This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
3/9/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Health Care Providers ,
Hospitals ,
Manufacturers ,
Medical Devices ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Self-Referral ,
Stark Law
In late January 2023, the Centers for Medicare and Medicaid Services (CMS) issued two updates relevant to provider and supplier organizations enrolled in Medicare: (1) a redesign to the Provider Enrollment, Chain and...more
The US Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) seeking comments on the creation of a national directory of healthcare providers and services that would become a “centralized...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
10/7/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Biotechnology ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Shared Savings Program ,
Nurses ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency ,
Technology ,
Telehealth ,
TRICARE
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more
9/1/2022
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Long Term Care Facilities ,
Medicare ,
OIG ,
Payment Systems ,
Section 1557 ,
Skilled Nursing Facility
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
8/8/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Roe v Wade ,
Skilled Nursing Facility
This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more
6/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Information Technology ,
Inpatient Prospective Payment System (IPPS) ,
Medical Devices ,
Nursing Homes ,
OIG ,
Payment Systems ,
Physicians ,
Regulatory Agenda ,
Skilled Nursing Facility ,
Telehealth ,
Telemedicine
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 November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the...more
The COVID-19 global health crisis has accelerated the demand for improved, economically viable and more robust delivery of healthcare services around the world. In years past, healthcare systems and operators, as well as...more
The Centers for Medicare and Medicaid Services (CMS) has started phasing out certain program flexibilities granted during the COVID-19 public health emergency. Beginning in October 2021, CMS will resume several provider and...more
In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more
11/18/2020
/ AdvaMed ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
Inspector General ,
Manufacturing Facilities ,
Medical Devices ,
New Guidance ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Risk Factors ,
Speaker Programs
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/14/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/13/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/7/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
HPE New York brings together preeminent healthcare private equity executives and investment bankers and unmatched keynote speakers to your remote workspace in a cutting-edge format – unlike any other conference this...more
10/6/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
The Centers for Medicare and Medicaid Services (CMS) issued blanket waivers under Section 1135 of the Social Security Act (Section 1135 waivers) on April 30, 2020. Fast on the heels of a more modest waiver announcement on...more
5/7/2020
/ 1135 Waivers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospice ,
Long Term Care Facilities ,
OCR ,
Public Health Emergency ,
Relief Measures ,
Telehealth ,
Telemedicine
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...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
The updated waivers build upon the more limited set of Section 1135 waivers issued on March 13, 2020, and address common concerns among Medicare providers and suppliers as they deal with the Coronavirus (COVID-19) pandemic....more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Physicians ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
Accelerated or advance Medicare payments can provide some cash flow as providers and suppliers combat the effects of the Coronavirus (COVID-19) pandemic. This program requires a one-page application and funds may be available...more
The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more
3/11/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part D ,
Physicians ,
Provider Payments
To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more
11/13/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Healthcare Reform ,
Incentives ,
Patients ,
Physicians ,
Proposed Rules ,
Regulatory Burden ,
Reimbursements ,
Safe Harbors ,
Self-Referral ,
Stark Law ,
Value-Based Care ,
Webinars
On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more