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 Treasury issued updated Coronavirus Relief Fund (CRF) FAQs (questions A42, A49, & A53 were modified and questions A57 – 59, B13 were newly added). These new and modified FAQs clarify:
– CRF payments may be used to meet the non-federal matching requirements for Stafford Act assistance, which includes FEMA’s Emergency Management Performance Grants (EMPG) and EMPG supplemental programs–provided such matching requirements entail COVID-19-related costs.
– Additional information related to using CRF payments for lost wages assistance
– Specific parameters and limitations on use of CRF payments toward expenses related to re-opening schools and distance learning- Permissible uses of CRF payments toward expense related to the acquisition of property & equipment; refunds to students of public universities for certain expenses; and grants provided to businesses that have previously received SBA or EIDL loans- The applicability of Single Audit requirements for CRF sub-recipients that received transfer payments from CRF recipients in the amount of $750,000 or more
HHS announced that it is broadening the eligibility criteria regarding providers eligible for the new, $20 billion allocation of the Provider Relief Fund, known as “General Distribution Phase 3.” HHS had previously announced that this Fund would be available to providers that bill Medicare and/or Medicaid/CHIP, as well as certain provider types regardless of whether they bill Medicare or Medicaid/CHIP, including behavioral health providers, dentists, and assisted living facilities. HHS is now further expanding the pool of eligible providers by including other providers of patient care services that do not bill Medicare or Medicaid/CHIP, including chiropractors, nursing service providers, hospice providers, laboratories, eye and vision service providers, nursing and custodial care facilities, among others. Notably, HHS does not seem to have yet updated the application instructions to reflect that these providers are eligible; nonetheless, these providers should submit their TINs for validation and submit their applications as soon as possible.
On October 21, HHS posted informational materials on the Provider Relief Fund Phase 3 General Distribution, including a one-page fact sheet, 12-page presentation, and recording of its October 15 informational webinar. Because the eligibility changes were announced on October 22, the latest broadening of eligibility does not yet appear in these materials.
HHS issued new guidance related to the reporting requirements tied to receiving Provider Relief Fund (PRF) payments, walking back the September 19 guidance, which changed “lost revenue” to mean net operating income. Under the October 22 guidance, providers can keep PRF dollars equal to their year-over-year change in revenue from 2019 to 2020. In other words, HHS has scrapped the change in net operating income definition from the September 19 guidance. This also eliminates the part of the guidance that allowed providers with negative 2019 margins to keep provider relief revenue up to a break even in 2020.
As was the case with the September 19 guidance, the provider-level impact will vary.
– Many providers are pleased with the change because they will have a better case for keeping more money by demonstrating lost revenue and not lost profit.
– Others—particularly those with negative 2019 margins—will be in a worse position.
– In either case, there is still a risk that some providers will not be able to retain their full PRF payment. For example, providers that received particularly large payments (e.g., hot spot hospitals and rural providers that received large targeted distributions) are at the greatest risk for needing to return funding.
HHS’s 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 six newly-announced COVID-related work plan items include:
– Audit of HRSA’s Controls Over Medicare Providers’ Compliance with the Attestation, Submitted-Revenue-Information, and Quarterly Use-of-Funds Reporting Requirements Related to the $50 Billion General Distribution of the Provider Relief Fund.
– Medicare Telehealth Services During the COVID-19 Pandemic: Program Integrity Risks.
– Audit of National Domestic Violence Hotline and Shelter-in-Place Orders During the COVID-19 Pandemic.
– Indian Health Service Use of Critical Care Response Teams To Support Health Care Facilities During the COVID-19 Pandemic.
– Public Health Actions Affecting Unaccompanied Children: Coordination Between CDC and the Office of Refugee Resettlement.
CMS issued reports on $106.7 billion in payments its made through the Accelerated and Advance Payment (AAP) Program. In accordance with the Continuing Appropriations Act, 2021 and Other Extensions Act enacted on October 1, 2020, the data includes information on the percentage of payments made from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Insurance Trust Fund. Additional data includes payments by provider and supplier type. In a separate report, CMS detailed payments amounts by provider/supplier.Note: On October 8, CMS issued a Fact Sheet and Frequently Asked Questions document explaining and implementing recent changes to its Advanced and Accelerated Payment programs for Medicare providers contained in the recent Continuing Appropriations Act. As required by the Act, CMS is delaying recoupments of advanced payments for a year from the advance, then collecting them over an extended 29-month period, followed by collection efforts (at a reduced rate of interest). Other than implementing the recent statutory change, the guidance notably points out that providers who cannot meet this recoupment schedule might be eligible for an Extended Repayment Schedule under existing CMS authority. CMS has stopped making new payments under these programs in April, and announced it has no intention of making more payments at this time, and will not accept applications for the programs.
HHS issued new Provider Relief Fund FAQs regarding Phase 3 of the General Distribution (which is currently open to applicants). HHS indicated that prescription sale revenues may not generally be included as part of patient care revenue submitted to HHS for its determination of payments–with one exception: Patient care revenues should include savings obtained by providers through enrollment in the 340B program.
HHS published updated data regarding providers that have received Provider Relief Fund General Distribution (Phase 1 or Phase 2) and/or Targeted Distribution payments (which includes allocations for high impact areas, safety net hospitals, rural providers, tribal facilities, clinics and urban health centers, and skilled nursing facilities); attested to receiving payment; and agreed to HHS’s terms and conditions as of October 12. As of this cut-off date, 358,598 providers have attested to receiving $90.6 billion in Provider Relief Fund payments.
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 issued a memo updating its COVID-19 reporting requirements for hospitals, hospital labs, and acute care facilities. The guidance also codifies new enforcement discretion related to these reporting requirements; in its September 2 interim final rule with comment period (IFC), HHS tied these reporting requirements (as specified by the HHS Secretary during the COVID-19 public health emergency) to conditions of Medicare participation for hospitals and critical access hospitals (CAHs). As part of this update, HHS published a Hospital Mandatory COVID-19 Reporting Enforcement Workflow, which outlines the steps HHS has taken and will take to implement its enforcement discretion.
The October 6 update made optional certain data elements that were previously required as part of hospitals and CAHs’ daily reporting. Additionally, the IFC adds new influenza-specific data elements that will be made optional for reporting beginning on October 19th, which CMS indicated in its FAQs will likely be transitioned to required reporting elements in the coming weeks. CMS further indicated in its FAQs that it will no longer send out one-time requests for data to aid in the distribution of remdesivir or any other treatments or supplies (remdesivir can now be purchased by hospitals from the manufacturer; HHS is no longer allocating supply).
FDA issued guidance for COVID-19 vaccine sponsors with recommendations regarding the scientific data and information that would support issuance of an emergency use authorization (EUA) for investigational vaccines intended to prevent COVID-19. This guidance also discusses FDA’s current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate, providing additional context to the discussion regarding EUAs in the guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID-19.”
HHS released the following materials with information for providers interested in applying for Phase 3 of the General Distribution of the Provider Relief Fund: – Application instructions – Sample application form – Provider Relief Fund FAQs (see section regarding Phase 3 of the General Distribution) – Webcast registration information for a webinar to be held October 15 at 3:00 pm
To help states respond to the ongoing coronavirus (COVID-19) pandemic, the White House, the U.S. Department of Health and Human Services (HHS), and the Centers for Medicare and Medicaid Services (CMS) have invoked their emergency powers to authorize temporary flexibilities in Medicaid and the Children’s Health Insurance Program (CHIP). Congress’s legislative relief packages have provided additional federal support for state Medicaid programs, subject to certain conditions. The timeframes for these emergency measures are summarized in the chart below, including the effective dates and expiration timelines dictated by law or agency guidance. The chart also includes current end dates, which are subject to change as federal and state officials take actions to renew or terminate particular authorities. This SHVS product has been updated to reflect HHS’s October 2 declaration renewing the federal Public Health Emergency).
HHS announced a new $20 billion Phase 3 General Distribution of the Provider Relief Fund, which providers may apply for between October 5 and November 6. The Phase 3 General Distribution makes the General Distribution available to additional behavioral health provider types and gives these and other providers the opportunity to receive additional payment–above 2% of net patient revenue–based on HHS’s assessment of applicant providers’ financial losses and changes in operating expenses caused by COVID-19. HHS also will take into consideration providers’ aggregate provider relief fund payments to date.Eligible Providers:
– Providers that previously received, rejected, or accepted a General Distribution payment. Providers that already received General Distribution payment(s) amounting to 2% or more of net patient revenue may submit more information to become eligible for an additional payment
– Behavioral Health providers, including those that previously received funding and providers that HHS determined with SAMHSA did not receive funding (HHS notes that this may include, for example, addiction counseling centers, mental health counselors, and psychiatrists)
– Providers that began practicing between January 1, 2020 and March 31, 2020 (these providers were ineligible for prior General Distribution payments).
This includes Medicare, Medicaid, CHIP, dentists, assisted living facilities and behavioral health providers
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.
As a follow-up to its September 19 guidance outlining the reporting requirements for Provider Relief Fund (PRF) recipients that received one or more General Distribution or Targeted Distribution payments exceeding $10,000 in the aggregate, HHS announced via its PRF “Reporting Requirements & Auditing” landing page that the PRF reporting system will be made available on January 15. Previously, HHS indicated that it planned to launch the PRF Reporting System on October 1. Providers are expected to submit the first reports regarding 2020 spending by February 15.
States quickly mobilized to implement emergency federal authorities (e.g., Section 1135 waivers, 1915(c) Waiver Appendix K, emergency Section 1115 waivers) and state-level regulatory flexibilities to respond to the COVID-19 pandemic; now they must determine which flexibilities to scale back or sustain, taking into account fiscal implications. The interaction of the stimulus package dates, the Public Health Emergency, and the President’s National Emergency Declaration, among other factors, are complex, and states are actively grappling with decision making regarding which flexibilities they need and want to keep, and how. This Excel workbook is intended to serve as a tool for states as they strategize about reopening and plan for the next phase of the COVID-19 pandemic. Specifically, states can utilize this template to conduct both a primary analysis as they determine which flexibilities to unwind or maintain and a secondary analysis to plan for operational and implementation implications. The workbook has been updated to reflect the renewal of the Public Health Emergency as of July 23, 2020.
As a follow-up to its August 14 and September 19 guidance outlining the reporting requirements for Provider Relief Fund (PRF) recipients that received one or more General Distribution or Targeted Distribution payments exceeding $10,000 in the aggregate,* HHS released a one-page summary of the reporting deadlines, reporting requirements, and permissible uses of Provider Relief Fund payments. HHS also updated its PRF “Reporting Requirements and Auditing” landing page to include the first FAQ regarding the reporting requirements. The single FAQ currently available on the page does not provide new substantive information about reporting requirements, but providers will want to monitor this page as HHS is expected continue to post FAQs related to the reporting requirements on this page.* Does not apply to the ~$2.5 billion Nursing Home Infection Control distribution.
To help states respond to the ongoing coronavirus (COVID-19) pandemic, the White House, the U.S. Department of Health and Human Services (HHS), and the Centers for Medicare and Medicaid Services (CMS) have invoked their emergency powers to authorize temporary flexibilities in Medicaid and the Children’s Health Insurance Program (CHIP). Congress has passed legislation that provides additional federal support for state Medicaid programs, subject to certain conditions. The table summarizes the timeframes for these emergency measures, including the effective dates and expiration timelines dictated by law or agency guidance. The chart also includes current end dates, which are subject to change as federal and state officials take actions to renew or terminate particular authorities. This SHVS product has been updated to reflect HHS’s July 23 declaration renewing the federal Public Health Emergency, as well as CMS’s June 30 Key Dates for Termination of COVID-19 Flexibilities Table.
HHS issued new Provider Relief Fund FAQs clarifying the application deadline for the $18 billion Phase 2 of the Provider Relief Fund General Distribution. As previously announced, providers were to submit a taxpayer identification number (TIN) by September 13 for HHS to validate in its determination of applicants’ eligibility for payment. In the September 17 update to the FAQs, applications must be started by September 21 and submitted by September 28.
HHS issued guidance outlining the reporting requirements with which Provider Relief Fund (PRF) recipients that received one or more General Distribution or Targeted Distribution payments exceeding $10,000 in the aggregate (“PRF Recipients) must comply. The requirements do not apply to the Nursing Home Infection Control distribution of the Provider Relief Fund or the HRSA Uninsured Program. HHS plans to announce separate reporting requirements for the Nursing Home Infection Control distribution.
The guidance clarifies that PRF Recipients will report data used to determine (1) their healthcare-related expenses attributable to coronavirus that another source has not reimbursed and is not obligated to reimburse; and (2) PRF payment amounts not fully expended on healthcare related expenses–represented as a negative change in year-over-year net patient care operating income, net of expenses that fall under #1. This second category of funds may be used to make up for lost revenues, up to a net zero gain/loss in 2020.
The PRF Reporting System will collect the following data from PRF Recipients:
– Demographic information, including reporting entity (TIN), NPI (optional), fiscal year-end date, and federal tax classification.- Expenses attributable to Coronavirus not reimbursed by other sources, including general and administrative expenses (including subcategories such as personnel, fringe benefits); and health care expenses (including subcategories such as supplies, equipment, IT, facilities). PRF Recipients of $500,000 or more are required to report more detailed information according to the list of subcategories enumerated in the guidance.
– Lost revenues attributable to Coronavirus Revenue. These data elements include total revenue/net charges from patient care related sources in 2019 and 2020; revenue from patient care payer mix for 2019 and 2020 (delineated by Medicare Part A+B, Medicare Part C, Medicaid, Commercial Insurance, Self-Pay, and Other); other assistance received including Treasury, Small Business Administration and Paycheck Protection Program funding, FEMA CARES Act funding, CARES Act Testing funding, local/state/tribal government assistance, business insurance, and “other assistance,” defined as the total amount of other federal and/or coronavirus-related assistance received by the recipient and other TINs included in its report as of the reporting end date”; and total calendar year expenses for 2019 and 2020, including a break-down of general and administrative expenses and healthcare related expenses.
– Additional non-financial data including facility, staffing and patient care metrics (e.g., total personnel, number of patient visits, number of available beds); change in ownership; and single audit status.
Notably, the guidance sets a new deadline by which PRF Recipients must expend PRF payments without returning funding to the federal government. The guidance indicates that “if recipients do not expend PRF funds in full by the end of calendar year 2020, they will have an additional six months in which to use remaining amounts,” meaning that funds should be expended by the end of June. (The Provider Relief Fund FAQs indicate that HHS expects providers to fully expend their payments by July 31). HHS plans to launch the PRF Reporting System on October 1 and PRF Recipients are expected to submit the first reports regarding 2020 spending no later than February 15. For PRF Recipients with unexpended funds after December 31, 2020, a second and final report is due no later than July 31, 2021. HHS anticipates issuing FAQs and hosting webinar(s) in the near future.
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).”)
CMS issued a letter to State Medicaid Directors regarding the Medicare Part D claw back adjusted per-capita drug payment expenditure rate. Each year, the phased-down state contribution per capita rates are updated for changes in the federal medical assistance percentage (FMAP) that typically occur with the beginning of a new fiscal year. The letter acknowledges that the increase in FMAP established by the Families First Coronavirus Act affects the contribution rates and includes Attachment 1 outlining each state’s October-December 202 contribution rates with and without the FMAP increase.
HHS published updated data regarding providers that have received Provider Relief Fund General Distribution (Phase 1 or Phase 2) and/or Targeted Distribution payments (which includes allocations for high impact areas, safety net hospitals, rural providers, tribal facilities, clinics and urban health centers, and skilled nursing facilities); attested to receiving payment; and agreed to HHS’s terms and conditions as of September 14. As of this cut-off date, 340,062 providers have attested to receiving $86.2 billion in Provider Relief Fund payments.
FEMA updated guidance regarding the Lost Wages Assistance program, clarifying that Lost Wages Assistance program payments are not countable as income for eligibility determinations for Medicaid and the Children’s Health Insurance Program.
FEMA released an interim policy, which defines the framework, policy details, and requirements for determining the eligibility of work and costs under the public assistance (PA) program. The guidance outlines the principles behind this policy, requirements for the PA program, including eligibility, coordination of funding, and time limitations. The policy applies to work performed on or after September 15, 2020; prior to this date, policies in place when the work was completed apply.
Although FEMA has, until now, been considered the “payer of last resort,” the new guidance indicates that FEMA PA funding should not be considered funding of last resort, adding that it is “advisable that PA funding is considered concurrently with other federal agency programs and sources.” FEMA may provide PA funding for eligible work under COVID-19 declarations that may also be eligible for funding under the authority of another federal agency. The guidance indicates that potential PA applicants may have the flexibility to determine, in these instances, which source of funding to use for their costs (subject to the purpose and eligibility requirements of each source of funding).
– If FEMA has not awarded PA funding, applicants should withdraw or amend their PA application.
– If FEMA has awarded PA funding already, the applicant should request an updated version of their project worksheet to amend their PA project.
This document provides a list of FAQs on the FEMA supplemental lost wages payments under the President’s executive order.
HHS announced the details of its $2 billion performance-based incentive payment distribution to nursing homes, a component of its previously announced $5 billion Provider Relief Fund allocation for nursing homes.
In order to qualify for payments under the incentive program, a facility must have an active state certification as a nursing home or skilled nursing facility (SNF) and receive reimbursement from CMS. HHS will administer quality checks on nursing home certification status through the Provider Enrollment, Chain and Ownership System (PECOS)and facilities must also report to at least one of the following data sources that will be used to establish eligibility and collect necessary provider data to inform payment: Certification and Survey Provider Enhanced Reports (CASPER), Nursing Home Compare (NHC), and Provider of Services (POS). The incentive payment program will entail four performance periods (September, October, November, December) with $500 million in distributions for each period.
Using CDC’s Community Profile Reports (CPRs) to determine baselines for COVID-19 infections per capita and COVID-19 test positivity rates, HHS will measure facilities’ performance based on: (1) ability to keep new COVID infection rates low among residents; and (2) ability to keep COVID mortality low among residents. To measure facility COVID-19 infection and mortality rates, the incentive program will utilize data from the National Healthcare Safety Network (NHSN) Long-Term Care Facility (LTCF) COVID-19 module. CMS issued guidance in early May requiring that certified nursing facilities submit data to the NHSN COVID-19 Module (see Column J).(On August 27, HHS announced it had distributed the first $2.5 billion in payments to nursing homes to help with upfront COVID-19-related expenses for testing, staffing, and personal protective equipment (PPE) needs.)
In addition to the Provider Relief Fund FAQ updates noted above, a new Provider Relief Fund FAQ reflects that some providers are receiving emails from HHS requesting financial information in response to the payment HHS issued to the provider as part of Phase 1 of the General Distribution. HHS indicates that this is because the Terms and Conditions requires providers that received a payment from the $20 billion, second tranche from Phase 1 of the General Distribution submit revenue information regarding this payment. HHS does not have that information from some providers, “due in some instances to system issues.” In order to be considered for an additional payment, providers must submit this information by September 13, 2020. The FAQ is unclear as to whether this limitation on additional payments refers to eligibility for any Provider Relief Fund payment or any further General Distribution payment (for which applications are due September 13).
HHS announced that assisted living facilities (ALFs) that do not bill Medicare or Medicaid and therefore have not otherwise been eligible for the Provider Relief Fund General Distribution are now eligible for Phase 2 of the General Distribution. To accommodate this eligibility expansion, HHS clarifies in its Provider Relief Fund FAQs that HHS has developed a curated list of assisted living facility TINs from third party sources and HHS datasets. Akin to the process HHS has taken to validate Medicaid/CHIP providers, HHS will work with states and its partners to authenticate assisted living facilities that are not on the curated list. All providers eligible for Phase 2 General Distribution funding–including newly-eligible ALFs–have until September 13, 2020 to begin their application by entering their Tax Identification Number (TIN) for validation. The FAQs also address how ALFs should calculate revenue from patient care.
HHS Office of Inspector General (OIG) issued updated FAQs regarding application of OIG’s administrative enforcement authorities to arrangements directly connected to COVID-19. The new FAQs, posted on September 3, provide guidance on: (1) a specific scenario in which a federally-qualified health center (FQHC) received a COVID-19 relief grant from a private foundation and is interested in whether it may use that funding to furnish cash-equivalent gift cards to address social determinants of health for financially needy individuals; and (2) whether a home health agency’s staff member may provide free blood draws to assisted living facility residents who are federal health care program beneficiaries and are not patients of the home health agency.
HHS issued new and modified Provider Relief Fund FAQs, clarifying:The Methodology & Parameters of the $5 Billion Nursing Home Infection Control DistributionAs previously announced, HHS distributed approximately $2.5 billion in upfront funding to nursing homes to support increased testing, staffing, and personal protective equipment (PPE) needs. The FAQs apply new nomenclature to this distribution, deeming it the “Nursing Home Infection Control Distribution.” Unlike other Provider Relief Fund distributions, these payments may only be used for the infection control expenses defined in the Terms and Conditions, which includes costs associated with administering COVID-19 testing for both staff and residents; reporting COVID-19 test results to local, state, or federal governments; hiring staff to provide patient care or administrative support; incurring expenses to improve infection control, including “mentorship” programs with subject matter experts or changes made to physical facilities; and providing additional services to residents, such as technology that permits residents to connect with their families if their families are not able to visit in person. Recipients received a per-facility payment of $10,000 plus a per-bed payment of $1,450. Eligible providers include nursing homes and skilled nursing facilities that are not revoked, have an active CMS certification, and have at least 6 certified beds.Application Processes for Phase 2 of the General DistributionHHS clarified that providers applying for Phase 2 of the General Distribution (for which applications are now being accepted through September 13):
– May submit a new application for Phase 2 even if there is an application still under consideration as part of Phase 1 of the General Distribution.
– If the provider experienced a change in ownership in 2019 or 2020, the provider should report the revenue, along with the proportion of revenue from patient care, for the acquisition or dispositions from the date of sale through the date of application in the Provider Relief Fund Application and Attestation Portal.
Considerations for Providers with Specific Ownership Structures and Financial Relationships
-Parent organizations that received a Provider Relief Fund Targeted Distribution on behalf of a subsidiary should attest to the Terms and Conditions rather than their subsidiary.
– Parent entities submitting applications on behalf of their subsidiaries may enter up to 1,200 subsidiary TINs in the application portal which will initiate the application process for each of their subsidiaries.
On July 31 and August 7, HHS announced that it planned to distribute an additional $5 billion in Provider Relief Fund payments to skilled nursing facilities, in two ~$2.5 billion tranches. On August 27, HHS announced it has distributed the first approximately $2.5 billion to over 15,000 skilled nursing facilities and nursing homes with 6 or more certified beds. Although HHS has not provided additional information about the eligibility criteria for this distribution, it appears to vary from the criteria that HHS applied to the first $4.9 billion Skilled Nursing Facility payments distributed earlier this summer. HHS indicated that those payments were distributed to approximately 13,000 facilities as compared to the 15,000 facilities that received this payment. Eligible facilities received a per-facility base payment of $10,000 plus a per-bed payment of $1,450. HHS published a state-by-state breakdown of the payments.
In its press release, HHS indicates that this $2.5 billion distribution is intended to support increased testing, staffing, PPE needs, and COVID isolation facilities, but it is unclear whether HHS will set specific parameters for eligible uses of this distribution of the Provider Relief Fund. HHS also noted that it plans to distribute a another $2 billion later this fall based on certain performance indicators that will be shared in the future. (It is unclear how it will distribute the remaining approximately $500 million of its distribution said to amount to $5 billion in total).
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:
– Hospital Recipients of Provider Relief Funds (PRF)—General and Targeted Distributions. OIG will audit a statistical sample of PRF recipients to determine whether providers that received PRF payments complied with federal requirements including “the terms and conditions for reporting and expending federal funds.” OIG expects the report to be issued fiscal year 2021. Although the title of the report title specifies hospitals, the description is unclear about whether the audit will indeed be limited to hospitals or other providers that have received PRF payments.
– Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19. OIG will audit whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with federal requirements. Notably, Section 3710 of the CARES Act directed the Secretary to increase the weighting factor that would otherwise apply to the assigned DRG by 20 percentage points for an individual who is diagnosed with COVID-19 and discharged during the COVID-19 public health emergency.
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.
This memorandum directs the Secretary of the Treasury to defer (not forgive) the withholding, deposit, and payment of certain Social Security taxes for wages between September 1 and December 31.
This memorandum directs FEMA to use Disaster Relief Fund dollars to continue a portion of the enhanced unemployment benefits authorized by the CARES Act that expired on July 31. This approach would require states to cover 25 percent of the cost.
CMS issued a Medicaid Informational Bulletin (CIB) offering guidance to state Medicaid agencies regarding the ways in which they may enhance payment for nursing facilities to account for potentially increased resident acuity levels and to support any necessary actions that facilities are implementing to mitigate the further spread of COVID-19. The CIB includes:- Examples of nursing facility payment enhancements available to states. These include base rate payment increases, establishing new payment methodologies for facilities that serve as isolation centers, establishing targeted supplemental payments, among others. – Flexibilities available in managed care. These include establishing state-directed payments to nursing homes; although actuarial soundness requirements must be met to implement these payments, CMS notes that it has established an expedited review process to accomodate states seeking to make sure payments. – Examples of states that have implemented these and other policies. The CIB also describes the Provider Relief Fund distributions announced to date, but provides no additional information about how nursing facilities may access the recently-announced, additional $5 billion for nursing homes.
DoL, in coordination with FEMA, issued FAQs (in addition to those previously released by FEMA) regarding the Lost Wages Assistance (LWA) program. In its guidance, DoL clarifies:• States’ responsibilities for contacting individuals who are potentially eligible for LWA to allow them to submit a self-certification• Technical requirements of the self-certification process• How states should determine if an individual meets the eligibility requirement for receiving at least $100 in benefits for the underlying unemployment benefit program• The “Period of Assistance” of the LWA program (August 1, 2020 to December 27, 2020 or termination of the program, whichever is sooner)• States’ flexibility as to whether it issues a combined payment or separate payment for LWA and underlying unemployment benefits• Application of Coronavirus Relief Fund payments• How state funds may be used to cover the state’s 25 percent match for LWA• Requirements to submit various financial and programmatic reports
CDC announced $206.4 million in awards to tribal nations, consortia, and organizations for responding to COVID-19 across tribal communities, including and exceeding the $165 million authorized by the CPRSA and CARES Acts. Awards were made as follows:• $142 million through the new “Supporting Tribal Public Health Capacity in Coronavirus Preparedness and Response” grant to support surveillance, epidemiology, laboratory capacity, infection control, mitigation, communication and other activities• $50.8 million through the existing “Tribal Public Health Capacity Building and Quality Improvement” cooperative agreement for surveillance, epidemiology, infection control and communications, as well as to build public health capacity to prevent injuries and violence, focusing on suicide, adverse childhood experiences and intimate partner violence• $12.9 million through the existing “Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nation’s Health” cooperative agreement to address COVID-19 and conduct national COVID-19 communication activities, and• $750,000 through the existing “Public Health Crisis Response” cooperative agreement to support COVID-19 incident management, information management, and other activities.
Following the President’s August 8 memorandum directing FEMA to use Disaster Relief Fund dollars to continue a portion of the enhanced unemployment benefits authorized by the Coronavirus, Aid, Relief, and Economic Security (CARES) Act that expired on July 31, FEMA announced it will provide up to $44 billion in Disaster Relief Fund grants to states, territories, and the District of Columbia (“states”) to administer lost wages assistance. FEMA also announced that, as of August 14, it has approved grants for Arizona, Iowa, Louisiana, and New Mexico. States may request assistance by submitting by September 10 an application for a grant award to administer the supplemental payments for lost wages. States must apply using the Grants.gov portal.
FEMA approved the first set of states (Arizona, Iowa, Louisiana, and New Mexico) for the Lost Wages Supplemental Payment Assistance program, which has been allocated up to $44 billion in Stafford Act Disaster Relief Funding to provide individuals with supplemental payments for lost wages due to COVID-19. States and territories can apply for the federal grants if they agree to certain conditions, such as a 25% state cost share and to administer the program in conjunction with the state’s unemployment insurance system. Individual recipients must be currently eligible for at least $100 per week in unemployment insurance compensation and can receive up to $400 per week through this program.
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.
The Treasury issued updated Coronavirus Relief Fund FAQs (see questions 49 – 52), clarifying and mostly reiterating technical requirements covering: • That states are permitted to use payments from the Fund to satisfy 100% of their cost share for lost wages assistance as authorized by the Stafford Act to the extent that costs are related to COVID-19 and otherwise satisfy the Fund’s eligibility criteria;• At what point costs are considered “incurred” when funds were used to make a loan; and• Relevant IRS guidance about using Coronavirus Relief Funds to establish grant or loan programs to support businesses
HHS announced a new $1.4 billion allocation of the Provider Relief Fund for free-standing children’s hospitals. HHS indicated in its announcement that the distribution is aimed at ensuring “that certain free-standing children’s hospitals, not affiliated with larger hospital systems, also receive the financial relief they urgently need to offset revenue losses,” suggesting that the distribution is meant to provide funding to hospitals that were left out of the prior safety net hospital distribution. These free-standing children’s hospitals—defined as those that are either exempt under the CMS inpatient prospective payment system or are HRSA-defined Children’s Hospital Graduate Medical Education facilities—will receive a payment in the amount of 2.5% of net patient revenue beginning the week of August 17. HHS also published a state/regional-level breakdown of validated children’s hospital distribution; the Department notes that an additional 24 children’s hospitals are being reviewed and the file will be updated once that validation is complete.
HHS announced that it is now accepting applications for the General Distribution: Phase 2 of the Provider Relief Fund–which now includes Medicaid, CHIP, and dental providers that did not bill Medicare in 2019 plus providers who missed out on their 2% of net patient revenue payment in Phase I–and released instructions for eligible providers to apply. The General Distribution is made up of two funding streams: • one for any provider who billed Medicare in 2019 (“Medicare General Distribution” or the “General Distribution: Phase 1”), and • one for Medicaid/CHIP/dental providers who did not bill Medicare in 2019 and therefore were entirely left out of the Medicare General Distribution (“Medicaid, CHIP, and Dental Provider General Distribution” or “General Distribution: Phase 2”). All Medicare, Medicaid, and dental care providers who have not received at least 2% of patient revenue from a General Distribution payment should apply for Phase 2 of the General Distribution by August 28, via the Provider Relief Fund Application and Attestation Portal.
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.
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.
CCIIO updated its FAQs on risk adjustment for telehealth and telephone services during COVID-19. The FAQs clarify which telehealth and telephone service codes are valid for data submissions for the HHS-operated risk adjustment program.
HHS provided new information about the Provider Relief Fund $5 billion allocation for nursing homes and long-term care facilities, first announced in July. Specifically, an initial $2.5 billion distribution will support increased testing, staffing, PPE needs, and COVID isolation facilities. The balance will be distributed based on nursing home performance, particularly a nursing home’s ability to minimize COVID spread and COVID-related fatalities among its residents with consideration of the prevalence of the virus in the nursing home’s local geography. According to HHS, the initial $2.5 billion distribution will occur in mid-August, and be followed by the performance-based distributions throughout the fall. HHS likely will provide additional information about the methodology for determining eligibility and payment for these funds via its Provider Relief Fund General Information page and/or FAQs.
SBA, in consultation with the Department of the Treasury, released FAQs on the PPP’s loan forgiveness policies. Topics highlighted include:• General loan forgiveness (e.g., regarding documentation for submission and overarching timing considerations),• Payroll costs (e.g., the inclusion of incurred but not expended payroll costs and non-salary types of payroll such as tips and commissions),• Nonpayroll costs (e.g., coverage for specific utility and electricity charges), and • Loan forgiveness reductions (e.g., whether and how to report reductions in full time employee counts or employee salary reductions).
HHS issued new and modified Provider Relief Fund FAQs, including FAQs specifying:- July 31, 2021 as the date by which providers must fully expend Provider Relief Fund dollars;- How Financial Management Services can apply for the Medicaid/CHIP Distribution on behalf of Home & Community Based Services (HCBS) providers, including how to count self-directed providers as full time employees (FTEs); and- Parent organizations may only redistribute General Distribution payments among subsidiaries. Control and use of Targeted Distribution payments must be delegated to/remain with the entity that was eligible for the Targeted Distribution payment.
HHS announced that it is extending the deadline for eligible providers to apply for the Medicare General Distribution and Medicaid, CHIP, and Dental Providers Distribution of the Provider Relief Fund. These announcements impact the following providers:Providers eligible for the Medicaid, CHIP, and Dental Providers Distribution. These providers (Medicaid/CHIP and dental providers that did not bill Medicare fee-for-service in 2019) now have until August 28, 2020 to apply for payment.Providers that billed Medicare fee-for-service in 2019 but did not receive their full 2% of patient revenue payment from the $50 Billion General Distribution. HHS has re-opened the $50 billion Medicare General Distribution–which it had previously closed on June 3, 2020.HHS also indicated that it is “working to address relief payments” for providers that were newly established in 2020 (and therefore are ineligible for both distributions described above) and other providers that have not yet received any payment (such as those that only bill commercial insurance).
OIG released two toolkits summarizing lessons learned from OIG reports on emergency preparedness and response published between 2002 and 2004 . The first toolkit addresses state and local actions during emergency events such as infectious disease outbreaks and natural disasters, and the second toolkit focuses on healthcare facility response during such events. While the evaluations referenced in the toolkits took place prior to the COVID-19 pandemic, OIG intends for this information to assist communities and healthcare facilities in responding to the current pandemic.
CMS modified a previously issued waiver regarding the deadline for hospital Wage Index Occupational Mix surveys. The original deadline for 2020 was July 1. On March 30, CMS granted an extension for hospitals nationwide affected by COVID-19 until August 3, 2020. Due to continued COVID related concerns from hospitals about meeting this deadline, CMS is further extending this deadline to September 3, 2020. Hospitals must submit their occupational mix surveys along with complete supporting documentation to their MACs by no later than September 3, 2020. Hospitals may then submit revisions to their occupational mix surveys to their MACs, if needed, by no later than September 10, 2020.
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.
The Treasury issued its first report detailing each state and local government’s Coronavirus Relief Fund payment amount, total costs incurred, and percent spend during the period from March 1 through June 30, 2020. Costs were considered to have been incurred if performance or delivery occurred during the covered period even if payment of funds had not yet been made. The data is based on recipients’ reporting, and the Treasury clarified that it has not yet verified or audited the data.
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
HRSA published updated data regarding providers that have received reimbursement from the Claims Reimbursement for COVID-19 Care of the Uninsured Program and agreed to HHS’s terms and conditions as of July 15. As of this cut-off date, 13,901 providers have received $419.1 million in claims reimbursement.
CCIIO issued guidance outlining temporary flexibilities that allow:• Issuers in the individual and small group markets to offer temporary premium credits for individuals, families and small employers that may struggle to pay premiums because of illness or loss of incomes or revenue resulting from COVID-19. When consistent with state law, issuers may offer premium reductions for one or more months of 2020 coverage. • States to permit issuers to provide premium credits in the same manner (i.e., CMS will not consider a state to have failed to substantially enforce applicable federal requirements).This temporary policy will be in effect until the end of 2020. Issuers wishing to provide premium credits for 2020 coverage must, in advance of providing these credits, receive the applicable regulator’s permission to provide premium credits as outlined in this bulletin, or CMS’s permission in states where CMS is the primary enforcer of the applicable federal requirements.
On Thursday, June 4, State Health and Value Strategies (SHVS) hosted a webinar during which experts from Manatt Health discussed the fiscal implications for states and Medicaid programs of the COVID-19 pandemic, the emerging economic downturn, and recent legislation to address these twin crises, including the Families First Coronavirus Response Act (“Families First”) and the Health and Economic Recovery Omnibus Emergency Solutions (“HEROES”) Act. The Databook is a follow-on product to the webinar. As discussed in the Overview, each table in the Databook displays projected changes in federal and state Medicaid and CHIP expenditures during calendar years 2020 and 2021 across all fifty states and the District of Columbia for a given scenario and policy response. Taken together, the Databook provides estimates that span across a range of plausible scenarios reflecting increased enrollment and per enrollee spending growth and changes to the duration of the federal Public Health Emergency.
HHS issued new Provider Relief Fund FAQs, clarifying:- Parent organizations with multiple billing TINs that each received General Distribution payments may attest and keep the payments (as long as the subsidiaries attest to the Terms and Conditions) and can control and allocate funds to its subsidiaries at its discretion provided that they parent organization attests to receiving the payments and accept HHS’ terms and conditions.- The revenue data used to determine payments for the Medicaid, CHIP, and Dental Providers Distribution will be based on the applicant’s most recent federal income tax return for 2017, 2018 or 2019.
HHS issued a revised Provider Relief Fund FAQs indicating that the application deadline for the Provider Relief Fund Dental Provider Distribution is extended to August 3rd from July 24th.
HHS announced the following Provider Relief Fund updates:• Medicaid providers eligible for the Medicaid Distribution may submit applications through August 3, rather than the original July 20 deadline. HHS indicated that it is “continuing to work with provider organizations, Congressional, state and local leaders to get the word out about this program,” suggesting that application rates have been low.• HHS will begin to distribute the second tranche of Provider Relief Fund payments to hotspot hospitals next week. HHS distributed the first round of funding to 395 hospitals that had at least 100 COVID-19 admissions between January 1 and April 10. This second tranche of funding will go to hospitals that had at least 161 COVID-19 admissions between January 1 and June 10—“taking into account” the amount of funding that hospitals received in the prior distribution. Alongside the press release, HHS published data listing the nearly 1000 hospitals that, between the first and second tranche of hotspot hospital allocations, have received or will receive payment.
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 Treasury publicly posted a July 2 letter to Coronavirus Relief Fund recipients indicating that primary recipients of the Fund will be required to report “costs incurred” for the covered period (March 1, 2020 – December 31, 2020) on a quarterly basis. – By July 17, recipients are required to costs data for March 1 through June 30, using the attached spreadsheet. – Beginning in September, data submissions will be facilitated via a GrantSolutions online portal that Treasury expects to launch on September 1In addition to meeting these reporting requirements, recipients must keep all payment records available for 5 years after final payments of the fund, to be made available to the Treasury OIG upon request.
Administrative Relief and Other Flexibilities for Recipients and Subrecipients of FEMA Financial Assistance for Response to or Direct Impacts from Novel Coronavirus (COVID-19)
CMS announced its plans to deploy additional Quality Improvement Organizations (QIOs) across the country to provide immediate assistance to nursing homes in the hotspot areas. QIOs are CMS contractors who work with healthcare providers to help them improve the quality of healthcare they provide to Medicare Beneficiaries. CDC also announced it is implementing an enhanced survey process to better coordinate federal, state and local efforts toward addressing quality and safety concerns for these facilities. On June 1, CMS announced it was allocating $80 million in CARES Act funding to support the deployment of QIOs and survey activities for nursing homes.
HHS announced the following new Provider Relief Fund distributions:- Additional ~$3 Billion for Safety Net Hospitals: On June 9, HHS announced a $10 billion distribution to safety net hospitals that met certain criteria (for more information, see Manatt’s newsletter). In today’s announcement, HHS indicated that it is expanding the criterion related to hospital profitability. To receive the June 9-announced payment, hospitals were required to (among other criteria) have demonstrated profitability of 3% or less on their most recent cost report. The new $3 billion distribution will now include hospitals that meet a profitability threshold of 3% or less over two or more of the last five cost reporting periods. HHS expects to distribute over $3 billion across 215 acute care facilities based on this criterion adjustment, bringing the total distribution to safety net hospitals to $12.8 billion across 959 facilities. – $1 Billion for Certain Rural Providers and Other Providers from Small Metropolitan Areas: In May, HHS announced $10 billion in funding for rural providers (including hospitals, health clinics, and health centers). HHS is expanding that payment formula to include certain special rural Medicare designation hospitals in urban areas, as well as others that provide care in smaller, non-rural communities (which may include some suburban hospitals). Payments will range from $100,000 to $4.5 million. – Allocation for Dentists: An application process is now open for dentists who may not have been eligible to receive funding through the Provider Relief Fund. Eligible dentists will receive 2% of their annual reported patient revenue and have until July 24 to apply for funding via the enhanced portal.
The Treasury issued new FAQs with clarifications on permissible uses of Coronavirus Relief Fund, indicating scenarios for which payments may be used to cover increased administrative leave costs of public employees who could not telework in the event of a stay at home order or a case of COVID-19 in the workplace.
HRSA issued a fact sheet on the $15 billion Provider Relief Fund Medicaid/CHIP Provider distribution, reiterating previous guidance on the eligibility requirements, application process, attestation requirements, and payment methodology for this distribution.
SBA announced that it has approved nearly $521.5 billion across nearly 4.9 million Paycheck Protection Program (PPP) loans through June 30, inclusive of funding authorized through both the CARES and PPPHCE Acts. This leaves $158.5 billion remaining until the funding authorized by the PPPHCE Act is exhausted, of which SBA has indicated $131.9 billion is available for additional loans.
FEMA issued guidance to state, local, tribal, and territorial (SLTT) governments clarifying conditions and scenarios under which FEMA may provide public assistance (PA) program funding and how SLTT governments may coordinate PA with other federal funding sources. Given the need to quickly address the public health threats of COVID-19 and the overlapping authories and funding for the federal response, FEMA may generally provide PA for eligible costs even in instances when SLTT governments may apply for coverage of those costs via other federal agencies.
HHS published updated data regarding providers who have received the following Provider Relief Fund and related payments: – Lump Sum Provider Relief Fund Payments: As of July 1, 215,667 providers have accepted $60.0 billion in Provider Relief Fund payment that match this criteria.- Claims Reimbursements from the HRSA COVID-19 Uninsured Program: As of July 1, HRSA has disbursed $250.6 million to 7,895 providers.
CMS approved COVID-19 Section 1115 waiver demonstrations in Hawaii and North Carolina. Similar to the prior approvals in Washington and New Hampshire, the new approvals are narrow in scope. In its approval letter, CMS continues to emphasize that it would prefer to use other authorities to give states flexibilities rather than Section 1115 authority. All of the expenditure authorities granted are relevant to long-term services and supports and the majority of the authorities approved are in the CMS COVID-19 1115 waiver template checklist, with limited exceptions.
This document outlines COVID-19 emergency declaration “blanket waivers” for healthcare providers and is regularly updated by CMS. The June 25 update indicates that CMS has terminated the waiver of 42 CFR 483.70(q) to provide relief to long-term care facilities on the requirements for submitting staffing data through the Payroll-Based Journal system. This is the first termination of a COVID-19 related 1135 waiver and in accompanying guidance, CMS justified the termination on the grounds that more than half of facilities continued to report data, and that staffing data is an important component of assessing quality.
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)
HHS, DoL, and the Treasury jointly issued FAQs regarding health coverage issues related to COVID-19. The guidance clarifies several key policies regarding group health plan and health insurance issuer COVID-19 testing coverage requirements, including:• The circumstances under which plans are and are not required to cover COVID-19 testing, clarifying for example that plans are not required to cover return-to-work or surveillance testing and are only required to cover items and services for diagnostic purposes;• The types of testing that must be covered, clarifying for example that at-home testing must be covered (provided such testing meets other coverage requirements described in the guidance);• The amount of testing that must be covered, clarifying for example that, if an individual receives multiple diagnostic tests, all tests must be covered; and• Billing and reimbursement policies, such as plans’ obligation to cover facility fees related to administration of a COVID-19 test or evaluation of an individual to determine their need for testing; and how to determine the reimbursement rate for providers of COVID-19 testing if the provider is not in-network with the plan.
FCC issued an updated notice of awards for the COVID-19 Telehealth Program, providing $29.4 million in 77 awards to providers in this tranche. As of June 24, the FCC has awarded $157.6 million to 444 health care providers in 46 states plus the District of Columbia. The CARES Act appropriated $200 million for the FCC to award to healthcare providers to purchase and adopt telecommunication technologies to support telehealth services for patients. FCC announces awards on a weekly basis.
The Treasury issued new FAQs with clarifications on permissible uses of the Coronavirus Relief Fund, indicating that funds may be used to: – Satisfy non-federal matching requirements under the Stafford Act; – Distribute payments to non-profits for distribution to individuals in need of financial assistance; – Provide assistance to farmers and meat processors to expand capacity provided that these payments are determined to be a necessary expenditure attributable to the public health emergency; and – Cover the entire payroll of a public safety, public health, health care, human services, or similar employee whose services are substantially dedicated to responding to the COVID-19 public health emergency. The FAQs also clarified that governments must structure all programs in a manner to ensure assistance is determined necessary in response to the public health emergency—for example, per capita payments to residents of a particular jurisdiction without an assessment of individual need would NOT be considered an appropriate use of the Fund.
This regulatory analysis provides an overview of New Hampshire’s directed payment and the documents used in the New Hampshire approval.
Responses to CMS’ questions regarding NH’s directed payment
Responses to CMS’ questions regarding NH’s directed payment
Letter from CMS to NH notifying the state of approval of their directed payment
New Hampshire directed payment preprint submission to CMS
States quickly mobilized to implement emergency federal authorities (e.g., Section 1135 waivers, 1915(c) Waiver Appendix K, emergency Section 1115 waivers) and state-level regulatory flexibilities to respond to the COVID-19 pandemic; now they must determine which flexibilities to scale back or sustain, taking into account fiscal implications. The interaction of the stimulus package dates, the Public Health Emergency, and the President’s National Emergency Declaration, among other factors, are complex, and states are actively grappling with decision making regarding which flexibilities they need and want to keep, and how. This Excel workbook is intended to serve as a tool for states as they begin to strategize about reopening and plan for the next phase of the COVID-19 pandemic. Specifically, states can utilize this template to conduct both a primary analysis as they determine which flexibilities to unwind or maintain and a secondary analysis to plan for operational and implementation implications.
CMS approved a COVID-19 Section 1135 waiver request for New York, all related to Medicaid managed care. The waivers:- Extend by up to 180 days the deadline for an MCO to reach a service authorization decision (for both standard and expedited requests) if the delay is in the enrollee’s interest (under current rules, the maximum extension is 14 days).- Extend by up to 120 days the timeframe for a managed care enrollee to request an internal MCO appeal following receipt of the adverse benefit determination (under current rules, the request must be filed within 60 days).- Extend by up to 30 days the timeframe for the MCO to resolve a standard appeal as long as the delay is in the enrollee’s interest (under current rules, standard—i.e., non-expedited—appeals must be resolved within 14 days).All three waivers are conditioned on the following: – The MCO must pay for the service until the extended timeline expires, and – Even if the enrollee’s appeal is ultimately unsuccessful, the enrollee is not liable for repaying the costs of services that were paid for in the interim
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
CMS issued guidance to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans regarding COVID-19 coverage policies. The guidance reiterates that MAOs must comply with general coverage guidelines included in fee-for-service Medicare manuals and instructions, including those related to testing for nursing home residents, which are enumerated in the guidance.
CMS posted the second set of COVID-19 nursing home data since its April 19 announcement that nursing homes are required to report COVID-19 cases and deathsto the CDC. The latest report includes data through June 7 with nursing home- and state- level data related to resident cases, suspected cases, and deaths. The Nursing Home Compare resource allows users to review additional data specific to individual nursing homes.
SBA issued an additional Interim Final Rule (IFR) on the PPP in its continued efforts to codify changes enacted by the PPP Flexibility Act of 2020, covering the use of loan proceeds, loan maturity, eligibility for loan forgiveness and the duration of the covered period. The provisions in this IFR related to loan forgiveness are effective March 27, 2020. The provision relating to the maturity date of PPP loans is effective June 5. Remaining provisions will be effective on the date the IFR is filed at the Office of the Federal Register. The IFR is awaiting publication in the Federal Register; comments will be accepted until 30 days after publication.
FCC issued an updated notice of awards for the COVID-19 Telehealth Program, providing $23.3 million in 62 awards to providers in this tranche. As of June 17, the FCC has awarded $128.2 million to 367 health care providers in 45 states plus the District of Columbia.
CMS’s Center for Consumer Information and Insurance Oversight (CCIIO) issued guidance indicating that it will not take enforcement action against health plan issuers that submit their 2019 Medical Loss Ratio Annual Reporting Forms by August 17, instead of the previous July 31 deadline, as required by 45 CFR 158.110(b).
The Treasury announced it completed making the majority of payments to Tribal governments as part of the $8 billion Tribal allocation of the Coronavirus Relief Fund and provided additional information regarding the allocations.
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.
HHS announced its latest allocations of the $175 billion Provider Relief Fund, including approximately $15 billion for Medicaid providers that do not bill Medicare (predominantly outpatient providers), $10 billion for safety net hospitals as defined by specific HHS criteria and an additional $10 billion for COVID-19 “hot spot” hospitals. HHS indicated that the safety net hospital payments will be distributed “this week.” The timing of the other distributions is not yet known.
FCC issued an updated notice of awards for the COVID-19 Telehealth Program, providing $20.2 million in 67 awards to providers in this tranche. As of June 10, the FCC has awarded nearly $105.0 million to 305 health care providers in 42 states plus the District of Columbia. The CARES Act appropriated $200 million for the FCC to award to healthcare providers to purchase and adopt telecommunication technologies to support telehealth services for patients.
HUD announced $2.96 billion in CARES Act funding in Emergency Solutions Grants (ESG) to state and local governments, which will support homeless individuals and those at risk of becoming homeless by making more emergency shelters available, covering the cost of operating emergency shelters and hotel/motel vouchers, providing other essential services and rapidly rehousing homeless individual.
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, through the Health Resources and Services Administration (HRSA), announced’- a $15 billion allocation of the Provider Relief Fund for Medicaid and CHIP providers that have not received a payment from the Provider Relief Fund General Allocation (roughly 38% of Medicaid/CHIP providers, according to HHS); -$10 billion allocation of the Provider Relief Fund for safety net hospitals; and- a new $10 billion distribution of the Provider Relief Fund, considered a second “high impact” paymen
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
In recent months, the Department of Health and Human Services (HHS) has issued ongoing announcements and updates with respect to the Provider Relief Fund. The guidance and updates that HHS has provided to date relate to the $100 billion authorized by the CARES Act; they do not yet contemplate how HHS will distribute the additional $75 billion.This analysis provides:• An overview of the available funds, the resources HHS has made available to providers, and the steps that providers will need to take (or must have already taken) to access these funds. • An overview of the longer-term reporting and documentation requirements that providers will need to satisfy by way of accepting these funds. See page 8.
To help states respond to the ongoing coronavirus (COVID-19) pandemic, the White House, the U.S. Department of Health and Human Services, and the Centers for Medicare and Medicaid Services have invoked various emergency authorities that allow for temporary flexibilities in the Medicaid and the Children’s Health Insurance Program programs. Congress also has passed legislation that provides additional federal support for state Medicaid programs, subject to certain conditions. The table describes the effective dates of these various provisions as well as the expiration timeline dictated by law or agency guidance; the table also includes current end dates, which are subject to change as federal and state officials take actions to renew or terminate particular authorities.
HHS Assistant Secretary for Preparedness and Response (ASPR) announced $250 M in Hospital Preparedness Program (HPP) awards to aid health care systems responding to the COVID-19 pandemic as authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. HPP funds support hospitals and other health care entities to train workforces, expand telemedicine and the use of virtual healthcare, procure supplies and equipment, and coordinate effectively across regional, state and jurisdictional, and local health care facilities to respond to COVID-19.
A blog post from the Urban Institute analyzing how HHS has distributed Provider Relief Fund payments to date. As of June 10, 2020, 35 percent of the aid remains unallocated.
FCC issued an updated notice of awards for the COVID-19 Telehealth Program, providing $16.5 million in 53 awards to providers in this tranche. As of June 3, the FCC has awarded a total of $85.0 million to 283 health care providers in 41 states plus the District of Columbia. The CARES Act appropriated $200 million for the FCC to award to healthcare providers to purchase and adopt telecommunication technologies to support telehealth services for patients. FCC announces awards on a weekly basis.
The Treasury issued FAQs explaining the payment methodology it used to determine the $8 billion Coronavirus Relief Fund allocation for Tribal governments. In particular, the Treasury clarified that it used the Decennial Census total American Indian Alaskan Native data used by the Department of Housing and Urban Development in its Indian Housing Block Grant Program after determining it is the most consistent and reliable metric on which to base the payments.
HRSA released a range of guidance for Ryan White HIV/AIDS Program (RWHAP) CARES Act recipients, including updated FAQ covering allowable costs among other topics. HRSA’s HIV/AIDS Bureau also released the COVID-19 Data Report to collect monthly, aggregate data on CARES Act funded activities, including types of services provided and number of RWHAP-eligible clients served for the treatment or prevention of COVID-19. HRSA is accepting public comment on the proposed data report module through June 8.
CMS issued a memo detailing changes to CMS Innovation Center models due to COVID-19. The memo includes model adjustments related to financial methodologies, quality reporting, and model timeline and indicates that CMS will provide additional information regarding the implementation of these changes to model participants.
CMS issued new guidance and data regarding nursing homes and COVID-19. In the guidance, CMS instructs states to complete Focused Infection Control surveys in all Medicare and Medicaid certified nursing homes by July 31. States that have not completed 100% of these surveys by July 31 will be required to submit a corrective action plan to CMS outlining their plan to complete the surveys within 30 days. Additionally, CMS released updated data that includes the percentage of nursing homes surveyed in the state, along with data related to the number of COVID-19 nursing home resident and staff cases and deaths in the state.
HRSA created a Coronavirus-related funding FAQ resource page for health centers, providing new information on required progress reports related to the receipt of Coronavirus-related funding awards. Progress reports must include narrative updates on activities related to testing, maintaining or increasing health center capacity and telehealth, among others. The first progress reports will be available for awardees starting July 1, with a submission date of July 10.
CMS released an updated toolkit on state actions to mitigate COVID-19 prevalence in nursing homes. The actions enumerated in the toolkit are sourced from healthcare providers, state governors, and other stakeholders and include topics related to cleaning/disinfection, reporting/guidance, testing, workforce and staffing, cohorting, establishing infection control “strike teams” and surveys, nursing home communications, procuring and improving utilization of personal protective equipment (PPE), housing and sheltering, addressing transportation needs, patient transfer, and telehealth (among others).
CMS issued guidance to states regarding implementation of the Medicaid Optional COVID-19 Testing (XXIII) Group established by the Families First Coronavirus Response Act (FFCRA) for uninsured individuals for COVID-19 testing and testing-related services. This guidance outlines the requirements associated with implementing the new group (including eligibility and enrollment, claiming, and data reporting), and provides guidance on strategies that states may employ to meet these requirements. The guidance also clarifies interactions between the XXIII group and the HRSA COVID-19 Uninsured Program for testing (and treatment) provided to uninsured individuals.
CMS approved COVID-19 Section 1135 waiver requests for Arizona which includes a new 1135 waiver authority regarding Medicaid home health and medical equipment. Specifically, the state may delay the required “face-to-face encounter” for up to one year from the date of service (normally, the encounter must occur before the initiation of medical equipment, or within 30 days after the start of home health services).
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
SBA and the Treasury Department are setting aside $10 billion of the $321 billion authorized by the PPPHCE Act for the PPP exclusively for CDFI lenders. As of May 23, CDFIs had approved $3.2 billion of PPHCEA-authorized PPP funds, leaving $6.8 billion to be fulfilled as part of the new set-aside.
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
Webinar on racial inequities of COVID-19 and impact on communities of color
On Thursday, May 21, State Health and Value Strategies hosted a webinar that reviewed potential information technology (IT) investments in responding to COVID-19 and strategies for states to support these investments. As states face the extraordinary challenges of the COVID-19 crisis, IT is an essential tool to support access to health coverage and the safe and effective evaluation, testing, and treatment of patients nationwide. The webinar outlined strategies states can employ to secure current and potential IT investments that enable ongoing Medicaid program operations and advance health information exchange.
As states face the extraordinary challenges of the COVID-19 crisis, information technology (IT) is an essential tool to support access to health coverage and the safe and effective evaluation, testing, and treatment of patients nationwide. Under the current statutory and regulatory framework, state Medicaid agencies are authorized to receive federal funding for Medicaid IT and associated activities, and much of it at an enhanced federal matching level. This issue brief outlines potential IT investments in responding to COVID-19 and strategies for states to support these investments, as well as secure current and future IT investments that enable Medicaid program operations. The issue brief also highlights the Medicaid authorities and the provisions that may allow states more expeditious access and flexible use of these funds.
An analysis by Manatt Health on a CMS Informational Bulletin regarding Medicaid managed care options to mitigate the impact of the COVID-19 pandemic on Medicaid providers. Most notably, the Bulletin highlights how, under certain conditions, states can use existing authority to require plans to make directed payments to providers to help them weather the financial impacts of the pandemic, including COVID-19 expenses and steep revenue declines.
SBA issued an IFR outlining the PPP loan forgiveness process for lenders, the process for borrowers to apply for loan forgiveness, and the types of costs that are eligible for loan forgiveness. SBA issued a separate IFR regarding how SBA may audit PPP loans, including their forgiveness, and the loan forgiveness process for lenders. SBA also announced that PPP has approved over $511 billion across 4.4 million PPP loans through May 23, inclusive of funding authorized through both the CARES and PPPHCE Acts. This leaves approximately $159 billion remaining until the funding authorized by the PPPHCE Act is exhausted.
SBA Loan Review Procedures and Related Borrower/Lender Responsibilities IFR
HHS OIG issued its strategic plan to support the COVID-19 response and recovery.
FEMA announced that government officials can now access the “Community Mitigation Decision Support Tool,” which makes data for each metric in the President’s Guidelines for Opening Up America Again available in one tool.
CMS issued guidance for state and local governments regarding receiving reimbursement from CMS programs (Medicare, Medicaid, CHIP) for care provided at an alternate care site. CMS advises that the easiest path is for an already-enrolled hospital or health system to treat the ACS as a temporary expansion of their “brick-and-mortar” location. In these circumstances, the local hospitals and health systems operate, staff, and bill for care furnished at the ACS. The guidance also describes the ways in which state and local governments that want to develop or build a hospital ACS may be paid by CMS for furnishing covered hospital inpatient and outpatient services.
HHS announced that providers who have received Provider Relief Fund payments now have an additional 45 days (90 days total) to accept the Terms and Conditions and the payment or return the funds.
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.
The COVID-19 pandemic continues to evolve and bring about significant–and rapidly occurring–changes in care delivery. As a result, states are examining their Medicaid managed care incentive arrangements to evaluate the impact of COVID-19 on their health care quality and cost performance requirements. This expert perspective identifies actions federal and state policymakers have taken to address the impact of COVID-19 on their managed care performance incentive programs, and 2020 quality and total cost of care performance. The examples detailed in the expert perspective can be used to inform state decisions on whether and how to modify Medicaid managed care reporting and performance incentives as a result of COVID-19.
This analysis by Manatt Health summarizes key provisions from the “Health and Economic Recovery Omnibus Emergency Solutions” (HEROES) Act introduced by House Democrats on May 12. The fifth COVID-19 stimulus bill includes numerous provisions with a significant price tag (a Congressional Budget Office score is not yet available).
HHS announced nearly $4.9 billion in awards for over 13,000 skilled nursing facilities (SNFs) in a new targeted allocation of the $175 billion Provider Relief Fund, made available through the CARES and PPPHCE Acts. Skilled Nursing Facilities (SNFs) with six or more certified beds are eligible for payments and may use the payments for critical needs such as labor, scaling up testing capacity, acquiring personal protective equipment and a range of other expenses directly linked to the pandemic. Each SNF will receive a fixed distribution of $50,000, plus a distribution of $2,500 per bed. Recipients must attest that they will only use Provider Relief Fund payments for permissible purposes, as set forth in the Terms and Conditions, and agree to comply with future government audit and reporting requirements.
The Treasury issued additional guidance to Tribal governments regarding required information that must be submitted to inform the second payment of their Tribal allocations of the Coronavirus Relief Fund. While the first 60% of their $8 billion allocation was based on population size of eligible tribes, the remaining 40% will be based on Tribes’ submissions regarding the number of employees of the Tribal government or its subsidiaries; governmental expenditures; and the amount of federal financial assistance for FY2019. An electronic form will become available early the week of May 17.
The Treasury announced final award amounts from the $150 billion Coronavirus Relief Fund authorized by the CARES Act, that were available to states, tribal governments, and local governments with populations of 500,000 or more.
The FCC issued an updated notice of awards for the COVID-19 Telehealth Program, providing $16.9 million to 50 providers in this tranche. As of May 20, the FCC has awarded a total of $50 million to 132 health care providers in 33 states plus the District of Columbia.
Through May 16, the SBA has approved over $513 billion across 4.3 million PPP loans, inclusive of funding authorized through both the CARES and PPPHCEA Acts. As of this cut-off date, PPP has approximately $156 billion remaining until the funding authorized by the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) is exhausted.
SBA released the PPP Loan Forgiveness Application, along with detailed instructions, for small business borrowers seeking forgiveness at the conclusion of the eight week covered period that begins with the disbursement of their PPP loans. The form indicates that the SBA will allow payers to align their covered periods with regular payroll cycles and the flexibility to include payroll and non-payroll expenses paid or incurred during the eight-week period.
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
CDC issued a set of health considerations for states, tribes, localities, and territories as they begin phased re-openings of summer camps, schools, youth sports organizations, institutes of higher education, restaurants, and bars. Considerations are framed as strategies to assist leaders with promoting healthy behaviors, environments, and operations as well as mitigation strategies in the event of incident COVID-19 cases.
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.
HHS OIG issued updated FAQs regarding application of OIG’s administrative enforcement authorities to arrangements directly connected to COVID-19. OIG is accepting inquiries from the health care community regarding the application of OIG’s administrative enforcement authorities.Healthcare providers and personnel are encouraged to submit questions to OIGComplianceSuggestions@oig.hhs.gov.
CMCS issued an informational bulletin (CIB) to provide states with guidance about temporarily modifying provider payment methodologies and capitation rates under their Medicaid managed care contracts to address the impacts of the public health emergency. The guidance enumerates several options states could choose to adopt and details example state proposals in an appendix. States may effectuate these actions through managed care contract amendments, rate amendments, and state directed payment preprints and CMS noted it is continuing to prioritize and expedite reviews of these COVID-19 related managed care actions.
SBA released two interim final rules (IFRs) and an FAQ for the PPP with the following updates:
• SBA will allow lenders to increase existing PPP loans to certain classes of borrowers, specifically to partnerships and seasonal employers, to take into account new guidance on how these borrowers should calculate maximum loan amounts.
• SBA extended a “Safe Harbor” related deadline for borrowers that are repaying their PPP loans from May 14 to May 18.
SBA released two interim final rules (IFRs) and an FAQ for the PPP with the following updates:
• SBA will allow lenders to increase existing PPP loans to certain classes of borrowers, specifically to partnerships and seasonal employers, to take into account new guidance on how these borrowers should calculate maximum loan amounts.
• SBA extended a “Safe Harbor” related deadline for borrowers that are repaying their PPP loans from May 14 to May 18.
On May 13, HRSA awarded $15 million to 159 organizations across five health workforce programs to increase telehealth capabilities in response to the COVID-19 pandemic. The funding will go towards training students, physicians, nurses, physician assistants, allied health and other high-demand professionals in telehealth.
FCC issued an updated notice of awards for the COVID-19 Telehealth Program. As of May 13, FCC has awarded a total of $33.26 million to 82 health care providers in 30 states. The CARES Act appropriated $200 million for FCC to award to healthcare providers to purchase and adopt telecommunication technologies to support telehealth services for patients. FCC announces awards on a weekly basis.
A rececent piece in Kaiser Health News highlights the fact that providers who predominately serve Medicaid beneficiaries have received very little, if any, federal funding meant provide financial relief.
HUD announced allocations for $1 billion in funding to Community Development Block Grant (CDBG) grantees, including all states and insular areas. This allocation is the second CDBG allocation from the CARES Act, with $3 billion of the total $5 billion awarded to date, and was based on: public health needs, risk of transmission of coronavirus, number of coronavirus cases compared to the national average, economic and housing market disruptions, and other factors.
SAMHSA announced a $40 million funding opportunity to leverage CARES Act funding for COVID-19 Suicide Prevention Programs available to various entities including but not limited to state/territorial governments, social service providers, emergency departments, public health agencies, emergency departments, and tribal organizations. . SAMHSA anticipates making 50 awards up to $800,000 each. Applications are due May 22, 2020.
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.
ACF notified Community Services Block Grant (CSBG) stakeholders that the agency is preparing to release the $1 billion in funding provided by the CARES Act to states, territories and tribes. The Office of Community Services (OCS) provided projected award amounts and additional instructions. Final amounts, including allocations for tribes, will be provided in subsequent guidance.
SBA issued a revised “Paycheck Protection Program Frequently Asked Questions” (FAQ) that provides clarification regarding borrowers’ required certification on their application that economic uncertainty made the PPP loan request necessary to support ongoing operations.
CMS updated its Medicaid managed care “state directed payments” page on Medicaid.gov to include COVID-19 delivery system and provider payment initiatives and post 2 example 42 CFR 438.6(c) pre-prints. The update supplements a May 14 informational bulletin in which CMS described Medicaid managed care options to mitigate the impact of the COVID-19 pandemic on Medicaid providers.
FEMA released Coronavirus guidance on medical care costs eligible for FEMA public assistance. This guidance provides information on topics including: • Primary Medical Care Facilities• Temporary and Expanded Medical Facilities
This document outlines COVID-19 emergency declaration “blanket waivers” for healthcare providers and is regularly updated by CMS. The May 11 update includes several new flexibilities, including, for example:• Relaxed requirements for hospitals to offer “swing-bed” services to patients who qualify for SNF-level care, subject to certain restrictions;• Reduced training requirements for paid feeding assistants in LTC facilities; and,• Expanded the list of clinicians who may perform home health initial and comprehensive assessments (prior waiver added OTs, new waiver adds PTs and speech language pathologists).
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.
Tri-agency guidance extending COBRA, SEP, and other group plan timelines due to COVID-19
Analysis of CARES Act Provider Relief Fund distribution to hospitals, including the implications of distributing funds based on net patient revenue. The analysis found that the formula used to allocate the $50 billion in funding favored hospitals with the highest share of private insurance revenue as a percent of total net patient revenue.
The Federal Reserve announced that it is establishing a “Main Street Lending Program,” which will provide additional credit to small and medium-sized businesses to help maintain their operations and payroll during the COVID-19 pandemic. Main Street consists of three programs: 1) Main Street New Loan Facility, 2) Main Street Expanded Loan Facility and 3) Main Street Priority Loan Facility. All three facilities use the same eligible lender and borrower criteria, and have many of the same features, including the same maturity, interest rate, deferral of principal and interest for one year, and ability of the borrower to prepay without penalty. The loan types also differ in how they interact with the Eligible Borrower’s existing outstanding debt, including with respect to the level of pre-crisis indebtedness a borrower may have incurred.
This analysis provides updated overview of guidance from the Treasury Department about the $150 billion “Coronavirus Relief Fund,” which obligates the Secretary of the Treasury to make payments for COVID-19 response efforts to states, territories, tribal governments, and certain local government.
On April 22, the federal government published guidance and FAQs on permissible uses for the $150 billion CARES Act Coronavirus Relief Fund for states, local governments, and tribal entities.
The Treasury issued guidance on its methodology for allocating Coronavirus Relief Fund awards to Tribal governments. Treasury will distribute 60 percent of the $8 billion reserved for Tribal governments immediately, based on the population size of eligible Tribes. Treasury will distribute the remaining 40 percent based on data from Tribes and tribally-owned entities on employment levels and and increased expenditures due to the public health emergency.
Treasury issued a notice that the Alaska Native regional and village corporations are eligible to receive payments from the Coronavirus Relief Fund. In determining the appropriate allocation of payments to Tribal governments, Treasury intends to take steps to account for overlaps between Alaskan Native village membership and Alaska Native corporation shareholders or other beneficiaries.
Treasury issued a revised FAQ document with more guidance on parameters for use of the Coronavirus Relief Fund, including use of the funds for state unemployment insurance, workers’ compensation for essential workers, contact tracing, assistance with enrolling in government benefit programs, eviction prevention, and other expenses.
CDC published in the Federal Register a proposed data collection, “Emerging Infections Program (EIP) Tracking of SARS-CoV-2 Infections among Healthcare Personnel.This program would determine the extent of COVID among health care workers, describe the characteristics of health care workers infected with COVID and compare exposures and other characteristics of workers who do not become infected. Public comments will be accepted on or before July 14.
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.
Federal Emergency Management Agency (FEMA) issued guidance clarifying that its award recipients and subrecipients may generally repurpose funds under FEMA programs not originally for COVID-19 response for the purchase of medical equipment or other resources to support the COVID-19 response, with prior approval from the FEMA program office.
CMS issued a memo regarding new COVID-19 infection control and reporting rules for nursing homes in the recent interim final rule. The memo indicates CMS will be publicly posting facility-level data from the CDC National Healthcare Safety Network.
SBA issued a new interim final rule for the Paycheck Protection Program (PPP), confirming the applicability of non-discrimination standards for PPP loans and providing guidance on religious employer exemption and other PPP loan eligibility criteria
The Emergency Food and Shelter Program (EFSP) National Board announced the allocations of CARES Act ($200 million) and annual FY 2019 appropriations ($120 million) distributed to Local EFSP Boards throughout the country. Local Boards will begin accepting applications from local organizations that can provide emergency food and shelter services. Local Boards’ plans for the funding are due to the National Board by 5/29/20. Organizations seeking to apply should contact their jurisdiction’s Local Board for more details.
This updated document outlines COVID-19 emergency declaration 1135 “blanket waivers” for healthcare providers and is regularly updated by CMS. The April 30 updates add new telehealth-related flexibilities, relax physical environment requirements for providers, and make changes to a number of policies related to Community Mental Health Centers and long term care providers.
This list details recipients of SAMHSA’s COVID-19 funding to date. SAMHSA has awarded $374 million in grants and supplements to address mental health and substance use disorders, support Certified Community Behavioral Health Clinics, and supplement funding for tribal behavioral health services.
HUD announced allocations for $685 million in funding to public housing agencies (PHA) through the Public Housing Operating Fund and can be used for a wide range of preparation, prevention and response actions.
The Office of Minority Health (OMH) and Office of the Assistant Secretary for Health announced a $40 million funding opportunity for the development and coordination of a strategic network of national, state, territorial, tribal and local organizations to deliver important COVID-19-related information to racial and ethnic minority, rural and socially vulnerable communities hardest hit by the pandemic. Applications are due by Monday, May 11 at 6 pm ET.
The Federal Reserve issued FAQs on the Main Street Lending Program for small and medium-sized businesses during the COVID-19 pandemic. The FAQs outline loan eligibilitiy, application process, and terms. The Program has not yet launched.
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 Administration for Community Living (ACL) released an FAQ on $85 million distributed to Centers for Independent Living to address needs of individuals with disabilities and allow them to remain safely in their communities. The FAQ covers funding allocation methodologies, allowable uses of funding, and reporting requirements.
The White House issued guidelines for easing stay-at home restrictions for states and employers. State responsibilities included development and implementation of testing and contract tracing, healthcare system capacity support, and planning with various industries and public leaders.
HRSA opened its program portal and issued FAQs for providers to receive reimbursement for COVID-19 testing and treatment for uninsured patients. Providers must register with HRSA and may start submitting claims electronically on May 6th, with reimbursement beginning in mid-May. The reimbursement is supported through the $1 billion through the Families First Act and an additional yet-to-be-specified amount under the CARES Act Provider Relief Fund.
HRSA announced a funding opportunity for $15 million to tribal organizations. Applications are due May 6, 2020.
CMS provided additional information on the $100 million in CARES Act supplemental funding for survey and certification efforts of nursing homes, noting it intends to make $81 million of the $100 million available to states through September 30, 2023.
FCC approved its fourth set of COVID-19 Telehealth Program applications, distributing an additional $4.2 million. FCC has awarded $13.7 million to date under the program, which allows for up to $200 million in funding, and continues to approve applications on a rolling basis.
CMS approved parts of the state of Washington’s COVID-19 section 1115 waiver request that aligned with CMS’ COVID-19 Section 1115 demonstration opportunity guidance and checklist template. CMS is still reviewing several aspects of the request (e.g., the establishment of a disaster relief fund to pay providers for uncompensated care related to COVID-19) and denied its request to establish a temporary eligibility group for individuals with incomes at or below 200% of the FPL. In deferring approval, CMS noted that a number of Washington’s requests may be approvable under a Medicaid Disaster state plan amendment (SPA) or Appendix K for 1915(c) waivers. This is the first approval of 1115 waiver authority related to the COVID-19 response.
ACF announced intent to award $45 million to states, territories, and tribes to support the child welfare needs of families during the crisis and to help keep families together, as authorized by the CARES Act.
Manatt Health’s analysis of CMS’ guidance for states about new increased Medicaid and CHIP matching rate.
CMS issues guidance on flexibilities to allow certain freestanding emergency departments to participate in Medicare and Medicaid to increase hospital capacity.
New toolkit and resource guide to help state and local decision-makers address health care workforce challenges in their communities.
HRSA announced nearly $165 million in awards to rural communities, including to support 1,779 small rural hospitals, and 14 HRSA-funded Telehealth Resource Centers (TRCs) providing technical assistance on telehealth in rural and underserved areas.
Webinar recording and slide deck from webinar hosted on March 18, 2020.
ACL announced that it is awarding $905 million in CARES Act funding for older adults and people with disabilities.
In response to the COVID-19 pandemic, the federal government is moving rapidly to help states and health care providers respond to mounting needs for new sources of funding and flexibility. Congress has passed three COVID-19 stimulus bills, and the U.S. Department of Health and Human Services has issued guidance outlining new flexibilities available to states and providers, and is working to approve additional requests from states, to award funds appropriated by Congress, and to issue more guidance about such funding. This Q&A provides a moment-in-time update in response to questions SHVS has received about the federal government’s response.
SAMHSA released a list of Certified Community Behavioral Health Clinic (CCBHC) awardees for grants to increase access to and improve the quality of community mental health and substance use disorder (SUD) treatment. Funding includes $200 million in annually appropriated funding and $250 million in emergency COVID-19 funding.
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.
DHS and FEMA announced an additional $100 million in supplemental Emergency Management Performance Grant Program funds; application submissions are required by April 28.
ACL announced $955 million in CARES Act grants for support of older adults and people with disabilities. These grants will fund services such as home-delivered meals, care services in the home, and respite care; the majority of these funds are being awarded to states, territories, and tribes for subsequent allocation to local service providers.
ACF announced distribution of $3.5 billion in additional Child Care Development and Block Grant funds to support families, health care workers, other first responders, and child care providers during the public health crisis.
CMS issued recommendations for healthcare facilities in areas that have low or stable incidence of COVID-19 to begin to restart care that has been postponed in response to the COVID-19 outbreak.
CCIIO issued an FAQ for commercial health insurance issuers on flexibilities related to utilization management and prior authorization.
Guidance from CMS increasing nursing home transparency related to COVID-19, including through reporting cases to the CDC, and notifying residents and families of confirmed cases.
SBA issued an interim final rule on the Paycheck Protection Program, to provide economic relief to small businesses-including small healthcare providers and community-based organizations adversely impacted by the COVID-19 public health emergency. Public comment is open through May 15, 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.
Section 3221 of the CARES Act changes federal law regarding the confidentiality of substance use disorder (SUD) records, including surrounding sharing of written consent with HIPAA covered entities.
Webinar slides and recording that explores the key health care provisions in the second COVID-19 stimulus bill.
ACL recently opened a competitive funding opportunity for states with Aging and Disability Resource Centers (ADRCs) to support immediate response to urgent needs resulting from COVID-19. $50 million available through this opportunitity and applications are due by April 27.
CMS’ website is now updated with a list of submitted and approved Medicaid Disaster State Plan Amendments (SPAs)
HRSA announces $1.3 billion in awards to 1,387 health centers across the United States with funding provided by the Coronavirus Aid, Relief and Economic Security (CARES) Act. This interactive map provides a summary of the CARES Act funding awarded to health centers in each state and US territory.
Federal Guidance on the Families First and CARES Act Legislation
A state-by-state breakdown of how the first $30 billion of the CARES Act funding will be distributed to US states and territories
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.
State-by-state tracker of 1135 waiver requests and approvals.
CMS announced it is granting exceptions from reporting requirements and extensions for clinicians and providers participating in Medicare quality reporting programs.
Summary of changes to the the Physician Self-Referral Law, also known as the Stark Law, in light of COVID-19 emergency
This analysis describes flexibilities given to providers under Section 1135 waivers, such as enabling providers to deliver care in alternate care settings and expand workforce capacity.
This page includes guidance and templates for the Medicaid State Plan Disaster Relief SPA and CHIP Disaster Relief SPA.
This page includes federal background information on Section 1135 waivers and a CMS-developed template for states and territories.
Arizona was the first state to have its Disaster SPA approved by CMS on 4/1/2020. The SPA includes several provisions including waiving copays, premiums and deductibles for all members and provision of continuous eligibility for children under the age of 19.
CMS issued a revised FAQ for state Medicaid and CHIP agencies, initially issued on March 12. The May 5-issued FAQ provides additional guidance on available waiver and state plan amendment authorities during the COVID-19 public health emergency, the Basic Health Plan program, presumptive eligibility categories for Medicaid plans, member enrollment flexibilities during the public health emergency, terms for states receiving the previously announced 6.2 percentage point FMAP increase, and other topics.
CMS released an interim final rule with comment period that proposes several changes to the Medicaid and Medicare programs. For the Medicaid program, the rule amends health home regulations by allowing other licensed practitioners to order home health services, without physician sign-off.
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.
Information on federal tax provisions, guidance, and operational changes responding to COVID-19.
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
CCIIO FAQs on telehealth coverage
CCIIO guidance on Rx coverage and COVID-19.
CCIIO guidance on grace periods.
Compilation of COVID-19 FAQs on private insurance issues.
CMS expands Accelerated and Advance Payments to all Medicare FFS providers and suppliers.
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 broad-sweeping guidance outlines a host of blanket waivers and flexibilities that the Administration is affording to health care providers.
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
The governor of theis state sent a letter to HHS and CMS requesting a SEP to allow for uninsured and underinsured residents to enroll in health coverage through healthcare.gov.
The governor of theis state sent a letter to HHS and CMS requesting a SEP to allow for uninsured and underinsured residents to enroll in health coverage through healthcare.gov.
Reinforces plans’ obligations under existing state authority to cover all medically necessary treatment, including for COVID-19, without prior authorization.
Second COVID-19 response / stimulus bill.
A new infographic detailing the U.S. Department of Health and Human Services (HHS) agencies allotted funds in the first COVID-19 bill, Preparedness and Response Supplemental Appropriations Act, 2020—including the Public Health and Social Services Emergency Fund, the National Institutes of Health (NIH) , the Health Resources and Services Administration (HRSA) and the Centers for Disease Control (CDC)—as well as the amounts of the funding, the uses and the recipients.
Summary of Key Healthcare Provisions in the Second COVID-19 Stimulus Bill.
This page catalogs CMS’s approved COVID-19 State Section 1135 waivers.
This page includes 1915(c) Waiver Appendix K templates, instructions, and CMS ‘s approved COVID-19 State Appendix K documents.
This page includes guidance and a template for COVID-19 1115 waiver demonstrations.