3.12.18 – 3.16.18 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.
BUDGET AND APPROPRIATIONS
FY 2018 Appropriations
Work on a fiscal year 2018 omnibus continued this week, but a final package is not expected to be released until Monday due to ongoing negotiations. It is being reported that negotiators are close to settling disputes over health agency spending levels, but several issues remain unresolved including whether to provide grants to Planned Parenthood, whether health care workers should be able to opt out of performing abortions under a "conscience" objection, and whether to include health insurance market stabilization provisions in the omnibus. Lawmakers are also still considering whether to roll back a decision made in the earlier budget agreement that increased the amount pharmaceutical companies pay the government for drugs that fall into the Medicare Part D coverage gap.
As you know, Senators Lamar Alexander (R-TN), Patty Murray (D-WA) and Susan Collins (R-ME) have tried since September to fund reinsurance and cost-sharing reduction subsidies for insurers. They feel that including provisions in the omnibus may be their last chance to stabilize the ACA markets before insurers set their 2019 rates. It is uncertain at this point, however, whether or not these provisions will be included in the omnibus due to objections from conservatives who say the stabilization bill is a bailout to insurers and democrat’s strong opposition to Republican’s demands to tie abortion restrictions to marketplace health plans.
On Tuesday, Senate Labor HHS Subcommittee Chairman Roy Blunt (R-MO) said there is also disagreement over how to count opioid abuse prevention and treatment funds in the bill. The budget deal enacted last month proposed $3 billion for anti-opioid efforts in FY18 spread among at least two appropriations bills. According to Blunt, “There are a lot of ways to count that money and there’s a little discussion going on about whether we’ve already reached that number or not.” Cole agreed there is a “discussion” about how to count the dollars, which involves figuring out “how much of it goes for law enforcement, prevention, cure, treatment,” but suggested they are working it out.
On a positive note, Cole suggested this week that House and Senate negotiators have agreed to a bigger bump in funding for the National Institutes of Health than the $2 billion recommended over two years in the budget deal.
The current continuing resolution expires on March 23. House Republicans hope to release the text of their omnibus spending bill by Monday night, in order to vote on the bill Wednesday and send it to the Senate for a vote before midnight Friday.
Fiscal Year 2019 Appropriations
On Thursday, the House Appropriations Committee Labor-HHS Subcommittee held a hearing on the Department of Health and Human Services’ (HHS) FY 19 budget request to Congress. HHS Secretary Azar was the only witness. A webcast of the hearing is available here.
While some of the topics covered during the hearing were contentious – particularly related to reproductive rights issues – overall there was largely bipartisan agreement about the need to fund the National Institutes of Health (NIH), address the opioid misuse and overdose epidemic, and strengthen the nation’s public health emergency and pandemic preparedness. Some of the key topics covered during the hearing included:
Gun violence research
Full Committee Ranking Member Lowey (D-NY) and Subcommittee Ranking Member DeLauro (D-CT) both raised the Dickey amendment and asked about the Centers for Disease Control and Prevention (CDC) prohibition on gun violence research. Azar reiterated comments he made at a previous hearing and said he confirmed with the Acting CDC Director that CDC is not prohibited from conducting research on gun violence.
He also noted that NIH has always had research on violence and firearms. In her closing remarks later in the hearing, Rep. DeLauro went back to this issue and said that NIH said it would not be releasing a funding opportunity in this area and urged the Secretary to get NIH to release an opportunity in FY 18.
Former Appropriations Committee Chairman Rogers (R-KY) said that he is concerned the Administration is focusing “almost exclusively” on law enforcement to address the opioid misuse and overdose epidemic. Rogers said that law enforcement is important, but it is just one leg of the stool. He also expressed concerns that the White House Office of National Drug Control Policy (ONDCP) is understaffed – Rogers said it is almost “un-staffed” - and that public messaging seems focused on drug cartels.
Secretary Azar responded that efforts are dedicated around prevention and treatment and said they are focusing on how to keep people from getting addicted, then transitioning to illegal drugs and getting those who are addicted treatment. He cited key guidances on Medication Assisted Treatment (MAT) from the Food and Drug Administration (FDA) and said that the budget proposed having Medicaid cover all FDA-approved drugs and changes to the Part D program to address misuse and abuse.
Mr. Rogers asked Secretary Azar how industry can help and noted that billions of pills have been produced. Azar noted that the Attorney General has filed a statement of interest in the state Attorney General actions against pharmaceutical manufactures. He also touted the public/private partnership proposed in the budget to develop the next generation of non-opioid pain treatments and non-pharmaceutical ways of treating pain.
Rep. Womack (R-AR) also said that Wal-Mart has started giving out a product called “DisposeRx” that, when mixed with water, turned unused pills into a hard substance. He said it is a great example of private sector innovation. Secretary Azar responded that prescriptions for minor procedures such as wisdom tooth extraction need to have limited prescriptions for opioids, that parents need to know is it not safe to have these pills in their homes and that FDA Administrator Gottlieb is looking at how to support states and the pharmacy community to keep prescribing limited.
Subcommittee Ranking Member Cole (R-OK) asked about disaster preparedness and raised a proposal with bipartisan support at the Committee to create a public health disaster fund. Secretary Azar said pandemic response needs to be a priority and he would support a federal emergency response fund.
Rep. Pocan (D-WI) brought up the issue of drug pricing with Secretary Azar. Azar said that Pharmacy Benefit Managers (PBMs) negotiate in the Part D program, but the challenge there is out of pocket costs. He referenced that they are not negotiating in Part B and the costs for drugs which Medicare is paying are often quite high. He noted that the President’s budget would move drugs from Part B to Part D where there is negotiation.
340B DRUG PRICING PROGRAM
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the 340B drug discount program. The following served as witnesses:
Bruce Siegel, MD, MPH, President and Chief Executive Officer, America’s Essential Hospitals
Lori M. Reilly, Executive Vice President, Policy, Research & Membership, Pharmaceutical Research and Manufacturers of America
Sue Veer, MBA, President and Chief Executive Officer, Carolina Health Centers, Inc.
Joseph M. Hill III, MA, Director, Government Relations Division, American Society of Health-System Pharmacists
In an often-contentious hearing, Chairman Lamar Alexander (R-TN) made it clear he wants to know where hospitals and clinics are applying the discounts they get from drugmakers, how much of the discounts go directly to patients and which kinds of programs the providers are funding for patients with the money that isn't directly passed on. He said that once lawmakers have a better understanding of the 340B program’s purpose, Congress can determine if changes to the law are necessary. Alexander said the committee will hold at least one more hearing on 340B, likely involving the Health Resources and Services Administration per a suggestion of Senator Kaine (D-VA).
Opening statements and a webcast of the hearing can be found here and a full summary of the hearing is attached.
SUBSTANCE USE AND MENTAL HEALTH
On March 21 – 22, the House Energy and Commerce Committee will hold a 2-day hearing on 25 public health bills addressing the opioid misuse and overdose epidemic. The list of bills the Committee announced it will consider is below. As of press time, a witness list has not been announced.
H.R. 5009, Jessie’s Law, authored by Reps. Tim Walberg (R-MI) and Debbie Dingell (D-MI), will ensure medical professionals have access to a consenting patient’s complete health history when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and disseminate best practices regarding the prominent display of substance use disorder (SUD) history in patient records of patients who have previously provided this information to a health care provider.
H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act (AINS), authored by #SubDCCP Chairman Bob Latta (R-OH), will direct HHS to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts and strategies to combat the opioid crisis.
H.R. __, FDA Packaging and Disposal, authored by Rep. Richard Hudson (R-NC), will direct FDA to work with manufacturers to establish programs for efficient return or destruction of unused Schedule II drugs, with an emphasis on opioids. These methods could include mail-back pouches to secure facilities for incineration, or methods to immediately inactivate/render unattractive unused drugs. In addition, this bill will facilitate utilization of packaging that may reduce overprescribing of opioids. Finally, this bill will require the Government Accountability Office (GAO) to study new and innovative technologies that claim to be able to safely dispose of opioids and other unused medications. GAO would review and detail the effectiveness of these disposal methods.
H.R. 5176, the Preventing Overdoses While in Emergency Rooms (POWER) Act, authored by #SubEnvironment Vice Chairman David McKinley (R-WV) and Michael Doyle (D-PA), will provide resources for hospitals to develop protocols on discharging patients who have presented with an opioid overdose. These protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patient’s needs.
H.R. 3545, the Overdose Prevention and Patient Safety Act (AINS), authored by Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR), will permit SUD records to be shared without patient consent, in accordance with Health Insurance Portability and Accountability Act (HIPAA), and only for very specific purposes. The bill would also increase the penalties in the event of disclosure, add breach notification requirements, and provide discrimination prohibitions to protect people seeking and receiving SUD treatment.
H.R. __, the Eliminating Opioid-Related Infectious Diseases Act, authored by #SubCommTech Vice Chairman Leonard Lance (R-NJ) and Rep. Joe Kennedy (D-MA), will authorize the CDC to undertake an injection drug use-associated infection elimination initiative and work with states to improve education, surveillance and treatment of injection drug-use associated infections, like human immunodeficiency virus (HIV) and hepatitis.
H.R. 5261, the Treatment, Education, And Community Help (TEACH) to Combat Addiction Act, authored by Rep. Bill Johnson (R-OH), will support Centers of Excellence, or institutions of learning that have championed SUD treatment and pain management education to improve how health professionals are taught about both SUD and pain.
H.R. __, the Comprehensive Opioid Recovery Centers Act of 2018, authored by #SubHealth Vice Chairman Brett Guthrie (R-KY), will establish Comprehensive Opioid Recovery Centers (CORCs) that will serve as models for comprehensive treatment and recovery. CORCs would utilize the full range of FDA-approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery as productive members of society.
H.R. 5272, the Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) Act, authored by Reps. Steve Stivers (R-OH) and Eliot Engel (D-NY), will require entities applying for funding that would be used to support programs or activities that address mental health or SUD, to submit materials to HHS demonstrating that the programs or activities are evidence-based.
Discussion Draft, PDMPs, authored by #SubOversight Vice Chairman Morgan Griffith (R-VA), will improve current federal support for Prescription Drug Monitoring Programs (PDMPs) by requiring a coordinated effort amongst the Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Office of the National Coordinator for Health Information Technology to improve surveillance, data collection, and integration into physician clinical workflow so that timely, complete and accurate information will get into the hands of providers and dispensers, allowing them to make the best clinical decisions for their patients.
H.R. __, the Poison Center Network Enhancement Act of 2018, authored by Reps. Susan Brooks (R-IN) and Eliot Engel, will reauthorize the important network of centers within the National Poison Data System that offer free, confidential, expert medical advice 24 hours a day, seven days a week. Oftentimes these programs serve as the primary resource for poisoning information and help reduce Emergency Room visits through in-home treatment.
H.R. 5140, Tribal Addiction and Recovery Act of 2018 (TARA), authored by Rep. Mullin would make Indian tribes eligible to be direct grantees of State Targeted Response to the Opioid Crisis Grants to fight the opioid epidemic in Indian Country, reflecting the government-to-government relationship between Indian tribes and the United States. Tribes would receive their own $25 million allocation that they could apply directly to the federal government, instead of having to go through their states.
H.R. __, FDA Accelerated Approval & Breakthrough Therapy Status, will take steps to make FDA pathways like the accelerated approval program available to take on the opioid crisis, leading to expedited development and review of drugs which may demonstrate substantial improvement over available therapies.
H.R. __, FDA and International Mail, authored by #SubCommTech Chairman Marsha Blackburn (R-TN), will streamline and enhance tools the Food and Drug Administration (FDA) has available to effectively intercept illegal products. In doing so, this bill will create efficiencies for government resources and better protect American citizens from dangerous imported substances.
H.R. __, FDA Opioid Sparing, authored by Rep. Barbara Comstock (R-VA), will direct FDA to articulate clear data collection methods that could be used to inform opioid-sparing labeling claims for products that may replace, delay, or reduce or the use of opioid analgesics.
H.R. 4684, the Ensuring Access to Quality Sober Living Act, authored by Reps. Judy Chu (D-CA), Mimi Walters (R-CA), Raul Ruiz (D-CA), and Gus Bilirakis (R-FL) will authorize SAMHSA to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment for sustained recovery from SUD.
H.R. 5002, the Advancing Cutting Edge (ACE) Research Act, authored by Rep. Debbie Dingell and #SubEnergy Chairman Fred Upton (R-MI), will provide the National Institutes of Health (NIH) with new, flexible authorities to conduct innovative research and spur urgently needed research on new non-addictive pain medications.
H.R. 5197, the Alternatives to Opioids (ALTO) in the Emergency Department Act, authored by Reps. Bill Pascrell, Jr. (D-NJ) and David McKinley, will establish a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments.
H.R. 5102, the Substance Use Disorder Workforce Loan Repayment Act of 2018, authored by Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY), will create a loan repayment program for SUD treatment providers. Specifically, the bill will offer student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program will be available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals.
H.R. 449, the Synthetic Drug Awareness Act, authored by Rep. Hakeem Jeffries (D-NY), will require the U.S. Surgeon General to submit a comprehensive report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 in order to further educate parents and the medical community on the health effects of synthetics.
H.R. 3692, the Addiction Treatment Access Improvement Act, authored by Rep. Paul Tonko (D-NY), will expand access to medication-assisted treatment (MAT) by allowing clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists to prescribe buprenorphine and permanently authorize non-physician providers to prescribe buprenorphine. The bill would also codify regulations that increased the cap on the number of patients a physician can treat with buprenorphine to 275 patients.
H.R. __, Fentanyl Testing, authored by Rep. Ann Kuster (D-NH), will provide grants to federal, state, and local agencies for the establishment or operation of public health laboratories to detect fentanyl, its analogs, and other synthetic opioids.
H.R. __, Peer Support Specialists Workforce Grants, authored by Reps. Ben Ray Lujan (D-NM), and Johnson would increase the funding for the Comprehensive Addiction and Recovery Act’s Building Communities of Recovery Program and authorize HHS to award grants to peer support specialist organizations for the development and expansion of recovery services.
H.R. __, FDA Long-term Efficacy, authored by Rep. Jerry McNerney (D-CA), will enhance FDA’s authorities and enforcement tools to ensure timely post-marketing studies for chronically administered opioids.
H.R. __, FDA Misuse/Abuse, authored by #SubHealth Ranking Member Gene Green (D-TX), will clarify FDA’s authority to consider misuse and abuse as part of the drug approval and assessment process for opioids. It would also augment FDA’s capacity to take necessary action to minimize the public health consequences of opioid misuse and abuse.
On the Senate side, while HELP Committee Chair Alexander (R-TN) previously said his Committee might mark up legislation as early as late March, staff have said the markup will not occur until April after the spring recess.
RIGHT TO TRY LEGISLATION
On Tuesday, the House of Representatives voted on 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 isn't already available under Expanded Access. Critics also objected to the process. The Energy and Commerce Committee held several hearings on the topic, but the bill in question was not introduced until the day of the vote, giving Congress no time to review it.
The bill came to the House floor under an expedited process called the "suspension calendar" which limits debate and prohibits amendments, but requires a 2/3 majority to pass the bill. The final vote was 259 to 140. Though the bill failed, Republican leaders are considering bring the legislation back to the floor under the regular process subject to a rule.
On Monday, President Trump and Secretary Azar may announce at least parts of a new Administration plan to address the opioid misuse and overdose epidemic while visiting New Hampshire. Components of the plan may include:
Addressing the Institutions of Mental Disease (IMD) exclusion in order to increase access to inpatient treatment
The death penalty for drug dealers
A Department of Justice (DOJ) task force on monitoring internet sales
Expanding naloxone for first responders
Calling on states to adopt prescription drug monitoring programs (PDMPs)
Screening federal inmates for opioid use upon arrival and treatment at residential re-entry centers
On Thursday, the FDA announced it will be undertaking a rulemaking to limit nicotine levels in cigarettes to minimally or non-addictive levels. FDA estimates that 480,000 Americans die annually from tobacco related causes. It further estimates that tobacco use cost the United States $300 billion annually in health costs and lost productivity. The FDA hopes that the new nicotine standards will reduce smoking rates in American adults from 15% to as low as 1.4%. In addition to the nicotine rule, FDA plans to address separate rulemakings regarding tobacco flavoring and premium cigars. Comments regarding this proposed rulemaking are due to FDA by June 14, 2018.
Katie Weyforth Vanlandingham
Van Scoyoc Associates
800 Maine Ave SW
Washington, DC 20024