Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
At the end of June, the U.S. Court of Appeals for the Fifth Circuit affirmed a district court order invalidating the Affordable Care Act preventive services mandate for “A” or “B” items and services recommended by the United...more
Summary - The Departments of Labor, the Treasury, and Health and Human Services have jointly issued FAQs that address the requirement to cover the full cost of certain preventive care services in view of the recent ruling...more
The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more
The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more
In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...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
On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more
In This Issue: - Top News ..Congress Passes Omnibus Spending Package ..HRSA Cancels Plan for 340B ‘Mega Reg’; Congress Weighs Options ..Supreme Court to Hear Challenge to ACA Subsidies ...more
In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more
On July 7, 2014, HHS Secretary Sylvia Matthews Burwell announced that HHS would be awarding $83.4 million under the Teaching Health Center Graduate Medical Education (THCGME) program administered by the Health Resources and...more
A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more
In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more
Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more
In Hobby Lobby Stores, Inc. et al. v. Sebelius, et al.,1 an en banc panel of the U.S. Court of Appeals for the Tenth Circuit held that Hobby Lobby Stores Inc. and Mardel Inc., two for-profit corporations owned and operated by...more
The Health Resources and Services Administration (“HRSA”) has issued a final rule (“HRSA Rule”) that will eliminate duplicative federal reporting requirements of provider sanctions and other adverse actions taken against...more