Regulatory roundup: US Court restricts access to abortion pill; CMS announces changes to ACO Reach for 2024; and more


Court restricts access to abortion pill, ruling on hold until Supreme Court weighs in

The U.S. Court of Appeals for the Fifth Circuit on Wednesday placed restrictions on mifepristone (Mifeprex) to the first seven weeks of pregnancy and blocked it from being distributed by mail, but the ruling will be on hold until the Supreme Court decides whether to hear the case.  

The three judges on the panel partially overturned a lower court’s order that would have nullified the Food and Drug Administration’s (FDA) approval of the drug in 2000 and its subsequent approval of its generic version. But it kept in place access limits on the abortion drug until the Supreme Court decides whether it wants to make the final determination on the case.

“This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016,” wrote Justice Jennifer Walker Elrod in the order. “The generic version of mifepristone will also be available under the same conditions as Mifeprex.”

The decision is the latest in the lawsuit brought by Alliance for Hippocratic Medicine against the FDA approval. In April, U.S. District Judge Matthew Kacsmaryk suspended approval of mifepristone. The Supreme Court temporarily blocked the ruling from going into effect and the case was sent back to the Fifth Circuit Court of Appeals.

In response to the latest Court of Appeals decision, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra said the ruling “undermines our nation’s entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA. This decision threatens Americans’ right to access the medications they need and, if it stands, would have a devastating impact on women’s health by restricting their access to reproductive health care.

“The most important thing to know is that mifepristone remains approved and available while we fight this decision in the courts. We remain confident the law is on our side, and we will continue to vigorously defend the FDA’s independent, science-based drug approval process, and Americans’ right to access the health care they need.” 

CMS announces changes to ACO Reach for 2024 

The Centers for Medicare & Medicaid Services (CMS) this week announced changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance year 2024 (PY2024). The modifications aim to improve the model test for participants by increasing predictability, protecting against inappropriate risk score growth and maintaining consistency across CMS programs and Center for Medicare and Medicaid Innovation models, and advancing health equity. The changes came as welcome news to the National Association of ACOs. In a statement, Clif Gaus, Sc.D., president and CEO, said that “these changes will satisfy many concerns and stabilize future participation. Additionally, we encourage CMS to explore adding features of REACH into a permanent track within the Medicare Shared Savings Program. Using MSSP as a chassis for innovation while infusing lessons learned from Innovation Center models into a permanent program is another path for stabilizing and growing participation in ACOs.”

National Quality Forum to join Joint Commission as an affiliate

The Joint Commission and National Quality Forum (NQF) announced Wednesday they will merge to share their expertise in measuring quality so the focus shifts away from competing measures to advancing key outcomes.

NQF will maintain its independence in developing and recommending quality measures. The affiliation will bolster The Joint Commission’s national and international accreditation and certification processes to be more evidence-based, data-driven, and outcomes-oriented.

Together, the groups will be able to provide fewer but more precise measures.

“Patients, payers, and provider organizations rely on NQF for measurement that focuses on what is most important to the people health care serves. Health care providers want to advance quality care, but all too often experience today’s measures as both burdensome and unrepresentative of what matters most in care delivery,” said Jonathan B. Perlin, M.D., Ph.D., MSHA, MACP, FACMI, president and CEO of The Joint Commission, in a statement. “No organization is more trusted than NQF to lead the consensus necessary across all stakeholders to get to the next generation of performance measures that creates safer, more equitable, higher-quality, and higher value health care.” 

CMS to offer assistance to Hawaii after wildfires

The Centers for Medicare & Medicaid Services (CMS) will provide additional resources and flexibilities in response to the public health emergency due to recent wildfires in the state of Hawaii so hospitals can continue to operate and provide access to care to those impacted by the wildfire. In addition to waivers, CMS has developed a toolkit with an inventory of Medicaid and Children’s Health Insurance Program flexibilities available, activated the Kidney Community Emergency Response program and End Stage Renal Disease Network 17 to help people obtain and maintain access to dialysis care, and it will waive requirements to enable people with Medicare to replace damaged or lost durable medical equipment, prosthetics, orthotics, and supplies.

HRSA announces $100M to grow the nursing workforce

The Health Resources and Services Administration (HRSA), an agency of HHS, has announced awards of more than $100 million to train more nurses and grow the nursing workforce. These investments will address the increasing demand for registered nurses, nurse practitioners, certified nurse midwives, and nurse faculty.

“Nurses are an essential part of our nation’s health care system,” said HHS Secretary Xavier Becerra. “Now more than ever, we need to double down on our investments in nurses who care for communities across the country.”

The awards will include $8.7 million to train licensed practical nurses and licensed vocational nurses to become registered nurses; $34.8 million to train nurses to increase the number of primary care nurse practitioners, clinical nurse specialists, and certified nurse midwives trained and prepared to provide primary care services, mental health and substance use disorder care, and/or maternal health care; $30 million to support comprehensive residency and fellowship training programs  to increase the number of trained advanced practice nurses in primary care; and $26.5 million for award recipient schools to provide low-interest and loan cancellation to incentivize careers as nursing school faculty.