Compliance Concerns Rise as Information Blocking Rules Become Fully Mandatory

By Mathew J. Levy, Esq. & Zoila Sanchez, J.D., M.P.H.

Health care providers constantly strive to do what is best for the patient. However, sometimes a practice’s policies and procedures may unintentionally fall short of this goal. For example, when a patient experiences challenges accessing his/her laboratory results and must wait until her physician has had a chance to review, this delaying of access could be considered preventing patient access to their own electronic health information (EHI). As a result, the provider may fall out of compliance with a new fully enforced rule on “Information Blocking.” 

Information Blocking is the interference with access, exchange, or use of EHI which can occur, for example, by a delayed lab result to a patient as illustrated above or charging excessive fees for patients to obtain their own records. The purpose of the regulation by the Office of the National Coordinator for Health Information Technology (ONC), is to promote patient control over their own health information by improving the facilitation of electronic access, exchange, and use of health information.

While the ONC information blocking regulations have been in full effect since April 5, 2021, many physicians, healthcare IT developers, and health information networks, are reportedly unprepared. In fact, a recent survey by Life Image, a health care interoperability company, discovered that most clinical, technology, and administrative healthcare leaders are unprepared to comply with the rule’s prohibition on information blocking. While 70% of participants reported to awareness of the rule, 50% of participants are reportedly unaware of the practices that constitute information blocking with reports of engaging in noncompliant practices such as sharing paper records or sharing records on CDs. Almost half of the participants responded that they either had not made any changes or did not know how to meet the requirements.  

Most concerning is that of those surveyed, 39% were unaware that noncompliance with information blocking practices could result in civil monetary penalties. OIG recently proposed that noncompliance with the rule could face penalties of up to $1 million. These penalties are significant, and it is imperative for providers to focus their attention on (1) understanding the requirements and exceptions (2) having a compliance program in place that integrates the rules into your practice and (3) maintaining your compliance program. New York no longer permits a per page copying charge when producing electronic records per patient request– providers can only charge for the time it takes to retrieve the record from its server which is usually de minimus. A reference for you to review related to this topic is “21st Century Cures Act Has Taken Effect” and “Understanding Compliance.”

About the Authors: 

Mathew J. Levy is a Partner of the firm and co-chairs the Firm’s corporate transaction and healthcare regulatory practice. Mr. Levy has extensive experience in, defending healthcare professionals in actions brought by State licensing authorities and the Federal agencies (OIG, Medicare, OMIG, Medicaid, DEA, OSHA, OCR OSHA, Hospital Review Boards, Office of Professional Medical Conduct and Office of Professional Discipline.) Mr. Levy has successfully defended numerous healthcare providers in actions involving the US Attorney’s Office investigations, Medicare Fraud Waste and Abuse investigations, Medicaid Fraud Control Unit investigations, OPMC, OPD, Medicare, Medicaid as well as commercial insurance audits including Prepayment Review, Post Payment Review, Medicare Hearings and Hospital Discipline Investigations.

Mr. Levy has successfully structured and negotiated joint venture agreements, private equity transactions, venture capital transactions, stock purchase agreements, asset sale agreements, shareholders agreements, partnership agreements, employment contracts, managed care agreements and commercial leases. Among the areas in which he focuses are coordinating mergers and acquisitions, compliance programs, ambulatory surgery centers, the establishment of diagnostic and treatment centers, HIPAA privacy regulations, fee-splitting issues, Stark law issues, fraud and abuse rules and regulations and Medicare/ Medicaid, Oxford, Americhoice, Fidelis, Healthfirst and other third-party payor settlements.

Zoila Sanchez, J.D., M.P.H. joined the Firm full-time upon graduating with her Juris Doctor degree from the Maurice A. Deane School of Law at Hofstra University. During law school, Ms. Sanchez served as a Legal Clerk with the U.S. Department of Health and Human Services Office of Counsel to the Inspector General in Washington, DC, where her work focused on health care fraud and abuse. Ms. Sanchez has experience in supporting the Firm’s business and health care law, and litigation practice areas. 

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

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