Following several years of lead-up, including public engagement, the review of more than 13,000 comments, and conducting focus group studies, on February 22, 2023, the U.S. Food and Drug Administration ("FDA") issued a draft...more
On January 31, 2023, the Food and Drug Administration ("FDA") announced plans to redesign its Human Foods Program (the "Program") to better coordinate the agency's regulation of food products....more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
The Federal Trade Commission ("FTC") has brought its first enforcement action for violations of the Health Breach Notification Rule ("HBNR"), signaling heightened federal agency scrutiny of digital health platforms,...more
The United States Department of Agriculture ("USDA") published the Strengthening Organic Enforcement ("SOE") Final Rule to improve farm-to-market traceability, deter and detect instances of organic fraud, increase oversight,...more
In Short -
The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more
On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal...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
On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...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
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
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
With the rise of plant-based alternatives to conventional meat products, the industry has come under scrutiny from government regulators, both in the United States and abroad. In 2019 alone, nearly 30 states considered...more
For years, natural sources of nitrates and nitrites have been used to cure meats as an alternative to traditional synthetic sources. The United States Department of Agriculture ("USDA") requires companies that cure meats...more
12/30/2019
/ Citizen Petitions ,
Comment Period ,
Consumer Confusion ,
Consumer Reports ,
Department of Agriculture ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Product Labels ,
Public Interest ,
Regulatory Agenda ,
Unfair or Deceptive Trade Practices ,
USDA
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: There has been longstanding uncertainty in the health care industry related to interpreting certain compensation valuation terms used throughout the statutory and regulatory exceptions to the federal physician...more
11/1/2019
/ Anti-Kickback Statute ,
Arms Length Transactions ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
Fair Market Value ,
OIG ,
Physician Compensation Arrangements ,
Physicians ,
Proposed Rules ,
Public Comment ,
Stark Law
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
The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more
12/6/2017
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
HRSA ,
Medicare ,
MedPAC ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B