The autumn months before a presidential election are quiet periods for health IT policy advocates — the calm before the storm. Traditionally, few bills make it through Congress during election season. The presidential candidates provide scant detail about their approaches to payment reform and the regulations regarding the underlying technology infrastructure. Yet within a few months, it is likely that most of the major players will change and the policy landscape could be quite different. Dr. Karen DeSalvo’s recent departure from the Office of the National Coordinator (ONC) is just the first of many significant personnel changes to come.
This year, the potential policy differences between a Trump presidency and a Clinton administration are so vast that it’s difficult to bring them into focus. “We have no policy platform on health IT from either candidate with any substance, so speculating would be like throwing darts at the wall,” says Mari Savickis, vice president for federal affairs for CHIME (College of Healthcare Information Management Executives). “We don’t have any sense of the direction they are going to take.”
Yet in some ways 2016 is different than previous election years. Although there are questions about who will lead the Department of Health & Human Services next year, there are major initiatives already in motion with the MACRA (Medicare Access and CHIP Reauthorization Act) final rule scheduled for release before Nov. 1, and several other value-based payment reforms already in place involving bundled payments, the oncology care model and Comprehensive Primary Care Plus. As they look ahead to 2017, policy advocates already have full agendas following all the regulatory moving parts as the Center for Medicare and Medicaid Services (CMS) adjusts its rule making.
Legislation is difficult to alter once it has passed. House Republican attempts to overturn the Affordable Care Act provide a great example of that. “The MACRA law provided a booster shot to the delivery reform movement,” says Jeff Smith, vice president of public policy at the American Medical Informatics Association (AMIA). “Because it is in legislation, it would be very difficult for any administration, if so inclined, to halt the direction of things. That train has left the station.”
Indeed, the policy advocates we spoke to for this article say they were laser-focused on the details and timeline surrounding the MACRA final rule and implementation of MIPS (Merit-Based Incentive Payment System) and APMs (Alternative Payment Models). In their written comments to CMS, most had expressed concern with the proposed rule, and they are anxiously awaiting CMS’ response. “Our overall assessment was that it was an incredibly complex set of policies,” Smith says. “CMS tried really hard to characterize MACRA and MIPS as a way to simplify by combining four programs into one. But in reality if you take four slices of pizza and put them together, you still have a pretty big pizza.”
Smith did point to the clinical practice improvement category in MIPS as evidence of a new and innovative line of thinking at CMS. “I don’t think that policy could have been put on the table 10 years ago, but there is a new culture at the Center for Medicare and Medicaid Innovation (CMMI), and because Patrick Conway leads the innovation center and also serves in a primary function on the more traditional side of CMS, you do see stripes of innovation making their way into traditional CMS policy.”
One key issue is whether CMS will really stick with a Jan. 1, 2017, start date for the reporting period. “That would give 60 days for the vendors to change their systems and get them to market,” says CHIME’s Savickis. “That is a big lift, and clinicians have to adapt to a whole new way of doing things. If I were a betting woman, I don’t think I would bet on Jan. 1.” [Editor’s note: This feature was written before CMS’ Sept. 8 announcement that the start date for the MACRA program will remain Jan. 1, as intended].
Savickis adds that CHIME would like to make sure that whatever is required on the ambulatory side for eligible MIPS clinicians is as closely aligned as possible to the inpatient side. “We are looking at multiple sets of rules,” she explains. “The hospital outpatient prospective payment system (OPPS) proposed rule makes Meaningful Use changes to three different groups of providers, so trying to manage and navigate the different flavors of Meaningful Use is going to be a challenge for providers. We are looking to CMS to see how it can align them as much as possible.”
AMIA’s Smith says it is hugely problematic that one survey found that 50 percent of doctors don’t know what MACRA is or what it will require. Other big federal programs such as Meaningful Use and e-prescribing programs followed a similar trajectory — large numbers of physicians didn’t become aware until there were penalties. “If the same thing happens, 2017 and 2018 will be incredibly complicated and messy times,” he adds, “but you won’t hear a public outcry until 2019, when the penalties start to hit.”
The Role of ONC
With Stage 3 of Meaningful Use wrapped into MACRA and re-branded as “Advancing Care Information,” as well as the recent departure of Karen DeSalvo as National Coordinator, and a new administration beginning, some advocates are saying this is a good time to re-evaluate the role and mission of ONC.
Robert Horne, executive director of the Health IT Now coalition, says he believes a public discussion needs to happen with Congress and stakeholders about ONC’s role in its entirety. “As part of that, people should consider whether ONC has fulfilled its purpose. I am not suggesting it has. But there should be a re-evaluation of its role.” He says Health IT Now does not see ONC’s role as being a regulator. “Developers looking to bring products to market don’t need another regulator,” he says.
Savickis says CHIME has some concerns with the way ONC proposes to measure interoperability as required under MACRA. “We also don’t want to see a situation where ONC is only focused on the meaningful users,” she says. “There are a lot of providers in the healthcare ecosystem, such as in long-term care and mental health, that are critical components of patient care that need to be folded in, too. Hopefully, ONC will take those into account as they measure interoperability. As far as expanding certification, that is a real question mark, too.”
Robert Tennant, the director of HIT policy for the Medical Group Management Association, says his organization would like to see ONC focus more on administrative efficiency. “Their focus has been on the clinical, but I think health IT deployments in practices and hospitals, if done the right way, can not only improve care but make the care delivery process far more efficient. That efficiency angle has not been a focal point for ONC or for CMS,” he says. One such effort is work on a standard for e-mail attachments to move data between settings.
Tom Leary, vice president of government relations for HIMSS, says it is important not to underestimate ONC’s value. “The work they have done in the last two years on the interoperability roadmap and the standards advisory has made great leaps forward for the overall community,” he says. ONC has a very clear role in terms of helping the industry focus on which are the best standards for achieving interoperability, Leary adds. Regarding the other very important role it plays in terms of certification, the program has evolved well and they seem to have hit their stride with the certification bodies, he says. “Whether ONC should be expanding into other components of health IT is a public discussion worth having, but the overall role of the organization and its value to interoperability standards is absolutely clear.”
On the Legislative Front
There is still an outside chance that legislation with health IT components could pass this fall, and it is something HIMSS is watching very closely, says Samantha Burch, the organization’s senior director of congressional affairs.
“We were involved in advising the U.S. Senate Committee on Health Education Labor and Pensions (HELP) as it drafted its innovation package, which has some components similar to the House’s 21st Century Cures Act,” she says. The Senate legislation would allow NIH to require researchers who use NIH funds to share their data. It would encourage interoperability of electronic medical records, reduction in excessive physician paperwork, clarify each patient’s right to own their own medical record, and discourage information blocking, according to the HELP Committee.
“The closer we get to an election, the more difficult passing large pieces of legislation gets,” Burch says. We are hopeful, but the clock is ticking.”
Health IT Now’s Horne says that he hopes that health IT provisions that became part of the 21st Century Cures Act in the House will make it to President Obama’s desk this fall. “We encourage the House and Senate to finish their work and get it to the President’s desk. We think it would be a huge, huge mistake to let this opportunity pass.”
But overall Burch says HIMSS is pleased to see that Congress has taken more interest than ever in health IT and is listening to the community about both challenges and opportunities. “As members of Congress look at larger policy goals such as improving chronic care, when they start to peel back the onion, they realize that for those programs to be successful there has to be a strong health IT infrastructure.”
Other areas she expects to be active in 2017 are cybersecurity and telehealth. “In 2016 we had a bipartisan, bicameral comprehensive bill introduced, the Connect for Health Act, which we strongly support,” Burch says. “That bill has its challenges because it would likely cost a significant amount of money, but we are headed toward a tipping point on telehealth where you have a significant group of bipartisan members of the Senate and House saying we need to have 21st century policies and regulations that match where we are today and that aren’t 20 years behind.”