Tag:CMS
Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?
As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.
President Biden’s COVID-19 Data-Driven Executive Order to Promote Health Equity
President Joe Biden has issued a number of Executive Orders, many of which address the ongoing COVID-19 public health emergency. On January 21, 2021, President Biden released another pillar of his Administration’s long-term plan to direct the United States out of the throes of the pandemic. The twelfth Executive Order titled, “Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats” orders the Department of Health and Human Services (“HHS”) Secretary Alex Azar to conduct a nationwide review of the interoperability of public health data systems in an effort to enhance the collection, sharing, analysis, and collaboration of de-identified patient data.
Hospitals Across the Country at Serious Risk for Coordinated Ransomware Attacks
The Federal Bureau of Investigation (“FBI”), the Department of Health and Human Services (“HHS”), and the Department of Homeland Security Cybersecurity and Infrastructure Security Agency (“CISA”) recently announced that hackers have been and will continue to target the United States hospitals and health-care providers. These attacks are cyber in nature and often lead to ransomware attacks, data left, and inevitable disruption of health care services when patient information is locked until the ransom can be paid.
Nursing Home Staff Turnover Rates Partially Explains Disproportionate Number of Deaths during COVID-19 Public Health Emergency
The COVID-19 pandemic has impacted residents and staff of nursing homes and long-term care facilities more than any other demographic, accounting for nearly 40 percent of the total mortality rate from the virus in the United States. According to Centers for Medicare & Medicaid Services (“CMS”), at least 132,000 residents and employees have died from complications of the COVID-19 across 31,000 facilities, although some estimates place the death count closer to 200,000. One factor aggravating the number of deaths in nursing homes is the extraordinarily high rate of staff turnover each year.
Improving Safety and Quality of Care in Poor-Performing Nursing Homes
The Centers for Medicare and Medicaid Services (CMS) manages an oversight program for nursing homes known as the Special Focus Facilities (SFF) program. Nursing homes that are placed in the program have almost double the deficiencies as other nursing homes, more serious issues in terms of injury and persistent problems that are never addressed. On October 21, 2022, CMS issued a press release regarding changes to its SFF program. The new changes will increase accountability for these facilities and encourage them to make quicker improvements. This action comes following the Biden-Harris Administration’s promise to increase safety and quality of care in poor-performing nursing homes.
Escobar’s Materiality Standard Shields Organizations from the Risk in Risk Adjustment Payments
Finance Director for UnitedHealth Group brought qui tam suit against UnitedHealth Group, Inc. alleging that the organization upcoded risk adjustment data resulting in increased payments (more than $1.14 billion) to UnitedHealth Group. The Department of Justice (DOJ) intervened in the case, yet UnitedHealth Group was successful in getting the primary False Claims Act Claims dismissed by arguing that the Centers for Medicare & Medicaid Services (CMS) would not have refused to make the adjustment payments had they known of the errors in the risk adjustment. The Escobar materiality standard helps clarify threshold level of risk to Managed Care Providers in attesting to their risk adjustment payments; the falsities must have had an impact on the respective payment.
CMS Issues Proposed Rule Addressing Multiple Fraud and Abuse Concerns
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 The Centers for Medicare and Medicaid Services (CMS) recently proposed a new rule in the Federal Register that addresses changes in Medicare payment policies. The proposed rule aims to inform providers of proper billing practices and prevent fraud and abuse. This post …
Read more
Medicare Advantage Audits Reveal Alleged Rampant Upcoding
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 Last month, the Center for Public Integrity obtained over three-dozen new Medicare Advantage (MA) audits through a lawsuit brought under the Freedom of Information Act. The audits indicate that overcharging is still a pervasive problem in the MA Program because Medicare Advantage …
Read more
The New Medicaid Managed Care Rule and Its Effects on Compliance Programs
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 The Centers for Medicare and Medicaid Services (CMS) recently published a new rule for state contracts with Medicaid Managed Care Organizations (MCO). Medicaid MCOs provide comprehensive services to beneficiaries for capitated payments. The effective date of the rule was July 5, 2016. …
Read more
An Active Summer of Healthcare Fraud Enforcement Actions
Alanna J. Kroeker Executive Editor Loyola University Chicago School of Law, JD 2017 Unprecedented DOJ Healthcare Fraud Takedown: On Wednesday June 22, Attorney General Loretta Lynch and Department of Health and Human Services (HHS) Secretary Sylvia Burwell announced the largest healthcare fraud takedown in history. This action was led by the Medicare Fraud Strike …
Read more