On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020.  This joint announcement was made by the Office of the National Coordinator for Health IT (“ONC”), the Centers for Medicare & Medicaid Services (“CMS”), and the HHS Office of Inspector General (“OIG”).

As we previously discussed, the final rules are intended to improve patient access to electronic health information (“EHI”) and to standardize the modes of exchanging EHI.  These rules greatly affect hospitals and other healthcare stakeholders, who are working at the forefront of the COVID-19 pandemic.  HHS considers the decision to exercise enforcement discretion as one of many steps “taken to ease [the] burden on the healthcare industry as it fights COVID-19.”  HHS will continue monitoring implementation of the rules to decide if additional actions are necessary.

CMS’s Enforcement Discretion

CMS announced that it will be extending by six months the time periods for implementing certain aspects of the Interoperability and Patient Access Final Rule.  Accordingly, the admission, discharge, and transfer notification Conditions of Participation rules, which were initially scheduled to take effect six months after the publication of the final rule, will now be effective 12 months after publication.

CMS will also exercise discretion for six months regarding the Patient Access API and Provider Directory API requirements for Medicare Advantage, Medicaid, and the Children’s Health Insurance Program (“CHIP”) under 42 C.F.R. Parts 422, 431, 438, and 457.  The requirements, which were to become effective on January 1, 2021, will not be enforced until July 1, 2021.  CMS will similarly defer enforcement of the new requirements for the Patient Access API for Qualified Health Plan (“QHP”) issuers under 45 C.F.R. Part 156 until July 1, 2021.

These are the only requirements for which CMS has announced it will exercise enforcement discretion.  Other policies and requirements must be implemented as set out in the final rule, including the payer-to-payer data exchange deadline of  January 1, 2022.

ONC’s Enforcement Discretion

ONC announced that it will exercise enforcement discretion for three months following the original compliance date for all new requirements in the ONC Final Rule. Therefore, ONC will not enforce such requirements, found at 45 C.F.R. Part 170, for three months after the initial date or time period provided in the final rule.  A detailed list of the requirements and new compliance deadlines can be found here.

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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience…

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and health information privacy. Ms. Kraus regularly advises clients on Medicare reimbursement matters, the Medicaid Drug Rebate program, health information privacy issues (including under HIPAA and the HITECH Act), and the challenges and opportunities presented by the Affordable Care Act.

Photo of Rujul Desai Rujul Desai

Rujul Desai advises clients on drug pricing, market access, reimbursement, strategic contracting, and regulatory solutions for drugs, biologicals, devices, and diagnostics. He brings deep experience with biopharma, specialty pharmacy, and pharmacy benefit management (PBM) companies.

Rujul has held a number of leadership roles…

Rujul Desai advises clients on drug pricing, market access, reimbursement, strategic contracting, and regulatory solutions for drugs, biologicals, devices, and diagnostics. He brings deep experience with biopharma, specialty pharmacy, and pharmacy benefit management (PBM) companies.

Rujul has held a number of leadership roles in the biopharma, PBM, and specialty pharmacy industry, including with CVS Caremark, UCB, and most recently as Vice President at Avalere Health. He has led engagements across a wide range of U.S. and global market access and reimbursement issues, including optimizing new product launches, pricing, PBM and payer formulary access, value-based contracting, distribution network design, patient access and hub services, affordability programs, e-prescribing, digital health, and the use of health economic data and modeling.

Photo of Paige Jennings Paige Jennings

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private…

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private sectors. Prior to earning her law degree and Master of Public Affairs, she worked in the U.S. Senate for over four years, advising Senators John Breaux and Tom Carper on health and social policy matters. Ms. Jennings later handled federal health policy issues at WellPoint, Inc. During law school, she worked with the U.S. Office of Management and Budget during consideration of the Affordable Care Act, and with the Federal Trade Commission for then-Chairman Jon Leibowitz.