Proposed info-blocking rule is too harsh on physicians

Andis Robeznieks , Senior News Writer

In recognition that greater health data sharing is an integral component of improved patient care, the AMA continues to voice strong opposition to information blocking. But since many physicians are still unclear about what exactly is prohibited, the AMA is urging the Biden administration to emphasize education and corrective action plans before issuing onerous penalties on doctors who may unintentionally violate regulations.

Your Powerful Ally

The AMA helps physicians build a better future for medicine, advocating in the courts and on the Hill to remove obstacles to patient care and confront today’s greatest health crises.

“The AMA strongly opposes the persistent and egregious practice of information blocking, which not only contravenes the spirit of open and collaborative health care, but also undermines patient trust and safety,” AMA Executive Vice President and CEO James L. Madara, MD, wrote in a letter (PDF) to Micky Tripathi, PhD, the national coordinator for health IT.

“Deliberate obstruction of vital health information access is antithetical to the principles of modern health care, which prioritize patient-centered care and data interoperability,” Dr. Madara’s 16-page letter adds. “Flagrant information-blocking practices impede the seamless flow of critical health data and significantly hamper the ability of physicians to provide timely, effective and coordinated care.”

The U.S. Department of Health and Human Services (HHS) began enforcing federal information-blocking rules last September, and violations by health IT developers, health information exchanges and health information networks are subject to fines of up to $1 million for every violation.

Physicians and hospitals, however, are not subject to those information-blocking fines—unless they could also be considered a health IT developer, a health information exchange or health information network.

HHS released a proposed rule in November that included “disincentives” for physicians, hospitals and other health professionals to engage in information blocking

Dr. Madara’s letter highlights specific AMA concerns in the proposal, including the lack of opportunities for education and corrective action and that there’s no consideration for the severity of the underlying alleged misconduct.

“Starting with notice and corrective action is consistent with enforcement approaches undertaken in various other HHS efforts, especially when the underlying regulatory scheme is novel and complex,” Dr. Madara wrote.

The AMA also has outlined how the proposed disincentive construct would:

  • Unfairly and arbitrarily penalize physicians.
  • Fail to give doctors a meaningful mechanism to address allegations or appeal adverse determinations.
  • Result in punishments that are not proportional to the underlying alleged misconduct.
  • Ultimately discourage participation in Medicare quality and value-based care programs and compound Medicare pay cuts.

As proposed, the disincentive structure unintentionally serves to disincentivize physicians from participating in the Merit-based Incentive Payment System, the Medicare Shared Savings Program and other Medicare quality and value-based care programs.

The information-blocking regulation was included in the 21st Century Cures Act that was passed in 2016 and took effect in 2021, and Dr. Madara’s letter noted that it continues to evolve with substantial changes to information-blocking exceptions finalized just this past December.

“There remains a lack of understanding about what constitutes information blocking across the physician community,” the letter says. “Physicians in overburdened and under-resourced practices have a particularly difficult task in trying to understand the regulations’ complexities and nuances.”

Moreover, physicians are likely to be blamed for information blocking rather than the underlying health IT system and the technological limitations that often prevent adequate access. Physicians should have both, “an opportunity to engage with OIG [HHS Office of the Inspector General] before it makes a determination that information blocking has occurred and an opportunity to administratively appeal any such determination,” the letter adds.

In stating its case, the letter notes that the Cures Act’s use of the term “disincentive” rather than “penalty” or “payment adjustment” signals an intent to initially focus on education and self-correction—which is an approach that aligns with the rollouts of many other new regulations.

“If anything, the creation of ‘disincentives’ … rather than the imposition of direct penalties, would seem to signal congressional intent to establish a more lenient and flexible enforcement process …  not one that would foreclose opportunities for education, corrective action, and meaningful appeal rights,” the letter says.

AMA information-blocking resources (PDF) are in included in its Patient Access Playbook. Other resources include a two-part explanation of the basics of information blocking (PDF) that helps physicians understand what information blocking is, when information can be withheld, and how physicians can comply with information-blocking regulations (PDF). The AMA has created a separate resource explaining what electronic health information is (PDF).