(Medicare National Coverage Determinations Manual)

Laparoscopic cholecystectomy is a covered surgical procedure in which a diseased gall bladder is removed through the use of instruments introduced via cannulae, with vision of the operative field maintained by use of a high- resolution television camera -monitor system (video laparoscope).  For inpatient claims, report the diagnosis code for laparoscopic cholecystectomy.  For all other claims, report the appropriate CPT code for laparoscopy, surgical; cholecystectomy (any method), and the appropriate CPT code  for laparoscopy, surgical: cholecystectomy with cholangiography.   100.14  Surgery for Diabetes  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section  100.14 has been  removed  from  the NCD Manual  and incorporated into  NCD 100.1 effective September 24, 2013.   110 - Hematology/Immunology/Oncology  (Rev. 1, 10- 03-03)  110.1 - Hyperthermia for Treatment of Cancer  (Rev. 1, 10- 03-03) CIM 35 -49  Local hyperthermia for treatment of cancer consists of the use of heat to make tumors more susceptible to cancer therapy measures.   Local hyperthermia is covered under Medicare when used in connection with radiation therapy for the treatment of primary or metastatic cutaneous or subcutaneous superficial malignancies.  It is not covered when used alone or in connection with chemotherapy.  110.2 - Certain Drugs Distributed by the National Cancer Institute  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Under its Cancer Therapy Evaluation, the Division of Cancer Treatment of the National Cancer Institute (NCI), in cooperation with the Food and Drug Administration, approves and distributes certain drugs for use in treating terminally ill cancer patients.  One group of these drugs, designated as Group C drugs, unlike other drugs distributed by the NCI, is not limited to use in clinical trials for the purpose of testing their efficacy.  Drugs are classified as Group C drugs only if there is sufficient evidenc e demonstrating their efficacy within a tumor type and that they can be safely administered.   A physician is eligible to receive Group C drugs from the Division of Cancer Treatment only if the following requirements are met:   A physician must be registered with the NCI as an investigator by having completed an FD -Form 1573;    A written request for the drug, indicating the disease to be treated, must be submitted to the NCI;    The use of the drug must be limited to indications outlined in the NCIs guidelines; and   All adverse reactions must be reported to the Investigational Drug Branch of the Division of Cancer Treatment.   In view of these NCI controls on distribution and use of Group C drugs, A/B MACs may assume, in the absence of evidence to the contrary, that a Group C drug and the related hospital stay are covered if all other applicable coverage requirements are satisfi ed.  If there is reason to question coverage in a particular case, the matter should be resolved with the assistance of the Quality Improvement Organization (QIO), or if there is none, the assistance of the MAC's medical consultants.  Information regarding those drugs which are classified as Group C drugs may be obtained from:   Chief, Investigational Drug Branch  Cancer Therapy Evaluation Program  Executive Plaza North, Suite 7134 National Cancer Institute  Rockville, Maryland 20852- 7426  110.3 - Anti -Inhibitor Coagulant Complex (AICC)  (Rev. 1, 10- 03-03) CIM 45 -24  Anti-inhibitor coagulant complex, AICC, is a drug used to treat hemophilia in patients with factor VIII inhibitor antibodies.  AICC has been shown to be safe and effective and has Medicare coverage when furnished to patients with hemophilia A and inhibitor antibodies to factor VIII who have major bleeding episode s and who fail to respond to other, less expensive therapies.  110.4 - Extracorporeal Photopheresis  (Rev. 143, Issued: 05- 18-12, Effective: 04 -30-12, Implementation: 10- 01-12)  A. General   Extracorporeal photopheresis is a medical procedure in which a patients white blood cells are exposed first to a drug called 8 -methoxypsoralen (8- MOP) and then to ultraviolet A (UVA) light. The procedure starts with the removal of the patients blood, whi ch is centrifuged to isolate the white blood cells. The drug is typically administered directly to the white blood cells after they have been removed from the patient (referred to as ex vivo administration) but the drug can alternatively be administered di rectly to the patient before the white blood cells are withdrawn. After UVA light exposure, the treated white blood cells are then re-infused into the patient.   B. Nationally Covered Indications   The Centers for Medicare & Medicaid Services (CMS) has determined that extracorporeal photopheresis is reasonable and necessary under 1862(a)(1)(A) of the Social Security Act (the Act) under the following circumstances:   1. Effective April 8, 1988, Medicare provides coverage for:   Palliative treatment of skin manifestations of cutaneous T -cell lymphoma that has not responded to other therapy.   2. Effective December 19, 2006, Medicare also provides coverage for:   Patients with acute cardiac allograft rejection whose disease is refractory to standard immunosuppressive drug treatment; and,   Patients with chronic graft versus host disease whose disease is refractory to standard immunosuppressive drug treatment.   3. Effective April 30, 2012, Medicare also provides coverage for:  Extracorporeal photopheresis for the treatment of bronchiolitis obliterans syndrome (BOS) following lung allograft transplantation only when extracorporeal photopheresis is provided under a clinical research study that meets the following conditions:  The clinical research study meets the requirements specified below to assess the effect of extracorporeal photopheresis for the treatment of BOS following lung allograft transplantation.  The clinical study must address one or more aspects of the following question:  Prospectively, do Medicare beneficiaries who have received lung allografts, developed BOS refractory to standard immunosuppressive therapy, and received extracorporeal photopheresis , experience improved patient -centered health outcomes as indicated by:  a. improved forced expiratory volume in one second (FEV1); b. improved survival after transplant; and/or, c. improved quality of life?  The required clinical study must adhere to the following standards of scientific integrity and relevance to the Medicare population:  a. The principal purpose of the research study is to test whether extracorporeal photopheresis potentially improves the participants health outcomes.  b. The research study 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.  c. The research study does not unjustifiably duplicate existing studies.  d. The research study design is appropriate to answer the research question being asked in the study.  e. The research study is sponsored by an organization or individual capable of successfully executing the proposed study.  f. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it must also be in compliance with 21 CFR  parts 50 and 56.  g. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).  h. The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for coverage with evidence development.   i. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR  312.81(a) and the patient has no other viable treatment options.  j. The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.  k. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org).  l. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.   m. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.   Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality supports clinical research studies that CMS determines meet the above-listed standards and address the above- listed research questions.  Any clinical study under which there is coverage of extracorporeal photopheresis for this indication pursuant to this national coverage determination (NCD) must be approved by April 30, 2014.  If there are no approved clinical studies on this date, this NCD will expire and coverage of extracorporeal photopheresis for BOS will revert to the coverage policy in effect prior to the is suance of the final decision memorandum for this NCD.   C. Nationally Non-Covered Indications  All other indications for extracorporeal photopheresis not otherwise indicated above as covered remain non-covered.   D. Other  Claims processing instructions can be found in chapter 32, section 190 of the Medicare Claims Processing Manual.   (This NCD last reviewed April 2012.)  110.5 - Granulocyte Transfusions  (Rev. 1, 10-03-03) CIM 45 -18  Granulocyte transfusions to patients suffering from severe infection and granulocytopenia are a covered service under Medicare.  Granulocytopenia is usually identified as fewer than 500 granulocytes/mm3 whole blood.  Accepted indications for granulocyte transfusions include:    Granulocytopenia with evidence of gram negative sepsis; and   Granulocytopenia in febrile patients with local progressive infections unresponsive to appropriate antibiotic therapy, thought to be due to gram negative organisms.  110.6 - Scalp Hypothermia During Chemotherapy to Prevent Hair Loss (Rev. 1, 10- 03-03)  CIM 45 -21  Keeping the scalp cool during chemotherapy has been noted to reduce the risk of hair loss. The cooling may be done by packing the scalp with ice -filled bags or bandages, or by specially designed devices filled with cold-producing chemicals activated during chemotherapy.   While ice- filled bags or bandages or other devices used for scalp hypothermia during chemotherapy may be covered as supplies of the kind commonly furnished without a separate charge, no separate charge for them would be recognized.   110.7 - Blood Transfusions  (Rev. 1, 10- 03-03) CIM 45 -27  Blood transfusions are used to restore blood volume after hemorrhage, to improve the oxygen carrying capacity of blood in severe anemia, and to combat shock in acute hemolytic anemia.   A.  Definitions   1. Homologous Blood Transfusion  Homologous blood transfusion is the infusion of blood or blood components that have been collected from the general public.  2. Autologous Blood Transfusion  An autologous blood transfusion is the precollection and subsequent infusion of a patients own blood.  3. Donor Directed Blood Transfusion  A donor directed blood transfusion is the infusion of blood or blood components that have been precollected from a specific individual(s) other than the patient and subsequently infused into the specific patient for whom the blood is designated.  For example, patient Bs brother predeposits his blood for use by patient B during upcoming surgery.  4.  Perioperative Blood Salvage   Perioperative blood salvage is the collection and reinfusion of blood lost during and immediately after surgery.   B.  Policy Governing Transfusions