Department of Health and Human Services April 6, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request from several food industry associations to extend open comment periods while their members focus on continuity of critical infrastructure operations due to the recent COVID-19 public health declaration. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The Council on Graduate Medical Education (COGME) meeting previously announced as in-person and webinar/conference call on Tuesday, April 28, 2020, and Wednesday, April 29, 2020, has changed its format, date, and time. The meeting will now be a one-day webinar and conference call only on Wednesday, April 29, 2020, from 12:00 p.m.-5:00 p.m. Eastern Time. The webinar link, conference dial-in number, meeting materials, and agenda will be available on the COGME website: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/meeting s/ index.html.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled a writing subcommittee public meeting. Information about NACNEP, the agenda, and materials for this meeting can be found on the NACNEP website at https://www.hrsa.gov/ advisory-committees/nursing/.

This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the 2019 Novel Coronavirus (COVID-19). Recognizing the urgency of this situation, and understanding that some pre-existing Medicare payment rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are changing Medicare payment rules during the Public Health Emergency (PHE) for the COVID-19 pandemic so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics (RHCs), and federally qualified health centers (FQHCs) are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community. We are also altering the applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing. We are also expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Medicare Part B. In addition, we are making programmatic changes to the Medicare Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint Replacement (CJR) Model in light of the PHE, and program-specific requirements for the Quality Payment Program to avoid inadvertently creating incentives to place cost considerations above patient safety. This IFC will modify the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic and also to avoid inadvertently creating incentives to place cost considerations above patient safety. This rule also amends the Medicaid home health regulations to allow other licensed practitioners to order home health services, for the period of this PHE for the COVID-19 pandemic in accordance with state scope of practice laws. We are also modifying our under arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital.