Last week, Texas Attorney General Ken Paxton filed a complaint in federal district court against HHS and the Office for Civil Rights (OCR) challenging a recently issued rule strengthening protection of protected health...more
Earlier this week, the Biden-Harris Administration, through the Office for Civil Rights (OCR) announced a Final Rule aimed at protecting protected health information (PHI) related to lawfully provided reproductive health care...more
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...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
On October 10, 2023, the Drug Enforcement Administration (DEA) published another temporary rule extending the COVID-era telemedicine flexibilities that allow physicians and other prescribers to prescribe controlled substances...more
10/25/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Mental Health ,
Patients ,
Pharmacies ,
Public Health Emergency ,
Ryan Haight Act ,
Shareholders ,
Telehealth ,
Telemedicine
A new Florida law will require certain Florida-licensed providers to ensure that patient information is physically maintained only in the continental United States and its territories or in Canada. Florida SB 264, which goes...more
6/21/2023
/ American Health Care Act (AHCA) ,
CEHRT ,
Data Security ,
Data Storage ,
Disclosure Requirements ,
Electronic Protected Health Information (ePHI) ,
Florida ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare Advantage ,
PHI ,
Privacy Laws
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
Covered Entities and Business Associates should promptly and carefully review their use of online tracking technologies on their websites and mobile apps following a bulletin (Bulletin) published by the U.S. Department of...more
12/8/2022
/ Class Action ,
Compliance ,
Data Collection ,
Dobbs v. Jackson Women’s Health Organization ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Apps ,
OCR ,
PHI ,
Reproductive Healthcare Issues ,
Risk Assessment ,
Websites
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 we’ve previously covered, the COVID-19 pandemic has brought about a major increase in the prevalence of telehealth services, due in large part to regulatory flexibilities at the federal and state levels. Beginning in...more
As previously discussed, many of the telehealth flexibilities in place during the COVID-19 pandemic are set to expire at the end of the federal Public Health Emergency (PHE), unless federal and state legislators act to make...more
On April 28, the Massachusetts Public Health Council (“PHC”) approved final proposed amendments to the clinic licensure regulations. The initial revisions presented by the Department of Public Health (the “Department”) in...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
In the waning days of the Trump administration, the Office for Civil Rights (“OCR”) announced a number of new initiatives, including proposed HIPAA amendments, and a very recent COVID-19 related Notice of Enforcement...more
As COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. The Public Health...more
Last week, CMS announced the finalized End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model), which will test whether incentivizing home dialysis and kidney transplantation will reduce Medicare expenditures while...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
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