The Department of Health and Human Services (HHS) updated its FAQs for the Provider Relief Fund and clarified two key points related to reporting requirements: Expenses for capital equipment, inventory, and facilities projects may be fully expensed if the purchase was directly related to preventing, preparing for, and responding to the coronavirus (e.g., ventilators, personal protective equipment, HVAC upgrades to... Read More
CDC: Funding Opportunity for Pediatric Immunization Surveillance; Includes COVID-19; LOI due Jan.7
The Centers for Disease Control and Prevention (CDC) recently announced a pediatric immunization-focused Notice of Funding Opportunity (NOFO) – US Enhanced Surveillance Network to Assess Burden, Natural History, and Effectiveness of Vaccines to Prevent Enteric and Respiratory Viruses in Children (RFA-IP-21-002). The NOFO aims to support grantees with developing and implementing standard research protocols to conduct prospective active surveillance for... Read More
WHG - Weekly, November 16-20
Progress around passage of a large coronavirus relief package this year has diminished as both parties have retreated to their respective corners, maintaining their pre-election positions on the topline figures for federal aid. President Trump didn’t provide much clarity as he urged Congress in a tweet to pass a “big and focused” relief package. The impasse on coronavirus relief does... Read More
NIH: Preliminary Data Demonstrates Effective Moderna COVID-19 Vaccine Candidate
The National Institutes of Health (NIH) announced that the preliminary data from Moderna's Phase 3 COVID-19 vaccine trial demonstrates that the candidate (mRNA-1273) is safe and 94.5 percent effective. This analysis comes from an independent data and safety monitoring board (DSMB) overseeing the phase 3 trial. The candidate was co-developed by Moderna and the National Institute of Allergy and Infectious... Read More
CMS: Agency Announces Coverage of Monoclonal Antibody Therapy at No Cost-Sharing for Medicare Beneficiaries
The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare now offers coverage of bamlanivimab (a monoclonal antibody therapy) used to treat COVID-19 at no cost-sharing for the duration of the public health emergency (PHE). Specifically, CMS is providing coverage for: Infusion: The initial payment rate for administration of bamlanivimab will be $309.60 and will be geographically adjusted... Read More
MedPAC: Commissioners Deliberate on Policy Options for Medicare Telehealth Expansions Post-Pandemic
The Medicare Payment Advisory Commission (MedPAC) convened a session further discussing the Commission’s views on expanding access to telehealth in Medicare following the COVID-19 pandemic. MedPAC staff outlined a series of policy options for the Commissioners to consider as they begin work to finalize a set of recommendations to Congress. Overall, Commissioners appeared largely in favor of broadly expanding access... Read More
HHS: Competition Seeks Kidney Solutions Related to COVID-19; Round 1 Submissions Due Dec. 4
The Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) announced the launch of the KidneyX COVID-19 Kidney Care Challenge. The Challenge is a prize competition that “seeks solutions that reduce the transmission of the coronavirus among people living with kidney disease and/or reduce the risk of kidney damage among people who contract the virus.”... Read More
CMS: Agency Finalizes CY 2021 ESRD PPS; Payments Expected to Increase by 2.0 Percent
The Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2021 prospective payment system (PPS) for end stage renal disease (ESRD) facilities (fact sheet; press release). What it is. The final rule outlines ESRD PPS payment policies applying to dialysis facilities beginning on or after Jan. 1, 2020. The rule also includes final changes to the... Read More
WHG - Weekly, November 2-6
The political stakes are huge for the upcoming elections tomorrow. At the moment, former Vice President Joe Biden appears to be maintaining his lead in the popular vote and in the crucial swing states that will be necessary to garner a majority of the electoral votes. The margin of victory for either candidate is sure to be close and could... Read More
WHG - October 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
NIH: Comments Due Dec. 7 on NIH-Wide Strategic Plan for COVID-19 Research
The National Institutes of Health (NIH) issued a request for information (RFI) to gather public input on the NIH-Wide Strategic Plan for COVID-19 Research. The agency notes that this will be a “living document,” which will be continually updated to reflect new challenges presented by COVID-19. The strategic plan can be found here and outlines the following five priorities and... Read More
CMS: Agency Issues Fourth COVID-19 Interim Final Rule; Includes Vaccine and Diagnostic Coverage and Payment Policies, Among Other Changes
The Centers for Medicare & Medicaid Services (CMS) released its fourth COVID-19 interim final rule (IFC), which includes several provisions to prepare for coverage of forthcoming vaccines and treatments for the disease (press release; fact sheet). Briefly, the new rule outlines policy changes in the following key areas: COVID-19 Vaccines: The rule implements coverage policies for vaccines and their administration... Read More
MACPAC: Commissioners Discuss Flexibility and Increased FMAP to Address Eligibility Redeterminations Post-PHE
The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a panel to discuss the process for restarting Medicaid eligibility redeterminations when the public health emergency (PHE) ends. The Families First Coronavirus Response Act (FFCRA) enacted continuous coverage for Medicaid enrollees to ensure that individuals do not lose coverage during the pandemic. In turn, states took action to prevent terminations,... Read More
HHS: COVID-19 Hospital Data Report Shows Only 62 Percent of Hospitals Are Meeting Reporting Requirements
Recently updated COVID-19 hospital data indicates only 62 percent of hospitals are reporting all mandated coronavirus data and about three-fourths of hospitals are 90 percent compliant. The Department of Health and Human Services (HHS) rolled out new mandatory reporting requirements via a Centers for Medicare and Medicaid Services (CMS) interim final rule with comment period and HHS’ COVID-19 Guidance for... Read More
WHG - Weekly, October 26-30
As negotiations over a COVID-19 relief package between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin drag into another week, the outlook for a deal before Election Day appears to be a long-shot given the remaining significant disagreements as well as resistance among Senate Republicans to a bill ranging from $1.9 trillion to $2.2 trillion. Senate Majority Leader... Read More
HHS: Department Revises Eligibility and Reporting Requirements for Phase 3 Provider Relief Funds
The Department of Health and Human Services (HHS) recently revised Provider Relief Fund (PRF) eligibility and reporting requirements for its forthcoming “Phase 3” general distribution. The changes expand eligibility to a broader array of provider types including those who do not serve Medicare and Medicaid beneficiaries, such as: allopathic and osteopathic physicians; nursing service and related providers; hospice providers; respiratory,... Read More
WHG - Candidates Offer Differing Approaches to Pandemic Response and Health Care in Final Presidential Debate
Last night, President Donald J. Trump faced former Vice President and Democratic presidential candidate Joseph R. Biden in the last of two 2020 general election debates. The event was hosted at Belmont University in Nashville, Tennessee. The Commission on Presidential Debates kept the format mostly the same as the first debate, with six 15-minute segments dedicated to topics selected and announced... Read More
HHS: Administration Expands Authorization for Pharmacists to Administer Vaccinations and COVID-19 Tests
Updating guidance it released in September, the Department of Health and Human Service (HHS) issued new guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) that further expands authorization for certain pharmacists (qualified pharmacy technicians and state-authorized pharmacy interns) to order and administer COVID-19 vaccinations, and permits them to administer childhood vaccines and COVID-19 tests. The guidance also... Read More
Senate: GOP Targeted COVID-19 Relief Package Fails
The Senate failed to pass a motion to invoke cloture on the GOP targeted COVID-19 relief package championed by Senate Majority Leader Mitch McConnell (R-KY). Leader McConnell lacked the support of 60 members to overcome the procedural hurdle needed to hold a final vote on the package. The cloture measure failed by a 51-44 vote along party lines. The package... Read More
Senate: Senate Slated to Vote on $500 Billion GOP Targeted Coronavirus Relief Package; Changes to Paycheck Protection Program
The Senate is slated to vote today on a targeted coronavirus relief package containing approximately $500 billion in federal aid focused on health care, education, and the economy. The package largely resembles the legislation that Senate Majority Leader Mitch McConnell (R-KY) attempted to advance in September that was blocked by Democrats. It remains unclear whether Leader McConnell has the votes... Read More
W&M: Oversight Subcommittee Examines Trump Administration Efforts to Undermine Health Insurance Coverage; ACA Supreme Court Case, Preexisting Conditions, and Alternative Insurance Options Discussed
The House Ways & Means Subcommittee on Oversight convened a hearing to examine health insurance coverage and the Administration’s efforts to undermine the Affordable Care Act (ACA). The hearing featured witnesses from state exchanges who spoke about state efforts to improve access and affordability of health insurance and witnesses that detailed the current state of health coverage under the ACA... Read More
District Court: Judge Vacates USDA Rule Limiting SNAP Benefits for ABAWDs
The United States District Court for the District of Columbia ruled against the December 2019 final rule from the U.S. Department of Agriculture (USDA) that would limit Supplemental Nutrition Assistance Program (SNAP) benefits for able-bodied adults without dependents (ABAWDs). The court's decision permanently blocks the Trump administration from implementing the rule. Judge Beryl Howell found that the administration's final rule... Read More
HHS: Agencies Announce COVID-19 Vaccination Program for Long-Term Care Facilities
The Department of Health and Human Services (HHS) and the Department of Defense announced a partnership with CVS and Walgreens pharmacies to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) with no out-of-pocket costs. Although no vaccines have been authorized or approved by the Federal Drug Administration yet, HHS explains it is establishing the Pharmacy Partnership... Read More
WHG - Weekly, Oct 19-23
House Speaker Nancy Pelosi (D-CA) has set tomorrow as the deadline for an agreement on a COVID-19 relief package before the election as prospects on a deal continue to dim. While Senate Majority Leader Mitch McConnell (R-KY) has agreed he would consider an agreement, he remains very dubious of the latest talks and is pressing on with a vote Tuesday... Read More
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