On April 21, 2025, the National Institutes of Health (NIH) issued a notice regarding its policy to require all US grant recipients to certify that:
1. They do not, and will not during the term of receiving funds from the...more
On March 24, 2025, the governor of Virginia signed into law Senate Bill 754, which amends the Virginia Consumer Protection Act (VCPA) to restrict the collection, use, sale, or sharing of personally identifiable reproductive...more
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
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
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
Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more
1/29/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Priorities ,
Medicaid ,
Medicare ,
Patient Safety ,
Prescription Drugs ,
Quality Assurance Programs ,
Regulatory Agenda ,
Skilled Nursing Facility ,
Trump Administration
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
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more
1/6/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Health Care Providers ,
Life Sciences ,
New Regulations ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Telehealth ,
Telemedicine
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
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