backOIG Publishes Final Information Blocking Enforcement Rule – On July 3, 2023, OIG published its final enforcement rule (the OIG Rule) permitting imposition of civil monetary penalties (CMPs) for certain actors that engage in information blocking in violation of the information blocking rules published by the Office of the National Coordinator for Health Information Technology (ONC) in May 2020 (the ONC Rule). Although health care providers are included within the “actors” subject to the ONC Rule, the OIG Rule only applies to developers or offerors of certified health information technology (IT) and to health information exchanges and networks (CMP Actors). If OIG determines that an individual or entity subject to the OIG Rule has committed information blocking, they may be subject to up to a $1 million penalty per violation. Enforcement of the OIG Rule will begin on September 1, 2023.
The Final Rule
The 21st Century Cures Act authorizes civil monetary penalties (CMPs) against CMP Actors that engage in information blocking, defined in the ONC Rule in the case of CMP Actors to mean individuals or entities that know or should have known that a practice is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI). CMP Actors subject to the OIG Rule include the following as defined in the ONC Rule:
- Health IT developers of certified health (IT);
- Health information exchanges (HIEs); and
- Health information networks (HINs).
Common examples of information blocking include disabling or restricting the use of a capability that enables users to share EHI with users of other systems, placing excessive fees on consumers for connecting with other health IT systems, and configuring or implementing technology in ways that limit the types of data that can be exported or used from the technology, such as using non-standard implementation methods.
Information blocking enforcement against providers is carried out separately through “provider disincentives” that are currently under development by the ONC. But, if OIG investigations into alleged information blocking suggest that a healthcare provider may not be in compliance with ONC requirements, then OIG may refer such matters to ONC. Additionally, OIG hinted that under current ONC definitions, a provider could be considered a HIN/HIE subject to the Final Rule depending on the particular facts and circumstances.
Enforcement Priorities
OIG expects to receive more complaints of information blocking than it is able to investigate. Recognizing this, OIG stated that it will likely prioritize for investigation cases that:
- resulted in, are causing, or had the potential to cause patient harm;
- significantly impacted a provider’s ability to care for patients;
- were of long duration;
- caused financial loss to Federal health care programs, or other government or private entities; or
- were performed with actual knowledge.
If OIG determines that information blocking subject to CMPs occurred, then OIG will determine the penalty amount by taking into account the nature and extent of the information blocking, the number of patients affected, the number of providers affected, the number of days the information blocking persisted, and the resulting harm. Per statute, such penalty is capped at $1 million per violation. In addition, OIG states that it will soon post an information blocking self-disclosure protocol on OIG’s website for actors seeking to resolve potential CMP liability.
Enforcement of the information blocking penalties outlined in the Final Rule begins on September 1, 2023. The Final Rule can be found here. For further background, ONC’s final May 2020 information blocking rule is available here.
Reporters, Peyton Pair, Washington, D.C., +1 202 626 9229, ppair@kslaw.com, and Rob Keenan, Atlanta, +1 404 572 3591, rkeenan@kslaw.com.
COMPLIANCE CORNER
CMS Review Choice Demonstration for Inpatient Rehabilitation Facility Services Beginning in August 2023 – On June 27, 2023, CMS hosted a Special Open Door Forum regarding its Review Choice Demonstration program for Inpatient Rehabilitation Facility Services (IRFs). CMS has stated that the Medicare IRF benefit continues to experience high levels of improper payments. The purpose of the Review Choice Demonstration is to establish a review choice process for IRFs to test for potential Medicare fraud and improve compliance with Medicare program requirements. IRF claim reviews are scheduled to begin in August in Alabama, and the program will then expand to Pennsylvania, Texas, and California. CMS also has future plans to expand to Medicare Administrative Contractor (MAC) jurisdictions JJ, JL, JH and JE (regardless of the physical IRF location).
Initially, IRFs will select between two review choices: (1) pre-claim review of all claims; or (2) post-payment review of all claims after final claim submission (this is the default selection if no choice is made). Every six months, a claim approval (or “affirmation”) rate will be calculated. If the IRF meets the target threshold, then the provider may select a subsequent review choice to: (1) continue with pre-claim review; (2) initiate selective post-payment review involving a statistically valid random sample of claims; or (3) spot check pre-payment review involving a random sample of 5% of claims.
For Alabama providers, the selection period for the first review cycle starts on July 7, 2023, and closes on August 6, 2023. The review dates will span August 21, 2023, through February 29, 2024.
A CMS webpage with additional information regarding the program is available here, and the June 27, 2023 Open Door Forum presentation is available here.
Reporter, Lauren S. Gennett, Atlanta, + 1 404 572 3592, lgennett@kslaw.com.
ALSO IN THE NEWS
CMS Publishes Proposed Rule on CY 2024 End-Stage Renal Disease Prospective Payment System – On June 26, 2023, CMS issued a proposed rule updating payment rates and policies related to renal dialyses services furnished to Medicare beneficiaries on or after January 1, 2024. The proposed rule, among other things, would increase Medicare payments to hospital-based dialysis centers and freestanding centers by 2.6% and 1.6%, respectively. As a result, CMS estimates expenditures under the End-Stage Renal Disease (ESRD) Prospective Payment System will increase by $130 million in CY 2024 compared to CY 2023. Other notable updates include an estimated 1.6% increase to beneficiary co-payments in CY 2024 and changes to the ESRD Quality Incentive Program for Payment Year 2026. The CMS fact sheet is available here and the proposed rule is available here. Comments to the proposed rule are due no later than August 25, 2023.
CMS Publishes Proposed CY 2024 Rule for the Home Health Prospective Payment System in Which it Proposes Cutting Home Health Agency Payments by $375 Million – O On June 30, 2023, CMS issued a proposed rule in which Medicare payments to home health agencies would drop by 2.2% in 2024, equating to $375 million in reduced payments. CMS had previously indicated that it would be implementing rate reductions to offset alleged overpayments occurring in 2020 and 2021 which CMS has stated were in the range of $2.1 billion. To this end, CMS cut the standard payment amount for a 30-day home health episode from $2,031.64 in 2022 to $2,010.69 in 2023. CMS is proposing a further reduction to $1,974.38 in 2024. CMS also proposes several changes to the measures used in the Home Health Value-based Purchasing program and the weighting methodology used to score performance and payment adjustments in the program. The CMS fact sheet is available here and the proposed rule is available here. Comments to the proposed rule are due no later than 5 p.m. EDT on August 29, 2023.