Week of May 6, 2013
House Panel Examines FDA Budget Request
On April 26, the House Appropriations Committee’s Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing to examine the Administration’s Fiscal Year 2014 budget request for the U.S. Food and Drug Administration (FDA). Subcommittee Chairman Robert Aderholt (R-AL) stated that the FDA was too slow in moving guidance, rules, and regulations through its review process. He noted that the FDA requested $4.7 billion for Fiscal Year 2014, including new user fee authorizations for food imports and food facility inspections. He said that these new fees did not appear to have the same level of industry support that the prescription drug or medical device industries give to their user fee programs because the food industry views this as a “food safety tax.” He said that the FDA has failed to communicate performance measurements associated with the program and said that the chances of Congress authorizing the new fees were “slim.”
Subcommittee Ranking Member Sam Farr (D-CA) stated that the FDA should have the authority to appropriate the user fees it collects, but are unable to because of unintended impacts of sequestration. He said the government is not being a fair partner to private industry. Farr asked if there was a backlog of user fees that could not be spent because of sequestration enforcement. Dr. Margaret Hamburg, Commissioner, FDA, said that the Agency was just now working out how the sequester would impact these programs. She noted that the FDA negotiated the amount to charge for user fees and that industry partners expect it to be used in areas of mutual benefit. Hamburg said the FDA was still collecting the same amount of fees but, because of the sequester requirements, the percentage that was cut was not available for use. Farr said the committee should work to grant FDA access to that money.
Full Committee Ranking Member Nita Lowey (D-NY) expressed concern about the safety of drug compounding facilities, noting that the FDA had conducted reviews of these facilities. She asked what the FDA found during inspections. Hamburg replied that the FDA inspected some facilities deemed ‘high risk’ while following up on facilities where specific problems had been reported. She observed that there were sterility problems found, and that facilities were not routinely inspected. She argued that the FDA needed legislative framework to clarify the authority of FDA, noting that some manufactures were not compliant in the inspection process and that administrative warrants were required to gain access. Lowey suggested that the FDA focus on compounding pharmacies, saying there should be clear uniform standards that apply to the sterile injectable products that are made at compounding facilities.
Key Republicans Propose Medicaid Change
This week, House Energy & Commerce Committee Chairman Fred Upton (R-MI) and Senate Finance Committee Ranking Member Orrin Hatch (R-UT) published a report entitled, “Making Medicaid Work.” In the blueprint, the authors propose the adoption of “per capita caps,” a limitation on the amount of Federal spending for each Medicaid beneficiary. The report cites the Federal government’s open-ended liability to match State Medicaid spending as a “significant risk to the program’s future financial soundness.”
The level of Federal funding for each State would be determined by a formula using the number of Medicaid enrollees in the State that belong to each of the following four beneficiary groups: (1) aged; (2) blind and disabled; (3) children; and (4) adults. The model would also account for geographic spending variation in Medicaid programs across states.
The blueprint also makes recommends several Medicaid integrity enhancements and advocates for the reduction of regulations that deter innovation.
Finally, the report pledges to build upon existing efforts to coordinate care for dual eligibles. The authors express optimism that the demonstration projects will help develop models that will reduce costs and enhance quality of care, and offer support for the “goal of better coordinated benefits and services for the dually-eligible populations.”
Leaders Continue to Clash Over ACA Implementation
In a response given this week at a press conference, President Obama credited already enacted provisions of the Affordable Care Act (ACA) for making health insurance “stronger, better, more secure” for families. He conceded that there will be “glitches and bumps” with implementation, but that the Administration is working very hard to meet the law’s deadlines.
Senate Majority Leader Harry Reid (D-NV) said this week that Republicans’ opposition to the law has led to funding shortages for implementation. He added that the Administration has been forced to take money from other parts of the law in order to finance implementation efforts. Senate Minority Leader Mitch McConnell (R-KY) called on Democrats to “prepare families and younger Americans for the skyrocketing premiums many of them will soon see.”
Meanwhile, West Virginia Democratic Governor Earl Ray Tomblin became the 26th governor to publicly support the ACA’s Medicaid expansion. In Florida, where Republican Governor Rick Scott had previously announced his support for the Medicaid expansion, the Republican controlled House and Senate have yet to come to an agreement before the scheduled end of the legislative session this week, complicating prospects that a plan will be approved by 2014. In Arizona and Ohio, similar efforts by Republican Governors to accept the Medicaid expansion remain unresolved due to opposition in each state’s legislature.
Senate Schedules Hearing on Drug Compounding Legislation
On May 9, the Senate Health, Education, Labor, and Pensions (HELP) Committee is set to convene a hearing on a bipartisan drug compounding proposal released on April 26. The draft legislation, authored by Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), Senator Pat Roberts (R-KS) and Senator Al Franken (D-MN), would put in place new Federal regulations on non-traditional drug compounding manufacturers, and provides for similar oversight for compounded animal drugs.
Upcoming Hearings and Meetings
Healthcare Costs: Health Affairs will hold a briefing titled "Tackling the Cost Conundrum”.
Medicare Physician Payment: The House Ways and Means Subcommittee on Health will hold a hearing titled “Medicare Physician Payment Policy Revision”.
VA Healthcare Legislation: The Senate Veterans' Affairs Committee will hold a hearing to examine “Pending Health Care Legislation”.
Drug Abuse: The National Institute of Health’s National Council on Drug Abuse will hold a meeting to discuss reports of administrative, legislative and program developments in the drug abuse field.
Impact of Health Insurance Fee: Health and Technology Subcommittee of House Small Business Committee will hold a hearing titled "The Health Insurance Fee: Impact on Small Business."
Drug Compounding Legislation: The Senate HELP Committee will hold a hearing on pharmaceutical compounding.
Technology and Healthcare: The NIH will hold a lecture titled “Smart Phones, Smart Devices, Social Networks, and Smart Healthcare”.
Healthcare Symposium: Dialogue on Diversity will hold its Health Care Symposium titled "The Elusive Concept: What Health Care Can Society 'Afford'."
June 4 and June 6
ADUFA Webinar: The FDA will host the final webinars related to the 2008 ADUFA Reauthorization. The workshop will focus on data quality.