The rule will come into effect on January 1, 2024.
While several pharmacy groups praised the Centers for Medicare and Medicaid Services (CMS) final rule on direct and indirect reimbursement (DIR) reimbursements retroactively, they are concerned about implementation delays and other issues.
The Last Line of CMS, Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs1 late last month. The provisions of the rule regarding DIR fees will come into effect on January 1, 2024.
According to the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), and other organizations, delaying implementation until 2024 is a missed opportunity for patients and pharmacies.
“We are disappointed that PPE and their insurer partners/owners have been given another year to manipulate the system and start charging seniors higher costs,” said NCPA CEO B. Douglas Hoey, R.Ph., in a press release.2
Furthermore, the last line does not prohibit: [pharmacy benefit manager] contract terms that allow for penalty payments after prescriptions leave the pharmacy; therefore, retroactive sanctions may still occur. CMS must close this loophole to realize the meaningful pharmacy DIR reform that so many of us have been fighting for,” Hoey added.
APhA praised the adoption of the final rule and the elimination of a proposed loophole “that would have left it up to Part D’s plans and PBMs to determine how much, if any, of the pharmacy’s price concessions they would pass on.” to patients at the point of sale during the coverage gap in the Medicare Part D program,” APhA said in a press release.3
CMS’s last line “only shifts the fees to the negotiated price at the point of sale. It doesn’t eliminate these fees,” APhA said.
“Using DIR fees retroactively is a step in the right direction, but it’s just the tip of the iceberg to end the business practices of PPE that harm patients and our pharmacies.” land,” said Scott J. Knoer, MS, PharmD, executive vice president and CEO of APhA.
NACDS President and CEO Steven C. Anderson praised CMS for “initiating the much anticipated reform of these appalling DIR fees in a way that benefits seniors.”4
“We appreciate CMS finalizing this rule and improving the proposed rule according to some recommendations from NACDS… CMS has taken action to address transparency across all components of Medicare — including prescriptions completed for patients in the ‘coverage gap,'” Anderson said.
“However, it is vital that additional regulatory guardrails are put in place and to avoid unintended consequences that could harm both patients and pharmacies,” Anderson noted.
“It is crucial that there are no further delays. Further, NACDS is calling on Congress and CMS to swiftly implement the additional comprehensive reforms that are essential for pharmacy viability and patient access. The pro-patient and pro-pharmacy work that remains includes establishing standardized quality measures for pharmacies, which deserve immediate legal remedy,” Anderson added.
Leslie G. Sarasin, president and CEO of FMI-The Food Industry Association, also praised CMS but expressed similar concerns to the association’s other executives.
“FMI is pleased that CMS has heard our long-held concerns about predatory PPE practices such as retroactive DIR fees and determined that regulatory action is desperately needed to reduce drug costs for patients and provide pharmacies with greater certainty so they can run their businesses. to continue and to continue. serve their customers,” Sarasin said in a press release.5 “While we welcome these important reforms, we also believe that the Biden administration has missed an opportunity to provide rapid relief to both consumers and pharmacies by delaying implementation of this rule until 2024.”
Despite their vital role in serving communities, particularly during the last 2 years amid the pandemic, supermarket pharmacies have struggled to stay in business or grow their pharmacy business, especially in underserved areas, due to the anticompetitive practices of PPEs, Sarasin said.
Some FMI members have even been forced to close or sell their pharmacies due to “exorbitant” DIR fees, which Sarasin says has significantly reduced access for consumers.
1. Final Rule: Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs. CMS. Published April 29, 2022. Accessed May 19, 2022. https://public-inspection.federalregister.gov/2022-09375.pdf
2. NCPA: Final Rule Improves Transparency; protection for patients and pharmacies is still needed. news item. National Pharmacy Association. May 2, 2022. Accessed May 19, 2022. https://ncpa.org/newsroom/news-releases/2022/05/02/ncpa-final-rule-improves-transparency-protections-patients-and
3. APhA appreciates CMS’s elimination of retroactive DIR fees. news item. American Pharmacists Association. May 2, 2022. Accessed May 19, 2022. https://pharmacist.com/APhA-Press-Releases/apha-appreciates-cms-elimination-of-retroactive-dir-fees
4. With the DIR Transparency Rule completed, NACDS urges continued push for comprehensive reforms. news item. National Association of Chain Drug Stores. May 2, 2022. Accessed May 19, 2022. https://www.nacds.org/news/with-dir-fee-transparency-rule-finalized-nacds-urges-continued-push-for-extensive-reform/
5. FMI welcomes reforms to pharmacy DIR regulations to reduce drug costs and increase transparency, despite delays in implementation. news item. FMI, the Food Industry Association. May 1, 2022. Accessed May 19, 2022. https://www.fmi.org/newsroom/latest-news/view/2022/05/01/fmi-welcomes-pharmacy-dir-regulatory-reforms-to-reduce- drug-cost-and-increase-price transparency-despite-implementation-delay