Republican lawmakers in an Aug. 26 letter to the Congressional Budget Office (CBO) criticized the rollout of a demonstration program that is intended to ease Medicare Part D premiums for beneficiaries and help stabilize the market but could cost taxpayers billions of dollars. It is the latest salvo from politicians since CMS announced the Part D Premium Stabilization Demonstration on July 29, the same day it revealed the national average monthly bid amount (NAMBA) would increase by nearly 180% next year.

Debra Devereaux, an executive consultant with Rebellis Group, speculates that some stand-alone Prescription Drug Plans (PDPs) “must have had eye-popping bids” to prompt CMS to launch the program. She suggests that PDPs likely increased their premiums for next year to offset major changes that are part of the Inflation Reduction Act (IRA) and will result in plans shouldering significantly more financial risk. The demonstration program is only for PDPs and does not include Medicare Advantage Prescription Drug (MA-PD) plans.

In the race between the largest PBMs to embrace — and monetize — biosimilars, UnitedHealth Group’s Optum Rx has quietly been making moves to counter its competitors’ headline-grabbing announcements. Specifically, Optum Rx next year will make Humira and Stelara biosimilars available through its new private-label drug distributor, Nuvaila, and change how its formularies treat the two drugs — echoing similar moves by CVS Health Corp. and The Cigna Group.

Now that CMS has revealed the prices of the first 10 drugs subject to Medicare price negotiation, all eyes are on how Part D plans will cover those drugs on their formularies in 2026, when the new prices go into effect.

To that end, a recent poll from Zitter Insights offers some clues about how payers and PBMs are thinking about this thorny question.

The flash poll was conducted after CMS revealed the results of the first round of the Medicare Drug Price Negotiation Program, which was authorized by the Inflation Reduction Act. Through that process, Medicare for the first time set a Maximum Fair Price (MFP) for 10 branded drugs selected due to their high cost and lack of generic or biosimilar competition.

Nearly 12% of generic prescription drugs could have had lower out-of-pocket costs if they were purchased through the Mark Cuban Cost Plus Drug Co. (MCCPDC) rather than through a traditional pharmacy using health insurance, according to a recent JAMA Health Forum study. Karen Van Nuys, Ph.D., a leading health policy expert who was not involved in the study, tells AIS Health the Mark Cuban company is doing a “tremendous service” by making medication prices transparent, although she suggests that it remains to be seen whether the firm and other cash pharmacies will have a major impact on the prices plans and members pay for drugs.

Mark Cuban, a billionaire, founded MCCPDC in 2022 to bring more transparency to drug pricing and improve access to medications. The company discloses the amount it pays for drugs and then adds a 15% markup, $5 pharmacy fee and $5 shipping fee.

If Medicare Part D covered GLP-1 drugs for obesity, rather than just Type 2 diabetes, it could increase annual spending by $3.1 billion to $6.1 billion, according to a recent Health Affairs study.

The introduction of GLP-1 medications for treatment of diabetes and obesity has reignited the debate over Medicare’s prohibition on covering weight loss medications. In June, the House Ways & Means Committee advanced legislation that would provide a limited pathway for adults 65 and older to get anti-obesity GLP-1s covered by Medicare. The bill has not yet passed the full House.

The Congressional Budget Office raised concerns about the potential harms of joint ownership of pharmacy benefits managers, health insurance companies and pharmacies in new responses to U.S. lawmaker questions, adding to the chorus of scrutiny that may be building toward 2025 congressional action against vertical integration in the health sector.

Insurance company and PBM mergers “tends to lower the prices paid for drugs” and “reduce spending on drugs for patients in vertically integrated health insurance plans,” the CBO found, but any reductions in spending by the plan may not be passed on to enrollees in the form of lower premiums.

From 2021 to 2023, the median share of health care dollars that large employers spent on pharmacy costs rose from 21% to 27%, according to the Business Group on Health’s 2025 Employer Health Care Strategy Survey. The survey also found that 56% of responding employers identified GLP-1s — which treat Type 2 diabetes, obesity and other indications — as driving health care costs to a “great extent” or “very great extent,” making it the top-cited trend driver. The next most cited cost driver was “high-cost therapies.” And when listing their top pharmacy benefit-related concerns, employers put “appropriate use and/or long-term cost implications of GLP-1s and other newer weight management medications” at the top of their list, with 70% and 20%, respectively, saying they were very concerned or concerned about that issue.

Echoing a proposal championed by the Biden administration, Democratic presidential candidate Kamala Harris said recently that if elected, she hopes to apply a $35 out-of-pocket cap on insulin to everyone in the country — not just those on Medicare. But newly published research into state out-of-pocket insulin cost caps raises questions about how much of an impact such a policy would make.

So far, 25 states and Washington, D.C., have passed legislation capping patients’ monthly out-of-pocket costs for insulin, with upper thresholds set between $25 and $100. Those caps apply only to state-regulated health insurance plans. Meanwhile, the Inflation Reduction Act (IRA) capped Medicare enrollees’ monthly out-of-pocket costs for insulin at $35, effective in 2023.

Bluebird Bio Inc. disclosed during its second-quarter earnings release on Aug. 14 that it has had only four patients start treatment with Lyfgenia (lovotibeglogene autotemcel), a gene therapy for sickle cell disease (SCD) that the FDA approved in December. While company executives claimed there was still strong patient demand and payer interest for the treatment, Wall Street analysts noted the launch was slower than expected and called into question the ability of the medication to make an impact in the market.

Bluebird executives also said they’re encouraged with the strides they’re making in discussions with payers, but admitted it was “too early to tell” if the drug will run into any coverage issues.

With the Medicare Part D national average monthly bid amount (NAMBA) set to spike 180% next year, CMS late last month unveiled a new demonstration program aimed at stabilizing a market that is experiencing unprecedented volatility.

However, some Republicans in Congress are up in arms over the demonstration, arguing that it contains “extra-statutory, eleventh-hour policy changes” aimed at cleaning up a problem created by the Biden administration’s most-touted health policy achievement.