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Major Drug Policy Developments

Major drug policy developments this week.

First, the hospital lobby scored a major victory when a court ordered the new 340B rebate pilot paused. The Trump administration is seeking to experiment with rebates as opposed to upfront discounts to curb the growth in the discount drug program. The administration rightfully alleges that the program is unaccountable and does not meet the original safety net purpose.

The judge ordered a preliminary injunction against the “hastily assembled” pilot set to kick off on Jan. 1 on the basis it “likely” violates the Administrative Procedure Act’s (APA’s) arbitrary and capricious standard. 

The judge noted Congress did authorize the federal government to create a rebate model, but regulators had not followed the APA’s requirements in doing so.

Second, Rep. Anna Paulina Luna, R-FL, says she is hopeful Congress will codify President Trump’s executive order on capping prescription drug prices next year. As you know, I believe that is essential.

Third, The Wall Street Journal finds that mail-order pharmacies owned by UnitedHealth and Humana dispensed Medicare prescription refills earlier and more frequently than industry peers. The analysis found mail-order pharmacies filled 9% of Medicare prescriptions between 2021 and 2023 but accounted for 37% of excess dispensing. Too-frequent refills across all pharmacies cost Medicare and patients $3 billion during that period, the newspaper reported.

Fourth, in 2025 the Food and Drug Administration approved 73 first-time generic drugs, many impacting major disease states. This is a boon for consumers but will hit brand drug makers’ margins.

Additional articles: https://www.fiercehealthcare.com/providers/hospital-groups-file-lawsuit-enjoin-pharma-supported-340b-rebate-pilot and https://www.beckershospitalreview.com/pharmacy/73-drugs-lost-exclusivity-in-2025/ and https://www.beckerspayer.com/payer/unitedhealth-humana-mail-order-pharmacies-led-in-excessive-medicare-refills-report/ and https://thehill.com/homenews/house/5665539-luna-hopes-congress-action/

(Some articles may require a subscription.)

#340B #drugpricing #generics

https://www.modernhealthcare.com/politics-regulation/mh-340b-drug-rebates-pilot-program-judge-preliminary-injunction

Exchange Subsidy Deal 50-50

Some lawmakers are saying that there may be a 50-50 shot at obtaining an agreement to extend enhanced Exchange premium subsidies in January. But there are major obstacles. GOP leaders in each house are tending to gravitate toward the larger conservative side of their caucuses, which is dead set against an extension. Minority Leader Chuck Schumer, D-NY, wants either a clean extension or to hang the issue around the GOP’s neck in midterms.

Sen. Bill Cassidy is advocating the possibility of extending subsidies as well as seeding health savings accounts (HSAs) for some and giving Americans the ability to decide one way or another. Another leading compromise would extend for two years with some reining in of the generosity of the enhancements.

The bill could come to life in this way. Four GOP lawmakers in the House signed on to a Democratic discharge petition which will force a vote for a three-year extension in the House. That has failed to pass the Senate, but the bill could be used as a vehicle for a compromise crafted in the Senate. The bill would then go back to the House.

Meanwhile, there are no public signs, yet enrollment is falling demonstrably due to the expiration of subsidies. Federal data released on Dec. 5 showed sign-ups across all 50 states increased 7.5% (5.7M vs. 5.3M) compared with the same period in 2024. Centers for Medicare and Medicaid Services (CMS) Administrator Dr. Mehmet Oz posted on social media Tuesday that more than 15.6 million people enrolled in a plan on the federal exchanges, down from 16 million last year — just a 2.5 percent decline.

But states are appearing to see falloffs, terminations, and changes to less robust plans. Time will tell.

In other news, a good article on changes to federal regulations since Trump 47 came in. Major streamlining, eligibility restrictions, 340B reform, site neutral reform, and major cost-savings pilots.

Additional articles: https://thehill.com/homenews/senate/5662800-gop-senator-health-care-deal/ and https://www.modernhealthcare.com/politics-regulation/mh-federal-health-regulation-2025-hhs-cms/

(Some articles may require a subscription.)

#exchanges #healthcare #coverage #regulations

https://www.politico.com/news/2025/12/24/obamacare-sign-ups-are-steady-but-warning-signs-emerge-00705604

Trump Administration Unveils GLP-1 Pilot

True to an earlier announcement, the Trump administration has taken the first step toward more expansive coverage of GLP-1 weight-loss drugs in Medicare and Medicaid. The president announced major deals with GLP-1 drug makers Eli Lilly and Novo Nordisk that both reduce net costs as well as set a proposed maximum $50 copay in Medicare for all coverage of GLP-1s.

The new step includes the creation of the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model. Under the model, the Centers for Medicare and Medicaid Services (CMS) negotiates directly with pharmaceutical manufacturers for lower net prices and standardized coverage terms. Negotiation areas include: 

• Guaranteed net pricing and potential out-of-pocket limits for beneficiaries.
• Standardized coverage criteria.
• Evidence-based lifestyle support offerings.

Participation will be voluntary for manufacturers, states, and plans. More information will be released in early 2026. The BALANCE Model will launch in Medicaid as early as May 2026 and in Medicare Part D in January 2027. Manufacturers, states, and Part D plans need to apply by January 8, 2026.

In Medicare, the model may adjust capitated payment rates for obesity and increase the government reinsurance for drug fills. Final details will be announced ahead of the 2027 Part D bid process. It is anticipated that existing users of GLP-1s in Medicaid and Medicare for approved disease states will benefit, not just new users for obesity alone. Lower costs for drugs will be via a prescribed rebate from manufacturers to Part D plans.

To bridge to 2027 in Part D, there will be a new GLP-1 payment demonstration beginning in July 2026. This will operate outside of Part D and plans will not carry risk for eligible GLP-1 products furnished under the demonstration.

In other news, the Food and Drug Administration (FDA) has approved Novo Nordisk’s oral version of the Wegovy weight loss pill. The pill forms of the drugs appear to be somewhat less potent, but are more convenient and could broaden use. Trump also gained concessions on oral forms of GLP-1s. Eli Lilly will likely gain approval of its oral GLP-1 in the coming weeks.

Additional articles: https://www.cms.gov/newsroom/press-releases/cms-launches-voluntary-model-expand-access-life-changing-medicines-promote-healthier-living and https://thehill.com/policy/healthcare/5660548-fda-approves-wegovy-weight-loss/ and https://www.healthcaredive.com/news/novo-nordisk-oral-wegovy-fda-approve-glp-1/808626/

#glp1s #weightlossdrugs #branddrugmakers #drugpricing #medicare #partd #medicaid

https://www.beckerspayer.com/pharmacy/cms-kicks-off-glp-1-model-6-notes/

Strategy On Exchange Subsidies Continues; Another Shutdown Possible

House Minority Leader Hakeem Jeffires, D-NY, predicted that an extension of enhanced Exchange subsidies will pass the House with backing from both sides of the aisle. “House Democrats are going to continue to fight to get this extension through the Congress on our side. It will pass with a bipartisan majority,” Jeffries told ABC News’ “This Week.” With four GOP members joining Democrats to force a vote on the floor in January via discharge petition, the likelihood is there that the vote could pass.

The three-year extension failed in the Senate, unable to get 60 votes. A bipartisan group there still thinks a compromise including a shorter extension, minimum premiums, an income cap, and fraud protections could be hammered out for each chamber. But there are reported barriers to a deal, including political pressures in the GOP caucus not to vote on any extension bill.

A further complication: Senate Democrats are raising the threat of another government shutdown in late January. Senate Democrats walked away from a potential deal to fund numerous departments covering about two-thirds of the discretionary budget.

Additional articles: https://thehill.com/policy/healthcare/5659243-jeffries-predicts-aca-extension/ and https://thehill.com/homenews/senate/5657868-senate-health-care-battle-obamacare/

#exchanges #healthcare #coverage #governmentshutdown

https://thehill.com/homenews/senate/5657834-senate-democrats-threaten-government-shutdown

Trump Moves Ball On Drug Prices

President Donald Trump registered more wins on drug price reform. The White House announced that nine additional pharmaceutical companies have agreed to follow a most-favored-nation (MFN) drug pricing policy, with some of the companies throwing in several months’ worth of emergency drug supplies.

As with other drug firms, the drug companies will lower the Medicaid prices for drugs that are more expensive than they’re sold in other countries, although prices are already deeply discounted through federal and state rebate programs. The firms will also deeply discount cash-pay customers’ drugs via the TrumpRx website. The deals also guarantee MFN prices on all new innovative medicines the nine companies bring to market.

Trump has now reached deals with 14 of the 17 drug makers to which he sent letters in July demanding that they lower prices.

At the same time, the Centers for Medicare and Medicaid Services (CMS) seeks to reduce Medicare drug costs through a pair of payment demonstrations announced Friday. CMS would tie the prices Medicare Part B and Part D pay for medicines to costs in foreign countries. The Global Benchmark for Efficient Drug Pricing Model, or GLOBE, would cover Part B drugs. A second mandatory initiative called Guarding U.S. Medicare Against Rising Drug Costs Model, or GUARD, would cover Part D drugs. The agency estimates that the Part B model will save $11.9 billion in net spending over seven years. Roughly a quarter of Medicare beneficiaries will participate in the program.

The models would run from 2027 through 2031, with rebate invoicing and reconciliation continuing into 2033.

Additional articles: https://thehill.com/policy/healthcare/5657095-trump-policy-pharma-agreement/ and https://www.beckerspayer.com/payer/cms-proposes-2-medicare-drug-pricing-models/

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#drugpricing #branddrugmakers #trump

https://www.modernhealthcare.com/politics-regulation/mh-cms-globe-guard-medicare-drug-pricing

Exchange Saga

Top House Democrats on Thursday called on House Speaker Mike Johnson, R-LA, to hold an immediate vote under the discharge process on extending the enhanced Exchange premium subsidies so they do not expire at the end of the year. Johnson is unlikely to do this due to objections from conservative caucus members. The House adjourns tomorrow for rest of the calendar year.

A discharge petition for a bill to extend the subsidies received 218 signatures, including four moderate GOP lawmakers who snubbed the Speaker after he broke promise to run an amendment on the subsidy extension. These members are now working with moderates in the Senate to vote on a consensus bill in January.

#exchanges #coverage #healthcare

https://thehill.com/homenews/house/5654903-jeffries-democrats-johnson-obamacare-subsidies/?tbref=hp

Houses Passes GOP Healthcare Reform Bill

The House passed its healthcare reform today with no vote or provisions to extend the enhanced Exchange premium subsidies. The vote was 216-211, with one Republican defecting. By and large, the bill does little to solve the affordability problem:

• Expands association health plans.
• Expands individual coverage health reimbursement arrangements (ICHRAs).
• Expands catastrophic stop-loss coverage for more employers.
• Funds cost-sharing subsidies that were removed under Trump 45.
• Implements pharmacy benefit manager (PBM) reforms.

The vote comes after Speaker Mike Johnson, R-LA, broke his promise to hold a vote on a subsidy amendment. Johnson broke his word after conservatives objected. The GOP leadership blames the backtrack on no plan from moderates to pay for the major cost of the extension. But the caucus recently passed the One Big Beautiful Bill Act (OBBBA) without major offsets, increasing budget deficits by $4.1 trillion with interest over 10 years. And conservatives on the Rules Committee turned down moderate amendments and simply did not want to allow a subsidy vote.

Given the duplicity of the speaker, GOP Reps. Rob Bresnahan (Pa.), Brian Fitzpatrick (Pa.), Mike Lawler (N.Y.) and Ryan Mackenzie (Pa.), have signed onto a Democratic discharge petition to pass a three-year extension. This is a stunning rebuke of the Speaker. The subsidy vote would not take place now until January, though. As is, even if the bill passed the House, a similar bill failed to get 60 votes in the Senate.

Due to that, some moderate Republicans are now meeting with moderates in the Senate to come to an agreement on a version that could get 60 votes in the Senate, which would require 13 GOP senators to votes with Democrats.

Additional articles: https://www.modernhealthcare.com/politics-regulation/mh-house-passes-healthcare-bill-aca-subsidies/ and https://www.medpagetoday.com/publichealthpolicy/washington-watch/119070 and https://www.fiercehealthcare.com/regulatory/house-gop-healthcare-bill-eschews-subsidy-extension-hsas and https://thehill.com/homenews/house/5653462-moderate-gop-obamacare-senators/ and https://thehill.com/homenews/house/5652673-gop-centrists-democratic-obamacare-discharge-petition/ and https://thehill.com/homenews/house/5652894-house-republicans-aca-subsidies-lawler-fitzpatrick-bresnahan-mackenzie/ and https://thehill.com/homenews/house/5653238-fitzpatrick-gop-leaders-obamacare/?tbref=hp

(Some articles may require a subscription.)

#exchange #congress #healthcare #coverage

https://thehill.com/homenews/house/5653811-house-gop-health-care-bill

Speaker Rebuffs Moderates On Exchange Extension Vote

In a rebuff to moderates in his caucus, House Speaker Mike Johnson, R-LA, said he won’t call a vote to extend the Exchange enhanced subsidies. Moderates are livid that the speaker has broken his promise to hold a vote.

Johnson says the party’s leadership was unable to reach an agreement with moderates on offsetting cuts to the pricey extension. But moderates did submit multiple amendments to the Rules Committee to pay for part of the extension. Conservatives refused to vote to support the vote on the amendment.

Moderates likely still vote for the main House reform bill to be voted on. But some media say some GOP moderates have not ruled out signing onto a Democratic-led discharge petition to force a vote on a three-year extension. But other media report that this is unlikely. Four GOPers would be needed to hit 218 to bring it to the floor. However, GOPers are asking Democrats to sign onto one of their discharges, which take a more moderate approach to extension. Some Democratic leaders say that could happen.

Meanwhile, a bipartisan group of senators is meeting again on a compromise. Roughly 20 senators met Monday night. They are looking at using a proposal by Sens. Susan Collins, R-ME, and Bernie Moreno, R-OH as a base for possible action.

It seems clear that no extension will occur before the year turns, if at all. Johnson’s move could very well seal the fate of the swing of the House to Democrats in the 2026 midterms.

Additional articles: https://www.beckershospitalreview.com/finance/house-gop-wont-call-vote-on-aca-subsidy-extension/ and https://thehill.com/homenews/house/5651966-republican-tensions-obamacare/ and https://thehill.com/homenews/house/5651296-democrat-bipartisan-obamacare-bills/ and https://thehill.com/homenews/senate/5650544-senate-health-care-talks-obamacare/

(Some articles may require a subscription.)

#exchanges #healthcare #coverage

https://www.modernhealthcare.com/politics-regulation/mh-house-speaker-mike-johnson-aca-subsidies-vote

No Smooth Sailing: Agreement To Run Exchange Amendment Hits Rocks

An agreement between moderate Republicans and the House GOP leadership to allow a vote on an amendment to extend the expiring Exchange is in doubt as the two sides squabble over whether any extension will be paid for by spending offsets.

The amendment would extend the enhanced subsidies for two years but add certain eligibility reforms. But the House leadership is demanding spending offsets due to conservative objections. A full subsidy extension would cost about $35 billion a year.

Conservatives could derail the amendment in the Rules Committee even before it gets to the floor. GOP moderates could vote against the bill as a whole and sink it as Democrats will not support it. As an alternative, the GOP moderates could team up with Democrats to force a vote via one of several discharge petitions, which need 218 signatures to come to the floor without the Speaker’s permission. House Democrats say they’re looking for the green light from their leadership to band together with moderate Republicans.

A free-standing extension would have a better shot at passing the House. In the Senate, 13 Republicans would have to vote with Democrats to reach a 60-vote requirement to pass the bill.

Meanwhile, more is being released on the GOP master reform bill. The bill would approve association health plans, which have employers band together to purchase coverage. These plans have some but not all Affordable Care Act (ACA) protections. Individual coverage health reimbursement arrangements, or ICHRAs, would be expanded. These provide employer subsidies to allow employees to purchase Exchange coverage. Broadened access to stop-loss coverage for mid-size and small employers would be included, which would encourage additional self-insurance vs insurer risk arrangements.

Pharmacy benefits manager reform is also included. And cost-sharing subsidies in the Exchange would be reappropriated. This was defunded under Trump 45. The move would lower overall Silver premiums but have the adverse effect of lowering subsidies now, causing 300,000 to perhaps drop coverage.

The House bill does not endorse expansion of health savings accounts (HSAs), which is what the leading Senate bill proposed to do in lieu of an enhanced subsidy extension.

Additional articles: https://www.modernhealthcare.com/politics-regulation/mh-house-aca-subsidies-association-health-plans/ and https://thehill.com/homenews/house/5650083-aobamacare-subsidies-amendment-vote/ and https://thehill.com/homenews/house/5647098-obamacare-subsidies-house-democrats/

(Some articles may require a subscription.)

#exchanges #healthcare #coverage

https://www.fiercehealthcare.com/regulatory/house-gop-healthcare-bill-eschews-subsidy-extension-hsas

House GOP To Allow Vote On Exchanges But By Amending Major Reform Bill

Two major decisions from GOP leaders in the House today. First, it will allow a vote on an Obamacare extension to appease several dozen vulnerable Republicans in swing districts. Second, but this will come via an amendment on a broad reform bill from Republicans focused on more conservative reforms.

The main bill will feature the following reforms. Exchange cost-sharing subsidies would be funded to lower Silver premiums. This has positive and negative effects depending on subsidy status and income. Greater self-insurance provisions would be included, along with pressing for cheaper plan designs. Some pharmacy benefits manager reforms would be included.

Even if the amendment passed, the bill would ultimately not pass in all chambers because it would be viewed as a poison pill by Democrats, especially in the Senate.

Democrats are attempting to force a separate vote on a clean three-year extension. Moderates from both parties are looking at passing bills with a shorter extension and some reforms to the credits.

Meanwhile, President Donald Trump said he might be willing to work with Democrats on healthcare reform given affordability issues. Moderate GOPers in each chamber are putting pressure on their leaders to arrive at a real compromise instead of theatrics.

Additional article: https://thehill.com/homenews/house/5646341-gop-leaders-obamacare-vote/ and https://thehill.com/homenews/administration/5646004-donald-trump-democrats-health-care-aca-subsidies/?tbref=hp and https://thehill.com/homenews/senate/5645498-republicans-pressure-health-care-costs/

#exchanges #healthcare #coverage

https://thehill.com/homenews/house/5646973-house-gop-health-care-bill-obamacare