HHS Issues Proposed Rule Outlining Provider Disincentives for Information Blocking

On November 1, 2023, the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” proposed rule (Proposed Rule). Comments are due by January 2, 2024.

Overview

The Proposed Rule would implement the provision of the 21st Century Cures Act (Cures Act) specifying that a health care provider that the HHS Office of the Inspector General (OIG) determines has committed information blocking would be referred to the appropriate agency for appropriate disincentives.

In the Proposed Rule, HHS outlines the process for OIG’s investigation of a claim of information blocking, which may result in the OIG determining that a health care provider committed information blocking; discusses how OIG would refer the health care provider to an appropriate agency; and sets forth the proposed disincentives that the Centers for Medicare and Medicaid Services (CMS) would apply to health care providers that participate in the Medicare Promoting Interoperability Program (PI), the Medicare Merit-based Incentive Payment System (MIPS) Promoting Interoperability performance category, and the Medicare Shared Savings Program (MSSP). This means that the proposed disincentives apply to health care providers that are eligible for those programs but not, for example, pharmacists, pharmacies or laboratories that are actors under the ONC Information Blocking Rule but do not participate in the PI, MIPS or MSSP. Any appeals of the disincentives are only available under existing authorities of the appropriate agencies and are not specifically provided under the Cures Act for the OIG’s findings of information blocking.

HHS also proposes to publicly post names of actors under the ONC Information Blocking Rule that OIG determines have committed information blocking, including health care providers.

Cures Act – Brief Background

 The Cures Act defines information blocking as a practice that, except as required by law or as is permitted in accordance with the enumerated exceptions in the ONC Information Blocking Rule, is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information. The Cures Act provides that the OIG may investigate claims that “a health care provider engaged in information blocking” and any health care provider the OIG determines has committed information blocking shall be referred to the “appropriate agency” to be subject to appropriate disincentives using authorities under applicable Federal law.

Proposed Rule - Highlights

Appropriate Agency

HHS proposes to define “appropriate agency” to mean a government agency that has established disincentives for health care providers that OIG determines have committed information blocking. HHS proposes to interpret the phrase “authorities under applicable Federal law” in the disincentives provision to mean that an appropriate agency may only subject a health care provider to a disincentive established using authorities that could apply to information blocking by a health care provider subject to the authority, such as health care providers participating in a program supported by the authority. HHS also proposes to define the term “disincentive” to mean a condition that may be imposed by an appropriate agency on a health care provider that OIG determines has committed information blocking. HHS also outlines the ways ONC, CMS, the HHS Office for Civil Rights (OCR), the Federal Trade Commission (FTC) and the OIG will consult, refer, and coordinate on information blocking claims.

Impacted Health Care Providers

The Proposed Rule’s disincentives would apply to a subset of the individuals and entities meeting the information blocking regulations' definition of health care provider. Specifically, the Proposed Rule would provide disincentives for health care providers that are eligible to participate in the PI Program; the MIPS Promoting Interoperability performance category (previously the EHR Incentive Programs); and the MSSP. HHS acknowledges that the provisions in the proposed rule would not establish disincentives for all health care providers included in the 45 CFR 171.102 definition, including pharmacies, pharmacists and laboratories, and that the information blocking regulations are also applicable to health care providers that are not eligible to participate in these programs.

OIG’s Investigations and Referrals to Appropriate Agencies

The OIG has discretion to choose which information blocking complaints to investigate and thus generally focuses on selecting cases for investigation that are consistent with its enforcement priorities. Similar to the OIG’s information blocking enforcement priorities outlined in the OIG Civil Monetary Penalty (CMP) Final Rule applicable to certified health IT developers and health information networks/health information exchanges, OIG’s priorities for investigations of health care providers would be for information blocking claims that: (i) resulted in, are causing, or have the potential to cause patient harm; (ii) significantly impacted a provider's ability to care for patients; (iii) were of long duration; and (iv) caused financial loss to Federal health care programs, or other government or private entities.

During OIG’s investigation of information blocking by a health care provider, but prior to making a referral, OIG will coordinate with the appropriate agency to which OIG plans to refer its determination of information blocking. OIG explains that this coordination will ensure that the appropriate agency is aware of a potential referral and that OIG provides the information the agency needs to take appropriate action. OIG's referral to the appropriate agency will explain its determination that a health care provider committed information blocking. As part of the referral, OIG will provide information to explain its determination.

Appropriate Agency Action

The appropriate agency that imposes a disincentive or disincentives would send a notice (using usual methods of communication for the program or payment system) to the health care provider subject to the disincentive or disincentives. This notice would include:

• A description of the practice or practices that formed the basis for the determination of information blocking referred by OIG;
• The basis for the application of the disincentive or disincentives being imposed;
• The effect of each disincentive; and
• Any other information necessary for a health care provider to understand how each disincentive will be implemented.

HHS clarifies in the Proposed Rule that a health care provider may have the right to administratively appeal a disincentive if the authority used to establish the disincentive provides for such an appeal. However, the Cures Act did not provide similar instruction regarding appeals of disincentives for health care providers established under the Cures Act. Any such right to administratively appeal a disincentive would have to be provided under the authorities used by the Secretary to establish the disincentive through notice and comment rulemaking. For example, in the context of the ACO disincentive, HHS explained that an ACO may be able to appeal the removal or denial of a health care provider from an ACO through the MSSP appeals process. But the underlying information blocking determination made by the OIG would have to be appealed separately.

Disincentives

The Proposed Rule establishes the following three disincentives for applicable health care providers:

1. Medicare Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (CAHs): HHS proposes that a determination of information blocking by an eligible hospital or CAH that OIG refers to CMS would result in the eligible hospital or CAH not being a meaningful electronic health record (EHR) user in an applicable EHR reporting period. An eligible hospital would lose 75 percent of the annual market basket increase, while a CAH subject to the disincentive would have payments reduced to 100 percent of reasonable costs instead of the 101 percent of reasonable costs associated with successful participation.
2. Promoting Interoperability Performance Category of Medicare MIPS: HHS proposes that a determination of information blocking by an eligible clinician would result in the eligible clinician not being a meaningful user of certified EHR technology in a performance period and therefore receiving a zero score in the Promoting Interoperability performance category of the Medicare MIPS, typically a quarter of the total MIPS score.
3. Medicare Shared Savings Program: HHS proposes that a determination of information blocking would result in a health care provider that is an accountable care organization (ACO), ACO participant, or ACO provider/supplier being deemed ineligible to participate as, or in, an ACO for at least one year.

Public Posting of Providers That Committed Information Blocking

The Proposed Rule also contains a provision proposing that ONC post on its public website information about actors that have committed information blocking. Public posting of providers on ONC’s website would include identifying the information blocking practices, actors who committed information blocking, and any settlements of liability, civil money penalties levied, and disincentives administered. OIG states that it also recognizes that an appropriate agency may have other obligations related to the release of information about a participant that is a health care provider in programs under that authority. Thus, HHS proposes that posting of the information about health care providers that have been determined to have committed information blocking and have been subject to a disincentive would be conducted in accordance with existing rights to review information that may be associated with a disincentive.

Requests for Comments/Information

HHS requests for public comment, including comments on its proposed definition of “appropriate agency.” HHS also requests information on how agencies can build on the proposals in this rule to establish disincentives for other health care providers, particularly those health care providers not participating in the CMS programs identified in the Proposed Rule.

On November 15, ONC held an information session and published presentation slides outlining the statutory background and various provisions of the Information Blocking Disincentives Proposed Rule. For more information or support to submit comments, please contact the professionals listed below, or your regular Crowell contact.