On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more
1/14/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Prescription Drugs ,
Telehealth ,
Telemedicine ,
Time Extensions
On April 26, 2024, almost a year after issuing a notice of proposed rulemaking to modify the Privacy Rule, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized the HIPAA Privacy Rule to...more
6/19/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Popular ,
Reproductive Healthcare Issues
On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (HHS-OCR) revised its controversial December 2022 bulletin (the December 2022 Bulletin) regarding the use of tracking technologies by...more
3/28/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Enforcement Priorities ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Tracking Systems ,
Web Tracking ,
Websites
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
5/19/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
NPRM ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
Under the Affordable Care Act, group health plans and health insurance issuers are required to provide health insurance coverage based on recommendations made by healthcare coverage professionals. The covered categories...more
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
8/5/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Funding ,
Medicaid ,
Medicaid Drug Rebate Program ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of...more
On October 1, 2021, Nevada became the latest of a small but growing number of states extending regulatory oversight of healthcare transactions involving physician practices. Over the past decade, several states have passed or...more
10/5/2021
/ Acquisitions ,
Attorney General ,
Department of Health and Human Services (HHS) ,
Filing Requirements ,
Health Care Providers ,
Hospitals ,
Joint Venture ,
Mergers ,
Notification Requirements ,
Physicians ,
Regulatory Oversight ,
Reporting Requirements
On December 27, 2020, former President Trump signed the Consolidated Appropriations Act, 2021 (H.R. 133) (the “Consolidated Appropriations Act”), an appropriations and stimulus package that includes changes to the Public...more
The U.S. Department of Health & Human Services, Centers for Medicare and Medicaid Services’ Hospitals Without Walls Program (the “Program”) may be more crucial to helping hospitals handle the latest surge in COVID-19 cases...more
The U.S. Department of Health and Human Services (HHS) announced last week that, on Thursday, October 5, it would begin to accept applications for an additional $20 billion in funding to reimburse providers for...more
As discussed in Goodwin’s prior Client Alert, on April 10, 2020, the U.S. Department of Health and Human Services (HHS) began disbursing $30 billion to Medicare providers and suppliers under the Public Health and Social...more
On Friday, April 10, 2020, the U.S. Department of Health and Human Services (HHS) announced it will begin disbursing $30 billion of the $100 billion of the Public Health and Social Services Emergency Fund recently allocated...more
4/14/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Fee-for-Service ,
Financial Stimulus ,
Health Care Providers ,
Healthcare Facilities ,
Medicare ,
Public Health ,
Reimbursements ,
Relief Measures