For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, or Labinot Alexander Berlajolli.

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 Patricia.Jackman@doh.nj.gov,
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.