President Joe Biden unveiled his administration’s “National Strategy for the COVID-19 Response and Pandemic Preparedness,” a roadmap to guide and centralize the federal government’s response to the pandemic. To begin implementation of the National Strategy, Biden issued a slate of executive actions aimed at: Ramping up COVID-19 testing and vaccines; Increasing the supply of personal protective equipment and other resources;... Read More
HHS: Department Releases Updated Reporting Requirements for PRF Recipients; Delays Start Date for Provider Reporting
The U.S. Department of Health and Human Services (HHS) announced reporting updates for the Provider Relief Fund (PRF). Specifically, HHS says that it is amending the reporting timeline for the PRF program and that, consequently, providers will be required to submit their reports later than initially announced due to the recent passage of the Coronavirus Response and Relief Supplemental Appropriations... Read More
MedPAC: Commission Continues Deliberations around Telehealth Expansion Following the PHE
The Medicare Payment Advisory Commission (MedPAC) convened a session (slides) to continue the discussion on a possible expansion of telehealth in Medicare following the COVID-19 public health emergency (PHE). Following MedPAC’s November session on the same issue, staff presented a modified list of policy options to Commissioners for their review and further input. Commissioners were largely in favor of the... Read More
CMS: Agency Launches New Platform for Section 1135 Waiver Requests
Earlier this week, the Centers for Medicare & Medicaid Services (CMS) launched a new web-based platform for Section 1135 waiver requests (press release). The new platform enables streamlined documentation and centralizes requests, which CMS asserts will reduce regulatory burden and improve responsiveness. Effective January 11, 2021, the agency expects providers to use the new system for all 1135 waiver requests... Read More
HHS: Department Releases Online Locator for Treatment Sites Offering Monoclonal Antibody Therapeutics for COVID-19
The U.S. Department of Health and Human Services (HHS) announced it has a developed a web-based locator for COVID-19 outpatient treatment sites offering monoclonal antibody therapeutics. HHS states it is making this locator service available to support health care providers and patients in identifying where such therapies are delivered, which have been authorized for emergency use to treat COVID-19 patients... Read More
CMS: MA Plans, PDPs Can Request COVID-19 Vaccine Data for Care Coordination; Effective Immediately
The Centers for Medicare and Medicaid Services (CMS) released a memo that explains how Medicare Advantage Plans, Prescription Drug Plans, and Medicare-Medicaid Plans can request COVID-19 vaccine data (COVAX) data from CMS regarding their enrollees, subject to approval, to assist with case management, care coordination, and other population-based activities to improve health. Data will include the following: Enrollee-identifying information (name,... Read More
HHS: Department Begins Distribution of $24.5 Billion in Phase 3 Funding to Providers
The U.S. Department of Health and Human Services (HHS) announced it has completed review of Phase 3 applications for the Provider Relief Fund (PRF) and will distribute approximately $24.5 billion to over 70,000 providers. HHS states this satisfies nearly 90 percent of the funding reported lost by each applicant and net change in expenses caused by the COVID-19 pandemic. Of... Read More
Other: Comments Requested on Cost of Assistance Estimates in the Disaster Declaration Process for the Public Assistance Program; Due Feb. 21
The Federal Emergency Management Agency (FEMA) recently issued a proposed rule to revise the “Estimated cost of the assistance,” which is one of the factors FEMA’s Public Assistance Program considers when evaluating requests from states for major disaster declarations and making recommendations to the President. The proposed rule aims to more accurately assess the disaster response capabilities of states and... Read More
WHG - WHG - Weekly, December 14-18
As the first COVID-19 vaccine begins to roll-out across the nation, negotiations on a coronavirus relief deal packaged with fiscal year (FY) 2021 spending step into overdrive as lawmakers now have until Friday of this week before government funding runs dry. President Trump is calling for another round of stimulus payments, which are not included in the $908 billion bipartisan... Read More
CMS: Informational Bulletin: Medicaid and CHIP Renewal Requirements
The Centers for Medicare & Medicaid Services (CMS) released a Informational Bulletin to states to clarify current federal regulations and expectations for completing redeterminations of eligibility for Medicaid and CHIP beneficiaries. The bulletin is intended as a resource for states that are returning eligibility and enrollment operations to their routine functioning after the COVID-19 Public Health Emergency (PHE). Though, the... Read More
MACPAC: Commissioners Discuss Implications of the 2020 Elections for Medicaid Policy; Begin to Prioritize Policy Issues to Highlight for Incoming Administration and Congress
The Medicaid and CHIP Payment Access Commission (MACPAC) convened a session to discuss the implications of the 2020 congressional and presidential elections for Medicaid policy. MACPAC staff provided a brief review of expected priorities of the Biden Administration, and then posed the question to Commissioners whether to send a letter to leaders of the 117th Congress and the Biden Administration, and... Read More
MACPAC: Commissioners Review State Survey of Nursing Facility Payment Methods
The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session to examine preliminary findings from a seven-state interview on nursing facility payment methods. Principal Policy Analyst Robert Nelb presented themes on nursing facility payment methods regarding the use of value-based payments, supplemental payments, and managed care and sought feedback on how these findings could inform future Commission work... Read More
CDC: Grants to Increase COVID-19, Flu Immunizations to Reduce Racial/Ethnic Disparities; Supports Provider Partnerships With Communities
The Centers for Disease Control and Prevention (CDC) announced a grant opportunity (CDC-RFA-1P21-2016) aimed at increasing COVID-19 and flu vaccination coverage in racial and ethnic populations experiencing disparities in vaccination rates. The grant opportunity is limited to national organizations and their partners. Funded activities include building partnerships between vaccination providers and the community, conducting vaccination activities, and deploying educational campaigns... Read More
House Appropriations: House Passes One Week Continuing Resolution, Including Health Care Extenders
The House voted 343 to 67 to approve H.R. 8900, a continuing resolution to extend federal government funding through December 18, 2020 - one week further than the existing expiration date of Friday, December 11. In addition to a funding extension, the legislation includes a one-week extension of certain Medicaid and public health care program "extenders." These include funding for... Read More
HHS: Eligible Nursing Homes Will Receive Second Round of Performance-based Incentive Payments Starting Dec. 9
The Health Resources and Services Administration (HRSA) announced it is distributing $523 million in second-round performance payments to more than 9,000 nursing homes in accordance with the Department of Health and Human Services’ (HHS) plan (WHG client summary) for Provider Relief Fund performance-based incentive payments. The payments are intended to reward nursing homes for successfully reducing COVID-19 related infections and... Read More
WHG - Weekly, December 7-11
Congressional leaders have made progress in their attempts to negotiate a coronavirus relief bill that they intend to combine with the fiscal year 2021 omnibus spending package. Lawmakers are expected to pass a one-week stopgap measure through December 18 to give negotiators more time, as a slew of issues still need to be ironed out. Legislative text for the bipartisan... Read More
CMS: Hospital Outpatient Final Payment Rule with Comment Period Maintains Existing 340B Cuts, Eliminates IPO Only List, Delays Radiation Oncology Model, Imposes New Pandemic-Related Reporting Requirements
The Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2021 hospital outpatient prospective payment system (OPPS) final rule with comment period (fact sheet) addressing payments to hospital outpatient departments and ambulatory surgery centers (ASCs). Addenda referred to in the final rule for the OPPS system and the ASC payment system are available here and here, respectively... Read More
HHS: Amendment Issued to PREP Act to Increase Access to Covered Countermeasures
The Department of Health and Human Services (HHS) issued an amendment to the Public Readiness and Emergency Preparedness (PREP) Act to increase access to covered countermeasures during the COVID-19 public health emergency (PHE) (press release). In general, the amendment defines covered countermeasures used to combat COVID-19, such as diagnostics, therapeutics, vaccines, and respiratory devices, and adds individuals that may order... Read More
OIG: Agency Issues Semiannual Report to Congress for April 1-Sept. 30, 2020
The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) posted its Semiannual Report to Congress for the six month period ending September 30, 2020. The April 1, 2020 – September 30, 2020 Semiannual Report includes data on HHS OIG reports issued, expected recoveries, criminal and civil actions, and other statistics. It also highlights significant results... Read More
WHG - November 2020 Edition: Catalogue of Health Agency Guidance and Government Response to COVID-19
In response to the novel coronavirus (COVID-19) pandemic, U.S. government agencies have continued the frequent release of fact sheets and guidance documents for health care and public stakeholders. To help navigate the outpouring of information, the Wynne Health Group has maintained the attached and newly updated catalogue, intended to capture and organize the full array of relevant guidance for health... Read More
HHS: Agency Requests Information About COVID-19 Regulatory Flexibilities to Inform Permanent Changes; Comments Due Dec. 25
The Office of the Secretary within the Department of Health and Human Services (HHS) recently issued a request for information (RFI) seeking comments on the regulatory relief actions HHS has taken to respond to the COVID-19 pandemic’s impact on the health care industry. Of note, Appendix A of the RFI includes a list of 382 actions that have been taken... Read More
HHS: RFI Seeks Information About Novel Approaches for Treating COVID-19 and Non-COVID-19 Conditions; Comments due Dec. 24
The Office of the Secretary within the Department of Health and Human Services (HHS) recently issued a request for information (RFI) to better understand the effects of the steps taken by health care systems and health care providers to respond to the COVID-19 pandemic. HHS notes that it is interested in “effective and innovative approaches and best practices implemented by... Read More
WHG - Weekly, November 30-December 4
Congress returns this week to a full plate of contentious issues – coronavirus relief and fiscal year (FY) 2021 spending – as the December 11 deadline for extending government funding approaches. An impasse remains on the overall price tag of a relief bill as House Speaker Nancy Pelosi (D-CA) continues to push for a $2.2 trillion package and Senate Majority... Read More
FDA: Consolidated List of Medical Devices with Emergency Use Authorization for COVID-19 Public Health Emergency
The Food and Drug Administration (FDA) published a consolidated list of medical devices that have received emergency use authorization (EUA) for the COVID-19 public health emergency. The list details the EUAs for the following categories of devices: Diagnostic and antigen tests (p. 5-14); In vitro diagnostics tests (p. 14- 15); and Personal respiratory protective devices (p. 15- 20). The full... Read More
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