Steptoe & Johnson Health Care

FDA Announces Plan to Speed Up Public Notification About Potentially High-Risk Device Recalls The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health recently announced a pilot program aimed at improving public notice about potentially high-risk medical device recalls. The pilot seeks to reduce the time between the FDA’s initial awareness and public notification of corrective actions taken for high-risk recalls. These actions may include a company’s removal of the product from the market, product corrections, or updates to product use instructions. The pilot program will provide early alerts of company actions related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices.

CMS Finalizes Changes to the Medicare Parts A and B Overpayment Rule The Centers for Medicare & Medicaid Services (CMS) recently finalized three notable changes to the Medicare Parts A and B Overpayment Rule. First, the definition of "knowing" and "knowingly" in the regulation now aligns with the Federal False Claims Act standard. Second, CMS updated the regulation to provide that if overpayments are suspected, the deadline for reporting and returning the overpayment can be suspended for up to 180 days to allow for a good-faith investigation. This change in timing will be welcomed by providers. Finally, CMS emphasized that the obligation to investigate potential overpayments is a fact-specific inquiry.

Health and Human Services Inspector General Issues Nursing Facility Compliance Guidance The Office of Inspector General (OIG) recently released new compliance guidelines for nursing facilities titled, “Nursing Facility Industry Segment-Specific Compliance Program Guidance” (ICPG). While primarily relevant to owners and operators of nursing facilities, its content may be of relevance to hospitals that provide Medicare services. Like other OIG compliance issuances, the Nursing Facility ICPG is a guidebook of best practices and is voluntary. The guidance covers three areas in detail: quality of care and quality of life, Medicare and Medicaid billing requirements, and the federal Anti-Kickback Statute. Other topics include the Stark Law, HIPAA, civil rights laws, and related party transactions.

CY 2025 Physician Fee Schedule Contains New Physical, Occupational Therapy Rule The Physician Fee Schedule final rule for 2025 contains a reduced supervision requirement for physical and occupational therapy assistants. The new rule requires general supervision of assistants instead of direct supervision. Thus, therapists will no longer need to by physically present while care is administered, instead the supervising therapists must be immediately reachable by telephone, via video or in person. The Centers for Medicare and Medicaid Services (CMS) anticipates that the change, “could help health systems and other providers manage patient volume, advance people through stages of care more quickly and reduce Medicare spending.” The health care consulting firm Dobson & DaVanzo estimates the rule “will save $242 million over 10 years.”

Ambulatory Surgical Centers and Outpatient Hospital Facilities Will Get 2.9% Medicare Increase Next Year The Centers for Medicare and Medicaid Services' (CMS) recently issued final rule will give outpatient hospital facilities and ambulatory surgical centers a 2.9% (3.4% market basket, less 0.5 percentage points for multifactor productivity) Medicare reimbursement increase in 2025. The payment increase is estimated to result “in an additional $2.2 billion in Outpatient Prospective Payment System (OPPS) payments for hospitals compared to 2024,” CMS said in a press release. The final rule also contains new conditions of participation related to obstetrical services, including new staffing requirements.

Participants Ask for Extension of ACO REACH Model After Savings Shown Participants in the Accountable Care Organization Realizing Equity, Access and Community Health (ACO REACH) Model have asked for an extension after the model produced substantial cost savings. In a recent report, The Centers for Medicare and Medicaid Services (CMS) stated that the model generated $1.6 billion in gross savings and $695 million in net savings in 2023. It also reported that 73% of the model’s participants earned net savings. Despite the good results, the agency has yet to announce whether ACO REACH will continue past its scheduled expiration in 2026. Read the report here: https://lnkd.in/eK-vGpkq

DOJ to Block UnitedHealth Group’s Purchase of Amedisys The U.S. Department of Justice (DOJ) and the attorneys general of Maryland, New Jersey, Illinois, and New York recently filed an anti-trust lawsuit in Maryland federal court, seeking to block UnitedHealth Group’s $3.3 billion purchase of Amedisys Inc. The complaint raises concerns that the acquisition “would harm competition in the market for home health services,” and that it could lead to higher prices in 23 states and Washington D.C. The DOJ stated that “eliminating the competition between UnitedHealth and Amedisys would harm patients who receive home health and hospice services, insurers who contract for home health services, and nurses who provide home health and hospice services.”

Federal Judge Approves Class-Action Settlement Between Ascension and its Employees Over COVID-19 Vaccine Mandates Federal judge, Jane M. Beckering, recently approved a class-action settlement between Ascension and a group of approximately 100 employees in order to resolve claims that its workers were denied religious exemptions to the company’s COVID-19 vaccination requirements. Under the settlement agreement, Ascension will offer the plaintiffs up to five weeks’ pay, reflective of the time many spent suspended from work.

Hospice Provider to Close Some Locations The home care and hospice provider, Enhabit, recently reported plans to close or consolidate several of its locations due to "financial challenges caused in part by a recent home health rule from” Centers for Medicare & Medicaid Services (CMS). Enhabit, “which is lowering its guidance for full-year 2024 net service revenue, said its primary focus now is to grow cash flow and pay down debt.” Recently, CMS “announced three final rules, one of which will increase payments for home health and dialysis providers.” However, many providers feel that the rates aren’t keeping up with costs.

California Scholarship Initiative Seeks to Address the Shortfall in Mental Health Care A bill recently passed in the California Senate and awaiting the Governor’s signature aims to create an annual scholarship fund that would cover tuition for students pursuing a career in mental health care. The bill comes as part of an effort to address existing staff shortages in the industry. The primary condition of the scholarship would require applicants to spend three years working in California’s Community Assistance Recovery and Empowerment (CARE) Court Program. The program allows patients with untreated mental illness or substance abuse disorders, or their family, friends, or providers, to petition their county court for assistance in connecting them with needed rehabilitation resources and housing. The bill faces some criticism amidst concerns that the CARE Program will draw experienced mental health care providers away from existing programs or facilities. Read more: https://lnkd.in/e9RGCbiB