Posts Tagged ‘OIG advisory opinion’
OIG Gives Okay to Cost-Sharing Subsidy in Clinical Trial
A company that makes a medical device that uses a patient’s cells to treat ischemic systolic heart failure – a life-threatening cardiac condition – would not face sanctions if it paid Medicare participants’ cost-sharing obligations they would otherwise owe for reimbursable items and services provided during the 2-year study. That was the finding of a…
Read MoreOIG Gives Blessing to Alzheimer’s Study Payment Arrangement
On September 29, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion regarding the proposed subsidization of certain Medicare cost-sharing obligations relating to a clinical study of Alzheimer’s disease. The requestor is a professional medical society that represents radiologists and a charity that provides support and research…
Read MoreOIG Opinion: Drug Maker Can Provide Free Medication
On March 23, the Department of Health and Human Services Office of the Inspector General issued a favorable ruling to a drug manufacturer looking to provide a free medication to patients in need of a one-time treatment made from their own cells. The drug maker (Requestor) makes the FDA-approved drug for two indications that is…
Read MoreOIG Rules Hospitals Can Sell Medical Debt Directly to Nonprofit Buyer
Can health systems and large physician groups sell or donate their unpaid medical debt to a medical debt forgiveness company without fear of violating federal anti-kickback laws? A recent Advisory Opinion issued by the Department of Health and Human Services Office of the Inspector General said yes, at least under the circumstances outlined in the…
Read MoreOIG Gives Drug Manufacturer Green Light to Cover Patient Expenses
The Office of Inspector General (OIG) in a Jan. 21 Advisory Opinion (No. 20-02) approved an agreement under which a pharmaceutical manufacturer would provide travel, lodging and other expenses to financially needy patients prescribed the manufacturer’s personalized medication. In doing so, the OIG noted that such an arrangement could potentially violate the Anti-Kickback Statute, (AKS)…
Read MoreFederal Health IT Officials Outline Five-Year Plan
The Department of Health and Human Services, led by the Office of the National Coordinator for Health Information Technology (ONC), recently released its 2020-2025 Federal Health IT Strategic Plan for public comment. The 28-page plan outlines goals and objectives to ensure that patients have access to their electronic health information (EHR) that allows them to,…
Read MoreOIG Issues Advisory Opinion on Hospital Training Facility
On January 13, the Office of Inspector General (OIG) posted an advisory opinion in which it approved a hospital’s request to provide discounted training to a fire department’s personnel at the hospital’s facility. The hospital asked the government watchdog whether such an arrangement would constitute grounds for the imposition of sanctions under the exclusion authority…
Read MoreOIG: Complimentary In-Home Care Permitted, Despite Potential Anti-Kickback Violation
A recent advisory opinion issued by the U.S. Department of Health and Human Services Office of the Inspector General has given a medical center the go-ahead to provide free in-home care to reduce re-admissions, despite a prohibition against giving patients handouts that might influence care decisions. The OIG advisory opinion is in response to a…
Read MoreAdvisory Opinion: Clinic Can Provide Free Telemedicine Equipment, Services
A nonprofit, federally qualified health center look-alike (FQHC) can use grant funds to provide telehealth equipment and services for free to facilitate encounters with patients of a county-run clinic that provides testing, treatment and counseling for HIV, based on a recent advisory opinion issued by the Department of Health and Human Services Office of the…
Read MoreOIG Opinion: Providing Sample Ostomy Products Does not Violate Anti-Kickback Statute
An ostomy product distributor can give free samples to Medicare patients without worrying about violating the federal Anti-Kickback Statute, according to a recent advisory opinion from the Office of Inspector General for the U.S. Department of Health and Human Services. The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit…
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