POLICY BRIEFINGS


HHS Confirms Previous Ruling on Orphan Drug Discounts


The Health Resources and Services Administration (HRSA)/HHS released a document containing an interpretive ruling under which safety-net providers can continue to receive 340B program discounts on common, non-orphan uses of drugs that have orphan indications. The ruling follows a recent court decision that HHS does not have the authority to rule on whether drugs with a rare-disease or orphan designation can be available at a discount for non-orphan uses. HRSA said the court did not impinge on the agency’s ability to interpret the law’s “exclusion” provisions.


FDA Issues


The FDA gave notice that, pending approval by the Office of Management and Budget (OMB), it will conduct a study to analyze how adolescents weigh the risks and benefits of drug classes that are marketed directly to consumers. Two different medical conditions will be used to determine the effect of direct-to-consumer (DTC) marketing and the potential adverse effects. Comments are due by August 20.


Upcoming Health-Related Hearings and Markups


House Energy and Commerce Health Subcommittee: will hold a hearing titled “Protecting Americans from Illegal Bailouts and Plan Cancellations Under the President’s Health Care Law;” 4:00 p.m., 2123 Rayburn Bldg. ; Monday, July 28.

House Energy and Commerce Health Subcommittee: will convene for opening statements only regarding pending legislation including: H.R. 3522, the Employee Health Care Protection Act of 2013; H.R. 4701, the Vector-Borne Disease Research Accountability and Transparency Act; H.R. 4067, a bill regarding supervision requirements for outpatient therapeutic services in critical access and small rural hospitals; a draft bill regarding clinical data registries and other legislation. 4:00 p.m., 2123 Rayburn, Tuesday, July 29.

House Oversight and Government Reform, Energy Policy, Health Care and Entitlements Subcommittee: will hold a hearing titled “Examining the Federal Government’s Failure to Curb Wasteful State Medicaid Financing Schemes.” 10:00 a.m., 2247 Rayburn; Tuesday, July 29.

Senate Finance Committee: will hold a hearing titled “Tobacco: Taxes Owed, Avoided, and Evaded;” 10:00 a.m., 215 Dirksen Bldg.; Tuesday, July 29.

House Energy and Commerce Health Subcommittee: will mark up pending legislation including: H.R. 3522, the Employee Health Care Protection Act of 2013; H.R. 4701, the Vector-Borne Disease Research Accountability and Transparency Act; H.R. 4067, a bill regarding supervision requirements for outpatient therapeutic services in critical access and small rural hospitals; a draft bill regarding clinical data registries and other legislation. 10:00 a.m., 2123 Rayburn; Wednesday, July 30.

Senate Special Aging Committee: will hold a hearing titled “Admitted or Not? The Impact of Medicare Observation Status on Seniors;” 2:15 p.m., 216 Hart Bldg.; Wednesday, July 30.

House Energy and Commerce Committee: will hold a hearing on implementation of the PPACA and its challenges since the opening of health care exchanges. 9:00 a.m., 2123 Rayburn; Thursday, July 31.

House Energy and Commerce Oversight Subcommittee: will hold a hearing on implementation of the PPACA, including updates from the Centers for Medicare and Medicaid Services and the Government Accountability Office; 9:00 a.m., 2123 Rayburn Bldg. ; Thursday, July 31.

House Small Business Health and Technology Subcommittee: will hold a hearing titled “Telemedicine: A Prescription for Small Medical Practices?” 10:00 a.m., 2360 Rayburn; Thursday, July 31.



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