3.19.18 – 3.23.18 Health Wrap Up
Please find below a summary of the latest major health policy developments in Washington this week. Please let us know if you have any questions.
Scheduling note: the House and Senate will be on recess for the next two weeks. Unless activity warrants, we will send the next wrap up on April 13th.
Budget and Appropriations
Early this morning, the Senate passed, 65-32, a $1.3 trillion omnibus spending bill. The House passed the bill, 256-167, on Thursday. While there was some uncertainty about if the President would sign the bill after a tweet this morning saying he was considering a veto, he said he signed the omnibus at his press conference this afternoon. As you know, the current continuing resolution (CR) expires at midnight tonight.
The agreement would provide $177.1 billion in discretionary appropriations for health, education, and labor agencies, $16 billion more than fiscal 2017. The Department of Health and Human Services (HHS) would receive $78 billion in budget authority, an increase of $10 billion above the FY17 enacted level. Overall, the omnibus allocates roughly $4.65 billion to addressing the opioid epidemic across the federal government — about three-quarters of that comes from the Labor-HHS section – about $3 billion of that amount is “new” money consistent with the budget agreement reached last month.
A summary of the Labor-HHS bill as prepared by the Senate Appropriations Committee is attached. Full text of the omnibus is available here and the report for the Labor-HHS-Education bill can be found here.
Health Resources Services Administrations (HRSA)
- $27 million for mental and behavioral health education training to recruit and train professionals and faculty in the fields of social work, psychology, psychiatry, marriage and family therapy, substance abuse prevention and treatment and other areas of mental health behavioral health
- $105 million to the National Health Service Corps to expand and improve access to opioid and substance use disorder treatment. The omnibus also expands loan repayment through the National Health Service Corps to include substance use disorder counselors
- $130 million for a new Rural Communities Opioids Response program
- $1.63 billion, $135 million above FY17 for Community Health Centers to expand behavioral health and substance use disorder prevention and treatment services, including opioid abuse, and provide access to overdose reversal drugs and recovery support services.
Centers for Disease Control and Prevention
The omnibus includes $7.2 billion in discretionary budget authority for CDC, or about a $1.1 billion increase over FY17. It also gives CDC $475 million for prescription overdose prevention activities — an increase of $350 million to help fight the opioid epidemic, with $10 million of those funds dedicated to an opioid abuse awareness campaign.
National Institutes of Health
The omnibus provides $37.084 billion for NIH, including the full $496 million from the 21st Century Cures Act Innovation Account. This represents a $3 billion increase over the FY17 level. Within NIH, the bill includes $500 million split evenly between NINDS and NIDA for research related to opioid addiction, development of opioid alternatives, pain management, and addiction treatment. A breakdown of some programs of interest includes:
- $37,084,000,000 for the National Institutes of Health, an increase of $3,000,000, or 8.8 percent, above FY17
- Including $496,000,000 for the 21st Century Cures Act, including:
- $300,000,000 for National Cancer Institute
- $43,000,000 to NINDS and $43,000,000 to NIMH for the BRAIN Initiative
- $110,000,000 will be allocated from the NIH Innovation Fund, in the Office of the Director, for the Precision Medicine Initiative cohort ($100,000,000) and regenerative medicine research ($10,000,000)
- Including $496,000,000 for the 21st Century Cures Act, including:
- Increases funding for All of Us precision medicine initiative by $60,000,000
- Increases funding for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative by $140,000,000
- Increases funding for regenerative medicine by $8,000,000
- Increases funding for antibiotic resistance research by $50,000,000
- Increases funding for the development of a universal influenza vaccine by $40,000,000
- Includes $500,000,000 for targeted research on opioid addiction:
- National Institute of Drug Abuse ($250 million)
- National Institute on Neurological Disorders and Stroke ($250 million)
- Includes a new initiative to expand research into Down syndrome
- Increases funding for Clinical and Translational Science Awards to $542,771,000, an increase of $26,651,000
- Increases funding for Institutional Development Awards to $350,575,000
- Continues to support the National Children’s Study Follow-on program at $165,000,000
- The Common Fund is supported as a set-aside within the Office of the Director at $588,116,000
The Omnibus also included the following NIH policy directives:
- Maintains the Salary Cap for NIH-funded extramural researchers to Executive Level II
- Prohibits the Department of Health and Human Services from developing or implementing modifications to Indirect Cost Rates (Facilities and Administration) that were in effect as of the third quarter of 2017
- For the additional $500 million in opioid funding, the agreement gives the NIH Director authority to transfer funds to other Institutes and Centers for the purpose of conducting research on opioid addiction, opioid alternatives, pain management and addiction treatment.
- The additional opioid funding is made available until September 30, 2019. For-profit recipients of opioid funds shall be subject to a matching requirement of funds or documented in-kind contributions of not less than 50 percent of the total funds awarded to such entity
Substance Abuse and Mental Health Administration (SAMHSA)
The bill funds SAMHSA at $5 billion – $1.3 billion above the FY17 level. The legislation maintains a prohibition on federal funds for the purchase of syringes or sterile needles, but allows communities with rapid increases in cases of HIV and Hepatitis to access federal funds for other activities, including substance-use counseling and treatment referrals.
The omnibus includes $1 billion in new State Opioid Response grants under SAMHSA; within these funds, there is a 15% set-aside for states with the highest mortality rates related to opioid use disorders and a $50 million set-aside for Indian tribes and tribal organizations. These funds are in addition to the $500 million for FY 18 from the 21st Century Cures Act.
The accompanying report directs SAMHSA to submit a report to the Appropriations Committee that includes, “a description of the activities for which each State has received funding and the ultimate recipients of the funds provided to States.” The report also directs $2 million to the National Academy of Sciences (NAS) to study the effectiveness of the Opioid Response Grants. The report states NAS will, “identify outcomes that are to be achieved by activities authorized in the Comprehensive Addiction and Recovery Act (P.L. 114-198) and the metrics by which the achievement of such outcomes shall be determined, as required by section 701 of such Act. The NAS study should report on the effectiveness of the programs in achieving their respective goals for preventing, treating, and supporting recovery from substance use disorders.”
Some of the other key SAMHSA programs in the omnibus include:
- $1.9 billion for the Substance Abuse Prevention and Treatment Block Grant
- $84 million for Medication-Assisted Treatment for Prescription Drug and Opioid Addiction
- $53.8 million for the National Child Traumatic Stress Network
- $30 million for Screening, Brief Intervention, Referral and Treatment (SBIRT)
- $29.9 million for pregnant and post-partum women
- $8.7 million for Opioid Treatment Programs/Regulatory Activities
- $5 million for Building Communities of Recovery
- $2.4 million for Recovery Community Services Program
- $1.9 million for disaster response
- $1 million for Improving Access to Overdose Treatment
Health Policy Provisions
The bill also:
- Continues the Hyde Amendment, which bars the use of federal funds to pay for abortion services, with exceptions for rape or incest or when the mother’s life is endangered.
- Continues the Weldon Amendment, which prohibits federal agencies from discriminating against providers that do not perform abortions.
- Continues to prohibit the CDC from advocating for gun control measures, a provision known as the Dickey Amendment, but the report accompanying the bill includes language stating that the agency has the authority to research the causes of gun violence.
- Does not include changes to the Medicare Part D coverage gap.
- Excludes a health insurance market stabilization package.
SUBSTANCE USE AND MENTAL HEALTH
House Energy and Commerce Committee
This week the House Energy and Commerce Committee held a 2-day hearing that included 19 witnesses and covered 25 public health bills that address the opioid misuse and overdose epidemic. The Committee plans to hold a third hearing on Medicare, Medicaid and other payer issues related to the epidemic next month. As we have previously reported, Chairman Walden (R-OR) wants the Committee to complete its work on a bill or bills by Memorial Day.
Summaries of both days of the hearing are attached.
Additionally, a summary of the hearing the Energy and Commerce Committee Subcommittee on Oversight and Investigations held on Tuesday with the Drug Enforcement Administration (DEA) on alleged pill dumping in West Virginia is attached.
Senate HELP Committee
Senate Health, Education, Labor and Pensions (HELP) Committee Chair Alexander (R-TN) had previously said he hoped his Committee would begin considering legislation to address the epidemic before the spring recess, but consideration has now officially slipped until April. The Committee may hold a legislative hearing on April 11 and may release a draft discussion bill around the same time.
RIGHT TO TRY LEGISLATION
After failing to secure the votes for passage under an expedited process last week, this week the House of Representatives again voted on and then passed what is commonly called the "Right To Try Act". The legislation (HR 5247) allows terminally ill patients who have unsuccessfully exhausted all available treatments for their conditions to enter into treatment plans with drugs not yet approved by the FDA. Eligible patients would waive various patient safety requirements in order to try the drug, provided it has completed Phase I trials.
Supporters argue that the patients will die within months, so providing them the "right to try" experimental drugs could be the only opportunity to save their lives. Critics of the bill claim the FDA already has a "right to try" program called the Expanded Access program. Further, they believe that nothing under the legislation would provide anything which is not already available under Expanded Access.
Last night, an effort lead by Sen. Johnson (R-WI) to move his right-to-try bill failed in the Senate; Johnson said he would continue working to get a bill through the chamber. The Senate previously passed Johnson’s right-to-try bill last summer, but the bill then faced criticisms from patient advocate groups and Food and Drug Administration (FDA) Commissioner Gottlieb.
TRUMP ADMINISTRATION
New CDC Director
The Trump administration on Wednesday announced that HIV/AIDS researcher Robert Redfield will be the new director of the Centers for Disease Control and Prevention. The appointment does not require Senate confirmation. Redfield takes over for Anne Schuchat, who has been CDC acting director since the end of January when Brenda Fitzgerald, the Administration's first choice, resigned
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