HHS Names 1st 10 Drugs Up for Negotiation Under Medicare

This Reform is Welcome – but Far from the Transformative Change Needed to Keep the Medicare Trust Fund Solvent

For the last 20 years, all Americans have been getting ripped off by pharmaceutical companies. The heist began when a prescription drug benefit was added for Medicare enrollees (Medicare Part D). Drug company lobbyists made sure Congress wrote the law to prohibit Medicare from negotiating drug prices.

As a result, Medicare is held hostage by drug companies and Medicare pays 300% more for prescription drugs than in Europe or Canada, and close to 10x higher than in developing nations. That means every American who gets a paycheck is paying way more than necessary for prescription drugs. We’re ALL being scammed (not just Medicare beneficiaries) because Medicare is financed with a (regressive) payroll tax.

The Inflation Reduction Act of 2022 finally included modest reform by allowing Medicare to begin negotiating the price of a handful (initially 10) of the thousands of drugs they cover in Medicare Part D.

No doubt you’ve heard politicians and even some stakeholders praise the legislation as historic and transformative when it comes to prescription drug price reform. It’s fair to say the Act is historic because Medicare is finally able to negotiate the price of a handful of drugs (for implementation in 2026).

But the bill IS NOT Transformative. While Medicare is now about to negotiate the prices – they’re limited to negotiating price of just 10 drugs starting this year for implementation in 2026. The next year (2027) they can negotiate the price of 15 more.

By contrast, the drug price reduction passed by the House of Representatives (H.R. 3, the Lower Drug Costs Now Act of 2019) would have allowed Medicare to negotiate the price of between 25-125 brand-name drugs without generic competitors in 2023 with the negotiated price available Medicare, Medicaid & private payers.

See: ‘Inflation Reduction Act of 2022’ Gets a C- for Cutting Prescription Drug Prices

The drug pricing reforms in the Inflation Reduction Act of 2022 are anemic. With a little more backbone, we could have had real price reform. As it is, it’s like bringing home a C- on your report card. Congress still gets credit for the class, but it’s nothing to brag about.

Today the US Department of Health & Human Services announced the first 10 drugs that they will negotiate with the manufacturers – with the new prices finally going into effect in 2026.

Factsheet: Medicare Drug Price Negotiation Program

Below is the list of 10 drugs covered under Medicare Part D selected for negotiation for initial price applicability year 2026, based on total gross covered prescription drug costs under Medicare Part D and other criteria as required by the law. For example, any drug that was approved by the FDA less than 7 years ago can’t be negotiated.

 

Drug                     Condition                                                       Part D Cost $               # of Part D Users

Eliquis                  Prevention &treatment of blood clots            $16,482,621,000                  3,706,000

Jardiance             Diabetes; Heart failure                                   $7,057,707,000                   1,573,000

Xarelto                 Prevention / treatment of blood clots             $6,031,393,000                   1,337,000

Januvia                Diabetes                                                         $4,087,081,000                     869,000

Farxiga                Diabetes; Heart failure                                    $3,268,329,000                     799,000

Entresto               Heart failure                                                    $2,884,877,000                     587,000

Enbrel                  Rheumatoid arthritis                                       $2,791,105,000                       48,000

Imbruvica            Blood cancers                                                 $2,663,560,000                        20,000

Stelara                Psoriasis; Ulcerative colitis                            $2,638,929,000                         22,000

Fiasp et.al.          Diabetes                                                         $2,576,586,000                       777,000

According to the HHS, the list of drugs above represents: “… the 10 drugs with the highest total Part D gross covered prescription drug costs after excluding from the ranked list of 50 negotiation eligible drugs any biologics that qualify for delayed selection as a result of there being a high likelihood that a biosimilar will enter the market within a specified time.”

Over the next 4 years, Medicare will negotiate prices for up to 60 drugs covered under Medicare Part D and Part B, and up to an additional 20 drugs every year after that.

I’m delighted that Medicare can finally actually negotiate the price of at least a few drugs, but quite honestly, I find it hard to be a cheerleader for such a tepid reform when transformative change is needed.

Member Profile: Diane Wasley

by Kelli Donley Williams / Diane Wasley

I had the chance to meet Diane several years ago. She reached out to Will before an annual conference to see if someone would be her “buddy.” She was studying public health at NAU and wanted to attend and learn, but she is autistic and knew she’d be overwhelmed in the crowd. Diane is shy, and at times struggles to make decisions. She is also very bright and passionate about public health. Walking through the conference with a friend would make the experience easier.

This was the beginning of our friendship. Since, Diane and I have attended a handful of conferences and other events together. My husband and I were in Flagstaff in May to watch Diane walk across the stage to receive her bachelor’s in public health. We screamed as loud as we could in the busy stadium to show our support, but our voices (and my tears) couldn’t capture the pride we felt for her.

Graduation was just one milestone Diane has maneuvered with sheer persistence. I asked her what brought her to public health.

“I have been in healthcare classes since high school,” she said. Diane started with classes at the East Valley Institute of Technology, initially thinking she wanted to be an allergist or dietitian. “I have sensory issues with smells and touch and bodily fluids. Mostly at EVIT I learned job skills and medical terminology. I really like medical terminology and am good at it.”

She later went on to volunteer in pediatrics and did an internship at a special needs school.

“Working at the hospital, I met the employees that did community programs. There were two staff who had years of experience in public health. They inspired me. When I found the public health program at NAU online, I was excited because transportation to school was a barrier. I really liked my public health classes, so I guess I finally found the right place with my health interest. I like the idea of education and preventing disease.”

Diane and her twin sister live independently in Phoenix, however, are not able to drive. Reliable transportation has been a concern. Finding an online program was key to her success.

“My associate and bachelor’s degrees took about 16 years, so graduation from NAU was a huge accomplishment for me. The problem now is, I don’t know what to do. I see many jobs online I’d like to do, but the problem is that they are all full time.”

Because of Diane’s support service schedule for her physical and behavioral health, she needs a part time public health position.

“I have anxiety because I really want to do a good job at my job and want to like my job,” she says. It takes patience to work with the special needs population. I need things repeated a lot. I need things written down. I like a quiet environment.  Structure is good. It is important to explain things.”

When I asked Diane what she’d like others working in public health to know about those with autism, she said, “Do not treat me differently. I am just like everyone else, but I learn and process information differently.  We need to find a way that works for everyone with a disability.”

Diane is currently interning for the Special Olympics. “My dream job is to educate the healthcare world about working with patients with disabilities. I would like sensory rooms in healthcare facilities. I designed one for my previous internship. I got my dream internship at Special Olympics Arizona and I continue to be involved with them, but their jobs are full time and require a driver’s license.”

Diane is a voice for those in her community, including adults who have other developmental disabilities. “To change the system there is a lot I would do. There should be supportive affordable housing options. There should be more reliable transportation options such as a reduced price for Uber. It would be easier to access needed support.”

I encourage Diane to stay positive. I know anyone who can be this tenacious to finish her degree and find a way into the field she loves will find a good job. In the meantime, she is teaching me how individuals with disabilities see the world in a different, beautiful, useful light.

Register & Nominate for Our Upcoming Annual AZPHA Awards Event!

Thursday, October 26, 2023

5:00pm – 8:30pm

Outdoor Courtyard at the Maricopa Medical Society
326 E Coronado Rd #101, Phoenix, AZ 85004

Tickets are only $60 and includes a full taco bar from Senor Taco with protein taco fillings plus beans, rice, guacamole, chips, tortillas & additional pre-rolled tacos.

Hosted Bar service by Top Shelf Bartenders includes wine, beer and soft drinks.

Register Today

_________________________

Please take a moment to nominate colleagues here by September 15!

Update on Excess Pandemic-Related Deaths in Arizona

Allan Williams, MPH, PhD

While the death toll from the Covid pandemic is usually measured by Covid deaths, these deaths do not reflect the full impact of the pandemic on mortality. A more complete measure of pandemic-related deaths includes all causes of excess mortality during the pandemic. AZ has had the unfortunate distinction of leading the nation in the percent of excess pandemic-related deaths during 2020 -2022 compared to pre-pandemic levels.

While most of the excess deaths are attributable to the largely preventable high rate of Covid deaths in Arizona, many other causes of death were also elevated during the pandemic. Indeed, the CDC estimates that since 2/1/2020, Arizona has experienced 3,020 excess heart disease deaths, 2,223 excess strokes, 3,307 hypertensive diseases, 3,569 excess cancer deaths, 5,174 excess Alzheimer and dementia deaths, and 1,531 excess diabetes deaths.

For all categories combined, Arizona experienced a 31.6% excess of all cause deaths during the pandemic, while the US experienced a 19.2% excess.

The CDC National Center for Health Statistics (NCHS) has provided frequent updates on the numbers and percent of weekly, monthly, and yearly excess deaths since the start of the pandemic. While 2020 and 2021 death counts are considered “final” and complete counts of deaths, 2022 data is several months away from final status and is still considered provisional although mostly complete.  2023 data is considered both provisional and incomplete due to the lag in completing a death certificate after death, submitting the data to NCHS, and data processing.

Consequently, data for recent weeks undercount observed deaths and would result in underestimates of excess deaths. To address this undercount, NCHS provides “weighted” estimates of deaths that occurred in 2022 and 2023. The weighting factor is applied to the death counts and is based on comparisons between provisional and final deaths during previous years by week, state, and for various lag times.

In the following charts, NCHS weighted estimates of observed death counts were utilized to determine the percent of excess deaths from all causes for both Arizona and the US.

This first chart shows the estimated percent of weekly excess deaths during the pandemic for every week between 02/01/20 and 07/15/23 for Arizona and the US. This chart shows that the peaks in excess death in Arizona were typically much higher than the US peaks.  It also shows that in both AZ and the US, excess deaths have declined dramatically several months into 2023, approaching pre-pandemic levels. NCHS also estimated that there were 40,712 excess deaths in AZ and 1,335,688 excess deaths in the US over that time period.

The second chart shows the overall percent of excess deaths during the pandemic by race and ethnicity. Except for the “Other” race category, the percent of excess deaths significantly exceeded the US percent of excess deaths.

For all categories combined, Arizona experienced a 31.6% excess of all cause deaths during the pandemic, while the US experienced a 19.2% excess.

Editorial Note by Will Humble: Arizona’s terrible (and lethal) performance during the pandemic was not bad luck. It was largely due to former governor Ducey and former ADHS director Christ’s unwillingness to implement well-established interventions to mitigate the spread of the virus. In the summer of 2020, it was the fact they had no enforced mitigation in bars, nightclubs and restaurants – leading to the lethal summer of 2020. The lethal January and February 2021 was also largely due to the lack of mitigation in those environments. The 3rd wave of excess deaths in late 2021 and early 2022 was largely due to the governor’s executive orders that thwarted efforts to improve community vaccination levels (e.g. their ‘vaccine passport executive order).

AzPHA Resolutions on Women’s Reproductive Rights Go Back to 1938

Many of AzPHA’s public health priorities are driven by Resolutions that are approved by our members.  AzPHA has dozens of Resolutions in place dating back to the 1930s. They are all available on our Wild Apricot site: https://azpha.wildapricot.org/sys/website/?pageId=1465233

Early resolutions focused on the importance of food safety regulations, tuberculosis control, family planning, and other contemporary public health issues. More recent Resolutions have focused on support for addressing the Opioid epidemic, certifying community health workers, and addressing electronic cigarettes.  Our Resolutions are important to us because they set our public health advocacy priorities.

AzPHA Resolutions stay in place until and unless the Members vote to remove or update a Resolution. There is a process for developing new Resolutions.  Resolutions are developed by AzPHA Members and are forwarded to the Board for review.  Members must approve all Resolutions.

AzPHA has a long history of promoting family planning, women’s reproductive rights and access to legal and safe abortion care, with AzPHA members having ratified 8 Resolutions over the years. Our Resolutions:

1938 Support for Local Birth Control Clinics

1938 Proper Medical Supervision in Birth Control Clinics

1971 Liberalization or Abolishment of Current Arizona Laws Concerning Abortion

1971 Family Planning Information & Services

1981 Opposition to Constitutional Amendments or Statutes that Prohibit Abortion

1981 Male Involvement in Family Planning

2018 Continuing Support of Title X: The Nation’s Family Planning Program

2018 Supporting Universal Access to Contraception

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Here’s a Full Compilation of AzPHA’s Resolutions Going Back to 1935:

1935 Request change in the recording of deaths Download

1935 Appreciation to Governor B. B. Moeur, designating him an honorary member of the Association Download

1935 Gratitude to the Surgeon General of the U.S. for sending representatives to the Association meeting Download

1935 Appointment of a special legislative committee to advise and consult with State Legislature on laws affecting public health affairs Download

*1938 Support for local Birth Control Clinics Download

*1938 Proper medical supervision in Birth Control Clinics (#6) Download

1947 Support of the Central Arizona Project Download

1951 Consideration of funds for Civil Defense Download

1951 Study of Public Health employee salaries with a view to periodic adjustment of basic salaries to fit rising cost of living Download

1953 Support of legislature to halt spread of T.B. Download

1953 Nurses’ section of AzPHA opposed to use of Jerome Hospital for State T.B. Hospital: supports construction of new hospital in more accessible areas Download

1953 Recommendation: All children in Az should be eligible for Crippled Children’s Care Download

1953 Availability of Public Health Nursing Service in every county Download

1957 Registration Act for Sanitarians Download

1957 Support of Az State Nurses Association on certification of school nurses Download

1957 Public Health agencies should urge their employees to take advantage of opportunities for Public Health Education and Provide educational leave for this purpose Download

1964 Recommend to President Lyndon Johnson that George Marx be appointed the Federal Water Pollution Advisory Control Board Download

1964 Solid Waste legislation Download

1965 Proposal: School Health Education Download

1967 Registration of Sanitarians Download

1967 Governor to designate the State Health Department as Health Planning Agency under P. L. 89-749 Download

1969 Preparation for Family Life within educational system Download

1969 Registration of Sanitarians Download

1969 Regulation and Licensing of labor Camps Download

*1971 Liberalization or abolishment of current Arizona Laws concerning abortion Download

1971 Preventative health Download

*1971 Family planning (birth control) information and services Download

1971 Legislated Health Practice Areas Download

1971Health Data Systems Download

1971 Relationship between Social Services and Economic Planning Download

1972 Fluoridation of water to optimal levels Download

1975 Establishment of Lloyd E. Burton Scholarship Download

1976 Vote No on Prop 300 – auto inspection Download

1976 Comprehensive health medical care through Medicaid Download

1976 Delegate authority for meat and milk control to Arizona State Department of Health Services Download

1977 Allocation of funds for immunization Download

1977 Family Life Education in schools Download

1977 Commends State Legislature for passage of H.B. 2047 – inspection of meat and dairy Download

1977 Commends Governor Raul Castro for support of Medicaid and expressing disappointment toward attitude of State Legislature Download

1977 Promote DEFEAT of the Hyde Anti-abortion Amendment and that Countries’ Boards of Supervisors provide funds for elective abortions Download

1978 Dispensing Drugs by nurses in rural areas Download

1978 Endorsement of E.R.A. Download

1980 Support for the wider role of the RN Practitioner Download

1980 Prioritized list of health concerns – Download

1980 Proposition 106 and Public Health Services passed unanimously Download

*1981 AzPHA supports the resolution of the Arizona Right to Choose, Inc., which unconditionally opposes Constitutional Amendments or Statutes to prohibit abortions Download

1981 Concerning Location of Services in an Indigent Health Care Program – passed Download

1981 Supporting development of an M.P.H. Degree in Arizona – passed Download

1981 Encouraging Legislature to Fund Comprehensive Disease Control Services – passed Download

1981 Concerning a state-funded office or rural health – passed Download

1981Encouraging Legislature to Fund Comprehensive Maternal and Child Health Services – passed Download

1981 Proposed resolution by APHA on “Male Involvement in Family Planning” – passed Download

1982 Endorsing the nomination of Alvin Robert Leonard, M.D., M.P.H. for the Sedgwick Memorial Medal Awarded by APHA – passed Download

1982 Request President to encourage FDA to enact regulations for labeling of sodium content of foods by 9/30/83; and petition AZ State Legislature to enact legislation requiring foods processed in AZ be labeled for sodium content Download

1983 Oppose the development and deployment of nuclear weapons Download

1983 Public access to data collected by AHCCCS program; foster public discussion of future of AHCCS; work toward expansion of the program Download

1983 AzPHA apply the AZ Sanitarians’ Registration Council for approval for valid continuing education credits for Sanitarians Download

1983 AzPHA actively support efforts to cause the AZ Legislature to appropriate funds to implementation of S.B. 1264. mandating perinatal services Download

1983 AzPHA seek legislative and regulatory support for development and implementation of a continuum of long term care services for the elderly and disabled, including home health care, and the utilization of the Title XIX funds in state of AZ Download

1983 AzPHA expresses to officials of Nogales, Sonora, its deepest concern effects of the flooding; and for the hospitality and friendship the officials and citizens of Nogales, Sonora have shown and pledge to promote to continue that same hospitality and friendship in AZ Download

1984 Increase drinking age to 21 Download

1984 call for action for ADHS director for smoking policy of ADHS Download

1985 AzPHA calls for major increases in funding for AIDS prevention and public education against discrimination Download

1985 Adoption of resolutions on smoke free hospitals Download

1986 Urge Hospitals and other health care providers to recruit Spanish-speaking professional staff, interpreters Download

1986 Reduce and/ or eliminate smoking from enclosed public places Download

1986 Requirement that all insurance carriers in AZ accept assignment of risks for voluntary and small non-profit health care programs Download

1986 Discourage the use and promotion of smoking products including smokeless tobacco Download

1987 Primary Health Care Download

1987 Student Loan Program Download

1987 AZ area Health Education centers Download

1987 Oppose proposed Title X regulations Download

1988 Oppose Registered Care Technologists, propose ways to alleviate the Nursing Shortage Download

1989 Impact of Webster Decision – reaffirms previous pro-choice stance Download

1989 Hazardous waste management Download

1989 Protecting Confidentiality of AIDS services Download

1989 Services to HIV infected individuals Download

1989 Supporting voluntary HIV testing Download

1989 Restricting mandatory HIV testing Download

1989 School Immunization Requirements Download

1989 AZ Pharmacists filling prescriptions written by foreign physicians – supports Download

1990 Health care for all Arizonans Download

1990 Basic Public Health Services Download

1992 Early Periodic Screening, Diagnostic and treatment programsDownload

1993 smoke free campus Download

1993 tobacco vending machines Download

1993 tobacco retail licensing Download

1993 Tobacco Excise tax Download

1994 Repeal of S.B. 1053 Download

1994 Public Health in Health Care Reform Download

1995 Support state resources for Arizona Health Education Center Download

1997 Support local, state, and national efforts to prevent, control and remedy environmental pollution Download

1998 Support activities as an organization, in coalitions or individuals to reduce incidence of domestic violence Download

1998 Prevent abuse of antibiotics Download

2000 Folic Acid Prevention and Neutral Tube defects Download

2000 Abolition of the Death Penalty Download

2000 Childhood Asthma Download

2000 First Oral Health Assessment Download

2000 Injury and violence prevention, and control programs in the state and local health departments Download

2003 Osteoporosis Prevention Download

2003 Perinatal mortality review Download

2003 Primary seat belt law Download

2005 Pharmacies and Pharmacists – Duty to Fill Prescriptions Download

2005 Adolescent Access to Comprehensive, Confidential Reproductive Health Care Download

2005 Hold AzPHA Meetings in Smokefree Cities Download

2005 Fairness in Domestic Partnerships for All Arizonans Download

2005 Protecting Environmental Quality and Health Download

2005 Support for Land Use and Transportation Policies to Promote Public Health Download

2005 Support the Tobacco Free Arizona Initiative Download

2005 Promoting Public Health and Education Goals through Coordinated School Health Programs Download

2006 Support Public Health infrastructure Download

2007 Health Care for Uninsured Download

2008 Comprehensive Approach to Health Disparities Elimination in Arizona Download

2009 Tax on Sugar Sweetened Beverages Download

2009 Breastfeeding Support at Worksites Download

2009 Actions to Reduce the Public Health Impacts of Climate Change Download

2013 AzPHA Recommends Adopting APHA Policy #201119: Increasing Efforts to Encourage Governmental Health Departments to Seek Accreditation Download

2013 Annual Influenza Vaccination Requirements for Health Workers Download

2015 Expanded Family and Medical Leave Download

2015 Supporting Regulation of Electronic Cigarettes Download

2016 Universal Access to Oral Healthcare for Pregnant Women in Arizona Download

2016 Reducing Non-Medically Indicated Elective Inductions of Labor Download

2016 Prevention and Intervention Strategies to Decrease Misuse of Prescription Pain Medication Download

2016 Support for Community Health Worker Leadership in Determining Workforce Standards for Training and Credentialing Download

2016 Regulating Commercially Legalized Marijuana as a Public Health Priority Download

2017 Restrict Tobacco Sales to Persons 21 and Over in Arizona Download

2017 Restrict Texting While Driving in Arizona Download

2017 Require 50 minutes of Unstructured Recess in Arizona Elementary Schools (K-5) Download

2018 Prevent Firearm Violence in Schools Download

*2018 Continuing Support of Title X – The Nation’s Family Planning Program Download

*2018 Supporting Universal Access to Contraception Download

2019 Updated the Firearm Violence in Schools Resolution to include community firearm violence prevention – Download.

2021 Elimination of the Use of Conversion Therapy Practices for LGBTQ Individuals

2021 End of Life Autonomy

2023 NEW: Structural Racism is a Public Health Crisis: Opportunities for Intervention

Arizona Supreme Court to Hear Abortion Care Case Appeal

The Arizona Supreme Court has agreed to hear and decide which of Arizona’s conflicting statutes about abortion care are the law of the land. Arizona has at least 2 competing statutes in the books. A law from 1864 and recoded in 1901 says that abortion care is illegal unless the procedure is needed to save the life of the mother.

ARS 13-3603. Definition; punishment A person who provides, supplies or administers to a pregnant woman, or procures such woman to take any medicine, drugs or substance, or uses or employs any instrument or other means whatever, with intent thereby to procure the miscarriage of such woman, unless it is necessary to save her life, shall be punished by imprisonment in the state prison for not less than two years nor more than five years.

A competing law from 2022, ARS 36-2322, states that abortion care is legal up to 15 weeks gestation, and beyond 15 weeks in a ‘medical emergency’.

ARS 36-2322 (B): B. Except in a medical emergency, a physician may not intentionally or knowingly perform, induce, or attempt to perform or induce an abortion if the probable gestational age of the unborn human being has been determined to be greater than fifteen weeks.

The state supreme court said last week they’ll hear the case (Planned Parenthood v Brnovich). The court didn’t release a date for oral arguments, so it’s impossible to predict when an eventual ruling might come out. If the court rules that the 1864/1901 law applies, legal abortions would effectively end in Arizona “unless it is necessary to save her life”.

When the US Supreme Court’s Dobbs ruling came out, former Republican Arizona Attorney General Mark Brnovich was able to convince a Pima County Superior Court judge to lift a 1973 injunction stopping implementation of Arizona’s territorial-era law outlawing abortion, and for a few months, abortions were illegal in Arizona beginning on September 24, 2022.

Planned Parenthood appealed that ruling, and in December 2022, a 3-judge panel of the Arizona Court of Appeals overturned the Pima County court ruling, saying that 2022 law limiting abortions to less than 15 weeks gestation and the 1864/1901 law could be “harmonized”… legalizing abortion care up to 15 weeks again…  which is where it stands today.

Expect a main component of the arguments to focus on the session law that accompanied the passage of 2022’ SB1161 (the 15-week law) which stated in the legislative intent section that: This act does not:

“…  Repeal, by implication or otherwise, section 13-3603 (the territorial era ban), Arizona Revised Statutes, or any other applicable state law regulating or restricting abortion.”

Expect the Alliance Defending Freedom (the group now representing Arizona’s 1964 law) to argue that the language above makes it clear the Legislature and Governor Ducey intended the 1864/1901 abortion to come back into effect if Roe were to be overturned, which of course it was.

Until the AZ Supreme Court makes its ruling, abortion care will likely remain legal up to 15 weeks gestation.

Planned Parenthood and other stakeholders have launched a plan to place an amendment in Arizona’s Constitution that would legalize abortion care up to the point of viability (about 24 weeks). See: Advocates to pass a ballot measure legalizing abortion in 2024.

That measure would require 383,923 valid signatures by July 2024 to make the ballot, will need to survive legal challenges to keep it off the ballot. If it survives that, voters will need to approve it by 50% plus one vote.

See: Reproductive-Rights-in-Arizona-1884-2022

Arizona Supreme Court to decide whether to reinstate 1864 abortion ban (azcentral.com)

Ray Stern Arizona Republic

CDC MMWR Explains their Recommendation that Kids <8mos Entering RSV Season Get the New RSV Monoclonal Antibody Injection

New MMWR: Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023 | MMWR

Respiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. In July 2023, the Food and Drug Administration approved nirsevimab, a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection among infants and young children.

On August 3, 2023, ACIP recommended nirsevimab for all infants aged <8 months who are born during or entering their first RSV season and for infants and children aged 8–19 months who are at increased risk for severe RSV disease and are entering their second RSV season.

On the basis of pre–COVID-19 pandemic patterns, nirsevimab could be administered in most of the US from October through the end of March. Nirsevimab can prevent severe RSV disease among infants and young children at increased risk for severe RSV disease.

The cost will be $495 for private health insurance. The government (VFC) price will be $395. CDC says the ROI pencils out at that price (e.g., preventing hospitalizations etc.).

WIC in Jeopardy in AZ as Counties Consider Dropping the Program: Finances Making Running WIC Untenable

Congress Needs to Pass the Pass the Healthy Meals, Healthy Kids Act (H.R.8450) Including Changes to TITLE III—Modernizing WIC

Child Nutrition Reauthorization (including reauthorizing the WIC program) comes up for renewal every five years, but Congress hasn’t reauthorized or updated the provisions and funding in the Act since 2010.

You heard that right. Congress hasn’t updated the statutes or funding in the WIC program since 2010 – thirteen years ago. The current law, the Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296), expired in 2015.

Child Nutrition Reauthorization Resources | National WIC Association

Ever since then Congress has just been kicking the can down the road and keeping the programs as-is through the annual appropriations process, via something called a continuing resolution – which allows them to continue to work.

However, this means we are 8 years overdue for changes that are needed to make federal child nutrition programs workable – especially WIC. The most urgent needs are to modernize and update WIC benefits and funding to account for increased costs due to inflation.

Text – H.R.8450 – 117th Congress (2021-2022): Healthy Meals, Healthy Kids Act | Congress.gov | Library of Congress

Federal reimbursement for WIC has gotten so bad that some county health departments are considering dropping their WIC programs. The word on the street is that nobody else will pick up the slack when a county quits because the business case is now upside down in WIC.

How Does WIC Work?

WIC is a federally funded program that supplies important nutritional services and support for eligible pregnant and postpartum individuals and their children until age 5. WIC uses nutritional education, breastfeeding support, nutrition help, and referrals to more services as mechanisms to improve the health of the low-income individuals it serves.

Family income needs to be below 185% of the federal poverty limit in order to qualify (slightly more generous than AZ’s Medicaid participation standard)

WIC money goes to states who further manage the overall program. ADHS mostly distributes the money to the county health departments and federally qualified health centers to implement WIC programming.

Arizona currently has 140 WIC clinics (run by 33 agencies) serving 165,422 individuals.

Funding for WIC flows through the US Department of Agriculture but Congress authorizes the amount.  Way back in 2010 congresses’ appropriations covered the costs associated with implementing WIC programs… but that’s no longer the case – mostly because the Act is now 13 years old.

Some states and local clinics may supplement this funding to improve access or more services. The State of Arizona does not, but a couple of counties do.

WIC Participation at a Glance

–          37% of AZ-born infants are on WIC,

–          87% of WIC participants are on AHCCCS (Medicaid),

–          52% of eligible Arizonans (mothers and children) participate in WIC,

–          $21,213 average family income,

–          $47.7M spent at AZ food retailers.

WIC is Becoming Unsustainable for Counties & FQHCs

WIC clinics (counties, FQHC’s, tribes) get their money based on a formula that includes caseload and food costs into consideration… but the funding formula hasn’t been updated in 13 years.

Staffing costs currently present the biggest challenge to local clinics, especially for clinics with large service areas. Insufficient pay and high workload lead to short staffing.

As a result, short-staffed clinics are unable to spend adequate time with each client or keep up with their caseload. When clinics fall short of their caseload, their funding drops for the next year, causing a cascade.

WIC has a Return on Investment of 3x

The United States has experienced inflation near 40% since 2010, when WIC funding was last adjusted and reauthorized. WIC benefits now have less buying power, lessening the incentive to take part in the program.

Studies suggest that every $1 spent on WIC results in up to a $3.13 reduction in spending for Medicaid programs. This is particularly pertinent given the large overlap between WIC and Medicaid recipients. Reductions in poor health outcomes because of nutrition aid programs such as WIC are also expected to save significant amounts in private healthcare as well.

AzPHA Recommendations

Congress needs to pass the Healthy Meals, Healthy Kids Act (H.R.8450) now. HR 8450 would save WIC by:

  • Updating funding formulas to actually cover staffing and administrative costs;
  • Modernizing WIC benefits to include online shopping (easier participation); and
  • Evaluating effectiveness of telehealth for WIC visits (makes participation easier).
Resources

Influenza Vaccine Makeup for this Fall

Each spring in the Northern Hemisphere scientists get together and examine global surveillance data (from both hemispheres) and decide what strains should be included in the upcoming flu season’s vaccine.

It’s important to get it right because how effective the vaccine ends up being depends on whether it correctly guesses what antigens to target. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met back in March to select the strains to focus on for the 2023-2024 U.S. influenza season.

The committee recommended that the vaccines for the U.S. 2023-2024 influenza season have the following antigens for the egg-based vaccines. The strain below in bold is the one that has been updated from last year’s shot:

  • A/Victoria/4897/2022 (H1N1)pdm09-like virus;
  • A/Darwin/9/2021 (H3N2)-like virus;
  • B/Austria/1359417/2021-like virus (B/Victoria lineage);
  • B/Phuket/3073/2013-like virus (B/Yamagata lineage). 

For trivalent influenza vaccines for use in the U.S. for the 2023-2024 influenza season, depending on the manufacturing method of the vaccine, the committee recommended A(H1N1)pdm09, A(H3N2) and B/Austria/1359417/2021-like virus (B/Victoria lineage).

How well flu vaccine works can depend in part on the match between the vaccine viruses and circulating viruses. Preliminary estimates show that last season, people who were vaccinated against flu were about 40% to 70% less likely to be hospitalized because of flu illness or related complications.