Over the past two months, the second Trump administration has shifted federal policies and priorities regarding abortion, in vitro fertilization (IVF), contraception, and other reproductive-health-related matters – and it is...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more
1/27/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
OIG ,
Regulatory Reform ,
Stark Law
Medicare reimbursement for hospital outpatient services has come under attack in recent years, with a focus on “site neutral” payment policies that would pay hospitals for outpatient services furnished in off-campus locations...more
On September 24, 2024, the Office of Inspector General (OIG) at the US Department of Health and Human Services issued a report recommending additional oversight of remote physiologic monitoring (RPM) services furnished to...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
5/29/2024
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Enforcement ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare Advantage ,
Medicare Fraud ,
Medicare Part D ,
Non-Compete Agreements ,
Nursing Homes ,
OCR ,
OIG ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Sentencing ,
Settlement ,
Telemedicine
The US Centers for Medicare & Medicaid Services (CMS) finalized important changes to the Medicare enrollment regulations applicable to hospices and home health agencies (HHAs), including increasing the level of screening that...more
On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important changes for Medicare providers...more
The US Centers for Medicare & Medicaid Services (CMS) finalized important changes to the Medicare provider and supplier enrollment regulations, including adding marriage and family therapists (MFTs) and mental health...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
11/15/2023
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Collection ,
Durable Medical Equipment ,
Final Rules ,
Food and Drug Administration (FDA) ,
FQHC ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Medical Billing Codes ,
Medical Devices ,
Medical Monitoring ,
Medicare ,
Mental Health ,
Payment Systems ,
Physician Fee Schedule ,
Public Health Emergency ,
Reimbursements
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
9/1/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
OIG ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Reimbursements ,
Settlement
Following an implementation delay during the COVID-19 public health emergency (PHE), on August 1, 2023, the Centers for Medicare and Medicaid Services (CMS) initiated Medicare hospital claims edits that will return certain...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more
7/31/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Telehealth ,
Telemedicine
Over the past several years, the Centers for Medicare and Medicaid Services (CMS) has expanded payment for care management and remote monitoring services in an effort to recognize and pay for non-face-to-face services that...more
7/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Beneficiaries ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Telehealth
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more
5/24/2023
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Antitrust Division ,
Class Action ,
Covered Entities ,
Drug Pricing ,
Medicare ,
Motion to Dismiss ,
Oral Argument ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more
4/28/2023
/ Banking Sector ,
Controlled Substances ,
DEA ,
Digital Health ,
Financial Crisis ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Silicon Valley ,
State and Local Government ,
Telehealth ,
Telemedicine
On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The...more
In the last few months, the US Centers for Medicare & Medicaid Services (CMS) has made several noteworthy changes and provided a material clarification for providers and suppliers who are subject to the federal physician...more
On February 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how Medicare disproportionate share hospital (DSH) payments are calculated with respect to the counting of...more
A recent multijurisdictional contractor advisory committee (CAC) meeting held by six of the seven Medicare Administrative Contractors (MACs) gave stakeholders an initial opportunity to provide feedback on the strength of...more
3/6/2023
/ Comment Period ,
Deadlines ,
Health Care Providers ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Physicians ,
Stakeholder Engagement ,
Subject Matter Experts (SMEs) ,
Technology Sector ,
Telehealth ,
Telemedicine
The Centers for Medicare and Medicaid Services (CMS) has revised its policy guidance on the coverage and payment for interprofessional consultations under Medicaid and the Children’s Health Insurance Program (CHIP)....more
Six of the seven Medicare Administrative Contractors (MACs) are scheduled to jointly host a multijurisdictional contractor advisory committee (CAC) meeting on February 28, 2023. This CAC panel meeting will allow the MACs to...more
On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...more
1/4/2023
/ Controlled Substances ,
Criminal Investigations ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medicare ,
OIG ,
Prescription Drugs ,
Telehealth ,
Telemarketing ,
Telemedicine
Rural emergency hospitals (REHs) are a new provider type that will allow Medicare to pay for emergency department and other outpatient hospital services in rural areas beginning on January 1, 2023, without requiring the...more
11/29/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Emergency Rooms ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Services ,
Provider Payments ,
Rural Areas ,
Rural Health Care Providers ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more
11/15/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
Medicare Part D ,
OIG ,
Regulatory Agenda
On November 1, 2022, the US Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2023 final rule for services reimbursed under the Medicare Physician Fee Schedule (MPFS) (the Final Rule). The Final...more