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 31, 2024, the Washington My Health My Data Act (MHMDA), a comprehensive consumer health privacy law, will come into force. Small businesses – defined as those processing consumer health data of fewer than 100,000...more
3/29/2024
/ Advertising ,
Consent ,
Consumer Privacy Rights ,
Data Privacy ,
Exemptions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Notice Requirements ,
Patient Privacy Rights ,
Personal Data ,
PHI ,
Popular ,
Small Business ,
State Privacy Laws ,
Wellness Programs
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 May 3, 2022, the New York Legislature passed legislation to regulate certain “material transactions” involving healthcare providers and others who provide administrative or management services to other healthcare...more
5/22/2023
/ Acquisitions ,
Affiliated-Business Arrangements ,
Corporate Practice of Medicine ,
Covered Transactions ,
FOIA ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Mergers ,
New Legislation ,
Notice Requirements ,
Physicians ,
State Health Departments
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
The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those...more
On March 28, 2023, the Maine Legislature proposed legislation that would prohibit certain “health care entities,” including medical and other professional practices, licensed health care facilities, and providers of...more
New York Gov. Kathy Hochul’s Executive Budget Proposal for FY 2023-2024 includes a proposal to require Department of Health (DOH) approval of certain mergers, acquisitions, and other significant transactions involving medical...more
3/30/2023
/ Acquisitions ,
Corporate Practice of Medicine ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Mergers ,
Physician Hospital Organizations ,
Physician-Owned Hospitals ,
Private Equity ,
Proposed Legislation ,
Regulatory Oversight ,
State Budgets ,
State Health Departments
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
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more
2/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
State and Local Government ,
Telehealth ,
Telemedicine ,
Waivers
Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations.
The metaverse uses technologies such as...more
1/27/2023
/ Artificial Intelligence ,
Blockchain ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Corporate Practice of Medicine ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Licensing Rules ,
Life Sciences ,
Metaverse ,
Popular ,
Regulatory Requirements ,
Regulatory Standards ,
Telehealth ,
Telemedicine ,
Virtual Reality
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
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
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
8/10/2022
/ Civil Monetary Penalty ,
Drug Pricing ,
Enforcement ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Secretary of HHS
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
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 U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
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
The final rules regarding special compensation under 42 U.S.C. § 1395nn, the Physician Self-Referral or Stark Law, go into effect on January 1, 2022 and will require many physician group practices to modify their compensation...more
The Department of Justice recently announced the launch of its new Civil Cyber-Fraud Initiative (the “Initiative”) which intends to use the False Claims Act to pursue “cybersecurity-related fraud by government contractors and...more
12/7/2021
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Department of Justice (DOJ) ,
Due Diligence ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Incident Response Plans ,
PHI ,
Popular ,
Privacy Laws ,
Risk Assessment
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
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
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...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