If you have any questions about this blog post, please contact Khaled J. Klele, Ryan M. Magee, or Labinot Alexander Berlajolli.

Skilled Nursing Homes

The Centers for Medicare & Medicaid Services ("CMS") recently announced a new independent Commission that will conduct a comprehensive assessment of the nursing home response to COVID-19.  The Commission is expected to develop recommendations on three key tasks: (1) putting nursing home residents first by ensuring they are protected from COVID-19 and improving the responsiveness of care delivery to maximize the quality of life for residents; (2) strengthening efforts to enable rapid and effective identification and mitigation of COVID-19 transmission and other infectious diseases in nursing homes; and (3) enhancing strategies to improve compliance with infection control policies in response to COVID-19.

In addition, CMS announced that it intends to require nursing homes to notify their residents and representatives within 12 hours of confirmed COVID-19 cases in the nursing home or notification if three or more residents or staff with new onset of respiratory symptoms occur within 72 hours.   The notice must also include information on mitigation actions implemented to prevent transmission, and describe if and how normal operations will be altered.

CMS Recommendations for Re-Opening Facilities

CMS has issued new guidelines for re-opening facilities to provide essential non-COVID-19 care to patients without symptoms of COVID-19 in regions with low and stable incidence of the virus.  These recommendations are intended to provide guidance for communities that have entered or anticipate immediately entering Phase 1 of the Guidelines for Opening Up America Again.   CMS still advises that healthcare facilities and providers in areas seeing a higher number of COVID-19 cases should continue to follow their recommendations issued in March 2019.

Interim Final Rule

85 FR 27550 – Interim Final Rule – Our last update focused on CMS’ second set of sweeping regulatory changes.   Since then, CMS published an interim final rule on May 8, 2020 formalizing those changes.  The interim rule was effective May 8, 2020.  Comments must be submitted by July 7, 2020.

Interoperability Final Rule Delayed

The Office of the National Coordinator for Health IT (“ONC”), CMS and the OIG announced that, in light of COVID-19, they will delay their respective portions of the Interoperability and Patient Access Final Rule (“Final Rule”). ONC stated that it will exercise its discretion in delaying enforcement of all new requirements under the Final Rule until 3 months after the initial compliance dates and timeframes.  The enforcement discretion dates and timeframes are listed here.  CMS released a statement that it is extending the implementation timeline for the admission, discharge, and transfer notification Conditions of Participation (“CoPs”) by an additional six months, such that CoPs will now be effective 12 months after the Final Rule is published in the Federal Register.  Finally, enforcement of the Patient Access API for Qualified Health Plan issuers will not be enforced until July 1, 2021.

Independent Freestanding Emergency Departments

In an effort to increase hospital capacity, CMS recently issued guidance allowing independent freestanding emergency departments (“EDs”) to provide care to Medicare and Medicaid patients and bill for those services during the COVID-19 pandemic.   EDs may participate in Medicare and Medicaid in three ways: (1) as a hospital‑affiliated ED under the 1135 emergency waivers; (2) as Medicaid-certified clinics under the state’s clinic benefit; and (3) as a Medicare-certified hospital by temporarily enrolling in Medicare as a hospital through the attestation process detailed in the CMS guidance.

Federal Regulations

85 FR 22024 – Final Rule – Following the Office of Civil Rights (“OCR”) announcement to allow alternative technologies to provide more flexibilities in providing telehealth, the Department of Health and Human Services (HHS) issued this final rule formalizing that flexibility.  As previously noted, providers may use video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom, or Skype.  However, Facebook Live, Twitch, TikTok, and similar video communication applications should not be used because they are public facing.  The rule is effective, retroactively, to March 17, 2020 and will remain in effect until the Secretary of HHS declares that the public health emergency no longer exists, or upon the expiration date of the declared public health emergency, including any extensions.

85 FR 22978 – Proposed – CMS recently extended the comment period to June 23, 2020 for the proposed rule titled ‘‘Medicare Program: Comprehensive Care for Joint Replacement (CJR) Model Three-Year Extension and Changes to Episode Definition and Pricing.”  The proposed rule, first published on February 24, 2020, sought to revise certain aspects of the CJR model.  Due to COVID-19, and in order to receive the benefit of an active commentary, the comment period has been extended.

New Jersey Statutes

S2357 – Approved – This bill requires hospitals to report COVID-19 demographic data to the Department of Health (DOH) including the age, ethnicity, gender, and race, of persons who have tested positive, who have died from, who have sought treatment for, who have been admitted for treatment, and who were turned away from testing for COVID-19. The bill provides that DOH is to publish the demographic data on its internet website, with daily updates providing the latest demographic data.  The data collected thus far has been uploaded to the DOH’s website. To review this data, which is updated daily, click here.

New Jersey Regulations

52 N.J.R. 890(b) – Final – The State Board of Medical Examiners (“BME”) adopted the telemedicine and telehealth rules it proposed last year.   Importantly, the BME rejected several commentators’ request that the BME delete the requirement that a physician be licensed in New Jersey if the physician is located in New Jersey while treating patients via telemedicine who are located outside of New Jersey at the time of treatment.

52 N.J.R. 894(a) – Final – The BME adopted these final rules that were proposed last year implementing telemedicine and telehealth rules for midwives.

52 N.J.R. 896(b) – Final – The Board of Nursing adopted rules, proposed last year, regarding the standards by which an advanced practice nurse may transmit, or have an authorized agent transmit, an electronic prescription to a pharmacy.

52 N.J.R. 866(a) – Proposed --  In 2019, New Jersey entered the Nurse Licensure Compact. The Compact is an agreement between states in which nurses licensed in one member state ("home state") may work in another member state ("remote state") without obtaining a license in the remote state. To effectuate the Compact, the Board of Nursing proposes amendments and new rules to establish the procedures for applying for licenses with multistate privileges. Comments are due by June 19, 2020.

52 N.J.R. 867(a) – Proposed – The Board of Nursing proposes to amend N.J.A.C. 13:37-5.3 and 7.2 to effectuate the requirements of P.L. 2017, c. 28. to complete continuing education or initial education in pharmacologic therapy, addiction prevention and management, and issues concerning opioid drugs. An applicant for certification as an advanced practice nurse must complete this education as part of his or her six hours in pharmacology.  Comments are due by June 19, 2020.

Please visit Riker Danzig’s COVID-19 Resource Center to stay up to date on all related legal issues.