Earlier Today, CMS Issued Some Revisions -- Including On Confidentiality -- To The Policies For Coming Drug Price Negotiations...

Some trade publications have already suggested that the changes in policies are the direct result of pressures exerted in the federal suits filed. I think that unlikely. [In fact, almost all the changes were drafted before the first suit was filed.]

The simpler, and likely more accurate explanation is that the government wants to maximize the chances that both drug-makers see fair prices, and the public sees. . . meaningfully reduced, or at least flattened, prices. . . on many older but widely prescribed drugs. Here's a bit from the factsheet, and the new guidance itself (of nearly 200 pages):

. . .Negotiation Process: CMS revised section 60.4.3 to clarify that CMS will respond in writing no later than 30 days after receipt of a manufacturer’s counteroffer regardless of whether CMS accepts or rejects the counteroffer. CMS has clarified that, to effectuate any MFP agreed upon by CMS and the Primary Manufacturer, both CMS and the Primary Manufacturer must sign and execute an Addendum to the Agreement. CMS also clarified in section 60.4.4 of the revised guidance that if an agreement on an MFP is not reached by the statutory end of the negotiation period, the Primary Manufacturer will enter a period during which an excise tax potentially may be assessed. The Primary Manufacturer can end this period by agreeing to an MFP or sending a notice terminating all of its applicable agreements under the Medicare and Medicaid programs and establishing that none of the Primary Manufacturer’s drugs are covered by an agreement under section 1860D-14A or section 1860D-14C of the Act. . . .

Publication of MFPs for Selected Drugs: CMS clarified in section 60.6 of the revised guidance that CMS will publish the following on the CMS website by September 1, 2024 for all initial price applicability year 2026 selected drugs where an MFP was agreed upon: the selected drug, the initial price applicability year, and the MFP pricing file (which would be updated annually to show the inflation-adjusted MFP for a selected drug). CMS will strive to publish the explanation of the MFP earlier than March 1, 2025, if feasible. . . .

More on all this, as it develops -- but the suits were and are. . . losers. The larger point would be that Americans are likely to see hundreds of billions of dollars in annual savings, on government spending for drugs. And that is something the Supreme Six cannot stop.

Smile.

नमस्ते