Could CMS’ Interoperability/Patient Access Final Rule Get Delayed Until 2022?

Nov. 22, 2019
The ONC/21st Century Cures rule appears to be on the verge of being finalized, but a later timetable could be in store for CMS’ regulation

The Office of Management and Budget (OMB) within the White House released its fall 2019 unified agenda earlier this week with some potentially interesting developments around the federal government’s proposed regulations on interoperability and patient access.

Two major proposals from the government released earlier this yearone from CMS (the Centers for Medicare & Medicaid Services) and the other from ONC (the Office of the National Coordinator for Health IT) are designed to further advance the nation’s healthcare interoperability progress. The two rules are aligned in terms of their broad goals of encouraging data sharing and making it easier for patients to access their health information, but also separate in terms of the particular elements involved and which stakeholders are affected by each.

For example, key elements of the ONC rule are related to application programming interface (API) standards, electronic health record (EHR) certification, and EHR vendor business practices and behaviors. It also has a significant section devoted to information blocking with potentially hefty fines for violators.

The CMS rule, meanwhile, proposes a mandate that would require all Medicare Advantage (MA) organizations, state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and QHP (qualified health plan) issuers in FFEs (federally-facilitated exchanges) to ensure that patient claims and other health information are available to patients through third-party applications and developers by 2020. The rule also proposes that payers in CMS programs be required to participate in a health information network of their choosing.

What are the latest timelines?

The CMS rule was sent to OMB for review in late September, and about a month later, the ONC rule was delivered to the White House office. But according to the latest agenda from OMB, it’s possible that the rule from CMS might not be finalized until 2022 as it was moved to a “long-term action item.” Essentially, this gives the federal agency three years from when the rule was first proposed—February 2019—to finalize it.

While it should be noted that there’s no guarantee the CMS rule will be pushed back that far, it does give the feds a lot more time to work with. According to OMB policy, “We schedule all Medicare final regulations for publication within the three-year standardized time limit in the current unified agenda. We do not intend to delay publishing a Medicare final regulation for three years if we are able to publish it sooner.”

Some prominent groups who represent the health plan stakeholders that the CMS rule will directly impact—such as America’s Health Insurance Plans (AHIP)—noted in its comments to the federal agency that  “the implementation timeline for the open-API should be phased-in, tied to the development of relevant standards, with full compliance starting no earlier than 2022.” It now seems possible that these folks will be getting their wish granted.

The ONC rule, meanwhile, is expected to be finalized by the end of the month. In its proposed regulation, ONC implements the information blocking provisions of the 21st Century Cures Act, which defined information blocking as interfering with, preventing, or materially discouraging access, exchange, or use of electronic health information. Violators can be subjected up to a $1 million fine if they are found to be bad actors.

That this rule could be finalized in the coming days is likely to be met with intense criticism by some industry stakeholders who have boldly attested that the proposed information blocking exceptions are “both complex and confusing.” One example of this is “significant confusion around the definition of ‘electronic health information’ or EHI, which forms the basis for much of the policies in the rule,” according to a group of prominent health IT groups who recently penned a letter to members of Congress, asking them to use their oversight authority to ensure that federal health officials improve certain elements of the rules.

One group— Health Innovation Alliance (HIA)—also went as far as to formally call on ONC specifically to rescind its regulation, noting that the information blocking exceptions to the proposed rule are so vague that "they will produce a market worse than today's status quo."

To this end, a recent survey from Accenture revealed that fewer than one in five (18 percent) of the executives surveyed in key leadership positions at U.S. healthcare companies said they are “very familiar” with the proposed regulations, while 17 percent said they either “know nothing” or “have never heard” about the Cures Act. Around 53 percent said they are “somewhat familiar,” with 12 percent “vaguely familiar.” Overall, nearly one in three (29 percent) of survey respondents lack familiarity over the proposals, the survey data found. For this research, Accenture surveyed 76 chief information officers (CIOs), chief technology officers and vice presidents of information technology at U.S. healthcare providers and healthcare payers with more than $1 billion in annual revenue.

A new proposal around Medicare Conditions of Participation

What’s more, per the new OMB agenda, CMS is also expected to release a proposed rule in January 2020 that “would revise conditions of participation for providers and suppliers of healthcare services to allow for increased patient electronic access to their healthcare information and encourage and support the exchange of health information among providers and suppliers.”

Last April, when CMS dropped a rule that would rebrand the Meaningful Use program, the agency also said it would be requesting stakeholder feedback through a request for information (RFI) on the possibility of revising Medicare Conditions of Participation to revive interoperability as a way to increase electronic sharing of data by hospitals. That rule was finalized later in the year and didn’t provide an update on if that RFI CMS issued will lead to anything further.

As we have reported, health IT policy experts have pointed out that if the Conditions of Participation were to get changed down the line, clinicians who do not engage in certain data sharing activities would be forced out of Medicare. During the public feedback period, industry groups and stakeholders had varying opinions on this potential change.

Healthcare Innovation will continue to follow these policy developments and keep readers updated as things progress.