Trending in Telehealth is a series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies,...more
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
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 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 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
On July 23, 2021, the Centers for Medicare & Medicaid Services (CMS) published its annual proposed changes to the Medicare Physician Fee Schedule (MPFS), which include several key telehealth and other virtual care-related...more
Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more
4/19/2021
/ Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Enforcement Actions ,
Health Care Providers ,
Health Technology ,
Healthcare Facilities ,
Hospitals ,
Patients ,
Physicians ,
Public Health Emergency ,
Regulatory Oversight ,
Risk Mitigation ,
Telehealth ,
Telemedicine ,
Waivers ,
Webinars
In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through...more
12/9/2020
/ Coronavirus/COVID-19 ,
Countermeasures ,
Department of Health and Human Services (HHS) ,
Fourth Amendment ,
Health Care Providers ,
Immunity ,
Licenses ,
Medical Licensure Compact ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
State and Local Government ,
Telehealth
In 2017, the New Jersey legislature passed the New Jersey Telehealth and Telemedicine Act (codified at N.J.S.A. 45:1-61 et seq.), which established registration and reporting requirements for “telemedicine and telehealth...more
Telemedicine guidance continues at a rapid pace at both the federal and state levels. To keep you in the know, our Digital Health team has joined forces with Larry W. Hansard of Arthur J. Gallagher Risk Management Services,...more
The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical...more
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
2/6/2019
/ ACOs ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Health Record Incentives ,
Enforcement Actions ,
Health Care Providers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
OIG ,
Popular ,
Regulatory Reform ,
Request For Information ,
Telehealth ,
Telemedicine
Introduction -
The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation...more
1/29/2019
/ Biometric Information ,
Biometric Information Privacy Act ,
California Consumer Privacy Act (CCPA) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Personally Identifiable Information ,
State Data Breach Notification Statutes ,
UK
On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on...more
The Centers for Medicare and Medicaid Services (CMS) recently posted revisions to the Voluntary Self-Referral Disclosure Protocol (SRDP). In an attempt to streamline the self-disclosure process, CMS requires the use of new...more
In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication...more
On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law (the Proposed Rule). 80 Fed. Reg. 41,686,...more
7/28/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
FQHC ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
Patient Referrals ,
Physician Compensation Arrangements ,
Physician-Owned Hospitals ,
Physicians ,
Proposed Regulation ,
Rural Health Care Providers ,
Stark Law
On April 27, 2015, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Cornell Prescription Pharmacy (CPP) pursuant to which CPP paid a $125,000...more
7/8/2015
/ Change Management ,
Compliance ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
OCR ,
Pharmacies ,
Physicians ,
Policies and Procedures ,
Risk Management ,
Security Risk Assessments