In mid-August, the Biden administration announced it had completed negotiations for the first 10 drugs in Medicare’s price program and that the new prices will be implemented in 2026. The achievement marks decades of effort and is a stellar achievement for the Democrats and the administration.

But Medicare already receives discounts and rebates on drugs, so it’s unclear what the savings will really be off the list price. And, as Stephanie Kennan points out, it is also unclear how much of any savings will filter through to patients because their costs will be determined by their insurance plans. Nor is it clear whether patients’ formularies will include the drugs whose prices were negotiated. Finally, Stephanie also describes how the Inflation Reduction Act fits into this landscape.

Name: Stephanie Kennan

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:47] The administration claims the prices for the first 10 drugs negotiated under the Inflation Reduction Act will save taxpayers $6 billion and another $1.5 billion to seniors in out-of-pocket costs.

[01:54] The Centers for Medicare & Medicaid Services based its savings figures off the list priced for drugs, but many of the drugs are currently available to Medicare plans for discounts and rebates.

[02:18] Medicare recipients don’t usually pay the list price for drugs; they pay the price dictated by their insurance plans.

[02:44] Some members of Congress and patient advocacy groups worry there aren’t enough rules to guarantee that insurance plans will include the first 10 drugs, with newly negotiated prices, in patient formularies.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com

In an ironic move, it’s likely that Medicare Part D insurance premiums will rise next year even as a 2022 law sought to lower costs for patients, but the administration is planning on implementing a program to stabilize the market.

Under the 2022 law, insurers must now make up the difference between costs formerly covered by patients and are raising drug premiums to compensate, explains host Stephanie Kennan. Join her as she explains the changes facing insurers and the efforts the government is making to stabilize the market during the transition brought about by the 2022 Inflation Reduction Act.

Name: Stephanie Kennan

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:47] Insurers will be expected to make up the difference between what Medicare Part D patients used to pay and what they will pay beginning next year. The government will help defray the cost.

[01:22] The administration’s program designed to help defray costs is expected to cost $5 billion if all Medicare Part D plans participate, but enrollment is not yet certain.

[03:11] Under the Inflation Reduction Act, when patients meet a spending cap, plans will pay a higher percentage than before, and drug manufacturers will be required to provide a discount.

[05:01] A new Part D stabilization demonstration has three components for prescription drug plans that participate: lowering the base cost of the beneficiary premium; limiting Part D premium increases, and narrowing the upper threshold of risk corridors while increasing government risk-sharing.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com

A revolution in the use of psychedelic drugs to treat mental health issues experienced a setback in early August when the FDA declined to approve MMDA as a treatment for post-traumatic stress disorder.

Host Stephanie Kennan provides important context to the FDA’s decision, which came as the agency has faced criticism for approving therapies without convincing evidence. She outlines the fallout, including a peer-reviewed journal’s decision to retract three papers about MMDA-assisted psychotherapy. She also looks ahead, explaining that, while this first attempt for MMDA stalled, other companies are working on their own applications.

Name: Stephanie Kennan

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

[00:40] On August 9, the FDA announced it would not approve an application for MMDA-assisted psychotherapy to treat post-traumatic stress disorder.

[01:18] MMDA would have been the first psychedelic drug approved by the FDA, but the government’s rejection was not unexpected, as an advisory panel had voted not to approve earlier this summer.

[01:50] In addition to denying approval, the FDA also said it would withdraw a planned study on people who buy psychedelic drugs.

[02:16] The FDA’s decision comes at a time when it has been criticized for approving therapies without convincing evidence.

[02:25] Fallout from the FDA’s decision includes the “Journal of Psychopharmacology’s” retraction of three papers about MMDA-assisted psychotherapy due to violations of protocol.

[02:47] Meanwhile, the company that sought approval is raising concerns about the composition and conduct of the FDA’s advisory committee meeting.

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Subscribe to Complications: Health Policy Unraveled in your preferred podcast app and never miss a healthcare update by subscribing to host and JD Supra’s #1 healthcare author Stephanie Kennan’s Washington Healthcare Update at www.mwcllc.com