Pursuant to California's Health Care Quality and Affordability Act (the "HCQA"), the newly created Office of Health Care Affordability ("OHCA") recently proposed statewide health care cost targets and standards and goals for...more
New, first-of-their-kind consumer health data privacy laws in Washington and Nevada are designed to provide state-level protections for personal health data not covered by the Health Insurance Portability and Accountability...more
The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more
2/19/2024
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Popular ,
Proposed Regulation ,
Public Health
In Short -
The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more
12/1/2023
/ Anti-Kickback Statute ,
Compliance Management Systems ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Physicians ,
Stark Law
Note From the Editors -
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
5/15/2023
/ Clinical Trials ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
OIG ,
Popular ,
Substance Abuse ,
Telehealth
The sweeping law imposes new requirements on the processing and sale of consumer health data in the state.
On April 27, 2023, Washington State Governor Inslee signed the "My Health My Data Act" ("Act"). This Act marks the...more
The Centers for Medicare & Medicaid Services and other agencies together issued final regulations concerning the independent dispute resolution process for settling provider-payor disputes over reimbursement for...more
In a win for health care providers across the nation, the U.S. District Court for the Eastern District of Texas has vacated a key regulation regarding the process for resolving payment disputes between insurers and...more
In support of the American Telemedicine Association's Telehealth Awareness Week (September 19-25, 2021), Jones Day's Digital Health team shared key insights on various legal topics applicable to telehealth. Jones Day's...more
9/27/2021
/ Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medical Reimbursement ,
Patient Access ,
Patient Privacy Rights ,
Rate Parity Agreement ,
Relief Measures ,
Rural Health Care Program ,
Taxable Income ,
Telehealth ,
Telemedicine
The California Attorney General ("AG") has issued guidance reminding health care providers of their duty to report health care data breaches and to comply with other state and federal data privacy laws....more
9/15/2021
/ Cyber Attacks ,
Data Breach ,
Data Protection ,
Electronic Medical Records ,
Health Care Providers ,
HIPAA Breach ,
Information Technology ,
Network Security ,
New Guidance ,
Popular ,
Regulatory Requirements ,
Reporting Requirements ,
Risk Management
Health care providers have seen an increase in litigation and disputes with commercial payors.
On January 13, 2021, a federal district court in Dallas, Texas, entered judgment against two health care providers and their...more
The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more
3/12/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more
2/27/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Electronic Health Record Incentives ,
Health Care Providers ,
PHSA ,
Proposed Rules ,
Rulemaking Process ,
Safe Harbors ,
Stark Law ,
Sunset Provisions
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or market value...more
2/12/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Fair Market Value ,
False Claims Act (FCA) ,
Financial Transactions ,
Health Care Providers ,
Personal Services ,
Physicians ,
Proposed Regulation ,
Remuneration ,
Retroactive Application ,
Stark Law
The Situation: The Office of Inspector General ("OIG") proposes modifications to the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand shelter to...more
The Situation: Despite the ongoing evolution of cybersecurity technology and services, patients' health information and other confidential data remain vulnerable to cyberattacks because such technology and services are often...more
The Situation: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while also reducing the costs of care.
The Action: The Office of Inspector...more
11/25/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
ESRD ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Medicare Part B ,
OIG ,
Public Comment ,
Stark Law ,
Telehealth ,
Telemedicine ,
Value-Based Care
The Situation: Earlier this year, Congress passed the Bipartisan Budget Act of 2018 ("BBA"), which expands coverage for telehealth in Medicare Advantage ("MA") plans beginning in 2020.
The Update: The Centers for Medicare...more
In July 2017, the United States Department of Health and Human Services' Office of Inspector General ("OIG") revealed two new Work Plan items related to digital health: first, a review of Medicare incentive payments for...more