Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
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
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more
With the onset of the COVID-19 pandemic, Congress initiated several programs to help businesses weather the difficult economic conditions. The Coronavirus Aid, Relief, and Economic Security (CARES) Act provided two of these...more
Report on Medicare Compliance Volume 32, no 25 (July 2023) The former chief hospital executive of Bayonne Medical Center (BMC) in New Jersey has filed a False Claims Act (FCA) lawsuit alleging the hospital and two others...more
The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently released guidance for group health plans on required preventive services coverage. The guidance was issued in response to a...more
On July 28, 2022, in light of the United States Supreme Court’s recent decision overturning Roe v. Wade, the United States Department of Labor (DOL), in conjunction with the Departments of Health and Human Services (“HHS”)...more
HHS sent notices to noncompliant physicians and facilities on March 10, 2022 giving them 30 days to return funds paid to healthcare providers who have not complied with the agency’s reporting requirements....more
In the latest installment of our “Let’s Talk Compliance” series, Foley & Lardner’s Alexis Bortniker and PYA’s Martie Ross answered numerous questions regarding Provider Relief Fund (PRF) reporting requirements. A recording of...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
On March 24, 2020, Health Resources & Services Administration (HRSA) released newly updated Novel Coronavirus (COVID-19) Frequently Asked Questions (FAQs), which outline multiple COVID-19 related issues for federally...more
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more
Review of 340B Program Omnibus Guidelines Extended – Last week, the White House Office of Management and Budget (OMB) posted that the review of the 340B Program Omnibus Guidelines had been extended. The Health Resources and...more
The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more
As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more
On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more