evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
 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).
(Medicare National Coverage Determinations Manual)
 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
(Medicare National Coverage Determinations Manual)
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;
(Medicare National Coverage Determinations Manual)
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.   The CMS, through the NCD process, through an individualized assessment of benefits, risks, and research potential, may determine that certain items and services for which there is some evidence of significant medical benefit, but for which there is insufficient evidence to support a reas onable and necessary determination, are only reasonable and necessary when provided in a clinical trial that meets the requirements defined in that NCD.   Medicare will cover the routine costs of qualifying trials that either have been deemed to be automatically qualified, have certified that they meet the qualifying criteria, or are required through the NCD process, unless CMSs Chief Clinical Officer subse quently finds that a clinical trial does not meet the qualifying criteria or jeopardizes the safety or welfare of Medicare beneficiaries.
(Medicare National Coverage Determinations Manual)
Should CMS find that a trial's principal investigator misrepresented that the trial met the necessary qualifying criteria in order to gain Medicare coverage of routine costs, Medicare coverage of the routine costs would be denied under 1862(a)(1)(E) of th e Act.  In the case of such a denial, the Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be held harmless from collection) for the costs consistent with the provisions of 1879, 1842(l), or 1834(j)(4) of the Act, as applicable.  Where appropriate, the billing providers would be held liable for the costs and fraud investigations of the billing providers and the trial's principal investigator may be pursued.  Medicare regulations require Medicare+Choice (M+C) organizations to follow CMS NCDs.  This NCD raises special issues that require some modification of most M+C organizations' rules governing provision of items and services in and out of network.  The items  and services covered under this NCD are inextricably linked to the clinical trials with which they are associated and cannot be covered outside of the context of those clinical trials. M+C organizations therefore must cover these services regardless of wh ether they are available through in -network providers.  M+C organizations may have reporting requirements when enrollees participate in clinical trials, in order to track and coordinate their members' care, but cannot require prior authorization or approva l.                               Transmittals Issued for this Chapter
(Medicare National Coverage Determinations Manual)
Rev #  Issue Date  Subject  Impl Date  CR#  R12364NCD  11/16/2023  NCD 220.6.20 - Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease  12/19/2023  13429  R12299NCD  10/12/2023  An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer  Screening - Full Agile Pilot CR   11/13/2023  13017  R12183NCD  08/03/2023  National Coverage Determination (NCD) 280.16 Power Seat Elevation Equipment on Power Wheelchairs  09/04/2023  13277  R12112NCD  06/29/2023  Technical Revisions Only to the National Coverage Determination (NCD) Manual, Publication (Pub) 100 -03 07/31/2023  13220  R11892NCD  03/09/2023  Technical Revisions Only to the National Coverage Determination (NCD) Manual  04/10/2023  13105  R11865NCD  02/16/2023  An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening -  Full Agile Pilot CR  - Rescinded and replaced by transmittal 12299  02/27/2023  13017  R11824NCD  01/27/2023  An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening -  Full Agile Pilot CR - Rescinded and replaced by transmittal 11865  02/27/2023  13017  R11692NCD  11/09/2022  National Coverage Determination (NCD) 200.3 -  Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (AD ) 12/12/2022  12950  R11587NCD  09/08/2022  Revision to National Coverage Determination (NCD)
(Medicare National Coverage Determinations Manual)
-  Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (AD ) 12/12/2022  12950  R11587NCD  09/08/2022  Revision to National Coverage Determination (NCD) 240.2 (Home Use of Oxygen) to Align to 1834(a)(5)(E) of the Social Security Act  01/03/2023  11587  R11426NCD  05/20/2022  An Omnibus CR Covering: (1) Removal of Two National Coverage Determination (NCDs), (2) Updates to the Medical Nutrition Therapy (MNT) Policy, and (3) Updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage  07/05/2022  12613  R11388NCD  04/29/2022  National Coverage Determination (NCD) 210.14 Reconsideration  Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)  10/03/2022  12691  R11272NCD  02/18/2022  An Omnibus CR Covering: (1) Removal of Two National Coverage Determination (NCDs), (2) Updates to the Medical Nutrition Therapy (MNT) Policy, and (3) Updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage - Rescinded and replaced by transmittal 11426  07/05/2022  12613  R11263NCD  02/10/2022  Revisions to National Coverage Determination (NCD) 240.2 (Home Use of Oxygen) and 240.2.2 (Home Oxygen Use for Cluster Headache)  06/14/2022  12607  R11214NCD  01/20/2022  National Coverage Determination (NCD) 270.3 Blood- Derived Products for Chronic, Non-Healing Wounds  01/03/2022  12403  R11171NCD  01/12/2022  National Coverage Determination (NCD) 270.3 Blood- Derived Products for Chronic, Non-Healing Wounds Rescinded and replaced by transmittal 11214  01/03/2022  12403  R11159NCD  12/16/2021  Transvenous (Catheter) Pulmonary Embolectomy National Coverage Determination (NCD)  240.6
(Medicare National Coverage Determinations Manual)
replaced by transmittal 11214  01/03/2022  12403  R11159NCD  12/16/2021  Transvenous (Catheter) Pulmonary Embolectomy National Coverage Determination (NCD)  240.6  01/17/2022  12537  R11158NCD  12/16/2021  National Coverage Determination (NCD) 220.6.19, Positron Emission Tomography NaF-18 (NaF -18 PET) to Identify Bone Metastasis of Cancer - Manual Update Only  01/17/2022  12526  R11119NCD  11/10/2021  National Coverage Determination (NCD) 270.3 Blood- Derived Products for Chronic, Non-Healing Wounds Rescinded and replaced by transmittal 11171  11/23/2021  12403  R10981NCD  09/08/2021  National Coverage Determination (NCD) 270.3 Blood- Derived Products for Chronic, Non-Healing Wounds  Rescinded and replaced by transmittal 11119  11/09/2021  12403  R10838NCD  06/08/2021  National Coverage Determination (NCD) Removal  06/22/2021  12254  R10818NCD  05/20/2021  National Coverage Determination (NCD) 210.3 -  Screening for Colorectal Cancer (CRC) -Blood -Based Biomarker Tests  10/04/2021  12280  R10797NCD  05/20/2021  National Coverage Determination (NCD) Removal - Rescinded and replaced by transmittal 10838  06/22/2021  12254  R202NCD  8/25/2017  Updates to Pub. 100 -04, Chapter 18 Preventive and Screening Services and Chapter 32 Billing Requirements for Special Services and Publication 100- 03, Chapter 1 Coverage Determinations Part 4
(Medicare National Coverage Determinations Manual)
09/26/2017  10199  R198NCD  06/29/2017  Screening for Hepatitis B Virus (HBV) Infection  10/02/2017  9859  R197NCD  06/09/2017  Screening for Hepatitis B Virus (HBV) Infection  06/09/2017  9859  R195NCD  04/28/2017  Screening for Hepatitis B Virus (HBV) Infection - Rescinded and replaced by Transmittal 197  10/02/2017  9859  190NCD  02/05/2016  Screening for the Human Immunodeficiency Virus (HIV) Infection  03/07/2016  9403  189NCD  02/05/2016  Screening for Cervical Cancer With Human Papillomavirus (HPV) Testing National Coverage Determination (NCD)  03/07/2016  9434  R185NCD  08/21/2015  Medicare Coverage of Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)  01/04/2016  9246  R183NCD  08/06/2015  National Coverage Determination (NCD) for Screening for Colorectal Cancer Using Cologuard  - A Multitarget Stool DNA Test  09/08/2015  9115  R181NCD  03/27/2015  Removal of Multiple National Coverage Determinations Using Expedited Process  04/06/2015  9095  R180NCD  03/06/2015  Removal of Multiple National Coverage Determinations Using Expedited Process  Rescinded and replaced by Transmittal 181  04/06/2015  9095  R177NCD  11/19/2014  Screening for Hepatitis C Virus (HCV) in Adults  01/05/2015  8871  R176NCD  10/17/2014  Medicare Coverage of Ultrasound Screening for Abdominal Aortic Aneurysms (AAA) and Screening Fecal -Occult Blood Tests (FOBT)  11/18/2014  8881  R174NCD  09/05/2014  Screening for Hepatitis C Virus (HCV) in Adults  Rescinded and replaced by Transmittal 177  01/05/2015  8871  R173NCD  09/04/2014  Pub 100 -03, Chapter 1, Language -only Update  Upon Implementation of ICD -10 8506  R168NCD  05/28/2014  Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for
(Medicare National Coverage Determinations Manual)
Chapter 1, Language -only Update  Upon Implementation of ICD -10 8506  R168NCD  05/28/2014  Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated February 6, 2014)  05/19/2014  8739  R166NCD  04/18/2014  Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated February 6, 2014)  Rescinded and replaced by Transmittal 168  05/19/2014  8739  R164NCD  03/27/2014  Medicare National Coverage Determination (NCD) for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease  07/07/2014  8526  R162NCD  02/06/2014  Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors  03/07/2014  8468  R160NCD  02/06/2014  Medicare National Coverage Determination (NCD) for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease  Rescinded and replaced by Transmittal 164  07/07/2014  8526  R159NCD  02/05/2014  Pub 100 -03, Chapter 1, Language -only Update  Rescinded and replaced by Transmittal 173  10/01/2014  8506  R156NCD  08/02/2013  Positron Emission Tomography  09/03/2013  8381  R154NCD  06/10/2013  Autologous Platelet -Rich Plasma (PRP) for Chronic Non -Healing Wounds  07/01/2013  8213  R153NCD  05/21/2013  Autologous Platelet -Rich Plasma (PRP) for Chronic Non- Healing Wounds  Rescinded and replaced by Transmittal 154  07/01/2013  8213  R152NCD  03/08/2013  Autologous Platelet -Rich Plasma (PRP) for Chronic Non- Healing Wounds  Rescinded and replaced by Transmittal 153  07/01/2013  8213  R149NCD
(Medicare National Coverage Determinations Manual)
R152NCD  03/08/2013  Autologous Platelet -Rich Plasma (PRP) for Chronic Non- Healing Wounds  Rescinded and replaced by Transmittal 153  07/01/2013  8213  R149NCD  11/30/2012  Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)  01/07/2013  7836  R146NCD  08/03/2012  Liver Transplantation for Patients with Malignancies  09/04/2012  7908  R144NCD  08/03/2012  Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)   Rescinded and replaced by Transmittal 149  01/07/2013  7836  R142NCD  02/03/2012  Intensive Behavioral Therapy for Obesity  03/06/2012  7641  R141NCD  01/26/2012  Screening for Sexually Transmitted Infections (STIs) and High Intensity Behavioral Counseling (HIBC) to Prevent STIs (ICD -10) 02/27/2012  7610  R139NCD  11/23/2011  Screening for Depression in Adults  12/27/2011  7637  R138NCD  11/23/2011  Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse  12/27/2011  7633  R137NCD  11/23/2011  Intensive Behavioral Therapy for Cardiovascular Disease  12/27/2011  7636  R135NCD  09/22/2011  Magnetic Resonance Imaging (MRI) in Medicare Beneficiaries with FDA -Approved Implanted Permanent Pacemakers (PMs) for Use in and MRI Environment  09/26/2011  7441  R134NCD  08/26/2011  Magnetic Resonance Imaging (MRI) in Medicare Beneficiaries with FDA -Approved Implanted Permanent Pacemakers (PMs) for Use in and MRI Environment  Rescinded and replaced by Transmittal 135  09/26/2011  7441  R132NCD  03/04/2011  Magnetic Resonance Imaging (MRI) in Medicare Beneficiaries with Implanted Permanent Pacemakers (PMs) or Implantable Cardioverter Defibrillators (ICDs)  04/04/2011  7296  R131NCD  02/23/2011  Screening for the Human Immunodeficiency Virus (HIV) Infection  07/06/2010  6786  R130NCD  01/14/2011  Home Oxygen
(Medicare National Coverage Determinations Manual)
7296  R131NCD  02/23/2011  Screening for the Human Immunodeficiency Virus (HIV) Infection  07/06/2010  6786  R130NCD  01/14/2011  Home Oxygen Use to Treat Cluster Headache (CH)  02/15/2011  7235  R126NCD  09/30/2010  Counseling to Prevent Tobacco Use  01/03/2011  7133  R124NCD  09/24/2010  Positron Emission Tomography (FDG PET) for Initial Treatment Strategy (PI) in Solid Tumors and Myeloma  10/25/2010  7148  R123NCD  07/09/2010  Magnetic Resonance Angiography (MRA)  08/09/2010  7040  R122NCD  06/04/2010  Dermal Injection for Treatment of Facial Lipodystrophy Syndrome (LDS)  07/06/2010  6953  R120NCD  05/06/2010  FDG PET for Solid Tumors and Myeloma  10/30/2009  6632  R119NCD  03/26/2010  Positron Emission Tomography (NaF -18) to Identify Bone Mestastasis of Cancer  07/06/2010  6861  R118NCD  03/23/2010  Screening for the Human Immunodeficiency Virus (HIV) Infection  Rescinded and replaced by Transmittal 131  07/06/2010  6786  R113NCD  02/19/2010  Screening for the Human Immunodeficiency Virus (HIV) Infection -  Rescinded and replaced by Transmittal 118  07/06/2010  6786  R110NCD  12/18/2009  Positron Emission Tomography (PET) (FDG) for Cervical Cancer  01/04/2010  6753  R109NCD  12/04/2009  Positron Emission Tomography (PET) (FDG) for Cervical Cancer -  Rescinded and replaced by Transmittal 110  01/04/2010  6753  R108NCD  10/16/2009  FDG PET for Solid Tumors and Myeloma  Rescinded and replaced by Transmittal 120  10/30/2009  6632  R107NCD  10/16/2009  Magnetic Resonance Imaging (MRI)  01/04/2010  6672  R106NCD  09/18/2009  FDG PET for Solid Tumors and Myeloma - Rescinded and replaced