On March 18, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released updated guidance to “increase clarity” for entities regulated by the Health Insurance Portability and Accountability...more
On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when...more
Funding Environment Toughest in 40 Years -
The consensus of the four members of a panel on funding and financing healthcare is that the environment is tougher than they experienced in the wake of the 2008 financial crisis....more
9/27/2023
/ Artificial Intelligence ,
Buyers ,
Digital Health ,
Financing ,
Funding ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Innovation ,
Investment ,
Investors ,
Private Equity ,
Technology ,
Value-Based Care
On August 18, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-05, finding that an entity’s proposal to facilitate referring surgeons’ ownership of turnkey...more
On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more
4/18/2023
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
NPRM ,
OCR ,
Patient Privacy Rights ,
PHI ,
Public Comment ,
Reproductive Healthcare Issues
On November 2, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the CY 2023 Medicare Physician Fee Schedule Final Rule (Final Rule), which will take effect January 1, 2023. The Final Rule includes noteworthy...more
On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more
Following a record-breaking first quarter, merger and acquisition (M&A) activity within the healthcare industry kept pace during the second quarter of 2021, showing no signs of slowing. Although the volume of deal activity...more
8/24/2021
/ Acquisitions ,
Ambulatory Surgery Centers ,
Buyers ,
Coronavirus/COVID-19 ,
Digital Health ,
Health Information Technologies ,
Hospice ,
Hospitals ,
Investors ,
Life Sciences ,
Managed Care Contracts ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Private Equity ,
Private Equity Funds ,
Special Purpose Acquisition Companies (SPACs)
On April 28, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) entered into a resolution agreement with Peachstate Health Management, LLC, doing business as AEON Clinical Laboratories...more
5/27/2021
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Due Diligence ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Privacy Rule ,
Holding Companies ,
Noncompliance ,
OCR ,
PHI ,
Private Equity Firms ,
Settlement ,
Telehealth
Private equity investors’ interest in gastroenterology (GI) practices continues to remain strong, despite some headwinds that GI practices have experienced as a result of the COVID-19 pandemic and further investment in this...more
On January 14, the Fifth Circuit vacated the University of Texas M.D. Anderson Cancer Center’s (M.D. Anderson) $4.3 million fine for HIPAA violations arising from its loss of more than 35,000 individuals’ protected health...more
1/26/2021
/ Class Action ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Employees ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Patients ,
Penalties ,
Vacated
On December 10, 2020, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) released a notice of proposed rulemaking (NPRM) to amend the Standards for the Privacy of Individually Identifiable Health...more
1/5/2021
/ Caregivers ,
Family Members ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Information Sharing ,
Notice of Privacy Practices ,
NPRM ,
OCR ,
PHI ,
Proposed Amendments ,
Proposed Rules ,
Right-To-Access ,
Value-Based Care
The Medicare Physician Fee Schedule Final Rule for Calendar Year 2021 (the Final Rule) issued by the Centers for Medicare & Medicaid Services (CMS) on December 1, 2020, and published in the Federal Register on December 28,...more
1/5/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Final Rules ,
Health Care Providers ,
Medical Coding ,
Medicare ,
Opioid ,
Physician Fee Schedule ,
Physicians ,
Public Health Emergency ,
Reporting Requirements ,
Scope of Treatment ,
Telehealth ,
Vaccinations ,
Verification Requirements
On August 3, the Centers for Medicare & Medicaid Services (CMS) released its proposed Medicare Physician Fee Schedule (MPFS) updates for the 2021 calendar year, addressing among other policy changes how CMS will treat...more
On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more
Centers for Medicare & Medicaid Services (CMS) has announced flexibilities and adjustments for current and future alternative payment models administered by the Center for Medicare and Medicaid Innovation (CMMI) to...more
On March 9, the Centers for Medicare and Medicaid Services (CMS) finalized its Interoperability and Patient Access Rule (Interoperability Rule), which aims to enhance patients’ control over their healthcare information. As...more
6/4/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Electronic Medical Records ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Information Blocking Rules ,
Medical Records ,
Medicare ,
Patient Access ,
Personally Identifiable Information ,
Request For Information
On March 9, 2020, the U.S. Department of Health and Human Services (HHS) published final rules to implement the information blocking prohibitions of the 21st Century Cures Act (Information Blocking Rules). The Information...more
Financial Relief for Healthcare Providers -
The CARES Act provides financial relief to healthcare providers that are being hit hard by the COVID-19 public health emergency. Perhaps most notably, the CARES Act establishes a...more
Responding to the COVID-19 national public health emergency, on March 13, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) exercised the authority granted by Section 1135 of the Social Security...more
3/18/2020
/ Coronavirus/COVID-19 ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Employee Privacy Rights ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Patient Privacy Rights ,
PHI ,
Popular ,
State of Emergency ,
Telehealth ,
Waivers
On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more
9/4/2019
/ Comment Period ,
Confidential Information ,
Consent ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Health Care Providers ,
Information Sharing ,
Medical Records ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Proposed Rules ,
Public Comment ,
SAMHSA ,
Substance Abuse
The Centers for Medicare & Medicaid Services (CMS) has issued an amendment to the Bundled Payments for Care Improvement (BPCI) Advanced Participation Agreement (Amendment). Changes imposed by the 18-page Amendment were...more
Enforcement activity by the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) showed no signs of slowing throughout 2018 and has already picked up speed in 2019. More recent and significant actions...more
4/25/2019
/ Administrative Law Judge (ALJ) ,
California Consumer Privacy Act (CCPA) ,
Civil Monetary Penalty ,
Compliance ,
Cybersecurity ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Medical Records ,
OCR ,
Patient Privacy Rights ,
Personally Identifiable Information ,
PHI
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
9/7/2018
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Commercial Reasonableness ,
Cost-Sharing ,
Cybersecurity ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
EHR ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Incentives ,
Medicare Shared Savings Program ,
OIG ,
Physicians ,
Public Comment ,
Request For Information ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care ,
Waivers
On January 3, 2018, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) issues a final rule to implement modifications to the Confidentiality of Substance Use...more