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 Congressional and State Initiatives
- Other Health Care News
- Upcoming Hearings and Markups
- Excerpt from Judge Rules Against 340B Drug Authority:
A federal judge in the DC District Court ruled that the Department of Health and Human Services (HHS) does not have the authority to implement regulations related to provisions in the Affordable Care Act (ACA) to expand the 340B drug discount program to rural and cancer hospitals. The regulation would have allowed certain health care facilities to access 340B discounts on orphan drugs for non-orphan indications. Safety Net Hospitals for Pharmaceutical Access released a statement expressing its disappointment in the ruling. This may have significant implications for the much anticipated 340B “mega-rule” that is currently under review at the White House and was expected as soon as this month. Most analysts believe that the ruling is limited to the orphan drug issue because the ACA did not direct HRSA to make exceptions for orphan drugs. However, if the court ruling is interpreted to be broader, then Congress would have to step in via legislation to reign in possible overuse of the program.
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