Update on HOPA’s Health Policy Activities

Sarah Nichelson, JD
HOPA Health Policy and Advocacy Manager

Congressional Actions
Congress used the latter part of 2017 to pass Public Law No. 115-97, known as the Tax Cuts and Jobs Act. One provision of the signed law repealed the “individual mandate” of the Affordable Care Act—the requirement that most Americans obtain and maintain health insurance, or an exemption, each month or pay a tax penalty. The Congressional Budget Office estimated that by 2025, 13 million fewer people would have health insurance because of this repeal.

Congress also passed a bill that would fund the government through September 30, the end of the 2018 fiscal year (FY). As part of the spending bill signed on March 23, 2018, the Department of Health and Human Services was funded at $37 billion (an increase of $10 billion). The bill also increased funding to the National Institutes of Health by $3 billion. The National Cancer Institute received $5.66 billion, and the Cancer Moonshot initiative received $300 million. Congress also allocated an additional $3 billion in 2018 and an additional $3 billion in 2019 to help address the opioid crisis. HOPA will continue to partner with those working in oncology and those affected by cancer to ensure adequate funding levels for FY 2019 initiatives and research programs.

The Opioid Crisis
As noted above, both the President and Congress have begun to address the opioid crisis through funding and legislation. The funding will help the Department of Health and Human Services carry out its five-part strategy to

• improve access to prevention, treatment, and recovery services
• increase the availability and distribution of overdose-reversing drugs
• improve public health data and reporting
• increase research on pain and addiction
• improve pain management practices.

In addition, the House of Representatives’ Ways and Means Committee recently requested input from stakeholders on efforts to address the opioid crisis. The committee sought to learn more about overprescribing, data tracking, treatment options, and ways to communicate with and educate both patients and providers about the adverse effects of opioid use. HOPA submitted comments that emphasized the need for oncology patients to have continued access to pain treatment options.

At the other end of the spectrum of concern about opioids, hospitals are reporting a shortage of injectable pain medications. This shortage has been caused by several factors, including third-party production issues and government-set restrictions on production. HOPA continues to monitor this issue.

Right-To-Try Legislation
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (H.R. 5247), a bill that would allow patients with a terminal or life-threatening illness to have access to unapproved experimental drugs, was passed along party lines in the House of Representatives on March 21, 2018. This bill differs slightly from S. 204, sponsored by Senator Ron Johnson (R-WI). H.R. 5247 broadens the definitions of the terms eligible patient and eligible investigational drug and requires the sponsor or manufacturer to notify the Secretary of Health and Human Services of the use of the eligible investigational drug, requires reporting of adverse events, and allows the Food and Drug Administration (FDA) to consider the clinical outcomes of eligible investigational drugs in certain scenarios. The bill also waives liability for alleged actions or omissions in certain scenarios. Critics fear a lack of sufficient FDA oversight, although FDA Commissioner Scott Gottlieb has recently said he believes that the FDA is equipped to protect patients under the right-to-try laws.

Commissioner Gottlieb has also indicated that the FDA may soon be reviewing its expanded-access (or compassionate-use) program, which allows patients with terminal or life-threatening illnesses to have access to investigational drugs (i.e., those that have not been approved by the FDA). The goal would be to change the program to make investigational drugs easier for such patients to access.

Joint Commission Statement on Using Closed-System Transfer Devices to Extend Beyond-Use Dates of Single-Dose Containers
In the “Standards FAQ Details” section of its website, the Joint Commission recently posted a statement on using closed-system transfer devices to extend beyond-use dates of single-dose vials:

“The Joint Commission would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not been approved as an indication.”

“The Joint Commission is aware of published articles which [support] the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.”

HOPA is investigating the implications of this interpretation for our members and developing a response. This information may be helpful to those whose institutions will soon be undergoing a Joint Commission survey. Please continue to monitor HOPA News and HOPA Member Updates for more information.