United States: Meaningful Disincentives: Proposed Rule Introduces New Consequences For Information Blocking By Health Care Providers

On November 1, 2023, the U.S. Department of Health and Human Services ("HHS") Office of the National Coordinator for Health Information Technology ("ONC") and the Centers for Medicare & Medicaid Services ("CMS") published a proposed rule in the Federal Register titled "21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking" (the "Proposed Rule").¹ Conceptually, information blocking is an "information sharing" mandate for certain stewards of electronic health information ("EHI")—specifically, developers of federally certified health information technology ("health IT"), health information exchanges and health information networks ("HIE/HINs"), and health care providers (collectively, "Actors")—when such sharing is legally permissible and there is no information blocking exception that would permit the Actor not to share the information.²

If finalized, the Proposed Rule would establish long-awaited disincentives under the 21st Century Cures Act (the "Cures Act") to deter health care providers from engaging in information blocking practices. The proposed disincentives would impact health care providers' participation in the Medicare Electronic Health Record ("EHR") Incentive Programs and the Medicare Shared Savings Program. In addition, ONC proposes to publish information blocking determinations, disincentives, and penalties that have been imposed to inform the public about how and where information blocking is occurring. The Proposed Rule represents a continuation of efforts by HHS agencies to promote health information exchange and interoperability among health IT systems.

I. Information Blocking Background

The Cures Act, enacted in December 2016, includes many provisions designed to reform health care in the United States, including the promotion of interoperability of health IT and the prevention of information blocking.³ The Cures Act delegates authority to the Secretary of HHS to "identify reasonable and necessary activities that do not constitute information blocking" and to the HHS Office of Inspector General ("OIG") to investigate claims that Actors have engaged in information blocking.⁴ Furthermore, the Cures Act describes the penalties that apply to Actors if they engage in information blocking.⁵ Developers of certified health IT must not take any action that constitutes information blocking as a condition of obtaining and maintaining certification under the ONC Health IT Certification Program.⁶ For developers of certified health IT and HIE/HINs, OIG may impose civil monetary penalties ("CMPs") of up to $1 million per violation.⁷ OIG may refer health care providers "to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law."⁸

Since the enactment of the Cures Act, HHS has taken several steps to promulgate regulations that address interoperability and information blocking. In May 2020, ONC issued a final rule, which codified a definition of information blocking, certain information blocking exceptions, and a requirement that developers not engage in information blocking as a condition of obtaining and maintaining health IT certification.⁹ In July 2023, OIG published a final rule establishing CMPs of up to $1 million per information blocking violation for developers and HIE/HINs—including health care providers that also meet the definition of a developer or HIE/HIN under ONC's regulations—effective September 1, 2023.¹⁰ Finally, ONC published a proposed rule in April 2023, which has not yet been finalized, that would introduce significant changes to the ONC Health IT Certification Program and targeted clarifications and updates to ONC's information blocking regulations.¹¹

II. The Proposed Rule

The Proposed Rule proposes "appropriate disincentives" for information blocking applicable to eligible hospitals, critical access hospitals ("CAHs"), and eligible clinicians¹² that participate in Medicare EHR Incentive Programs and the Medicare Shared Savings Program. In addition, the Proposed Rule proposes that ONC would publish information blocking determinations, disincentives, and penalties on its website.

a. Appropriate Disincentives for Eligible Hospitals, CAHs and Eligible Clinicians Participating in the Medicare EHR Incentive Programs

CMS established Medicare and Medicaid EHR Incentive Programs in 2011 pursuant to the Health Information Technology for Economic and Clinical Health Act of 2009 to encourage eligible hospitals, CAHs, and eligible clinicians to demonstrate meaningful use of ONC-certified Electronic Health Record technology ("CEHRT"). The Medicare EHR Incentive Programs have subsequently undergone numerous changes, and the Medicaid EHR Incentive Program expired effective calendar year 2022.¹³ Currently, the Medicare Promoting Interoperability ("PI") Program applies to eligible hospitals and CAHs, while the Merit-Based Incentive Payment System ("MIPS") under CMS's Quality Payment Program applies to eligible clinicians.¹⁴ MIPS consists of four performance categories, one of which is a PI performance category with similar requirements as the PI Program applicable to hospitals and CAHs.¹⁵ PI requirements for eligible hospitals and CAHs and eligible clinicians require the participating provider to be a "meaningful user" of CEHRT.¹⁶

Under the Proposed Rule, OIG would refer to CMS eligible hospitals, CAHs, and eligible clinicians that OIG has determined to have committed information blocking, and CMS would consider such providers not to be meaningful users of CEHRT. Not being a meaningful user of CEHRT can have significant financial consequences on the provider's Medicare reimbursement. For an eligible hospital, failure to meet the requirements to be a meaningful user of CEHRT leads to a 75% lower annual increase in Medicare payments based on an inflation market basket update or rate of increase for hospitals that CMS publishes each year.¹⁷ For a CAH, loss of "meaningful user" status would lead to a reduction in payments received from CMS under the Medicare Promoting Interoperability Program from 101 percent to 100 percent of its reasonable costs.¹⁸ Eligible clinicians that are not meaningful users of CEHRT receive a PI performance category score of 0.¹⁹ The PI performance category represents 25% of the clinician's MIPS score.²⁰ Eligible clinicians' MIPS scores are compared to a CMS-established benchmark, with those scoring above the benchmark receiving a bonus of up to 9% more in Medicare payments and those scoring below the benchmark receiving a penalty of up to 9% less in Medicare payments.²¹

While the financial impact of the disincentive would vary depending on the provider's circumstances, the Proposed Rule provides the following estimated ranges:

While CMS did not separately simulate the impact on CAHs, CMS believes that "receiving 100 percent of reasonable costs instead of 101 percent of reasonable costs . . . would deter information blocking by CAHs because it would reduce the reimbursement a CAH could have received had it met other requirements under the Medicare Promoting Interoperability Program."²²

b. Appropriate Disincentives Related to the Medicare Shared Savings Program

Under the Medicare Shared Savings Program, groups of providers of services and suppliers and their associated health care providers ("ACO participants" and "ACO providers/suppliers," respectively) that meet certain criteria "may work together to manage and coordinate care for Medicare fee-for-service beneficiaries through an [accountable care organization]" ("ACO").²³ If an ACO meets certain quality performance standards established by the Secretary of HHS, the ACO is eligible to receive payments for any shared savings that the ACO generates for Medicare.²⁴ ACOs that generate losses for Medicare may share in those losses, although loss sharing may be mitigated if the ACO meets HHS quality performance standards.²⁵

One of the conditions of participation in the Shared Savings Program is that an ACO must coordinate care for assigned beneficiaries using enabling technologies,²⁶ which CMS has interpreted as requiring "[s]haring health information using enabling technologies across all health care providers engaged in a beneficiary's care."²⁷ Using its authority to administer the Shared Savings Program,²⁸ CMS proposes to bar ACOs, ACO participants, and ACO providers/suppliers determined by OIG to have committed information blocking from participating in the Shared Savings Program for at least one year.²⁹

c. Transparency for Information Blocking Determinations, Disincentives, and Penalties

The Proposed Rule also proposes that ONC will publish on its public website certain information about Actors that have been determined by OIG to have committed information blocking, including the Actor's name, a description of the practice found to have been information blocking, the disincentives applied, and where to find additional information from the applicable government agency.³⁰ ONC believes that it has authority to publish such information pursuant to the provision in the Cures Act that "requires that [ONC] maintain an Internet website 'to ensure transparency in promotion of a nationwide health information technology infrastructure.'"³¹ According to ONC, this transparency would allow the public to better understand how information blocking regulations are being enforced, and the types of information blocking violations that Actors have committed.

III. Conclusion

If finalized, these proposed appropriate disincentives would introduce real consequences for health care providers that engage in information blocking and would represent one of the last outstanding pieces of information blocking enforcement nearly seven years after enactment of the Cures Act. Furthermore, the Proposed Rule would publicize information blocking determinations, disincentives, and penalties that have been imposed, allowing the public to easily discover what entities have committed information blocking and what information blocking practices are occurring in the industry.

Comments on the Proposed Rule may be submitted until 5:00 p.m. Eastern Time on January 2, 2024.

Footnotes

1. 88 Fed. Reg. 74,947 (Nov. 1, 2023).

2. 45 C.F.R. § 171.103 defines information blocking as a practice that—

1. Except as required by law or covered by an exception set forth in the regulations, is likely to interfere with access, exchange, or use of EHI; and
2. If conducted by a Certified Health IT Developer or HIE/HIN, such developer, network, or exchange knows, or should know, that such practice is likely to interfere with access, exchange, or use of EHI; or
3. If conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with access, exchange, or use of EHI.

3. 21st Century Cures Act, H.R. 34, 114th Congress, Pub. L. No. 114-255 (Dec. 13, 2016).

4. 42 U.S.C. §§ 300jj–52(a)(3), 300jj–52(b)(1).

5. 42 U.S.C. § 300jj–52(b)(2).

6. 42 U.S.C. § 300jj–11(c)(5)(D)(i).

7. 42 U.S.C. § 300jj–52(b)(2)(A).

8. 42 U.S.C. § 300jj–52(b)(2)(B).

9. "21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program," 85 Fed. Reg. 25,642 (May 1, 2020).

10. "Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's Civil Money Penalty Rules," 88 Fed. Reg. 42,820 (July 3, 2023). See also, Christine Moundas, Gideon Zvi Palte & Carolyn Lye, Compliance Takeaways From HHS Information Blocking Rule, Law360, July 28, 2023, https://www.law360.com/articles/1704395.

11. "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing," 88 Fed. Reg. 23,746 (April 18, 2023). See also Christine Moundas, Gideon Zvi Palte & Carolyn Lye, ONC proposes significant changes to health IT certification program and information blocking rule, Westlaw Today (May 3, 2023), https://www.ropesgray.com/-/media/files/articles/2023/05/20230503_westlaw_today_article/20230503_westlaw_today_article.pdf?rev=e17668d41f1c43bd8c290edee6e8d279&hash=A0F5EBE473917679C3E6A91AE7282F50.

12. "Eligible clinician" means "'eligible professional' as defined in section 1848(k)(3) of the [Social Security] Act, as identified by a unique TIN and NPI combination and[] includes any of the following: (1) A physician[;] (2) A practitioner described in section 1842(b)(18)(C) of the Act[;] (3) A physical or occupational therapist or a qualified speech-language pathologist[; and](4) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act)." 42 C.F.R. 414.1305. CMS explains that all eligible clinicians except audiologists would fall within the definition of "health care provider" in ONC information blocking regulations and therefore could be subject to the disincentives described in the Proposed Rule. See 88 Fed. Reg. at 74,959.

13. See CMS, Promoting Interoperability Programs (last rev. Oct. 19, 2023), https://www.cms.gov/medicare/regulations-guidance/promoting-interoperability-programs?redirect=/ehrincentiveprograms.

14. There are two "payment tracks" under the Quality Payment Program: MIPS and Advanced Alternative Payment Models ("APM"). MIPS participants earn "performance-based payment adjustments for the services [they] provide to Medicare patients," while participants in an APM receive incentives for high-quality, high-value care, "focus[ed] on special clinical conditions, care episodes, or populations." See CMS, Quality Payment Program Overview, https://qpp.cms.gov/about/qpp-overview.

15. Id. See also CMS, Traditional MIPS Overview, https://qpp.cms.gov/mips/traditional-mips.

16. 42 C.F.R. §§ 495.40(a), (b).

17. 42 U.S.C. § 1395ww(3)(B)(ix).

18. 88 Fed. Reg. at 74,955.

19. Id.

20. 88 Fed. Reg. at 74,958.

21. Id.

22. 88 Fed. Reg. at 74,956.

23. 42 U.S.C. § 1395jjj.

24. 88 Fed. Reg. at 74,963.

25. 42 C.F.R. § 425.600.

26. 42 U.S.C. § 1395jjj(b)(1)(G).

27. 88 Fed. Reg. at 74,963.

28. 42 C.F.R. §§ 425.305(a), 425.206(a)(1)(iii), 425.118(b)(1)(iii).

29. 88 Fed Reg. at 74,964.

30. 42 U.S.C. § 300jj–52(a)(1). See also 88 Fed. Reg. at 74,953–54.

31. 88 Fed. Reg. at 74,953.

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