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CDPH Proposes Detailed Changes to California Hospital Licensure Regulations

The California Department of Public Health (CDPH) proposed changes to regulations regarding general acute care hospital (GACH) licensing requirements related to clinical laboratory, dietetic, and pharmaceutical services....more

CMS Recommends That Hospitals Adopt Updated EMTALA Signage

The Centers for Medicare and Medicaid Services (CMS) recently announced the release of updated model signage for use by Medicare-participating hospitals to inform patients of their rights under the Emergency Medical Treatment...more

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

Special Report - FDA v. Alliance for Hippocratic Medicine: Conscience Rights Implications for Healthcare Providers

The Supreme Court of the United States’s (SCOTUS’s) unanimous decision in Food and Drug Administration v. Alliance for Hippocratic Medicine (FDA v. AHM) on June 13, 2024, articulated a much more absolute view of the...more

CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under...more

Nondiscrimination on the Basis of Disability

For the first time in nearly 50 years, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has finalized revisions to regulations implementing Section 504 of the Rehabilitation Act of 1973,...more

Ten Takeaways From Long-Awaited Section 1557 Nondiscrimination Protections

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the...more

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

Ensuring Nondiscrimination in Patient Visitations

Reflecting on lessons learned and complaints received during the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released detailed frequently asked questions (FAQs)...more

HHS Publishes New Rights of Conscience Final Rule

Several federal laws protect the “rights of conscience” of federally funded healthcare entities and healthcare providers and prohibit recipients of federal funds from requiring individuals to participate in actions that they...more

New Proposed Rules Aim to Enhance Healthcare Accessibility for People With Disabilities

The US Department of Health and Human Services (HHS) and the US Department of Justice (DOJ) recently published new proposed rules that update and create various requirements under Section 504 of the Rehabilitation Act of 1973...more

Private Equity and REITs, Take Note! CMS Finalizes Nursing Facility Ownership Disclosure Requirements

On November 17, 2023, the US Department of Health and Human Services (HHS) published a final rule requiring nursing facilities participating in Medicaid and skilled nursing facilities participating in Medicare to disclose...more

HHS Promotes Improved Accessibility To Department-Funded Activities for Individuals With Limited English Proficiency

On November 15, 2023, the US Department of Health and Human Services (HHS) released its updated Language Access Plan (Updated Plan) to further ensure that the limited English proficiency (LEP) community and individuals with...more

New Illinois Protections Against Patient Medical Debt May Also Help Reduce Hospital Bad Debt

Starting in mid-2024, Illinois hospitals will be required to take a much more active role in limiting consumers’ medical debt by screening all consenting uninsured patients for both public health insurance program coverage...more

OIG Pathology Lab: Don't Pay for Services You Don't Need

In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more

Healthcare Regulatory Check-up Newsletter | September 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA), the...more

Special Report - HHS Proposes to Update Disability Nondiscrimination Regulations for First Time in Nearly 50 Years

Discrimination on the basis of disability has contributed to significant disparities in healthcare and child welfare. To address these disparities, the US Department of Health and Human Services (HHS) has proposed updated...more

With New Facility Staffing Expectations, CMS Proposes Sea Change for Long-Term Care Industry

In February 2022, US President Joseph Biden announced an overhaul of regulations affecting nursing homes. These reforms, aimed at enhancing the safety and quality of care for nursing-home residents, focus on improving...more

New Illinois Laws Aim to Address Health Disparities

Since 2022, Illinois has enacted two laws that aim to meet federal requirements for promoting health equity and are pertinent to healthcare providers. Beginning in 2025, certain licensed healthcare providers in Illinois will...more

HHS Releases Ownership Data of Medicare-Certified Hospices and Home Health Agencies

On April 20, 2023, the US Department of Health and Human Services (HHS) made ownership data of all Medicare-certified hospices and home health agencies publicly available for the first time. This move is consistent with the...more

Biden Administration and CMS Propose New Rule to Provide Greater Transparency for Nursing Home Ownership

Following the Biden administration’s efforts to promote nursing home safety, transparency, accountability and quality, the US Centers for Medicare & Medicaid Services (CMS) announced a proposed rule governing nursing home...more

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more

Biden Administration Takes Steps to Reinforce Nursing Home Safeguards

In connection with the Biden-Harris administration’s stated goals of improving safety, transparency, accountability and quality in nursing homes, the US Centers for Medicare & Medicaid Services (CMS) have announced new...more

Health Equity Elevated to a Joint Commission National Patient Safety Goal

Starting July 1, 2023, The Joint Commission (TJC) will set health equity as a National Patient Safety Goal for certain TJC-accredited organizations and roll out a new Health Care Equity certification program to recognize and...more

HHS Continues to Refine COVID-19 Testing, Visitation Guidance for Long-Term Care Facilities

Nursing homes and long-term care facilities were hit hard by COVID-19. However, as of September 11, 2022, 87.3% of residents and 86.9% of staff have completed primary vaccination. Such adherence may have been instrumental in...more

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