evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Providers may request that a drug be approved for off-label use by submitting this request in writing and including the data supporting its use. The data must include:A use supported by clinical research that appears in at least two Phase III clinical trials that definitively demonstrate safety and effectiveness; or,If no Phase III trial evidence is available, at least two Phase II clinical trials with reasonably large patient samples showing consistent results of safety and efficacy may be considered in certain instances such as use in rare diseases in which a Phase III study might be difficult to complete in a reasonable period of time after completion of the Phase II studies, or when overwhelmingly good evidence of safety and effectiveness is noted in the Phase II studies.A use that is an accepted standard of medical practice. "Are there published recommendations from specialty societies or in other authoritative evidence-based guidelines?" (For example, a state of the art review article published in a recognized textbook or a reputable publication) It should be noted that acceptance by individual health care practitioners, or even a limited group of health care practitioners normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with potential financial conflict of interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence must be considered and its quality must be evaluated before a conclusion is reached.The Phase III or Phase II trials must come from different centers and be published in national or international peer-reviewed (editorial committee is comprised of physicians) journals. Peer reviewed medical literature includes scientific and medical publications. It does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts).In principle, rankings of research design have been based on the ability of each study design category to minimize bias. The following is a representative list of study designs (some of which have alternative names) ranked from most to least methodologically rigorous in their potential ability to minimize systematic bias:Randomized controlled trialsNon-randomized controlled trialsProspective cohort studiesRetrospective case control studiesCross-sectional studiesSurveillance studies (e.g., using registries or surveys)Consecutive case series andSingle case reportsThe design, conduct and analysis of trials are important factors as well. For example, a well designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size.
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
The design, conduct and analysis of trials are important factors as well. For example, a well designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size.In determining whether there is supportive clinical evidence for a particular use of a drug, the quality of the published evidence must be considered. Such consideration involves the assessment of the following study characteristics:The adequacy of the number of subjects;The response rate;The effect on key status and survival indications. That is, the effect on the patient's well-being and other responses to therapy that indicate effectiveness (e.g., reduction in mortality, morbidity, signs and symptoms);The appropriateness of the study design, that is, whether the experimental design in light of the drugs and conditions under investigation is appropriate to address the investigative question. (For example, in some clinical studies, it may be unnecessary or not feasible to use randomization, double blind trials, placebos, or crossover.); andThe prevalence and life history of the disease when evaluating the adequacy of the number of subjects and the response rate.After such evidence is received, National Government Services will, with appropriate help of specialty-specific consultants as indicated, make a coverage determination for the non-FDA approved indication (off-label use) of the drug or biological.National Government Services may determine a drug use to be reasonable and necessary for the treatment of illness or injury if, on the basis of available or presented evidence, if it is shown to be safe and effective and does not violate national or local Medicare determinations and regulations. The approval will include, but is not limited to, diagnosis, dose and route of administration, duration and frequency, and appropriate patient population.Limitations:If a use is identified as not indicated by CMS or the FDA, or if a use is specifically identified as not indicated in the American Hospital Formulary Services (AHFS), Elsevier/Gold Standard Clinical Pharmacology, NCCN Drugs and Biologics Compendium, Truven Health Analytics Micromedex DrugDex and/or Wolters Kluwer Lexi-Drugs compendium, the off-label use is not supported and the drug will not be covered.
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Regardless of the evidence supporting coverage for a particular off-label use, payment may only be made if the use is reasonable and necessary for the treatment of illness or injury of the specific patient receiving the drug.Services related to non-covered services or drugs are also not covered (e.g., administration services).Upon review, if the drug use is not on the FDA label, does not appear on the American Hospital Formulary Services (AHFS), Elsevier/Gold Standard Clinical Pharmacology, NCCN Drugs and Biologics Compendium, Truven Health Analytics Micromedex DrugDex and/or Wolters Kluwer Lexi-Drugs compendium or National Government Services has not published an LCD or article covering the off-label use as listed below, then the drug use is not approved and the use of the drug may be denied. However, determinations as to whether medication is reasonable and necessary for an individual patient may be made on appeal on the same basis as all other such determinations (i.e., with support from the peer-reviewed literature, with the advice of medical consultants, with reference to accepted standards of medical practice, and in consideration of the medical circumstance of the individual case).The route of administration must be reasonable and necessary as well as the drug.(Pub 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.2 - Determining Self-Administration of Drug or Biological (Rev. 91; Issued: 06-20-08; Effective/Implementation Date: 07-21-08)). National Government Services will use evidence-based clinical guidelines to determine medical necessity of the route of administration.Specific Drugs and Biological CoverageFDA and approved Compendia UsesThe following drugs will be covered for their FDA approved uses as well as their approved compendia uses.Bevacizumab and biosimilarsDenosumab (Prolia , Xgeva )Hyaluronans Intra-articular Injections ofOmalizumabRanibizumaband AfliberceptFDA, approved Compendia and Off-label Uses
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
FDA, approved Compendia and Off-label UsesThe following drugwill be covered for off label uses described below in addition to their FDA approved use and approved compendia uses.Eculizumab- NGS has approved eculizumab for biopsy proven dense deposit disease.Ibandronate Sodium- NGS has approved ibandronate for senile osteoporosis in male patients.Infliximaband biosimilars- NGS has approved infliximab for the following:Behets Disease (BD), also known as Behets Syndrome, in patients without an adequate response to initial therapy, for the treatment of clinical manifestations of BD such as severe ocular involvement, major organ involvement, severe gastrointestinal or neurological involvement and resistant cases of joint or mucocutaneous involvement (i.e., painful oral and genital ulcers).Pyoderma gangrenosum with coexisting inflammatory bowel disease.Sarcoid refractory to treatment with steroids and other standard drug regimens.Severe immune-related colitis that does not respond promptly (within 1 week) to therapy with high-dose steroids. A single dose of infliximab is sufficient to resolve immune-related colitis in most patients.Treatment of microscopic colitis deemed refractory because of lack of response to standard pharmacologic therapy.Luteinizing Hormone-Releasing Hormone (LHRH) Analogs - NGShas approvedLeuprolide Acetate for the following:Carcinoma, breast (treatment): palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal womenSuspected endometriosis causing chronic (6 months or more) pelvic pain after an appropriate pretreatment evaluation (to exclude other causes) and failure of initial treatment with OCs and NSAIDs; not to continue beyond 3 months if there is not significant symptomatic improvementHead and Neck cancers-salivary gland tumorsGoserelin Acetate -NGS has approvedGoserelin Acetate for the following:Treatment of leiomyomata: 3.6 mg per month for short duration (3-6 months).
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Goserelin Acetate -NGS has approvedGoserelin Acetate for the following:Treatment of leiomyomata: 3.6 mg per month for short duration (3-6 months).Paclitaxel (e.g., Taxol/Abraxane ) - NGS has approved paclitaxel for the following:Hormone refractory prostate carcinomaCarcinoma of the renal pelvis and ureterRhabdomyosarcomaLeiomyosarcomaGeneral InformationAssociated InformationN/ASources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.Decision Memo for Anticancer Chemotherapy for Colorectal Cancer (CAG-00179N), Appendix B, The Centers for Medicare and Medicaid Services, January 28, 2005.Based on a reconsideration the following sources have been added:Jacobsen PB, Bovbjerg DH, Redd WH. Anticipatory anxiety in women receiving chemotherapy for breast cancer.Health Psychology.1993;12(6):469-475.Osoba D, Zee B, Pater J, Warr D, Latreille J, Kaizer L. Determinants of postchemotherapy nausea and vomiting in patients with cancer.J Clin Oncol.1997;15(1):116-123.Petrella T, Clemons M, Joy A, Young S, Callaghan W, Dranitsaris G. Identifying patients at high risk for nausea and vomiting after chemotherapy: the development of a practical validated prediction tool.J Support Oncol.2009;7(4):W1-W8.Shih V, Wan HS, Chan A. Clinical predictors of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant doxorubicin and cyclophosphamide.Ann Pharmacother.2009;43:444-452.
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Tsavaris N, Kosmas C, Mylonakis N, et al. Parameters that influence the outcome of nausea and emesis in cisplatin based chemotherapy.Anticancer Research.2000;20:4777-4784.Park T, Cave D, Marshall C. Microscopic colitis: A review of etiology, treatment and refractory disease.World J Gastroenterol. 2015;21(29):88804-88810.Verhaegh BPM, Mnch A, Guagnozzi D, et al, Course of Disease in Patients with Microscopic Colitis: A European Prospective Incident Cohort Study.Journal of Chrons and Colitis. 2021;15(7):1174-1183. .Burke KE, DAmato M, Ng SC, Pardi DS, Ludvigsson JF, Khalili H. Microscopic colitis.Nat Rev Dix Primers.2021;7:1-10.Shor J, Churrango G, Hosseini N, Marshall C. Management of microscopic colitis: challenges and solutions.Clinical and Experimental Gastroenterology.2019;12:111-120.Daferera N, Hjortsuvang H, Ignatova S, Mnch A.Single-centre experience with anti-tumour necrosis factor treatment in budesonide-refractory microscopic colitis patients.UEG Journal.2019;7(9):1234-1260.Miehlke S, Verhaeg B, Tontini GE, Madisch A, Langner C, Milnch A. Microscopic colitis: pathophysiology and clinical management.The Lancet Gastroenterology & Hepatology.2019;4(4):305-314.Boland K, Nguyen GC. Microscopic Colitis: A Review of Collagenous and Lymphocytic Colitis.Gastroenerology & Hepatology. 201713(11):671-677.Cotter TG, Kamboj AK, Hicks SB, Tremaine WJ, Loftus EV, Pardi DS. Immune modulator therapy for microscopic colitis in a case series of 73 patients.AP&T Alimentary Pharmacology & Therapeutics. 2017:1-6.
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Anderson RJ, Makins R. Successful use of adalimumab in patients with treatment-refractory microscopic colitis.BMJ Case Rep. 2016. Doi:1031136/bcr-2016-215639.Pola S, Fahmy M, Evans E, Tipps A, Sandborn WJ. Successful Use of Infliximab in the Treatment of Cortico-steroid Dependent Collagenous Colitis.American College of Gastroenterology. 2013.doi:10.1038ajg.2013.43.Barahona-Garrido J, Quionez NF, Cerda-Contreras E, Sarti HM, Tleiz-Avila F. Fosfomycin-Containing Second-Line Treatment for Helicobacter Pylori Infection.American College of Gastroenterology. 2013.doi:10.1038ajg.2013.48.Mnch A, Ignatova S, Strm M. Adalimumab in budesonide and methotrexate refractory collagenous colitis.Scandinavian Journal of Gastroenterology.2012;47:56-63.Esteve M, Mahadevan U, Sainz E, Rodrigez E, Salas A, Fernndez-Baares F. Efficacy of anti-TNF therapies in refractory severe microscopic colitis.Journal of Chrons and Colitis.2011;5:612-618.
Proposed LCD - Lower Limb Prostheses (DL33787)
CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must: 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act  1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act  1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.A lower limb prosthesis is covered when the beneficiary:Will reach or maintain a defined functional state within a reasonable period of time; andIs motivated to ambulate.FUNCTIONAL LEVELS:A determination of the medical necessity for certain components/additions to the prosthesis is based on the beneficiarys potential functional abilities. Potential functional ability is based on the reasonable expectations of the treating practitioner and prosthetist, considering factors including, but not limited to:The beneficiarys past history (including prior prosthetic use if applicable); andThe beneficiarys current condition including the status of the residual limb and the nature of other medical problems; andThe beneficiarys desire to ambulate.Clinical assessments of beneficiary rehabilitation potential must be based on the following classification levels (see the FUNCTIONAL LEVEL CHARACTERISTICS section in the LCD related Policy Article for additional details):
Proposed LCD - Lower Limb Prostheses (DL33787)
The beneficiarys desire to ambulate.Clinical assessments of beneficiary rehabilitation potential must be based on the following classification levels (see the FUNCTIONAL LEVEL CHARACTERISTICS section in the LCD related Policy Article for additional details):Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility.Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator.Level 2: Has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs or uneven surfaces. Typical of the limited community ambulator.Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.Level 4: Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.The medical records must document the beneficiarys current functional and physical capabilities and their expected functional potential, including an explanation for the difference, if that is the case. It is recognized, within the functional classification hierarchy, that bilateral amputees often cannot be strictly bound by functional level classifications.GENERAL:If a prosthesis is denied as not reasonable and necessary, related additions will also be denied as not reasonable and necessary.
Proposed LCD - Lower Limb Prostheses (DL33787)
GENERAL:If a prosthesis is denied as not reasonable and necessary, related additions will also be denied as not reasonable and necessary.When an initial below knee prosthesis (L5500) or a preparatory below knee prosthesis (L5510, L5520,L5530, L5540) is provided, prosthetic substitutions and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5629, L5638, L5639, L5646, L5647, L5704, L5785, L5962, and L5980 which will be denied as not reasonable and necessary. When a below knee preparatory prefabricated prosthesis (L5535) is provided, prosthetic substitutions and/or additions of procedures are covered in accordance with the functional level assessment except for codes L5620, L5629, L5645, L5646, L5670, L5676, L5704, and L5962 which will be denied as not reasonable and necessary.
Proposed LCD - Lower Limb Prostheses (DL33787)
When an above knee initial prosthesis (L5505) or an above knee preparatory (L5560, L5570, L5580, L5590, L5595, L5600) prosthesis is provided, prosthetic substitution and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5610, L5631, L5640, L5642, L5644, L5648, L5705, L5706, L5964, L5980, and L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780, L5790, L5795 which will be denied as not reasonable and necessary. When an above knee preparatory prefabricated prosthesis (L5585) is provided, prosthetic substitution and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5624, L5631, L5648, L5651, L5652, L5705, L5706, L5964, and L5966 which will be denied as not reasonable and necessary.In the following sections, the determination of coverage for selected prostheses and components with respect to potential functional levels represents the usual case. Exceptions will be considered in an individual case if additional documentation is included which justifies the medical necessity. Prostheses will be denied as not reasonable and necessary if the beneficiarys potential functional level is 0.FEET:A determination of the type of foot for the prosthesis will be made by the treating practitioner and/or the prosthetist based upon the functional needs of the beneficiary. Basic lower extremity prostheses include a SACH foot. Other prosthetic feet are considered for coverage based upon functional classification.An external keel SACH foot (L5970) or single axis ankle/foot (L5974) is covered for beneficiaries whose functional level is 1 or above.A flexible-keel foot (L5972) or multiaxial ankle/foot (L5978) is covered for beneficiaries whose functional level is 2 or above.
Proposed LCD - Lower Limb Prostheses (DL33787)
A flexible-keel foot (L5972) or multiaxial ankle/foot (L5978) is covered for beneficiaries whose functional level is 2 or above.A microprocessor-controlled ankle foot system (L5973), energy storing foot (L5976), dynamic response foot with multi-axial ankle (L5979), flex foot system (L5980), flex-walk system or equal (L5981), or shank foot system with vertical loading pylon (L5987) is covered when one of the following criteria is met:The beneficiarys functional level is 3 or above; or,The beneficiary's functional level is 2; and,Meets the functional level 2 coverage criteria for a fluid, pneumatic, or electronic/microprocessor control addition for a prosthetic knee; and,A higher-level (i.e., functional level 3) foot is required for the safe and proper use of the prescribed knee system.The microprocessor foot or ankle system additionwithpower assist which includes any type motor (L5969) is not covered because there is insufficient information to demonstrate that the item meets the Medicare standard to be considered reasonable and necessary as per PIM Chapter 13. Claims for L5969 will be denied as not reasonable and necessary.Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of foot. This information must be retained in thetreating practitioner'sor prosthetist's files.A user-adjustable heel height feature (L5990) will be denied as not reasonable and necessary.KNEES:A determination of the type of knee for the prosthesis will be made by the treating practitioner and/or the prosthetist based upon the functional needs of the beneficiary. Basic lower extremity prostheses include a single axis, constant friction knee. Other prosthetic knees are considered for coverage based upon functional classification.A high activity knee control frame (L5930) is covered for beneficiaries whose functional level is 4.