Tag: Patient Protection and Affordable Care Act

PhRMA Challenges HRSA Interpretative Rule on Orphan Drugs in the 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive Rule” regarding orphan drugs in the 340B Drug Discount Program (the “2014 Interpretive Rule”).  PhRMA’s lawsuit alleges that the 2014 […]

HRSA Stands By Its Interpretation of 340B Drug Discount Program Orphan Drug Availability, Despite Court Decision Vacating Regulation

The U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published today a statement responding to the recent court decision vacating the 340B Drug Discount Program Orphan Drug Rule.  As we previously reported, the D.C. District Court permanently enjoined HRSA from implementing its July 23, 2013 […]

340B Drug Discount Program Orphan Drug Rule Vacated:  ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs Under the 340B Program, Regardless of Indications

[UPDATE 6/18/2014: HRSA has issued a statement that it continues to stand by its interpretation of ACA permitting new covered entities to purchase orphan drugs under the 340B program for non-orphan use. See our more recent post for updated information.] The D.C. District Court permanently enjoined the U.S. Department of Health & Human […]

Supreme Court to Review ACA’s Contraception Mandate

The U.S. Supreme Court (SCOTUS) agreed to review provisions within the Affordable Care Act (ACA) by granting petitions for writs of certiorari yesterday, November 26, 2013. Specifically, SCOTUS will review the provisions that require large employers to offer insurance coverage for birth control and other reproductive health services. 

Update on HHS “Qualified Health Plans” Determination: Grassley Weighs in…

As we reported earlier this week, the U.S. Department of Health & Human Services (“HHS”) recently issued a letter concluding that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to be federal […]

HHS: Qualified Health Plans are NOT “Federal Health Care Programs” – Implications for Anti-Kickback, CMP, and Exclusion Analyses

In an October 30, 2013, letter to Representative Jim McDermott (D-WA), U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, stated that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to […]

States Continue Medicaid Expansion Debate

As President Obama responds to healthcare.gov’s glitches, many states continue to debate whether to expand the Medicaid program in their respective states. The Supreme Court’s decision on the Affordable Care Act (“ACA”) allows states to opt out of the ACA’s Medicaid expansion provisions. Many states have stated their Medicaid expansion plans definitively; however, not all […]