On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more
6/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Gender Identity ,
Government Agencies ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
Reporting Requirements ,
Trump Administration
On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more
5/30/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Gender Identity ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
Regulatory Requirements ,
Reporting Requirements ,
Trump Administration
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2025, including long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability Act...more
4/1/2025
/ Anti-Kickback Statute ,
Controlled Substances ,
Criminal Prosecution ,
Executive Orders ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
OIG ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Freeze ,
Telehealth ,
Telemedicine ,
Trump Administration
The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more
3/12/2025
/ Anti-Kickback Statute ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medical Billing Codes ,
Medicare ,
Nursing Homes ,
OIG ,
Popular ,
Regulatory Requirements ,
Skilled Nursing Facility
On March 5, 2025, the Center for Clinical Standards and Quality (CCSQ) within the Centers for Medicare & Medicaid Services (CMS) released a Quality & Safety Special Alert Memo for hospitals related to President Trump’s...more
Beginning in the first quarter of 2025, California healthcare service plans, health insurers, Medi-Cal managed care plans, and PACE organizations must ensure that staff who have direct enrollee contact receive evidence-based...more
1/20/2025
/ California ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Legislative Agendas ,
Medicaid ,
New Legislation ,
PACE ,
Regulatory Requirements ,
Training ,
Transgender
In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more
1/20/2025
/ Algorithms ,
Artificial Intelligence ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Technology ,
Healthcare ,
Machine Learning ,
New Regulations ,
Regulatory Requirements ,
Section 1557
On December 5, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a “Dear Colleague” letter reiterating obligations that covered entities have under the May 2024 final rule related...more
On the issue of gender-affirming care, how would a Harris-Walz administration affect clients in your practice?
Bottom line: A Harris-Walz administration would likely provide health plans and health plan sponsors with...more
10/22/2024
/ Affordable Care Act ,
Donald Trump ,
Employee Benefits ,
Employer Group Health Plans ,
Employer Liability Issues ,
Employment Policies ,
Gender Equity ,
Health Insurance ,
Healthcare ,
Kamala Harris ,
LGBTQ ,
Political Campaigns ,
Political Candidates ,
Presidential Elections ,
Proposed Legislation ,
Proposed Regulation ,
Sex Discrimination ,
Telemedicine
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
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
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
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
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/26/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Nursing Home Reform Act (FNHRA) ,
Global Code of Ethics ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Regulatory Agenda
The Centers for Medicare and Medicaid Services (CMS) published an interim final rule with comment period (IFR) on November 5, 2021, that implements the Biden administration’s previously announced vaccine mandate for...more