*This was originally posted on 8/28/20 updated on 9/16/20 to reflect additional details issued by the Trump Administration.
In recent weeks, President Donald Trump has signed several Executive Orders (EOs) and memoranda that Susan G. Komen is closely following. Typically, EOs describe broad strategies for addressing an issue without specific details on implementation. All the policies described below would have to be implemented via regulation or guidance by the appropriate executive agency or agencies, which could take anywhere from weeks to years, so there will likely be opportunities for further advocacy engagement. Komen has been closely monitoring these orders to assess their potential effects on the breast cancer community. Here are links to the recent Presidential actions that are relevant to breast cancer patients and providers, with a brief summary and details of any relevant Komen-related advocacy on the issue previously:
- Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen: This directs the Department of Health and Human Services (HHS) to finalize a rule that would require rebates in Medicare Part D to be passed on to patients. Failure to pass along these rebates would result in a kickback to Pharmacy Benefit Managers (PBMs) and be illegal. It may be difficult for this policy to actually be enacted because language in the EO says the passing along the rebates could not increase premiums, patient out-of-pocket costs or Federal spending. This policy was first released as a regulation in 2019, and Komen submitted a comment letter expressing general support for the idea of lowering patient out-of-pocket costs but expressing concern about the lack of clarity in the rule about what the effects on patients would ultimately be.
- Executive Order on Increasing Drug Importation to Lower Prices for American Patients: This EO is trying to promote importation of some drugs, including insulin, from Canada. It is less clear whether this policy would apply to breast cancer treatments, and if so, what the effects may be on breast cancer patients and survivors. Komen supports policies that lower out-of-pocket costs for treatments but also seeks to ensure that all treatments are safe and effective.
- Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States: This “Buy American” EO directs several agencies to implement policies to increase the proportion of “essential medicines” produced in the United States – or from a list of “qualifying countries” – rather than bought from a broader list of countries as it is today. The effects of this EO are also less clear for breast cancer treatments, which may not be included on the list of “essential medicines” included in the new policy, which will be defined by the Commissioner of the Food and Drug Administration (FDA).
- Executive Order on Improving Rural Health and Telehealth Access: This EO seeks to expand access to telehealth services, especially for rural Americans. There has been a broad expansion of telehealth due to the COVID-19 emergency. This EO directs federal agencies to improve access to rural health care via telehealth and evaluate which of the COVID-related, temporary changes should be made permanent. Komen has been advocating with Congress and the Trump Administration for telehealth access to be permanently expanded and to address barriers to its use by patients and providers.
- Executive Order on Lowering Drug Prices by Putting America First: Released in September, this EO seeks to ensure that the prices for some drugs in Medicare Parts B and D are not higher than prices paid in other countries (also called a “most favored nation” policy). The policy for Part B drugs was called the International Pricing Index when first proposed in 2018. Back then, Komen submitted comment letters, both alone and within coalitions, stating opposition to the broad implementation of the policy and asking for safeguards to ensure that access to care is not harmed. The potential expansion of the policy to Part D drugs is new and could have even broader effects. Similar to the other EOs, further policymaking is required for the policy to be implemented. Komen will carefully review the details of the policy when rulemaking is released and assess the impact on the breast cancer community. Komen will also continue its advocacy to ensure that access to care for breast cancer patients and survivors is maintained.
- Memorandum on Deferring Payroll Tax Obligations in Light of the Ongoing COVID-19 Disaster: This memorandum directs the Secretary of the Treasury to allow employers to defer payroll tax obligations for employees earning less than $8,000 per month from September through December 2020. There have been news stories about the Administration pursuing a longer deferment or cancellation of payroll tax obligations, as well. Since payroll taxes fund Social Security and Medicare, Komen would be concerned about the potential effects of such permanent policies on the long-term viability of these programs and the impact on coverage for elderly Americans if payroll tax breaks were extended.
Komen will continue to monitor for implementation of these policies and any additional Executive Orders or memoranda that may be released affecting our community. Sign up to become an Advocacy Insider to stay up to date on the activities of Komen’s Center for Public Policy.