December 27, 2020
Today, President Trump signed the Coronavirus Response and Relief Supplemental Consolidated Appropriations Act of 2021 into law. The House (359 to 53) and Senate (91 to 7) passed the legislation by a vote of 359 to 53 on December 22. The bill combines a $1.4 trillion omnibus with a $900 billion COVID stimulus measure. This is also good news for physician reimbursement, as the bill provides temporary relief from Medicare payment cuts resulting from the planned evaluation and management (E/M) code changes slated for implementation on January 1, 2021. Some highlights of the bill pertaining to relief from physician reimbursement cuts and COVID-19 are below:
Supporting Physicians and Other Professionals in Adjusting to Medicare Payment Changes During 2021: The bill delays the G2211 add-on code reimbursement for 3 years. The money saved from the delay is estimated to mitigate the MPFS final rules cuts resulting from the preservation of budget neutrality. Thus, the bill increases the physician fee schedule for services furnished on or after January 1, 2021, and before January 1, 2022, by 3.75%. It transfers $3 billion dollars to the Federal Supplementary Medical Insurance Trust fund to remain available until expended to pay for this fee schedule increase. The bill requires the Secretary of HHS to submit a report to Congress by April 1, 2022 ,regarding the 2021 physician fee schedule increase.
SNMMI is awaiting more details on specifically how this bill will in impact reimbursement rates in radiology and nuclear medicine.
Food and Drug Administration (FDA): The bill appropriates $55 million to prevent, prepare for, and respond to COVID-19, domestically or internationally, for salaries and expenses of the FDA. This includes: (1) $9 million for development of necessary medical countermeasures and vaccines; (2) $30.5 million for advanced manufacturing for medical products; (3) $1.5 million for monitoring of medical product supply chains; (4) $7.6 million for other public health research and response investments; (5) $1.4 million for data management operation tools; and (6) $5 million for after action review activities.
Centers for Disease Control and Prevention (CDC): The bill appropriates $8.75 billion to remain available until September 30, 2024, for CDC-Wide Activities and Program Support, to prevent, prepare for, and respond to COVID-19, domestically or internationally, including activities to plan, prepare for, promote, distribute, administer, monitor, and track COVID-19 vaccines to ensure broad-based distribution, access, and vaccine coverage. The bill allocates $4.5 billion of this sum for states, localities, and territories, which includes $210 million for the Indian Health Service. The bill requires that $1 billion of the sum be made available within 21 days of enactment. The bill requires that $300 million of the sum be designated for high-risk and underserved populations, including racial and ethnic minority populations and rural communities. The bill requires the director of CDC to provide an updated comprehensive vaccine distribution strategy and spend plan, to be submitted to Congress within 30 days of enactment, to be updated every 90 days through the end of the fiscal year.
National Institutes of Health (NIH): The bill appropriates $1.25 billion to remain available through September 30, 2024, to prevent, prepare for, and respond to COVID-19, domestically or internationally, for the Office of the Director of NIH. The bill allocates $1.15 billion of this sum for research and clinical trials related to long-term studies of COVID-19, including $100 million for the Rapid Acceleration of Diagnostics.
Vaccine, Therapeutic, and Diagnostic Development and Procurement: The bill appropriates $22.95 billion to remain available until September 30, 2024, for the Public Health and Social Services Emergency Fund (PHSSEF), to prevent, prepare for, and respond to COVID-19, domestically or internationally, including: (1) the development of necessary countermeasures and vaccines, prioritizing platform-based technologies with U.S.-based manufacturing capabilities (including to demonstrate innovations for such platforms); (2) the purchase of vaccines, therapeutics, diagnostics, and necessary medical supplies; (3) medical surge capacity; and (4) other preparedness and response activities. The bill directs the secretary of HHS to use these funds to purchase COVID-19 vaccines in sufficient quantities to address the public health need, and to ensure that vaccines, therapeutics, and diagnostics developed from those funds are affordable in the commercial market without delaying the development of such products. The bill permits the secretary of HHS to use up to $3.25 billion for purchase of products to be deposited in the Strategic National Stockpile (SNS). The bill allocates $19.67 billion of the funds for the Biomedical Advanced Research and Development Authority (BARDA) for manufacturing, production, and purchase of vaccines, therapeutics, and ancillary supplies necessary for the administration such vaccines and therapeutics. Of this sum, the bill permits funds to be used for construction or renovation of non-federally owned U.S.-based next-generation manufacturing facilities, other than facilities owned by the U.S. government, for such purposes.
Testing and Contact Tracing: The bill appropriates an additional $22.4 billion to remain available until September 30, 2022, for the PHSSEF to prevent, prepare for, and respond to COVID-19, domestically or internationally, for testing, contract tracing, surveillance, and mitigation to monitor and suppress COVID-19, for states, localities, and territories for activities including the following: (1) tests for both active infection and prior exposure, including molecular, antigen, and serological tests; (2) the manufacturing, procurement and distribution of tests, testing equipment and testing supplies, including personal protective equipment needed for administering tests; (3) the development and validation of rapid, molecular point-of-care tests, and other tests; (4) support for workforce; (5) epidemiology; (6) to scale up academic, commercial, public health, and hospital laboratories; (7) to conduct surveillance and contact tracing; (8) support development of COVID–19 testing plans; and (9) and other related activities related to COVID–19 testing and mitigation. The bill requires that funds be made available within 21 days of enactment. The bill allocates $790 million of the sum for the Indian Health Service. The bill allocates $2.5 billion of the sum for strategies for improving testing capabilities in high-risk and underserved populations, including racial and ethnic minority populations and rural communities. The bill requires governors of states and territories to update testing and contact tracing plans (pursuant to PL 116-139) and submit updates to the Secretary of HHS within 60 days of receiving funds.
Provider Relief Fund: The bill appropriates an additional $3 billion for the PHSSEF to prevent, prepare for, and respond to COVID-19, domestically or internationally, to reimburse, through grants or other mechanisms, eligible healthcare providers for healthcare-related expenses or lost revenues that are attributable to COVID-19. The bill requires recipients of funds to submit reports and maintain documentation to ensure compliance with the requirements of the Provider Relief Fund. The bill clarifies that funds distributed under the Provider Relief Fund may be made available for the costs of construction of temporary structures, leasing of property, medical supplies, equipment including personal protective equipment, testing supplies, workforce and training, emergency operation centers, retrofitting facilities, and surge capacity. The bill directs providers to use the Frequently Asked Questions guidance released by HHS in June 2020 for calculating lost revenues. The bill requires the Office of Inspector General of HHS report within three years to the respective House and Senate Appropriations Committees on audit findings of the Provider Relief Fund.