On June 27, 2023, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“OIG Final Rule”) that implements statutory provisions for its enforcement of the information blocking penalties created by the 21stCentury Cures Act (“Cures Act”) and assessment of civil money penalties (“CMPs”) of up to $1 million per violation of information blocking for certain individuals or entities subject to the information blocking requirements.Continue Reading HHS-OIG Releases Final Rule Implementing Information Blocking Penalties

HHS-OIG published a new favorable advisory opinion on October 21, 2015 regarding free transportation services offered by an integrated health care system.  Integrated health care systems continually seek ways to provide seamless, connected care to patients who may be using multiple providers for treatment of medical conditions. Free transportation is a potential way to ensure that patients attend their numerous appointments, but offering such a benefit without appropriate safeguards implicates the Anti-Kickback Statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) or the Beneficiary Inducement Civil Monetary Penalty (“CMP”) Law (42 U.S.C. § 1320a-7a(a)(5)).

Advisory Opinion 15-13, largely reinforces the existing guidance that HHS-OIG has published on the subject of free transportation.  We note that HHS-OIG released Advisory Opinion 15-13 even though it published a proposed rule in October 2014 that would specifically establish a new safe harbor for free or discounted local transportation services.  Regardless, until a final rule describing a transportation safe harbor is available, Advisory Opinion 15-13 clarifies that arrangements where a health care system provides free transportation services to patients who see physicians with offices located on that health care system’s campus or at affiliated locations are acceptable under the applicable fraud and abuse laws, even if such physicians are not bona fide employees of the health care system.  These arrangements will be permissible so long as the benefits of such free transportation services are “incidental” and do not serve to induce referrals to the non-employed physicians or influence beneficiaries to choose these non-employed physicians.Continue Reading Health Care System Receives Favorable Advisory Opinion for Free Transportation Services