NJ Eases Testing Requirements for Elective Surgeries, but Do You Know the Difference Between Molecular, Antigen, and Antibody Testing? A New Federal Statute Proposes to Increase the Shared Savings for ACOs. Also, New Adopted and Proposed NJ Regulations.

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeLabinot Alexander BerlajolliBrianna J. Santolli, or Daniel J. Parziale.

New Jersey Executive Directive No. 20-016 Modifies Testing Protocols for Ambulatory Surgery Centers Resuming Elective Surgery and Invasive Diagnostic Procedures

The New Jersey Department of Health has further modified its previous guidance on the resumption of elective surgeries and invasive procedures in Ambulatory Surgery Centers (“ASCs”). Under the modified guidance, patients still have to undergo COVID‑19 testing and receive results within six days before the scheduled surgery. However, if a negative test is not received by day six, the ASC may proceed with the procedure as scheduled, provided that the decision to proceed is based on a clinical assessment performed by a physician prior to surgery evaluating the risk involved if the patient is COVID positive during the procedure. The physician must note in the patient’s medical record why awaiting the test result is not necessary and that it is appropriate to move forward with the procedure. The physician must document that the patient’s health will be endangered if the procedure is delayed, and the ASC must follow certain infection control procedures, as set forth in the modified guidance.

Importantly, the modified guidance further limits the type of COVID-19 testing. By way of background, a diagnostic test can show if a patient has an active coronavirus infection. There are two types of diagnostic tests to detect the virus according to the Food and Drug Administration (“FDA”): (1) a molecular test, such as the RT-PCR test, which detects the virus’s genetic material and (2) an antigen test (not to be confused with an antibody test) that detects specific proteins on the surface of the virus. Most point of care tests (i.e., rapid tests) are antigen tests.

Under the modified guidance, antigen tests cannot be used. Only molecular tests can be used. All tests must be either approved by the FDA, authorized by the FDA through an Emergency Use Authorization, and/or approved by the New Jersey Clinical Laboratory Improvement Services as permitted by the FDA. 

Antibody tests, which determine whether or not antibodies to COVID-19 are present, may not be used. 

Some point of care tests are molecular tests and they are acceptable if the test provides a confirmed negative. Any point of care molecular tests that only return a “presumption negative” are not acceptable.

Surgery centers still cannot perform procedures on patients who tested positive for COVID‑19 unless, according to the modified guidance, it is excepted in Executive Order No. 109 as an “urgent case.” 

New Federal Legislation Hopes to Increase the Shared Savings Rate for Accountable Care Organizations

The Value in Health Care Act (the “Value Act”), recently introduced in the U.S. House of Representatives, aims to create more accountable care organizations (“ACOs”) and update several of Medicare’s alternative payment models (“APMs”). The new bipartisan legislation would boost the percentage of shared savings for new ACOs and also extend bonus payments to clinicians working in advanced APMs for an additional six years (from 2024 to 2030). The Value Act also would increase the shared savings rate for Medicare Shared Savings Program (“MSSP”) and make other technical updates to the MSSP benchmarking and risk adjustment methodologies. This is a much needed boost in light of the record number of hospitals experiencing financial distress in light of COVID-19. The bill has received major support from 13 provider groups, including the National Association of ACOs, the American Hospital Association, the American Medical Association, and the Federation of American Hospitals.

New Jersey Adopted and Proposed Regulations

Regulation Expanding Graduates of International Medical Schools

52 N.J.R. 1336(a) – Final – The State Board of Medical Examiners (“BME”) adopted a regulation proposed in November 2019 (51 N.J.R. 1597(a)) that updated the eligibility requirements for graduates of international medical schools who seek licensure or authorization to engage in the practice of medicine as residents. The regulation allows the BME to rely on recognized accrediting bodies for international medical schools that adhere to standards substantially similar to the bodies that currently accredit domestic medical schools. The rule became effective July 6, 2020.

Regulation Expanding Services Provided by Advanced Practice Nurses

51 N.J.R. 1338(a) – Final – The Board of Nursing adopted a regulation proposed in July 2019 (51 N.J.R. 923(a)), which expands the ability of advanced practice nurses to dispense narcotic drugs for maintenance treatment or detoxification treatment if he or she has met the training and registration requirements of 21 U.S.C. § 823.  The rule became effective July 6, 2020

Proposed Regulation Expands Services Provided by Licensed Midwives

52 N.J.R. 1392(a) – Proposed – The BME proposes to amend N.J.A.C. 13:35-2A.10 and 2A.12, so that licensed midwives may administer or facilitate the administration of nitrous oxide for pain relief during the intrapartum and postpartum stages when they are providing services in a health care facility licensed by the Department of Health. Comments are due by September 18, 2020. For more information about this Update, please contact any of the authors below.