The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...more
5/11/2023
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Public Health Emergency ,
Rulemaking Process ,
SAMHSA ,
Substance Abuse ,
Telehealth ,
Telemedicine
On February 24, 2023, the US Drug Enforcement Administration (DEA) issued two proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule) that would establish...more
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
The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more
8/4/2022
/ AdvaMed ,
Advisory Opinions ,
Anti-Kickback Statute ,
Continuing Education ,
Fair Market Value ,
Global Code of Ethics ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
OIG ,
PHRMA ,
Third-Party
Stay current on the healthcare enforcement issues impacting your business’ compliance strategies. In this installment of the Healthcare Enforcement Roundup, we address:
• Key areas of enforcement scrutiny in 2021,...more
4/2/2021
/ 1135 Waivers ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Orders ,
False Claims Act (FCA) ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Regulatory Oversight ,
Revocation ,
Telehealth ,
Telemedicine
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
Government officials and hospital, medical and dental associations have issued guidance and statements regarding whether to continue performing elective surgeries in light of the Coronavirus (COVID-19) pandemic. Some...more
On February 26, 2020, the US Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM), which proposes waiving the requirement of a separate DEA registration at each principal place of business or...more
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law
On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more
10/1/2019
/ Affiliates ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Document Retention Policies ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Opt-Outs ,
Physicians ,
Public Comment ,
Reporting Requirements
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more
8/16/2019
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Certification Requirements ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Fees ,
Health Care Providers ,
Medicare ,
Physician Fee Schedule ,
Physicians ,
Proposed Amendments ,
Proposed Rules ,
Public Comment ,
Self-Referral ,
Stark Law