State Health and Value Strategies (SHVS), in partnership with Manatt Health, Georgetown’s Center on Health Insurance Reforms (CHIR), State Health Access Data Assistance Center (SHADAC), Bailit Health, and GMMB developed this resource page to serve as an accessible “one-stop” source of COVID-19 information for states. This resource is designed to support states seeking to make coverage and essential services available to all of their residents, especially high-risk and vulnerable people, during the COVID-19 pandemic. SHVS will update this page frequently with new resources as they become available.
| If you have materials you are willing to share with other states through this page, or if there are topics of particular concern that you would like addressed, please contact SHVS. |
The Centers for Disease Control and Prevention (CDC) today announced a plan to invest $2.25 billion over two years to address Coronavirus Disease 2019 (COVID-19)-related health disparities and advance health equity among populations that are at high-risk and underserved, including racial and ethnic minority groups and people living in rural areas.
A podcast that examines how American Indian and Native communities are faring during the COVID-19 pandemic.
The National Strategy provides a roadmap to guide America out of the worst public health crisis in a century. It outlines an actionable plan across the federal government to address the COVID-19 pandemic, including twelve initial executive actions issued by President Biden in his first two days in office.
Recommendations for Governors to support them in taking targeted action to prevent unchecked transmission, protect hospitals, and flatten the curve.
HHS announced that CDC will award $140 million for COVID-19 vaccine preparedness and almost $87 million for tracking and testing to 64 jurisdictions, including all 50 states and U.S. territories. Authorized through the CARES Act, the COVID-19 vaccines preparedness funding will provide infrastructure support to existing grantees through the Immunizations and Vaccines for Children cooperative agreement. These funds, along with previous support of $200 million allocated in September, will help awardees prepare to distribute COVID-19 vaccines. Authorized through the PPPHCEA, the testing and tracking funding will provide support to existing CDC grantees through the agency’s Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) Cooperative Agreement. These eligible uses of the funding includes: increasing the use of Advanced Molecular Detection technologies, such as whole genome sequencing of SARS-CoV-2; strengthening public health laboratory preparedness; and ensuring safe travel through optimized data sharing and communication with international travelers.
CMS issued guidance to psychiatric hospitals, Psychiatric Residential Treatment Facilities (PRTFs) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to improve their infection control and prevention practices, and in part, to reduce the use of seclusion and restraint as an infection control intervention. The guidance is intended to provide strategies for Medicare or Medicaid certified facilities to help address COVID-19 prevention, treatment and mitigation. The guidance includes FAQs covering the following topics:
– Promising practices, measurement, and mitigation strategies for infection control during the PHE
– Use of isolation, cohorting and PPE- Intervention, mitigation, and training strategies- Transition and discharge during the PHE
– Engaging family, caregiver, support personnel, and community resources
– Available local, State and Federal resource guides and web links
HHS announced its plans for continued support of SARS-CoV-2 testing efforts by states and territories in the first quarter of 2021, including:
– Continued weekly shipments of SARS-CoV-2 sample collection supplies to states and territories through at least March 2021
– Collaboration with the General Services Administration (GSA) to provide a streamlined process for states, territories, and other government agencies to purchase point-of-care diagnostic tests. Through a contract between the federal government and Abbott, states, territories, and tribes will be able to purchase tests at a fixed price through an existing Federal Supply Schedule program. The contract eliminates the need for states and territories to spend resources negotiating and establishing individual purchasing contracts with manufacturers. The maximum number of tests that states and territories will be able to purchase each month will be predetermined to help ensure adequate supplies for all on an ongoing basis. The program is expected to launch in mid-January.
– Allocating an additional 30 million Abbott BinaxNOW tests for nursing homes, assisted living facilities, and home health care, hospice organizations, HBCUs, tribes, and other vulnerable groups likely through March 2021.
CMS issued an updated frequently asked questions (FAQ) on Clinical Laboratory Improvement Amendments (CLIA) guidance for the COVID-19 public health emergency. The December 17 updates indicate:
– Laboratories may develop their own quality control plans for “non-waived” COVID-19 test systems with an emergency use authorization in instances when the manufacturers’ quality control instructions are less stringent than the CLIA quality control requirements at 42 CFR § 493.1256. Laboratories that opt to implement an individualized quality control plan are instructed to refer to the State Operations Manual, Appendix C.
– FDA authorized the first prescription home use COVID test, the Lucira COVID-19 All-In-One Test Kit, in November. This test is also authorized for Point of Care (POC) use in patient care settings operating under a CLIA Certificate.
HHS’s Office of the Assistant Secretary for Health issued guidance indicating it is extending coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) to qualified National Guardsmen administering COVID-19 vaccinations that have been authorized or licensed by the FDA to individuals ages 3 and older. HHS conveyed this will allow states and territories to fully utilize National Guard health and medical personnel to increase access to COVID-19 vaccinations .Similar to other categories of “covered persons” under the PREP Act, the Guardsmen may receive immunity under the PREP Act with respect to all claims for loss related to the administration or use of vaccines and will be subject to other applicable requirements of the Act as follows:
– The vaccine must be FDA-authorized or FDA-licensed.
– The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP’s) COVID-19 vaccine recommendation.
– The Guardsman must be authorized by his or her National Guard unit to administer vaccines.
– The Guardsman must have a current certificate in basic cardiopulmonary resuscitation.
– The Guardsman must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines
– The Guardsman must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination program provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
This authorization preempts any State and local law that prohibits or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines.
FDA issued frequently asked questions (FAQs) on the Pfizer COVID-19 Vaccine, providing guidance on publicly available data of the vaccine’s safety and effectiveness as well the rationale for FDA’s decision on issuing the emergency use authorization.
FDA issued the second emergency use authorization (EUA) for a vaccine for the prevention of COVID-19. The EUA allows the Moderna COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older. The Moderna vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA include an analysis of 28,207 of the participants enrolled in an ongoing randomized, placebo-controlled study. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 COVID-19 cases in the vaccine group and 185 in the placebo group. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
The Department of Health announced that it is providing free, safe and effective vaccinations to help prevent future COVID-19 infections. The state published a vaccination plan that establishes priorities for who should receive the first-available vaccine doses.
The Oregon Health Authority finalized its recommendations for who will be the first to receive doses of new COVID-19 vaccines. With a focus on health equity, the plan adds more granularity to federal recommendations and outlines specific populations within the broad groups—and in a wide range of health settings—that should be the focus for vaccination given the limited availability of the vaccine
NCDHHS has selected 17 school districts and 11 charter schools to participate in a pilot program to deploy COVID-19 rapid testing in K through 12 public schools where any in-person instruction is happening. NCDHHS sent the selected districts and schools more than 50,000 federally funded rapid antigen tests. Students and staff will have access to more than 200 school-based testing locations across 17 counties as part of the pilot.
The North Carolina Department of Health and Human Services will offer more than 300 no-cost, walk-up or drive through COVID-19 testing events over the next two weeks, including testing in partnership with new retailers in seven counties across the state. Retailers in seven counties are offering testing December 18 through 20 and December 26 through 27 in the parking lots of select Agri Supply, Carlie C’s IGA, Home Depot, Piggly Wiggly and Wegman’s stores.
Governor John Carney and the Delaware Division of Public Health announced Delaware’s plans to distribute the Pfizer BioNTech COVID-19 vaccine that was granted Emergency Use Authorization by the U.S. Food & Drug Administration. The Division of Public Health is responsible for providing the framework for acquiring and distributing the vaccine and has devised a three-tier strategy for distribution.
HHS announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic (casirivimab and imdevimab) which received an emergency use authorization (EUA) from the FDA on November 21 for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19. Beginning immediately, HHS will allocate weekly shipments to state and territorial health departments with distributions based proportionally on confirmed COVID-19 cases in each state and territory over the previous seven days. State and territorial health departments will, in turn, determine which healthcare facilities receive the infusion drug. The treatment doses will be available to patients at no cost; healthcare facilities may charge for administering the medicine.HHS also posted a dashboard that will be updated each week detailing the casirivimab and imdevimab shipments to states, territories, and jurisdictions. This dashboard will be available until the FDA issues a revised EUA indicating the U.S. government involvement in the allocation and distribution process is no longer needed.
HHS announced that all tribal health programs and urban Indian organizations (UIOs) have chosen their preferred method for receiving COVID-19 vaccines. Tribal health programs and UIOs had the option of receiving the vaccine either through the IHS or their respective state. Once available, COVID-19 vaccines will be allocated to jurisdictions, including the IHS, which will then distribute to tribal health programs and UIOs.In November, the IHS released its COVID-19 Pandemic Vaccine Plan which details how the IHS health care system will prepare for and operationalize a vaccine when it becomes available. The plan is based on the CDC’s COVID-19 Vaccination Interim Playbook for Jurisdiction Operations. The IHS plan also provides guidance for all tribal health programs and UIOs that choose to receive a COVID-19 vaccine coordinated through IHS as well as guidance for IHS federal sites.
The Advisory Committee on Immunization Practices (ACIP) issued an “interim recommendation” to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommends that the first available doses of the COVID-19 vaccine should go to healthcare workers and residents in long-term care facilities. Following the issuance of an emergency use authorization, ACIP will decide whether to modify those recommendations based on the safety and efficacy profile of the specific vaccine that has been authorized. ACIP’s recommendations trigger guaranteed vaccine coverage under certain payers for any populations that fall within ACIP’s recommendations.
The White House issued an executive order authorizing the 75 percent federal cost share for use of National Guard forces deployed in states and territories for COVID-19 response through March 31, 2021. As previously announced, the 100 percent federal cost share for Florida and Texas will terminate on December 31.
HHS issued a request for information (RFI), to be posted on the Federal Register on November 24, soliciting the input of healthcare systems and clinicians on innovative approaches and best practices in health care in response to the COVID-19 pandemic for both COVID-19 and non-COVID-19 health conditions. HHS further indicated they are interested in approaches that are validated by data confirming efficacy and/or effectiveness with demonstrated improvements in one or more of the following measures: patient outcomes, access to health care, safety, quality, and/or value. HHS plans to use responses to the RFI in order to inform HHS priorities and programs. Responses to the RFI should be submitted via the online RFI portal (see column J) by 11:59pm ET on December 24, 2020.
FEMA issued guidance to state, tribal, and territorial (STT) governments on countermeasures they must implement to mitigate medical staff constraints prior to requesting supplemental medical staffing through FEMA. Specifically, STT governments must implement and attest to implementing the following measures prior to submitting any medical staffing requests to FEMA:
– Decompressing hospitals in the impacted area, executing only the most critical patient procedures and ceasing all elective procedures
– Maximizing coordination of healthcare providers internal to the state to balance patients and staff
– Expanding use of telemedicine
– Recalling retired clinicians and activating the Medical Reserve Corps
– Restructuring staffing models, staff-to-patient ratios, and licensing practices
– Communicating key staffing shortages and priority workforce needs to relevant partners, including the state workforce agency and the state unemployment Insurance office
– Implementing expanded scope of practice for pre-hospital care providers
– Soliciting medical volunteers through the National Governor’s Association or Emergency Management Assistance Compacts
Following recent announcements from HHS and CMS regarding distribution of and reimbursement for the COVID-19 antibody therapeutic bamlanivimab, HRSA updated its COVID-19 Uninsured Program FAQs, indicating that it will cover the drug in the same manner as Medicare. Providers may bill the HRSA COVID-19 Uninsured Program for infusion of bamlanivimab, for which Medicare set an initial rate of $309.60 (subject to geographic adjustments). Currently, healthcare providers receive allocations of the drug free, as determined by federal and state health officials (see below for more information). In the future, when healthcare providers begin to purchase monoclonal antibody products, CMS plans to set payment rates in a similar fashion to the rates for COVID-19 vaccines, such as based on 95% of the average wholesale price.
HHS announced its partnerships with approximately 60 percent of pharmacies throughout the United States, District of Columbia, Puerto Rico, and the U.S. Virgin Islands as part of the federal pharmacy COVID-19 vaccine program. HHS conveyed it will coordinate with the participating pharmacies to provide access to COVID-19 vaccines. Vaccine will be administered at partners’ pharmacy locations at no cost to patients. Pharmacies that do not participate in the federal allocation program are encouraged to coordinate with their jurisdiction’s health department to become COVID-19 vaccine providers.Currently, there are no COVID-19 vaccines that have been authorized or approved by the FDA. However, this pharmacy partnership is being established in anticipation that one or more COVID-19 vaccines will be authorized or approved and recommended for use in the United States before the end of 2020.
HHS announced plans to allocate initial doses of Eli Lilly’s investigational monoclonal antibody therapeutic (bamlanivimab) which received an emergency use authorization (EUA) from the FDA on November 9 for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19. Beginning immediately, HHS will allocate weekly shipments to state and territorial health departments with distributions based proportionally on confirmed COVID-19 cases in each state and territory over the previous seven days. State and territorial health departments will, in turn, determine which healthcare facilities receive the infusion drug. The treatment doses will be available to patients at no cost; healthcare facilities may charge for administering the medicine.
HHS also posted a dashboard that will be updated each week detailing the bamlanivimab shipments to states, territories, and jurisdictions. This dashboard will be available until the FDA issues a revised EUA indicating the U.S. government involvement in the allocation and distribution process is no longer needed.
With several COVID-19 vaccine candidates in clinical trials, acclaimed California physician scientists will review vaccine process for safety before vaccine is distributed in California. State also details how safety, equity and transparency will guide COVID-19 vaccine planning and eventual distribution
In September, Governor Andrew M. Cuomo announced that New York State will form an independent Clinical Advisory Task Force comprised of leading scientists, doctors, and health experts who will review every COVID-19 vaccine authorized by the federal government, and will advise New York State on the vaccine’s safety and effectiveness in fighting the virus.
The Governor’s COVID-19 Vaccine Advisory Group advises the governor on preparations for a COVID-19 vaccine, including the optimization of a statewide vaccine distribution strategy, and communicating critical medical information about the vaccine with the state’s residents.
The group is administered by staff from the Connecticut Department of Public Health. Meetings are open to the public and available to watch online at https://ct-n.com/
Several COVID-19 vaccines could be on the market soon. State and federal officials have begun devising strategies for distributing and administering the vaccine and communicating with the public, but an equally important element will be the extent to which health care payers, including private insurers, will cover the costs for recipients. The Affordable Care Act (ACA) requires that most health insurers and employer health plans cover certain preventive services without cost-sharing, including vaccines recommended by the Advisory Committee on Immunization Practices (ACIP). However, ensuring that a COVID-19 vaccine is a free preventive service for all who need it, when they need it, is by no means guaranteed. This expert perspective discusses recent federal efforts to expand private insurance coverage of a vaccine, and provides a roadmap for states to close remaining coverage gaps that could inhibit vaccine uptake.
This expert perspective provides a roadmap for states to assess their vaccine coverage policies in Medicaid and, if necessary, to close any coverage gaps that might otherwise inhibit vaccine uptake during a crucial period of mass immunization.
The FDA issued a letter alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests. The guidance conveys that the FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings. The FDA provided recommendations for health care providers and clinical laboratory staff to help ensure accurate reporting of test results by following the authorized instructions for use of a test and key steps in the testing process as recommended by the CDC.
HHS announced it is preparing to provide ancillary supply kits to help healthcare workers who will be administering COVID-19 vaccines once the FDA approves or authorizes any vaccine for use.HHS has contracted with McKesson to produce, store and distribute these vaccine ancillary supply kits on behalf of the Strategic National Stockpile. Each kit will contain enough supplies to administer up to 100 doses of vaccine and will include:
– Needles (various sizes for the population served by the ordering vaccination provider)
– Syringes- Alcohol prep pads
– Surgical masks and face shields for vaccinators- COVID-19 vaccination record cards for vaccine recipients
– Needle information card
McKesson also is contracted to distribute the COVID-19 vaccines to administration sites on behalf of the federal government and under the guidance of the CDC. COVID-19 ancillary supply kits will be automatically distributed in amounts to match vaccine orders and will be provided at no cost to enrolled COVID-19 vaccination providers. Providers do not need to order these supplies in anticipation of administering the vaccine. Vaccination provider facilities and organizations must enroll in the federal COVID-19 Vaccination Program coordinated through their jurisdiction’s immunization program.
HHS announced that 389,040 Abbott COVID-19 rapid tests have been distributed at no cost to 83 Historically Black Colleges and Universities (HCBUs) in 24 states. The Abbott test is the only rapid point of care test that does not require instrumentation, produces COVID-19 test results within fifteen minutes, and costs five dollars.
On October 25, HHS announced that, of the 150 million test kits acquired by HHS, 50 million test kits are reserved for direct shipments to congregate care settings such as nursing homes, assisted living facilities, home health, hospice, the Indian Health Service, and historically black colleges and universities (HBCUs).
CMS issued new COVID-19 Patient Counseling FAQs for providers. The October 28 issue of the FAQs clarify that rural health clinics (RHCs) and federally qualified health centers (FQHCs) can bill CMS for counseling services on isolation, quarantine, and contact tracing during an office visit or telehealth visit to those tested for COVID-19. Payment for the counseling services would be included in the RHC all-inclusive rate and the FQHC PPS rate.
Under the PREP Act, HHS previously authorized pharmacists to order and administer CDC-recommended pediatric vaccines and COVID 19 vaccines, as well as COVID 19 tests. The October 20 guidance extends a similar authority to pharmacy interns and pharmacy technicians, allowing them to administer pediatric and COVID 19 vaccines under pharmacist supervision, and also to administer COVID 19 tests, subject to meeting certain requirements. The guidance lays out different considerations that may apply depending on a given state’s approach to licensing or otherwise regulating pharmacy interns and technicians.
HHS, DoL, Treasury, & HHS released the fourth COVID-19 interim final rule. The IFC:- Outlines HHS’ plan for COVID-19 vaccine coverage and, in particular, coverage of vaccine administration. Prior to the rule’s release, HHS had announced that it planned to distribute the vaccine to providers—but there were several open questions about coverage for the professional services to administer the vaccine. The rule lays out HHS’ plan to make the vaccine widely available without cost-sharing through a combination of regulatory changes (for Medicare and commercial coverage) and preamble language and supplemental toolkits (clarifying, for example, how existing Medicaid regulations and statute apply).
– Establishes an additional payment for certain Medicare-covered COVID-19 patients who are treated in inpatient settings with an eligible COVID-19 treatment. Additionally, it establishes a similar separate payment for patients who are treated in hospital outpatient departments.
– Provides states with flexibility to alter benefits and cost-sharing for Medicaid enrollees, despite a continuous enrollment provision of the FFCRA that requires states, as a condition of receiving the temporary increase in the federal matching rate, to maintain Medicaid beneficiary enrollment.
– Creates a process for states to propose exceptions to the public participation requirements for Section 1332 waivers during the public health emergency; it appears that CMS is seeking to establish a pathway for approving Georgia’s pending Section 1332 waiver.
The IFC will become effective once published on the Federal Register on November 6. Public comment will be due January 5, 2021.
HHS released preliminary data on states’ reported use of the 150 million Abbott rapid point-of-care (POC) SARS-CoV-2 diagnostic tests distributed by HHS beginning in late September. Per preliminary reports from states, allocations are largely being deployed to local health departments, K-12 schools and institutes of higher education, nursing homes, hospitals and correctional facilities. Of the 150 million test kits acquired by HHS, 100 million test kits are reserved for weekly shipments to Governors, who have discretion to allocate test kits as they see fit. The remaining 50 million tests are reserved for direct shipments to congregate care settings such as nursing homes, assisted living facilities, home health, hospice, the Indian Health Service, and historically black colleges and universities (HBCUs).
HRSA issued revised FAQs clarifying that the COVID-19 Uninsured Program (the “HRSA Program”) will reimburse providers for the costs of COVID 19 vaccine administration for uninsured individuals, once a COVID-19 vaccine receives either an Emergency Use Authorization (EUA) or full licensure from the FDA (the program previously covered COVID-19 testing and treatment but not vaccine services). Consistent with HRSA’s prior guidance regarding treatment services, it appears that an individual with public or private health coverage will be deemed “uninsured” for purposes of the HRSA Program if the individual lacks specific coverage for the COVID 19 vaccine. Thus, in addition to supporting access for individuals who are fully uninsured (including undocumented immigrants), the HRSA Program could help to address certain gaps in vaccine coverage. Notably, a vaccine authorized via EUA (as opposed to full licensure) may not be covered by Medicare. As for Medicaid, vaccine coverage is required during the federal Public Health Emergency (PHE), but once the PHE ends, each state may decide for itself whether to cover COVID-19 vaccines for “non-expansion” adult populations, including those who are eligible for Medicaid by virtue of advanced age, disability, or parenthood.
Addressing these coverage gaps will provide crucial support for healthcare providers participating in the COVID-19 vaccine distribution effort. The Administration’s September 16 vaccine planning guidance suggests that, although the federal government will bear the costs of acquiring and distributing COVID 19 vaccines (at least at first), the Administration will not necessarily take on the cost of vaccine administration, especially in cases where such costs are covered by public or private payers. Even so, the participation agreement for the COVID 19 vaccination program requires participating providers to administer the COVID 19 vaccine to any eligible individual regardless of coverage or ability to pay. Although the HRSA Program generally links reimbursement to Medicare rates for testing and treatment services, it is not clear how HRSA will set a fee schedule for vaccine administration, particularly if, with respect to a vaccine authorized via EUA, HRSA Program reimbursement becomes available before Medicare coverage kicks in. Whereas Congress appropriated specific funds to cover testing costs in the HRSA Program, the testing and vaccine administration are paid for using the Provider Relief Fund, of which $27 billion remains unallocated to date.
HHS, DoD, and Operation Warp Speed (OWS) announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs. The program is:
– Free of charge to facilities.- Available for residents in all long-term care settings, including skilled nursing facilities (SNF), nursing homes, assisted living facilities, residential care homes, and adult family homes.
– Available to all remaining LTCF staff members who have not been previously vaccinated for COVID-19 (e.g., through satellite, temporary, or off-site clinics).
– Available in most rural areas that may not have an easily accessible pharmacy.
The pharmacies will receive and manage vaccines and associated supplies (e.g., syringes, needles, and personal protective equipment); ensure cold chain management for vaccine; provide on-site administration of vaccine; and report required vaccination data (including who was vaccinated, with what vaccine, and where) to the state, local, or territorial, and federal public health authorities within 72 hours of administering each dose.Starting October 19, 2020, LTCFs will be able to opt in and indicate which pharmacy partner their facility prefers to have on-site. LTCFs are not mandated to participate in this program and can request to use their current pharmacy contracts to support COVID-19 vaccination. Nursing homes can sign up via the National Healthcare Safety Network and assisted living facilities can sign up via an online survey they will receive.
CDC issued updated guidance on the transmission of COVID-19 on its website, acknowledging published reports demonstrating circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19-positive person left an area. CDC maintains that close contact with a COVID-19-positive person is still the most common pathway of transmission and it is not modifying its COVID-19 prevention recommendations at this time. The October 5 update follows a previous update to the guidance, and subsequent redaction, that indicated there is “growing evidence” that droplets and airborne particles can travel distances beyond 6 feet and contribute to COVID-19 transmission.
CMS announced an update to its methodology for cascading testing requirements for nursing homes based on the community-specific rate of COVID-19 positivity. Under guidance CMS issued on August 26, nursing homes must test staff: monthly if the facility’s county positivity rate is less than 5%; weekly if the county positivity rate is between 5-10%; and twice weekly if the county positivity rate exceeds 10%. In response to concerns from governors of rural states that the frequency guidelines did not work well for rural areas that had low utilization of COVID-19 tests, CMS revised its methodology such that:
– Counties with 20 or fewer tests over 14 days are not required to test staff more frequently than once per month, regardless of county test positivity rates
– Counties with both fewer than 500 tests and fewer than 2,000 tests per 100,000 residents, and greater than 10 percent positivity over 14 days are not required to test staff more frequently than once per week
Following the August 27th announcement of the federal government’s purchase of 150 million rapid point-of-care (POC) SARS-CoV-2 diagnostic tests from Abbott, HHS announced a national distribution plan for the tests to assist Governors’ efforts to continue to reopen their states. The press release did not indicate state-by-state allocations of the distribution. According to the press release, governors have discretion to distribute tests in support of specific priorities or target populations, including K-12 teachers and students, higher education, critical infrastructure, and first responders.
HHS announced an agreement with The Rockefeller Foundation to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools. The partnership establishes a pilot program with select cities and states in The Rockefeller Foundation’s Testing Solutions Group (TSG), a network of public officials devoted to scaling COVID-19 testing, tracing, and tracking in their communities. HHS will provide at least 120,000 Abbott COVID-19 POC SARS-CoV-2 diagnostic tests to TSG pilot sites which include: Louisville, Los Angeles, New Orleans, Tulsa, and Rhode Island. The Rockefeller Foundation will help communities define problems, set policy goals, explore options, and craft solutions to help them fight the pandemic in a science-based manner. The POC testing pilot program will also provide data on how testing strategies can be operationalized in laboratories, retail pharmacies, and other community entities. The Federal government purchased 150 million Abbott COVID-19 POC SARS-CoV-2 diagnostic tests on August 27 for distribution to priority populations, including vulnerable groups and schools.
The National Academies National Academies of the Sciences, Engineering, and Medicine (NASEM) published “A Framework for Equitable Allocation of COVID-19 Vaccine”. The 236-page report, which was commissioned by the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), builds on the shorter “discussion draft” that NASEM released in early September . Four risk-based criteria informed NASEM’s recommendations for how to prioritize vaccine allocation across populations: (1) risk of acquiring infection, (2) risk of severe morbidity and mortality, (3) risk of negative societal impact, and (4) risk of transmitting infection to others. Based on these criteria, NASEM recommends the followed phased approach for vaccine allocation (which closely resembles the phases outlined in the discussion draft):
– Phase 1a (representing an estimated 5% of total U.S. population): First responders, as well as high-risk health workers involved in direct patient care and facility services (e.g., transportation or environmental services).
– Phase 1b (est. 10% of U.S. population): People with two or more health conditions that put them at significant risk of severe illness or death from COVID-19 (per CDC guidelines), as well as older adults living in nursing homes and other congregate settings.
– Phase 2 (est. 30–35% of U.S. population): K–12 teachers, school staff, and child care workers; critical workers in high-risk settings who cannot avoid a high risk of exposure to COVID-19 (e.g., workers in the food supply system or public transit); all older adults not included in Phase 1; people health conditions that put them at moderately higher risk of severe COVID 19 consequences (per CDC guidelines); and people in homeless shelters, group homes for individuals with physical or mental disabilities, incarcerated individuals and detention staff (if not already included in Phase 1).
– Phase 3 (est. 40–45% of U.S. population): Children and young adults under age 30, as well as any essential workers at increased risk of exposure who are not covered in Phases 1 and 2.
– Phase 4: Everyone living in the United States. Individuals who do not fall into the preceding phases include adults between the ages of 30 and 65 who do not work in essential occupations or industries.
HHS Secretary Azar extended the public health emergency (PHE) declaration, which was set to expire on October 22, through January 20. The PHE, in conjunction with the President’s National Emergency Declaration, authorizes Section 1135 waivers, and several other statutory and regulatory flexibilities related to COVID-19 are tied to the PHE.
HHS’ Office of the Inspector General (OIG) released an updated list of its Active Work Plan Items reflective of OIG’s audits, evaluations, and inspections that are underway or planned in determination of providers’ compliance with temporary authorities during the COVID-19 public health emergency. The newly-announced items include:
– COVID-19 Testing Data From Federal Programs. The CARES Act created the Pandemic Response Accountability Committee (PRAC) in order to promote transparency, support oversight, and detect/prevent fraud, waste, abuse, and mismanagement in the federal government’s COVID-19 response. PRAC members include Offices of Inspectors General (OIG) from the Departments of Defense (DoD), Education, Health and Human Services (HHS), Labor (DOL), and Veterans Affairs (VA), as well as the Office of Personnel Management (OPM). HHS-OIG will work with PRAC to produce a data brief describing COVID-19 testing in federal health-related programs managed or operated by these agencies to help provide transparency and inform policymakers about COVID-19 testing resources in federal programs.
– HHS and ASPR Actions Related to Resources, Supplies, and Treatments Needed to Address COVID-19. HHS OIG will examine actions taken by HHS, including the Office of Assistant Secretary for Preparedness and Response (ASPR), to protect public health in response to the COVID-19 pandemic. The announcement notes that HHS may take a variety of actions, and specifically notes actions related to resources, supplies, and treatments needed to address COVID-19.
– Infection Control at Home Health Agencies During the COVID-19 Pandemic. HHS OIG will interview corporate officers from the three Home Health Agency providers with the largest market share in 2019 as well as HHAs that have recently been cited by CMS for infection control and prevention deficiencies to determine the extent to which their infection control and prevention policy and procedures comply with CMS guidance regarding COVID-19.(Note, OIG references CMS’ March 10 CMS State Survey Directors Letter, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs).”)
HHS announced and issued notices of awards to to 64 jurisdictions for $200 million in CARES Act funding for vaccine preparedness, issued through the existing CDC Vaccines for Children cooperative agreement. A list of jurisdictions that received awards is available in the document linked in column J (see the column titled “COVID-19 Vaccine Preparedness Complete”). The press release indicates that the funds are intended to “plan for and implement COVID-19 vaccine services”; CDC has not yet made additional guidance about the funding–including its specific eligible uses–publicly available.
CMS issued guidance in a PowerPoint format for nursing homes, highlighting its recent actions relevant for nursing homes, including:
The Inception of its National COVID-19 Training for Frontline Nursing Home Staff and Management. As previously announced on August 25, CMS reiterated its provision of five training modules designed for frontline clinical staff as well as ten designed for nursing home management. Supplemental to the training, CMS is hosting weekly webinars every Thursday between 4:00 to 5:00 pm ET that are available via the Quality Improvement Organization (QIO) homepage.
Testing & Reporting Requirements Introduced by CMS’s Third Interim Final Rule with Comment Period (IFC). Previously issued on August 25, CMS reiterated key provisions for nursing homes included in its third IFC related to the COVID-19 public health emergency: (1) mandatory testing requirements for staff and residents in nursing homes; and (2) mandatory reporting requirements for hospitals and CLIA-certified labs. The guidance also outlines the ways in which nursing homes may report COVID-19 testing data to the CDC. CMS reiterated recent guidance on the use of antigen, point-of-care testing in nursing homes as a means to augment other testing efforts, especially in settings where testing capacity is limited or testing results are delayed. The guidance further indicated that CMS is assessing available methods to gather data for determining compliance with the laboratory reporting mandate. Failure to report SARS-CoV-2 positive and negative results will result in civil money penalties of $1,000 for the first day of noncompliance and $500 for each additional day of noncompliance.
MS released the independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission) report. The Commission was convened to solicit lessons learned from early experience during the pandemic and develop recommendations for future actions to improve infection prevention and control measures, safety procedures, and quality of life for residents of nursing homes. Alongside the report, CMS issued a response to the report, which compares the Commission’s recommendations to a list of actions the agency has taken to date; the response does not describe which, if any, of the recommendations issued by the Commission it plans to build upon. CMS also prepared and issued a compilation of guidance and updates for nursing homes during COVID-19.
The 186-page final Commission report submitted by the Commission to CMS includes 27 recommendations and accompanying action items organized into 10 themes with recommendations and associated action steps. These themes and some of the key recommendations include:
– Testing and screening: Develop and execute a national strategy with federal partners and SLTT authorities for testing and delivering rapid turnaround of results
– Equipment and PPE: Assume responsibility for a collaborative process with federal and SLTT partners regarding PPE procurement and availability; issuing specific guidance on the use, decontamination, and reuse of PPE; and issuing guidance on training on proper use of PPE and equipment, as needed
– Cohorting: Update cohorting guidance to balance resident and staff wellbeing with infection prevention and control; update cohorting guidance and reimbursement policies to reflect differences in nursing home resources
– Visitation: Emphasize visitation as a vital resident right and update and release consolidated, evidence-based guidance on safely increasing controlled, in-person visitation prior to Phase 3 re-opening; issue guidance on effectively planning for and implementing virtual visitation tools and techniques; provide resources to help facility staff assess the pychological wellbeing of residents; and streamline these and other resources into a single visitation source document
– Communication: increase specificity and expand breadth of guidance on communications between nursing home staff, residents, and families
– Workforce – stopgaps for resident safety: Mobilize resources to support a fatigued nursing home workforce, provide equity-oriented guidance that allows nursing home workforce to safely continue working in multiple nursing homes; support 24/7 registered nurse staffing resources at nursing homes in the event of a positive COVID-19 test within that facility, and leverage certified infection preventionists
– Workforce – strategic reinforcement: Catalyze interest in the certified nurse assistant profession and create a national CNA registry; update regulations to allow more fully qualified infection preventionists to be available in nursing homes; catalyze an overhaul of the workforce ecosystem in partnership with federal, SLTT, and other partners and convene a Long-Term Care Workforce Commission
– Technical assistance and quality: Increase availability of collaborative, on-site, data-driven and outcomes-oriented support prior to, during, and after a public health emergency
– Facilities: Identify and share with nursing homes short-term facility design enhancements to address pandemic-related risks; establish a national forum to share best practices and recommendations; establish long-term priorities and seek appropriate funding streams for redesign/facility strengthening
– Data: Standardize nursing home data; create an easy-to-use interactive technical infrastructure for nursing homes that streamlines reporting, dissemination of guidance, etc; enhance HIT interoperability to facilitate better communication, quality measurement standards, and data sharing
On August 24, CDC issued updated guidance, modifying its recommendations for the instances in which individuals should receive diagnostic (molecular or antigen) testing for COVID-19. The guidance changes include modifications to indicate that:
Amid backlash from public health experts, on August 27, CDC Director Redfield made a further statement and offered “clarification” in a page relating to contact tracing guidance for health departments that “Testing should be considered for all close contacts of confirmed or probable COVID-19 patients.” Notably, the CDC did not alter its underlying testing guidance or recommendations leaving further confusion.
CMS issued guidance in coordination with its release of the interim final rule with comments (IFC) regarding new/modified Clinical Laboratory Improvement Amendments (CLIA) regulations related to laboratory reporting of COVID-19 test results. The guidance emphasizes that health care facilities using Point of Care COVID-19 testing devices under a CLIA Certificate of Waiver, including nursing homes, pharmacies, or other settings will be required to report test results under the IFC. The guidance also enumerates the mandatory citations and civil monetary penalties that will apply to CLIA-certified laboratories who fail to meet the IFC requirements.
In coordination with its release of its third interim final rule with comments (IFC) related to the COVID-19 public health emergency, CMS issued guidance that builds upon the nursing home COVID-19 testing requirements established in the IFC. The guidance sets out facility requirements for testing resident and staff based on “testing triggers” such as a symptomatic individual being identified, an outbreak (i.e., any new case arises in the facility), or routine testing. The guidance requires that:• Staff and residents with signs/symptoms of COVID-19 are tested;• In the event of an outbreak, all staff and residents that previously tested negative should be retested every 3 to 7 days until there are no new cases for a period of at least 14 days; • Routine testing should be completed for staff, but not residents unless the resident “leaves the facility routinely.” Routine testing for staff should be conducted in accordance with parameters set forth related to the weekly positivity rate in the county in which the facility is located.The guidance also includes: other testing considerations; information about the steps facilities should take to address individuals who refuse testing; information about conducting, documenting, and reporting testing; an updated COVID-19 focused survey for nursing homes; and additional resources.
CMS issued an interim final rule with comments (IFC) related to the COVID-19 public health emergency. The rule includes a focus, in particular, on COVID-19-related testing and reporting requirements for nursing homes and hospitals. It also includes modifications to quality reporting program requirements impacting plans and providers.Key areas addressed by the rule include:
CMS’s Center for Consumer Information and Insurance Oversight (CCIIO) issued a fact sheet describing the applicability of the IFC to individual and small group market health plan issuers. The fact sheet describes the impact of the IFC on Medical Loss Ratio (MLR) reporting and rebate requirements for issuers electing to provide temporary premium reductions.The IFC will become effective upon its pending publication to the Federal Register through the duration of the Public Health Emergency. Public comment will be available for 60 days upon the IFR’s publication to the Federal Register.
HHS’ Office for Civil Rights (OCR) amended previously-issued guidance asserting that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered entities to contact individuals who have recovered from COVID-19 to inform them about how they can donate their plasma containing antibodies (known as “convalescent plasma”) to help treat others with COVID-19. Originally directed specifically to healthcare providers, OCR extended the guidance to include health plans. This guidance follows President Trump’s recent remarks encouraging commercial labs, insurers, providers, and pharmacies to send communications to individuals who have recovered from COVID-19 encouraging them to donate their convalescent plasma as well as the FDA’s recent issuance of an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in some hospitalized patients.
HHS’ Office of the Assistant Secretary for Health (OASH) issued guidance under its authority under the Public Readiness and Emergency Preparedness Act (PREP Act) intended to expand access to safe and effective COVID-19 vaccines when they are made available. This guidance authorizes state-licensed pharmacists to order and administer COVID-19 vaccinations; state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist may also administer COVID-19 vaccinations. Among other requirements outlined in the guidance, state-licensed pharmacists and pharmacy interns must ensure the following conditions are met:
– The vaccine must be FDA-authorized or FDA-licensed.
– The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation.
– The licensed pharmacist and/or intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE).
– The pharmacist/pharmacy intern must comply with any applicable requirements set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
(Previously on August 19, HHS issued the third amendment to the Declaration under the PREP Act to authorize state-licensed pharmacists to order and administer any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to individuals ages three to 18 years according to ACIP’s standard immunization schedule. This amendment was intended to mitigate decreasing rates of routine childhood immunizations due to COVID-19, The order does not affect federal requirements regarding screening and enrollment of Medicare and Medicaid providers (42 CFR Part 455, subpart E).)
CDC issued interim guidance for clinicians who order antigen tests, receive antigen test results, and/or perform point-of-care testing, as well as for laboratory professionals who perform antigen testing in a laboratory setting or at the point of care and report those results. CDC indicated its guidance is intended to support the effective use of antigen tests for various testing situations. This guidance applies to all uses of antigen tests and is not specific to the application of antigen tests to any particular age group or setting. The guidance also outlines the regulatory requirements for using rapid antigen tests for SARS-CoV-2 for the purposes of diagnostic and surveillance testing.
The IRS issued interim guidance that states that the Treasury Department and the IRS have determined that the optional Medicaid COVID-19 testing group (under section 6004(a)(3) of the Families First Coronavirus Response Act is not minimum essential coverage (MEC). Therefore:- Individuals who are enrolled in the optional COVID-19 testing group can enroll in a Qualified Health Plan (QHP) and receive APTCs. However, their enrollment in a QHP would mean that the individual would no longer be eligible for the optional COVID-19 testing group. – When the optional COVID-19 testing group expires at the conclusion of the public health emergency (PHE), those individual who were enrolled in the group will not be eligible for a special enrollment period as a result of losing Medicaid coverage.
HHS announced that it invested, collectively, $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional SARS-CoV-2 tests per month. HHS estimates that that the U.S. will be able to perform an additional 1 million tests each week by early October.
The HHS Office of the Inspector General (OIG) issued updated FAQs regarding application of OIG’s administrative enforcement authorities to arrangements directly connected to COVID-19. The new FAQ addresses whether clinical laboratories may offer free COVID-19 antibody testing to federal healthcare program beneficiaries who are contemporaneously receiving other medically necessary blood tests during the COVID-19 public health emergency. The guidance clarifies that the arrangement described in the FAQs offers the possibility of substantial public health benefits through the identification of additional potential convalescent plasma donors and valuable public health information and data. Provided the arrangement includes a series of safeguards enumerated in the FAQs, OIG asserts that the scenario would post a sufficiently low risk of fraud and abuse.
HHS released COVID-19 testing plans for July through December developed with the federal government by states, territories, and localities that received COVID-19 testing funding via the CDC Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement, including the $10.25 billion in Stimulus “3.5” funding distributed specifically for testing purposes. State plans were due to HHS by July 10 with details on critical parameters for state testing strategies, including target numbers of tests per month, as outlined in CDC’s ELC guidance document. Each plan includes the testing entities and laboratories that will perform tests, along with each laboratory’s available platforms and capacity by month. HHS’s designated review panel, chaired by the HHS Assistant Secretary for Health, will review state testing progress, needs assessment, and plans on a monthly basis to determine if modifications are required or additional assistance is needed.
HRSA published updated data regarding providers that received reimbursement from the Claims Reimbursement and Uninsured Program and agreed to HHS’s terms and conditions as of August 5; $167.7 M has been paid for testing claims and $382.4 M for treatment claims.
CDC issued a press release and updated guidance clarifying the intent of updates first made to its isolation guidance on August 3. The guidance indicated that people can continue to test positive for up to 3 months after diagnosis and may not be infectious to others. In its clarification, CMS indicated that its August 3 guidance does not imply that a person is immune to re-infection with COVID-19 in the 3 months following infection and, at this time, it is not known whether someone can be re-infected with COVID-19. Rather, the latest data suggests that retesting someone in the three months following initial infection is not necessary unless that person is exhibiting symptoms of COVID-19 and the symptoms cannot be associated with another illness. Individuals who test positive for COVID-19 should be isolated for at least 10 days after symptom onset and until 24 hours after their fever subsides without use of fever-reducing medications
HHS issued a press release detailing recent national trends in COVID-19 testing, indicating that more than 59 million COVID-19 tests have been conducted nationally to-date. In the prior week, over 810,000 tests have been completed per day on average with 56% of tests completed within three days, compared to 45% of lab tests that were completed within three days in July.
HHS released a fact sheet explaining Operation Warp Speed’s (OWS) goals, timeline, and major accomplishments. OWS is a public-private partnership led by HHS with the goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. The fact sheet included a summary of OWS’ actions to support vaccine development, manufacturing and distribution, as well as plans for making COVID-19 vaccines affordable to Americans.
CMS and CDC announced that payment is available to physicians and health care providers to counsel patients, at the time of COVID-19 testing, about the importance of self-isolation after they are tested and prior to the onset of symptoms. CMS will use existing evaluation and management (E&M) payment codes to reimburse providers who are eligible to bill CMS for counseling services (regardless of where the test is administered). The agencies also issued:-Provider FAQs, which clarify that payment is available for both Medicare- and Medicaid-enrolled patients, and include instructions for billing E&M visits for Original Medicare patients. -A provider checklist and talking points document about providing counseling to patients with a focus on discussing isolation protocols, encouraging their household to get tested for COVID-19, reviewing the signs and symptoms, and conveying services available to them to aid in isolating at home. -Consumer-facing guidance for patients awaiting COVID-19 test results and for patients that test positive.
CMS issued FAQs on COVID-19 testing in SNFs and nursing homes, which primarily provide additional information about the testing platforms and tests being distributed by CMS to certain facilities. The FAQs address:• Plans for distribution of testing platforms and FDA-authorized antigen diagnostic tests, including which facilities will receive them and the number of tests they will receive• Training for nursing home staff to administer COVID-19 tests• Required safety precautions for performing COVID-19 tests• Requirements for reporting results of COVID-19 tests
The Departments of Health & Human Services, Labor, and Treasury (collectively, the “tri-agencies”) published guidance on April 11 in attempt to clarify some of the testing coverage requirements under FFCRA and the CARES Act. However, as calls have increased for more widespread and frequent testing, particularly of at-risk populations such as health care workers, residents and staff of long-term care facilities, and people potentially exposed at protests or rallies, insurers have questioned their responsibility to cover all testing in all circumstances.On June 23, the tri-agencies published new guidance that attempts to answer implementation questions from states, plans, and insurers, including the definition of “medically necessary”, surveillance or workplace related testing, coverage of hospital “facility fees”, and protections against provider balance billing.
The DOE, HHS, and VA jointly announced the formation of the COVID-19 Insights Partnership, an initiative to coordinate and share health data to support research and analysis on COVID-19. Specific focus areas of the initiative include the evaluation of vaccine and therapeutics candidates for COVID-19, outcomes data, and virology. HHS and VA will provide additional updates and information on research projects as they become available.
While efforts to reduce the spread of COVID-19 have been difficult in all environments, the conditions for those working in agricultural production raise additional challenges. Migrant and seasonal farmworkers, many of whom travel as crops ripen throughout the spring and summer, live and work under conditions that even before COVID-19 posed risks to their safety and wellbeing. This expert perspective examines approaches to addressing the particular risks of COVID-19 faced by farmworkers, provides a survey of state and local policies and outlines some key themes and recommendations for policymakers as they work to support agricultural workers and stem the spread of COVID-19.
This expert perspective provides a survey of actions that state and local governments have taken to intentionally incorporate equity into their recovery and reopening policies.
This expert perspective provides a survey of actions that state and local governments have taken to intentionally incorporate equity into their recovery and reopening policies.
This analysis highlights some of the innovative policy changes of states to support children and families during the pandemic.
DC requested public comment on its proposal to collect additional data for the residential care community (RCC) and adult day services center survey components of the National Post-Acute and Long-Term Care Study (NPALS). Specifically, the proposal calls for adding supplemental questions related to: – COVID-19 case incidence among service uses and staff- Hospitalizations and mortality data- Availability of PPE – Shortages of COVID-19 testing- Use of telemedicine/telehealth- Restrictions on visitation policies – General infection control policies and practicesThe proposal will be published on the Federal Register on July 28 and public comment will be open until August 26.
This analysis includes several key considerations intended to help state policymakers identify and overcome common barriers associated with integrating and operationalizing CHWs in Medicaid and other state health programs
Considering both the public health crisis and future patient needs, Families USA has assembled state policy recommendations around three themes: 1) improving telehealth financing and implementation models to increase reach; 2) removing provider barriers to increase access to telehealth; and, 3) bridging the digital divide to improve patient access to telehealth services.
CMS announced an additional $5 billion in Provider Relief Fund payments for Medicare-certified long term care facilities and state veterans’ homes (“nursing homes”). Nursing homes must participate in CMS’ Nursing Home COVID-19 Training to be qualified to receive this funding. The training will focus on infection control and best practices and will be available online. CMS also announced it will begin requiring that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week. The press release further indicated that federal Task Force Strike Teams have been deployed to provide onsite technical assistance and education to nursing homes experiencing increases in COVID-19 cases among residents. The first deployments took place in 18 nursing homes in Illinois, Florida, Louisiana, Ohio, Pennsylvania and Texas between July 18 and July 20. The White House and CMS will begin releasing a list of nursing homes with an increase in cases that will be made available to states each week.
The U.S. Department of Health and Human Services and the Department of Defense (DoD) announced an agreement with U.S.-based Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine in the United States following the vaccine’s successful manufacture and approval. The agreement also allows the U.S. government to acquire an additional 500 million doses.
This post will present a framework for understanding health disparities during the COVID-19 pandemic, as well as provide short-term and long-term solutions to reduce these disparities.
HHS announced a one-time, large-scale procurement of rapid point-of-care diagnostic test instruments and tests to be distributed to nursing homes in COVID-19 hotspots to facilitate on-site testing of nursing home residents and staff. HHS conveyed the distribution will begin the week of July 20 and nursing homes can procure additional tests directly from manufacturers after the initial distribution. HHS further indicated that nursing homes must have the capability to test residents and staff on a weekly basis or according to specific guidance by the state and local health departments.
HHS released May and June COVID-19 testing plans submitted by states, territories, and localities that received COVID-19 testing funding via the CDC Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement, including the $10.25 billion in Stimulus “3.5” funding distributed specifically for testing purposes. Notably, complete 2020 testing plans, which include states’ testing plans through the end of the year, are due to CDC today, July 10. HHS published updated instructions for completion of these testing plans, noting that a group of experts from the CDC and HHS Office of the Assistant Secretary for Health (OASH) reviewed the initially-submitted testing plans and provided feedback to states.HHS released May and June COVID-19 testing plans submitted by states, territories, and localities that received COVID-19 testing funding via the CDC Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement, including the $10.25 billion in Stimulus “3.5” funding distributed specifically for testing purposes. Notably, complete 2020 testing plans, which include states’ testing plans through the end of the year, are due to CDC today, July 10. HHS published updated instructions for completion of these testing plans, noting that a group of experts from the CDC and HHS Office of the Assistant Secretary for Health (OASH) reviewed the initially-submitted testing plans and provided feedback to states.%MCEPASTEBIN%
HHS announced free COVID-19 testing in select COVID-19 hotspots—Jacksonville, Florida; Baton Rouge, Louisiana; and Edinburg, Texas. Temporary surge testing sites will be set up beginning on July 7 and offer 5,000 tests per day in each of these communities by July 19. Testing will be available to all individuals five years and older regardless if symptoms are present or if individuals are residents of the communities.
Policy makers can help ameliorate disparities by mandating standardized case and fatality reporting requirements and directing public health agencies to investigate why particular populations, including Asian Americans, face a seemingly heightened risk of death from COVID-19.
HHS and DoD jointly announced: – A $1.6 billion agreement with Novavax to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational vaccine, NVX-CoV2373. The agreement expands upon a June agreement for Novavax to provide 10 million doses for use in Phase 2/3 clinical trials. The July 7 agreement is expected to provide the federal government with 100 million doses of the investigational vaccine.- A $450 million agreement with Regeneron to demonstrate commercial-scale manufacturing of the company’s investigational therapeutic treatment, REGN-COV2. The agreement is expected to produce between 70,000 and 300,000 treatment doses expected by fall. Clinical trials for the investigational therapeutic are currently underway.
Health system leaders and policy makers should take the lead in addressing alarming disparities in COVID-19 deaths.
HHS announced it is extending through August 2020 its partnership with CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and eTrueNorth (through services at Kroger, Health Mart, and Walmart) as part of the Community-Based Testing Program. The contract utilizes a federal bundled payment program paid directly to retailers that receive a flat fee for each test administered. To participate in the program, partners must ensure the availability of online and telephone registration and appointment scheduling; provide order and notification of result; on-site personnel and security; medical supplies and equipment; and lab testing (on-site or commercial lab) capabilities. This partnership accounts for 600 COVID-19 testing sites in 48 states and the District of Columbia. HHS has also made available an online tool, “Community-Based Testing Sites for COVID-19” (in Column K), for users to search for community-based testing sites in their community.
CDC issued a new and updated list of people at risk of severe COVID-19 illness. CDC has removed its previous age threshold, indicating that those 65 years and older are at elevated risk, to indicate that risk increases steadily with age and elevated risk is not specific to those 65 years and older. CDC also updated its list of conditions that may contribute to elevated risk of severe COVID-19 illness, including:- Chronic kidney disease- COPD (chronic obstructive pulmonary disease)- Obesity (BMI of 30 or higher)- Immunocompromised state (weakened immune system) from solid organ transplant- Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies- Sickle cell disease- Type 2 diabetes
CMS issued dozens of new COVID-19 FAQs for state Medicaid/CHIP agencies addressing questions related to a range of topics (e.g., Presumptive Eligibility, premiums and cost sharing, optional COVID-19 testing group and coding guidance)
The Pennsylvania Department of Health and Pennsylvania Emergency Management Agency (PEMA) are partnering with CVS Health to offer COVID-19 testing services to skilled nursing facilities statewide, free of charge.
This memo provides a summary of policy approaches to address the disproportionate impact of COVID-19 on communities of color.
The Health Opportunity and Equity (HOPE) Initiative, funded by the Robert Wood Johnson Foundation, provides an interactive data tool to help the nation and states to move beyond measuring disparities to spur action toward health equity.
Louisiana Gov. John Bel Edwards announced two co-chairs and appointed members to the Louisiana COVID-19 Health Equity Task Force and several subcommittees.
CMS issued FAQs for clinical labs and other stakeholders regarding conducting surveillance testing using a pooled sampling procedure with non-patient specific reporting. The FAQs clarify:- The circumstances in which facilities must receive a CLIA certificate to perform surveillance testing using a pooled sampling procedure- The risks and considerations of using pooled sampling procedures- CMS does not have oversight authority to ensure quality and safety of result reporting in testing facilities without CLIA certification
CDC released consolidated and updated recommendations for COVID-19 testing, including the following: Updated testing guidelines for nursing homes regarding testing of residents and healthcare personnelGuidance for high-density critical infrastructure workplaces after a COVID-19 case is identified
EEOC updated their technical assistance questions and answers, prohibiting employers from requiring COVID-19 antibody testing before allowing employees to return to the workplace. Under the Americans with Disabilities Act (ADA), antibody testing constitutes a medical examination; citing the CDC guidance that antibody testing “should not be used to make decisions about returning persons to the workplace,” the EEOC explains antibody testing does not meet the ADA’s “job related and consistent with business necessity” standard for medical examinations or inquiries for current employees. Viral tests, however, are permissible under the ADA.
HHS issued a fact sheet reiterating the composition and objectives of Operation Warp Speed (OWS), a private-public partnership between CDC, FDA, NIH, BARDA, DoD, and private firms to deliver 300 million doses of a COVID-19 vaccine by January 2021. The fact sheet also provides updates on OWS activities and investments to develop the manufacturing and distribution capacity necessary for accomplishing its objectives. The CARES Act appropriated $10 billion for OWS, including over $6.5 billion for vaccine development through BARDA and $3 billion for NIH research.
CMS hosted an all-state call on June 16th that reviewed key dates for termination of COVID-19 flexibilities and clarified issues related to retaining Meidcaid state plan flexibilities adopted during the public helath emergency once the emergency ends.
HRSA’s Health Center Program released updated COVID-19 FAQs for health centers. The updated FAQs include guidance:• Reminding health centers of their responsibility to seek reimbursement for their costs from third-party payors , and apply their sliding fee discount programs. Third-party payors may have cost-sharing which allows health centers to charge patients for co-payments or coinsurance;• Clarifying that health centers are permitted to request reimbursement through the HRSA COVID-19 Claims Reimbursement for Testing and Treatment of the Uninsured Program but are prohibited from “balance billing” patients for any cost-sharing payments if they do so;• Noting the expectations for health centers to develop and maintain an emergency preparedness communication plan as well as annual training and testing programs.
The Center for Consumer Information & Insurance Oversight (CCIIO) issued guidance to sponsors of non-federal governmental plans clarifying the following policies:- Requirement to cover COVID-19 Diagnostic Testing and Certain Related Items and Services without Cost Sharing or Medical Management. T- Temporary Period of Relaxed Enforcement of Certain Timeframes Related to Group Market Requirements under the Public Health Service Act (PHS Act).- Expanding and Promoting Access to Telehealth Options and Prescription Drugs during the COVID-19 Outbreak.
HHS launched a COVID-19 testing website that collates testing background information, HHS guidance related to the availability of COVID-19 tests (e.g., emergency use authorizations), guidance for providers and public health providers about who should be tested for COVID-19 (issued by CDC), and other guidance.
The White House issued an addendum to its Testing Blueprint, outlining a prioritization approach for COVID-19 diagnostic and surveillance testing. The guidance includes the following “areas of focus”:1) Diagnosing active infection in individuals. 2) Using testing for proactive surveillance. 3) Developing innovative approaches to support the reopening of colleges and universities
The short-term bump in federal funding granted to states are welcome fiscal relief, but as the depth of the economic crisis becomes clearer, so does the need for additional and more-targeted support.
The CARES Act requires that every lab that performs or analyzes a COVID-19 test report the results from each test to the Secretary of HHS. On June 4, HHS issued guidance and FAQs clarifying these requirements.
The New Jersey COVID-19 Information Hub addresses privacy concerns around contact tracing, including around public charge, in their FAQ page.
In an effort to address health disparities, the Governor of North Carolina signed an executive order directing resources to historically underutilized businesses, ensuring equitable distribution of pandemic relief funds, and supporting mass testing of migrant farm workers and food processing plant workers.
The Governor of New Jersey signed legislation requiring hospitals to report demographic data to the Department of Health, including age, ethnicity, gender, and race of individuals who have tested positive for COVID-19, who have died from COVID-19, and who have tried to get testing but have been turned away.
In his vision to restart the state economy, Governor Murphy outlined six key principles to guide the process for restoring New Jersey’s economic health by ensuring public health, which included creating the Governor’s Restart and Recovery Commission to advise on the process and recommend responsible and equitable decisions.
Based on recommendations of the Health Disparity Task Force, Governor Tom Wolf announced the state is now collecting sexual orientation and gender identity data as part of the state’s COVID-19 data collection effort.
The Ohio Department of Health created a new position that will build on existing efforts to respond to health inequity by working directly with local communities on their specific long-term health needs and Ohio’s response to COVID-19.
The Wisconsin Department of Health Services (DHS) announced $10 million in funding for health care providers serving the state’s most underserved populations, including rural health clinics, tribal health clinics, community health centers, and free and low cost clinics.
The city of Los Angeles’ reopening plan incorporates testing rates by poverty levels and race/ethnicity into its Effectiveness Indicators, which guide future decisions about loosening or tightening social distancing restrictions.
The city of Chicago’s reopening plan monitors cases over time by zip code, age, sex, race, and ethnicity to determine movement into different phases.
The city of New York hired over 1,700 contact tracers to join their Test & Trace Corp, with 700 of the new hires being from the neighborhoods that have been the hardest hit by COVID-19.
In a letter to the state’s Patient Protection Commission, the Governor of Nevada requested that the Commission develop long-term policy recommendations that address COVID-19 and broader health equity concerns.
In addition to helping New Yorkers safely separate, the city will also support those who are separating at home by designating Resource Navigators, who work with community-based organizations across the city, to help New Yorkers overcome logistical issues such as accessing medicine or clean laundry.
The state of Rhode Island submitted a waiver to CMS to use Medicaid funds to provide food, housing, and mobile phone minutes for people who are housing insecure.
West Virginia is increasing COVID-19 testing access for marginalized populations and those in medically underserved counties, making testing free and available to all residents in the targeted localities.
The state of Virginia is partnering with the City of Richmond to expand access to personal protective equipment in underserved communities.
The Virginia Department of Health and the Health Equity Task Force partnered with a local media outlet to provide information about the next phases of the recovery process and its implications for health equity.
To contain the spread of COVID-19, states are rapidly ramping up their contact tracing efforts.
FDA approved three emergency use authorizations (EUAs) including two for antibody test kits and one for a serology test.
HRSA issued updated FAQs about claims reimbursement for COVID-19 care for the uninsured, indicating that: • Providers are not required to confirm immigration of status for any uninsured patients• Providers may submit claims for the balance not covered by a hospital charity care program• Providers may submit claims for testing performed by a lab with which the provider has a client bill arrangement provided that the provider pays the lab under their billing arrangement• Claims for certain screening activities conducted via telehealth may be submitted for reimbursement
Ohio’s Minority Health Strike Force recommended the hiring of public health workers who reflect the makeup of their own community to expand exposure notification capacity.
The state of New York is expanding access to testing for communities of color and low-income neighborhoods by establishing an initial 24 testing sites at churches in predominantly minority communities in downstate New York.
HRSA awarded $15 million to 52 Tribes, Tribal organizations, urban Indian health organizations, and other health services providers to Tribes across 20 states. HRSA made these CARES Act awards in response to applications submitted through the Rural Tribal COVID-19 Response (RTCR) program. Applicants could request up to $300,000 in funding and were assessed based on their needs and capacity to implement COVID-19 related activities in their rural communities
Recommendations developed by the Connecticut Health Foundation aimed at ensuring the state’s COVID-19 response reaches those who are most at risk.
This report outlines three guiding principles for state policymakers in their equity efforts.
Medicaid agencies can leverage existing and new authorities, enabled through recent COVID-19 federal regulatory flexibilities, to develop a broad plan for addressing disparities in the near-and long-term.
The Washington State Department of Health’s reopening plan relies on distinct data-driven categories to determine the state’s readiness for safely reopening.
This brief describes health equity principles for states as they design and implement their responses.
This resource highlights solutions to ensure more equitable enforcement of public health laws.
Synopsis from GAO on the development of COVID-19 vaccine, including how the typical vaccine development process may be accelerated due to the severity of the COVID-19 crisis.
The state of Virginia has formed a Health Equity Work Group that is intentionally embedded into the state’s Uniform Command center addressing COVID-19. Both the Work Group and the Taskforce meet on a regular basis and work to apply a health equity lens to each phase of the state’s response, ranging from preparedness to mitigation to recovery.
HHS submitted its initial report to Congress detailing the national approach to testing and the testing ecosystem. The report includes key components of a state’s testing plan and actual and recommended targets for states’ and territories’ COVID-19 test rates. HHS is required to submit this report to Congress every 90 days until funds are expended.
This analysis examines the interplay between the Provider Relief Funds and its impact on balance/surprise billing.
New York’s Department of Health issued a directive determining that COVID-19 testing of nursing home and adult care facility personnel is medically necessary and twice weekly testing is essential. The health directive was accompanied by a concurrent New York Department of Financial Services directive to insurers requiring coverage of twice weekly testing of all nursing home and adult facility personnel without cost sharing.
This Health Affairs blog post highlights states’ policy responses to the COVID-19 pandemic, as well as their proactive approaches to addressing a wide range of health concerns.
New York’s Department of Financial Services released a directive to insurers requiring coverage of twice weekly testing of all nursing home and adult facility personnel without cost sharing. The directive applies broadly to insuers, including Medicaid and Marketplace plans. The insurance directive was accompanied by a concurrent New York’s Department of Health directive determining that COVID-19 testing of nursing home and adult care facility personnel is medically necessary and twice weekly testing is essential.
CARES Act Provider Relief Fund General Distribution FAQs
CDC issued a compilation of guidance on its COVID-19 surveillance activities and a framework of indicators for state and local jurisdictions to assess the feasibility of re-opening
IHS announced its allocations of the $750 million Public Health and Social Services Emergency Fund for Tribal Organizations authorized through the Paycheck Protection Program and Health Care Enhancement Act.
On May 18, the CDC announced $10.25 billion in awards for states, localities, and territories to spend on: the development, purchase, administration, processing, and analysis of COVID-19 tests; surveillance; contact tracing; and related activities. States are required to submit COVID-19 testing projections for May and June 2020 to the CDC by May 30, 2020 and projections for July through December 2020 by June 15, 2020
The guidance document outlines COVID-19 emergency declaration “blanket waivers” for healthcare providers and is regularly updated by CMS. Recent updates include: – Revising the existing “”physical environment”” waivers for hospitals to support activities related to both surge capacity and appropriate quarantining and to clarify that it does not modify hospitals’ obligations under the Americans with Disabilities Act (ADA), to “avoid subjecting persons with disabilities to unjustified institutionalization or segregation
HHS announced that the Indian Health Service (IHS) will administer the $750 million allocation for Tribal organizations of the $11 billion authorized by the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) for Public Health and Social Services Emergency Fund for COVID-19 testing and tracing. HHS conveyed that a more detailed announcement for this funding opportunity is expected in the coming days.The remaining $10.25 billion will be administered by the CDC as part of the Epidemiology and Laboratory Capacity (ELC) Cooperative Agreement for states, localities, and territories to spend on COVID-19 testing and tracing.
HRSA announced $225 million in awards to 4,549 Rural Health Clinics (RHCs) for COVID-19 testing, as authorized through the Paycheck Protection Program and Health Care Enhancement Act. Each RHC received a flat amount of just under $50,000, which may be used for a wide range COVID-19 testing and related expenses.
Price Transparency: Requirements for Providers to Make Public Cash Prices for COVID-19 Diagnostic Testing
CMS issued an interim final rule with comment period (IFC) that provides additional flexibilities for Medicare, Medicaid, and Exchange coverage programs as a result of COVID-19 and also implements regulations in response to recently enacted stimulus legislation.
In April, the state of Ohio formed the Minority Health Strike Force, which is tasked with responding to the disproportionate impact of the Coronavirus on African Americans. The state is now focused on implementing recommendations from the Strike Force.
The Pathways to Coverage for COVID-19 Testing and Treatment for Adults toolkit provides an overview for states of various coverage pathways for individuals, including those who are uninsured, in need of COVID-19 testing and treatment. The toolkit provides varying pathways for Medicaid expansion and non-expansion states.
CMS issued an interim final rule with comment period (IFC) that provides additional flexibilities for Medicare, Medicaid, Basic Health Program, and Exchange coverage programs as a result of COVID-19 and also implements regulations in response to recently enacted stimulus legislation. The IFC is scheduled to be published in the Federal Register on May 8. Public comments will be accepted for 60 days following posting to the Federal Register.
HRSA awarded nearly $583 million to 1,385 HRSA-funded health centers in all 50 states, the District of Columbia, and eight U.S. territories to expand COVID-19 testing.
The Social Interventions Research and Evaluation Network (SIREN) at the University of California San Francisco, is a research organization focused on the intersection of medical and social services. In response to the COVID-19 crisis, SIREN has developed a resource center of sites aggregating data about health equity, policy, and social risk related to the coronavirus and related financial crisis.
Webinar recording and slide deck from webinar hosted on March 18, 2020.
HRSA announced an upcoming funding opportunity to make $15 million in awards available to tribal organizations. The funding opportunity announcement is expected on 4/21/2020 and the estimated application due date is 5/12/2020.
On Thursday, April 16 State Health and Value Strategies hosted a webinar, Implications of Health Care Provisions for States in the CARES Act, on the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27. The CARES Act contains a number of health care related provisions and federal funding sources to support states as they continue to work tirelessly to respond to the COVID-19 outbreak. During the webinar experts from Manatt Health and Georgetown’s Center on Health Insurance Reforms highlighted funding opportunities and conducted a deep dive on key provisions relevant to states included in the CARES Act.
Webinar slides and recording that explores the key health care provisions in the second COVID-19 stimulus bill.
New joint guidance from the Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury that addresses questions on the Families First and CARES Acts requirements on coverage of COVID-19 related testing services, including, for example, the requirement to cover (without cost sharing) diagnostic tests to rule out other conditions such as influenza.
Federal Guidance on the Families First and CARES Act Legislation
CMCS issued new Medicaid FAQs regarding the new optional COVID-19 testing Medicaid eligibility group, benefits and cost-sharing for COVID-19-related testing and diagnostic services, the increased FMAP available under Section 6008 of the FFCRA, and other FAQs
This expert perspective, written by experts at Manatt Health, discusses strategies state Medicaid and CHIP agencies can pursue as part of their response to COVID-19.
CMS releases an FAQ in support of communicating key changes outlined in the Medicare Interim Final Rule issued on 3/31/2020. Topics in the FAQ include payment for specimen collection, hospital services, ambulance services, RHCs, FQHCs, telehealth, and physician services.
This resource center for health departments includes FAQ, guidance and other tools related to evaluating/reporting persons under investigation, risk assessment, risk management, and emergency preparedness.
This page includes guidance and templates for the Medicaid State Plan Disaster Relief SPA and CHIP Disaster Relief SPA.
CMS issues guidance for clinicians on flexibilities related to accelerated/advance payments, telehealth services, COVID-19 testing, and claims process modifications during the COVID-19 public health emergency.
California guidance to providers to prevent discrimination related to screening and treatment for COVID-19
Infographic detailing funding to key health agencies and programs in the second COVID-19 bill, Families First Coronavirus Response Act—including the Public Health and Social Services Emergency Fund, Centers for Medicare & Medicaid Services (CMS), Administration for Community Living, the Indian Health Service and Department of Veterans Affairs—as well as the amounts of the funding, the uses and the recipients
This page includes federal background information on Section 1135 waivers and a CMS-developed template for states and territories.
Infographic describing diversion scenarios for COVID-19 screening under the Emergency Medical Treatment & Labor Act (EMTALA).
This guidance allows practitioners further flexibility in prescribing and dispensing buprenorphine to new and existing patients with opioid use disorder via telephone without examination in person or via telemedicine.
In light of the growing number and diversity of approved 1135 waivers, this Q&A document provides a general primer on Section 1135 to help healthcare stakeholders understand the scope of what HHS and CMS can and cannot do under this emergency authority.
IRS Notice allowing HDHPs to waive cost-sharing for COVID-19 testing & treatment.
Plain-Language Information about Coverage Options, Eligibility, and COVID-Related Benefits
CCIIO guidance on COVID-19 coverage and catastrophic plans
Compilation of COVID-19 FAQs on private insurance issues.
Recordings and transcripts of CMS calls on COVID-19 with states and other stakeholders
Compilation of resources for state on Medicare, Medicaid, and CHIP, including transcripts and recordings of all-state calls
This letter requests that hospitals report testing data to HHS and bed capacity and supplies to CDC’s National Healthcare Safety Network on a daily basis.
Resources on waivers and flexibilities available to states and providers
MA developed a managed care plan bulletin that outlines requirement’s for coverage and billing related to COVID-19.
Second COVID-19 response / stimulus bill.
A state-by-state compendium of actions related to COVID-19 coverage.
Summary of Key Healthcare Provisions in the Second COVID-19 Stimulus Bill.
Interactive 50-state map on state DOI actions re: COVID-19
NY allowed out-of-state providers and providers in New York that are not currently registered to provide telehealth services.
This page catalogs CMS’s approved COVID-19 State Section 1135 waivers.
NY waived cost-sharing for telehealth visits with in-network providers.
In MA, through executive order, Governor Baker expanded access to telehealth services in all commercial insurers and MassHealth programs, waived all cost-sharing for any medically necessary treatment delivered via telehealth related to COVID-19 at in-network providers, waived any prior authorization barriers needed to obtain medically necessary telehealth services, and established a 24-hour process to allow medical professionals to receive a license to practice in Massachusetts
This page includes guidance and a template for COVID-19 1115 waiver demonstrations.