(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.   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   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) 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  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