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It has taken CMS more than 50 years, but the agency has finally proposed a regulatory definition for determining whether an item or service is "reasonable and necessary" for Medicare coverage purposes. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary," 85 Fed. Reg. 54327 (Proposed Rule, September 1, 2020). This move comes in response to the President's October 3, 2019 Executive Order 13890 directing the Secretary of HHS to ensure that Medicare beneficiaries have access to new cures and technologies that improve health outcomes. While CMS simultaneously seeks to establish a Medicare coverage pathway for medical devices designated as breakthrough by the FDA in this proposed rule, the proposed regulatory definition, including a possible consideration of whether an item or service is covered in the commercial insurance market, marks some progress toward clarifying when Medicare coverage is available. Comments to the proposed rule must be received by November 2, 2020."Reasonable and Necessary" (1) safe and effective;(2) not experimental or investigational; and(3) appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it isfurnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;furnished in a setting appropriate to the patient's medical needs and condition;ordered and furnished by qualified personnel;one that meets, but does not exceed, the patient's medical need; andat least as beneficial as an existing and available medically appropriate alternative. The sources of data that could be used to implement this policy;The most appropriate source(s) for these coverage policies and best way to determine which commercial plan(s) it would rely on for Medicare coverage;Whether beneficiaries, providers, innovators, or others wishing to gain coverage for an item or service demonstrate that the item or service is covered by at least one commercial insurance plan policy. If they can provide CMS with evidence of commercial coverage or if CMS or its MACs identify such coverage from its review of compilations of health insurance offerings or data from other sources, CMS would consider factor (3) to be satisfied;Whether CMS should limit its consideration of commercial plan offerings or covered lives to a subset of the commercial market in the interest of simplicity, including looking at geographic subsets, subsets based on number of enrollees, subsets based on plan type (HMO, PPO, etc.), or other subsets of plans – including utilizing a singular plan; andWhether CMS should adopt the most or least restrictive coverage policy since commercial plans may impose certain restrictions on an item or service (related to clinical criteria, disease stage, or number and frequency of treatment). Key Takeaways
The 2021 ICD-10-CM files below contain information on the ICD-10-CM updates for FY 2021. These 2021 ICD-10-CM codes are to be used for discharges occurring from October 1, 2020 through September 30, 2021 and for patient encounters occurring from October 1, 2020 through September 30, 2021.
2021 Coding Guidelines (PDF)
2021 POA Exempt Codes (ZIP)
2021 Code Descriptions in Tabular Order (ZIP)
2021 Addendum (ZIP)
2021 Code Tables and Index (ZIP)
2021 Conversion Table (ZIP)
Overview of Changes
The final update includes hundreds of new ICD-10-CM codes including (but not limited to):128 additions to Chapter 19: Injury, poisoning and certain other consequences of external causes for adverse effects and poisoning by fentanyl and tramadol as well as other synthetic narcotics.125 additions to Chapter 20: External causes of morbidity, including more specific codes for collisions involving electric scooters and other nonmotor vehicle accidents.57 musculoskeletal codes, including several in category M24.- (other specific joint derangements) for other articular cartilage disorders, disorders of ligament, pathological dislocation, recurrent dislocation, contracture, and ankylosis.21 codes to describe withdrawal from substances including alcohol, cocaine, and opioids.18 detailed codes for sickle cell anemia. New codes such as D57.213 (sickle-cell/Hb-C disease with cerebral vascular involvement) and D57.431 (sickle-cell thalassemia beta zero with acute chest syndrome) specify complications related to the condition.Three codes to capture stage 3 chronic kidney disease (CKD) in two new sub-stages. The new Chapter 22: Codes for Special Purposes (U00-U85) so far includes just two codes: U07.0 (vaping-related disorder) and U07.1 (COVID-19), which took effect in the early part of this year.The final update deletes code Q51.20 (other doubling of uterus, unspecified) and all codes within subcategory T40.4X- (poisoning by adverse effect of and underdosing of other synthetic narcotics), without code replacements.Visit ERM365 to learn more