dose heparin if it is prescribed by a physician for a homebound patient who:    Is pregnant and requires anticoagulant therapy, or    Requires treatment for deep venous thrombosis or pulmonary emboli or for another condition requiring anticoagulation and documentation justifies that the patient cannot tolerate warfarin.   If the patient or caring person is unable to administer the injection, nursing visits to give the injections on a daily basis, 7 days a week, for a period of up to 6 months (in the case of pregnancy, visits may be made for a period beyond 6 months if reasonable and necessary) would be reimbursed by Medicare.  Coverage for these services after 6 months of treatment would be provided only if the prescribing physician can justify and document the need for such an extended course of treatment.  Documentation of  need for heparin injections beyond 6 months would not be required for pregnant patients who meet the homebound criteria.  Cross -reference:   The Medicare Benefit Policy Manual, Chapter 7, Home Health Services, 30.4,  300 - Diagnostic Tests Not Otherwise Classified  (Rev.)   300.1 - Obsolete or Unreliable Diagnostic Tests  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A.  Diagnostic Tests   Do not routinely pay for the following diagnostic tests because they are obsolete and have been replaced by more advanced procedures.  The listed tests may be paid for only if the medical need for the procedure is satisfactorily justified by the physician who performs it.  When the services are subject to the Quality Improvement Organization (QIO) re view, the QIO is responsible for determining that satisfactory medical justification exists.   When the services are not subject to QIO review, the A/B MAC (A) or (B) is responsible for determining that satisfactory medical justification exists.  This includes:   Amylase, blood isoenzymes, electrophoretic,   Chromium, blood,   Guanase, blood,   Zinc sulphate turbidity, blood,  Skin test, cat scratch fever,   Skin test, lymphopathia venereum,   Circulation time, one test,   Cephalin flocculation,   Congo red, blood,  Hormones, adrenocorticotropin quantitative animal tests,  Hormones, adrenocorticotropin quantitative bioassay,  Thymol turbidity, blood,   Skin test, actinomycosis,   Skin test, brucellosis,  Skin test, psittacosis,   Skin test, trichinosis,   Calcium, feces, 24 -hour quantitative,  Starch, feces, screening,   Chymotrypsin, duodenal contents,  Gastric analysis, pepsin,   Gastric analysis, tubeless,   Calcium saturation clotting time,   Capillary fragility test (Rumpel- Leede),   Colloidal gold,   Bendiens test for cancer and tuberculosis,   Bolens test for cancer,   Rehfuss test for gastric acidity, and  Serum seromucoid assay for cancer and other diseases.   B.  Cardiovascular Tests   Do not pay for the following phonocardiography and vectorcardiography diagnostic tests because they have been determined to be outmoded and of little clinical value.  They include:    Phonocardiogram with or without ECG lead; with supervision during recording with interpretation and report (when equipment is supplied by the physician),    Phonocardiogram; tracing only, without interpretation and report (e.g., when equipment is supplied by the hospital, clinic),   Phonocardiogram; interpretation and report,    Phonocardiogram with ECG lead, with indirect carotid artery and/or jugular vein tracing, and/or apex cardiogram; with interpretation and report,   Phonocardiogram; without interpretation and report,   Phonocardiogram; interpretation and report only,   Intracardiac,    Vectorcardiogram (VCG), with or without ECG; with interpretation and report,   Vectorcardiogram; tracing only, without interpretation and report, and,    Vectorcardiogram; interpretation and report only.  310 - Clinical Trials (Rev. 1, 10- 03-03)  310.1 - Routine Costs in Clinical Trials (Effective July 9, 2007)  (Rev. 173, Issued: 09 -04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complic ations arising from participation in all clinical trials.  All other Medicare rules apply.   Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non- coverage decision) tha t are provided in either the experimental or the control arms of a clinical trial except:    The investigational item or service, itself unless otherwise covered outside of the clinical trial;   Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and    Items and services customarily provided by the research sponsors free -of-charge for any enrollee in the trial.   Routine costs in clinical trials include:   Items or services that are typically provided absent a clinical trial (e.g., conventional care);    Items or services required solely for the provision of the investigational item or service (e.g., administration of a non- covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of com plications; and    Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service --in particular, for the diagnosis or treatment of complications.   This policy does not withdraw Medicare coverage for items and services that may be covered according to local medical review policies (LMRPs) or the regulations on category B investigational device exemptions found in 42 CFR 405.201- 405.215, 411.15, and 411.406.  For information about LMRPs, refer to www.lmrp.net, a searchable database of MAC local policies.  For non- covered items and services, including items and services for which Medicare payment is statutorily prohibited, Medicare only covers the treatment of complications arising from the delivery of the non- covered item or service and unrelated reasonable and necessary care.  However, if the item or service is not covered by virtue of a national non- coverage policy in Pub. 100-03, National Coverage Determination (NCD) Manual, and is the focus of a qualifying clinical trial, the routine costs of the clinica l trial (as defined above) will be covered by Medicare but the non- covered item or service, itself, will not.   A.  Requirements for Medicare Coverage of Routine Costs   Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:    The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosm etic surgery, hearing aids).    The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.    Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers.  Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.  The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs.  Clinical trials also should have the following desirable characteristics; however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:   1.  The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes;   2.  The trial is well- supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;   3.  The trial does not unjustifiably duplicate existing studies;   4.  The trial design is appropriate to answer the research question being asked in the trial;   5.  The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;   6.  The trial is in compliance with Federal regulations relating to the protection of human subjects; and   7.  All aspects of the trial are conducted according to the appropriate standards of scientific integrity.   B.  Qualification Process for Clinical Trials   Using the authority found in 1142 of the Social Security Act (the Act) (cross -referenced in 1862(a)(1)(E) of the Act), the Agency for Healthcare Research and Quality (AHRQ) will convene a multi -agency Federal panel (the "panel") composed of representativ es of the Department of Health and Human Services research agencies (National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), AHRQ, and the Office of Human Research Protection), and the research arms of the Department of Defense (DOD) and the Department of Veterans Affairs (VA) to develop qualifying criteria that will indicate a strong probability that a trial exhibits the desirable characteristics listed above.  These criteria will be easily verifiable, and where possible, dichotomous.  Trials that meet these qualifying criteria will receive Medicare coverage of their associated routine costs. This panel is not reviewing or approving individual trials.  The multi -agency panel will meet periodically to review and evaluate the program and recommend any necessary refinements to the Centers for Medicare & Medicaid Services (CMS).   Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria.  This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development.  Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by AHRQ, in consultation with the other agencies represented on the multi -agency panel to be highly likely to have the above -listed seven desirable characteristics of clinical trials.  The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry for administrative purposes, once the registry is established.  Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:   1.  Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;   2.  Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA;   3.  Trials conducted under an investigational new drug application (IND) reviewed by the FDA; and   4.  Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place.  At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs.  This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deem ed status.