You’ve probably already read a number of articles about HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance and the expected impact of the proposed changes. Now, you need to act. Attempts to modify existing regulations could greatly impact the already frail margins that are a reality for many hospitals and health centers – but HRSA may never know the true impact of the proposed changes unless they hear directly from affected covered entities.

Since the proposed changes were issued as “interpretive guidance,” HRSA was not required to complete a regulatory impact study. It’s up to you to help HRSA understand the expected costs to your organization and your patients. (Sentry clients can get assistance estimating the potential financial impact by reaching out to a 340B Compliance and Audit Team member.) The proposed guidance is open for public commenting on the Federal Register website through Tuesday, Oct. 27.

Here are four tips for responding to the proposed guidance before the deadline:

1. Consult with 340B Health, as well as your lawyers, compliance officers and consultants, to determine your talking points and get required approvals. Some points to consider:
   • How well does the proposed guidance reflect the business and clinical realities of healthcare at your hospital or health center?
   • How will the proposed guidance affect your current processes, procedures and technology? What changes will be required to meet new compliance requirements?
   • What is the direct and indirect impact to the patients you serve?
   • Does the proposed guidance fall within the rule-making authority of HRSA as clarified by a 2014 judicial ruling? The ruling noted that HRSA lacks the authority to create and enforce new regulations regarding the 340B program — but can provide interpretive guidance and clarification of the existing legislation.

2. Prepare comments on behalf of each hospital and child site, rather than one set of comments for multiple sites. This allows you to be more specific about the financial impact and affected services at each site, and helps HRSA better quantify the full impact of the proposed changes.

3. Consider how these six critical aspects of the proposed changes will affect each site:
   • Prescriptions resulting from follow-up care
   • Infusions administered at hospitals
   • Discharge scripts
   • Classification of outpatient medications
   • Provider limitations
   • Bundled drugs

4. Share your comments with your Congressional Representative and Senators to let them know how the proposed guidance could impact your ability to provide crucial patient services.

As proven before, your comments could make all the difference in avoiding drastic changes to the 340B program and keeping the original intent of the program intact: “to help covered entities stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services” by reducing the amount you spend on outpatient drugs. Proposed guidance drafted in 2007 was never implemented — due in part to the concerns raised by covered entities during the commenting period.

Please act now. Visit the Federal Register and submit your comments on the proposed guidance.