The Centers for Medicare & Medicaid Services ("CMS") aims to expand digital health technology usage among Medicare beneficiaries and providers under its new Advancing Chronic Care with Effective, Scalable Solutions ("ACCESS")...more
3/30/2026
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Chronic Care Managment (CCM) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Part B ,
Telehealth ,
Value-Based Care
A new bipartisan bill, the "Break Up Big Medicine Act," takes aim at the ownership structures fueling health care's vertical integration, but ambiguities in its text risk forcing divestitures beyond the conglomerates it...more
3/2/2026
/ Antitrust Provisions ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda
The Centers for Medicare & Medicaid Services ("CMS") unveiled the Long-term Enhanced Accountable Care Organization ("ACO") Design ("LEAD") model, which aims to expand provider participation, increase beneficiary involvement...more
2/25/2026
/ ACOs ,
Alternative Payment Models (APM) ,
Benchmarking ,
Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Part D ,
Value-Based Payments
2025 was an incredibly busy year for digital health, and 2026 is likely to be no different. This edition of Vital Signs covers numerous developments, along with a look to 2026 in Industry Insights. Thank you to our Jones Day...more
2/10/2026
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicare ,
New Legislation ,
Request For Information ,
State and Local Government ,
Telehealth
The Center for Medicare & Medicaid Services Innovation ("CMMI") announced the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-Based Approaches Through Evidence ("MAHA ELEVATE") Model, designed to improve...more
2/4/2026
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Cooperative Agreements ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Funding ,
Grants ,
Health Care Providers ,
Healthcare ,
Medicare ,
Pilot Programs ,
Preventive Health Care ,
Public Health ,
Value-Based Care
New CMS program, WISeR, will leverage third parties to screen prior authorization requests using technologically enhanced processes....more
8/7/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Medicare ,
Medicare Advantage ,
Prior Authorization ,
Regulatory Requirements ,
Technology-Assisted Review
The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more
7/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Patent Quality Metrics ,
Patient Access ,
Physicians ,
Regulatory Reform ,
Trump Administration ,
Value-Based Care
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
6/13/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Data Collection ,
Data Management ,
Digital Health ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Value-Based Care
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more
6/6/2025
/ AI Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Comment Period ,
Digital Health ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Mobile Apps ,
Patient Access ,
Regulatory Reform ,
Telehealth ,
Value-Based Care
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the first of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding health care...more
6/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Government Agencies ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Regulatory Reform ,
Value-Based Care
The Center for Medicare and Medicaid Services ("CMS") has announced significant changes to its value-based payment model portfolio projected to save $750 million as part of a shift in the agency's refocused strategy toward...more
4/16/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Government Agencies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
Physicians ,
Regulatory Reform ,
Value-Based Care
The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more
1/29/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Incentives ,
Medicare ,
Organ Transplant Centers ,
Penalties ,
Regulatory Requirements ,
Value-Based Care
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 Situation: The Office of Inspector General ("OIG") recently modified the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand protections to...more
The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more
The Situation: Under the federal Physician Self-Referral Law ("Stark Law"), many physician arrangements must meet one or more of the so-called "big three" requirements: that the arrangement be "commercially reasonable," that...more
The Situation: The adoption of new technologies has been a hallmark of the health care industry in the twenty-first century. While these technologies have helped to improve both industry efficiency and patient outcomes, the...more
The Situation: On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the long-awaited final rule to modernize and clarify the Stark Law. As part of this final rule, CMS reviewed stakeholder...more
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 fair market value...more
The Situation: As health care providers transition to value-based care models, they have often been forced to rely on safe harbors under the Anti-Kickback Statute, or AKS, that were never designed with value-based payment...more
The Situation: The spread of the novel coronavirus (COVID-19) pandemic has significantly impacted the delivery of health care services and increased demand for telehealth services.
The Result: The pandemic has encouraged...more
Hospitals, physician practices, and other provider organizations are dealing with unprecedented challenges in the present public health emergency following the spread of the novel coronavirus (COVID-19). Providers can expect...more
The Issue: On June 24, 2019, President Trump signed an executive order, which instructed the Department of Health and Human Services to publish rules requiring hospitals to publicly disclose their negotiated rates for...more
With the passage of the Eliminating Kickbacks and Recovery Act in October 2018, Congress took aim at the ongoing opioid crisis threatening communities across the U.S. This new criminal statute targets healthcare providers...more
3/25/2019
/ ACOs ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Exceptions ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse