Bill would reform PBM practices to lower Part D costs

Last Wednesday, bipartisan members of the Senate Finance Committee introduced legislation titled, Patients Before Middlemen Act. The bill is designed to reduce costs for Medicare Part D plans by cutting the compensation to pharmacy benefit managers (PBMs).

The sponsors believe the bill will lower Part D costs by increasing transparency and reducing fees paid to PBMs, which they assert misalign incentives, distort the market via insufficient transparency, reduce hurdles to pharmacy access, and increase competition.

The Patients Before Middlemen Act would prevent PBMs contracting with Part D plans from linking service fees to the price of a drug, rebates, discounts, or other fees. The bill would also bar PBMs from stipulating compensation based on drug price as a condition of entering a contract. Additionally, the bill would create an enforcement mechanism requiring PBMs to repay the Department of Health and Human Services (HHS) any amount that exceeds the designated fees.

The next step would be to have the committee vote to place the bill before a full Senate vote.

The bill adds to what Becker’s Hospital Review has listed as (at least) 7 other PBM-related bills working their way through Congress. PBMs have been Congress’ punching bag this term; they have, so far, escaped serious reform efforts. That is likely going to change.

Legislative bytes

IRA snippets

It was just my imagination (once again) 

Does it seem like the comment period for the Institute for Clinical and Economic Review (ICER) proposed updates to its value assessment framework is going by in a flash? It’s not your imagination. Comments are due on June 30, which caps a ridiculously short 18 business-day comment period (even fewer if you factor in the busy conference season and summer vacation plans). In 2019, the last time ICER opened its framework for public comment, 55 organizations commented during the open input period, and 42 organizations commented on the proposed changes after the open input. This time around, there were 0 open input comments (ICER skipped that part), and Value Corner predicts a sharp drop-off in the number and diversity of stakeholder comments ICER will receive on its proposed changes due to the shortage of available time.

On Wednesday, ICER announced The Commonwealth Fund has provided a grant to support ICER’s third annual “Barriers to Fair Access” assessment. If this sounds familiar, it’s not your imagination. Health Policy Weekly previously covered ICER’s announcement of the third installment of this report and its updated protocol in April, but it’s nice to know that the already-announced report has funding in place. The release date for the report has been delayed to November 2023.

On the topic of fair access, last week researchers at the American Enterprise Institute released an analysis that included a look at Medicare Part D insurance coverage. Researchers found that “high value products are not covered at greater frequency than low value products.” Among the many potential reasons for this finding, one possibility raised by the authors is that ICER’s value-based prices “may simply not accurately reflect the full value of the product.” We imagine that statement will make it into many ICER comment letters next week.

If you need assistance with all things value assessment or ICER-related, please contact Kimberly Westrich (but maybe wait until after July 4, as I’m hoping to retain the tail end of my ICER-interrupted vacation).

MedPAC’s recommendations to Congress to reduce Medicare Part B spending 

Last Thursday, the Medicare Payment and Advisory Commission (MedPAC) sent Congress its June report with recommendations to reduce Part B spending, among recommendations for other Medicare programs. According to the report, as new therapeutics entered the market, Part B spending increased an average of 9% per year from 2009 to 2021 in response to the rising prices of drugs and biologics. MedPAC attributes this increase to the high initial price of therapeutics with limited evidence on clinical efficacy and the subsequent growth in the cost of existing treatments. To control the price of newly released drugs, encourage competition among products and their alternative therapeutics, and reduce the financial burden on beneficiaries, the commissioners unanimously approved the following 3 recommendations:

Although Congress is not required to implement these recommendations, the report sets a tone for MedPAC’s objectives in decreasing Medicare Part B spending. Manufacturers releasing novel drugs, both on and off the accelerated approval pathway, and healthcare providers will need to be aware of these policies and their implications for future actions as MedPAC continues toward its goals.

CMS provides details about Alzheimer’s disease registries 

Late Thursday afternoon, CMS released a fact sheet providing additional details about how a registry will work to ensure beneficiaries will have coverage for any monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease that receives FDA traditional approval.

The agency indicated it is working with multiple organizations preparing to open their own registries, all of which will be listed at https://www.cms.gov/medicare/coverage-evidence-development/monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease-ad. Clinicians will be able to choose in which registry to participate.

CMS stated the registry will obtain information relevant to the questions in the NCD, including clinician/submitter demographic information, patient’s demographic information, and patient’s clinical information.

Information buffet (AKA, other stuff that caught our attention)