Tag: The Affordable Care Act

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 […]

HRSA Finalizes 340B Drug Discount Program Orphan Drug Rule – 340B Discounts Available to New Covered Entities for Non-Orphan Indications

On June 22, 2013, the Health Resources and Services Administration (“HRSA”) released its final rule on the exclusion of orphan drugs for certain covered entities under the 340B Drug Discount Program.  The advance copy is currently available for viewing at the Office of the Federal Register Public Inspection Desk, and […]

Administration Delays Implementation Of Employer Shared Responsibility Obligations Under Health Reform

The Obama Administration, through the U.S. Department of Treasury, recently announced that it was delaying implementation of key provisions of the Affordable Care Act (“ACA”) for a year. Originally scheduled to go in effect on January 1, 1014, the shared responsibility provisions of the ACA would subject employers with 50 or […]

With the 1st Pick of the 2013 Draft, the Department of Health and Human Services Selects…

Like the success of a sports team, the success of the Affordable Care Act (“ACA”) depends on many factors.  However, one critical factor contributing to the success of ACA is the enrollment of individuals in the exchanges. In an effort to promote enrollment, the U.S. Department of Health and Human […]

The Countdown until October

On June 19, 2013, the Government Accountability Office (“GAO”) released two reports, Status of CMS Efforts to Establish Federally Facilitated Health Insurance Exchanges and Status of Federal and State Efforts to Establish Health Insurance Exchanges for Small Businesses, that collectively cast doubt on whether the health insurance exchanges (the “exchanges”) […]

Available Now: CMS Templates for Data Collection and Reporting Under the Federal Sunshine Provisions

As the health care industry prepares for data collection beginning August 1, 2013, in accordance with the federal sunshine provisions in Section 6002 of the Affordable Care Act and its implementing regulations, industry must also plan ahead for reporting the data collected. Data collection and reporting are inextricably linked, as […]