Tip Sheets

Fishing in Regulations.gov for savvy sources

By Kerry Dooley Young

Many major decisions about medical care and health policy in the United States are settled in the wonky world of federal regulations, which are frankly a treasure trove for journalists. Why? Because federal agencies almost always have to publicly propose major rule changes before making them and allow the public to offer comments on these proposals.

The federal laws on rulemaking require agencies, including the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA), to explain what they intend to do and why they want to do it. So, the agencies release draft rules that are posted on the Federal Register and Regulations.gov. And the public comments offered on these rules are posted on Regulations.gov.

Sometimes comments will include a few sentences written by someone and submitted anonymously. Controversial rules may attract many comments reflecting misinformation on a topic or cases where people offer opinions with no fact.

But many of the comments offered on draft regulations come from savvy people and organizations. These comments often are richly detailed and well researched. They can offer great background and new perspectives on a story. And they sometimes include the direct email contact of the person who wrote the comment, a time saver when seeking new sources.

For a reporter on a tight deadline writing on a complex topic, a dive into Regulations.gov may turn up a decent comment written by an expert on the subject — or at least give you ideas for new people to try.

All of this makes it worth taking a little time to familiarize yourself with navigating the Regulations.gov website in search of sources, even if it’s admittedly not the clearest website to navigate.

We’re going to use the example in this tip sheet of the fiscal year 2023 Medicare draft rule that included a controversial provision about reporting a hospital quality measure. But the lessons shown here can be applied to many other issues. If a federal agency has ever seriously considered taking an action on an issue, you can probably find something about it on Regulations.gov. (Feel free to email me at patientsafety@healthjournalism.org if you are new to this concept and want a little help with the Regulations.gov website.)

In this blog post, we write about a battle over the PSI 90 measurement, one of the ways CMS is supposed to track how well hospitals protect their patients from harm such as acquired infections.

Let’s say you were interested in writing about this PSI 90 battle for a California audience. You would want to find comments about the rule from people and organizations with a California connection.

Here’s how you would find them:

1. Find the rule on Regulations.gov. There are a few ways to do this. You can put some of the relevant words into the Regulations.gov search engine and look for the rule. You might turn up a lot of different rules.

Another option would be to check another great resource for journalists, the Unified Agenda. 

This is the website where federal agencies list the regulations on which they are working. It’s a great place to get an overview of the work underway — or at least theoretically underway — at any big federal agency. Reporters following a federal agency should check at this website at least once in a while.

In this tip sheet, we’re interested in a CMS rule. So, we would pick the option for the Department of Health and Human Services, as shown in the screenshot below.

You know you want a rule about hospitals, so you could search the HHS page for the term “hospital,” as shown below. We want the hospital inpatient payment rule. We can find that listed and then look for the number in blue in the right-hand column, the regulation identifier number (RIN).

So, you have the key information, the RIN number. When you enter that number into the Regulations.gov search bar, you may see more than one entry. There are often technical corrections and addenda to federal rules. But you should be able to find the main version of the draft rule or rule you want, usually because that’s the one with the most comments submitted.

Once you have the main rule, you can click on the comments section and add terms to narrow your search, as shown below. In our example, we’re looking for people and organizations with connections to California and an interest in the PSI 90 rule change.

When I ran this search on July 11, eight results appeared. One was a comment letter from the California Hospital Association expressing its support for the CMS plan. Another comment letter came from Sharp HealthCare, the largest provider of care and health services in San Diego County. It supported the CMS plan.

But also writing to CMS on this issue was a well-known advocate for patient safety, Alicia Cole. In her comment, Cole mentions her previous work in getting passed a California law regarding public reporting of hospital-acquired infection rates. She tells of having survived “catastrophic harm following a routine fibroid surgery,” including seven surgeries and nine blood transfusions.

“I went into the hospital as a perfectly healthy patient and left facing over a decade of follow-up care,” Cole wrote. “At the time, I employed due diligence to find out the safety standards of my hospital, but there was no way for me to have access to that data at the time.”

In her comment to CMS, Cole argues that the public still has “very limited access to information about medical harm events.”

“If CMS suppresses this data, America’s families will be in the dark on which hospitals put us most at risk, yet we all shoulder the burden of these dangerous preventable complications: lost life, pain and suffering, lost productivity, and wasteful health costs,” she said.

For more on the benefits of noodling around with federal rules, please read this 2019 post by Joseph Burns in which he interviews Noam N. Levey, now with Kaiser News, “Journalist explains why a deep dive into comments on proposed regulations is worth time, effort.”