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
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
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
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
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
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
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
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
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
5/27/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Co-payments ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Manufacturers ,
Medicaid Drug Rebate Program ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stark Law
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
On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s...more
3/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health and Safety ,
Health Care Providers ,
Healthcare Reform ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
Regulatory Oversight ,
Skilled Nursing Facility
As we continue our three-part webinar series, McDermott’s litigation and healthcare lawyers will focus on how payors can actively prepare for possible enforcement and litigation stemming from recent and potential changes to...more
4/29/2021
/ Affordable Care Act ,
Anti-Discrimination Policies ,
Commercial Litigation ,
Continuing Legal Education ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Payor Contracts ,
Reimbursements ,
Rulemaking Process ,
Section 1557 ,
Webinars
In this installment of the Healthcare Enforcement Roundup we cover new and longstanding issues impacting the healthcare enforcement landscape. First, we explore the impact of the Coronavirus (COVID-19) on the healthcare...more
7/27/2020
/ 1135 Waivers ,
Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
e ,
False Claims Act (FCA) ,
Guidance Update ,
Health Care Providers ,
Hospitals ,
Objective Falsity ,
Physicians ,
Split of Authority ,
Stark Law ,
Whistleblowers
Long-term care facilities, including nursing homes, (collectively, LTCF) have been a hot spot for the transmission of the novel coronavirus disease (COVID-19). In an effort to balance quality, transparency and infection...more
On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Quality, Safety and Oversight Group (QSO) memorandum (QSO-20-26-NH) informing long term care facilities, including nursing homes, about certain...more
On March 30, 2020, CMS issued updates to its prior QSO memorandum, expanding its infection control and prevention guidance to include hospitals, critical access hospitals and psychiatric hospitals. The updated QSO memorandum...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medicare ,
Mental Health ,
OCR ,
Psychiatric Hospitals ,
Public Access Laws ,
Public Health ,
Quarantine ,
Relief Measures ,
Telemedicine ,
Waivers
On March 30, 2020, CMS issued updates to its March 9, 2020, memo from the Quality Safety and Oversight (QSO) Group on controlling and preventing the spread of Coronavirus (COVID-19) in dialysis facilities and other...more
4/1/2020
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Dialysis Providers ,
Emergency Response ,
Health Care Providers ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Nursing Homes ,
Risk Management ,
State of Emergency