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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.
Spending Bill Stalls As End of Fiscal Year Looms
September 23, 2016—The Senate Sept. 22 appeared to inch closer to consideration of a stopgap spending bill as Republican leaders released text of a spending package (H.R. 5325) to continue funding for most federal agencies through Dec. 9, fund the Department of Veterans Affairs (VA) through the end of FY 2017, and provide emergency supplemental funding for Zika and disaster relief efforts. But Democrats quickly objected to the bill as “Republican-only,” citing the need for continued negotiations to resolve outstanding issues before they can support the bill.
The spending package includes a continuing resolution (CR) to extend temporary funding for programs in 11 of the 12 annual spending bills, which would allow appropriators to resume discussions on final funding levels after the election. To ensure the bill adheres to the $1.067 trillion discretionary spending cap, the text applies a 0.496 percent cut to the 11 appropriations bills in the CR. The package also rescinds $400 million from various programs; most of the rescissions are from non-health agencies, but does include $168 million in unused funding from the Affordable Care Act to establish exchanges in U.S. territories.
In addition to the stopgap for other federal agencies, the package includes full text of the FY 2017 Military Construction-VA spending bill. It provides $675 million for VA Medical and Prosthetic Research, a $44 million (7 percent) increase over the FY 2016 level, as urged by the AAMC and the friends of VA Medical Care and Health Research (FOVA) coalition during conference negotiations [see Washington Highlights, June 24]. A press statement released by the Senate Appropriations Committee Majority indicates that enacting the bill “would mark the first time since 2009 that a regular appropriations bill has been signed into law before the end of the fiscal year.”
The Zika portion of the package provides $1.1 billion in emergency supplemental funding to be available through the end of FY 2017, with $933 million to the Department of Health and Human Services (HHS). Within the total, lawmakers include $152 million for vaccine development, diagnostics, and other Zika research through the National Institutes of Health (NIH), as well as $245 million for vaccine work through HHS’s Biomedical Advanced Research and Development Authority (BARDA).
The package also includes $6 million to assign National Health Service Corps (NHSC) clinicians – including pediatric subspecialists, who typically are not eligible for NHSC – to Puerto Rico and other areas affected by Zika.
Other HHS funds for Zika would support the Centers for Disease Control and Prevention ($394 million, including $44 million to restore funding withdrawn previously from the Public Health Emergency Preparedness, or PHEP, cooperative agreement); unreimbursed treatment costs and other expenses in areas with active or local transmission cases of Zika virus ($75 million); various services and projects in Puerto Rico ($60 million); and oversight activities ($1 million).
Unlike previous iterations of the Zika supplemental, the package does not include language that would have made certain family planning clinics in Puerto Rico ineligible for funding, a point of contention in previous iterations [see Washington Highlights, Sept. 16].
Democrats object to other, non-health related riders in the package, and believe aid to address lead-contaminated water in Flint, Mich., should be included in the bill, given $500 million the bill would provide for disaster relief efforts in Louisiana and other states.
Lawmakers are expected to continue negotiations over the weekend, and the next procedural vote in the Senate is expected to occur on or after Sept. 27. If the chamber is able to advance the package, it will need to be considered by the House, which has triggered its own procedural tactics to expedite consideration.
A stopgap must be enacted by Sept. 30 to avoid a government shutdown when the new fiscal year begins Oct. 1.
Sr. Director, Public Policy & Strategic Outreach
AAMC Applauds Bill Aimed At Addressing Flawed Hospital Ratings
September 23, 2016—Reps. Jim Renacci (R-Ohio) and Kathleen Rice (D-N.Y.) introduced the Hospital Quality Rating Transparency Act of 2016 (H.R. 6088), bipartisan legislation that would delay release of the Centers for Medicare and Medicaid Services’ (CMS) Hospital Compare Star Ratings to give CMS and stakeholders time to work together to address concerns with the methodology. Currently, Star Ratings do not take into account important differences in the patient populations and the complexity of conditions that teaching hospitals treat [see Washington Highlights, April 22].
AAMC President and CEO Darrell G. Kirch, MD, applauded the introduction stating, “Patients need accurate and reliable information in order to make decisions about their health care. The current proposed methodology for the Hospital Compare Star Ratings does not provide this, but rather may mislead patients into making poor decisions about hospitals.”
In related Star Ratings activity, Medicare Payment Advisory Commission (MedPAC) Chairman Francis J. Crosson, MD, sent a September 22 letter to CMS Acting Administrator Andy Slavitt expressing concern “that the current Hospital Star Rating program may not fully account for differences in the intrinsic health risks that patients bring to the hospitals, and therefore may not produce a true “apples-to-apples” comparison of hospitals.” It further encourages “the use of outcome over process measures to assess provider quality” and states concern that there “are currently too many, overlapping hospital quality payment and reporting programs, which creates unneeded complexity in the Medicare program.”
Director, Government Relations
Senior Legislative Analyst
CMS Publishes Final Rule on Emergency Preparedness Requirements
September 23, 2016—The Centers for Medicare and Medicaid Services (CMS) September 16 published a final rule on Emergency Preparedness Requirements for providers participating in Medicare and Medicaid, which requires providers to coordinate with federal, state, and local emergency preparedness systems to increase patient safety during emergencies.
CMS asserts that current emergency preparedness regulations fail to address various complexities of emergency preparedness such as coordination with other systems of care within cities or states, contingency planning, and personnel training. CMS also states that providers have raised concerns about the need for advanced preparation, effective policies and communication plans, and sufficient training that will assist in providing adequate care to patients during an emergency.
To meet patient needs during disasters and emergency situations, the final rule requires providers participating in Medicare and Medicaid to meet the following four core elements and industry best practice standards:
Based on a risk assessment, develop an emergency plan that uses an all-hazards approach focusing on capabilities that are critical to preparedness for a full spectrum of emergencies or disasters most likely to occur in the location of provider or supplier;
Develop and implement policies and procedures that support execution of the plan and risk assessment;
Develop and maintain a communication plan that complies with both federal state law; and
Develop and maintain training and testing programs, including initial and annual staff trainings, and conduct drills and exercises or participate in an actual incident that tests the plan.
The regulations are effective November 15. Providers have until November 15, 2017, to implement the requirements.
Ayeisha Cox, J.D.
Hospital Policy & Regulatory Specialist
AAMC Nominee Appointed to PCORI Board of Governors
September 23, 2016—The Government Accountability Office (GAO) September 22 announced the appointment of Russell M. Howerton, MD, FACS, chief medical officer and vice president of clinical operations at Wake Forest Baptist Medical Center, to the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors. The AAMC had nominated Dr. Howerton based on his current clinical leadership at Wake Forest Baptist Medical Center and primary role in implementing research and improving the linkage between research and clinical care.
AAMC President and CEO Darrell G. Kirch, MD, applauded Dr. Howerton’s appointment stating “As a member of the Board of Governors, Russell Howerton, MD, FACS, will bring a broad range of perspectives and expertise in clinical health sciences research to PCORI, helping that organization identify critical research questions, fund patient-centered comparative clinical effectiveness research, and disseminate the results in ways that are useful to patients and to our community.” Dr. Howerton serves as the current chair of the AAMC’s Chief Medical Officers Group.
PCORI, an independent nonprofit, nongovernmental organization was authorized (Subtitle D of Title VI - Sec. 6301) through the Patient Protection and Affordable Care Act (ACA, P.L. 111-148 and P.L. 111-152) in 2010. It is charged with improving the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions. The organization funds comparative clinical effectiveness research and supports improving the methods used to conduct such studies.
PCORI is governed by a 21-member Board of Governors. The Board represents a broad range of perspectives and collective expertise in clinical health sciences research. The Comptroller General of the United States appoints members of the Board, including its Chairperson and Vice Chairperson, in accordance with PCORI’s authorizing law.
Senior Legislative Analyst
NIGMS, NINDS, and NCATs Councils Meet
September 23, 2016—The National Institute of General Medical Sciences (NIGMS), National Institute of Neurological Disorders and Stroke (NINDS), and National Center for Advancing Translational Sciences (NCATS) councils met September 15-16.
The NIGMS council meeting included a report by NIGMS Director Jon Lorsch, PhD, who shared data from the institute’s first review of the Maximizing Investigator’s Research Award (MIRA) for New and Early Stage Investigators. MIRA, which is under the R35 mechanisms, is a five-year grant intended to increase the flexibility and stability of funding to NIGMS investigators. The success rate for the award was 29.4 percent with a median award for direct costs of $250K. Dr. Lorsch also noted that NIGMS is working on a new funding opportunity announcement to allow those with an NIGMS R01 to apply for a MIRA when their R01 is up for renewal.
Dr. Lorsch announced the planned creation of a T32 funding opportunity announcement tailored to promote the development of pre-doctoral training programs in fundamental biomedical research. The forthcoming announcement responds to comments received by the research and research training community to the Modernizing Biomedical Graduate Education Request for Information [see Washington Highlights, September 9].
During the NINDS council meeting, Director Walter Koroschetz reported that due to prior increases in applications, the anticipated continuing resolution, and out-year commitments of 8 percent over the prior year, the payline will reduce from 15 percent to 12 percent. Dr. Koroschetz expressed his concern regarding how the prior flat funding of NINDS has negatively impacted the infrastructure for neuroscience. Dr. Koroschetz also indicated that they would discuss the level of support of investigators and number of grants at the February 2017 council meeting.
Chris Austin, MD, director of NCATS, discussed regulation and a policy on posting clinical trials summary results, released later that day, as part of a series of initiatives to improve the quality of information generated from clinical trials. The NCATS council, which meets together with the Cures Acceleration Network, approved two concept clearances: the first to develop tools and networks for the National Institutes of Health (NIH) big-data-to-knowledge initiative within the Clinical and Translational Science Awards consortia; the second, to renew the drug repurposing program. With these approvals, NCATS staff can move to develop new requests for approvals based on these concepts.
Jodi B. (Lubetsky) Yellin, Ph.D.
Director, Science Policy
Director, Science Policy
House Energy and Commerce Leaders Ask HHS IG to Investigate NFL-NIH Research Funding
September 23, 2016—Members of the House Energy and Commerce Committee sent a September 15 letter to the Health and Human Services (HHS) Office of Inspector General (OIG) requesting an investigation of the interaction between the National Football League (NFL) and the National Institutes of Health (NIH) regarding funding for brain injuries research.
In the letter, Reps. Fred Upton (R-MI), Tim Murphy (R-Pa.), Joe Pitts (R-Pa.) and Michael Burges, MD, (R-Texas) raise questions about a May report, released by Energy and Commerce Ranking Member Frank Pallone (D-N.J.), which accused the NFL of attempting to pressure the NIH to take away a $16 million research project from Boston University, which was funded with an unrestricted $30 million donation from the NFL.
The Republican-led letter states, “[G]iven the significant public attention to these events, it is clear that a thorough and objective review by the HHS OIG is necessary. If the conduct of the NFL or its advisors was, in fact, inappropriate, NIH not only failed to identify and address this behavior, but rather encouraged ongoing discussion, thus creating a perception that the League had input on the use of the SHRP funds. While NIH may have clear rules and processes for evaluating these types of potential conflicts, given the controversy ignited by these events it is important to clarify how the Institutes evaluate these situations.”
Director, Science Policy
On The Agenda
Sept. 27: PCORI Board of Governors Meeting
12 p.m.; 1828 L Street NW, Suite 900, Washington, D.C.
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors will meet to consider approval of funding for a research proposal that was submitted under the New Oral Anticoagulants (NOACs) in the Extended Treatment of Venous Thromboembolic Disease funding announcement, among other agenda items. Registration and materials can be found online.
Sept. 27: House E&C Committee Hearing on Investigational Therapies
10 a.m.; 2322 Rayburn House Office Building, Washington, D.C.
The House Energy and Commerce Subcommittee on Health will hold a hearing to examine expanded access to investigational therapies. Witness testimony will be posted to the committee’s website when available.
Sept. 28: House W&M Committee Hearing on Health Care Fraud
10 a.m.; 1100 Longworth House Office Building, Washington, D.C.
The House Ways and Means Subcommittee on Oversight will hold a hearing on health care fraud investigations. Witness testimony will be posted to the committee’s website when available.
Sept. 28: National Advisory Council on The National Health Service Corps Webinar
The National Advisory Council National Advisory Council on The National Health Service Corps (NACNHSC) will host a webinarto discuss a variety of topics related to issues that communities with a shortage of primary care professionals face in meeting their health care needs. A webinar agenda is available online.
Sept. 30: PCAST Public Meeting
8:30 a.m.; National Academy of Sciences; 2101 Constitution Avenue NW, Washington, D.C.
The President's Council of Advisors on Science and Technology (PCAST) will meet to discuss a variety of topics regarding science, technology, and innovation. Registration information, including an agenda, can be found online. A webcast of the meeting is also available.
Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.
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Sr. Program & Policy Specialist, Govt Relations
Senior Legislative Analyst