The evidence base for remote pulmonary rehabilitation (PR) has been explored in Canada (1), Australia (2) and other countries. The US has minimal experience in this emerging area of therapy excluding a few clinical trials (3) and isolated commercial models. This is at least in part due to lack of reimbursement, evidence-based guidelines and clinical experience. The COVID 19 pandemic has brought with it physical distancing, shelter in place and the increased risk of infection and sequelae for older people and those with chronic lung disease. This has led to a need and possibly an opportunity for PR programs to consider a remote approach while center-based PR programs are closed, are functioning at reduced capacity, and/or patients are uncomfortable returning to clinical and/or group settings.
Reimbursement for remote PR is not currently provided by Medicare, despite uncertainty regarding safe provision of center based PR during the pandemic. All major US pulmonary organizations have collaborated to request Medicare payment for remote PR. The author suggests that providers contact all other insurers to request authorization for payment of remote PR.
Remote PR should deliver the essential components of pulmonary rehabilitation, including exercise training, education, and behavior change. Remote PR can be one of home exercise under supervision, telerehabilitation, video rehabilitation, and home exercises with the aid of online tools and videos. An Australian study included a phone based intervention with motivational interviewing by trained clinicians (2). Presented below are general resources that focus on helping patients understand the necessary interface with the PR clinician and safety considerations.
Exercise assessment, recommendations and prescription including progression should be derived from evidence based guidelines such as those published by the ATS (4) or the American College of Sports Medicine (5), and adapted by the prescribing provider to be appropriate for the individual patient and for use in a remote setting. The following resources are a compilation of information from various guidelines and PR providers. Importantly, these considerations lack the evidence base of center-based PR and extensive experience in the US. Exercise prescription, in particular, must utilize a collaborative approach by the prescribing clinician, patient and (ideally) family and/or caregiver, and must include safe and appropriate approaches that consider:
An exercise assessment is needed for effective PR, yet is often not included in remote models. A center-based exercise test pre PR should be performed to assess exercise capacity and desaturation, and enable individualized exercise prescription. This may not be possible in all settings but should be included when local infection prevention guidelines permit, and prioritizing patients for walk tests that cannot safely start remote PR without it.
Successful remote PR must also include exercise progression and reassessment with an expectation that the exercise prescription will increase over time. These features of PR should be based on national guidelines such as ACSM, ATS or AACVPR.
It needs to be acknowledged that, for a substantial number of patients with chronic lung disease, remote rehabilitation will not be an appropriate mode of therapy. For those who are judged good candidates, effective remote rehabilitation can be accomplished only with close and continuing contact between the patient and the rehabilitation team. Technological aids such as videoconferencing and remote monitoring may be useful adjuncts.
Suggestions for Remote Pulmonary Rehabilitation
The options below are not an endorsement of a specific approach to remote PR. Any approach or information should only be used by patients with involvement and agreement of their provider. These considerations are not medical advice. The author, CTS, and UCSF make no warranty or representation that these considerations will ensure the health of patients or preclude the possibility of negative outcomes. This is not a comprehensive approach, and it does not contain all available information on the subject matter. This document was prepared based on available information existing at the time of publication and therefore may be superseded by later developments.
Below are general recommendations for exercise in chronic obstructive pulmonary disease (COPD) from the American College of Sports Medicine (ACSM). They require clinical assessment and insights regarding exercise prescription in lung disease from the prescribing clinician.
ACSM FITT Aerobic Recommendations for Those with COPD
ACSM: American College of Sports Medicine
FITT: Frequency, Intensity, Time, Type
ACSM FITT Resistive Exercise Recommendations for COPD and Asthma
Key: RM = repetition maximum, RPE = rating of perceived exertion
These considerations are for the general information of PR professionals and clinicians. Each rehabilitation program, its clinicians and patients must decide which practices if any to implement based on a collaborative approach involving the PR team, medical director and potential patients. Please refer to the ACSM Guidelines for Exercise Testing and Prescription, 10th edition, Wolters Kluwer Health (5) for full information.
Remote Pulmonary Rehabilitation
Information to be provided to patients
Thank you for considering remote pulmonary rehabilitation (PR). Below are a few considerations we would like you to know.
We will be evaluating you for exercise in your home using established questions and tools. We are eager to know what your goals are and what you would like to do differently or improve. Below is information about remote pulmonary rehabilitation and factors that will help it to be safe and effective.
Please let us know if you have questions. And most importantly, if any of the exercises create discomfort before, during or after the PR sessions or any exercise or activity, please let us know immediately. Any pain is a signal to stop doing what you are doing and rest. Muscle or joint pain can occur with exercise. Mild pain often responds to rest, ice (apply to area of soreness for 20 minutes to every 4 hours using an ice pack or frozen peas or corn wrapped in a towel or thick cloth), elevation and mild pain medicine such as acetaminophen (provided you are not allergic to the medication). Alert us for any pain you have. If you experience moderate to severe joint or muscle pain, contact your physician promptly or call your local emergency room. Chest pain requires prompt medical attention normally in an Emergency Room setting.
We will provide you with suggestions for exercise. We want and need your input regarding what you feel you can do fairly easily without discomfort, somewhat severe or severe breathlessness, or other abnormal symptoms. Below are examples of symptoms that should alert you to stop exercising and to get help.
When to Stop Exercise and Seek Help
Monitoring your oxygen saturation level, heart rate and shortness of breath at rest and during exercise is an important and required part of remote pulmonary rehabilitation.
Oxygen is an essential nutrient for muscle, brain, and heart function and for human life. We will need you to purchase and use a ‘finger oximeter’ to measure oxygen saturation at rest before and during exercise. https://www.thoracic.org/patients/patient-resources/resources/pulse-oximetry.pdf These are available at from many suppliers (e.g., Amazon and various local pharmacies).
Your doctor may prescribe oxygen and advise you what ‘flow rate’ or how many liters per minute of oxygen to use at rest and with exercise. We want you to check your oximeter reading (oxygen saturation) and heart rate at rest and during exercise daily. If your saturation level is below 88% (below 90% in people with pulmonary hypertension or pulmonary fibrosis), slow down and rest. Your goal is to keep your oximeter reading at or above this number. Ask your lung specialist or rehabilitation clinician what your goal is for oxygen saturation and heart rate at rest and during exercise. Let him/her know if you need assistance with monitoring oxygen saturation or heart rate.
Shortness of breath is common in persons with breathing disorders. Breathlessness can be frightening, especially if severe. We use the Borg scale to rate your breathlessness and fatigue on a scale of one to ten. Exercise in persons with breathing disorders results in some breathlessness. This breathlessness occurs normally with exercise at a moderate or greater level of work. Mild to moderate breathlessness is normal and usually safe during exercise. If your shortness of breath is greater than 5 or ‘strong’ on the Borg scale, slow down or rest. If you quickly return to your baseline, it’s usually OK to resume exercise at a slower pace. Your goal is 2-3 on the Borg scale or mild to moderate breathlessness with exercise unless your therapists recommend otherwise.
Positions to Relax when you have Shortness of Breath
Safe Exercise at Home
Think about what part of your home is the safest for exercise. This area should be free from electrical cords, long oxygen tubing, throw rugs or furniture that may increase your risk for tripping or falling. If your doctor has advised you to use a cane or walker, you will need to use it for any walking exercises. Think about walking where you can hold on to a countertop or stable, heavy piece of furniture if needed for balance. IF YOU HAVE DIFFICULTY WITH VISION, BALANCE, WEAKNESS, CHEST PAIN, DIZZINESS OR LEG CRAMPING, LET US KNOW RIGHT AWAY.
Ask your provider if you should measure your blood pressure at home before and after exercise. If recommended, ask your provider to let you know what blood pressure range is safe for you and what range you should stop exercising and get help. Have your provider observe you taking your blood pressure to ensure your measurements are accurate.
We ask that you use a stable surface such as a kitchen counter and/or a stable chair with arms and no wheels to hold on to during balance exercises.
Items that can be used for home exercise include your current equipment (discuss this with your rehab staff), and inexpensive additions including a rollator (see photo above), foot peddler (see photo above and Amazon) and elastic bands. If possible, let a family member or friend know when you start and stop exercising at home so that they can be available to help to you in case of problems.
Getting the Most Out of Remote Exercise
You will get more out of home rehabilitation if you keep track of your exercise type, time and/or distance, steps, and your oxygen saturation, heart rate and shortness of breath before and during exercise. Note any abnormal symptoms associated with exercise. Over the course of the program we will work with you to progress your exercise, by gradually increasing the amount you are able to do, while ensuring you remain comfortable. This progression is an important ingredient for the success of your program. We encourage you to invite or involve a family member or caregiver to join you and support your success together. Please discuss with your pulmonary rehabilitation providers any new exercise before your try it.
Daily Exercise Log
Resources for home exercise are important. A few are listed below. These are not for everyone but may offer options for you to get stronger and feel better. Discuss any option you wish to explore with your physician.
Living Well with COPD https://www.livingwellwithcopd.com/
Pulmonary Wellness Foundation https://pulmonarywellness.org/
Live Better from the American Thoracic Society: Pulmonary Rehabilitation Information, Resources and program directory from the American Thoracic Society http://www.livebetter.org/
British Thoracic Society resources
Stay Active and Stay Well from the British Lung Foundation
Resource Pack from the British Thoracic Society
AACVPR Remote PR video
Home Based Rehab: A resource for the development of home-based pulmonary rehabilitation programs from Australia: https://homebaserehab.net/
Better Living with Chronic Obstructive Pulmonary Disease—A Patient Guide: The State of Queensland (Queensland Health) and Australian Lung Foundation. 2008. http://www.lungfoundation.com.au/lung-information/patient-educational-material/better-living-with-copd-a-patient-guide
Telerehabilitation for people with chronic lung disease by Anne E Holland and Narelle S Cox. https://www.thoracic.org/members/assemblies/assemblies/pr/quarterly-bite/telerehabilitation-for-people-with-chronic-lung-disease.php
Blue Marble Health: A digital remote pulmonary rehab program connects clinicians with clients at home using a computer, smartphone, or iPad. This program incorporates recommendations from the AACVPR Guidelines for Pulmonary Rehabilitation Programs. Get started today www.bluemarblehealthco.com/pulmonary-rehab or contact firstname.lastname@example.org
The American Lung Association pilot Zoom-based Better Breathers group focuses on education and support related to lung health and disease. If you or a client would like to join a Zoom-based group that is based in the San Francisco Bay Area, you are welcome to join the group at 12 noon Pacific time on the first Tuesday of every month by internet or phone. Internet link is at https://ucsf.zoom.us/j/2858728213 ; phone number is 669-900-6833, meeting ID 285 872 8213. Please contact email@example.com for more information.
The author gratefully acknowledges Richard Casaburi PhD, MD, Anne Holland PhD, PT and Surya Bhatt MD for their expert review and recommendations.
Prepared by Chris Garvey NP, Anne Holland PT, PhD and Judy Corn, MSEd, ATS Staff. Nearly every aspect of life has changed dramatically in a matter of days. This new world order impacts providers, patients and our communities. Pulmonary rehabilitation (PR) is not immune to these changes. As Jean Bourbeau MD https://rimuhc.ca/-/jean-bourbeau-md-msc-frcp-c- has taught us, behavior change and self-management training should target a framework of adaptation, and adaptation is likely a key approach to PR during the COVID 19 pandemic.
We cannot endorse a specific approach to PR during the current challenges. Users are advised to inform patients that the resources below should only be used with involvement and agreement of their provider. To date, home PR alternatives have not had a robust body of evidence to suggest they are a substitute for center-based PR. A key concept is that, for the immediate future, PR is unlikely to be delivered with the patient and the provider face-to-face. The following approaches are offered as possible models to help patients initiate or continue rehabilitative programs in collaboration with a clinical team. This document is shared to help provide options in the current challenging circumstances and should not be considered an endorsement of any individual program model.
A number of remotely delivered PR models are available, with some published evidence of their efficacy. Remote PR should deliver the essential components of pulmonary rehabilitation, including exercise training, education, and behavior change.
1. Anne Holland PT, PhD and her group have developed a home-based rehabilitation model that is telephone based, using highly structured calls delivered by a health professional trained in Motivational Interviewing. The details are on the website https://homebaserehab.net/
2. The UCSF PR program has transitioned to a zoom https://zoom.us video-based exercise training model coordinated by Chris Garvey NP and Julia Rigler RRT. The approach targets stable patients who have been screened as clinically appropriate for this approach (e.g., those without cardiovascular contraindications, fall risk, cognitive impairment, etc. based on AACVPR PR Guidelines 5th edition). Below are strategies that may have a role for a PR program’s needs.
ACSM FITT Aerobic Recommendations for Those with COPD
ACSM: American College of Sports Medicine
FITT: Frequency, Intensity, Time, Type
ACSM FITT Resistive Exercise Recommendations for COPD and Asthma
Key: RM = repetition maximum, RPE = rating of perceived exertion
An inexpensive “resistive circuit” may be developed if space is available. An example of this type of resistive circuit training could include the following stations:
For frail or deconditioned patients, use knee extensions without weights.
*initial squats and sit to stand require supervision for proper form.
When to Stop Exercise and Seek Help
3. https://www.livingwellwithcopd.com/ is an online PR resource that provides helpful tools, handouts and materials found under the “Rehabilitation” tab.
The section on “PR Program” has been enriched with the contributors’ collective experience, with pre-existing resources, as well as consultation and feedback from the larger respiratory community. This PR Program includes web-based comprehensive resources with reference guides for all the elements of PR:
i) Pre-program evaluation & physician consultation
ii) Exercise program & prescription
iii) Self-management behavior modification intervention
iv) Post-program evaluation
v) Follow-up and keeping a healthy lifestyle in the long-term
The Livebetter PR Program supports healthcare professionals with i) prescription of exercises, ii) exercise tracking, iii) maintenance and iv) gradual return to exercise at home when patient have stopped exercise training, including acute exacerbations (see the tab “Rehabilitation - Exercise maintenance at home under Healthy Lifestyle, a Guide for the gradual return to exercise”). Thanks to Jean Bourbeau MD for providing this resource.
4. Livebetter.org is an online resource developed by the American Thoracic Society and the Gawlicki Family Foundation to increase public awareness of PR by informing and educating individuals with chronic lung disease about potential benefits of PR.
5. An Electronic Medical Record (EMR) Draft Note for video visit documentation below may be updated to potentially meet PR program needs. There are no current plans for reimbursement of home PR models in the US.
Video Visit for Home Exercise performed this visit using real-time Telehealth tools, including a live video connection between my location and the patient's location. Prior to initiating the session, I obtained informed verbal consent to perform this visit using Telehealth tools and answered all the questions about the Telehealth interaction.
Video visit via Zoom conducted from *** to ***
Medication changes? ***
Reviewed home exercise program with patient per individualized guidelines for aerobic and resistance exercises.
Home Exercise progress:
Aerobic home exercise program***
Resistance/strength home exercise program ***
During video visit we focused on ***. Pt able to do ***
6. The British Thoracic Society has a Resource Pack for Pulmonary Rehabilitation that can be found here (along with numerous excellent resources for pulmonary clinicians). https://www.brit-thoracic.org.uk/about-us/covid-19-information-for-the-respiratory-community/
Below is information from Centers for Medicare and Medicaid (CMS). There is no clear position on billing video visits for PR at this point.
The authors thank Richard Casaburi PhD MD, Linda Nici MD, Richard ZuWallack MD and Grace Anne Dorney Koppel MA, JD for their helpful insights.
This resource is dedicated to the memory of John Murray, MD, who improved the science and care of all with lung disease.
Originally published March 25, 2020, updated March 28, 2020.
We are asking all CSPR/AACVPR members to contact their own local Representative
To give Missy and Julie the best chance for success in Washington, DC, March 2 – 3, Day On The Hill (DOTH) 2020, we are asking all CSPR/AACVPR members to contact their own local Representative. (It's easy to lookup up your Representative with just your zip code.)
During the Day On The Hill (DOTH) 2019 AACVPR members found that all Representatives were very receptive to the Site of Service Bill but they really listened to their own state’s constituents.
The GOAL: Visit all 55 offices to ask for bill sign-on
There is true power in numbers! How amazing would it be for Missy and Julie to walk into those offices, and be able to say: “Hundreds of your constituents have sent letters to you about this bill.” With your help we can get H.R.4838 passed and behind us so AACVPR can move forward on the next Medicare need!
Once you are on your Representative’s web page, simply click on the email icon. You can copy and paste the following statement or feel free to formulate your own or use AACVPR's customizable letters.
“I am asking if you will support H.R.4838 SOS Site of Service Bill with your sign-on. This bill will remove a barrier that prevents many cardiac and pulmonary rehab programs from growing to provide access to more patients. On March 2 and 3, 2020, the cardiac and pulmonary rehab organization AACVPR is sending two individuals to Washington, DC, to speak on my behalf, Missy Von Luehrte (firstname.lastname@example.org) and Julie Rounds (email@example.com). They would like to meet with you or your healthcare advisor to discuss this important bill. Would you please consider scheduling a meeting?”
Please Continue to Lobby, Lobby, Lobby
Learn more about Day on the Hill (DOTH) and H.R.4838 - SOS: Sustaining Outpatient Services Act.
Additional LOBBYING IDEAS/TIPS:
We Appreciate Your Continued Support!
Grassroots - YOU ROCK!
AACVPR members are demonstrating an understanding of the importance of improving access for cardiac and pulmonary patients and the financial necessity to expand space and capacity without being forced to take a 40%+ cut in reimbursement.
To date, over 1,974 letters, tweets, and Facebook posts have been sent to US House of Representatives members, asking for support of H.R. 4838. Take Action! This request is coming from CR and PR practitioners, physician champions and medical directors, hospital administrations, and most importantly, patients who are grateful they received the benefits of cardiac or pulmonary rehabilitation and want others to have the same opportunity. Template letters that can be personalized are posted for each of these groups.
A companion bill will soon be introduced in the US Senate. You’ll then be asked to send a letter to each of your two US Senators, again utilizing an AACVPR template letter, personalizing it as you wish.
With enough support in Congress over the next 2-3 weeks, this bill could even conceivably be attached to a larger, year-end Medicare package. Every Congressional sponsor name on this bill is valuable.
Thank you for all you’re doing for your profession and for your patients.
AACVPR has made it easy to become an advocate for CR and PR services with pre-drafted, customizable letters to contact your U.S. House representative and advocate for bill HR 4838. Just 5 minutes and one letter could make a huge difference!
The CSPR leadership team mixed fun and business in Livermore during a recent weekend in November. Our retreat was complete with strategic planning, conference development, walks, brainstorming, bocci ball and team building. We want to welcome you to be part of our great leadership group. If interested reach out by email cspr@cspr. org.
I would like to share with you an important and vital story in CNN Health on how Ted Koppel and his wife have dedicated themselves to fighting COPD. We are all stakeholders in this puzzle of creating more awareness of COPD and Pulmonary Rehabilitation. The article and links provided within, provide a great launching pad in raising awareness and addressing key issues of this public health problem.
Watch the CBS news story by Ted Koppel "Clearing the Air - Living with COPD" which aired November 26, 2017. Here the couple advocates for more research into prevention and treatment, which lags far behind what is devoted to other diseases. You will be amazed!
Learn more about the key stumbling point in making pulmonary rehab available. Read Chris Garvey, NP, Phil Porte and Casburi Ph.D., MD blog post on the CSPR website. “Medicare only reimburses pulmonary rehab at 50% of the rate of cardiac rehab.”
CSPR is taking a grassroots effort in this national campaign and our ask of you is to come together with our similar goals and directions to position ourselves to improve the quality of delivering healthcare to this patient population.
Thank you for taking the time out of your busy schedule to read through this and sharing it with others. This is really a team effort from all of us - healthcare providers, patients, and the general public. As stated in the CBS news story by Dr. Gary Gibbons, (from NHLBI) in order for greater federal funding we need greater appropriation. "Lend your breath and voice that affects so many Americans".
Please lend your voice and tell your congressperson about this great healthcare need. I also encourage you to share your thoughts through our website and social media.
In great appreciation,
CSPR is proud to thank:
Missy Von Luehrthe (CSPR) and Lori Waddell, Julie Rounds (CSCR) for advocating for California!
Focus is on Advocacy: To request to Congress in 2019 is to seek support for legislation that would correct the unintended consequences of Section 603 of the Bipartisan Budget Act of 2015. This mandates payment reduction for hospital outpatient services that re-locate or open at an off-campus site. For cardiac and pulmonary rehabilitation services wanting to expand to improve patient access, this is a major barrier.
You can get involved too! AACVPR website has wonderful resources for Day on the Hill (DOTH) 2019 from Home and Advocacy Day on the Hill.
Pulmonary Rehabilitation Reimbursement Challenges and Strategies for Survival by Chris Garvey NP, Phil Porte and Richard Casaburi PhD, MD
The decline in PR reimbursement in the US is at least in part tied to a Medicare change in PR reimbursement in 2010, when a new ‘bundled’ payment code ‘G0424’ for COPD was introduced. This code pays for one hour of PR including all costs of staff, medical director, rehabilitation facilities, overhead, etc. Initially in 2010, Medicare arbitrarily established a payment rate of $50 for one unit of G0424. Medicare acknowledged in 2011 that “failure to carefully construct the charge for G0424 that reports a combination of services previously reported separately under-represents the cost of providing the service described by G0424 and can have significant adverse impact on future payments” [Federal Register 11/30/11].
Historically, PR had been paid for in 15 minute increments for most services. The majority of PR providers and hospitals have never adequately modified PR charges to reflect the increase in time and resources used for the ‘bundled’ G0424 billing code. The impact on reimbursement is due to Medicare’s use of PR charges (as well as information from the hospital cost report) to calculate annual changes in PR reimbursement. A recent review of charges for PR for COPD patients submitted to Medicare in 2015 from claims billed by 1350 US hospitals indicates that lower charges for the PR bundled code continue to persist. This practice has likely contributed to the reality that, as indicated below, cardiac rehabilitation reimbursement is now double that of PR.
CMS Final CY 2017 Outpatient Services Payment Rates:
HCPCS Code Short Descriptor APC Payment Rate
93798 Monitored cardiac rehabilitation 5771 $110.18
G0424 Pulmonary rehabilitation w/ exercise 5733 $54.53
It is possible that PR clinicians are not aware that the amount actually paid for services is often a small fraction of submitted charges. Below is an example of amount charged for services vs. what Medicare pays.
Summary for Medicare Outpatient Prospective Payment System Hospitals for 2015
Ambulatory Payment Classifications (APC) Average Estimated Submitted Charges Average Total Payments
0269 - Level I Echocardiogram Without Contrast $2,386.36 $409.22
0369 - Level II Pulmonary Function Test $1,354.23 $229.25
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Outpatient2015.html accessed 10/1/17
What can be done? Hospital administrators set charge rates for all their services, including PR services. These administrators need to be aware of the concerns regarding G0424 billing and the impact of undervalued charges on Medicare payment. A Pulmonary Rehabilitation Toolkit is available that details resources for PR billing at https://www.aacvpr.org/Advocacy/Pulmonary-Rehabilitation-Toolkit.
It is time for the pulmonary medicine and scientific community to bring these concerns to hospital administration. It is also time for practitioners and scientists to partner with PR clinicians and administrators to determine if charges for their PR program reasonably represent the complexity of the intervention, the acuity of the target population, and the value of this evidence based intervention.
Medscape News Troy Brown, RN 6/23/16
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) voted to recommend that live attenuated influenza vaccine (LAIV;FluMist Quadrivalent, MedImmune) should not be used in the United States for the 2016 to 2017 influenza season. LAIV is the only nasal spray influenza vaccine; the CDC recommends annual influenza vaccination for all persons aged 6 months and older and says people should use either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine instead.
ACIP is a committee of immunization experts that advises the CDC; this is an interim recommendation for the 2016 to 2017 influenza season, as data may be different in future seasons.
Case in point, the ACIP endorsed the quadrivalent nasal spray over influenza shots for children aged 2 to 8 years in 2014.
The vote (13 yes, 1 no, 1 abstain for conflict of interest) follows a review of new data that show LAIV has been ineffective for the last three influenza seasons (2013-2014 through 2015-2016) in children aged 2 to 17 years. The new data show that IIV is more effective than LAIV against influenza A(H1N1)pdm09, and there is uncertainty about whether or not LAIV quadrivalent (LAIV4) is effective against influenza A(H3N2) and influenza B viruses.
Preliminary data from the US Influenza Effectiveness Network showed that during the 2015 to 2016 season, LAIV vaccine effectiveness against any influenza virus among children aged 2 through 17 years was only 3% (95% confidence interval, −49% to 37%) compared with 63% (95% confidence interval, 52% - 72%) for IIV. LAIV vaccine effectiveness was also "poor and/or lower than expected," during the 2014 to 2015 and 2013 to 2014 seasons, according to a CDC news release.
There are fewer data in adults, but tests in active military personnel showed poor vaccine effectiveness for LAIV3/4 against A(H1N1)pdm09.
Data about the effectiveness of LAIV before and soon after licensure suggest it was at least as effective as IIV. The US Food and Drug Administration approved quadrivalent LAIV in February 2012. An earlier trivalent version of LAIV was approved in June 2003 and was later replaced by the quadrivalent formulation.
Tom R. Frieden, MD, MPH, director of the CDC, addressed the committee before the meeting; he acknowledged that yesterday's decision was a challenging one, but urged the committee not to postpone it. "In public health, we are often faced with a situation of having to take action based on what we know today, because if there is one thing we always have to keep in mind, [it is that] a nondecision is also a decision," he said.
The committee discussed potential programmatic implications of taking the LAIV off the table. There are a total of 171 to 176 million projected influenza vaccine doses; LAIV accounts for 8% (14 million projected doses) of the total projected influenza vaccine supply. Providers may have difficulty purchasing other vaccines, and not all vaccine products are licensed for all age groups.
Some 5% of schoolchildren were vaccinated against influenza at school in recent seasons. Of those, 55% received LAIV.
The committee was asked to vote on whether to recommend that LAIV not be used at all, or whether it could be used in certain situations in which a person might not otherwise be vaccinated, such as when IIV is not available or when a patient or their parent refuses an injectable vaccine such as IIV.
"Dr Frieden had certainly seen this data before he came this morning. What he tried to focus on was the need to make decisions based on imperfect data, and that, as a science-driven group, you have to make a decision about whether we have actionable data," Nancy Messonnier, MD, director, National Center for Immunization and Respiratory Diseases, CDC, said. Dr Messonnier is an Ex Officio committee member.
"My understanding from the working group deliberations is that despite the fact that there are discrepancies in the data, the working group felt strongly that this data was actionable...where they fell out of consensus was whether that was an absolute, 'you should not use this vaccine,' which is what [the American Academy of Pediatrics] is saying, or whether or not — partly because of some of these programmatic issues, which [the American Academy of Family Physicians] is pointing out — there should be some space where, if clinicians didn't have another option, it was better to give this than nothing," Dr Messonnier explained.
"It's the younger adults and children who tend to get more severe disease with H1N1, which is also the group that the IIV is targeted for," said voting committee member Kelly Moore, MD, MPH, director, Tennessee Immunization Program, Tennessee Department of Health, and assistant clinical professor, Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee. "I would not feel comfortable knowing ahead of time that [LAIV] wouldn't work against that or there is not evidence of effectiveness."
Dr Moore added, "The public looks to us to make recommendation about the best possible vaccine.... We can find other places, other providers for those children to get vaccines if there are individual spot shortages."
The CDC's director must review and approve the committee's recommendation before it becomes CDC policy.
Reasons for Ineffectiveness Unclear
A number of factors can affect how well the influenza vaccine works, and its effectiveness can vary a great deal from season to season. These factors include characteristics of the person receiving the vaccination, the similarity between viruses used in the vaccine and circulating viruses, and which vaccine is being used. LAIV vaccines, which contain live, weakened influenza viruses, can stimulate a stronger immune response than IIV vaccines, which contain inactivated virus.
Vaccines for Children Program
The committee voted (13 yes, 1 no, 1 abstain for conflict of interest) to remove LAIV from the Vaccines for Children (VFC) program. The IIV component of the program will not be changed.
The VFC program is a federally funded program that provides free vaccines to children who are unable to pay for them.
"For VCF vaccines, providers receive those; they don't purchase [or] pay for those. We provide contracts and make doses available to states for the VFC program...we will make vaccines available for children that are covered by the VFC program, and those are the vaccines that providers in the VFC program will get and will be able to administer," Jeanne Santoli, MD, MPH, deputy director, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC, explained.
"[Providers] don't bill for those; they bill for the administration fee, and that will happen as normal, but this is limiting what the formulary will be for the vaccines in the VFC program this year," Dr Santoli added.