The Trump administration unveiled Thursday a plan to allow prescription drug rebates to be paid more directly to patients in the Medicare Part D pharmacy program, while disrupting the flow of drug rebates that drug manufacturers are now paying for. Intermediate.

The secretary of the US Department of Health and Human Services (HHS), Alex Azar, intends to use the revisions of the exceptions to the federal anti-recession law to reduce the total cost of drugs. The HHS proposal, published as a draft rule, calls for reorganizing certain exceptions now allowed in the federal bribe rules. Known as security havens in political circles, these exceptions are intended to allow "relatively harmless" commercial collaborations to take place without the threat of prosecution, according to the rule.

Under the new HHS proposal, there would be a new derogation from the federal bribe legislation for drug rebates offered directly to patients, as well as fixed-price service agreements between drug manufacturers and drug companies. responsible for pharmaceutical benefits, HHS said.

The proposal would then exclude from the protection of safety zones the rebates on medications paid by manufacturers to Medicaid's PBMs, Part D regimes and care management organizations, HHS said.

Complex behind-the-scenes transactions by pharmaceutical sales intermediaries in the United States have long been criticized, although PBMs defend their work as seeking to offer better prices for drugs to consumers. The ambitious plan would almost certainly need congressional support.

"An obscure system"

Azar immediately launched a campaign to gain the support of lawmakers. "Democrats and Republicans looking to reduce prescription drug costs have been criticizing this opaque system for years and could adopt our proposal immediately," Azar said in a statement. Thursday press release.

On Friday, Azar appeared at the Bipartisan Policy Center, a Washington think tank, to outline his arguments. Former president of Eli Lilly, Azar summarized the complex dynamics of the pharmaceutical supply chain in simple terms in his speech.

Congress has allowed specific exemptions from federal anti-redress laws to protect "legitimate trade agreements from the threat of prosecution," he said.

"The drug industry is hidden behind these protections, building a system of dark bribes that has long drawn the attention of people preoccupied with the price of prescription drugs – so much Democrats than Republicans, "said Azar in the text of his speech.

The HHS proposal would replace this with "transparent initial discounts, sent directly to patients at the pharmacy counter," Azar said.

Nevertheless, even HHS admits that some costs could increase for Medicare registrants and for the government under the proposal. HHS included in the proposed rule a set of financial estimates that were made by the internal actuaries of Centers for Medicare and Medicaid Services and by two external consulting firms.

The estimated increases for the 2020 Part D premiums ranged from $ 3.20 per month per registrant to $ 5.64, HHS said in the draft rule. These new costs would then be offset by the newly shared savings from the reallocation of drug rebates in many cases, according to HHS.

"Taken together, the actuarial project analyzes for total cost allocation will exceed total premium increases, however, the impact on recipients will vary considerably with some beneficiaries saving while others will experience increase their personal expenses, "HHS said in the project. rule.

Mixed reviews

Senator Ron Wyden of Oregon, the most Democratic Senate finance committee, appeared in an initial statement to at least agree with HHS's choice as the target for his proposal.

"For years, I said that intermediaries had no responsibility and that consumers did not see any savings at the pharmacy counter," Wyden said. in a report. "I'm going to take the next step and lobby to force pharmaceutical companies to lower their catalog prices in order to fully take into account the removal of discounts rather than pocketing the difference as a boon."

The initial response of other powerful Democrats was clearly skeptical. Leaders of the two House committees responsible for overseeing Medicaid and Medicare issued a joint statement in which they focused on estimates drawn from the HHS proposal, which gave it a poor financial prognosis.

"The Trump administration rebate proposal will increase government spending by nearly $ 200 billion and the majority of Medicare beneficiaries will see their premiums and total fees increase if this proposal is finalized," said the president. of the House, Means and Means, Richard Neal -MA) and Frank Pallone Jr (D-NJ), President of Energy and Trade, in a joint declaration.

"While we agree that the cost of prescription drugs must be addressed, we are concerned that this approach is not the right one," they said.

The proposal garnered immediate support from the drug manufacturers lobby group, while the PBM professional group objected.

Stephen J. Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America, said the HHS proposal would attack "misaligned incentives" that may make it more cost-effective for insurers and manufacturers. PBM to favor higher-priced drugs.

In the current system, patients often have copays for drugs that do not reflect off-the-shelf discounts.

"We need to ensure that negotiated discounts and rebates of $ 150 billion are used to reduce costs for pharmacy patients," said Ubl. in a report.

The Pharmaceutical Care Management Association (PCMA) has expressed concern over the proposal to remove the exception to the anti-retrocession rules applicable to MBPs.

"PBMs maintain affordable coverage by negotiating rebates with drug manufacturers, which are used to improve benefits and reduce cost-sharing with recipients and premiums," said JC Scott, CEO of PCMA. in a report.

Alternative way?

In assessing the prospects for the rebate proposal, HHS admitted that no action could be taken at the end of its proposal. The ministry is already waiting for a downturn in the industry. In the draft regulation, HHS stated that the proposed start date for 2020 could be extended to 2021 to give the industry groups more time to prepare.

HHS also included in the proposal another suggestion, a suggestion which, he said, would not be tied to the changes contemplated in the commission commission exemption. Sponsors of drug plans could include in the price at the point of sale a specific minimum percentage of average discounts expected for their therapeutic class, HHS said.


The initial response to the HHS proposal pays too little attention to its potential effects on Medicaid, said Edwin Park, a researcher at the Center for Children and Families at Georgetown University in Washington, DC.

Park said Medscape Medical News most states rely on Medicaid-managed care management plans and PBMs to negotiate additional discounts on behalf of their registrants. The proposed changes could increase Medicaid costs by $ 1.9 billion over 10 years.

States will have to act to prevent rising drug costs if the proposal is to come into effect, he said.

"Further discounts between states and manufacturers will continue to be allowed, so states will need to move quickly to support direct price negotiations on behalf of their beneficiaries in the managed care sector," Park said.

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