The indictment, arrest, and arraignment of Ruthia He, the founder, CEO, and clinical president of Done Global (Done), and David Brody, clinical president of Done and the sole shareholder of Done Health, P.C. (PC) in...more
As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more
1/26/2024
/ Artificial Intelligence ,
Cybersecurity ,
Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Information Blocking Rules ,
Mental Health ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Request For Information ,
SAMHSA ,
Substance Abuse ,
Transparency
As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur...more
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances...more
3/6/2023
/ Comment Period ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Regulation ,
Proposed Rules ,
Public Health Emergency ,
Telehealth ,
Telemedicine
The COVID-19 Public Health Emergency (PHE), which was originally declared nearly three years ago, has been renewed through April 2023. As we’ve previously covered, the PHE allowed federal and state regulators to relax certain...more
1/12/2023
/ American Hospital Association ,
American Telemedicine Association ,
Coronavirus/COVID-19 ,
DEA ,
Hospice ,
Medicare Beneficiaries ,
Mental Health ,
Public Health Emergency ,
Rural Health Care Providers ,
Ryan Haight Act ,
Telehealth
As we covered in a prior Telehealth Update, many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (the...more
9/2/2022
/ Consolidated Appropriations Act (CAA) ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
Pending Legislation ,
Public Health Emergency ,
Rural Health Care Providers ,
Telehealth ,
Waivers
On June 24, 2022, the Supreme Court of the United States ruled on Dobbs v. Jackson Women’s Health Organization. This ruling overturned Roe v. Wade, which held that women had a fundamental right to an abortion. Since the Dobbs...more
7/26/2022
/ Abortion ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
Employer Group Health Plans ,
Executive Orders ,
NDAA ,
PHI ,
Roe v Wade ,
SCOTUS ,
Stafford Act
As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled...more
Last week saw a lot of great news in the world of telehealth. On March 15, President Biden signed into law H.R. 2471, the “Consolidated Appropriations Act, 2022”, which extends many of the Medicare telehealth flexibilities...more
3/23/2022
/ Appropriations Bill ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
FQHC ,
Joe Biden ,
Medicare ,
Mental Health ,
OIG ,
Public Health Emergency ,
Rural Health Care Providers ,
Telehealth
On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers...more
2/11/2022
/ Controlled Substances Act ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medicare ,
Patients ,
Physicians ,
Proposed Legislation ,
Public Health Emergency ,
Secretary of HHS ,
Telehealth
Last week, CMS announced its final Physician Fee Schedule Payment Policies (the “Final Rule”), which will become effective January 1, 2022. The Final Rule included several updates to Medicare coverage of telehealth services,...more
As previously covered, over the past year the telehealth landscape has been a patchwork of temporary waivers and regulations, expanding access during the COVID-19 pandemic but leaving providers and patients uncertain about...more
As we’ve discussed in previous posts, since the beginning of the pandemic, telehealth providers have seen a dramatic increase in demand for their services along with a number of temporary regulatory measures aimed at...more
As we’re all painfully aware, public health issues dominated 2020 and with the country’s attention focused on COVID-19 testing, status, transmission and care, HIPAA went mainstream. Health information became critical not only...more
On August 4, CMS posted a proposed rule on CY 2021 Payment Policies, which included important updates about the expansion of Medicare covered telehealth services due to the COVID-19 pandemic. This follows on the heels of...more
8/6/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Public Health Emergency ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
Last Thursday, the Massachusetts Board of Registration in Medicine (BORIM) approved its first permanent telehealth policy. The Board’s policy provides that: (1) a “face-to-face encounter" is not a pre-requisite for a...more
Earlier this month, we wrote about what the future of telehealth might look like in a post-COVID-19 world. In that post, we referenced comments made by CMS Administrator Seema Verma, in which she voiced her support for...more
During a live virtual event yesterday with STAT News, CMS Administrator Seema Verma expressed support for permanently expanding access to telehealth services after the COVID-19 public health emergency resolves. As we...more
6/11/2020
/ 1135 Waivers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Governor Baker ,
Health Care Providers ,
IRS ,
Professional License ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine
Last week, the Centers for Medicare and Medicaid Services (CMS) announced additional waivers of limitations on Medicare reimbursement of telehealth services and updated its summary of COVID-19 blanket waivers. We’ve...more
As we’ve previously discussed on the blog, telehealth is playing a critical role in delivering care during the COVID-19 pandemic. Both Congress and states continue to take action to expand the use and reimbursement of...more
On Monday, the Chairman of the Federal Communications Commission (FCC), Ajit Pai, circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
FCC ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Interstate Telecommunications Service Providers (ITSP) ,
Medicare ,
OCR ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
Telehealth is going to play a critical role in the delivery of care in the coming weeks and months as health care providers respond to the COVID-19 pandemic. As the CDC and other public health agencies continue to recommend...more
As the decade winds down, it’s hard to believe that the HIPAA Privacy and Security Rules are almost twenty years old. It has been ten years since the U.S. Department of Health and Human Services (HHS) Office for Civil Rights...more
12/24/2019
/ Business Associates ,
California Consumer Privacy Act (CCPA) ,
Civil Monetary Penalty ,
Covered Entities ,
Data Breach ,
Data Security ,
Enforcement Actions ,
FBI ,
General Data Protection Regulation (GDPR) ,
Government Investigations ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Phishing Scams ,
Ransomware
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
Earlier this month, the Department of Health and Human Services Office of the Inspector General (OIG) issued an advisory opinion (Advisory Opinion No. 19-03) (Opinion) concluding that a program consisting of free, in-home...more