(Story updated at 7 p.m. EDT)
Draft regulations the CMS issued Friday would make significant changes to the federal incentive program that requires doctors and hospitals to adopt and meaningfully use electronic health records.
With some exceptions, hospitals, physicians and other eligible professionals would be expected to conform to the rules (PDF) by 2018.
Physicians and hospitals have lobbied aggressively for the CMS to relax the program's parameters. The agency said in January it would issue separate regulations narrowing the reporting period to 90 days for attesting to meeting the requirements for 2015.
The proposed rule would require nearly all providers to report on a full calendar-year cycle beginning in 2017 and would require electronic reporting of clinical quality measures beginning in 2018.
“The release of today's rule demonstrates that the agency continues to create policies for the future without fixing the problems the program faces today,” the American Hospital Association said in a statement Friday. “It is difficult to understand the rush to raise the bar yet again, when only 35% of hospitals and a small fraction of physicians have met the Stage 2 requirements.”
Physicians and other eligible professionals who fail to meet the requirements are expected to pay $500 million in Medicare penalties between 2018 and 2020, according to the proposed rule. The agency said it expects all hospitals to achieve meaningful use by 2018.
Upgrading EHRs to meet the requirements, the agency estimates, will cost physicians $54,000, plus $10,000 in annual maintenance costs. That's at the high end of what the Congressional Budget Office calculated in 2008. The CMS said upgrades would cost hospitals $5 million, plus $1 million for annual maintenance.
The rule would give providers three options for ensuring patient engagement with their care, of which providers must fulfill two: access to their own records; secure messaging between patients and providers; and collection of patient-generated health data.
The first two elements had attracted consistent criticism from providers in previous stages of the program, but the exact impact is unclear. In the Stage 2 rules, 5% of patients would have to view, download or transmit data from their records, which providers said made them responsible for the engagement regardless of whether patients were interested.
The new rule would raise that engagement threshold to 25% of patients downloading or transmitting their health data. But providers can now satisfy the requirement with an application programming interface, or API, that allows third-party developers to access the data on their patients' behalf.
The rule would also impose a similar increase in the rate of secure messaging: from 5% in Stage 2, to 25% in Stage 3.
Meanwhile, the provision would compel providers to collect patient-generated health data in their EHRs from devices such as Fitbits or mobile apps developed with Apple's HealthKit API. Providers would have to capture data from 15% of their patients to comply.
The digital health industry pushed aggressively for the CMS to push providers to collect the data their products generate. “I'm beyond pleased and finally vindicated,” said Robert Jarrin, Qualcomm's senior director of government affairs.
The proposal also raises the thresholds for “computerized physician order entry,” which allows doctors to send requests for drugs, lab tests and imaging electronically. Providers would be expected to order 80% of medications electronically, up from 60% under Stage 2 of the program. The requirement for electronic lab and imaging orders would rise to 60% from 30%.
For imaging, the proposed rule expands the requirement from radiology to a broader array of tests, including ultrasound, MRI and CT scans.
Separate regulations proposed by HHS' Office of the National Coordinator for Health Information Technology overhaul the certification program (PDF) for healthcare IT, which is intended to give healthcare providers certainty that the software they buy can perform the functions required under the meaningful-use program.
Comments on the proposals are due May 29.