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CMS Finalizes The Increasing Organ Transplant Access Model

The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more

Recent Changes to the Anti-Kickback Statute’s Personal Services Safe Harbor

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

OIG and CMS Modify AKS Safe Harbor and Stark Law Exception for EHR Donations

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

CMS Finalizes and Clarifies Key Valuation Terms in the Stark Law

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

New Stark Law and Anti-Kickback Statute Protections for Cybersecurity Technology

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

New Limited Remuneration Exception and Additional Tools to Ensure Compliance with the Stark Law

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

CMS Finalizes New Limitations to the Isolated Transactions Exception to the Stark Law

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

HHS Finalizes New AKS Safe Harbors for Patient Engagement and CMS-Sponsored Arrangements

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

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