Despite Congressional interest in delaying Stage 3 of the electronic health record Meaningful Use program and the AMA coming out strongly against the roll out, HHS recently went forward and published its 752-page Final Rule for Stage 3 and Stage 2 modifications. One of the central pieces to the Affordable Care Act, along with the American Reinvestment and Recovery Act (ARRA) was the implementation and "meaningful use" of electronic health records (EHRs)—through the HITECH provision. Implemented in stages, Stage 3 is the final step of the program.
The 2015-2017 Meaningful Use (MU) Final Rule establishes MU program requirements for 2015 - 2017, creating a new "Modified Stage 2." All providers, including those in the Medicaid program, would attest to a single set of objectives and measures beginning in 2015. The Modified Stage 2 program reduces the number of requirements and lowers certain measure thresholds compared to Stage 2. All providers are required to move to Stage 3 beginning in 2018 regardless of their prior participation or Stage of MU.
The final rule establishes a modified version of Stage 2 for 2015 - 2017 for all participants. In 2015, all participants must follow Modified Stage 2 with accommodations for providers who were schedule to demonstrate Stage 1 in 2015. Next year, in 2016, all participants would follow the Modified Stage 2 with a smaller set of accommodations for providers who were scheduled to demonstrate Stage 1 in 2016. The following year, in 2017, participants may select to report on Modified Stage 2 or the full version of Stage 3 outlined in the Stage 3 rule. By 2018 all participants would follow the full version of Stage 3.
CMS recently announced a new FAQ that allows any provider to apply for a hardship exception for 2015 under the "extreme and uncontrollable" circumstances category due to the lateness of the modifications rule. The agency has also clarified that physicians switching EHRs or experiencing issues with a vendor product may apply for a hardship exemption under the existing "extreme and uncontrollable circumstances" category.
The MU Stage 3 Final Rule allows for a 60-day public comment period to continue to consider program changes and align requirements with the Medicare Access and CHIP Reauthorization Act (MACRA). This is the last stage of MU and Stage 3 requirements are optional in 2017 and mandatory for all participants in 2018, no matter when they started the MU program.
All Stage 3 MU participants (both physicians and hospitals) must meet 8 objectives. Each objective may include multiple measures. Objections include: (1) Protect Electronic Health Information; (2) Electronic Prescribing (eRx); (3) Clinical Decision Support (CDS); (4) Computerized Provider Order Entry (CPOE); (5) Patient Electronic Access; (6) Coordination of Care through Patient Engagement; (7) Health Information Exchange (HIE); and (8) Public Health and Clinical Data Registry Reporting.
Physicians in opposition, economics of practice changing in part due to Health IT
As reported by Politico, the American Medical Association helped lead the charge to pause finalization of the Stage 3 rules. AMA argued Stage 3 takes a "drastic step backwards" from CMS's proposed changes to Stage 2. The implementation of electronic health records has been especially difficult for independent and smaller physician practices—one of the most consistent arguments against moving forward with the MU program.
As also reported in Modern Healthcare, according to a recent report, independent practices acquired by hospitals are seeing operating costs spike as they try to keep up with the federal electronic health record requirements. Multispecialty physician practices spent an average of $20,693 per full-time-equivalent doctor in 2014, a 12% increase from the year before and a 34% increase from 2010.
More than 3,100 physician groups were surveyed for the report, which includes information on other administrative issues such as staffing ratios. It found that between 2010 and 2014, physician practices increased use of non-physician providers, such as physician assistants and nurse practitioners, to meet demand and compete to hire from a limited supply of doctors. Administrative burdens and costs related to running an independent practice has a growing number of physicians opting to become employees of hospitals. Reports indicate that physicians will continue leaving private practice to work for hospitals and that only a third of physicians would remain independent by the end of 2016.
Along these lines, Politico recently asked if electronic health records are creating a spike in hospital mergers. According to American Hospital Association CEO Rick Pollack in a recent House Judiciary Committee hearing, he estimated hospitals will spend between $20 million and $200 million on EHRs each year depending on their size, and that dollar amount is unmanageable for smaller hospitals. This causes them to merge and results in fewer players in the market. "The fundamental restructuring that CMS anticipates in response to its alternative reimbursement models will undoubtedly come with a high cost that will be particularly difficult to bear for small and stand-alone hospitals," Pollack testified.
GOP Doctors Caucus Resistance
In line with the aforementioned physician resistance, the GOP Doctors Caucus announced plans to ask House of Representatives Speaker Paul Ryan for end-of-year legislation to include a delay in Stage 3 of meaningful use and broad exemptions for the programs penalties. This forthcoming letter is in addition to a letter sent in September to the Obama administration. The September letter asked for a delay in meaningful use Stage 3, and was signed by approximately 25% of House members.
Tennessee Representative Phil Roe, chairman of the GOP Doctors Caucus, said, "Many of us believe the appropriations process is also an effective way to get this done. The Caucus is open to various vehicles for these requests and looks forward to working with Speaker Ryan and other House leaders on these important initiatives."
Problems with vendors
Over the past year, health IT vendors have come under scrutiny for the practice of intentionally blocking the sharing of patient information, hurting progress toward a national goal of interoperability. New legislation, the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, or the "TRUST IT Act" hopes to combat this practice. The legislation aims to ensure that certified health IT systems are performing as promised in the field, and establish a rating system that will enable consumers to compare different products based on that performance.
According to Senator Bill Cassidy's press release—one of the three Senate physicians—the legislation will also:
- Authorize the Office of the National Coordinator for Health Information Technology to make publicly available information, such as summaries, screen shots, or video demonstrations, showing how certified health information technology meets certification requirements;
- Require the certification program to establish that health IT products meet applicable security requirements, incorporate user-centered design, and achieve interoperability, consistent with the reporting criteria developed for the Health IT Rating Program;
- Require health IT vendors to attest they do not engage in certain information blocking activities, including nondisclosure clauses in their contracts, as a condition of certification and maintenance of certification;
- Authorize the Inspector General of the Department of Health and Human Services to investigate claims of information blocking and assess civil monetary penalties on any person or entity determined to have committed information blocking.
This comes after CMS also published recommendations earlier this year to address the information blocking problem, including:
- Assisting federal and state law enforcement agencies in identifying information blocking cases that violate current laws;
- Bolstering oversight of certified health IT capabilities "in the field" through new requirements;
- Creating a nationwide health information exchange governance framework;
- Requiring certified health IT developers to disclose additional costs, limitations and restrictions associated with their products;
- Working with CMS to create incentive payments that reward interoperability and health data sharing; and
- Working with HHS' Office for Civil Rights to educate stakeholders on how HIPAA privacy and security standards apply to information sharing.
Now, despite federal rules, many developers of electronic health records are not meeting federal design requirements, according to research published in JAMA. The researchers from the National Center for Human Factors in Healthcare at MedStar Health in Washington, D.C. found that not all vendors filed required reports on usability testing. The report adds to the mounting concern that EHRs are failing to raise the quality and safety of healthcare and lower its costs.
Gag orders, another previously raised issue, are a separate, but related concern. A Politico investigation found that some of the biggest firms marketing electronic record systems inserted "gag clauses" in their taxpayer-subsidized contracts, effectively forbidding health care providers from talking about glitches that slow their work and potentially jeopardize patients. The website obtained 11 contracts through public record requests from hospitals and health systems in New York City, California, and Florida that use six of the biggest vendors of digital record systems. With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure. This is the first time the existence of the gag clauses has been conclusively documented. Politico faults the government's slow response, noting that little has been done to address the problem despite many years of warnings.
There is a significant amount of opposition to current health information technology policies both within the government and the larger medical community. Stage 3 of Meaningful Use could ultimately be delayed through Congressional action, and larger legislative fixes may be necessary to combat the litany of problems raised by stakeholders over the past few years. The ultimate goals of electronic health records may be laudable, but the unintended consequences could be far greater than the Administration had originally perceived.