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ePolicy News May 2017

Wednesday, May 10, 2017



Lab Professionals: You May Qualify for HRSA Faculty Loan Forgiveness Program

ASCP is pleased to report that the Health Resources and Services Administration (HRSA) has announced that its 2017 Faculty Loan Repayment Program is now open. Applications must be submitted by June 29 (7:30 p.m. EST). This program provides individuals from various disadvantaged backgrounds who have a degree or certificate in medical laboratory technology with the opportunity to receive loan repayment while serving as faculty members at accredited and eligible health professions schools. Participants may receive up to $40,000 for two (2) years of service to repay the outstanding principal and interest of qualifying educational loans. Applicants must obtain all qualifying educational loans prior to the application deadline. For technical assistance, HRSA will hold a conference call on Thursday, June 15, at 2 p.m. The dial-in number for this call is 888-790-3359, and the passcode is 4694412. ASCP strongly encourages all laboratory professionals who might benefit to apply!



Trump Budget Proposal Would Slash Funding on Medical Research and Disease Prevention

President Donald J. Trump unveiled yesterday last week his 2018 Fiscal Year budget proposal, outlining his Administration’s priorities for federal funding. His budget proposes steep cuts in healthcare programs, including medical research, scientific research, and disease prevention. Federal spending for the National Institutes of Health (NIH) would be slashed by 18 percent, with funding reduced from $31.8 billion to $26 billion in 2018. Among the NIH agency’s receiving significant cuts are the National Cancer Institute, which would lose $1 billion. The National Science Foundation, which provides grants for scientific research would receive a $775 million cut—11 percent of its 2017 budget. Federal funding for Centers for Disease Control and Prevention (CDC) would be 17 percent, a reduction of $1.2 billion. At the CDC, Global Health Programs intended to monitor and respond to disease outbreaks, would be cut 18 percent under the President’s plan; however, three-fourths of this cut would come for CDC’s Global HIV/AIDS program, which funds infrastructure and base support components of the CDC’s commitments to the President’s Emergency Plan for AIDS Relief (PEPFAR). Funding for this program would be reduced from $128 million in 2017 to $69.6 million next year. PEPFAR, it should be noted, receives most of its program funding from the Department of State. Funding for the Food and Drug Administration (FDA) would be cut by 31 percent. However, to supplement the Agency’s budget, the President is seeking significant increases in the user fees paid by companies to support the Agency’s review of their products. As is often the case, many of the proposals outlined in presidential budgets do not come to fruition. Many of the programs targeted in the President’s budget have significant support in Congress and are unlikely to receive cuts in funding on par with the proposals outlined in the budget.



CBO Complicates GOP Repeal of ACA

On May 24, the non-partisan Congressional Budget Office (CBO) released its analysis of the cost and impact of the American Health Care Act—the House Republican’s plan to repeal the Affordable Care Act (ACA). The CBO’s analysis of the measure shepherded through Congress by House Republican leadership projects that it would increase the number of uninsured Americans by 23 million while saving $119 billion over 10 years. The analysis projects that the cost of insurance could soar for those who have pre-existing conditions or have health issues while insurance costs could decline for the healthy. The CBO’s impact analysis of the revised bill is very similar to its assessment of original legislation House Republicans proposed. That measure, which was projected by the CBO to result in 24 million patients losing access to insurance, was pulled from consideration by the House GOP leadership due to a lack of support within their party. The House Republicans’ goal of passing the AHCA was complicated by unified Democratic opposition to repealing the ACA.



Does Trump’s Budget Proposal Complicate LDT Oversight? Trump’s FY 2018 budget calls for doubling FDA user fees

President Donald Trump’s Fiscal Year 2018 Budget Proposal lays out his vision that the Food and Drug Administration (FDA) should double the cost of user fees imposed on companies with products under the Agency’s review. Trump’s proposal is problematic as it would require Congress to abandon current plans, negotiated over the last two years, to re-structure FDA user fees. These user fees are applied on products involving FDA premarket review, such as pharmaceuticals and medical devices, among others. These fees are not insignificant. The current fee for a premarket approval is $234,495, though it is much lower for entities that can be classified by FDA as a small business. It should be obvious that doubling these fees carries with it significant financial implications for companies required to get FDA approval of their products. When the budget bill funding the remainder of FY 2017 was signed into law in May, it required FDA help Congress develop legislation to regulate Laboratory Developed Tests (LDTs). Assuming the FDA gains oversight of LDTs and that the Trump user fee plan becomes law, it would seem possible that costs of FDA’s review of LDTs could in the years ahead increase substantially. While the vast majority of Presidential budget proposals do not become law, it raises the question of what impact significant increases in user fees could have on the development of new LDTs.



What are LCDs and Why Should We Support their Reform?

Dr. Gregory Sossaman explains Local Coverage Determination (LCD) reform and why it is important in a May ONELab blog post: “Reform of the LCD Process.” In this post, Dr. Sossaman describes the coverage policies Medicare contractors develop, some of the problems that make reform of the process necessary, and steps ASCP is taking to accomplish reform.


For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).


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