Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
The U.S. Department of Health and Human Services (HHS) Office of Inspector General ("OIG") issued Advisory Opinion No. 25-02 ("Opinion") on April 4, 2025, regarding a Health Center proposal to link social support services to...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
Hospitals and other providers should brace for recoupment of possibly hundreds of millions of dollars they were reportedly overpaid for services provided under the COVID-19 uninsured program (UIP) in the wake of new audit...more
Are you a health care provider who received funds from the Health Resources and Services Administration's ("HRSA' s") COVID-19 Uninsured Program? If so, more inquiries and repayment demands may be coming....more
On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General (OIG) released the long-awaited audit (A-02-21-01013) of the Health Resources and Services Administration...more
The Health Resources and Services Administration (HRSA) reminded providers through a program update on Monday, June 5, 2023, that the Provider Relief Fund (PRF) and COVID-19 Uninsured Program (UIP) Terms and Conditions...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently conducted two audits of HHS management of healthcare provider loan and funding programs during the COVID-19 pandemic. Two...more
Provider Relief Fund (PRF) Period 3 reports and the first independent audits (e.g., Single and Financial Audits) were due September 30. Recovery actions and enforcement activity are likely to follow and may be informed by...more
Below is Alston & Bird's Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
One Health Resources and Services Administration program, “COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured,” has been a huge source of...more
The US Department of Health and Human Services (HHS) recently announced that it will make $25.5 billion available in new COVID-19 relief funds to providers through the Health Resources and Services Administration (HRSA). To...more
Report on Medicare Compliance 30, no. 15 (April 19, 2021) - CMS’s supplemental medical review contractor (SMRC) has added outpatient therapy claims to its list of postpayment reviews, according to its website. The SMRC,...more
As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement...more
In OIG Advisory Opinion No.19-05, the Department of Health and Human Services Office of the Inspector General (OIG) concluded that it would not impose sanctions against a requestor under the civil monetary provision of the...more
On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to...more
If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more
I. Regulations, Notices, & Guidance - On February 12, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more