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
09-16-2020 | A-07-17-01176 | Complete Report | Report in BriefWhy OIG Did This Audit
This audit involved individuals eligible for Medicare who were covered under traditional Medicare in one year but chose to enroll in Medicare Advantage (MA) the following year (transferred enrollees). The Centers for Medicare & Medicaid Services (CMS) maps certain diagnosis codes into Hierarchical Condition Categories (HCCs). For transferred enrollees who, while covered under traditional Medicare, receive a diagnosis that maps to an HCC, CMS makes higher payments to MA organizations for the following year.
Through data mining and discussions with medical professionals, we have identified several diagnosis codes that were at high risk of being miscoded and resulting in inaccurate payments. For this audit, we focused only on selected acute stroke diagnosis codes (which map to the Ischemic or Unspecified Stroke HCC) that were reported on one physician's claim without being reported on a corresponding inpatient claim.
Our objective was to determine whether selected acute stroke diagnosis codes submitted by physicians under traditional Medicare that CMS later used to make payments to MA organizations on behalf of transferred enrollees complied with Federal requirements.How OIG Did This Audit
We reviewed 582 of 8,437 transferred enrollees (that we selected with a stratified random sample) who received one instance of a high-risk acute stroke diagnosis code during 2014 or 2015. We had reviews performed to determine whether the medical records supported the submitted diagnosis codes. We relied on these reviews as the basis for our conclusions.What OIG Found
Almost all of the selected acute stroke diagnosis codes that physicians submitted to CMS under traditional Medicare and that CMS later used to make payments to MA organizations for 2015 or 2016 on behalf of the 582 transferred enrollees did not comply with Federal requirements. For 580 of the transferred enrollees, the medical records did not support the acute stroke diagnosis codes. Thus, the Ischemic or Unspecified Stroke HCCs were not validated.
These errors originated from physicians submitting incorrect acute stroke diagnosis codes on claims billed under traditional Medicare. However, these errors were unnoticed and caused inaccurate payments in MA because CMS did not have policies and procedures to (1) identify beneficiaries who transferred from traditional Medicare to MA, and (2) evaluate whether the acute stroke diagnosis codes submitted under traditional Medicare on their behalf complied with Federal requirements. As a result, we estimated that CMS made inaccurate payments of just over $14.4 million to MA organizations.What OIG Recommends and CMS Comments
We recommend that CMS (1) educate physicians on how to correctly submit acute stroke diagnosis codes and how these diagnosis codes may impact the MA program, and (2) develop and implement policies and procedures to identify beneficiaries transferring from traditional Medicare to MA and evaluate whether the acute stroke diagnosis codes submitted under traditional Medicare comply with Federal requirements.
CMS concurred with our recommendations and described actions that it had taken or planned to take to address them. Specifically, CMS stated that it would continue to educate physicians on how to correctly submit acute stroke diagnosis codes, including updated information on how these codes may impact the MA program. CMS also stated that although our findings account for less than 0.5 percent of all transferred enrollees, it would review its existing policies and procedures to evaluate whether any further clarification is needed with regards to acute stroke diagnoses.
Filed under: Centers for Medicare and Medicaid Services
Billions in estimated risk-adjusted payments supported solely though HRA’s raise concerns about the completeness of payment data, validity of diagnoses on HRA’s and quality of care coordination for beneficiaries.
OIG findings highlight concerns about the extent to which MAOs are using HRAs to improve care and health outcomes, as intended, and about the sufficiency of the oversight by the Centers for Medicare & Medicaid Services (CMS).
From an analysis of 2016 MA encounter data, the OIG found that:
Diagnoses that MAOs reported only on HRAs, and on no other encounter records, resulted in an estimated $2.6 billion in risk-adjusted payments for 2017.
In-home HRAs generated 80 percent of these estimated payments. Most in-home HRAs were conducted by companies that partner with or are hired by MAOs to conduct these assessments—and therefore are not likely conducted by the beneficiary’s own primary care provider.
Twenty MAOs generated millions in payments from in-home HRAs for beneficiaries for whom there was not a single record of any other service being provided in 2016.
Read the full report here
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By Jeff Overley
Law360 (August 5, 2020, 9:39 PM EDT) -- Cigna Corp. overbilled Medicare Advantage by more than $1.4 billion by persuading nurses to diagnose policyholders with exaggerated medical problems, according to a newly unsealed suit that joins a growing list of False Claims Act cases targeting Medicare Advantage insurers. The whistleblower suit made public Tuesday in New York federal court alleges that from 2012 to 2017 a company division called Cigna-HealthSpring billed for medical conditions that "did not exist, were not recorded in any medical records and were not based on any clinically reliable information." Whistleblower Robert A. Cutler, an employee of Cigna contractor Texas Health Management LLC, filed the complaint under seal in 2017. Whistleblower complaints under the FCA are usually unsealed only after the U.S. Department of Justice has announced whether it will intervene in the case. An order in February from U.S. District Judge Kenneth Karas said that the DOJ had declined to intervene in some of the allegations and would not intervene for the time being in the remaining allegations. The same order called for the complaint to be unsealed in April, but it only hit the docket on Tuesday for reasons that were not immediately clear. Law360 on Wednesday afternoon asked DOJ representatives at the U.S. Attorney's Office in Manhattan to clarify whether the government would be intervening. Within 40 minutes, the entire case docket was again placed under seal on Pacer. A DOJ representative late Wednesday declined to comment on the status of intervention or the resealing of the case. In a short statement Wednesday, Cigna also didn't say whether the federal government had decided to join the case. "We are proud of our industry-leading Medicare Advantage program and the manner in which we conduct our business," the company said. "We will actively defend Cigna against unjustified allegations." Cutler, who represented himself when filing the case, didn't immediately respond to an email and voicemail seeking comment on Wednesday. Cutler's complaint focuses primarily on Cigna's arrangements with contractors that sent nurse practitioners to patient homes for health screenings. "On numerous occasions, THM managers made clear to executives at Cigna-HealthSpring" that nurses couldn't definitively diagnose serious conditions, but Cigna went ahead and billed Medicare Advantage as if the assessments were "confirmed medical diagnoses," the complaint alleges, referring to Texas Health Management. Cutler's suit describes one instance of billing codes being added for dementia and chronic obstructive pulmonary disease even though a nurse practitioner reported that a patient's mental and respiratory functions were normal. In another section, the suit describes Cigna training contractors to diagnose rheumatoid arthritis based solely on fatigue, weight loss and certain symptoms of pain and stiffness. The government was "unaware that these claims were false and fraudulent," and it "overpaid Cigna-HealthSpring by more than $1.4 billion," the complaint said of claims submitted over the five-year period. Cigna paid $3.8 billion in 2012 to acquire HealthSpring Inc., which at the time had 340,000 Medicare Advantage enrollees. There are 22 million enrollees nationwide among all Medicare Advantage insurers, and Cigna is a relatively small player in the space, according to the Kaiser Family Foundation. Medicare Advantage insurers are paid more than $200 billion annually, and FCA litigation against them by the DOJ is a relatively new phenomenon. The DOJ joined two whistleblower cases in 2017 against UnitedHealth Group Inc., which has defeated one of those cases and trimmed allegations in the other one. More recently, the DOJ in March hit Anthem Inc. with allegations of Medicare Advantage fraud. All the cases involve allegations that insurers overstated the severity of illnesses to get more money from the government. Cigna noted in its most recent annual report that the DOJ "is conducting an industrywide investigation of Medicare Advantage" billing by insurance companies. Cigna added that it was "currently responding to ... civil investigative demands received from the ... U.S. Attorney's Offices for the Eastern District of Pennsylvania and the Southern District of New York." Counsel information for the government and Cigna were not immediately available. The case is U.S. ex. rel. Cutler v. Cigna Corp. et al., case number 7:17-cv-07515, in the U.S. District Court for the Southern District of New York. --Editing by Jill Coffey.
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