Health

Health Policy Snapshot: July 2024

Greg Chesmore
July 08, 2024

If you didn’t pay attention to the Supreme Court’s overturning of the Chevron precedent…it’s time to take a look

The U.S. Supreme Court set aside 40 years of precedent on June 28, and the impacts will likely be felt for decades. The bottom line: The ability of federal agencies to interpret what Congress intended when it passed the original law is now extremely limited. Previously, if a law wasn’t crystal clear, federal judges deferred to agency interpretation. The Court’s decision in Loper Bright Enterprises v. Raimondo significantly weakened the power of federal agencies to approve regulations in a major decision that could have sweeping implications for the environment, public health and the workplace. The 6-3 ruling, overturning what’s referred to as the 1984 “Chevron precedent”, will shift the balance of power between the executive and judicial branches and hands an important victory to critics of strong federal agencies who have sought for years to rein in the regulatory authority of the “administrative state.” The ruling will likely have major implications on health care issues where federal agencies, such as the Centers for Medicare & Medicaid Services (CMS), that have long utilized the Chevron precedent to fill in the gaps on interpreting congressional intent when developing regulations. The new environment will require Congress to be more diligent when writing legislation and empower the judicial branch. According to The New York Times, there have been 70 previous Supreme Court decisions that relied on the Chevron precedent and more than 17,000 lower court rulings that were based on it. Republicans were quick to applaud the decision, while Democrats and the Court’s liberal justices criticized the decision. “Agencies report to the president, who in turn answers to the public for his policy calls,” Justice Elena Kagan said. “Courts have no such accountability,” nor do they have the kind of expertise that agencies have to carry out broad mandates from Congress, she continued. Some members of Congress said the ruling was a call to action for Congress to be more diligent in its lawmaking. Almost immediately, some legal observers opined that existing and future challenges to the Inflation Reduction Act’s drug pricing negotiations could be emboldened by overturning the Chevron precedent. “This will be another instance in which the pharmaceutical industry will challenge CMS, saying that CMS too broadly interpreted their authority in terms of how they’re setting negotiation parameters,” Reshma Ramachandran, an assistant professor at Yale University, stated. Amidst a flurry of other major Court decisions in the last few weeks, the Loper Bright decision could be the most impactful of them all, impacting a variety of policy areas, including health care policy.

National Plan to End Parkinson’s Act signed into law; HHS to convene national workgroup to develop multi-faceted strategy

President Joe Biden signed the National Plan to End Parkinson’s Act into law on July 2. The new law, which does not include new funding, requires the U.S. Department of Health & Human Services to convene public and private sector specialists — Parkinson’s patients, their care partners, researchers, clinicians, and members of federal agencies — together in a federal advisory council. It is to regularly report on its progress to the U.S. Congress and the HHS secretary. The Act also seeks to develop recommendations to increase federal research funding, create standards and measures to promote Parkinson’s prevention, improve ways of diagnosing the disease earlier, develop more effective pathways to Parkinson’s treatments, and find new or better patient care models. “Today, the Parkinson’s community has made history,” said Ted Thompson, MJFF’s senior vice president of public policy. “Signing this bill into law will ensure much-needed collaboration between the public and private sectors in the name of better treatments, earlier diagnosis and greater access to quality care,” Thompson said. “For every American living with Parkinson’s or an atypical parkinsonism, their families and caregivers, we look forward to continuing our work with policymakers to bring the National Plan to fruition.” The Act is the first Parkinson’s-specific federal bill to become law. The bill was championed by U.S. Rep. Gus Bilirakis (R-FL), whose brother lives with Parkinson’s. The bill was also named after U.S. Rep. Jennifer Wexton (D-VA), who was diagnosed last year with an aggressive form of atypical parkinsonism at the age of 56. The Act was modeled after the National Plan to Address Alzheimer’s Disease, which was passed in 2011.

Cell & Gene Therapy Access Model draws fresh criticism from top Republican as CMS rolls forward with implemention

As more gene therapies to treat various diseases move forward in the development pipeline, the federal government’s Cell & Gene Therapy Access Model has drawn harsh criticism from a key Republican member of the House Energy & Commerce Committee.  During a June 13 committee hearing examining CMS’ Center for Medicare and Medicaid Innovation (CMMI) and its impact on innovation, Rep. Brett Guthrie (R-KY) criticized CMMI and the CGT Access Model specifically. The model seeks to have CMS negotiate outcome-based agreements with cell and gene therapy manufacturers on behalf of states. Guthrie’s public comments are noteworthy since Rep. Guthrie is the lead candidate to replace Chairwoman Cathy McMorris Rodgers (R-WA) if the GOP keeps control of the House. If they don’t, Guthrie would be the ranking member (still a powerful voice on the committee).  McMorris Rodgers is not seeking re-election to Congress. Guthrie’s criticism, which focuses heavily on giving CMS—and CMMI specifically—too much control in negotiations with manufacturers (removing the ability of states to be innovative in their negotiations), reflects ongoing tensions between Republicans and the Biden Administration on a plethora of health care issues. For its part, CMMI continues to ramp up its CGT Model, meeting with states to discuss their potential participation in the model in anticipation of a rolling start in 2025. In late June, CMMI released its state request for applications document, providing states with more details on the model. CMS announced last year that is initial focus will be newly-approved gene therapies for the treatment of sickle cell disease. 

2024 Elections: What’s on tap on how will impact access to innovative medicines? Schedule your presentation now

While many Americans can’t wait for the November elections to be behind us, this election’s ramifications for health care policy, especially for the patient access and the biotech and biopharma communities, will be enormous. With slim majorities in both the House and Senate, and a race for the White House that takes fascinating turns every hour of the day, Gridiron’s crystal ball is somewhat murky as we enter the summer months. Republicans will meet in Milwaukee for their national convention in mid-July (with a running mate for anticipated nominee Donald Trump to be announced at some point before or at the convention) and Democrats meet in Chicago August 19-22. It’s important for companies and organizations to prepare for the various scenarios and the issues that will likely be front-and-center if those scenarios become reality. It’ll also be important to absorb and analyze the results after November 6. Book your time for a Gridiron Public Affairs presentation (either before, after or both) on Election 2024 today, before the calendar fills up. Email Greg at greg@gridironpublicaffairs.com for more information.

Health Policy Snippets:

  • Inflation Reduction Act: Good or bad for patients? The Biden Administration countered a recent Milliman study (commissioned by PhRMA) that found the Medicare Prescription Drug Negotiation Program will increase Part D beneficiary premiums by 12% in 2026, with its own analysis touting the IRA’s inflation penalty (which charges manufacturers a fee if they raise the price of a drug more than the rate of inflation) saved many Medicare beneficiaries thousands of dollars for certain Part B drugs.
  • Colorado PDAB continues aggressive price setting agenda. Colorado’s Prescription Drug Affordability Board (PDAB) continued its bold path toward subjecting more prescription drugs to an upper-payment limit. The board voted July 3 to initiate the process to set a price cap on Stelara® and Cosentyx®. In February, the Board voted to do the same for Enbrel®, sparking a lawsuit from Amgen. In 2023, the PDAB began a similar process for the cystic fibrosis drug Trikafta®, but ultimately decided against setting an upper-payment limit. Colorado PDAB members said they need to hear more from health insurance companies, PBMs and pharmacists during the investigation process, with some bemoaning the lack of broad-based participation from key health care stakeholders.