A summary of presentations from the weekly Summit partner webinars
December 15, 2022 – The latest Summit Summary
- Flu Surveillance Update – Alicia Budd (CDC)
- IRA Part D Vaccine Provision Update – Stephanie Hammonds (Centers for Medicare and Medicaid Services) and Tram Dao (Centers for Medicare and Medicaid Services)
- Announcements
Flu Surveillance Update – Alicia Budd (CDC)
Alicia Budd, MPH, Influenza Division, CDC, gave an update on flu surveillance for week 48 ending December 3, 2022.
Virologic Surveillance – Percent Positive for Influenza
- The last few weeks the percent positivity has remained stable, nationally
- We are seeing some declines in activity in some regions
- Lab-confirmed flu activity is still elevated across the country
- In regions where there is a slight decline, there are still high levels of activity
- Thanksgiving week may have caused an artificial elevation
- Data is challenging to interpret around holidays
- More sick visits than healthy check-ups
- Too early to know for sure if turning corner
Virologic Surveillance – Virus Characteristics
- Seeing almost exclusively influenza A
- Influenza A H3N2 is about 80%
- Influenza A H1N1 is 20%
- Influenza B Victoria very low
- Circulating strains of the virus are antigenically similar to the vaccine strain
- Of the viruses tested, none of them have markers of antiviral resistance
Outpatient Respiratory Illness
- This season has started early
- There has been a slight downturn and leveling off, but this may have to do with the holiday
- There has been a slight decline in respiratory illness among the pediatric and young adult groups
- Steady increase, but at a lower level for adults
- Respiratory illness is very high in almost all of the country
Long-term Care Facilities (LTCF) and Hospitals
- The percent of LTCFs with at least one flu positive resident is increasing
- There is a sharp increase in positive admissions and hospitalizations across the country
- FluSurv-NET shows population-based rates of flu admissions – the surveillance network includes about 9% of the U.S. population
- Activity is much higher than we see typically at week 48
Mortality
- The number of influenza deaths from pneumonia, flu, or COVID-19 are increasing
- Never made it below the epidemic threshold since the pandemic started
- Influenza-coded deaths are increasing
- Influenza deaths are about equal to the highest flu week since COVID-19 started
- There are now 21 pediatric deaths
- All subtyped are influenza A (H3)
- Of the pediatric deaths reported, 80% were not vaccinated, which is what is typically seen
Preliminary In-season Burden Estimates 2022–23
- So far there have been at least 13 million illnesses
- 1 million medical visits
- 120,000 hospitalizations
- 7,300 deaths
There are still elevated levels for this time of year, however, it’s still too early to tell what that will mean. There is still elevated but decreasing levels of RSV and rhinovirus. COVID-19 may be increasing in some parts of the country. There are a whole lot of respiratory viruses out there, however there is a flu vaccine available and there’s still time to get vaccinated. Continue to remind people of that.
Questions
Q: Do you know if the vaccine is a good match to the circulating strains at this time?
Alicia Budd: We don’t have vaccine effectiveness estimates yet. That information is still being gathered. Looking at the viruses, structurally and genetically, things are looking good. We are seeing the similarities genetically and antigenically between circulating strains to the vaccine strains.
Q: Are adult vaccination rates similar to previous years?
Alicia Budd: Generally speaking, vaccination is lower than we want it to be given the amount of activity we are seeing. For pregnant people, we are concerned because there is a significant drop in flu vaccine coverage. Coverage rates are 20% lower than last season but there’s more flu activity out there, which is particularly dangerous for pregnant people.
IRA Part D Vaccine Provision Update – Stephanie Hammonds (Centers for Medicare and Medicaid Services) and Tram Dao (Centers for Medicare and Medicaid Services)
Stephanie Hammonds, PharmD, Centers for Medicare and Medicaid Services, and Tram Dao, PharmD, MS, Centers for Medicare and Medicaid Services, gave an update on the changes in Part D Vaccine Provisions as contained in the Inflation Reduction Act (IRA)
Medicare Part D traditionally (before January 1, 2023)
- Covers most vaccines except for COVID-19, flu, pneumococcal, hepatitis in some scenarios, and other vaccines when they are administered to protect from a recent exposure, for example, a tetanus or rabies vaccine (those would be covered by Part B)
- Planned sponsors have been required since the beginning of the program to put all commercially available vaccines on their formularies.
- These vaccines could be placed in any tier and with any cost sharing so far as such placement and cost sharing was consistent with the annual Part D benefit parameter threshold values, as well as the annual formulary review and approval process under 42 CFR, 423, 120 B.
Inflation Reduction Act (IRA public law 117-69) (enacted August 16, 2022; goes into effect on January 1, 2023)
- Section 11 401 of the IRA made changes to Medicare Part D Coverage of Vaccines
- Amended 1860D-2 of the Social Security Act by:
- Adding B8 – the term “adult vaccine” recommended by ACIP means a covered drug as it’s defined at 42 CFR 423 100, is a vaccine licensed by the FDA under section 351 of the Public Health Service Act (PHSA) for use by adult populations and administered in accordance with the recommendations of the ACIP.
- Adding C5 – other conforming amendments to require effective for plan years beginning on or after January 1, 2023, the deductible shall not apply to vaccines and there is no cost sharing for an adult vaccine recommended by the ACIP
- Amended 1860D-2 of the Social Security Act by:
Contract Year 2023 Program Guidance Related to Inflation, reduction Act Changes to Part D Coverage of Vaccines and Insulin
September 26, 2022, there was a program guidance issued to assist with Part D plans and their implementation of section 11 401 via a health plan management system or HPMS memorandum titled “Contract Year 2023 Program Guidance Related to Inflation, reduction Act Changes to Part D Coverage of Vaccines and Insulin,” that updates guidance for contract years 2024 and beyond to be put out at a later date.
- CMS interpreted adult vaccine and vaccine for use by adult populations solely for the purpose of section 1860 2B 8 of the act to refer to those vaccines licensed by the FDA, and recommended by ACIP for use in adults as described by the CDC and ACIP in the adult immunization schedule, or other applicable ACIP recommendations
- Interpreted the term recommended to mean all categories of ACIP recommendations, including those that are specified as based on shared clinical decision making
- Noted that ACIP vaccine recommendations and guidelines also provide recommendations for use in limited populations and circumstances for certain other vaccines that are not in the CDC or ACIP adult immunization schedule for routine immunization
- Interpreted the requirements of section 1860 D to B 8 of the act to apply to vaccines provided in such limited populations and circumstances, if and when they’re used for adults in accordance with ACIP recommendations.
- Clarified Part D vaccines are not subject to the new requirements of the act if:
- Not recommended by ACIP for use in adults
- Administered to an individual who is not an adult
- Section 1862 B8 of the act advised party sponsors that the cost sharing for such vaccines should be administered as it was reflected in the party sponsors approved 2023 bid
- Provided that new party vaccines that become available during the plan here, and have an ACIP recommended use in the adult population are subject to the new requirements, regardless of whether a Part D sponsor adds those vaccines to the formula in mid-year or obtains them by a formulary exception
- If a new vaccine recommendation for use in adults during the plan year, it’s required that Part D sponsors must apply the cost sharing requirements to any applicable vaccine claims with the dates of service after the issuance of such recommendation
Questions
Q: Transact RX has been one mechanism for medical providers to bill Part D vaccines. Is this still a viable option for medical providers to be able to bill Part D vaccines?
Stephanie Hammonds: Yes, the provider billing mechanisms are still in place. The new requirements under section 11 401 of the IRA are largely on the party planned sponsors so it’s largely up to the party plan sponsors to make sure that however they’re interfacing with providers, be they pharmacy or providers in office, that they are implementing those provisions accordingly.
Q: If a travel vaccine is not included on the adult immunization schedule but is recommended in certain situations for an adult, is that also included?
Stephanie Hammonds: Travel vaccines that are recommended by CDC are covered under the IRA.
Q: Are shared clinical decision making vaccines also covered?
Stephanie Hammonds: Yes.
Q: Does this mean that Part D now covers flu and COVID-19 vaccine administration?
Tram Dao: The IRA provision doesn’t change flu or COVID-19 vaccines. They are covered under Part B.
Q: Are there things about the implementation of this new Medicare change that people are getting the most confused about, or that you’re the most concerned needs to be especially highlighted for clinicians to get this right as soon as possible?
Tram Dao: As far as the beneficiaries are concerned, I don’t think there will be much confusion. There may be some confusion on the Part D sponsor part. We are continuing to have meetings to communicate with them and provide guidance because there are some pediatric vaccines like the pentavalent polio vaccines that are going to be eligible for this $0 cost share. That’s because the CDC believes that these vaccines may be administered and are recommended in adults that are undergoing hemopoietic STEM cell transplants. So, there are certain situations, and we want all our beneficiaries to be covered and have the medication that they need. So that’s why we’re including some of the pediatric vaccines. All the adult scheduled vaccines are going to be included in the zero-cost share provision as well as travel vaccines.
Q: Do any partners on the call have recommended resources that would document the changes that happened to party coverage, so a summary of what was just presented by Stephanie and Tram?
Stephanie Hammonds: The September 26 HPMS memo:
Q: What are the implications for the overall cost of Part D for the public?
Stephanie Hammonds: They have always been able to share zero-cost sharing if they wanted to. I don’t have data now to know how many did and how many did not, but they have always had the option. No, that it’s going to be required, vaccines on whatever tier can be at whatever cost sharing they want if it’s not discriminatory. The vaccines are going to be $0 so we think that represents a very big step forward and hope that it provides a food incentive for folks to get their vaccines.
Q: What proportion of adults age 65+ are enrolled in Part D and what proportion may not have access to Part D vaccines?
Stephanie Hammonds: I know it’s something in the ballpark of 47 million enrolled.
Announcements
- We are trying to settle on dates for the Summit in person meeting in May in Atlanta. We have decided to settle on the dates for the meeting on May 9–11 and not May 16–18, which were the original dates.
- The Summit released Get Adults’ Vaccinations Back on Track, a 2-page clinician tip sheet on new CDC recommendations and tools to help adults catch up on needed vaccinations. NAIIS is a large coalition of public and private organizations dedicated to increasing immunization rates, co-led by Immunize.org, CDC, and the Health and Human Services Office of Infectious Disease and HIV/AIDS Policy.
- If you are not getting the emails from Mailchimp, please add “NAIIS” at info@izsummitpartners.org to your contact list. Also, make sure that our email address isn’t blocked or going to spam/junk. The last thing you may need to do is reach out to your organization’s IT department to determine if there is an internal firewall that might be blocking our Mailchimp emails.
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