Congress Clears FY 2016 Continuing Resolution
Congress on September 30 cleared a Continuing Resolution (CR) to fund the Federal government from October 1 through December 11, the first 72 days of fiscal year 2016. The Senate gave final approval to the resolution by a vote of 78-20 and the House cleared it by a vote of 277-151. House passage garnered the support of 186 Democrats with Republicans voting 91-151 against the CR. The CR does not contain the contentious policy riders that have caused legislative chaos, but does include an across the board reduction of 0.21 percent for both defense and non-defense discretionary programs.
Senator Mitch McConnell (R-KY) in late September said the CR was necessary to allow for negotiations with the Administration in an effort to adjust the statutory budget caps to allow for regular appropriations bills to pass. The current caps, approved in 2011, mandate cuts in both defense and nondefense domestic discretionary spending in fiscal year 2016, a prospect that neither party finds acceptable. As a result, none of the 12 regular FY 2016 appropriations bills have cleared Congress.
Negotiating a new budget agreement will be difficult, especially given the leadership issues facing Republicans in the House. House Speaker John Boehner in late September announced that he will step down in late October. Initial leadership elections were cancelled after the House Majority Leader Kevin McCarthy (R-CA) withdrew. As of mid-October, no serious negotiations have taken place. No one currently in the House GOP leadership is in any position to credibly negotiate with the Administration and a timetable for the selection of a new speaker is uncertain.
FY 2016 Appropriations Action
Before action ground to a halt, both the House and Senate Appropriations Committees approved all 12 of the regular appropriations bills. Previous detailed reports on the provisions of interest to ASPPH are available online. A chart detailing ASPPH’s appropriations priorities is also available online. There is great uncertainty whether the work of the Committees on these bills will be reflected in the final budget agreement. If an agreement is not reached, a full year CR is likely.
National Institutes of Health: The Association supports the FY 2016 recommendation of the Ad Hoc Group for Medical Research Funding of $32 billion for the NIH. The Association also is seeking an appropriation of $12.91 million for the NIH Office of Disease Prevention (ODP), a $3 million increase over the Administration’s request. Although the Senate version of the appropriation’s bill provides NIH with more than our request, maintaining that level of funding in the budget and/or appropriations conference committee negotiations will be difficult. Neither the House of the Senate versions of the bill allocate funds for the ODP.
Centers for Disease Control and Prevention: The Association supports the FY 2016 recommendation of the CDC Coalition of $7.8 billion. The House provides $24 million (-$1.46 million) for the Prevention Research Centers (PRCs) and the Senate provides $25.461 million, the same level as in FY 2015. The Association is seeking $32 million for the program. The House report asks the Government Accountability Office to review the PRC Special Interest Projects (SIPs). The Committee said “it remains concerned that SIP funds made available through Prevention Research Centers are not being competed from all qualified entities.”
The House provides $8.2 million (+$0.02 million) for the Academic Centers for Public Health Preparedness, the level advocated by the Association. The Senate did not fund the program. The House provided $28.5 million for the NIOSH Education and Research Centers (+$1.05 million). The Senate provided $27.445 million, the amount advocated by the Association. The House provided $27 million (+$3 million) for the NIOSH Agriculture, Forestry, and Fishing Centers, $3 million above the Association’s recommendation. The Senate did not fund the program.
Health Resources Services Administration: The Association has partnered with the American College of Preventive Medicine (ACPM) to recommend funding the Health Resources and Services Administration (HRSA) “public health workforce” line-item at $17 million in FY 2016. This recommendation represents level funding for both the Public Health Training Centers ($9.864 million) and the Preventive Medicine Residency Training Program ($7.136 million). The Senate provided each program with $4.93 million.
Agency for Healthcare Quality and Research: The House would not fund AHRQ and would transfer the Prevention Public Health Task Force to the Office of the Assistant Secretary of Health. The Association supports the recommendation of the Friends of AHRQ that the Agency be provided with an appropriation of $365 million. The House proposed a major reduction in AHRQ funding.
The ASPPH works with numerous coalitions on funding and policy matters, including: the Coalition for Health Funding, the Ad Hoc Group for Medical Research Funding; the CDC Coalition, Friends of HRSA, Friends of AHRQ; ACT for NIH: Advancing Cures Today; the Campaign for Tobacco-Free Kids, Federation of Associations of Schools of Health Professions; and the Prevention and Public Health Fund Coalition. Details on some of our joint activities with these coalitions are available online.
Overhaul of the Common Rule Proposed
Multiple Federal agencies on September 8 published in the Federal Register a 130-page Notice of Proposed Rulemaking (NPRM) proposing major changes in the Federal Policy for the Protection of Human Subjects (or the so-called “Common Rule”). The agencies have established a 90-day comment period on the proposal, ending on December 7. The NPRM proposes the most radical changes in human subject protections since the Common Rule was adopted in 1991. Among the most significant proposals:
- The NPRM creates a new section called “exclusions,” and details eleven types of activities that will not be subject to the Common Rule.
- The NPRM also details eight categories of “exempt research.” The agencies propose creating an “exemption determination tool,” the accurate use of which would create a “safe harbor” for users, meaning that agencies will presume that the use is appropriately exempt. The tool could be used by investigators and obviate the need for IRB review.
- The obtaining, use, study or analysis of biospecimens would be covered under the Common Rule, regardless of identifiability. Consent could be obtained through a broad consent for future unspecified research. This new provision would only apply to biospecimens collected in the future and its application would be delayed until three years after the publication of a final rule.
- S. institutions that engaged in cooperative research will be required to rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions.
- Continuing review requirement would be eliminated for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
- The scope of the Common Rule would be extended to cover all clinical trials, regardless of funding source, conducted at U.S. institutions that receive federal funding for non-exempt human subjects research.
- Throughout the NPRM there is increased emphasis on data security and confidentiality.
ASPPH intends to comment on the proposal and welcomes hearing of concerns identified by members during their review of the NPRM.
Selected Other Legislative and Regulatory Activities
Prevention and Public Health Fund: In recent years, the House and Senate appropriations bills fully allocate the Prevention and Public Health Fund, which was created by the Affordable Care Act. Nonetheless, Hill efforts to repeal the fund have continued. The House Budget Committee on October 9 approved a reconciliation bill on a straight party line vote, 21-11. The bill includes numerous provisions of perennial interest to House conservatives, including a repeal of most of the Affordable Care Act, including the Prevention and Public Health Fund (Prevention Fund or PPHF). The Congressional Budget Office reported that the Prevention Fund repeal would “save” $15.5 billion in budget authority and $12.7 billion in outlays over the 2016-2025 period. The bill is expected to pass the House, but its fate in the Senate is more precarious. In any case, President Obama said he would veto the measure. ASPPH wrote to members of the Committee strongly opposing the repeal provision. Reconciliation is a process to consider legislation changing existing law in order to bring spending, revenues, or the debt ceiling into conformity with the budget resolution. The process allows the bill to be considered in the Senate without the threat of a filibuster. The budget resolution itself is not binding, as the President does not sign it into law.
Tobacco Regulation: On September 10, ASPPH joined a letter to the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations urging them to support the $216.5 million in funding for CDC’s tobacco prevention work approved by the Senate Appropriations Committee and reject the rider in the House Agriculture Appropriations bill that would weaken FDA’s authority to protect Americans, including children, from e-cigarettes, cigars and other harmful tobacco products.
Health Education: In late-September, the Association joined a letter to the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies to express opposition to the proposed $21.7 million cut to the Title V Maternal and Child Health Services Block Grant in the FY2016 Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) bill, which passed out of the Senate Appropriations Committee. These grants support training programs within universities across the country to prepare the next generation of maternal and child health leaders who will go on to serve in communities throughout the United States.
NIH Strategic Plan Framework: On August 12, ASPPH submitted comments to NIH on the proposed framework for its NIH-wide strategic plan. The plan was ordered by Congress and is due in December. While supporting the Health Promotion/Disease Prevention opportunity area in the proposed framework, we expressed concern about the illustrative bullets in the proposal. We urged that the plan support a life course approach to prevention and the creation of long-term health. We also expressed concern that there was insufficient emphasis on NIH’s role in advancing translational research and implementation science. We urged an increased emphasis on NIH’s role in ameliorating health disparities, in supporting research on the broad range of social and environmental influences on population health, and in providing policy makers with research findings to help them determine how to best invest in health. We concluded by recommending that NIH explain to taxpayers –with some specificity– how the National Institutes of Health will advance the nation’s collective health and not solely advance scientific knowledge.
NIH Salary Cap: ASPPH joined with over 170 other organizations on August 24 in writing to leaders of the House and Senate Appropriations Committees urging Congress not to reduce further the salary cap on federal research grants funded by the Labor-HHS-Education Appropriations bill. The FY 2016 Labor-HHS appropriations bill passed by the House Appropriations Committee on June 24 would reduce the salary limit from Executive Level II to Executive Level III ($168,700 in 2015), a cut of $14,600 (8 percent). The Senate bill would leave the cap unchanged. The groups said that this proposed cut, “which follows a $20,000 (10 percent) cut in the FY 2012 funding bill, comes at a time when research institutions’ discretionary funds from clinical revenues and other sources are increasingly constrained and less available to invest in research. As institutions and departments draw further from internal funds to compensate for the reduction in the salary limit, they will have less funding for critical activities such as providing bridge funding to investigators between grants and supporting seed grants and start-up packages for young investigators.”
NIH ECHO Program Proposal: ASPPH on August 14 submitted comments to NIH on the proposed plan for the Environmental Influences on Child Health Outcomes (ECHO) program. The Association voiced its strong support for efforts to continue the study of environmental factors on children’s health. Noting that primary prevention represents the best hope to effectively reduce the global burden of chronic disease for both children and adults, the Association urged that the ECHO program focus data collection and implementation strategies on reducing the impact of environmental influences in utero and during the first two years of infancy. ASPPH said that “ECHO should represent the NIH’s commitment to develop a comprehensive strategy for the primary prevention of chronic diseases and conditions in both children and adults.”
Health Disparities Research: On July 31, ASPPH submitted comments on issues related to the planned NIH Science Vision for Health Disparities Research. The Association urged NIH and the National Institute on Minority Health and Health Disparities (NIHMD) to engage, in addition to NIH institutes and centers, other key federal agencies, such as the CDC, HRSA, and CMS. The letter also suggested that NIH’s review of existing health disparities research be expanded to include research sponsored by other federal agencies, foundations and others. The Association highlighted the interest and expertise or our members in engaging communities in health equity research efforts, as well as in interprofessional education, a critical vehicle for delivering equitable care in the evolving health system. We also asked NIH and NIMHD to consider including in its vision the generation of early career and mid-career awards focused on minority health, noting that in the current fiscal environment it is essential to create career “on-ramps” for academic researchers focused on health disparities issues – and to enable them serve as role models and conveners within their institutions.