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
On February 16, 2024, the Alabama Supreme Court issued a significant and controversial ruling that gave personhood status to unimplanted human embryos—a decision with considerable implications for in vitro fertilization...more
The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more
9/15/2023
/ Children's Health Insurance Program (CHIP) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
PHSA ,
Prescription Drugs ,
Proposed Legislation ,
Reporting Requirements ,
Section 340B ,
Shipping
On April 17, 2023, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking to modify the Standards for Privacy for Individually Identifiable...more
8/11/2023
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
EMTALA ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HITECH Act ,
NPRM ,
OCR ,
PHI ,
Reproductive Healthcare Issues ,
Subpoenas ,
Warrants
With the passage of SB-184 (the “Bill”), California — like Maine, New York, and several other states — has addressed “pervasive” mergers and acquisitions across the healthcare industry by requiring prior notice to regulators...more
6/22/2023
/ Acquisitions ,
Ambulatory Surgery Centers ,
Confidential Information ,
Corporate Practice of Medicine ,
Disclosure Requirements ,
Health Insurance ,
Hospital Mergers ,
Hospitals ,
Merger Reviews ,
Mergers ,
New Legislation ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Regulatory Approval
Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced...more
3/24/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
Laws on abortion vary from state to state, and may affect fertility services, selective-reduction procedures, and genetic testing. In providing services, clinics and physicians will need to navigate a patchwork of...more
The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more
11/17/2022
/ Controlled Substances Act ,
Corporate Practice of Medicine ,
DEA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Clinics ,
Informed Consent ,
Licensing Rules ,
Mental Health ,
Mental Illness ,
Prescription Drugs ,
Public Health Emergency ,
Regulatory Requirements ,
Telehealth
Millions of women use reproductive health applications (or “apps”) to track menstrual cycles, ovulation, and pregnancy. These apps provide women that use the rhythm method for birth control and women seeking to become...more
7/19/2022
/ Abortion ,
Business Associates ,
Covered Entities ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Mobile Apps ,
OCR ,
PHI ,
Reproductive Healthcare Issues ,
Sensitive Personal Information ,
State Privacy Laws ,
Technology Sector
Can human reproductive tissue (“HRT”) held by a fertility clinic serve as collateral for a loan to (or investment in) the fertility clinic? In short, the scope and extent of governmental regulation addressing the sale of or...more
7/15/2022
/ Article 9 ,
Collateral ,
Consideration ,
Healthcare Facilities ,
Organ Donation ,
Organ Transplant Centers ,
Perfected Security Interest ,
Reproductive Healthcare Issues ,
Secured Debt ,
State and Local Government ,
Uniform Commercial Code (UCC)
On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional...more
The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated...more
2/23/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Medicare ,
Medicare Beneficiaries ,
Mental Health ,
Physicians ,
Public Health Emergency ,
Reimbursements ,
Telehealth ,
Telemedicine
Laboratory tests play a critical part of the healthcare system. Ordering and billing for these tests, however, is not always cut-and-dry. Compliance with federal laws and rules (like the Clinical Laboratory Improvement...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
The Department of Justice (“DOJ”) has reported that in 2020, the government prosecuted dozens of laboratory owners and operators for anti-kickback related offenses responsible for hundreds of millions in alleged federal...more
8/16/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Laboratories ,
Medicare ,
Medicare Advantage ,
Medicare Part B ,
OIG
Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more
8/13/2021
/ Co-payments ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medical Supplies ,
Medicare ,
Settlement Agreements
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