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.
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.
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.
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.
The Centers for Medicare & Medicaid Services (“CMS”) Innovation Center (“CMMI”) recently announced a new model for health care providers in rural areas to receive payment from the federal government. The Community Health Access and Rural Transformation (“CHART”) initiative aims to improve rural health care while promoting the Trump Administration’s push to shift health care providers into a more expansive value-based payment model.
Recent regulatory waivers and rule changes by the Centers for Medicare and Medicaid Services (“CMS”) have resulted in a notable increase in patients seen remotely, according to two recent studies. The studies suggest that CMS regulatory waivers and rule changes, which included expanded access to COVID-19 testing and telehealth services in response to challenges faced by health care providers and patients during the COVID-19 pandemic, have increased remote delivery of mental health care and highly specialized clinical practices like plastic surgery.
The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.
COVID-19 was an unexpected pandemic that hit the United States, causing Centers for Medicare and Medicaid Services (“CMS”) to rush to make accommodations for the states. States administer their Medicaid programs following a state plan and under the regulation of federal rules. With approval, states are allowed to amend their state plan and apply for waivers to improve the effectiveness of their Medicaid program. During COVID-19, the Trump Administration made available for states to apply for 1115 waivers, creating a new section labeling 1115(a), the 1135 waiver, and Appendix K to amend 1915(c) waivers for national emergencies. As of May 2020, CMS reported over 200 approved waivers across multiple states.
According to the Centers for Disease Control (“CDC”), older adults and people with severe underlying medical conditions are at higher risk for developing more serious complications from the COVID-19 illness. For this reason, among others, long-term care facilities have been hit particularly hard by the virus. Although it was difficult to be prepared for this pandemic, there are concerns that many long-term care facilities did not have proper preventative measures in place in even before COVID-19 became an issue. Because of this, long-term care facilities have become hot spots for the viruses spread. As states and the federal government continue to monitor long-term care facilities’ compliance with local and federal laws, regulatory agencies are now also faced with added pressure to not only slow the spread of COVID-19 within the facilities, but also to control the legal environment in the anticipated aftermath of the outbreak.
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.