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: 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 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: 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: The Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") released an advisory opinion providing new insight into the evaluation of fraud and abuse risks of per-click fee...more