(Medicare National Coverage Determinations Manual)

B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Effective for dates of service on or after March 2, 2006, the Centers for Medicare & Medicaid Services has determined that there is sufficient evidence to conclude that the use of Nesiritide for the treatment of CHF is not reasonable and necessary for Medi care beneficiaries in any setting.   D. Other   Effective for dates of service on or after March 2, 2006, this determination applies only to the treatment of CHF and does not change Medicare Administrative Contractor (MAC) discretion to cover other off -label uses of Nesiritide or use consistent with the  current FDA indication for intravenous treatment of patients with acutely decompensated CHF who have dyspnea at rest or with minimal activity.   200.2 - Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases  (Effective September 10, 2007)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma are characterized by airflow limitation that may be partially or completely reversible.  Pharmacologic treatment with bronchodilators is used to prevent and/or control daily symptoms that may cause disability for persons with these diseases.  These medications  are intended to improve the movement of air into and from the lungs by relaxing and dilating the bronchial passageways.  Beta adrenergic agonists are a commonly prescribed class of bronchodilator drug.  They can be administered via nebulizer, metered dose inhaler, orally, or dry powdered inhaler.   Nebulized beta adrenergic agonist with racemic albuterol has been used for many years.  More recently, levalbuterol, the (R) enantiomer of racemic albuterol, has been used in some patient populations.  There are concerns regarding the appropriate use of ne bulized beta adrenergic agonist therapy for lung disease.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   N/A  D. Other   After examining the available medical evidence, the Centers for Medicare & Medicaid Services determines that no national coverage determination is appropriate at this time.  Section 1862(a)(1)(A) of the Social Security Act decisions should be made by local  MACs through a local coverage determination process or case- by-case adjudication.  See Heckler v. Ringer , 466 U.S. 602, 617 (1984) (Recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudi cation.).  See also, 68 Fed. Reg. 63692, 63693 (November 7, 2003).  200.3 - Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (AD)  (Rev.: 11692, Issued:11- 09-22, Effective: 04 -07-22, Implementation: 12- 12-22)  A. General   Alzheimers disease (AD) is a currently irreversible brain disorder that progressively degrades memory, cognitive function, and ability to carry out tasks of daily living. AD is the number one cause of dementia in older Americans.   Antiamyloid -beta monoclonal antibodies (antiamyloid mAbs) are laboratory- made proteins designed to bind a specific substance in the body, with the goal of marking it for destruction by the bodys immune system.  Scientists design various mAbs as treatments  with the goal of targeting and neutralizing or clearing infections (like the COVID -19 virus), cancer cells, and in the case of AD, amyloid accumulation in the brain.   B. Nationally Covered Indications   Effective April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) covers Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of AD when furnished in accordance with Section B under coverage with evidence development (CED) for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD.   Coverage Criteria:   1)    Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as reasonably likely to predict clinical be nefit may be covered in a randomized controlled trial conducted under an investigational new drug (IND) application.   2)    Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit may be covered in CMS -approved prospective comparative studies.  Study data for CMS -approved prospective comparative studies may be collected in a registry.   3)    For CMS -approved studies, the protocol, including the analysis plan, must include:  a. A study population whose diversity of patients are representative of the national population with MCI due to AD or mild AD dementia. b. A neurocognitive evaluation and a description of the instruments used to assess cognition and function for the clinical diagnosis of MCI due to AD or mild AD dementia for study enrollment and outcomes assessment. c. A description of:  i. The multidisciplinary dementia team and optimal medical management.  ii. Study sites with clinical expertise and infrastructure to provide treatments consistent with the safety monitoring outlined in the FDA -approved label.  4)    CMS -approved studies of a monoclonal antibody directed against amyloid (antiamyloid mAb) approved by the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit must address all of the questions below:  a. Does the antiamyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?   b. Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, depend on characteristics of patients, treating clinicians, and settings?  c. How do the benefits and harms change over time?  5)   CMS -approved studies must adhere to the following standards of scientific integrity that have been identified by the Agency for Healthcare Research and Quality (AHRQ):  a. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.  b. The rationale for the study is well supported by available scientific and medical evidence.  c. The study results are not anticipated to unjustifiably duplicate existing knowledge.  d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination (NCD).  e. The study is sponsored by an organization or individual capable of completing it successfully. f. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the FDA, it is also in compliance with 21 C FR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual disposition of the collected data.  g. All aspects of the study are conducted according to appropriate standards of scientific integrity.  h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.  i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR 312.81(a) and the pati ent has no other viable treatment options.  j. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the AHRQ Registry of Patient Regis tries (RoPR).  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 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for prima ry and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessible manner; either in a peer -reviewed scientific journal (in print or on- line), in an on- line publicly accessible registry dedi cated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).  l. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service 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 in 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 study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.  The principal investigator must submit the complete trial protocol, cite where the detailed analysis plan for the CMS CED questions occurs in the protocol, and provide a statement addressing how the study satisfies each of the standards of scientific integ rity (a. through m. listed above), as well as the investigators contact information, to the email address below.  The information will be reviewed, and approved trials will be identified on the CMS Website.  The Email address for protocol submissions is:  clinicalstudynotification@cms.hhs.gov. The Email subject line should be: "CED Monoclonal Antibodies for the Treatment of Alzheimers Disease [name of sponsor/primary investigator]"   Monoclonal antibodies directed against amyloid indicated for the treatment of AD are  covered when furnished according to the FDA  approved indication in National Institutes of  Health (NIH) -supported trials.  For any CMS -approved study, or NIH -supported trial, that includes a beta amyloid positron emission tomography (PET) scan as part of the protocol, it has been determined that these trials or studies also meet the CED requirements included in the Beta Amyloid PET in Dementia and Neurodegenerative Disease NCD (220.6.20).   C.     Nationally Non -Covered Indications   Monoclonal antibodies directed against amyloid for the treatment of AD provided outside of an FDA -approved randomized controlled trial, CMS -approved studies, or studies supported by the NIH, are nationally non- covered.   D.   Other   N/A.   (This NCD last reviewed April 2022.)   210 - Prevention  (Rev. 1, 10- 03-03)  210.1 - Prostate Cancer Screening Tests  (Rev. 48, Issued:  03- 17-06; Effective/Implementation Dates:  06 -19-06) CIM 50 -55  Covered   A. General   Section 4103 of the Balanced Budget Act of 1997 provides for coverage of certain prostate cancer screening tests subject to certain coverage, frequency, and payment limitations.  Medicare will cover prostate cancer screening tests/procedures for the early detection of prostate cancer.  Coverage of prostate cancer screening tests includes the following procedures furnished to an individual for the early detection of prostate cancer:    Screening digital rectal examination; and   Screening prostate specific antigen blood test.  B. Screening Digital Rectal Examinations   Screening digital rectal examinations are covered at a frequency of once every 12 months for men who have attained age 50 (at least 11 months have passed following the month in which the last Medicare -covered screening digital rectal examination was perfor med).  Screening digital rectal examination means a clinical examination of an individuals prostate for nodules or other abnormalities of the prostate.  This screening must be performed by a doctor of medicine or osteopathy (as defined in 1861(r)(1)  of the Act), or by a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (as defined in 1861(aa) and 1861(gg)  of the Act) who is authorized under State law to perform the examination, fully knowledgeable about the beneficiarys medical condition, and would be responsible for using the results of any examination performed in the overall management of the beneficiarys specific medical problem.   C. Screening Prostate Specific Antigen Tests