New Jersey Waives Certain Regulations Applicable to Collection Stations

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeLabinot Alexander Berlajolli, or Brianna J. Santolli.

In an effort to increase testing capacity in New Jersey, the Department of Health waived certain regulations applicable to collection stations, which is when a licensed clinical laboratory occupies office space in a physician’s office for the purpose of collecting specimens on the physician’s patients.   According to a June 5, 2020 Notice of Waiver, New Jersey licensed clinical laboratories may open collection stations to collect specimens for COVID-19 testing without completing the collection station licensing process or paying the required fee. Additionally, the temporary collection stations do not need to comply with the location and layout requirements set out at N.J.A.C. 8:44-2.14(b)(2)-(6). This waiver is limited to only collecting specimens related to COVID-19 testing.  Clinical laboratories that open a temporary COVID-19 specimen collection station must contact Patricia Jackman at the Department via e-mail at, and provide (1) the name of the parent clinical laboratory; (2) the address where the temporary collection station will be located; and (3) a contact phone number and e-mail for a representative from the parent laboratory.

Federal Final and Proposed Regulations

85 FR 25510 – Final – This final rule comprises the first phase of policies focused on advancing interoperability of health information using the authority available to CMS.  For patients, the rule creates electronic access to stored health information by creating a patient-facing application programming interface (API) to which third-party software applications make data available to patients for personal use.  For clinicians, the rule expands access to health information about prospective new patients by integrating APIs and removing procedural limitations that otherwise restrict the flow of health information between providers and payers.  For payers, such as payers in Medicare Advantage, Medicaid, and CHIP, the rule requires use of an API to facilitate a flow of information that follows the patient in the event the patient changes providers or payers.  Because of potential privacy concerns associated with the rule’s increased use of technology and introduction of third party software developers, the rule also promulgates a set of technical approaches and standards to be implemented to protect health information from unwanted dissemination.  The rule is effective June 30, 2020

85 FR 33595 – Proposed – The Centers for Medicare & Medicaid Services ("CMS") proposed a rule that would change the risk adjustment data validation (“RADV”) error estimation methodology for states where the Department of Health and Human Services (HHS) operates the risk adjustment program, starting with the 2019 benefit year.  These proposals seek to further the HHS-RADV program, address stakeholder feedback, promote fairness, and improve the predictability of HHS‑RADV adjustments.  Comments are due by July 2, 2020.

85 FR 32460 – Proposed – The proposed rule would make payment and policy changes to the Medicare inpatient prospective payment systems for operating and capital‑related costs of acute care hospitals, as well as for certain hospitals and hospital units excluded from the IPPS, for the fiscal year 2021.  CMS also wants to update the payment policies and annual payment rates for the Medicare prospective payment system for inpatient hospital services provided by long-term care hospitals.  In an effort to reduce the disparity between high and low wage index hospitals, CMS is proposing to increase the wage index values and to apply a budget neutrality adjustment to the standardized amount so that increases are implemented in a budget neutral manner.  The rule also includes changes to new technology add-on payment policies, updated policies for the Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program, and new or revised requirements for quality reporting by acute care hospitals, PPS-exempt cancer hospitals, and hospitals participating in the Medicare and Medicaid Promoting Interoperability Programs.  Comments are due by July 10, 2020.

CMS Makes Changes to Accountable Care Organization (ACO) Models

In response to COVID-19, CMS issued a table detailing model adjustments related to financial methodologies, quality reporting, and model timelines.  Multiple changes have been made to the financial methodology for the Next Generation ACO (“NGACO”) model, including capping gross savings upside potential at 5 percent.  CMS also is reducing 2020 downside risk by reducing shared losses by the proportion of months during the public health emergency.  The 2020 financial guarantee requirement and episodes of care that include treatment for COVID-19 will be removed.  A retrospective regional trend, rather than prospective, will be used for 2020.  Additionally, CMS is canceling the 2019 quality audit and continuing to monitor the effect on 2020 quality reporting.  The NGACO model will also be extended through December 2021.