An insider's view of Stage 2 rulemaking

The general public sometimes chides the federal government for its seemingly slow pace of operations, so it's instructive to examine what it actually takes to put in place a massive piece of rulemaking. To bring the discussion into focus, let's take a behind-the-scenes look at the development of the final rule for Stage 2 meaningful use, which was released Aug. 23 by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC).

[See also: Final rules for Stage 2 meaningful use released]

As director of the HIT Initiatives Group in the Office of E-health Standards and Services at CMS, Elizabeth Holland is intricately involved in shaping the meaningful use rules that some view as having the potential to transform healthcare. Holland is a veteran policymaker. She joined CMS in 1991, when the proposed rule for the Medicare fee schedule was in the works. CMS received 100,000 comments – all on paper.

In the interview transcript that follows, Holland offers a glimpse of the process…what it was like for her and her colleagues to read, assess the comments and make adjustments in order to craft the final rules for meaningful use Stage 2:

In final rules you gave an idea of what you were thinking about each comment.

Yes, and we feel very strongly about that. We feel that was our responsibility. For us, for this program, the real challenge was Stage 1 NPRM (Notice of Proposed Rulemaking) because that was when we were designing the program from scratch. This round of rulemaking was somewhat easier because we had a framework, and people knew what to expect. They knew how the program worked or where it didn’t work. We read all the comments, and we really do puzzle over them, and we have to balance how we’re going to move forward, and there were a lot of debates and analyses done. You try to satisfy as many people as you can.

[See also: ONC outlines next steps in HIE strategy]

How many people are in the room discussing these issues before you come out with the final rule?

It’s an iterative process. I would say for a lot of the objectives we didn’t start from scratch. We had recommendations from the HIT Policy Committee. We always use that as our starting place. It’s hard to say how many people in the room, because there are a lot of people in the room virtually. So it’s a little hard to know how many voices, but it is a sizable number.  It takes months to hammer through all the issues. Then once we believe we have a position for a particular measure, for example, it gets written up, and it goes into a document and that eventually goes into clearance.

What about the process do you like the most?

That so many opinions get aired. It's really interesting to hear all the different positions. I try to negotiate a place where everybody’s OK with how we move forward.

What was the biggest concern from physicians?

It’s probably the patient engagement measure, where providers were being held responsible for the actions of their patient. They’re not pleased that that remained. It did remain, but we tried to compromise by lowering the threshold. In the NPRM it was 10 percent, and we lowered it to 5 percent. That was an area where we felt strongly, but we wanted to acknowledge the comments. It’s one of those tipping point things. Once people realize it’s available, and they can do these things, I think it will come.

The process sounds methodical, laborious.

And it’s always unexpected. That’s the thing. You can try and anticipate what’s going to be controversial, but half the time we’re wrong.

Among your group was there something you were in disagreement about?

Many things. But you have to understand, for CMS, this is a unique program. This is a program that encompasses Medicare and Medicaid together. My office sort of manages the whole program overall, but then we have all these other offices that manage their slice of the program. So all the people collaborate together to make this big rule. So it’s [about] playing in the sandbox well together.

What was the hardest part to write or finalize?

For me personally the part I had trouble with was the payment adjustment piece, only because I want to be an optimist and hope that nobody will get payment adjustments because everybody will be meaningful users. So it was almost like I wanted it to be a superfluous piece of the regulation. But we needed to do it. I’m hoping that that piece doesn't scare people away. I would love to have the program have 100 percent success.

What is your best hope for Stage 2?

If you think about Stage 1 focusing on the capture of information into the EHR, Stage 2 is really focused on the exchange of information. That to me is what’s really exciting. Through the sharing of information we can really make great strides in improving patient care and outcome. That’s what’s exciting. That’s what this is all about.

Do you foresee data exchange working well in the next couple of years?

That’s why our rule is a partner to the ONC rule. They set the standards where everybody should be communicating the same way.  It wouldn’t work without standards. We’re looking for a tipping point, and hopefully it will come earlier. And as more patients realize and understand that this capability exists, they’ll start demanding it, and they’ll drive the whole industry.

Any big surprises along the way?

No, but I guess there’s still time. Now I think people are still in the reading process and trying to get through all the pages. Then it will be interesting to see where there is some confusion. That’s exciting in a weird sort of way. You think you’ve written something that’s really clear and then it turns out there are several interpretations, and that’s what we try to resolve as quickly as we can.

Anything you wish you had done differently?

I wish I could figure out a way I could make it easier for providers. I probably talk to at least one provider every day, and that’s good. It’s very grounding to hear the problems they are struggling with and hear the issues they have. It’s really so wonderful to hear them so committed to doing this and doing this the right way. So, I’m always looking for ways to explain things differently for people. I feel we did a big push with Stage 1 explaining the program, but we did not reach everybody. So now our challenge is how do we continue to reach those people starting in Stage 1 and not lose sight of them while were focusing on getting all of our Stage 1 people to Stage 2. So it’s almost like my job becomes two-pronged.

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