Q: How can I use Expanding COVID-19 Vaccination (ECV) and Bridge funds to cover the COVID-19 vaccine that my health center previously purchased or to pre-order the forthcoming COVID-19 vaccine?

A: You may use ECV funds to pre-order planned, but currently unavailable, COVID-19 vaccine to ensure you have an adequate supply of the newest vaccine compilation in the fall. This includes past pre-order costs that have not and will not be reimbursed by other sources. Consult with your Grants Management Specialist if this is a change of more than 25% of your current approved budget. If ECV-purchased vaccines are administered to individuals with payer sources (e.g., Medicaid, Medicare, private insurance), you must seek reimbursement and adjust your financial records accordingly. Reimbursed funds are considered Program Income and must be used in accordance with 45 CFR Part 75.307. HRSA anticipates that you may use the upcoming Bridge funding to pre-order the newest vaccine compilation. However, HRSA also expects there will be requirements on Bridge funding awards for making and documenting reasonable efforts to obtain such vaccines for free. More information will be available when Bridge funding is awarded.

With the end of the COVID-19 Vaccine Program, questions remain about where health centers can order COVID-19 vaccines. Utilize the Immunization Program Directory to contact your immunization program manager to order vaccines after August 23. Once available, vaccines for adults can be ordered through the CDC Bridge Access Program for COVID-19 Vaccines, Expanding COVID-19 Vaccination (ECV) funds may be used to purchase COVID-19 vaccines. If ECV-purchased vaccines are administered to individuals with payer sources (e.g., Medicaid, Medicare, private insurance), you must seek reimbursement and adjust your financial records accordingly. The Pennsylvania Department of Health has approximately 7,000 free POC COVID-19 tests expiring on September 27 and October 29.

Using data from the Centers for Medicare & Medicaid Services (CMS) researchers report on the challenges faced by CMS-designated Critical Access Hospitals during the federal Public Health Emergency, and the impact of special funding on their financial performance. The report is the work of the Flex Monitoring Team, a consortium of researchers from the Universities of Minnesota, North Carolina-Chapel Hill, and Southern Maine, funded by the Federal Office of Rural Health Policy to evaluate the impact of the Medicare Rural Hospital Flexibility Grant Program (the Flex Program).

From Becker’s

The federal government is formally withdrawing the COVID-19 vaccine mandate for employees of CMS-certified healthcare facilities that was enacted in November 2021 and moving to treat the virus, from an oversight standpoint, more like the flu.

The Biden administration announced on May 1 that HHS would begin the process to end the COVID-19 vaccine requirement for employees of CMS-certified healthcare facilities. Requirements under the Omnibus COVID-19 Health Care Staff Vaccination rule were no longer enforced at the end of the day May 11, 2023, the same day the COVID-19 PHE ended, a CMS spokesperson told Becker’s.

While CMS might be done enforcing the rule, it still needs to come off the books. To do so, CMS has issued an 82-page final rule formalizing the end of the vaccination requirement. In the final rule set to be published in the Federal Register June 5, HHS and CMS withdraw the 2021 vaccination requirement, outline reasoning for its end, and note upcoming plans to regulate healthcare workers’ protections against COVID-19 as part of certain Medicare quality programs.

The final rule is set to take effect 60 days after the date it is published in the federal register. As scheduled, that would be Aug. 4. CMS told Becker’s it will not enforce the vaccination requirement before the effective date of the rule — it is no longer in effect as of May 11.

“As conditions and circumstances of the COVID-19 PHE have evolved, so too has CMS’ response. At this point in time, we believe that the risks targeted by the staff vaccination [interim final rule with comment] have been largely addressed, so we are now aligning our approach with those for other infectious diseases, specifically influenza,” the 82-page final rule states. “Accordingly, CMS intends to encourage ongoing COVID-19 vaccination through its quality reporting and value-based incentive programs in the near future.”

Hospitals’ COVID-19 vaccination rates will effectively go from being a condition of participation in Medicare to being part of a quality reporting process, which hospitals are familiar with.

“CMS has been pretty clear that it no longer needs the condition of participation mechanism to follow through on the vaccination process,” Mark Howell, director of policy and patient safety for the American Hospital Association, told Becker’s. “It feels comfortable with the outlook that the quality measures provide. The [public health emergency] is over and COVID-19 has moved from pandemic to endemic stage, but that doesn’t mean COVID is gone. It makes sense [CMS] would want some measurement there.”

Hospitals and health systems would learn of the vaccination-related measures under consideration for inclusion in CMS programs by Dec. 1, the deadline by which HHS is required to publicly release a list of measures on the table for adoption in certain Medicare programs.

CMS, in its Hospital Inpatient Prospective Payment System proposed rule for fiscal year 2024, had proposed adjusting the measure for COVID-19 vaccination among healthcare personnel to go from reporting on the primary vaccination series only to reporting on the cumulative number of healthcare personnel who are up to date with recommended COVID-19 vaccinations.

Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, said the association is prepared to give CMS feedback that recommends the shift from primary series to up-to-date vaccination reporting coincide with improvements to the recommended cadence of COVID-19 vaccinations. U.S. health officials proposed simplifications to COVID-19 vaccine protocol, making it more like the routine process for annual flu shots, earlier this year.

“There is a challenge with the measure right now in trying to figure out if someone is up to date in their vaccination,” Ms. Foster told Becker’s. “It is so haphazard. When we know everyone should have gotten their shot sometime between September and December, for instance, that will make it administratively much easier to know who has been vaccinated if they are up to date.”

In the new final rule from HHS and CMS, the agencies note that withdrawal of the vaccination rule does not prohibit healthcare organizations from instating their own COVID-19 vaccination requirements for staff, consistent with other federal, state and local laws. It is likely that hospitals and health systems are in internal conversations and decision-making about what changes, if any, to make to their own individual COVID-19 vaccination requirements in light of the federal-level change.

The final rule from HHS and CMS also requires long-term care facilities to educate and offer the COVID-19 vaccine to residents, resident representatives and staff, as well as perform the appropriate documentation for these activities, as terms of participation in Medicare and Medicaid.

The Food and Drug Administration (FDA) approved the oral antiviral Paxlovid for the treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19 on May 25. Paxlovid packaged under the emergency use authorization (EUA) will continue to be available to ensure access for adults and treatment of eligible children ages 12-18 who are not covered under new FDA approval. Because of the importance of reducing the risk of significant drug-drug interactions with Paxlovid, the approved label and authorized Fact Fact Sheet for Health Care Providers for the Paxlovid EUA come with a boxed warning with instructions for prescribers. Prescribers should review all patient medications prior to prescribing.

Researchers from the University of Minnesota Rural Health Research Center examine the differences in the distribution of federal funding between rural and urban counties in Minnesota and Illinois.

On May 11, 2023, the federal Public Health Emergency (PHE) for COVID-19 expired. Some Medicaid services, such as telehealth flexibilities, will not be affected and have been extended through December 31, 2024, as indicated in The Consolidated Appropriations Act of 2023.

There are certain Medicare and Medicaid waivers, broad flexibilities for health care providers, and coverage for COVID-19 testing that will be affected.

To better assist with the impact PHE unwinding will have on different areas of people’s health, the Centers for Medicare & Medicaid Services Office of Minority Health (CMS OMH) updated its Coverage to Care (C2C) resources to help the consumers you serve understand their health coverage.

Updated C2C Resources Available

Ahead of PHE Unwinding, these resources will help consumers prepare to transition forward and continue to feel confident in how they will receive coverage for COVID-19 testing and telehealth services.

The following resources are now available on the C2C website:

• C2C COVID Overview Factsheet Explains basics of health coverage for protecting you and your family, Medicare updates, Medicaid renewal (new!), and more.
• C2C Telehealth Patient Toolkit Serves as a guide to explain telehealth basics and help patients and their families properly navigate telehealth services.
• C2C Telehealth Provider Toolkit Provides informational tips to assist providers with implementing telehealth services to their patients.

Spread the Word: Renewing Medicaid/CHIP Coverage

Additionally, to ensure Medicaid and CHIP beneficiaries are up to date on the Medicaid continuous enrollment condition that expired on March 31^st, CMS has created many resources, including the Anticipated 2023 State Timelines for Initiating Unwinding-Related Renewals as of February 24, 2023 (PDF, 93 KB, 2 pp).

For the most updated information about Medicaid and CHIP renewal processes, we encourage all enrollment assisters and outreach workers to communicate with Medicaid and CHIP beneficiaries the following three important messages:

• Update your contact information – Make sure the state Medicaid agency or CHIP program has your current mailing address, phone number, email address, or other contact information so they can contact you about your Medicaid or CHIP renewal
• Check your mail – State Medicaid agencies or CHIP programs will mail you a letter about your Medicaid or CHIP coverage
• Complete your renewal form (if you get one) – Fill out the form and return it to the state Medicaid agency or CHIP program right away to help avoid a gap in your Medicaid or CHIP coverage

Make sure to review the updated communications toolkit, Medicaid and CHIP Continuous Enrollment Unwinding (PDF, 3.2 MB, 21 pp) and the Medicaid Unwinding Toolkit Supporting Materials (ZIP, 47 MB) to help inform people with Medicaid or CHIP about steps they should take to renew their coverage or find other health care options. *People who no longer qualify for Medicaid or CHIP are advised to visit Healthcare.gov to find out if they are eligible to enroll in a Marketplace plan.

Preparing for Medicaid Unwinding is important for all. To learn more about the Unwinding and Medicaid and CHIP Renewals, visit CMS OMH at https://www.cms.gov/about-cms/agency-information/omh/resource-center/moving-forward-after-covid-19-public-health-emergency..

 This Center for Medicaid & CHIP Services (CMCS) Informational Bulletin (CIB) lists the end dates of certain COVID-19-related Medicaid and CHIP coverage and enhanced federal funding if the COVID-19 Public Health Emergency (PHE) ends on May 11, 2023, as expected. As part of their response to the COVID-19 PHE, states adopted many temporary flexibilities to support providers and individuals enrolled in Medicaid and CHIP, such as coverage of COVID-19 testing, treatment, and vaccinations.  The bulletin provides key dates to assist states with returning to routine Medicaid and CHIP operations.  About a quarter of rural adults under age 65 are covered by Medicaid.

In response to the unprecedented nature of COVID-19, the federal government declared numerous types of emergencies, Congress enacted several pieces of legislation, and various executive actions were taken and waivers issued, which, collectively, established time-limited flexibilities and provisions designed to protect individuals and the health system during the pandemic. The effective end dates of many, though not all, of these flexibilities and provisions are tied to the public health emergency (PHE) declaration made pursuant to Section 319 of the Public Health Service Act, first declared in January of 2020.  Others are linked to the public health emergency declaration made under Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act; the declaration made under the Public Readiness and Emergency Preparedness (PREP) Act; and emergency and major disaster declarations made under the Stafford Act. In some cases, subsequent legislation has either delinked provisions from these declarations or otherwise changed their duration.

The Biden Administration recently announced that it will end the PHE on May 11, 2023 and FEMA has announced that the emergency incident period under the Stafford Act will also end on that date. Other related emergency declarations or provisions have already ended or are ending soon. The following table (Table 1) provides a timeline identifying key health-related flexibilities and provisions specified by these various measures, the specific measure that determines their end date, and their end date (an end date for the Section 564 declaration has not yet been announced).

In addition to the end of the flexibilities detailed in Table 1 below, there are also expectations that the federal supply of COVID-19 vaccines could be depleted or need to be replaced by an updated booster dose sometime this year and, similarly, the federal supply of COVID-19 treatments will also be depleted. At a result, COVID-19 vaccines and treatments are transitioning to the commercial market. Importantly, this change is not tied to the end of the public health emergency.

Click here to see the list of deadlines in the referenced table.