On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more
On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more
2/3/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
New Regulations ,
Proposed Rules ,
Regulatory Requirements ,
Reporting Requirements
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
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
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
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 August 4, 2022, the US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM or proposed rule) to reinterpret section 1557 of the Affordable Care Act (ACA), which prohibits...more
8/5/2022
/ ADEA ,
Affordable Care Act ,
Americans with Disabilities Act (ADA) ,
Bostock v Clayton County Georgia ,
Children's Health Insurance Program (CHIP) ,
Civil Rights Act ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Enforcement ,
Final Rules ,
Limited English Proficiency (LEP) ,
Medicare Part A ,
Medicare Part B ,
Non-Discrimination Rules ,
Notice of Proposed Rulemaking (NOPR) ,
PACE ,
Proposed Rules ,
Rehabilitation Act ,
Reproductive Healthcare Issues ,
Title VI
One day before an updated rule of the US Department of Health and Human Services regarding Section 1557 of the Patient Protection and Affordable Care Act took effect, the US District Court for the Eastern District of New York...more