About Krystyna Monticello Krystyna H. Monticello is a partner of Attorneys at Oscislawski LLC (Oscislawski LLC), a nationallyrecognized boutique health law firm based in Princeton, New Jersey, with an office in Scottsdale, Arizona. Every year since 2018, Oscislawski LLC has been included among the ’Best Law Firms’ in healthcare law in Princeton, New Jersey (issued by Best Lawyers®), and for 2024, included among the Best Law Firms both nationally as well as for healthcare law in New Jersey. Krystyna was recently recognized as one of the Best Lawyers® for 2024. Krystyna has extensive experience in the privacy and health information technology space, representing some of the most sophisticated health care clients in New Jersey and nationally. She counsels several leading health information exchange organizations (HIOs), hospitals and health care systems, and works extensively with health care clients in the areas of HIPAA and other privacy and security laws, health information technology and electronic health information exchange, fraud and abuse, state licensing requirements and other federal and state standards governing health care entities and the exchange of health information. responsibility for compliance with the Information Blocking Rules. While it is true that these actors have their own direct compliance obligations, HCPs remain independently responsible for and may be held accountable for their own practices which result in information blocking. Although the good news is that enforcement will be limited for HCPs in the interim, HCPs should take this time to re-familiarize themselves with the Information Blocking Rules and evaluate their current practices which could directly or indirectly affect access to, exchange or use of EHI, such as medical record access, fee schedules, and security practices, as well as their participation in federal incentive programs affected by the proposed disincentives. 1 21st Century Cures Act, P.L. 114-225 (December 13, 2016). 2 42 U.S.C. § 300jj-52(b). 3 Electronic health information has such definition set forth in 42 U.S.C. § 300jj(4) and 42 U.S. Code § 1320d(4). 4 42 U.S.C. 300jj–52(a). Notably, subsequent rulemaking did not retain “prevent or materially discourage”. See 45 C.F.R. 171.103. 5 42 U.S.C. 300jj–52(a)(2). 6 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally- Facilitated Exchanges, and Health Care Providers, 85 Fed. Reg. 25510 (May 1, 2020). 7 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, 85 Fed. Reg. 25642 (May 1, 2020). 8 Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General’s Civil Money Penalty Rules, 88 Fed. Reg. 42820 (July 3, 2023). 9 45 C.F.R. 171.103. 10 45 C.F.R. 171.103. 11 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking, 88 Fed. Reg. 74947 (November 1, 2023). 12 42 U.S.C. § 300jj-52(b)(2)(A). 13 42 U.S.C. § 300jj-52(b)(2)(B). 14 42 U.S.C. § 300jj(3). Health Care Providers includes hospitals, skilled nursing facilities, nursing facilities, home health, long term care facilities, health care clinics, community mental health centers, renal dialysis facilities, blood centers, ambulatory surgical centers, emergency medical services providers, federally qualified health centers, group practices, pharmacists, pharmacies, laboratories, physicians and other practitioners, among others. OIG has previously expressed that it would coordinate with other agencies to avoid duplication of penalties. - No disincentives for HCPs that do not fall under one of the existing quality incentive programs. The Cures Act requires the disincentives be established using “authorities under applicable federal law” which HHS would propose to mean only a government agency that has established disincentives for HCPs that OIG determines have committed information blocking could subject a HCP to disincentives using authorities that could apply to information blocking by a HCP subject to the authority, such as HCPs participating in a program supported by the authority. What should healthcare providers now be doing before the Final Rule is published by HHS regarding compliance with the Cures Act information blocking requirements? HHS is accepting public comment and feedback on its proposed disincentives until January 2, 2024. HCPs who would be affected by the Proposed Disincentives Rule are encouraged to submit their comments and concerns about the impact of the proposed disincentives. A common misconception is that Developers of Certified Health IT and HIEs/HINs have primary WWW.LAWYER-MONTHLY.COM 43 Additional rulemaking in the future would be warranted to address these categories of providers not subject to the proposed disincentives.
RkJQdWJsaXNoZXIy Mjk3Mzkz