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
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
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
8/1/2024
/ AIDS ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HIV ,
Hospitals ,
Medicare ,
Medicare Part B ,
MIPS ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
Stark Law
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
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
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
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
5/9/2024
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Disability Discrimination ,
Final Rules ,
Gender Discrimination ,
Gender Identity ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare Part B ,
New Regulations ,
Non-Discrimination Rules ,
Race Discrimination ,
Section 1557 ,
Sexual Orientation Discrimination
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
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
2/23/2024
/ Coronavirus/COVID-19 ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Healthcare ,
Hospitals ,
Long Term Care Facilities ,
OCR ,
Patients ,
Policies and Procedures ,
Regulatory Requirements
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
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
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
12/11/2023
/ Business Ownership ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Investment ,
Investors ,
Mortgage REITS ,
Private Equity ,
Skilled Nursing Facility
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
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
12/4/2023
/ Affordable Care Act ,
Debt ,
Debt Collection ,
Enforcement Actions ,
Financial Regulatory Reform ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Illinois ,
Medical Debt ,
New Legislation ,
New Regulations ,
No Surprises Act (NSA) ,
Patients ,
Uninsured Patients
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
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
10/23/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
OIG ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
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
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
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
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
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
3/31/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Data Reporting ,
Disclosure Requirements ,
Medicare ,
New Rules ,
Nursing Homes ,
REIT ,
Reporting Requirements ,
Skilled Nursing Facility ,
Transparency
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
2/8/2023
/ Anti-Kickback Statute ,
Audits ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Fraud ,
Health Care Violations ,
Medicaid ,
Medical Devices ,
OIG ,
Regulatory Agenda
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
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
2/1/2023
/ Affordable Care Act ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Certifications ,
Critical Access Hospitals ,
Health Care Providers ,
Hospitals ,
Mental Health ,
Patients ,
Proposed Rules ,
The Joint Commission
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