(CNN) — Undeterred by a growing number of lawsuits, the Biden administration on Friday released revised guidance for Medicare’s new drug price negotiation program.
The latest guidance outlines how the Centers for Medicare and Medicaid Services will negotiate with drugmakers to reach agreement on a maximum fair price for a selected medicine, the agency said. It was informed by public input on the initial guidance the agency released in March, which explained how it will select the drugs and how the negotiations will be conducted.
The program, which was authorized by the Inflation Reduction Act that congressional Democrats passed last year, has prompted a fierce backlash from the pharmaceutical industry. Two drug manufacturers and two industry groups have filed lawsuits, arguing the measure is unconstitutional.
But the administration is not backing down from implementing its historic new power. It intends to keep its timeline of announcing the first 10 drugs that will be selected for negotiation by September 1. CMS and the drugmakers will negotiate during 2023 and 2024. The prices will be effective starting in 2026.
“The Biden-Harris Administration isn’t letting anything get in our way of delivering lower drug costs for Americans,” Secretary of Health and Human Services Xavier Becerra said in a statement. “Pharmaceutical companies have made record profits for decades. Now they’re lining up to block this Administration’s work to negotiate for better drug prices for our families. We won’t be deterred.”
The initial set of drugs will be chosen from the top 50 Part D drugs that are eligible for negotiation that have the highest total expenditures in Medicare. CMS will consider multiple factors when developing its initial offer, including the drugs’ clinical benefits, the price of alternatives, research and development costs and patent protection, among others.
If drugmakers don’t comply with the process, they will have to pay an excise tax of up to 95% of the medications’ US sales or pull all their drugs from the Medicare and Medicaid markets. The pharmaceutical industry contends that the true penalty can be as high as 1,900% of sales.
Changes to the process
CMS said it received more than 7,500 comments on its initial guidance from patient groups, drug companies, pharmacies and others.
The changes it is making are aimed at improving transparency while keeping confidentiality in mind, as well as fostering “an effective negotiation process,” the agency said.
They include revising the confidentiality process to state that CMS will release information about the negotiations when it publishes the explanations of the prices. Also, drug companies may publicly discuss the negotiations – the prior secrecy requirement had been a point of contention among manufacturers that was mentioned in the lawsuits. And they won’t be required to destroy data relating to the negotiations.
In addition, CMS will hold patient-focused listening sessions to provide drug companies and the public more opportunities to engage with the agency. The sessions – which will give patients, caregivers and others the chance to share input on how a medication addresses unmet needs, how it impacts specific populations and what therapeutic alternatives exist – will be held in the fall for the first round of drugs.
Merck, Bristol Myers Squibb, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, and the US Chamber of Commerce have all recently filed lawsuits in federal courts across the US. They each argue the program is unconstitutional in various ways.
The challengers also say that the negotiation provision will harm innovation and patients’ access to new drugs.
Among the arguments are that the program violates the Fifth Amendment’s “takings” clause because it allows Medicare to obtain manufacturers’ patented drugs, which are private property, without paying fair market value under the threat of serious penalties.
Plus, the negotiations process violates the First Amendment, the challengers say, because it coerces manufacturers into saying that they agree to the price that the government has dictated and that it’s fair.
Another argument is that the process violates the Eighth Amendment by levying an excessive fine if drugmakers refuse to negotiate and continue selling their products to the Medicare market.
Merck expects its diabetes drug Januvia to be among the drugs named in September and its blockbuster cancer treatment Keytruda and diabetes drug Janumet to be subject to negotiation in the future. Bristol Myers Squibb believes its blood thinning medication, Eliquis, will be subject to negotiations this year, and its cancer medication, Opdivo, will be selected in a subsequent round.
The changes in the revised guidance did not allay the complaints of the pharmaceutical industry. PhRMA said that transparency remains “severely limited,” patients’ views are not being taken into account and Medicare beneficiaries could have less access to drugs.
“The very few substantive changes to the final guidance demonstrate CMS saw this as a box checking exercise, not an opportunity to mitigate the negative impacts this price setting policy will have on patients or the broader health care sector,” PhRMA said in a statement.
“The approach CMS took in this final guidance confirms what we claimed in our lawsuit – Congress’ unconstitutional shortcuts taken in the law have given the administration far too much flexibility to set prices at their whim without any oversight or accountability to anyone,” the group continued.
The Biden administration will “vigorously defend” the drug price negotiation program, said CMS Administrator Chiquita Brooks-LaSure.
“We feel the law is on our side,” she said in a call with reporters Friday.
This story has been updated with additional information.