About two and a half years ago, par8o decided to dive into the "grey area" of 340B - "referrals for consult" and resulting prescriptions. Given these scripts are more likely to be specialty scripts than scripts written by PCPs - and therefore carry higher price tags - the 340B benefit can be important to community health centers - if they can establish a compliant, scalable method of meeting HRSA's compliance requirements.
That's when our market research informed us that this particular area of 340B Drug Pricing Program was a bit like the Wild West - people understood the potential, but when it came to compliance and staffing requirements, most pharmacy managers and compliance officers said "No, thanks" due to fear - fear of manufacturer repayment and audit findings.
We uncovered that most health centers avoid "referral prescriptions" because the compliance requirements and resulting interpretations were unclear - or, if they were clear, the staffing requirements were prohibitive requiring funds that would be better allocated elsewhere.
Some health centers are fortunate enough to have a dedicated referral center, so "closing the loop" on referrals and retrieving specialist encounter notes to qualify resulting prescriptions was already in place - while others who chose to venture into the "wild west" relied a combination of the referral, ICD-10 codes, date ranges, and other "proximal" rules. But without the consult note, one can argue the evidence doesn't support the spirit of the 340B allowance - e.g. making sure 340B pricing is only awarded to health centers that truly own patient care.
Our Compliance Requirement Findings & Approach
During our research, we spoke with auditors, compliance experts, lawyers, Apexus, Captain Pedley, and so on - here are our takeaways on the requirements and approach, and what we use in our own operations to qualify prescriptions for our clients.
- Documentation of the patient encounter at the 340B covered entity's registered or eligible site with an employed or contracted provider. This is the basic premise for establishing responsibility for patient care. We require a 12-13 month maximum timeframe of the most recent patient encounter predating a matched prescription fill date.
- Documentation of the specialist referral in the patient's health record. This referral needs to originate from a site where you own the patient's care - so you'll want to exclude certain referrals, such as ED discharges. Secondly, documentation of the referral order within the EMR is the cleanest approach. Depending on your organization, this may require retraining of PCPs to input every referral into the EMR - if not already in place, this can be the most challenging part of the critical success factors to implement (aside from retrieving the consult note, which is the .
- Consult note from the referred-to specialist. The most challenging part of achieving compliance, but also the "gold standard" as far as compliance as it demonstrates true ownership of patient care by the referring organization. Secondly, the time frame between the encounter date on the consult note and the prescription fill date must be within reasonable time frames as well.
- All documentation is maintained at the 340B registered site. Documentation should be auditable and retrievable from your EMR. This key requirement proves an organization owns patient care.
- Updated Policies and Procedures with detailed descriptions of an organization's approach to prescriptions resulting from referrals. Detailed descriptions should include the timeframes your organization requires relating to encounters, timeframes and fill dates, and what a consult note must include in order to justify including a resulting prescription as a 340B claim.