Articles

A recent policy event in Washington, DC featured top policymakers discussing a wide variety of public policy and political concerns; healthcare issues featured prominently.

SUMMARY:

• FDA Drug Approval: Commissioner Marty Makary is advancing faster, more transparent drug approvals through public rejection letters and a new priority review program (CNPV) that could cut review times to 1–2 months.
• Rural Hospital & Medicaid Concerns: Lawmakers debated the impact of recent Medicaid reforms on rural hospitals, with some warning of major funding cuts, while others argued the changes (like work requirements) wouldn’t harm providers.
• Medicare Payment Overhaul: Rep. Jodey Arrington called for site-neutral Medicare payments to reduce costs and prevent monopolies, criticizing delays in reform implementation.

Speaking at the Hill Nation Summit on July 16, Dr. Marty Makary, Commissioner of the Food and Drug Administration (FDA) addressed a variety of reforms he has been pursuing since taking office earlier this year, such as efforts to “reduce the amount of animal testing” and the wasteful delays in drug approval, to help “deliver more cures for the American people.”

He talked about the “radical” transparency measures being pursued at the FDA, especially starting to make drug rejection letters viewable by the public, which he said would give more information to pharmaceutical and biologics developers in what to expect and how to navigate the approval process. The FDA has begun publishing "complete response letters" (CRLs) on its website, which respond to drug approval applications, and provide, according to the FDA, "significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved."

Dr. Makary also talked up his “priority pathway” program, formally called the National Priority Voucher (CNPV) pilot program, which aims to reduce the drug review process from as long as a year to as short as a month or two, with rolling review, constant communications, in-the-moment problem solving, while still sticking to the FDA’s standards. Interestingly, he said, the affordability of the drug or biologic could also help determine the priority given to its review.

                                                                                    -------

[A quick note about us… the Insights Association is a growing community of the nation's researchers, data scientists, and strategy professionals, representing the entire insights and analytics spectrum. As the leading voice of our industry, we serve a crucial role in leading global improvements in data quality and fostering trust in market research. With a common commitment to evidence, ethics, and impact, we are a go-to resource for professional and business development, transforming business and policy outcomes that drive better decisions for a complex world. Learn more about becoming a member here.]

                                                                                    -------

Meanwhile, Rep. Kevin Hern (R-OK-01), Chairman of the House Policy Committee, talked about rural hospitals, which have been expressing great concerns about changes to Medicaid in the new One Big Beautiful Bill Act law (the same law that delivered on an important educational boost for the insights industry and raised the threshold for 1099 tax reporting).

According to the American Hospital Association, the new law "would result in a $50.4 billion reduction in federal Medicaid spending on rural hospitals over 10 years and 1.8 million individuals in rural communities losing their Medicaid coverage by 2034." Further, a study referenced by the AP suggested that more than “could be at risk for closure.”

In response, Rep. Hern asserted that “Obamacare destroyed the rural hospital network,” in particular by “preventing doctors from ownership in a hospital.” Further, he said, the changes to Medicaid in the new law “aren’t going to kill rural hospitals.” He said that a rural hospital closed in Wyoming the day before and blamed the new law, whose changes have not even been enacted yet. Further, he pointed out that one of the biggest Medicaid changes in the law was requiring able-bodied adults to work, volunteer or go to school – “if you can work, you should go to work” – which he said should not impact rural hospitals’ finances. Finally, he pointed out that the law restricts states’ ability to tax health care providers, including rural hospitals, to help fund state Medicaid programs.

The health care provider tax issue was also raised by Rep. Jodey Arrington (R-TX-19), Chairman of the House Budget Committee, who called it “a scheme that does not benefit the American people… There are better ways to resource hospitals.”

Arrington decried “non-beneficiary benefits” in Medicaid and Medicare, since resources should be dedicated and focused on patients. He also said he was pushing for site-neutral payments, which would “save $150 billion... and stop concentrating resources and supporting monopolies." Currently, the Centers for Medicare and Medicaid Services (CMS) pays more for the services provided at a hospital than it does for the same services provided at a doctor’s office, which Arrington said, “drives up premiums and limits choice.” The chairman lamented that, while there are “lots of ways to improve healthcare and reform welfare… we have to strike a balance in such legislation.” Asked why, if there is so much waste, fraud and abuse in the system, that Congress did not make the changes effective immediately, instead of delaying them until 2027, Arrington replied that, "It was a balance of interest that you always have to strike when you are doing the sausage-making... of writing big omnibus bills... everything we did, we should have done immediately."

The Insights Association advocates across the U.S. for the market research, insights and analytics industry’s interests.

Here are some more healthcare-related items of interest, all only available to members of the Insights Association:

• Senate Committee Considering Updates to HIPAA Privacy and Security Restrictions: An important part of confronting cyber threats and health care data privacy and security will be modernizing the Health Insurance Portability and Accountability Act (HIPAA), according to a leading Senate Republican.
• Compliance Resource Guide for the HIPAA Security Rule: The National Institute of Standards and Technology (NIST) published a resource guide for complying with the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. The guide focuses on how HIPAA covered entities and business associates should assess and manage risks to electronic protected health information (ePHI).
• Healthline $1.55 M CCPA Settlement: A Wake-Up Call on Health Data, Ad Tech & Compliance: On July 1, 2025, California Attorney General Rob Bonta announced a $1.55 million settlement with Healthline Media LLC — the largest penalty ever issued under the California Consumer Privacy Act (CCPA). While the headline figure itself is record-setting, the Healthline case holds deeper implications for market research, insights and analytics professionals who handle sensitive data, particularly in the realm of health information.
• HHS Tracking Guidance Struck Down: Federal guidance for healthcare entities and their contractors was recently struck down by a court, and the issuing agency has given up its appeal.
• Washington Health Data Privacy Law is in Effect: The Act, a comprehensive state privacy law ostensibly focused on consumer health information, but written extremely broadly, came into effect on March 31, 2024. It is enforced by the state Attorney General and easy (and extensive) private lawsuits.