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
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
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
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 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
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
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
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
5/26/2022
/ 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 & Medicaid Services (CMS) recently published detailed databases summarizing changes of ownership of Medicare-enrolled hospitals and skilled nursing facilities (SNFs). The databases currently include...more
4/28/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
Hospitals ,
Long Term Care Facilities ,
Nursing Homes ,
Payment Systems ,
Proposed Rules ,
Rate Parity Agreement ,
Skilled Nursing Facility ,
Transparency ,
Value-Based Purchasing
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
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
The Centers for Medicare and Medicaid Services (CMS) notified state survey agency directors that it has lifted previously imposed hospital survey suspensions and resumed routine hospital reaccreditation and recertification...more
Since the early stages of the Coronavirus (COVID-19) pandemic, long term care facilities (LTCFs) have been an epicenter of transmission. Medicare Requirements for Participation for LTCFs include an obligation to establish and...more
6/9/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
Quality Control Plan ,
Re-Opening Guidelines ,
Safety and Oversight Group (QSO) ,
Surveys
As previously reported, President Trump’s Opening Up America plans introduce measures to slowly ease business and social restrictions and require enhanced testing and reporting of Coronavirus (COVID-19) incidences in long...more
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