Approximately 70 percent of Americans take one or more prescription medications per day, and 24 percent of Americans take at least four prescription medications per day.¹ Additionally, 41 percent of people in the U.S. have medical debt, and many people delay care because they’re afraid of the cost.² In addition to this, more than 60 percent of Americans live paycheck to paycheck.³
This leaves people in very difficult financial situations on top of potentially being in poor health if they’re delaying care. Several pieces of legislation have been created to begin addressing these problems, and in late September 2023, updates were made to the Transparency in Coverage Final Rules and Section 106 of the Lower Costs, More Transparency Act. Let’s take a look at the changes and what they could mean for you.
Affordable Care Act Implementation Part 61 Updates
On Sept. 27, 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) clarified the prescription drug machine-readable file (Rx MRF) requirements provision of the Transparency in Coverage Final Rules.
CMS determined that enforcement of the Rx MRFs won’t meaningfully conflict with the reporting requirements outlined in Section 204 of division BB of the Consolidated Appropriations Act (CAA). The CAA requires different and additional information to be disclosed than what’s required in the final rules of the Transparency in Coverage Act. Therefore, case-by-case enforcement—rather than overall enforcement—is appropriate.
While Rx MRF requirements aren’t in effect for Jan. 1, 2024, Healthcare Bluebook is continuing to monitor communications for continued guidance on the file layout and timeline to implement the Rx MRF requirements.
The federal rule-making process has several steps, beginning with the publication of draft rules and open public commentary before issuance of final rules, which is then followed by implementation guidance. CMS has signaled that it intends to move directly to implementation guidance on the Rx MRF requirements, which would shorten the process. However, it’s important to note that requirements can and do change, so Healthcare Bluebook is continuing to monitor changes.
Section 106 of the Lower Costs, More Transparency Act Updates
The Lower Costs, More Transparency Act was written with patients in mind; it requires hospital pricing to be made clear and understandable to patients. Additionally, it addresses the cost of prescription drugs by expanding access to more affordable generic options and providing employers with the drug price information they need to get the best deals for their employees.
The act also requires complete transparency of rebates and claims information in the form of MRFs to be delivered to plan sponsors at least every six months, with civil penalties of up to $10,000 per day for delays. These changes are effective two years after the passage of the amendment, and MRFs are to be standardized one year after the passage of the amendment.
The updates will require pharmacy benefit managers (PBMs) to disclose information for the plan sponsor to create reporting every six months (or every three months if the plan sponsor requests) in MRF format for all covered drugs during the reporting period.
Information to Be Included in MRFs
The following information must be included in Rx MRFs:
- Standard claims data
- Rebate price per drug per fill after rebates, fees, and other adjustments
- Total amount the plan did or will receive in drug manufacturer rebates, fees, and alternative discounts
- Total rebates the drug manufacturer paid during the period for claims and utilization
- Total amount of remuneration, including copayment assistance dollars or other discounts the drug manufacturer provided to the participants enrolled in the plan
- Total gross spending on drugs in each category or class before rebates and the net spending after such rebates
- Rebates paid per claim, utilization, and category and rebates paid to consultants
How Healthcare Bluebook Is Addressing These Updates
Nearly 20 years ago, we introduced the concept of transparency in healthcare. Healthcare Bluebook was founded on the belief that everyone should have access to the true cost and quality of healthcare, and our commitment to transparency is unwavering.
Healthcare Bluebook will be able to handle MRFs created by PBMs, and we’re continuing to monitor updates and new communications regarding the Transparency in Coverage Final Rules and the Lower Costs, More Transparency Act.
A Different Perspective on Compliance
We understand that compliance can be daunting. But it’s time to look at compliance from a different angle and use it as a unique opportunity to transform it into a business strategy. Download our guide to find out how Healthcare Bluebook can help you use compliance to your advantage.