Public Policy Update - PMD Alliance

Anxious to get back home to start campaigning for the November midterm elections, Congress took bold action to advance President Biden’s legislative agenda in August with passage of a large legislative package. In addition, advocates for the Parkinson’s community achieved a “first-step milestone” with the introduction of legislation that would create a national plan to end Parkinson’s.

“Inflation Reduction Act”: New law impacts prescription drug prices and potential innovation

Following defeat of a broader legislative package in late 2021, President Biden and his allies on Congress succeeded in passing the so-called “Inflation Reduction Act” in early August. The President signed the bill into law on August 16. The $737 billion package includes a wide range of provisions dealing with energy and climate change, tax reform and prescription drug pricing.

For the first time, the U.S. Department of Health & Human Services will be allowed to negotiate with pharmaceutical companies within the Medicare program. This long-sought change is a major restructuring of the program and will be phased in over time. It will begin with 10 Part D drugs in 2026; 15 Part D drugs in 2027; 15 Part B and D drugs in 2028 and 20 Part B and Part D drugs in 2029 and later years. The drugs would be selected from among 50 identified drugs with the highest Medicare spending.

Of particular interest to the PD and movement disorder community, the new law includes a $2,000 Medicare Part D out-of-pocket cap for patients (currently there is no maximum out of pocket cap in the program). This cap would go into effect in 2025. The law also instructs payers to create a process for patients to pay the $2,000 (if a patient hits the maximum limit) over the course of the year, instead of one lump sum. The law also includes penalties for companies who increase the price of a drug more than the annual inflation rate.

While an out-of-pocket limit in Medicare Part D is something that consumers, health care providers, pharmaceutical companies and advocates have long supported, there is concern that the government negotiation piece of the new law will ultimately result in government price controls and reduced investment in research and development of new products, especially for challenging diseases (including many neurological diseases). The Congressional Budget Office (CBO) has estimated that the provisions could reduce the number of new medicines by 10-15 in the next decade. A University of Chicago Department of Economics study estimates that up to 135 new medicines will not come to market over the next two decades as a result of these new provisions. Either way, the impact of the “Inflation Reduction Act” on medical innovation will be closely analyzed over the next several years.

“National Plan to End Parkinson’s Act” introduced

On Thursday, July 28, the U.S. House of Representatives introduced the first-ever legislation solely devoted to ending Parkinson’s disease.

The National Plan to End Parkinson’s Act (H.R.8585) will, for the first time, unite the federal government and private enterprise in a mission to prevent and cure Parkinson’s, alleviate financial and health burdens on American families, and ensure those living with the disease have access to the care they need.

This bipartisan legislation is led by Representative Paul Tonko (D-NY) and Representative Gus Bilirakis (R-FL). Advocates are still pursuing Senate leadership for the legislation.

The legislation seeks to develop a national strategy to accomplish the following:

  • Dramatically increase federal research funding;
  • Develop more effective pathways for treatments and cures;
  • Improve early diagnosis;
  • Spark new and improved models for patient care;
  • Create standards and measures to prevent Parkinson’s disease;
  • Address health disparities in diagnosis, treatment and clinical trial participation; and
  • Enhance public awareness of the disease.

A public-private advisory council would be created to submit a report every year to Congress on their progress and impact in ending Parkinson’s.

PMD Alliance is supportive of this legislation and believes it provides a great opportunity to engage, educate and build relationships with elected officials, helping them understand PD and the need for a coordinated strategy. It’s important to realize that bill introduction, while important, is only a first step. The effort to create this framework, secure subsequent funding for its recommended initiatives and ensure effective execution, will be a multi-year struggle. We commend Reps. Tonko and Bilirakis for their leadership and look forward to growing the ranks of Parkinson’s Champions in Congress.

While we work on a long-term strategy, PMD Alliance launched the Parkinson’s and Movement Disorders Policy Panel in July. This panel, which brings people with movement disorders, health care providers, key thought leaders, care partners and the innovative biopharmaceutical and medical device communities together to develop strategies, beginning with comprehensive data collection and analysis, to ensure that people living with PD and movement disorders have access to life-changing medicines. For more information on the Policy Panel visit: Policy Panel – PMD Alliance.


About Greg:

Greg Chesmore serves as a strategic advisor on public policy to the PMD Alliance and is the CEO of Gridiron Public Affairs. He has more than 25 years of experience in government affairs working for non-profit advocacy organizations, the federal government and the innovative biopharmaceutical community. Greg’s partner, Chad, was diagnosed with Young Onset Parkinson’s 19 years ago at the age of 33.


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