New CMS & ONC Regulations – Reading Between the Lines
As most of you know, CMS and ONC announced major proposed regulations at the HIMSS Conference. Together they total nearly a thousand pages and the ONC reg, in particular, should have gotten a bit of a trim before its final release. However, as someone who once ran a CMS reg shop, I know that department lawyers and players in the sausage-making process often add a lot of additional clarifying language to various provisions discussed in reg preambles. Both regs have and will undergo a lot of scrutiny from the policy folks at the major health associations, trade press, and others over the next several months. However, a few things are clear right now.
The CMS reg represents significant movement in expanding the HealthEData initiative to the rest of the major programs that they oversee. They also push transparency and the use of FHIR-based APIs to provider directories and other areas.
As I have noted previously, CMS still needs to do more to help educate the patients and beneficiaries so that they better understand the impact of BlueButton 2.0 and related initiatives to make such transparency meaningful. Educational partnerships with HIMSS, AARP, and other consumer groups as well as a major outreach campaign should be pushed. The plans, who were a primary target of the regulation, can also play key roles in helping to educate their members.
The 700+ page ONC regulation is focused mainly on implementing a number of provisions around the 21st Century Cures Act, including some changes to certification. Importantly, ONC provides the long-awaited information blocking policy proposals. The ONC reg goes into exhaustive, but their rationale is basically sound.
One of the things that I look for in the HHS regulations and RFIs is how well coordination is occurring between the different parts of the Department where there are overlapping roles. This coordination was always a challenge for me while at CMS, given that each HHS agency has unique missions and drivers. In this case, there is not only the two regs focusing on interoperability but also the recent Office of Civil Rights request for information for the HIPAA Privacy Rule. I think that the CMS and ONC regs do a fairly good job of pointing back to each other when necessary and do tie back to the Privacy Rule, although not really to the RFI. It would be helpful for the Department to provide more crosswalks that show how the various HHS Agencies’ proposed policy changes are linking towards common, overarching goals and priorities.
I want to commend both CMS and ONC for the herculean effort it took to get these regulations out, especially given the government shutdown that slowed the OMB release. They cover a lot of ground and move the interoperability needle further along. It will take another big lift to finalize these regulations as the comments will soon be flowing in. I’m looking forward to the discussions in the coming months.