Medicare Compliance & Reimbursement

Warning: Medicare providers are the target demographic.

Since the 21st Century Cures Act was enacted in 2016, the feds have methodically executed data sharing regulations — and penalties for violations. Information blocking continues to be a top enforcement concern, and the latest proposed rule focuses on Medicare providers’ interoperability practices and how that impacts incentive payments.

Context: On Nov. 1, the Department of Health and Human Services (HHS) published a proposed rule in the Federal Register that builds on previous information blocking policies from both the HHS Office of the National Coordinator for Health Information Technology (ONC) and the HHS Office of Inspector General (OIG). Implementing Cures Act provisions, HHS proposes to deter Medicare providers, who participate in Centers for Medicare & Medicaid Services’ (CMS) incentive payment programs, from information blocking by decreasing their pay, cutting their scores, or taking away their eligibility to participate, depending on the program they’re in.

“HHS is committed to developing and implementing policies that discourage information blocking to help people and the health providers they allow to have access to their electronic health information,” explains HHS Secretary Xavier Becerra in a release. “We are confident the disincentives included in the proposed rule, if finalized, will further increase the appropriate sharing of electronic health information and establish a framework for potential additional disincentives in the future.”

Here’s What Led to the Proposals

HHS and auxiliary agencies have steadily been instituting data sharing policies since the Cures Act inception. Here’s a timeline of the particulars for reference:

• December 2016: The 21st Century Cures Act is enacted.
• May 2020: ONC publishes the 21st Century Cures Act final rule and CMS publishes the Interoperability and Patient Access final rule.
• 2021: During the height of the COVID-19 public health emergency (PHE), ONC begins implementing key policies from the Cures Act final rule. Guidance is across the board, including information blocking instruction for health software developers, health IT managers, providers, and more.
• June 2022: In the fiscal year (FY) 2023 budget, the feds add information blocking-centered provisions, including updated penalties and disincentives for violations as well as a request for a new authority for advisory opinions and policymaking.
• June 2023: Using the Cures Act guidelines, OIG publishes a civil monetary penalties (CMP) final rule, which sets up statutory penalties for information blocking violations for individuals and entities with a possible penalty as high as $1 million per violation, the watchdog agency explains in the rule.

Understand What Programs Are Impacted By the Rule

HHS’ proposed rule is comprehensive in nature and affects the following Medicare programs:

1. MIPS: If a Merit-Based Incentive Payment System (MIPS)-eligible clinician or group commits information blocking, they wouldn’t be considered a “meaningful user of certified EHR technology” and would receive a zero score under the Promoting Interoperability (PI) category, suggests the rule. Since the PI category accounts for 25 percent of the total, this could have a negative impact on the final total score.

“The final MIPS score is the basis for a per claim payment adjustment on claims submitted two years after the performance period,” remind attorneys Beth Neal Pitman, Eddie Williams III, and Sakinah N. Jones with law firm Holland & Knight LLP in online legal analysis. “For that reason, an information blocking determination would result in the future reduction of revenue from claims submitted in the future (i.e., a 2024 determination will affect 2026 claims payments),” Neal Pittman, Williams, and Jones expound.

For individual MIPS-eligible clinicians, HHS estimates a median individual disincentive amount of $686 while the agency estimates a median group practice at six clinicians with a disincentive average at $4,116, the rule maintains.

2. PI Programs: An eligible hospital or critical access hospital (CAH) that OIG determines committed information blocking during a reporting period would not be considered a meaningful EHR user. “The impact on eligible hospitals would be the loss of 75 percent of the annual market basket increase; for CAHs, payment would be reduced to

100 percent of reasonable costs instead of 101 percent,” HHS says.

HHS estimates “a median disincentive amount of $394,353, and a 95 percent range of $30,406 to $2,430,766 across eligible hospitals” that are determined to have violated information blocking regulations, the rule indicates.

3. MSSP: Healthcare providers in the Medicare Shared Savings Program (MSSP) operating as an Accountable Care Organization (ACO), ACO participant, ACO supplier or provider that commit information blocking could potentially be ineligible for a year and could possibly be excluded from future ACO/MSSP participation.

Know These 4 Points on Investigations

First, know that HHS is using the CMP final rule as a guideline for enforcement. Additionally, “OIG has discretion to choose which information blocking complaints to investigate,” the proposed rule says. “To maximize efficient use of resources, OIG generally focuses on selecting cases for investigation that are consistent with its enforcement priorities and intends to apply that rationale to its approach for selecting information blocking complaints for investigation,” the rule notes.

OIG will prioritize enforcement for information blocking based on these four criteria, according to the rule:

1. Incidents that resulted in or will potentially cause patient harm;
2. Incidents that interfere with a provider’s ability to care for patients;
3. Incidents that occurred over a long duration; and
4. Incidents that lead to financial loss to federal health care programs or other government or private entities.

Dates: HHS will accept comments on the proposed rule through Jan. 2, 2024.

Resources: Review the HHS proposed rule at www.govinfo.gov/content/pkg/FR-2023-11-01/pdf/2023-24068.pdf. Find OIG’s CMP final rule and additional information at https://oig.hhs.gov/reports-and-publications/featured-topics/information-blocking/.