Goodsurance
ES

Drug prices & Part D

Biotech Industry Group Files Second Lawsuit to Block Medicare's GLOBE Drug Pricing Model

BIO and two California biotech groups sued CMS on November 6, arguing the program exceeds legal authority. A first challenge from PhRMA filed in October remains pending.

By the Goodsurance editorial teamNovember 12, 2026

A second coalition of industry groups has filed suit in federal court to block Medicare's GLOBE drug pricing model. On November 6, the Biotechnology Innovation Organization, Biocom California, and California Life Sciences filed a complaint in the U.S. District Court for the Northern District of California seeking to halt the program before it takes effect.

The GLOBE model, finalized by CMS in October 2026, is set to begin January 1, 2027. Under the model, drugmakers would pay rebates when their Medicare Part B drug prices exceed benchmarks set by prices paid in 19 economically comparable countries, including Canada, Germany, Japan, and the United Kingdom. CMS has said the model would initially apply to randomly selected geographic areas covering roughly 25 percent of original Medicare beneficiaries.

A second industry group, this one from biotech, has sued to block Medicare's GLOBE international drug pricing model, opening a new legal front in California.

The plaintiffs argue that GLOBE exceeds CMS's legal authority under the law governing Medicare innovation models and does not function as a genuine demonstration project as the law requires. They characterize the model as a mandatory price-control mechanism structured as a pilot program.

The suit follows an earlier challenge filed in October by PhRMA, the brand pharmaceutical industry's leading trade association. As of this publication, neither case has produced a court order stopping the model, and both are in early stages.

For beneficiaries in original Medicare, the model is designed to bring rebates back to the program when Part B drug prices top the international reference level. Whether that happens depends, in part, on how federal courts assess these legal challenges.

In plain words

Medicare has a new program called GLOBE. It is set to start January 1, 2027. The program would make drug companies pay money back to Medicare when they charge more for certain medicines than other countries pay. At first, only about one in four original Medicare beneficiaries would be part of it, chosen by where they live.

A group called BIO, which speaks for biotech companies, is now suing to stop GLOBE. Two California groups joined the lawsuit. They say Medicare does not have the legal right to run this kind of program the way it is set up.

This is the second lawsuit against GLOBE. Another drug industry group called PhRMA filed the first lawsuit in October 2026.

No court has told Medicare to stop GLOBE yet. If the program runs as planned, some people on original Medicare could pay less out of pocket for certain medicines their doctor gives them in the office.

Source: STAT News
Read at the source →

More news

Other stories on what is moving in Medicare.

Drug prices & Part D

KFF: Medicare's 340B Drug Payment Cut Reduces Revenue for Safety-Net Hospitals While Raising It for For-Profit Ones

Now that the 2027 outpatient rule is final, a KFF analysis finds the 340B reimbursement cut falls hardest on hospitals that serve low-income patients, while for-profit hospitals see a net gain.

November 11, 2026

Drug prices & Part D

Medicare Drug Price Negotiation Rules Are Now Permanent, Federal Register Shows

The CMS-4215-F final rule, published today, converts the negotiation program from administrative guidance into binding federal regulation for every drug-price cycle starting in 2029, and requires Part D plans to cover negotiated-price drugs on their formularies.

November 9, 2026

Drug prices & Part D

Third Medicare Drug Negotiation Cycle Closes, Including Part B Doctor-Office Drugs for the First Time

The formal negotiation period for 15 drugs ended November 1; CMS must publish any agreed-upon maximum fair prices by November 30, including the first-ever negotiated prices for drugs given in doctors' offices.

November 1, 2026

Drug prices & Part D

Average Medicare Part D Stand-Alone Premium Projected to Rise 50 Percent for 2027, KFF Finds

A KFF analysis published today finds the average monthly premium for stand-alone Part D drug plans is on track to climb from 34 dollars to 51 dollars for 2027, with deductibles also rising sharply, for enrollees who do not switch plans before December 7.

October 30, 2026

Drug prices & Part D

Study: Medicare Drug Price Negotiations Cut Costs for Most Enrollees, but Not for Those Already Hitting the Annual Spending Limit

A research letter in Annals of Internal Medicine finds that patients on six of the first ten negotiated Part D drugs saw out-of-pocket costs fall 26 to 49 percent, while patients on the three highest-priced negotiated drugs saw no additional benefit because they were already reaching the annual cap.

October 24, 2026

Drug prices & Part D

A Customs Rule That Would Have Complicated Drug Orders From Canada Is Delayed Three Months

A new paperwork and bonding requirement for international mail containing medications was set to take effect today but was pushed back to January 20, 2027, preserving a cost-saving pathway that many Medicare beneficiaries and other older adults have come to rely on.

October 22, 2026