RISE summarizes recent regulatory news.
CMS suspends prior authorization requirements for certain spine and knee devices
In a rule published Tuesday in the Federal Register, the Centers for Medicare & Medicaid Services (CMS) announced it has suspended prior authorization requirements for select orthopedic devices prescribed under urgent or special circumstances. Providers often must obtain authorization from an insurer before a patient can receive a necessary test, device, or medical procedure. CMS said that it would suspend the requirement when the two-day expedited review would delay care or risk the health or life of the Medicare member if a procedure is urgently needed that involves spine and knee braces. However, prior authorization will continue for these devices when provided under circumstances not covered by the latest update, as well as for all other items on the required prior authorization list. Updates to prior authorization initiatives can be found here. Lawmakers are pushing for bipartisan legislation that would streamline the Medicare Advantage (MA) prior authorization process in the wake of reports that MA organizations sometimes delayed or denied MA members’ access to services even when the requests met Medicare coverage rules.
HHS action paves way for emergency use authorization for monkey pox vaccine
A week after declaring monkey pox a public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra has issued a determination under Section 564 of the Food, Drug Cosmetic Act that circumstances justify emergency use authorization of monkeypox vaccines.
“Last week, I declared monkeypox to be a public health emergency to unlock additional tools that will help us contain and end this outbreak and to signal to the American people that we are taking our response to the next level,” Becerra said in the announcement. “Today’s action will allow FDA to exercise additional authorities that may increase availability of vaccines to prevent monkeypox while continuing to ensure the vaccine meets high standards for safety, effectiveness, and manufacturing quality.”
HHS said that to date it has made more than 1.1 million doses of the JYNNEOS vaccine available to order and, so far, has shipped more than 620,000 doses. HHS also has made the smallpox ACAM2000 and smallpox treatment TPOXX available for states and other jurisdictions to order.
NC women convicted in $34M health care fraud scam
A federal jury has convicted a North Carolina woman for her role in a scheme to defraud several private health insurers by submitting more than $34 million in false and fraudulent claims for physical therapy services that were never actually provided. According to court documents and evidence presented at trial, Jaroslava Ruiz, 50, of Chapel Hill, paid kickbacks and bribes to patient recruiters and patients with private insurance in exchange for allowing four Miami physical therapy clinics to bill for medical services that weren’t provided to those patients. Ruiz and her co-conspirators falsified medical records to give the impression that the physical therapy services were medically necessary, prescribed by a doctor, and actually rendered. However, none of the services had been provided. Ruiz and her co-conspirators submitted approximately $34.6 million in false and fraudulent claims to several private insurers for those nonexistent physical therapy services, of which the insurers paid approximately $7.7 million.
Ruiz was convicted of one count of conspiracy to commit health care fraud and wire fraud, and nine counts of health care fraud. She faces up to 20 years in prison on the conspiracy count, and up to 10 years in prison on each health care fraud count. Sentencing is scheduled for Oct. 26.
Feds release a national tool to measure health impacts of environmental burdens
The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR), in partnership with the Department of Health and Human Services’ Office of Environmental Justice, has released the Environmental Justice Index (EJI) to help public health officials map areas most at risk for the health impacts of environmental burden.
It is the first national, geographic-driven tool designed to measure the cumulative impacts of environmental burden through the lenses of human health and health equity. Cumulative impacts are the total harm to human health that occurs from the combination of environmental burden such as pollution and poor environmental conditions, pre-existing health conditions, and social factors.
“Addressing environmental injustice is critical to advancing health equity,” CDC Director Rochelle P. Walensky, M.D., MPH, said in the announcement. “While everyone is at some risk from the health impacts of environmental hazards, the communities that are most affected are often those that are already experiencing health inequities. CDC is taking action to address the adverse health effects associated with environmental injustice by identifying those most at risk with tools like the Environmental Justice Index.”
The EJI was created to help public health officials and communities identify and map communities most at risk for facing the health impacts of environmental hazards. Social factors, such as poverty, race, and ethnicity, along with pre-existing health conditions, may increase these impacts.
The EJI can help public health officials, policymakers, and communities identify and respond to the unique environmental and social factors that affect a community’s health and well-being by:
- Identifying areas that may require special attention or additional resources to improve health and health equity
- Educating and informing the public about their community
- Analyzing the unique, local factors driving cumulative impacts on health to inform policy and decision-making
- Establishing meaningful goals and measure progress towards environmental justice and health equity