Following through on Republican campaign promises, two key Congressional committees released legislation yesterday that further the process of repealing and replacing the Affordable Care Act (ACA). After more than 60 attempts to repeal the ACA since 2010, GOP members of the House Energy and Commerce and Ways and Means Committees released details of the “American Health Care Act” (AHCA). Reaction to the AHCA has been swift and sharp portending a long road from producing legislation that can reach the President’s desk. Continue reading
Tag Archives: Health Reform
Today, the Supreme Court issued its highly anticipated ruling in King v. Burwell. The case questioned whether individuals who purchased health insurance through the federal Healthcare.gov marketplace were entitled to receive tax subsidies pursuant to the Patient Protection and Affordable Care Act (ACA), or whether such subsidies were reserved for individuals who purchased health insurance through state exchanges. The Supreme Court ruled 6-3 that Americans who purchased insurance through the federal exchange could keep the tax subsidies that made their insurance more affordable. Chief Justice John Roberts drafted the majority opinion.
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 Interpretive Rule “violates the plain language of the statutory orphan drug exclusion” and should be invalidated as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” The lawsuit is pending before the D.C. District Court.
On September 16, the American Medical Association (AMA) released a new framework intended to improve the development and integration of Electronic Health Record (EHR) systems. While the AMA recognizes the potential value of EHRs, it notes that adoption and effective use has been slow due, in large part, to poor optimization for efficient and effective clinical work. This call for a new framework follows up the joint AMA and Rand Corporation study documenting physician discontent with EHRs.
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 final rule on “exclusion of Orphan Drugs for Certain Covered Entities under 340B Program” (the “Orphan Drug Rule”). The Orphan Drug Rule permitted “new” covered entities established under the Affordable Care Act (free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals) to access 340B pricing on orphan drugs, so long as the drugs were not to be used for an orphan indication. On its website today, HRSA stated that although the court “vacated the orphan drug regulation on the grounds that HHS lacks the statutory authority to engage in such rulemaking,” the court “did not invalidate HRSA’s interpretation of the statute”.
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 Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan Drugs for Certain Covered Entities under 340B Program” (the “Orphan Drug Rule”). The Orphan Drug Rule initially became effective October 1, 2013, and permitted “new” covered entities established under the Affordable Care Act, (free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals), to access 340B pricing on orphan drugs, so long as the drugs were not to be used for an orphan indication. (See our July 22, 2013, post for more detail about the Orphan Drug Rule, and our October 3, 2013 post for more detail about the lawsuit.)
On Friday, January 3, 2014, the U.S. Solicitor General filed a memorandum in opposition to the emergency application for an injunction temporarily granted by the U.S. Supreme Court on December 31, 2013. The injunction temporarily enjoined the government from enforcing the contraceptive coverage requirements imposed by the Affordable Care Act (ACA) and its related regulations against the Little Sisters of the Poor Home for the Aged, pending the receipt of a response from the government and further order by the U.S. Supreme Court. Continue reading