PBM Reform and 340B Program Changes Lead Federal Healthcare Policy Agenda
核心洞察
Over 500 state-level bills impacting managed care pharmacy are currently under consideration, with significant focus on PBM (搜索) reforms and 340B (搜索) hospital regulations to address drug pricing concerns.
The Medicaid VBPs for Patients (MVP) Act aims to improve transparency in drug pricing by clarifying definitions in the Medicaid best price rule and establishing federal standards for price calculations.
Congressional gridlock has delayed comprehensive PBM (搜索) reform legislation, though bipartisan support exists for banning spread pricing and de-linking PBM compensation from drug costs.
Pharmacy benefit managers (PBMs) and 340B (搜索) hospitals are facing increased scrutiny as federal and state legislators push for greater transparency and reform in drug pricing mechanisms. According to Adam Colborn, JD, associate vice president for congressional affairs at the Academy of Managed Care Pharmacy (搜索) (AMCP (搜索)), approximately 500 state-level bills targeting managed care pharmacy are currently under consideration.
"The state level is going crazy. There's a lot of legislation we're tracking; almost 500 bills at the state level that impact managed care pharmacy," Colborn stated during a recent policy update. "There's a lot of AI [artificial intelligence] activity at the state level as well, mostly focused on utilization management, so step therapy, prior authorization, that sort of thing."
Federal PBM Reform Efforts Face Delays
At the federal level, PBM (搜索) reform legislation that was included in a December package ultimately collapsed at the last minute. Despite this setback, industry experts anticipate these measures will resurface in 2025, likely as part of an end-of-year package rather than through reconciliation.
"The sentiment that I'm hearing is that there's bipartisan support for these PBM (搜索) reform packages, especially with the December version that was basically fully negotiated and agreed to," Colborn explained. "They don't want to put it in something that's going to be very partisan. They want to keep it as an option for a bipartisan endeavor later in the year."
The proposed reforms focus on several key areas:
- Eliminating spread pricing practices
- De-linking PBM compensation from drug costs
- Enhancing reporting requirements and transparency
340B Program Under Increasing Scrutiny
The 340B (搜索) Drug Pricing Program has become another focal point for potential reform, though stakeholders remain divided on specific changes. Hospitals and pharmaceutical manufacturers appear to have reached a stalemate in negotiations.
"There's this growing idea that reform is needed on the Hill, but no one can agree to what the exact reforms should be," Colborn noted. "We're seeing an emerging reliance on 340B (搜索) hospitals in certain sectors of the health care industry. Some of these health care benefit companies that are directing enrollees to 340B hospitals, either via telemedicine or going in person, that's a little bit new."
Several bills addressing the 340B (搜索) program are under consideration, including the Protect 340B Act, the Sustain 340B Act, and the 340B Access Act. These proposals aim to increase transparency, prevent duplicate Medicaid discounts, and potentially expand program access.
Medicaid VBPs for Patients Act: A Path to Price Transparency
One promising development is the Medicaid VBPs for Patients (MVP) Act, a bipartisan initiative that would clarify definitions in the Medicaid best price rule and establish federal definitions for average manufacturer price and wholesale acquisition cost.
"It would codify the best price rule, and then it would also, for the first time, create federal definitions around average manufacture price and wholesale acquisition cost," Colborn said. "Right now, the multiple best price rule sort of directs parties to use those figures in their calculations of their best price, but it doesn't go into all of the needed detail on how that might be calculated."
This legislation could particularly benefit Medicaid beneficiaries by improving access to high-cost treatments like cell and gene therapies that are currently unavailable under value-based arrangements.
Congressional Challenges and Budget Considerations
The current political landscape presents significant challenges for healthcare reform. Congress remains divided, with Republicans holding a slim House majority and a 53-47 split in the Senate. Legislative progress has been limited, with continuing resolutions (CRs) being used to maintain government operations.
The most recent CR extended funding for seven months, preserving most programs at prior-year levels. Budget reconciliation processes have revealed differing priorities between the House and Senate, with the House favoring broader spending cuts while the Senate takes a more conservative approach.
Potential Medicare and Medicaid Reforms
Several potential reforms to Medicare and Medicaid are under consideration:
- Site neutrality adjustments for Medicare Part B
- Changes to bad debt coverage
- Extension of sequestration policies
- Equalization of payments for able-bodied Medicaid adults
- Implementation of per capita spending caps
- Introduction of work requirements
Additionally, reductions to the Federal Medical Assistance Percentage (FMAP) floor could shift financial responsibilities to states, potentially affecting Medicaid expansion efforts.
Regulatory Updates and Agency Leadership
Key agency nominations include Robert F. Kennedy Jr. as HHS secretary, Marty Makary, MD, as FDA commissioner, and Janette Nesheiwat, MD, as surgeon general. These appointments may significantly influence healthcare policy direction in the coming years.
The Inflation Reduction Act (搜索)'s drug price negotiation process continues to advance, with the second negotiation round concluding in November and the first set of negotiated prices scheduled to take effect in January 2026.
Other regulatory developments include CMS terminating several payment model trials, the administration rescinding prior guidance on gender-affirming care, and HHS releasing a strategic plan for artificial intelligence in healthcare.
Looking Forward: Advocacy and Engagement
As the legislative and regulatory landscapes continue to evolve, healthcare professionals and stakeholders must remain engaged in the policymaking process. The complex interplay between federal and state initiatives will shape the future of managed care pharmacy, with significant implications for drug pricing, patient access, and healthcare delivery systems.
For managed care pharmacy professionals, staying informed about these developments and participating in advocacy efforts through organizations like AMCP (搜索) will be essential to navigating the changing policy environment and ensuring optimal patient outcomes.